In re Hyon: Substantial Evidence Standard Helps Preserve Finding of Obviousness

By Chris Reaves

A recent appeal of a lengthy prosecution ended last week, when the Federal Circuit in In re Hyon, 102 USPQ2d 1889 (Fed. Cir. 2012) upheld the Board of Patent Appeals and Interferences (BPAI) findings that a person of ordinary skill would have reason to combine two references to create the invention at issue.  The Board’s decision, though possibly “flawed,” could not be found unreasonable under the applicable standard of review, emphasizing the challenge that patent prosecutors face in overcoming a factual finding.

Background

The applicants, Suong-Hyu Hyon and Masanori Oka, were granted U.S. Patent No. 6,168,626 on a specific type of “Ultra High Molecular Weight Polyethylene” (abbreviated throughout the patent and the opinion as “UHMWPE”), and on the method for creating these material.  The inventors intended the material to be used for artificial joints although the claims were not limited to this embodiment.  The patent had only eleven claims, with limitations such as thickness of the UHMWPE and orientation of the crystal planes within.

Deciding these limitations were unnecessary, the applicants filed a reissue application (No. 10/643,674) within the two-year window, cancelling the original claims and adding several dozen new claims.  These new claims generally consisted of a method of four steps:

(a) crosslinking an ultra high molecular weight polyethylene block having a molecular weight not less than 5 million by irradiating the block with a high energy radiation at a level of at least 1 MR;

(b) heating said crosslinked block up to a compression deformable temperature below the melting point of the UHMWPE;

(c) subjecting said heated block to pressure; and then

(d) cooling said block.

(All claims to the UHMWPE material itself were eventually cancelled voluntarily.)

The examiner rejected all the reissue claims as obvious over two prior art patents, “Zachariades” and “Kitamaru” (Patent Nos. 5,030,402 and 3,886,056, respectively).  As the applicants acknowledged, Zachariades contained all the steps of the applicants’ claims, but in a different order – irradiation occurred after cooling.  (The exact radiation levels and molecular weights also varied, but not to a degree that the examiner thought relevant, and the applicants did not address this difference before either the Board or the Federal Circuit.)  Kitamaru, meanwhile, used a somewhat different method to prepare UHMWPE for use in films and sheets, but it began the process with an irradiation step.  The examiner found that it would be obvious to take the teaching of Kitamaru, to begin with the irradiation crosslinking, and apply it to Zachariades.

The applicants appealed to the Board of Patent Appeals and Interferences, arguing that there was no motivation to combine the references.  The Board, however, affirmed the rejection, and the applicants appealed again to the Federal Circuit.

Ruling: Board Had Substantial Evidence to Support Finding

The majority opinion, written by Judge Bryson and joined by District Judge Jeremy Fogel (N.D. Cal., sitting by designation), opened by recalling that “existence of a reason for a person of ordinary skill to combine references” is a factual finding, reviewed under the “substantial evidence” standard.

Examining the applicants’ arguments, the majority first rejected the suggestion that the prior art came from “fundamentally different material technologies.”  Both patents spoke to the preparation of UHMWPE products, and although each focused on different embodiments, “[n]either reference limits the structure of the UHMWPE product that can be made”.

The majority also found arguments that Zachariades taught against irradiating before molding, or that the examiner and Board had cherry-picked one aspect of Kitamaru to combine with Zachariades, unconvincing.  Although its claims were limited to irradiating after molding, nowhere had Zachariades stated that the opposite was unfeasible or inadvisable.  More importantly, Kitamaru had emphasized that irradiation before molding was the key to creating desired improvements in UHMWPE, namely “a higher melting or softening point, improved transparency, and excellent dimensional stability.”  Therefore, the suggestion to select that element from the reference was in the reference itself.

Judge Newman, in dissent, found it telling that Kitamaru predated Zachariades (indeed, the former issued over a decade before the latter was filed).  It was therefore “noteworthy that Zachariades, seeking mechanical strength and dimensional stability, did not follow the known Kitamaru processing sequence, but instead crosslinked the polyethylene after deformation”.  Newman found this sufficient to show that a person of ordinary skill would not find the results of the combination predictable; had it been obvious to combine, Zachariades would have already done it in his own patent.  The Board, she concluded, had engaged in impermissible hindsight analysis, “reasoning backward from” the patent at issue to see what Zachariades himself had not.

Analysis: Don’t Directly Challenge a “Reason to Combine” Finding

The majority emphasizes the standard of review in its decision.  “Substantial evidence,” a standard used in review of factual findings by both juries and quasi-judicial agency decisions, requires deference to the Board’s decision unless it was without “such relevant evidence as a reasonable mind might accept as adequate to support [the] conclusion” (Universal Camera Corp. v. NLRB, 340 U.S. 474).  In other words, unless no reasonable fact-finder could come to the same conclusion given the same evidence, the appellate court will affirm.

Given this emphasis, the standard was likely what tipped the court.  The applicants may have presented a sufficiently convincing case under a preponderance standard, but could not show that the Board’s decision was “unreasonable.”  (Notably, the dissent did not mention the standard of review once, merely calling the Board’s reasoning “flawed”.)

The substantial evidence standard reminds prosecutors that the Board hearing is the stage to win questions of obviousness.  A Circuit panel with a clear focus on this standard is highly unlikely to overturn such a finding, so prosecutors should treat the Board as their only chance.  Should that fail, however, a prosecutor can also focus more energy on the meaning of claims, both prior art and present, which are reviewed de novo.  Finally, although expensive, a § 145 civil action can reset the entire record and remove all deference (see the recent Kappos v. Hyatt, 132 S.Ct. 1690), should the applicant be in true need of a do-over.

The opinion is available at: http://www.cafc.uscourts.gov/images/stories/opinions-orders/11-1239.pdf

Oral arguments may be heard at: http://oralarguments.cafc.uscourts.gov/default.aspx?fl=2011-1239.mp3 (NOTE: the Federal Circuit’s oral argument database has been inconsistently accessible as of this article’s posting)

Federal Circuit Reaffirmed Lead Compound Analysis for Evaluating Obviousness of a New Chemical Compound

James Jang

In Otsuka Pharmaceutical Co. v. Sandoz, Inc., 678 F.3d 1280 (Fed. Cir. 2012), the Federal Circuit affirmed the decision of the district court that the patent was not obvious based on prior art evidence, nor the asserted claims were invalid for nonstatutory double patenting.

The Defendants are drug manufacturers who submitted ADNA filings to the Food and Drug Administration (FDA) for an approval to manufacture, use, or sale of generic aripiprazole products. Otsuka Pharmaceutical Corporation brought action against the drug manufacturers for infringement of patent on the compound claimed in Patent No. 5,006,528, aripiprazole, an atypical antipsychotic compound approved by the FDA for the treatment of schizophrenia. The Defendants counterclaimed that the patent was invalid for obviousness and nonstatutory double patenting. The Federal Circuit analyzed three ‘lead compounds’ asserted by the Defendants, unsubstituted butoxy compound, 2,3-dichloro propoxy compound, and OPC-4392 compound. A ‘lead compound’ means “a compound in the prior art that would be most promising to modify in order to improve upon its … activity and obtain a compound with better activity.” Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.d 1350, 1357 (Fed. Cir. 2007). The patents which disclosed the lead compounds, unsubstituted butoxy and 2,3-dichloro propoxy, also disclosed numerous examples of agents useful for the central nervous system, including an antischizophrenia agent.

