95000440 (P.T.A.B. Feb. 24, 2014)

Ex Parte 7381804 et al

Patent Trial and Appeal BoardFeb 24, 2014

95000440 (P.T.A.B. Feb. 24, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 95/000,440 03/18/2009 7381804 03369/7001505-000 2649 22852 7590 02/25/2014 FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER LLP 901 NEW YORK AVENUE, NW WASHINGTON, DC 20001-4413 EXAMINER TURNER, SHARON L ART UNIT PAPER NUMBER 3991 MAIL DATE DELIVERY MODE 02/25/2014 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE PATENT TRIAL AND APPEAL BOARD ____________ Maxygen, Inc. Requester v. Amgen, Inc. Patent Owner and Appellant ____________ Appeal 2013-004840 Reexamination Control 95/000,440 Patent 7,381,804 B2 Technology Center 3900 ____________ Before LORA M. GREEN, RICHARD M. LEBOVITZ, and RAE LYNN P. GUEST, Administrative Patent Judges. GUEST, Administrative Patent Judge. DECISION ON REHEARING In the Decision on Appeal dated June 25, 2013 (“Decision”), we affirmed the Examiner‟s rejections rejection of claims 1-8 under 35 U.S.C. § 103 based on the following references either as stated or in view of additional prior art (see Appendix D of PO App. Br.): Appeal 2013-004840 Reexamination Control 95/000,440 Patent 7,381,804 B2 2 1. Camble ‟6301 and Shaw ‟5842 (Rejection 1; Rejections 2-4 cite additional prior art); 2. Camble ‟630 and Shaw ‟8243 (Rejection 5); 3. Camble ‟2954 (Rejection 6; Rejections 7-10 cite additional prior art); 4. Camble ‟295 and Shaw ‟584 (Rejection 11); and 5. Shaw ‟584 and Cunningham5 (Rejection 12; Rejections 13-14 cite additional prior art). Patent Owner requests rehearing of this decision under 37 C.F.R. § 41.79. Request for Rehearing (“Request”) dated July 25, 2013. Patent Owner contends the Board misapprehended or overlooked two points. First, Patent Owner contends that the Board misapprehended the standard for determining a prima facie case of obviousness of a new chemical compound, particularly considering “case law precedent, the vast number of possible solutions provided by the prior art, and the inherent 1 EP 0 459 630 A2, published April 12, 1991 and naming Roger Camble, et al. as inventors (hereinafter “Camble ‟630”). 2 US 4,904,584, issued February 27, 1990 to Gray Shaw (hereinafter “Shaw ‟584”). 3 WO 89/05824, published June 29, 1989 and naming Gray Shaw as the sole inventor (hereinafter “Shaw ‟824”). 4 GB 2 246 295 A, published January 29, 1992 and naming Roger Camble et al as inventors (hereinafter “Camble ‟295”). 5 WO 92/21029, published November 26, 1992 and naming Brian Cunningham, et al. as inventors (hereinafter “Cunningham”). Appeal 2013-004840 Reexamination Control 95/000,440 Patent 7,381,804 B2 3 unpredictability of designing G-CSF analogs as established by the record and admitted by the Requester” Request 3. Second, Patent Owner contends that the Board should consider the Federal Circuit opinion in Wyeth v. Abbott Labs., Nos. 2012-1223 and 2012-1224, 2013- WL 3198008 (Fed. Cir. June 26, 2013), issued one day after the Board‟s Decision, which, according to Patent Owner, “stands in opposition to the Board‟s definition of „routine‟ preparation, testing and verification.” Id. Requester filed comments under 37 C.F.R. §41.79(c) in opposition to Patent Owner‟s Request. Requester‟s Comments (“Req. Com.”) filed August 26, 2013. Determining Prima Facie Obviousness of a Chemical Compound According to Patent Owner, the Decision failed to set forth “a reasoned identification of some motivation that would have led one skilled in the art to 1) select a lead compound from the prior art, and 2) modify that compound in a particular way to achieve the claimed invention” which Patent Owner asserts is the standard for a new claimed chemical compounds. Request 4 (citing Procter and Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009); Takeda Chem. Indus. Ltd. v. Alphapharm Pty. Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007)). Patent Owner states that “[i]f the „lead compound‟ is simply taken to be native G-CSF, then the cited prior art references provide millions of possible point mutations that could be made to the native sequence-the overwhelming number of which do not result in an analog within the scope of the claimed invention.” Request 5. Appeal 2013-004840 Reexamination Control 95/000,440 Patent 7,381,804 B2 4 We disagree with Patent Owner‟s characterization of the teachings of the cited prior art. The prior art references may disclose different embodiments, but the cited prior art also directs the skilled artisan to specific examples. The Decision discusses in detail the actual examples of specific point mutations in the native G-CSF molecule described in the Camble, Cunningham, and Shaw references and the known properties resulting from such specific mutations. See Decision 6-8. Patent Owner does not dispute that these examples include point mutations that fall within the scope of the claims, e.g., Example 28 of Camble ‟630 and Example 7 of Shaw ‟584. In this case, Patent Owner ignores the specific examples and argues only about the scope of the broader teachings of the prior art in assessing the sheer number of mutations proposed by the prior art. See Request 7 and PO App. Br. 11. We find Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008), cited by Patent Owner (Request 8), to be factually distinguishable from this case. In Ortho-McNeil, the prior art lacked guidance that presented obstacles not found in the present case, namely a lack of a clear starting compound, a lack of a route to the claimed product, and the failure to provide any utility of an intermediate product that would lead the skilled artisan towards that product. Unlike in Ortho-McNeil, the Decision in the present case describes a finite number of exemplary mutations to native G-CSF, the resulting properties of the mutated protein, and why these properties are known advantages, which would have directed the skilled artisan to make and use the known mutations. The Decision states that the Examiner is not relying on Example 28 of Camble ‟630 or Example 7 of Shaw ‟584, but rather the general teachings of Appeal 2013-004840 Reexamination Control 95/000,440 Patent 7,381,804 B2 5 those references as to what was known regarding structural modifications to native G-CSF and how these modifications affect the desirable properties of the resulting G-CSF (Decision 13-14). This statement was made in response to the Patent Owner‟s contention that these examples have lower activity or are merely prophetic in nature and thus “teach away” from a combination. See Decision 12-13 (citing PO App. Br. 13 and 16-17, and 18-21). Each of the prior art reference describes point mutations to address the same problem affecting the native G-CSF, namely achieving an improved degree of biological activity, whether it be improved solution solubility (as described in the Camble references), agonist or antagonist properties (as described in Cunningham), or reduced adverse response, increased solubility, desirable circulatory levels and therapeutic efficacy (as described by the Shaw references). The Decision further concludes that “[t]he prior art has shown that the problems of activity, solution stability, solubility, etc. are all addressed by known mutations in the art. The skilled artisan would have pursued any combination of these known options to provide a particularly desired improvement over unaltered G-CSF.” Decision 12. While Patent Owner places much emphasis on why the skilled artisan would have chosen specific examples over others, the case law suggests that all of the examples suggesting some degree of hematopoietic activity would have been at the skilled artisan disposal. A person of ordinary skill in the art would have good reasons to pursue the known options within his or her technical grasp. See KSR, 550 U.S. at 402-403. Accordingly, Patent Owner has not argued that the skilled artisan would not have combined the Appeal 2013-004840 Reexamination Control 95/000,440 Patent 7,381,804 B2 6 separately disclosed mutations in a native G-CSF molecule to predictably achieve an analog with each of these known desirable properties. Regarding, Patent Owner‟s evidence of unpredictability, the Decision state that Patent Owner‟s expert testimony does not address the known analogs in the art or the properties they are known to provide . . . . The skilled artisan having evidence, from the Shaw, Camble, and Cunningham references, of known analogs which are known to have certain properties would have had a reasonable expectation of success in combining the mutations of these analogs for providing the properties thereof. Patent Owner has provided no meaningful evidence to the contrary. While we agree that the properties identified in the prior art must be verified for each analog and that some combined analogs may not, in fact, possess the expected properties, verification is not indicative of nonobviousness because the expectation of success need only be reasonable, not absolute. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1367-369 (Fed. Cir. 2007) (simply because the properties of a compound must be verified through testing does not mean that the compound satisfies the test for patentability "since the expectation of success need only be reasonable, not absolute"). The evidence shows that such verification was routine in the art. Decision 15-16. We find no error in this determination as the Patent Owner has not shown why the skilled artisan would not have expected the exemplary mutations described in the prior art to have the expected combined attributes, particularly considering the express finding in the prior art that (1) Camble describes the mutations as combinable (Decision 6) and (2) that the mutations of Camble may be further modified by the mutations in Shaw (Decision 9). The prior art directs the skilled artisan not only to specific exemplary point mutations, including those that fall within the Appeal 2013-004840 Reexamination Control 95/000,440 Patent 7,381,804 B2 7 claimed locations, but also suggests that these exemplary point mutations exhibit some degree of hematopoietic activity. Thus, the predictability of hematopoietic activity for exemplary point mutations has been established by the prior art. Further, the Decision recognizes that “low activity may be just as desirable of a property, perhaps such that the analog may be used as an agonist or antagonist, as is high activity.” Decision 13. Accordingly, Patent Owner‟s assertion of unpredictability without “the three-dimensional framework provided in the ‟804 Patent” is not persuasive. Request 9. Moreover, we agree with the Requester that the Patent Owner‟s claims are not directed to any particular G-CSF analogs, but to a set of G- CSF analogs that have point mutations to the native G-CSF in specific locations and that have hematopoietic activity. The Decision states that “[w]hile it is apparent that certain exemplary combinations would have fallen within the scope of the claims, the claims are quite broad and many combinations of modifications disclosed in the art would have met the claims‟ limitations.” Decision 11. Wyeth’s applicability Patent Owner asks us to consider the holding of Wyeth and Cordis Corp. v. Abbott Laboratories, 720 F.3d 1380, 2013 WL 3198008 (Fed. Cir. June 26, 2013). Wyeth is distinguishable in that it considers the issue of undue experimentation not with respect to obviousness but rather with respect to whether the patent‟s disclosure is sufficiently enabling. The holding in Wyeth states that the patent‟s specification provided no guidance or predictions about particular substitutions that might preserve the desired activity observed in the native compound. See 720 F.3d at 1384. It is Appeal 2013-004840 Reexamination Control 95/000,440 Patent 7,381,804 B2 8 reasonable that a specification is not properly enabled if the skilled artisan would have no guidance as to how to synthesize candidate compounds or which candidate compounds might have the desired activity. 6 See 720 F.3d at 1386. As discussed in detail above, unlike in Wyeth, the Decision in the present case describes a finite number of exemplary mutations to native G- CSF, the resulting properties thereof, and why these properties are known advantages which would have directed the skilled artisan to use the known mutations. For the foregoing reasons, we decline to modify our decision affirming the Examiner‟s rejections of claims 1-8 under 35 U.S.C. § 103 based on the teachings of the Camble, Cunningham and Shaw references as detailed in the Decision. REHEARING DENIED 6 While an interesting issue with respect to the present case considering the lack of guidance and examples in the ‟804 Patent as to which of the large number of analogs that fall within the structural requirements of the claims also exhibit hematopoietic activity, the issue of enablement of the claims of the ‟804 Patent are not before us and not appropriate for inter partes reexamination of original claims. See 35 U.S.C. § 301 and 311 (limiting the scope of inter partes reexamination of original claims to rejections based on prior art patents and printed publications). Appeal 2013-004840 Reexamination Control 95/000,440 Patent 7,381,804 B2 9 PATENT OWNER: FINNEGAN, HENDERSON, FARABOW, GARRET & DUNNER, LLP 901 NEW YORK AVENUE, NW WASHINGTON, DC 20001-4413 THIRD-PARTY REQUESTER: ROTHWELL, FIGG, ERNST & MANBECK, P.C. 607 14 th ST., NW SUITE 800 WASHINGTON, DC 20005 cu