Somewhat unexpected results yield to strong evidence of obviousness to try
| August 8, 2014
Roche and Genentech v. Apotex Inc; Roche and Genentech v. Dr. Reddy’s laboratories; Roche and Genentech v. Watson etc.; Roche and Genentech v. Orchid chemicals & pharmaceuticals etc; and Genentech v. Mylan etc.
April 11, 2014
Before Newman, Lourie, and Bryson. Opinion by Bryson. Dissent by Newman
Summary
Plaintiff Roche appeals from the decision of the U.S. District Court for the District of New Jersey granting the defendant generic drug companies summary judgment of invalidity of Roche’s two patents related to Boniva®, a commercial drug for the treatment of osteoporosis. CAFC affirms.
Prima facie case of obviousness is not established solely because end point of claimed range is close to disclosed range
| July 31, 2014
In re Rajen M. Patel
July 16, 2014
Panel: O’Malley and Hughes. Opinion by O’Malley.
Summary
PTAB affirmed Examiner’s rejections of Applicants’ claims reciting a range limitation of weight percent of a polymer component, as being obvious over a cited reference because it discloses a range whose upper limit is very close to the claimed lower limit. Applicants appealed from the PTO decision and argued before CAFC that the PTAB erred in finding a prima facie case of obviousness where the amounts do not overlap. CAFC agreed with the Applicants and distinguished this case from its previous cases where range overlapping at least to some degree was required to find obviousness.
出願クレームは、ポリマーの量（26 wt%以上）を記載し、先行技術はポリマーの量（25 wt%以下）を開示していた。その差は僅か1％ほどである。米国特許庁審査官はこの場合、数値は重複していないが、非常に近接しているので、それだけで自明性の存在が一応証明され（prima facie case of obviousness）、したがって、出願人が非自明性（たとえば予期せぬ効果）を証明しなければ特許されないと判断した。同特許庁審判部はこの結論を維持した。この決定を不服として出願人はCAFCに上訴し、クレームの数値範囲に「近い」という理由だけで即座に自明であるとした特許庁の判断は間違いであると主張した。CAFCは出願人の意見に同意し、特許庁の判断を覆した。本件は、先行技術の数値がクレームの数値と重複しておらず、クレームの数値へ増量するという教示が先行技術にはないことに着目し、単に数値が「近い」というだけで自明であるとしてはいけないとの判断である。特許庁のガイドラインは、数値範囲が重複していなくても、同様の特性が予期できる程度に「近い」といえる場合は一応の自明性があると説明しているが、本件はこの基準の適用範囲を制限した判決であると考えられる。
Post-filing recognition of a drug compound’s unexpected property may not be sufficient to establish the compound’s nonobviousness.
| July 24, 2014
Bristol-Myers Squibb Company v. Teva Pharmaceuticals USA, Inc.
June 12, 2014
Summary
The Federal Circuit found that a patent claim directed to a drug compound for treating hepatitis B was invalid as an obvious modification to a structurally similar lead compound. In so finding, the Federal Circuit dismissed evidence of later discovery, after the time of invention, that the lead compound was highly toxic and therapeutically useless. The Federal Circuit then determined that evidence of the drug compound’s later-discovered unexpected lack of toxicity was insufficient to prove nonobviousness, despite additional evidence demonstrating the drug compound’s unexpectedly high potency and unexpectedly high barrier to resistance. The Federal Circuit’s decision may have taken some bite out of the court’s precedents that an invention’s properties and advantagesneed not be fully known as of the filing date of the patent application to be relevant to nonobviousness.
Not All Secondary Considerations are Probative of Nonobviousness
| July 23, 2014
Galderma Labs v. Tolmar, Inc.
December 11, 2013
Before NEWMAN, BRYSON, and PROST, Circuit Judges. Opinion for the court filed by Circuit Judge PROST. Dissenting opinion filed by Circuit Judge NEWMAN.
SUMMARY
This Hatch-Waxman case is based on Tolmar’s filing of an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic drug (Differin® Gel,0.3%), which is a topical medication containing 0.3% by weight adapalene approved for the treatment of acne.
Tags: commercial success > secondary considerations > teaching away > unexpected results
CAFC reminds applicants to be wary of functionally defined genus claims
| July 22, 2014
AbbVie Deutschland GMBH & CO., KG et al., v. Janssen Biotech, Inc.
July 1, 2014
Panel: Lourie, O’Malley, and Chen. Opinion by Lourie. Concurring opinion by O’Malley.
Summary
Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date.
KSR does not do away with the requirement that the Patent Office provide documentary evidence to show that structural elements of a claim were known in the art
| July 22, 2014
K/S HIMPP v. Hear-Wear Technologies, LLC
May 27, 2014
Panel: Lourie, Dyk and Wallach. Opinion by Lourie. Dissent by Dyk.
Summary
The Federal Circuit found that the Board of Patent Appeals and Interferences (“Board”) and the Examiner did not err during an inter partes reexamination of U.S. Patent No. 7,016,512 in refusing to accept a conclusory assertion from the third party requester that particular structural elements of claims 3 and 9 were known prior art elements in the absence of documentary evidence on the record because an assessment of basic knowledge and common sense as a replacement for documentary evidence for core factual findings lacks substantial evidence support. The Federal Circuit also found that the decision of the Board was not contrary to the holding in KSR.
