Ex Parte Palczewski et al

Patent Trial and Appeal Board

Jul 12, 2017

13420465 (P.T.A.B. Jul. 12, 2017)

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. 13/420,465 03/14/2012 KRZYSZTOF PALCZEWSKI 066765-0139/8001.US03 1064 110661 7590 07/20/2017 McDermott Will & Emery LLP (University of Washington) 500 North Capitol Street NW Washington, DC 20001 EXAMINER HUANG, GIGI GEORGIANA ART UNIT PAPER NUMBER 1621 NOTIFICATION DATE DELIVERY MODE 07/20/2017 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): mweipdocket @ mwe. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KRZYSZTOF PALCZEWSKI and DAVID A. SAPERSTEIN Appeal 2015-003640 Application 13/420,465 Technology Center 1600 Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and DAVID COTTA, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35U.S.C. § 134 involving claims to a method for treatment of an endogenous 11-cis-retinal deficiency in a human eye. The Examiner rejected the claims as obvious and on the ground of obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Statement of the Case Background “Leber Congenital Amaurosis is a very rare childhood condition that affects children from birth or shortly there after. It affects both rods and cones. There are a few different gene defects that have been associated with 1 Appellants identify the Real Party in Interest as University of Washington (see App. Br. 1). Appeal 2015-003640 Application 13/420,465 the disease. These include the genes encoding the RP65 and LRAT proteins” (Spec. 113). “Photoreceptor function can be restored or stabilized, for example, by providing a synthetic retinoid act [sic, acting?] as an 11 -cis- retinoid replacement. . . The synthetic retinoid also can ameliorate the effects of a retinoid deficiency on a vertebrate visual system” (Spec. 139). The Claims Claims 59-61, 63, 64, 66-68, 70-73, and 75-81 are on appeal. Independent claim 59 is representative and reads as follows: 59. A method for treatment of an endogenous 11-cis-retinal deficiency in a human eye, the method comprising: administering to a human subject an effective amount of 9-cis-retinal, wherein the 9-cis retinal is administered by intraocular or periocular injection. The Issues A. The Examiner rejected claims 59, 61, 63, 64, 66, 67, 70-72, and 75- 81 under 35 U.S.C. § 103(a) as obvious over Van Hooser2 (Ans. 2-4). B. The Examiner rejected claims 60, 68, and 73 under 35 U.S.C. § 103(a) as obvious over Van Hooser and Freeman3 (Ans. 4-6). C. The Examiner provisionally rejected claims 59, 61, 63, 64, 66, 67, 70- 72, and 75-81 on the ground of nonstatutory double patenting as being unpatentable over claims 59-62, 64-66, and 68-70 of copending Application No. 13/619,6074 in view of Van Hooser. 2 Van Hooser et al., Recovery of Visual Functions in a Mouse Model of Leber Congenital Amaurosis, 277 J. Biol. Chem. 19173-82 (2002). 3 Freeman, US 5,869,468, issued Feb. 9, 1999. 4 This application issued as US 8,962,691 on Feb. 24, 2015. 2 Appeal 2015-003640 Application 13/420,465 Because all of the Examiner’s rejections turn on the same issue, the prior art status of Van Hooser, we will consider these rejections together. The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that the Palczewski Declaration5 is insufficient to remove Van Hooser as prior art? Findings of Fact 1. Van Hooser was published on May 24, 2002, with ten authors, including Dr. Krzysztof Palczewski (see Van Hooser 19173). 2. US provisional application 60/455,182 was filed Mar. 14, 2003, listing a single inventor, Dr. Krzysztof Palczewski (see Provisional Application Cover Sheet, filed Mar. 14, 2003). 3. PCT/US 04/07937 was filed Mar. 15, 2004, claiming benefit of priority to US 60/455,182 and listing two inventors, Dr. Krzysztof Palczewski and Dr. David A. Saperstein (see PCT/RO/101, filed Mar. 15, 2004). 4. US 10/548,612 was filed Sept. 7, 2005 as a US national stage application of PCT/US 04/07937 under 35 U.S.C. § 371, and the instant application, US 13/420,465, filed Mar. 14, 2012, is a continuation of US 10/548,612. Both of these Applications list two inventors, Dr. Krzysztof Palczewski and Dr. David A. Saperstein (see Bibliographic Data Sheet, July 16, 2013). 5. The Palczewski Declaration states: I declare that the subject matter in the Van Hooser reference relied on to reject the claims of the instant application in the 5 Declaration of Dr. Krzysztof Palczewski, dated Nov. 6, 2013. 3 Appeal 2015-003640 Application 13/420,465 rejections ... is my own work, and is not “by another”, notwithstanding that the Van Hooser reference names other individuals as coauthors. The co-authors J. Preston Van Hooser, Yan Liang, Tadao Maeda, Vladimir Kuksa, Geeng-Fu Jang, Yu-Guang He, Fred Rieke, Henry K.W. Fong, and Peter B. Detwiler worked under my direction and supervision and/or did not contribute to the conception of the invention as presently claimed in the instant application. (Palczewski Deck 14). 6. The Palczewski Declaration also states: Further, I declare that the inventorship of the instant application is correct, i.e., that Dr. Saperstein and I are correctly named as inventors of the presently claimed subject matter in the instant application. The Van Hooser reference discloses subject matter invented by me, rather than invented by my co-authors of the Van Hooser reference. (Palczewski Deck 1 5). Principles of Law Where the applicant is one of the co-authors of a publication cited against his or her application ... the applicant may overcome the rejection by filing a specific affidavit or declaration under 37 CFR 1.132 establishing that the article is describing applicant’s own work. An affidavit or declaration by applicant alone indicating that applicant is the sole inventor and that the others were merely working under his or her direction is sufficient to remove the publication as a reference under pre-AIA 35 U.S.C. 102(a). In re Katz, 687 F.2d 450 . . . (CCPA 1982). MPEP § 715.01(c)(1). 