Patent and Trademark Office Publishes Final Rules for Derivation Proceedings

By Charles Pierce

On September 10, The Patent and Trademark Office published finals rules designed to ensure that a person applying for a patent is the true inventor through a new trial proceeding, the derivation proceeding.  An applicant who is not first to file (the petitioner) will be able to petition for a derivation proceeding and attempt to show that  another applicant’s (the respondent) claimed invention was derived from the petitioner’s invention.  Derivation proceedings will take place before the Patent Trial and Appeal Board.

The petition must show by substantial evidence that the petitioner’s application has at least one claim which is the same or substantially similar to the respondent’s claimed invention and demonstrate that the respondent’s claimed invention was derived from the petitioner’s invention.  The petitioner must also show, for each of his claims, why the respondent’s claimed invention is substantially similar, and identify how the claim should be construed.[1]  Such a petition must be filed within one year of the publication of the petitioner’s relevant claims.[2]

These new rules will be codified in 37 C.F.R. Part 42, Subpart E, and will take effect on March 16, 2013.  The full text of the rules along with the PTO’s responses to comments may be found at http://www.uspto.gov/aia_implementation/Derivation_Proceedings.pdf or 77 Fed. Reg. 56067 (Sept. 11, 2012).

[1] Changes to Implement Derivation Proceedings, 77 Fed. Reg. 56067, 56091 (Sept. 11, 2012) (to be codified at 47 C.F.R. Part 42).
[2] Id.

Update on Implementation of American Invents Act Effective As of September 16, 2012

By Dennis Clarke and James McEwen

On September 16, 2011, the “Leahy-Smith America Invents Act” (AIA) was signed into law. The AIA makes the most substantial changes in U.S. patent law in decades and sets various dates on which these changes are to take effect.

The most profound of those changes is the switch to a first-inventor-to-file system, in place of the current first-to-invent practice in the U.S. This change takes effect only for applications originally filed on or after March 16, 2013. However, on September 16. 2012, other major changes will take effect, including the possibility of requesting inter partes review and other post-grant trial procedures before the newly renamed “Patent Trial and Appeal BoarcL” This paper will predominantly relate to the new requirements relating to declarations and assignments and other miscellaneous provisions that have an effective date of September 16, 2012. The new trial proceedings are discussed briefly hereinbelow.

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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.

The “Apple v. Samsung” Global Patent Battles Continue

Meera El-Farhan

 

What started a year ago, with Apple filing suit in the U.S. District Court for the Northern District of California against Samsung Electronics Co., has now expanded to more than 50 patent war lawsuits across four continents and at least eight countries. Throughout this escalating legal global battle, with billions of dollars at stake, the smartphone and tablet powerhouses continue, however, to be dependent business partners, and Samsung remains Apple’s largest semiconductor component supplier for iOS devices (a deal worth $8 billion). [1]

In its initial 38-page complaint, Apple claimed unfair competition, trademark infringements, and patent infringements; whereby, Apple alleged Samsung’s smartphones and Galaxy Tab 10.1 “slavishly” copied the iPhone and iPad designs. Samsung responded to Apple’s design patent and trade dress infringement claims by filing cross-claims. Samsung sought revocation of the patent claims and further alleged that the iPhone and iPad infringed on Samsung’s technology patents (including wireless data communication technology). Additionally, Samsung filed suit in South Korean, Japanese, and German courts.

On December 2, 2011, the district court denied Apple’s motion for preliminary injunction for the following devices:

(1) Samsung Galaxy S 4G and Infuse 4G smartphones for allegedly infringing on U.S. Des. Patent No. 618, 677 (“the D’677 patent”), U.S. Des. Patent No. 593,087 (the D’087 patent”), and (3) U.S. Patent No. 7, 469,381 (the ‘381 patent).

(2) Samsung Galaxy Tab 10.1 tablet computer for allegedly infringing on U.S. Des. Patent No. 504,889 (the D’889 patent”), and U.S. Patent No. 7469,381 (the ‘381 patent).