In its ruling, the Federal Circuit reaffirmed the lead compound analysis, employed in Takeda Chemical Industries and Eisai Co. v. Dr. Reddy’s Labs, 533 F.3d 1354 (Fed. Cir. 2008) for evaluating obviousness of a new chemical compound, which were the first two lead compound cases decided post-KSR. The Federal Circuit explained that the lead compound analysis consists of a two-part inquiry:

First, the court determines whether a chemist of ordinary skill would have selected the asserted prior art compounds as lead compounds, or starting points, for further development efforts . . . . The second inquiry in the analysis is whether the prior art would have supplied one of ordinary skill in the art with a reason or motivation to modify a lead compound to make the claimed compound with a reasonable expectation of success.

The Federal Circuit also noted that for the lead compound selection, mere structural similarity between a prior art compound and the claimed compound is not enough, but it should be guided by the compound’s “pertinent properties.”

Applying this approach, the Federal Circuit rejected the Defendant’s argument that the lead compound analysis applied by the district court was a “rigid” obviousness analysis precluded by KSR because the court assumed that only the most obvious choice could serve as a lead. The Federal Circuit found that after evaluating all of the potential choices available to one of ordinary skill the district court correctly determined that the compounds asserted by the Defendants, unsubstituted butoxy, 2,3-dichloro propoxy, and OPC-4392, would not have been selected as lead compounds. Furthermore, focusing on the pertinent property of the new compound, rather than the structural similarity, Federal Circuit found that two other compounds — clozapine and risperidone — were viable lead compounds because these were the only capable antipsychotic compounds at the time of the invention. The Federal Circuit concluded that the Defendants failed to prove that the patent would have been obvious under 35 U.S.C. § 103.

The ruling in Otsuka Pharmaceutical Co. might be seen as the Federal Circuit’s return to the “rigid” motivation rules precluded by KSR.1 However, It appears that the Federal Circuit attempted to avoid this concern by addressing that to keep with the “flexible” nature of the obviousness inquiry, “the reason or motivation for modifying a lead compound may come from any number of sources and need not necessarily be explicit in the prior art.” This is consistent with the rulings in the previous chemical compound cases after KSR, such as Eisai Co. v. Dr. Reddy’s Labs, where Judge Rader found that the decision in KSR for flexibility would not preclude the Federal Circuit from assessing motivation in the case. Thus, the post-KSR chemical compound cases may imply that the flexible motivation test is still viable.2

“Laundry List” of potential effects is not sufficient to prove the obviousness

The Federal Circuit also rejected the Defendants’ argument that the three lead compounds asserted by the Defendants were known to have antipsychotic activity so that the claimed compound, aripiprazole, would have been obvious to one of ordinary skill. The Federal Circuit found that the patents’ “laundry list” of the potential central nervous system controlling effects, would not have informed one of ordinary skill in the art that the three compounds would have antipsychotic activity.

Nonstatutory Double Patenting

The double patenting doctrine is a judicially created doctrine “precluding one person from obtaining more than one valid patent for either (a) the ‘same invention,’ or (b) an ‘obvious’ modification of the same invention.” In re Longi, 759 F.2d 887, 892. The latter is referred to as the obviousness-type double patenting. The Federal Circuit differentiated obviousness-type double patenting from obviousness under § 103 by addressing that when examining the obviousness-type double patenting in chemical compound cases, the earlier-filed application need not qualify as prior art and “the issue is not whether a skilled artisan would have selected the earlier compound as a lead compound.” However, the Federal circuit rejected the Defendants’ argument that the double patenting never requires identifying the motivation to modify the earlier claimed compound. The Federal Circuit noted that the identification of the reason for modification is an essential part of the question whether the two claimed compounds are “patentably distinct” in the obviousness-type double patenting analysis.

In concluding that the asserted claims were not invalid for obviousness-type double patenting, the Federal Circuit also noted that predictability is an important element to consider in the obviousness analysis. The Federal Circuit held that given the high degree of unpredictability in antipsychotic drug discovery at the time of the invention, “the prior art would not have provided a skilled artisan with a reason to make the necessary structural changes.”


1. Mark D. Janisal, Tuning the Obviousness Inquiry After KSR, 7 Wash. J. L. Tech. & Arts 335 at 344-45 (2012), available at http://digital.law.washington.edu/dspace-law/bitstream/handle/1773.1/1125/7WJLTA335.pdf?sequence=4.

2. Id. at 342-44.

Board of Patent Appeals and Interferences Rules on Indefiniteness of the Term “Substantially Filled,” Prima Facie Obviousness in an Engine Cooling Method

By Charles Pierce

In Ex Parte Evans et al. (Appeal 2011-004119; Application serial no. 11/823,993), the Board of Patent Appeals and Interferences reversed examiner rejections under 35 U.S.C. § 112 for indefiniteness, and 35 U.S.C. § 103(a) for obviousness.

Claim 1 of the patent states:

A method for cooling an internal combustion engine using a reduced toxicity, ethylene glycol and water based heat transfer fluid, said method comprising the steps of:

(a) formulating a heat transfer fluid comprising (1) a glycol component consisting of ethylene glycol and propylene glycol, wherein the weight of the propylene glycol is between 5% less to less than 30% of the total weight of the glycol component and wherein the glycol component is less toxic than 10,000 mg/kg on an acute LD50(rat) oral toxicity basis, and (2) water, wherein the water comprises between 40% and 70% by weight of the total weight of the heat transfer fluid; and

(b) substantially filling the cooling system of the internal combustion engine with the heat transfer fluid such that the heat transfer fluid absorbs heat that is produced by the internal combustion engine and releases the absorbed heat to the atmosphere. (emphasis added).

The examiner rejected this claim reasoning that because the term “substantially” is not defined, the specification does not sufficiently describe the invention such that a person of ordinary skill in the art would be reasonably apprised of its scope.  The board disagreed.  They noted that “substantially” was used to describe how much a cooling system should be filled, and any person skilled in the art would know what can be considered substantially filled.  The term “substantially” was used to avoid a strict measurement,  because slight variations in the amount of fluid may still be considered to have filled a cooling system.  The board decided that the claim was sufficiently definite.

The board also disagreed with the examiner’s obviousness rejections.  The examiner’s rejection was that the claims were prima facie obvious.  The board noted that no reference disclosed the weight range of the propylene glycol in the glycerol component, or the weight range of the glycerol in the polyhydric alcohol component.  Because the references also disclosed only the components of the invention, the board ruled that they were not enough for a person of ordinary skill in the art to create the claimed cooling method.

Federal Circuit finds Patent Obvious in view of Common Sense despite Objective Evidence

In Wyers v. Master Lock Co., 95 USPQ2d 1525 (Fed. Cir. 2010), plaintiff Philip W. Wyers (Wyers) sued defendant Master Lock Company (Master) for infringement of its patents for hitch pin locks.  Hitch pin locks are typically used to secure draw bars or tow-ball mount to a hitch receiver attached to a motor vehicle.  Wyers’ patents describe a barbell-shaped lock with a stop portion on one end, a locking head on the other end, and a shank portion which passes through the aligned apertures of the hitch receiver and the tow-ball mount.

The use of barbell-shaped locks and locks on trailer hitch receivers was well known in prior art.  Specifically, the prior art had examples of locks with a lock head, a shackle having a stop member, a shank, and a latch.  Moreover, the prior art also had examples of barbell-shaped locks being used as a trailer hitch receiver lock.

Wyers’ patents claim improvements to the prior art locks; mainly a removable sleeve to increase the shank’s diameter.  The removable sleeve allows adjusting the diameter of the shank which can be used with trailer hitch receivers of different apertures sizes.  The patent claims also include an external seal designed to protect the locking mechanism from contaminants.

