11891812 (P.T.A.B. Jul. 10, 2018)

Ex Parte Collins et al

Patent Trial and Appeal BoardJul 10, 2018

11891812 (P.T.A.B. Jul. 10, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 11/891,812 08/13/2007 James E. Collins 26386 7590 07/12/2018 DA VIS, BROWN, KOEHN, SHORS & ROBERTS, P.C. THE DA VIS BROWN TOWER 215 10TH STREET SUITE 1300 DES MOINES, IA 50309 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 8966537/62 2816 EXAMINER CHESTNUT, BARRY A ART UNIT PAPER NUMBER 1648 NOTIFICATION DATE DELIVERY MODE 07/12/2018 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): kentherink@davisbrownlaw.com pattylaw@davisbrownlaw.com shelbykosiek@davisbrownlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAMES E. COLLINS, DAVID A. BENFIELD, DANNY W. CHLADEK, LOUIS L. HARRIS, and DAVIDE. GORCYCA Appeal 2017-003711 Application 11/891,812 Technology Center 1600 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and TIMOTHY G. MAJORS, Administrative Patent Judges. Opinion for the Board filed by MAJORS, Administrative Patent Judge. Opinion Concurring filed by ADAMS, Administrative Patent Judge. DECISION ON APPEAL Appellants 1 submit this appeal under 35 U.S.C. Â§ 134(a) involving claims to a method of growing swine infertility and respiratory syndrome virus. The Examiner rejected the claims for failure to satisfy the written description requirement and for non-statutory obviousness-type double patenting. We have jurisdiction under 35 U.S.C. Â§ 6(b). 1 Appellants identify the Real Party in Interest as Boehringer Ingelheim Vetmedica, Inc. Br. 3. Appeal 2017-003711 Application 11/891,812 We REVERSE and REMAND. STATEMENT OF THE CASE According to the Specification, "[ s ]ince 1987, the swine-producing industry has been subjected to a devastating epidemic of an unknown disease, often referred to a 'Mystery Swine Disease"' (MSD) and "more recently referred to as 'Swine Infertility and Respiratory Syndrome (SIRS)"' and that "researchers have been unable to identify the causative agent." Spec. ,r 2. The Specification explains that MSD/SIRS can quickly spread from one pig to an entire herd, and that "[ f]rom 1987 to 1991, the swine industry has lost millions of dollars in revenue as a result." Id. 2 "According to the present invention, however, the isolation and growth of the infectious agent [i.e., a SIRS virus] causing MSD has been achieved," which isolation the Specification states "is a major breakthrough and discovery." Id. ,r 18. 3 Appellants' invention "is directed to a vaccine and sera for prevention and treatment of mystery swine disease and to a method for its diagnosis in swine." Id. ,r 6. The Specification explains that the vaccine is derived from an infectious agent "obtained from an inoculum of processed tissue of swine infected with the disease [MSD/SIRS], preferably lung tissue" and that preferably "the infectious agent is the product of an in vitro mammalian cell 2 The application on appeal was filed on August 13, 2007, but claims priority to a series of parent applications, the earliest of which was filed on August 26, 1991 (U.S. Appl. No. 07/749,839). 3 The Specification states that "[a] viral agent causing SIRS has been deposited on Jul. 18, 1991 ... under the accession number ATCC VR- 2332." Spec. ,r 8. 2 Appeal 2017-003711 Application 11/891,812 culture such as a simian cell line infected with the inoculum of the infected swine tissue." Id. ,r 7. According to the Specification, "[p]referably the mammalian cells are monkey kidney cells, most preferably African green monkey kidney embryonic cells - monkey kidney cell line (MA- I 04 ). " Id. i124. Claims 6-10 are on appeal. Claim 6, the only independent claim, is illustrative and is reproduced below: 6. A method of growing swine infertility and respiratory syndrome virus comprising: (a) inoculating swine infertility and respiratory syndrome virus on a first culture of simian cells; (b) incubating the inoculated first culture; ( c) lysing the incubated first culture prior to the appearance of cytopathic effects in the first culture to form a lysate; ( d) inoculating the lysate on a second culture of simian cells; ( e) incubating the inoculated second culture; and (f) titrating the swine infertility and respiratory syndrome virus comprising: (i) inoculating serial dilutions of the swine infertility and respiratory syndrome virus on simian cells; (ii) incubating the inoculated simian cells for at least 5 days; and (iii) calculating the 50% tissue culture infective dose (TCID50) of the swine infertility and respiratory syndrome virus. Br. 32 (Claims App.). The claims stand rejected as follows: I. Claims 6-10 under 35 U.S.C. Â§ 112, first paragraph (pre-AIA) for failure to satisfy the written description requirement. 3 Appeal 2017-003711 Application 11/891,812 II. Claims 6-10 for non-statutory obviousness-type double patenting over the following: U.S. Patent No. 7,264,804 (claims 15-17); U.S. Patent No. 6,982,160 (claims 6-9); U.S. Patent No. 6,241,990 (claims 1-9); U.S. Patent No. 6,110,468 (claims 1-9); U.S. Patent No. 5,846,805 (claims 16-18); U.S. Patent No. 6,080,570 (claims 1-13); and U.S. Patent No. 5,840,563 (claims 1-9). I. WRITTEN DESCRIPTION The Examiner rejected claims 6-10 for including new matter and, thus, for failure to comply with the written description requirement. Ans. 2- 4. According to the Examiner, claim 6's step (c), which recites "lysing the incubated first culture prior to the appearance of cytopathic effects in the first culture to form a lysate," is unsupported in Appellants' Specification. Id. at 2-3. The closest