(3) Samsung 4G LTE smartphone for allegedly infringing on U.S. Patent No. 7,469,381 (the ‘381 patent”)[2]

The federal circuit affirmed the court’s order in part, but remanded for further proceeding with respect to the D’889 Patent. [3]  On June 26, 2012, the district court found the balance of hardship for the D’889 patent to tip in Apple’s favor.[4] The court acknowledged that “although Samsung will necessarily be harmed by being forced to withdraw its product from the market before the merits can be determined after full trial, the harm faced by Apple absent an injunction on the Galaxy Tab 10.1 is greater.”[5]  The court further found the design to be an important driver for sales; thus the injunction was not based on “one aspect of the overall product.”[6] However, as a condition of the injunction, the court ordered Apple to secure a $2.6 billion bond to repay Samsung for any damages in the event the injunction is found to have been issued wrongfully.[7]

With the trial starting on July 30, 2012, Apple demanding $2.5 billion in damages in addition to an injunction barring the sale of any infringing Samsung devices, in addition to the U.S. large electronic consumer market, the two electronic giants face high stakes in the trial’s outcome.

Germany: a preliminary injunction in August of 2011 was ordered by a German court to ban the sales of Galaxy 10.1 Tab in all the European Union except for the Netherlands. A week later, the ban was scaled back to Germany, and the 10.1 tab was returned to the EU shelves. Samsung sidestepped the injunction by introducing a Galaxy Tab 10.1N model for Germany. Apple contested the new design immediately. Although Apple lost twice on appeal for banning the sale of the 10.1 Tab, the German court in July, 2012 ruled in favor of Apple by banning the sale of Galaxy Tab 7.7 in Europe.

Australia: the battle extended to an Australian Federal Court in October, 2011. Apple sought, and was granted, an interlocutory injunction restraining Samsung from releasing the 10.1 Tab. Although the Australian Court granted Apple an interlocutory injunction, Samsung won on appeal. Apple continued to file for an appeal to the High Court.  The High Court, in refusing a special leave, allowed Samsung to sell the 10.1 just in time for  Christmas season. Samsung counter-sued Apple in April, 2012. The federal court began its hearing in late July, 2012.

Other Countries: The UK court ruled in favor of Samsung by finding Tablets 10.1, 8.9, and 7.7 did not infringe upon the alleged Apple patent.  Samsung and Apple continue to battle in patent-related lawsuits in Japanese, Korean, and European courts.

 

Aftermath

The multi-billion dollar patent warfare is likely to reshape legal and production strategies for both parties. Unfortunately, in the expanding smartphone market, price effects on consumer electronics are too uncertain to predict for now; however, the outcome of lawsuit battle will draw the line between competition and protection of intellectual property in the smartphone industry.


[2] Apple, Inc. v. Samsung Electronics Co., Ltd., 11-CV-01846-LHK, 2011 WL 7036077 (N.D. Cal. Dec. 2, 2011) aff’d in part, vacated in part, remanded, 678 F.3d 1314 (Fed. Cir. 2012)

[3]Apple, Inc. v. Samsung Electronics Co., Ltd., 678 F.3d 1314 (Fed. Cir. 2012)

[4] Apple, Inc. v. Samsung Electronics Co., Ltd., 11-CV-01846-LHK, 2012 WL 2401680 (N.D. Cal. June 26, 2012)

[5] Id.

[6] Id.

[7] Id.

USPTO Issues Proposed Rules for Implementing the America Invents Act

Charles Pierce and James G. McEwen

On July 25, 2012, the United States Patent and Trademark Office (USPTO) announced proposed rules as a result of changes in the America Invents Act (AIA) converting the U.S. patent system from a first to invent to a first to file system.  These changes will take place on March 16, 2013.

The proposed rules are intended to promote consistency caused by the changes in the AIA for pending applications, and to implement the AIA for future applications.  Comments on the proposed rules are open until October 5, 2012.  Below is a summary of significant elements of the proposed rules.

The proposed rules will treat commonly owned or joint research agreement patents and patent application publications as having the same inventive entity for the purposes of 35 U.S.C. §§ 102 and 103 as required under 35 U.S.C. § 102(c) of the AIA.  35 U.S.C. §102(c) of the AIA essentially broadens the current 35 U.S.C. §§ 103(c) by making these provisions usable for novelty.  The broadened use of this exclusion should be beneficial to holders of large families of patents.