At the trial level, the two main questions the court asked were “whether the use of the removable sleeve to adjust the operative thickness of a shank would have been obvious;” and “whether Master Lock presented clear and convincing evidence that the use of the external flat flange seal would have been obvious.” JMOL Order, 2009 WL 1309774 at 3 and 5.  The district court found held that plaintiff’s patents were not obvious and awarded $5.35 million in damages, $1.1 million in interest, and a 24% royalty for any infringing products Master sold based on Wyers’ patent.

On appeal, the parties agreed that the case turned on whether the claims were obvious based on prior art.  The court said that the issues in dispute were, “(1) whether the prior art references are in the same field of endeavor as the patented invention; (2) whether there was sufficient motivation to combine the references; (3) the existence and significance of pertinent secondary considerations.”

In reviewing the first question, the Federal Circuit noted that the test of whether the art is from the same field of endeavor is “(1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Comaper Corp. v. Antec, Inc., 596 F.3d 1343, 1351 (Fed. Cir. 2010) (quoting In re Clay, 966 F.2d 656, 658-59 (Fed. Cir. 1992)).”  The Federal Circuit noted that the jury at the trial court applied the wrong standard.  The correct standard is whether a person of ordinary skill in the field of locksmithing would find this improvement to be obvious, not the standard of a layman on a jury.  The appellate court, also said the prior art was relevant because the prior art was within the “same field of endeavor.”  The prior art was directed towards trailer-towing applications, as were most of Wyers’ patents.

On the second question as to whether there was motivation to combine the adjustable sleeve with the prior art barbell locks and whether there was motivation to combine the prior art locks with an external sealing mechanism, the Federal Circuit noted that the test is no longer strictly one of express motivations to combine.  KSR International Co. v. Teleflex, Inc., 550 U.S. 398 (2007).  “Common sense” is one standard when looking for a reason to combine references.  Moreover, the Federal Circuit noted that, while the facts supporting obviousness are to be determined by a jury, the ultimate question of whether the facts support “common sense” or reasons to make combinations are susceptible to resolution at summary judgment and motions JMOL.

In applying this standard, the Federal Circuit said that sleeves were used in prior art in a towing arrangement similar to a hitch receiver/tow bar arrangement, and could be combined with a barbell-shaped hitch pin lock in order to address different aperture sizes in standard hitch receivers.  In addition, the Federal Circuit noted prior art in the Down patent that “sleeves of different external diameter may be provided for the attachment of trailer towing eyes of different internal diameter.  When the sleeve is used, the pin accommodates larger diameter towing eyes; without the sleeve, the pin fits smaller ones.”    Thus, a person of ordinary skill in the art of locksmithing would have been likely put these two designs together.

The Federal Circuit concluded that “it was a mater of common sense to combine the Down patent with the prior art barbell locks in order to arrive at the invention claimed in the [Wyers’ patents], and that one of ordinary skill in the art would have had a reasonable expectation of success in doing so.”

Furthermore, the Federal Circuit noted that “it is a matter of common sense that a flat external seal used in the prior art padlocks could be combined with a barbell-shaped hitch pin lock.”  This is because prior to Wyers’ filing, the concept of using external or internal seals to protect a lock’s head from contaminants, was widely known.

Lastly, in evaluating the effect of secondary considerations, the Federal Circuit noted that for objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention. In re Huang, 100 F.3d 135 (Fed. Cir. 1996); In re GPAC Inc., 57 F.3d 1573 (Fed. Cir. 1995).  Here, plaintiff could not prove that Master’s $20 million in sales of the accused product were the result of any of the supposed features of Wyers’ patents.  Further, there was no evidence of copying of Wyers’ design.  Thus, any secondary considerations here can not overcome a strong prima facie case of obviousness, as was the case here.

Significance for Patent Applicants and Owners

Rejections under 35 U.S.C. §103 using common sense as a basis are particularly perplexing for patent practitioners as what constitutes common sense appears to be a subjective test.  As is evident from the Federal Circuit’s analysis, the use of common sense is based upon an analysis of prior art within the record.  While such a robust record is expected in inter partes proceedings, however, it is unclear as to how Patent Examiners performing examination in an ex parte process would be able to develop a sufficient record to substantiate a prima facie burden.  Moreover, the United States Patent and Trademark Office has not provided examples of how such a conclusion would be made in its proposed Examination Guidelines Update: Developments in the Obviousness Inquiry After KSR v.Teleflex, Fed. Reg. Vol. 75, No. 169, pp. 53643 (September 1, 2010).  Thus, patent applicants should be mindful that, when faced with a rejection based upon common sense, the Examiner must still provide evidence supporting this conclusion and require this evidence as grounds of traversing the rejection.

 

Federal Circuit Finds Well Known But Undefined Claim Element Definite and Evidence of Copying a Secondary Consideration for Non-obviousness

Power-One, Inc. v. Artesyn Technologies, Inc., Docket No. 08-1501 & -1507 (Fed. Cir. March 30, 2010), Power-One, Inc. (“Power-One”) owns U.S. Patent No. 7,000,125 (the ‘125 patent).  The ‘125 patent relates to power supply systems which control, program and monitor point-of-load (POL) regulators. Each of the claims recites the use of POL regulators, but the specification does not specifically define the term “POL regulator”.

Artesyn Technologies, Inc. (“Artesyn”) sells a competing power control system, which Power-One asserts infringes the ‘125 patent.  At trial, the District Court defined the term “POL regulator” to be a “dc/dc switching voltage regulator designed to receive power from a voltage bus on a printed circuit board and adapted to power a portion of the devices on the board and to be placed near the one or more devices being powered as part of a distributed board-level power system.”  Based upon this definition, the jury found that the ‘125 patent was a valid patent, and that Artesyn infringed the ‘125 patent.

On appeal, Artesyn contended that the District Court’s definition of the POL regulator was unduly broad and that the term is indefinite.  Moreover, Artesyn appealed the District Court’s decision that the ‘125 was non-obvious.

Undue Breadth of District Court Definition

On the issue of whether the District Court’s definition was unduly broad, the Federal Circuit first cited to Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) for the rule that claim terms are “generally given their ordinary and customary meaning,” which is the meaning “a person of ordinary skill in the art . . . at the time of the invention” would give to a particular claim term.  In reviewing the specification, the Federal Circuit noted that the definition of POL regulator was supported by the intrinsic record.  Importantly, the Federal Circuit found that the definition adopted by the District Court provided sufficient meaningful guidance to the jury as to be definite and not unduly broad.  Specifically, the Federal Circuit has found that the terms “adapted to” and “near” can be definite, and the District Court was entitled to utilize these terms without rendering the resulting definition unduly broad as these terms are understandable in light of the ‘125 patent specification.  As noted by the Federal Circuit, “[t]he fact that the claim is not defined using a precise numerical measurement does not render it incapable of providing meaningful guidance to the jury because the claim language, when taken in context of the entire patent, provides a sufficiently reasonable meaning to one skilled in the art of distributed power systems.”

Definiteness of Undefined, Well-known Claim Term

Consistent with this holding, the Federal Circuit also found that the term “POL regulator” was definite for purposes of 35 U.S.C. §112, paragraph 2.  In making this determination, the Federal Circuit outlined the test for definiteness as being whether the claim boundaries are discernible to a skilled artisan based on the language of the claim, the specification, and the prosecution history, as well as the artisan’s knowledge of the relevant field of art. See Halliburton Energy Servs., Inc. v. M-1 LLC, 514 F.3d 1244, 1249-51 (Fed. Cir. 2008).”  The mere fact that the claim term may be difficult to understand or subject to some disagreement is not enough to find a claim indefinite.  Exxon Research & Eng’g Co. v. United States, 265 F.3d 1371, 1373 (Fed. Cir. 2001) (“if the meaning of the claim is discernible, even though the task may be formidable and the conclusions may be one over which reasonable persons will disagree, we have held the claim sufficiently clear to avoid invalidity on indefiniteness grounds.”).