Details
This is an appeal from a decision of the Board in an inter partes reexamination affirming the reexamination Examiner’s decision not to reject claims 3 and 9 of U.S. Patent No. 7,016,512 (“’512 patent”) as obvious.
Claims 3 and 9 recite:
3. The at least partially in-the-canal module for a hearing aid of claim 2 wherein said insulated wiring portion is terminated by a plurality of prongs that provide a detachable mechanical and electrical connection to an audio processing module.
9. The hearing aid of claim 8 wherein said insulated wiring portion is terminated by a plurality of prongs that provide a detachable mechanical and electrical connection to said behind-the-ear module.
Hear-Wear is owner of the ‘512 patent. During prosecution of the application, the Examiner rejected claims 3 and 9 as obvious by concluding that “providing a plurality of prongs for the electrical connections or for the plugs is known in the art.” The Examiner did not take an Official Notice. Hear-Wear did not dispute the Examiner’s assertion of “known in the art”; instead, Hear-Wear amended independent claims and all claims were allowed.
The PTO granted a third party request by HIMPP for inter partes reexamination of the ‘512 patent. In its request for the inter partes reexamination, HIMPP did not submit documentary evidence to show that the features of claims 3 and 9 were “known in the art.” Relying on the statement by the Examiner during the prosecution of the application, HIMPP argued that claims 3 and 9 would have been obvious because “such detachable connections were known at the time of the alleged invention as concluded by the Examiner during prosecution” and the modification of the primary reference to include detachable connections for a signal cable “would have been no more than the predictable use of prior art elements according to their established functions.”
The reexamination Examiner did not agree with HIMPP’s position because HIMPP failed to provide documentary evidence in support of their position. The Examiner maintained the patentability of claims 3 and 9. Hear-Wear appealed to the Board. The Board also disagreed with the HIMPP position that the limitations of claims 3 and 9 were “well known” as HIMPP failed to point “to any portion of the record for underlying factual support for the assertion. The Board stated that it was ‘not persuaded that the record before [it] adequately conveys that the particular distinct connection structures set forth in those claims are disclosed.’”
“The Board also found that during the original prosecution the Examiner never took official notice with respect to the ‘plurality of prongs’ feature of claims 3 and 9, and that there was no further indication that Hear-Wear acquiesced to the alleged position of official notice so as to qualify the limitations of the claims as admitted prior art.” Accordingly, the Board affirmed the Examiner. HIMPP timely appealed to the Federal Circuit.
The issue on appeal was whether the Board’s refusal to accept a conclusory assertion from HIMPP that particular structural elements of claims 3 and 9 were known prior art elements in the absence of documentary evidence on the record was contrary to the holding in KSR.
In KSR International Co. v. Teleflex Inc., “the Supreme Court criticized a rigid approach to determining obviousness based on the disclosures of individual prior art references that were already on the record, with little recourse to the knowledge, creativity, and common sense that an ordinarily skilled artisan would have brought to bear when considering combinations or modifications.”
The majority found that KSR was distinguishable from the instant case because the instant “case involves the lack of evidence of a specific claim limitation, whereas KSR related to the combinability of references where the claim limitations were in evidence.”
In view of the majority’s interpretation of the KSR, the majority found that “[t]he Board’s decision was correct because an assessment of basic knowledge and common sense as a replacement for documentary evidence for core factual findings lacks substantial evidence support.” Also, the majority found that “the Board’s holding is not inconsistent with KSR’s caution against the overemphasis on publications and patents for combining or modifying prior art that are already on the record.”
Also, the majority stated that the Board’s position is supported by the USPTO examination procedure as neither the Board nor the Examiner determined that the facts at issue met the standard justifying official notice.
“Although a patent examiner may rely on common knowledge to support a rejection, that is appropriate only in narrow circumstances. See M.P.E.P. § 2144.03 (“It would not be appropriate for the examiner to take official notice of facts without citing a prior art reference where the facts asserted to be well known are not capable of instant and unquestionable demonstration as being well-known.”)”
“If an examiner chooses to rely on personal knowledge to support the finding of what is known in the art, and the applicant adequately traverses that assertion, then the examiner must provide an affidavit or declaration setting forth specific factual statements and explanations to support that finding. 37 C.F.R. § 1.104(d)(2); M.P.E.P. § 2144.03(c).”
In the absence of any evidence on the record to support the HIMPP’s position that claims 3 and 9 were known prior art elements, the Federal Circuit affirmed the Board’s decision to refuse to adopt HIMPP’s obviousness contention.
In the dissent’s view the majority’s holding is inconsistent with the Supreme Court’s decision in KSR. In the dissent’s view precluding the Patent Office from relying on their own common knowledge and common sense would significantly impair the agency’s ability to review applications adequately and undermines the purpose of the post-grant agency review.