support, the Examiner asserts, is in paragraphs 41 and 55, yet, those paragraphs "do not appear to provide support for a general indication that one would always lyse (using any process) simian cells prior to the appearance of CPE ... [and] the specification does not disclose any process of lysing (only the freeze thaw)." Id. at 3--4. We are unpersuaded. As Appellants point out, the Specification discloses expressly, as part of the process of growing and isolating the SIRS virus, that "[i]f no cytopathic effect (CPE) was observed within seven days, cultures were frozen, thawed and inoculated on MA-104 cells and incubated." Spec. ,r 55; Br. 13. Also, after processing of the virus in a simian cell line (MA-104), the Specification discloses generally that mice, pigs, and other mammals can 4 Appeal 2017-003711 Application 11/891,812 be immunized "with MSD containing cell culture lysate or gradient purified MSD as described above." Spec. ,r,r 24--27 ( emphasis added). The Specification further describes filtering a homogenate of cellular tissues to release and recover the desired viral agent. Id. ,r 21. Appellants contend, citing supporting evidence, that cell lysis is a widely-used technique for processing cellular samples and releasing cellular contents ( e.g., nucleic acids, viral agents, etc.), and that freeze/thaw, sonication, homogenization and filtering are well-known techniques used for lysis. Br. 12. The Examiner provides no persuasive rebuttal to the contrary. Nor does the Examiner provide evidence that methods other than freeze/thaw would provide a result other than what the skilled artisan would expect - cell lysis. Instead, the Examiner states that there is no support for the notion that "one would always lyse" before CPE appears without explaining why such support is even required. Ans. 3--4. The fact remains that the Specification describes at least one process where simian cells are lysed (via freeze/thaw) prior to appearance of CPE. Spec. ,r 55. The Examiner admits that freeze/thaw is disclosed in the Specification, and that it is a known method of lysis. Ans. 3--4. But the Examiner criticizes the Specification's lack of detail about freeze/thaw (or other lysis techniques). Ans. 3 ("The only indication of a type of lysis is a freeze-thaw, which is not disclosed in the specification in sufficient detail."). The Specification, however, "preferably omits from the disclosure any routine technology that is well known at the time of [the] application." Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254 (Fed. Cir. 2004) (citations omitted). Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005) ("[t]he descriptive text needed 5 Appeal 2017-003711 Application 11/891,812 to meet these requirements varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence."). We are satisfied on this record that the Specification's example using the freeze/thaw technique, its description of using lysates as inoculants, and the routine knowledge already in existence at the time of the invention related to lysis techniques is sufficient to show possession of the claimed subject matter. Because the preponderance of the evidence does not support the Examiner's rejection for failure to comply with the written description requirement, we reverse. II. DOUBLE PATENTING As noted above, the Examiner rejected claims 6-10 of the pending application for non-statutory obviousness-type double patenting over seven U.S. patents. Ans. 5-20. These patents all appear to have issued from, or be directly related to, applications to which the present application claims priority. See Spec. ,r 1. The present application claims the benefit of a series of continuation applications, each of which descended from US Application No. 08/316,529 (filed on September 30, 1994), which was a divisional application that later issued as U.S. Patent No. 5,846,805. Ans. 14--15; Spec. ,r 1. And, like the present application, this divisional application claims the benefit of the earlier filing dates of further continuation and continuation-in-part applications, the earliest of which was filed on August 26, 1991. Spec. ,r 1. 6 Appeal 2017-003711 Application 11/891,812 For the reasons below, we remand this case to the Examiner for reconsideration of the double patenting rejections on appeal. 37 C.F.R. Â§ 4I.50(a)(l)-(2). 4 First, the Examiner should provide sufficient findings and analysis on whether (or not) the safe harbor under 35 U.S.C. Â§ 121 is applicable to the double patenting rejections presented here. The assertion thatÂ§ 121 "does not apply where the present application is other than a divisional application" (Ans. 6) overstates the law. See, e.g., Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1353 (Fed. Cir. 2009) ("[A] patent 4 On remand we also encourage consideration whether the continued prosecution of this application is in applicants' interests. The application was filed on August 13, 2007 (after June 8, 1995), yet the application claims the benefit of applications filed in the early 1990s - as noted above, the earliest of which appears to have been filed on August 26, 1991. Spec. ,r 1. Under 35 U.S.C. Â§ 154, the putative expiration of the claims in the present application, should they ever be allowed, would appear to be roughly seven years ago in 2011 (i.e., 20 years after the August 26, 1991 filing date). We do not specifically opine on or foreclose a potential for some term extension, yet we observe that acts taken by the applicants in prosecution may have substantially limited the extension that might be