In applying this standard, the Federal Circuit found that the intrinsic record did support the recited term “POL regulator”.  Specifically, the Federal Circuit found that the intrinsic record showed that POL regulators are well known devices in the field.  Since one of ordinary skill in the art would understand what a POL regulator does and how it operates, the Federal Circuit upheld the District Court’s decision that the term “POL regulator” is definite despite any express definition in the specification.

Nonobviousness of claims

On the issue of obviousness, the Federal Circuit upheld the District Court’s decision that the ‘125 patent was nonobviousness.  During trial, Artesyn asserted that the ‘125 patent was obvious based upon seven pieces of prior art, and testimony of its expert.   Power-One provided its own expert, as well as secondary considerations of non-obviousness.  The Federal Circuit found that the jury was entitled to credit Power-One’s expert at the expense of Artesyn’s expert on the issue of obviousness.

Further, the Federal Circuit noted that Artesyn’s primary argument was that each of the recited elements were known in the prior art.  In rejecting this argument, the Federal Circuit quoted the Supreme Court for the proposition that “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements is, independently, known in the prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).  As such, to show obviousness, there needs to be evidence as to why the known arguments would have been combined.

Lastly, the Federal Circuit noted that the jury was entitled to take into account secondary considerations.  Specifically, Power-One put into evidence that Artesyn had copied Power-One’s patented design, which Artesyn then touted as an advancement in the industry on introduction of its copied product.  According to the Federal Circuit, “Artesyn’s contemporaneous reaction to Power-One’s invention, and the industry’s reaction, demonstrate the unobviousness of the invention disclosed in the ’125 patent.”  See Allen Archery, Inc. v. Browning Mfg. Co., 819 F.2d 1087, 1092 (Fed. Cir. 1987) (praise in the industry for a patented invention, and specifically praise from a competitor tends to “indicat[e] that the invention was not obvious”).  As such, the evidence of copying, as well as Artesyn’s own advertising represented an admission usable as a secondary consideration of nonobviousness.

Significance for Patent Owners and Applicants

In Power-One, the Federal Circuit provides a reminder that tests such as definiteness under 35 U.S.C. §112 and obviousness under 35 U.S.C. §103 are primarily factual inquiries to be based upon evidence, not formulaic rules.  Thus, claim terms are not rendered indefinite merely because they are undefined specifically in the specification so long as there is evidence that one skilled in the art would understand the meaning of the term.  Moreover, merely because each claim element is known does not render a claim obvious without evidence as to why the particular recited combination would be made.  Lastly, it is interesting to note that the Federal Circuit based its nonobviousness ruling, at least in part, on the fact that the infringer had copied the patented design as evidence of copying is not classically considered a secondary consideration.

Federal Circuit Clarifies Use of “Common Sense” under KSR

Federal Circuit Confirms the Need For Evidence to Support Use of Common Sense During Obviousness Determinations

In Perfect Web Techs. v. InfoUSA, Inc., 92 U.S.P.Q.2d 1849 (Fed. Cir. 2009), the Federal Circuit expounded on the use of common sense in the determination of obviousness under 35 U.S.C. § 103(a).  The Supreme Court looked favorably upon the use of a common sense approach in KSR International Co. v. Teleflex Inc., 127 S.Ct 1727;  82 USPQ2d 1385 (2007) decision.  The Federal Circuit, in Perfect Web Techs. v. InfoUSA, Inc. relied upon that decision in finding that a bulk E-mailing patent was obvious in light of the prior art reference and the common sense of a person of ordinary skill. Continue reading

Federal Circuit Reverses BPAI Anticipation and Obviousness Rejection for Insubstantial Evidence

Also Finds Time to Appeal Begins From the Mailing Date as Opposed to Date Printed On Opinion

In In re McNeil-PPC, Inc., 91 USPQ2d 1576 (Fed. Cir. 2009), McNeil owns U.S. Patent 6,310,269, which claims a tampon for feminine hygiene with a solid fiber core, where the core is denser than the radially projecting “ribs” and the ribs are narrower at their base than at their distal end.  McNeil requested that the PTO re-examine its patent on the basis of unexamined Japanese application No. 55-168330 by Tetsu Sasaki (hereinafter “Sasaki”).  Sasaki discloses the process of making a tampon blank via stitching layers of material and then molding the blank into a finished tampon.  The Examiner rejected claims 1 and 3 as anticipated by Sasaki and claim 4 as obvious over Sasaki.  McNeil appealed to the Board of Patent Appeals and Interferences (BPAI), arguing that Sasaki failed to disclose key elements of his claim (the relative densities and coarseness of the core and ribs on the tampon, and ribs that were narrower at the base than at the proximal end).

The BPAI affirmed the Examiner’s rejection and denied McNeil’s request for a rehearing.  The date of the Board’s decision was May 30, 2008.  The date of mailing, as per the mailing sheet for the order, was June 2, 2008.  Further, the online “Transaction History” for the re-examination contains two entries both dated May 30, 2008: “Mail BPAI Decision on Reconsideration – Denied” and “Dec on Reconsideration – Denied.”  Finally, the image file wrapper (hereinafter “IFW”) lists the “Mail Room Date” of the decision as June 2, 2008.  McNeil filed the notice of appeal to this court on August 1, 2008.  The Director responded that the appeal was untimely because it was filed more than sixty days after the Board made its final decision on May 30, 2008.

Patent Owner’s Appeal was Timely As Measured from Mailing Date

Before turning to the merits of the case, the Federal Circuit addressed the issue of the timeliness of McNeil’s appeal.  The Federal Circuit first stated that it could not grant extensions of time for an appeal (citing In re Reese, 359 F.2d 462, 463 (CCPA 1966) (per curiam)).  The Court noted that Congress gave the Director authority to set the timing for an appeal in 35 U.S.C. § 142, allowing the Director to prescribe a time no less than 60 days after the date of decision during which the appellant could appeal the decision of the BPAI.  Accordingly, the Director set a time for appeal, if a request of rehearing or reconsideration had been made to the Board, as within two months after action on the request.  (37 C.F.R. § 1.304(a)(1)).

The Court held that the issue of timeliness hinged on whether the Date of Decision was the date of decision noted on the Board’s decision, or the date that the decision was mailed to the applicant.  The Federal Circuit then opined that there was little information to guide the Court as to whether to attribute meaning to the date of decision appearing on the Board’s written decision.  The Court stated that the Director failed to explain the Board’s internal procedures for issuing opinions, or whether the June 2, 2008 mailing date reflects the first time that the decision was released to the public.  The Federal Circuit did take into account an unchallenged declaration from a now-retired member of the Board Jeffrey Nase, which was presented by McNeil.

The Federal Circuit summarized Nase’s declaration as follows.  Historically, the date that the PTO mailed a document was the date that triggered a response period.  Before August 2006, the date decided was hand-stamped on the front of opinions.  In August 2006, the Board began to have the decision date typed on the front of opinions.  Nase found it to be unclear why the date on the opinion and the mail date differed, unless the mail room was slow or a member of the Board panel had decided to revise or reconsider the opinion over the weekend of May 31 and June 1, 2008.  Nase opined that if the PTO had intended this minor formatting change to have substantive effect, there would have been public notice of the change (which there was not).

The Court noted the PTO’s argument that it would be contrary to the language of both 35 U.S.C. § 142 and 37 C.F.R. § 1.304(a)(1) to deem the date of the decision to be the date that the order was mailed.  However, the Court dismissed this argument as superficial due to the import of the inner workings of the agency.  Rather, the Federal Circuit asserted that, based upon the evidence, only when an opinion is released to the public is it truly decided and safe from possible revision.  The Court did note that the PTO’s position was supported by the entries on the “Transaction History” page indicating that the case was decided and opinion mailed May 30, 2008.  However, the Court found that the parties do not dispute that the decision was mailed on June 2, 2008, making the “Transaction History” date both inaccurate and moot.