Since new 35 U.S.C. §102(b) provides exceptions to 35 U.S.C. §102(a) based upon prior disclosure by the inventor, the rule changes also allow the submission of affidavits or declarations to show that a disclosure upon which a claim rejection is based was made by an inventor, joint inventor, or someone who obtained the disclosed subject matter from the inventor or a joint inventor.  These provisions will also allow the submission of affidavits to show that there was a prior public disclosure by an inventor, joint inventor, or someone who obtained the disclosed subject matter from the inventor or a joint inventor.  This will be codified in 37 CFR §§ 1.104, 1.130, and 1.131.

Another change being implemented relates to using the effective dates of foreign priority applications against third party patents.  In order to ensure that the foreign priority documents are received in time for publication and use, the USPTO is now requiring that the certified copy be received within the deadline now only required for submitting the priority claim: the later of four months from the filing date or sixteen months from the foreign priority date.  The claim must also be included in an Application Data Sheet.  While these changes are likely not an issue where the applicant is able to retrieve priority documents using the priority document exchange (PDX) system, this timing will be an issue for all other applications.  Therefore, applicants need to ensure that the certified copies are provided as soon as possible in the prosecution process or be required to file a Petition for late acceptance.

The last major change in this round of AIA rulemaking is relate to the transitional period between first to invent and first to file, and probably will have the greatest short term impact on patent practitioners.  In order to ensure that the USPTO can properly evaluate which set of rules to apply when faced with priority claims for applications filed prior to March 16, 2013, the USPTO is requiring the applicants identify which rules will apply.

Specifically, where the application is filed after March 16, 2013, but claims the benefit of a foreign, provisional, or nonprovisional application having an effective filing date prior to March 16, 2013, the applicant will need to provide a statement whether the claims in the application are entitled to the earlier effective filing date.  Also, if the nonprovisional application that claims such benefit does not contain a claim to a claimed invention that has an effective filing date on or after March 16, 2013, but discloses subject matter not also disclosed in the prior application, the applicant must provide a statement to that effect.  For example, under proposed 37 C.F.R. 1.55, where the application claims priority to a foreign application filed prior to March 16, 2013, the applicant will need to specify if there is new matter in the application, and whether the claims are supported by the foreign priority date.  Examples of such statements include “upon reasonable belief, this application contains subject matter not disclosed in the foreign application” or “upon reasonable belief, this application contains at least one claim that has an effective filing date subject matter on or after March 16, 2013”.

These statements will have to be filed within the later of four months from the actual filing date of the later application, four months from the date of entry into the national stage in an international application, or sixteen months from the filing date of the prior filed application, or the date that a first claim to a claimed invention that has an effective filing date on or after March 16, 2013 is presented in the application.  Failure to make such a statement after these deadlines will require a Petition, and any changes will result in the Examiner issuing a Request for Information under 37 CFR 1.105 to require the applicant to prove by line and element number where support is found.  For continuations, divisionals, and continuation in part applications, this requirement will be codified in 37 CFR § 1.78.

As these rules are still only being proposed, applicants and the legal community are reviewing the proposed changes and preparing comments.  While many of the changes seem consistent with the requirements of the AIA, the transitional requirement for identifying whether disclosures and claims can have an effective filing date in a prior application are likely the most controversial and the most likely to cause significant problems for applicants having families of patents.  Therefore, as a short term solution, in order to avoid these potential issues should the USPTO not retract this provision, applicants should ensure that they file applications prior to March 16, 2013 if any priority claim is going to be made to an application filed prior to March 16, 2013.

Stein McEwen issues Vol. 8, Issue 2 of the SteinMcEwen Newsletter (July 2012)

We are pleased to present the latest edition of the Stein McEwen, LP Newsletter, Vol. 8, Issue 3 (July 2012).
The newsletter includes information on the following:

  • USPTO Issues Proposed Rules for Implementing the America Invents Act
  • In re Hyon: Substantial Evidence Standard Helps Preserve Finding of Obviousness
  • Viacom v. YouTube: Open Questions of “Substantial Influence” Weaken a Safe Harbor
  • McDonnell Boehnen Hulbert & Berghoff LLP Respond to John Wiley & Sons Ltd.’s Copyright Infringement Complaint
  • Federal Circuit Finds Prior Use By Another Invalidates Patent
  • Per se legal? The Eleventh Circuit Rejects FTC’s “Unlikely to Prevail” Antitrust Challenge to “Reverse Payment” Patent Settlements
  • Bear Declines Invitation to Oust MDL from Patent Infringement Realm

For more information on Stein McEwen, LLP, please visit www.smiplaw.co