available. See, e.g., Request for Continued Examination filed July 3, 2012; Request for Continued Examination filed on August 19, 2014. It also appears that all the patents applied in the double patenting rejection are expired. As a practical matter, therefore, it may be that the double patenting rejections and the resolution thereof is a moot point for pending claims that, if allowed, have no term remaining. The point of the judge-made doctrine of obviousness- type double patenting is "to prevent an unjustified extension of the term of the right to exclude granted by a patent by allowing a second patent claiming an obvious variant of the same invention to issue to the same owner later." In re Berg, 140 F.3d 1428, 1431-32 (Fed. Cir. 1998) (citation omitted). If there is no reasonable way for the claims, should they issue, to have any remaining term, the right to exclude would appear to have extinguished. 7 Appeal 2017-003711 Application 11/891,812 need not have issued directly from a divisional application to receive Â§ 121 protection. . . . [I]ntervening continuation applications do not render a patent ineligible for Â§ 121 protection so long as they descended from a divisional application filed as a result of a restriction requirement"). To clarify, insofar as the Examiner is suggesting on the present record that Â§ 121 does not apply, the Examiner may be correct, and this remand should not be understood as indicating otherwise. But the record is wanting for a sufficient analysis on that question. Second, the Examiner should address the September 9, 2011 Restriction Requirement ("Restriction") entered in connection with the prosecution of the present application. Pursuant to the Restriction, which does not appear to have been withdrawn, the Office required a restriction between allegedly "distinct" inventions underÂ§ 121. See Restriction, 2. 5 The Office grouped the inventions into five categories and classifications, including, inter alia, "a diagnostic kit for detecting [SIRS]," "a method of growing [SIRS] virus," and "an immunogenic composition comprising attenuated SIRS virus." Id. According to the Office at that time, the "Inventions of Groups I-V are mutually exclusive and patentably distinct products and methods each are structurally and functionally different products and methods which are substantially different. The products are made by different methods, and multiple methods have different uses." Id. 5 The Restriction was entered by a different examiner than the one handling the rejections on appeal. Restriction, 5; Ans. 22. The Restriction appears to have not been raised by Examiner or Appellants in this appeal. Br, passim; Ans., passim. 8 Appeal 2017-003711 Application 11/891,812 at 2-3 ("Restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required."). The Examiner should address the Office's prior position in the Restriction as compared with the Examiner's position on appeal that the pending claims are "not patentably distinct" from the patent claims cited in support of the double patenting rejections. See, e.g., Ans. 6, 8. Lastly, the Examiner should determine whether the claims remain in consonance. See Symbol Techs., Inc. v. Opticon, Inc., 935 F.2d 1569, 1579 (Fed. Cir. 1991) ("Consonance requires that the line of demarcation between the 'independent and distinct inventions' that prompted the restriction requirement be maintained .... Where that line is crossed the prohibition of the third sentence of Section 121 does not apply.") SUMMARY We reverse the rejection for failure to satisfy the written description requirement, and remand for further consideration of the double patenting rejections as explained above. 9 Appeal 2017-003711 Application 11/891,812 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 3 7 C.F .R. Â§ 1.13 6( a )(1 )(iv). REVERSED REMANDED (37 C.F.R. Â§ 4I.50(a)(l)-(2)) 10 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAMES E. COLLINS, DAVID A. BENFIELD, DANNY W. CHLADEK, LOUIS L. HARRIS, and DAVIDE. GORCYCA Appeal 2017-003711 Application 11/891,812 Technology Center 1600 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and TIMOTHY G. MAJORS, Administrative Patent Judges. ADAMS, Administrative Patent Judge, concurring. I concur with the majority's decision to reverse the rejection under the written description provision of 35 U.S.C. Â§ 112, first paragraph. With regard to the rejections under the judicially created doctrine of obviousness-type double patenting, I write separately to direct attention to Ex parte Edward K.Y. Jung and Lowell L. Wood, Jr., 2016 WL 4208332, at *5 (Patent Tr. & App. Bd. August 2, 2016) (nonprecedential) and Ex parte Edward K. Y. Jung and Lowell L. Wood, Jr., 2016 WL 4159312, at *7 (Patent Tr. & App. Bd. August 2, 2016) (nonprecedential). In each of the Appeal 2017-003711 Application 11/891,812 Jung Appeals, this Board reversed the obviousness-type double patenting rejection over a co-pending application, finding: An obviousness-type double patenting rejection as between the two applications is improper under 35 U.S.C. Â§ 121, which states that: [a] patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application. There has been no showing that Appellants failed to maintain consonance with the original restriction requirement. See Gerber Garment Technology Inc. v. Lectra Systems Inc., 916 F.2d 683, 688 (Fed. Cir. 1990). (See 2016 WL 4208332, at *5; 2016 WL 4159312, at *7.) Therefore, I agree with majority's finding that this Application should be remanded to Examiner to consider the foregoing and take appropriate action. 2