The Federal Circuit also dismissed the PTO’s reliance on an unpublished order, Barbacid v. Brown, 223 F. App’x. 972 (Fed. Cir. 2007).  In the opinion, the Federal Circuit held that the PTO’s failure to mail its decision to Barbacid when mailing the opinion to the other party did not abrogate the untimeliness of Barbacid’s appeal.  There, the Federal Circuit stated that “[T]he time is not measured from the date of receipt of the Board’s decision but from the date of the decision itself.” However, this Court noted that the opinion did not specify what “the date of the decision” was.  Further, the Federal Circuit noted that Barbacid’s appeal was so late that a few days would not have impacted the timeliness of his appeal. 

The Federal Circuit held that the instant appeal was timely for several reasons.  First, the Court noted that the “Transaction History” page appeared inaccurate and Nase’s declaration provided the most plausible explanation for the conflicting evidence of the action taken on by the Board in response to McNeil’s request for reconsideration.  Further, the IFW entry corroborates the fact that action was taken on June 2, 2008, instead of May 30, 2008.  Thus, the Federal Circuit held that the Board decided this case on June 2, 2008, the date of mailing, making McNeil’s appeal timely.

BPAI’s Anticipation and Obviousness Decision Not Supported By Substantial Evidence

Next, the Federal Circuit turned to the merits of the case.  The Court stated that the standard of review would be one of substantial evidence to support the Board’s determination. (citing In re Graves, 69 F.3d 1147, 1151 (Fed. Cir. 1995)).  The Federal Circuit noted, with added emphasis, that McNeil’s claim 1 (which was chosen as representative of the other claims), was for a tampon for feminine hygiene that comprised an absorbent portion having a “generally cylindrical compressed, solid fibre core from which longitudinal ribs extend radially outward,” where each of the ribs has a proximal end attached to the fibre core, “is compressed less than the fiber core, thereby having a coarser capillary structure than the fibre core,” and is separated from adjacent ribs at the proximal end “by an amount greater than such rib is separated from an adjacent longitudinal rib proximate the distal end.”

The Board had found that Sasaki taught all the limitations of claim 1.  Upon review of the Board’s findings, the Federal Circuit was unsure if the Board understood McNeil’s claim.  First, the Court observed that the Board equated McNeil’s limitation of a tampon “each of the ribs is compressed less than the fiber core, thereby having a coarser capillary structure than the fibre core” with Sasaki’s Figures 8 and 10, which the Board found to reasonably depict the ribs of a tampon “as being compressed less at their distal ends than at their ends proximal to the drawstring at the center of the drawn fiber strips.” (emphasis added by the Court).  The Court noted that the claim required the ribs to be less dense than the core, not the distal ends of the ribs to be less dense than their proximal ends. 

The Federal Circuit failed to find any evidence in Sasaki of the relative compression of any portion of Sasaki’s tampon.   The Court found that Figure 6, which showed relative compression of the strips of absorbent material, depicted a tampon blank, not a finished tampon.  The Court noted that Figures 7 and 8 of Sasaki, which depicted a finished tampon, did not disclose any evidence a core that is denser than the ribs of the tampon.  Further, the Federal Circuit stated that the PTO failed to explain how the change in shape from the tampon blank to the finished tampon necessarily made the ribs less dense than the tampon core.   The Federal Circuit noted that the Board’s initial decision stated that “compressed masses [are] formed at equal intervals along the axial line direction on the outside circumferential surface of the tampon.” However, the Court found that Sasaki made no comparison between the “compressed masses” and a core.  Further, the Court observed that it was not clear that Sasaki even disclosed a “core,” pointing to Sasaki’s Figure 8 to show that Sasaki’s tampon was composed of six ribs and no core.  The Court held that there was not substantial evidence (or even any evidence) that Sasaki disclosed ribs “compressed less than the fiber core” or “a generally cylindrical compressed, solid fibre core.”  Thus, the Federal Circuit reversed the Board’s rejections based on Sasaki.

The Federal Circuit also dismissed the PTO’s argument that McNeil waived arguments about Sasaki’s lack of a “generally cylindrical compressed, solid fibre core” and “coarser capillary structure than the fibre core.”  Specifically, the PTO asserted that it waived arguments regarding Sasaki’s lack of a core because McNeil, in its appeal brief, argued only that two key elements (relative rib compression and spacing from adjacent ribs) were missing from Sasaki.  The Federal Circuit disagreed, noting that McNeil included arguments about the core in its brief.  Thus, McNeil did not have to explicitly assert that the core was missing from Sasaki, because the brief mentioned in passing that “Sasaki does not disclose, teach, or suggest a tampon, wherein ‘each of the ribs is compressed less than the fiber core, thereby having a coarser capillary structure than the fibre core.’” (emphasis added).

The Court noted that the Sasaki figures also failed to disclose any relative coarseness of different portions.  Further, the Court stated that the lack of a core was discussed earlier in the opinion.   The Court also observed that Figure 8 showed some spacing between the bottommost ribs, and arguably disclosed spacing between other ribs.  However, the Court noted that this disclosure of Sasaki did not overcome the failing of Sasaki to teach the other features of McNeil’s invention.  The Court held that it was not clear that Sasaki disclosed “a core nor which portions of Sasaki’s tampon the Board considered to be the ribs and which the Board considered to be the core.”  The Court stated that there was not substantial evidence to support the Board’s determination that Sasaki disclosed ribs separated from each other “at the proximal end by an amount greater than” at “the distal end.” Thus, the Court reversed the Board’s rejections of claims 1, 3 and 4 for lack of substantial evidentiary support.

The Federal Circuit held that McNeil’s appeal of his rejection at the BPAI was timely because it was within two months of the date that the decision was mailed to him.  Further, the Federal Circuit reversed the Board of Patent Appeals and Interferences’ rejection of claims 1, 3 and 4 of McNeil’s re-examination application for lack of substantial evidentiary support based on the lack of the prior art’s disclosure of a fibre core, which was mentioned but not explicitly disputed by the appellant.

Judge Dyk’s Dissent

The dissent disagreed with the majority’s opinion with regards to timeliness only.  Specifically, it observed that the decision of the BPAI clearly stated on its face that it was decided May 30, 2008.  The dissent found that because McNeil did not appeal until August 1, 2008, two days after the regulatory period for review from a decision of May 30, 2008, the appeal was untimely filed and should not have been granted jurisdiction.   The dissent noted that the jurisdiction of the Federal Circuit is statutorily limited by the timeliness regulations of the PTO, and quoted 35 U.S.C. § 142 to show that an appeal must be filed within such time as prescribed by the Director after the date of the decision from which the appeal is taken.  The dissent also cited to the Supreme Court, which stated that statutorily limited times for filing a notice of appeal are “mandatory and jurisdictional.” Bowles v. Russell, 551U.S. 205, 127S. Ct. 2360, 2363 (2007).

Next, the dissent noted that 35 U.S.C. § 142 sets forth a time for filing the notice of appeal as within two months after action on the request for rehearing or reconsideration.  The dissent asserted that the notice accompanying the promulgation of 35 U.S.C. § 142 characterized the relevant date as the date of “decision on reconsideration.”  54 Fed. Reg. 29,548, 29,550 (July 13, 1989). The dissent then observed that the majority also correctly noted that the term “action on the request” has the same meaning in this context as “date of the decision” and that the issue was what the phrase “date of the decision” means.