4 Appeal 2015-003640 Application 13/420,465 Analysis The Examiner contends that “provisional application of 60/455182 only names a single inventor: Palczewski - which does not support for a claimed invention which is to two inventors as addressed by the declaration; which further addresses that the claimed invention is only supported to the priority date of 3/15/2004” (Ans. 8). The Examiner finds that, in the alternative situation where: “Even if one could assert that the provisional of 60/455182 which is only to Palczewski, supports the instant claims which are to both Palczewski and Saperstein; the claim is to two inventors and Van Hooser is now only invented by Palczewski (per the declaration) which it is still ‘by another’ and still be prior art” (Id.). Appellants contend to the extent that the Examiner’s analysis turns on the fact that the instant inventive entity includes Dr. Saperstein as a co- inventor, who is not named on the cited Van Hooser reference, it is clear that the earlier reference may be removed as the work of a subset of the joint inventors of a patent application. Dr. Palczewski has unequivocally stated in the § 1.132 Declaration that the portion of Van Hooser that is relied on in the present rejection is his own work. Thus, Van Hooser is not prior art as to the present application. (App. Br. 9). We find that Appellants have the better position and we agree with their detailed and careful analysis of the MPEP and caselaw. In particular, as the MPEP notes: “The fact that an application has named a different inventive entity than a patent does not necessarily make that patent prior art.” Applied Materials Inc. v. Gemini Research Corp., 835 F.2d 279, 15 USPQ2d 1816 (Fed. Cir. 1988). The issue turns 5 Appeal 2015-003640 Application 13/420,465 on what the evidence of record shows as to who invented the subject matter.... In fact, even if applicant’s work was publicly disclosed prior to his or her application, applicant’s own work may not be used against him or her in an application subject to pre-AIA 35 U.S.C. 102 unless there is a time bar under pre-AIA 35 U.S.C. 102(b). MPEP § 2136.05. In this case, we agree with Appellants that Dr. Palczewski’s Katz type 1.132 declaration properly removed the Van Hooser reference as prior art against Dr. Palczewski’s invention (FF 5-6). We agree with Appellants that: As clearly stated in MPEP § 2137(V), a joint inventor must make “some contribution to at least one of the claims made by each of the named inventors”. Further, joint inventors do not need to make a contribution to the subject matter of every claim of the patent application. MPEP § 2137(V). Thus, the statements in the Declaration are not inconsistent. Dr. Palczewski is the inventor of the subject matter disclosed in the Van Hooser reference and Dr. Saperstein made an inventive contribution to at least one claim of the patent. (Reply Br. 4). Therefore, Van Hooser was removed as prior art consistent with Katz. We also agree that the claim for benefit of priority to provisional US 60/455,182 by PCT US 04/07937 is proper. As Appellants explain: Under 35 U .S.C. § 119(e)(1) four requirements must be met for a non-provisional application to claim priority to a provisional application: 1. The provisional application must comply with the requirements of section 112, first paragraph and the non-provisional must be for the same invention; 6 Appeal 2015-003640 Application 13/420,465 2. The non-provisional application must be filed within 12-months of the provisional filing date; 3. There must be an overlap of inventors between the provisional and nonprovisional applications; and 4. The non-provisional application must include a specific reference to the provisional. E.I. du Pont v. MacDermid Printing, 525 F.3d 1353 (Fed. Cir. 2008). The only issue for priority raised by the Examiner in the Advisory Action relates to overlap of inventorship. Both the 60/455,182 provisional application and the present application name Krzysztof Palczewski as inventor. Thus, the present application has overlap of at least one inventor with the 60/455, 182 provisional application. App. Br. 10-11. As the present application and the 60/455,182 provisional share a common inventor, and as the Examiner has not identified any other deficiencies in the Appellant’s claim to priority from the provisional, we find that the Examiner erred in denying Appellants claim to priority. Conclusion of Law The evidence of record does not support the Examiner’s conclusion that the Palczewski Declaration is insufficient to remove Van Hooser as prior art. In addition, the evidence does not support the Examiner’s conclusion that the claim for benefit of priority to provisional US 60/455,182 by PCT US 04/07937 is improper. SUMMARY In summary, we reverse the rejection of claims 59, 61, 63, 64, 66, 67, 70-72, and 75-81 under 35 U.S.C. § 103(a) as obvious over Van Hooser. 7 Appeal 2015-003640 Application 13/420,465 We reverse the rejection of claims 60, 68, and 73 under 35 U.S.C. § 103(a) as obvious over Van Hooser and Freeman. We reverse the rejection of claims 59, 61, 63, 64, 66, 67, 70-72, and 75-81 on the ground of nonstatutory double patenting as being unpatentable over claims 59-62, 64-66, and 68-70 of copending Application No. 13/619,607 in view of Van Hooser. REVERSED 8