Takeaway
As a general rule, the use of an Official Notice regarding structural elements to reject claims is improper. This is because the substantial evidence requires the Patent Office to provide a record that includes sufficient documentary evidence to enable judicial review; otherwise, as noted in this case by Judge Lourie, “‘basic knowledge” or ‘common sense’ as a replacement for documentary evidence for core factual findings in a determination of patentability” would “render the process of appellate review for substantial evidence on the record a meaningless exercise.” Notwithstanding, an Official Notice based on personal knowledge regarding structural features of a claim if not adequately traversed may render the noticed facts as admitted prior art. Therefore, always adequately traverse the Official Notice and ask the Examiner to produce documentary evidence or an affidavit. Also, in the absence of an Official Notice, the rejection based on the Examiner’s assertion that certain structural features are “know in the art” should also be traversed on the premise that a prima facie case is absent as necessary structural element is not shown.
Tags: basic knowledge > common knowledge > common sense > General Knowledge > known in the art > Official Notice
Practical Points From The Supreme Court’s Alice Decision
| June 26, 2014
Alice Corp. v. CLS Bank Int’l
June 19, 2014
Summary:
The Supreme Court’s Alice decision does not eliminate software patents as per se ineligible subject matter under 35 USC §101. The Court confirms the application of Mayo’s two step §101 analysis and provides some new considerations for addressing patent eligibility issues for computer-implemented inventions. Unfortunately, the Supreme Court’s admonition that the mere addition of “conventional” computer functionality to an abstract idea does not transform the claim into patent eligible subject matter conflates the §101 analysis with patentability issues under 35 USC §§102 and 103.
Tags: abstract idea > Alice Corp. > CLS Bank > computer > processor > software
The Effect of an Expiration Date on Obviousness-Type Double Patenting
| June 25, 2014
Gilead Sciences, Inc. v. Natco Pharma Ltd.
April 22, 2014
Panel: Rader, Prost and Chen. Opinion by Chen. Dissent by Rader.
Summary:
An objective of the obviousness-type double patenting doctrine is to preserve the public’s right to use not only the exact invention claimed by an inventor when his patent expires, but also obvious modifications of that invention that are not patentably distinct improvements. Thus, a patent that issues after but expires before another patent may qualify as a double patenting reference for that other patent.
PTAB Finally Considers “Processor” As Clearly Structure
| June 19, 2014
Ex Parte Cutlip
June 2, 2014
Panel: Lorin, Mohanty and Hoffman.
Summary:
After the debacle of three March 2013 PTAB decisions by a five judge PTAB panel relying on a strange American Heritage dictionary definition of “processor” as being software, this PTAB decision sets the record straight about a “processor” as clearly being structure.
Tags: §101 > 112 sixth paragraph > 112(f) > abstract idea > algorithm > Alice Corp. > CLS Bank > computer > CPU > indefiniteness > MPF > patent eligible subject matter > processor > software
BEWARE OF A SURPRISE CO-OWNER OF A PATENT WHO DOES NOT WANT TO ENFORCE ITS PATENT
| June 12, 2014
STC.UNM v. Intel Corp.
June 6, 2014
Panel: Rader, Dyk, and Newman. Opinion by Rader. Dissent by Newman
Summary:
The ‘998 patent was a CIP of the ‘312 patent, which was jointly owned by STC.UNM and Sandia. Because a terminal disclaimer (which required a common ownership of both patents) was filed during prosecution of the ‘998 patent, STC.UNM and Sandia are co-owners of the ‘998 patent even if Sandia did not make any contribution to the ‘998 patent. STC.UNM filed an infringement suit concerning the ‘998 patent against Intel, and Sandia refused to join the lawsuit. The district court dismissed the case for a lack of standing, and the CAFC affirmed by holding that all co-owners must ordinarily consent to join as plaintiffs in an infringement suit. Furthermore, both the district court and the CAFC refused to involuntarily join Sandia to the case as a necessary party (FRCP Rule 19).
본사건은연방지방법원뉴멕시코지원의판결에불복하여 STC/UNM이연방순회항소법원 (CAFC)에항소한사건이다. CAFC는연방지방법원과같이‘312 특허를바탕으로일부계속출원된특허 (continuation-in-part)인‘998 특허심사도중원고STC/UNM가존속기간포기서 (terminal disclaimer)를제출함으로써특허심사거절을극복하였으므로, STC/UNM과 Sandia는‘998 특허의공동소유자(co-owners)라고판단하였다 (Sandia는‘998 특허발명에공헌을하지않았다). 또한CAFC는 Sandia의소송참여의사에상관없이 STC/UNM이인텔을상대로‘998 특허침해소송을제기한것에대해STC/UNM은원고적격(standing)이없다고판단하여소송을기각하였다. 왜냐하면특허침해소송에서는특허의모든공동소유자가원고로참여해야하지만Sandia는소송참여를하지않기로결정하였기때문이다. 마지막으로CAFC는연방지방법원과마찬가지로본사건은연방민사소송규칙 19조의involuntary joinder rule이적용되지않아Sandia를원고로강제참여시킬수없다고판단하였다.
Tags: Continuation-in-part-application > Joinder > Rule 19 > Standing > terminal disclaimer