The dissent then reviewed the four sources for dates referenced by the parties in the case (the date of decision on the Board’s opinion, the PTO’s online Transaction History, the IFW wrapper entry of the “Mail Room Date”, and a “mailing sheet” attached to the paper copy of the opinion when mailed to McNeil).  The first two sources refer to a date of May 30, 2008, while the last two reference June 2, 2008.  The dissent notes that the only dispute is about which of these dates represents the “date of decision” as reflected in the statute and regulations.  

The dissent held that the majority’s view that the “date of decision” is the date of mailing instead of the date of decision as clearly written on the opinion is contrary to the plain language of the regulation and against precedent interpreting the nearly identical language of 35 U.S.C. § 142’s predecessor rule.  It observed that the only reason for the majority to reject May 30, 2008 was its theoretical concern that the Board could change the decision at some point after the “Decided” date was affixed to the decision before the decision was mailed.  However, the dissent notes that no evidence of such revision exists.  Further, the plain language of the statute and regulation state that the relevant date is the “date of decision,” not the date of mailing.  In adopting these regulations and statutes, the dissent notes that both the PTO and Congress rejected the date of mailing as determinative.  The dissent then pointed to examples in which the PTO explicitly used and prescribed the mailing date as determinative for setting a time limit for action.  (citing 37 C.F.R. § 1.181(f); § 1.97(c); and § 2.105(a)).

The dissent then pointed to precedent that rejected the majority’s approach.  Specifically, the dissent cited Burton v. Bentley, 14 App. D.C. 471 (C.A.D.C. 1899), in which the Court of Appeals (a predecessor of the District Court of D.C.) addressed the time for appealing a decision of the PTO when the decision date and mailing date differed.  At that time, the prior rule required that appeals from the Patent Office “shall be taken within forty days from the date of the ruling or order appealed from, and not afterward.” (emphasis added).  The court in Burton held that the relevant date was the date that the order was made and signed by the deciding official, and that a delay in mailing the order was irrelevant to the date of decision. The Court of Appeals asserted that the terms of the rules must be allowed their “ordinary meaning and import.”  The Court held that to allow the time limit to be computed from any other act or event other than the date of the order appealed from would be violative of the rule. 

The dissent agreed with the court’s view in Burton, and provided further support for its position from In re Reese. There, the Court of Customs and Patent Appeals (a predecessor of the Federal Circuit) asserted that the “date of the decision appealed from” was the date of the decision on the petition.  In re Reese, 359 F.2d 462, 463 (CCPA 1966).  The dissent also pointed to Barbacid v. Brown, in which the Federal Circuit held in a non-precedential decision that “the time for filing the appeal to this Court is two months from the date of the decision of the Board. The time is not measured from the date of receipt of the Board’s decision but from the date of the decision itself.”  Barbacid v. Brown, 223 F. App’x 972, 973 (Fed. Cir. 2007).  The Federal Circuit rejected the mailing date as determinative of the appeal time limit, despite the appellant’s allegation that he had never been mailed a copy of the decision because of an error by the Board. 

The dissent then pointed out that the existence of any delay in mailing a decision does not impose an unfair burden on the parties because of the lengthy period for appeal and the Board’s ability to extend the time for appeal in situations where there has been excusable neglect.  (citing 37 C.F.R. § 1.304(a)(3)(ii)).  The dissent noted no allegations of inadequate time to prepare an appeal by the appellant.  Thus, the dissent held that because the date of decision in this case was May 30, 2008, the Federal Circuit did not have jurisdiction to review because of the untimely notice of appeal filed August 1, 2008, and advocated dismissal of this appeal.

Significance to Patent Applicants

For practitioners, In re McNeil-PPC presents a useful combination of practical issues.  In regards to timing for response, it is common for the date of decision (either for Board opinions as well as for office actions) to be substantially different from dates on which the opinions or office actions are mailed.  Even when receiving electronic notifications of office actions, there is generally a lag of one to three days between when the Examiner or Board has made their decision (and had their decision counted in the USPTO’s internal system), and the date on which that decision is communicated to the applicant.  The Federal Circuit In re McNeil-PPC confirmed what most practitioners had assumed (and hoped was true) in that the response dates are counted from the notification or mailing date as opposed to the date of decision.

Additionally, patent applicants should be interested in the requirements for substantial evidence as set forth in In re McNeil-PPC.  A common problem in attempting to respond to an Examiner’s action is that it is unsupported by evidence.  Without evidence, it becomes difficult to supply rebuttal evidence as opposed to simply contrary arguments.  In re McNeil-PPC provides a reminder that the USPTO is required to provide evidence in order to maintain a prima facie rejection based upon prior art.

 

Federal Circuit Finds Obviousness Despite Evidence of Commercial Success

In Ritchie v. Vast Resources, Inc., 563 F.3d 1334 (Fed Cir. 2009), Steven D. Ritchie and H. David Reynard own a medical device patent, U.S. Patent No. Re 38,924, which is a reissue of U.S. Patent No. 6,132,366 (hereinafter the ‘924 patent).  They also own a device manufacturer, Know Mind Enterprises, that manufactures medical devices for sexual purposes.  The defendant, Vast Resources, Inc., owns Topco Sales, a manufacturer producing the same category of medical devices.  The devices manufactured by the two parties are generally shaped into a rod made of rubber, plastic, glass or other similar materials or a combination of such materials.  Prior to the plaintiff manufacturing the device of the ‘924 patent, such glass devices were typically manufactured from soda-lime glass.  However, the plaintiff manufactures such devices using an “oxide of boron” or borosilicate glass as the ‘924 patent claims a device “fabricated of generally lubricious glass-based material containing an appreciable amount of an oxide of boron to render it lubricious and resistant to heat, chemicals, electricity and bacterial absorptions.” 

The plaintiffs sued Vast Resources for patent infringement.  Plaintiff offered evidence of commercial success as evidence of nonobviousness, but did not otherwise offer evidence of nonobviousness.  The U.S. District Court, Middle District of Florida, found the patent valid and ruled in favor of the plaintiffs.  The defendants appealed the decision, challenging the patent’s validity and the plaintiffs cross-appealed on the matter of the amount of relief the District Court granted.  The Federal Circuit Court, hearing the appeal, reversed the District Court judgment with instructions to dismiss the suit. 

The Federal Circuit Court only considered whether the invention of the ‘924 patent would have been obvious to a person of ordinary skill in the art, as per 35 U.S.C. §103(a).  In analyzing the claimed invention of the ‘924 patent, the Federal Circuit looked at the use of and features attributed to borosilicate glass, which in the device of the ’924 patent is substituted for soda-lime glass as compared to the conventional art.  Specifically, since it was not contested as to the well known nature of each component in the claimed invention, the Federal Circuit focused on the use and features of the substituted element, the borosilicate glass, and the effect of evidence of commercial success as evidence of nonobviousness when using well known components. 

As an initial point, the Federal Circuit interpreted “lubricious” to include borosilicate glass, which is smoother than soda-lime glass, and thus, the borosilicate glass becomes slippery with less lubricant when compared to soda-lime glass.  The Federal Circuit noted that the term “appreciable amount,” as recited in the ‘924 patent, while vague, can be interpreted and defined to mean an amount of boron oxide usually found in borosilicate glass.  As such, the amount of boron oxide would be known to those of ordinary skill in the art.

Since no other evidence was contested related to obviousness, the Federal Circuit focused on the extent to which commercial success, which was not contested, is useful for showing nonobviousness.  In discussing the commercial success of the invention of the ‘924 patent, the Federal Circuit noted that borosilicate glass has been used in glassware for nearly 100 years as Pyrex glassware, manufactured by Corning, Inc. (previously Corning Glass Works).  AlthoughCorningnow also manufactures Pyrex using tempered soda-lime glass, borosilicate glass has been used in the glassware market since in 1893, when borosilicate glass was invented.  The Federal Circuit acknowledged that borosilicate glass has the properties recited in the ‘924 patent, and this fact was not contested on appeal.  The Federal Circuit also stated that even if the device is useful due to the recited properties, the invention would not be patentable as it was obvious “to a person having relevant technical skills.” 

The Federal Circuit noted that because the device of the ‘924 patent has commercial value, to call the device obvious “may seem the triumph of hindsight over insight.”  However, because borosilicate glass has been commercially available and used since 1893 and was otherwise very well known, the Federal Circuit proceeded to weigh whether commercial success was an indicator of nonobviousness as per the ‘924 patent. 

The Federal Circuit acknowledged that commercial value is an indicator of nonobviousness (citing Graham v. John Deere, 383 U.S. 1, 17-18 (1966); Simmons Fastener Corp. v. Illinois Tool Works, Inc. 739 F.2d 1573, 1575-76 (Fed. Cir. 1984)).  However, this evidence can work both ways.  Where an invention with commercial value appears on the market soon after the idea or impetus behind the invention appears, this is evidence of obviousness.  In contrast, the delayed appearance of the invention on the market, despite the commercial value, is evidence that an invention was not obvious.  Nonetheless, commercial success is considered as a “secondary” indicator of nonobviousness.  The Federal Circuit cited Graham v. John Deere Co., supra, 383 U.S. at 18; Richardson-Vicks Inc. v. Upjohn Co., 122 F.3d 1476, 1483-84 (Fed. Cir. 1997)), as per commercial success being a secondary indicator and noted that commercial success is reliant upon many factors unrelated to patentable inventiveness, such as the marketing of a product or invention.  Thus, commercial success is not sufficient in and of itself to show nonobviousness. 

Also, the Federal Circuit stated that inventions deemed obvious are those that are “modest, routine, everyday, incremental improvements of an existing product or process that confer commercial value…but do not involve sufficient inventiveness to merit patent protection.”  The Court went on to state that “[t]his class of inventions in well illustrated by efforts at routine experimentation with different standard grades of a material used in a product—standard in the sense that their properties, composition, and method of creation are well known…This is such a case.”  As per the recitation of “an appreciable amount of an oxide of boron,” the Federal Circuit Court noted that the ‘924 patent “does not claim any variant of off-the-shelf borosilicate glass.”  Furthermore, the Court stated that because borosilicate glass is a standard product with well known properties, substituting borosilicate glass for ordinary glass, in the device category of the ‘924 patent, “was not a venture into the unknown.” 

The Federal Circuit Court went on to state that the present case exemplifies the Supreme Court’s analysis in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), wherein the Supreme Court stated:

“[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one.  If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability.  For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Id.at 417.  

The Federal Circuit stated that the final sentence of the above quotation describes the present case, and further quoted the Supreme Court, which stated that a court need not “seek out precise teaching directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.”  Id at 418. 

With respect to supporting the Federal Circuit’s statement as per inventions that are “incremental improvements of an existing product or process that confer commercial value…but do not involve sufficient inventiveness to merit patent protection,” the Federal Circuit cited cases involving substitution of one feature or element for another.  The cases the Federal Circuit cited include Hotchkiss v. Greenwood, 52 U.S. (11 How.) 248 (1851), Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1535-38 (Fed. Cir. 1983) and Brunswick Corp. v. Champion Spark Plug Co., 689 F.2d 740, 749-750 (7th Cir. 1982).  Thus, in the case where well known materials are substituted from one another, there needs to be some evidence that the substitution is more than routine in the art.

In summary, the Federal Circuit Court said that commercial value of an invention is an indicator of nonobviousness.  However, while an indicator, it is only one secondary consideration and commercial success can be attributed to a variety of factors unrelated to patentable inventiveness, such as successful marketing.  Furthermore, the Court stated that the present case exemplifies the Supreme Court’s analysis in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), which states that “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”  Thus, as no other evidence of nonobviousness was on appeal, the Federal Circuit reversed the District Court’s judgment with instructions to dismiss the suit.

Significance for Patent Applicants

On one level, Ritchie stands for the proposition that, under KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), substitutions of well known components is obvious.  However, what is more problematic in Ritchie is that the Federal Circuit gives scant weight to evidence of commercial success, which Graham v. John Deere, 383 U.S. 1 (1966) cites as evidence of non-obviousness.  While the Federal Circuit noted that there were many potential reasons for commercial success, the Federal Circuit in Ritchie chose not too give this evidence much weight in comparison with the evidence that the materials were all well known.  Little explanation was given as to why the commercial success evidence was of little evidentiary value, or why the evidence of being well known was of such greater value to eclipse the evidence of commercial success in the context of an analysis under Graham v. John Deere, 383 U.S. 1 (1966).  In light of the ruling in Ritchie, it is therefore doubtful that evidence of commercial success will be deemed a deciding factor in finding nonobviousness even where the evidence of obviousness itself is scant.

Federal Circuit Rejects Ensnarement Defense and Finds that the Ensnarement Defense is an Issue of Law

In DePuy Spine, Inc. v. Medtronic, Inc., Civ. Case Nos. 90 USPQ2d 1865 (Fed. Cir. 2009), DePuy owns U.S. Pat. No. 5,207, 678 (the ‘678 patent).  The ‘678 patent is directed to a medical device that is a pedicle screw used in spinal surgeries.  DePuy sued Medtronic, accusing Medtronic of infringing the ‘678 patent with Medtronic’s Vertex pedicle screws.  The U.S. District Court for the District of Massachusetts denied Medtronic’s ensnarement defense, found that Medtronic engaged in litigation misconduct, with both decisions being appealed before the Federal Circuit Court.  Additionally, DePuy cross-appeals from the District Court’s granting of Medtronic’s motion for judgment as a matter of law (JMOL) of no willful infringement and from the denial of DePuy’s motion for a new trial for reasonable royalty damages. 

In a prior appeal, the Federal Circuit Court upheld the District Court’s granting of summary judgment as per Medtronic not literally infringing the ‘678 patent with Medtronic’s Vertex pedicle screws.  However, the Federal Circuit Court reversed the District Court’s granting of summary judgment of noninfringement under the doctrine of equivalents.  In the prior appeal, the Federal Circuit Court remanded the case because it found a question of fact existed on whether the Vertex screw’s conical shape was insubstantially different from the ‘678 patent’s screw having a limitation in claim 1 of the patent reciting a “spherically-shaped portion.  In the remanded case, Medtronic asserted an “ensnarement” defense against the doctrine of equivalents issue, wherein the Medtronic asserted that the scope of equivalency of the ‘678 patent would “ensnare” the prior art.  Continue reading

Federal Circuit Affirms Obviousness of Gene Sequencing Claim As “Obvious To Try.”

In In re Kubin, 561 F.3d 1351 (Fed. Circ. 2009), the applicants filed Patent Application Serial No. 09/667,859 drawn to gene sequencing claims.  The applicants applied for a patent claiming DNA molecules (“polynucleotides”) that encoded a protein (“polypeptide”) known as the Natural Killer Cell Activation Inducing Ligand (“NAIL”).  Natural Killer (“NK”) cells play a major role in fighting tumors and viruses, and express surface molecules that can activate cytotoxic mechanisms when activated.  NAIL is a specific receptor protein on the cell surface that is involved in activating NK cells.  Applicants claimed the DNA that encodes the CD48-binding region of NAIL proteins.  Applicants’ claim 73 described a genus of isolated polynucleotides that encode a protein that binds CD48 and is at least 80% identical to the amino acid sequence that Applicants have disclosed in their specification.  In their specification, Applicants disclosed generic examples of variants of the amino acid sequence that could be contemplated under their claimed invention as at least 80% identical to the disclosed sequence.  However, the applicants did not set forth any specific examples of sequences of any such variants.

The Board upheld a rejection of applicants’ claimed invention under 35 U.S.C. § 112, 1st paragraph for lack of written description and a rejection under 35 U.S.C. § 103(a) for obviousness.  With respect to the lack of written description, the Board asserted that applicants had not described what domains of their described amino acid sequences were associated with the required binding to CD48, and thus did not describe which of NAIL’s amino acids could be varied and still bind.  The Board held that, without correlating the structure of the sequence with function, the specification did not provide adequate written description for claim 73.

The Board also affirmed that claim 73 was obvious under 35 U.S.C. § 103(a), under the combined teachings of U.S. Patent No. 5,688,690 (“Valiante”) and 2 Joseph Sambrook et al., Molecular Cloning: A Laboratory Manual 43-84 (2d ed. 1989) (“Sambrook”).  The Board found (and Applicants did not dispute) the receptor protein p38 of Valiante to be the same protein as NAIL, existing on the surface of the NK cell and able to activate cytotoxicity.  Valiante taught that the DNA and protein sequences for p38 could be obtained by conventional methods (such as those set forth in Sambrook).  The Board held that the disclosure of p38, along with a detailed method of isolating its DNA, including disclosure of a specific probe to do so, established Valiante’s possession of p38’s amino acid sequence and provided a reasonable expectation of success in obtaining a polynucleotide encoding p38, within the scope of applicants’ claim 73. Further, the Board asserted that, given the importance of NAIL’s role in human immune response, motivation existed to apply conventional methodologies (like those of Sambrook) to isolate the NAIL cDNA.

On appeal, the Federal Circuit sustained the Board’s factual inquiries underlying the 35 U.S.C. § 103(a) rejection.  Specifically, the Applicants argued that there is insubstantial evidence to find that their methodology of isolating NAIL is equivalent to the teachings and methodologies of Valiante and Sambrook.  However, the Federal Circuit asserted that the claimed invention is not to the processes used, but rather to the results of those processes.  The Court held that the record was sufficient to show that Valiante’s examples would produce the claimed nucleotide.

Further, the Federal Circuit found that substantial evidence existed that the Applicants used conventional techniques as taught by Valiante and Sambrook to isolate the gene sequence for NAIL.  The Court rejected the Applicants’ argument that Valiante and Sambrook fail to provide guidance for preparing the cell culture to serve as a useful source of mRNA for the preparation of a cDNA library due to Applicants’ own admissions.  Specifically, the argument was rejected because Applicants asserted that the nucleic acid molecule had been derived from DNA or RNA isolated in pure form and in a quantity or concentration that enabled identification, manipulation and recovery of its component nucleotide sequences using standard biochemical methods (such as those provided by Sambrook). 

The Federal Circuit further held that prior art showing NAIL’s binding to the CD48 protein was not necessary to assert a finding of obviousness because CD48 binding is a property necessarily present in NAIL.  The Federal Circuit noted that discovering new qualities in a product that others had discovered or new functionality in a structure suggested by prior art is not an invention.  In re Wiseman, 596 F.2d 1019, 1023 (CCPA 1979); Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326US 242, 249 (1945).  Since the Board found that Valiante’s p38 was the same protein as applicants’ NAIL protein, Valiante’s teaching to obtain the cDNA encoding of p38 necessarily teaches one to obtain the cDNA of NAIL.  P38’s cDNA would necessarily exhibit the CD48 binding property and would fall under the scope of claim 73.

The Federal Circuit next rejected the idea that the “obvious to try” test should only be applied to predictable arts (as opposed to a more unpredictable arena like biotechnology).  The Federal Circuit held that patent law does not customize its tests for specific scientific fields.   In so doing, the Federal Circuit noted that its prior decision in In re Deuel, 51 F.3d 1552 (Fed. Cir. 1995), which held that obvious to try was inappropriate as an obviousness rationale in the biotechnological arts, was suspect and greatly limited or overruled after the Supreme Court’s decision in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007).  Rather, the Supreme Court held in KSR that where there is an identified need or pressure, and a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue known options within his or her technical grasp.  Solutions of this kind would not be the product of innovation, but rather one of ordinary skill and common sense.  Thus, the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. § 103.

After rejecting the analysis in In re Deuel, the Federal Circuit noted that the Supreme Court “actually resurrects this court’s own wisdom in In re O’Farrell [853 F.2d 894, 903 (Fed. Cir. 1988)].“  In re O’Farrell, which predated In re Deuel, noted that obvious to try was a rationale supporting an obviousness rejection.  However, the Federal Circuit also noted that the court in In re O’Farrell “cautioned that ‘obvious to try’ is an incantation whose meaning is often misunderstood.”  In order to differentiate between obviousness resulting from obvious to try and impermissible hindsight, the court in In re O’Farrell outlined situations (paralleled in KSR) in which passing the “obvious to try” test would be erroneously equated with obviousness. 

The first class of cases to which “obvious to try” should not be applied were those where the prior art gave no indication which parameters to vary or which choices were likely to be successful.  The second class of cases consisted of those exploring new technologies or a general approach where only general guidance existed as to the particular form of the invention or how to achieve it.  However, in contrast to these two cases, an obviousness finding under an “obvious to try” test would be appropriate when the prior art “contained detailed enabling methodology for practicing the claimed invention, a suggestion to modify the prior art to practice the claimed invention, and evidence suggesting that it would be successful.” 853 F.2d at 902 (emphasis added).  The prior art did not have to require absolute predictability of success, but merely a reasonable expectation of such.

The Federal Circuit held that the Applicants’ case was dissimilar to either of the erroneous “obvious to try” classes.  With regards to claim 73, Valiante and Sambrook, which together teach a protein identical to NAIL, a commercially available monoclonal antibody specifically for NAIL, and explicit instructions for obtaining the DNA sequence for NAIL, gave more than general guidance as to how to achieve the specific form of the invention and provide clear direction as to which methods are likely to be successful.  Further, the prior art provided a reasonable expectation of successfully obtaining a polynucleotide of claim 73.  Thus, the Federal Circuit held that the “obvious to try” test should be applicable in this case.  Further, the Court asserted that use of the test shows that claim 73 was obvious and thus not patentable.

The Federal Circuit affirmed the Board’s ruling that applicants’ claims were obvious as a matter of law under the “obvious to try” test.  The prior art provided an identical protein to that claimed by applicants, a commercially available monoclonal antibody for that protein, and explicit instructions for obtaining the DNA for that protein.  Thus, the “obvious to try” test was appropriate because the prior art provided clear direction as to which methods were likely to be successful to achieve the invention, and a reasonable expectation of successfully obtaining a polynucleotide under claim 73.

Significance to Patent Applicants

In re Kubin removed a bright line distinction in how to apply obviousness analysis in predictable arts as opposed to those deemed unpredictable.  As such, merely by labeling a technology such as biotechnology unpredictable will no longer immunize applicants from the full scope of analysis authorized by the Supreme Court in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) and Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966). 

That being said, In re Kubin also reinforces the requirement that rejections based upon a conclusion that something is “obvious to try” must still be substantiated by evidence.  The Federal Circuit in In re Kubin heavily relied upon the existence of a manual as evidence of routine processing, and that the claimed result was merely the routine processing of a known protein.  Without such evidence, “obvious to try” is merely a conclusory statement.  Therefore, even after KSR, applicants should require that examiners provide evidence as to why a particular result would have been obvious to try.