Ex Parte Dietrich et alDownload PDFPatent Trials and Appeals BoardMay 2, 201914371161 - (D) (P.T.A.B. May. 2, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 14/371,161 07/08/2014 Alexandra Dietrich 48329 7590 05/06/2019 FOLEY & LARDNER LLP 3000 K STREET N.W. SUITE 600 WASHINGTON, DC 20007-5109 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. 118577-0103 8657 EXAMINER REYNOLDS, FRED H ART UNIT PAPER NUMBER 1654 NOTIFICATION DATE DELIVERY MODE 05/06/2019 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): ipdocketing@foley.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ALEXANDRA DIETRICH and MICHAEL MYERS Appeal 2017-008617 1 Application 14/3 71,161 Technology Center 1600 Before FRANCISCO C. PRATS, JOHN G. NEW, and J. JOHN LEE, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to methods of preparing modified collagen. The Examiner rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE The sole ground of rejection before us for review is the Examiner's rejection of claims 19, 20, 28-32, and 38-42 under 35 U.S.C. § 103(a) as 1 Appellants identify Innocoll Pharmaceuticals Limited as the real party in interest. Br. 2. Appeal2017-008617 Application 14/3 71,161 being unpatentable over Chen,2 Chvapil,3 Noishiki,4 a webpage describing a science module for middle school chemistry relating to dissolution ("Middle School Chemistry"), 5 Einstein, 6 and the webpage "Introduction to Lyophilization."7 Ans. 2-6. Claim 19 is the sole independent claim on appeal and reads as follows: 19. A method for manufacturing a composition comprising a modified collagen, the method comprising the steps of: (a) providing isolated collagen; (b) freezing the isolated collagen to obtain frozen collagen; ( c) dehydrating the frozen collagen to obtain dehydrated collagen; ( d) maintaining the dehydrated collagen at a temperature of about 40°C to about 65°C for a period of at least one week; ( e) preparing an aqueous dispersion of the collagen obtained in step (d); (f) mechanically degrading the aqueous dispersion; and (g) dehydrating the aqueous dispersion. 2 US 2001/0014667 A 1 (published Aug. 16, 2001 ). 3 M. Chvapil et al., Effect of Collagen Cross linking on the Rate of Resorption of Implanted Collagen Tubing in Rabbits, 11 J. BIOMED. MATER. RES. 297-314 (1977). 4 Yashuharu Noishiki et al., Succinylated Collagen Crosslinked by Thermal Treatmentfor Coating Vascular Prostheses, 22 ARTIF. ORGAN 672-680 (1998). 5 http://middleschoolchemistry.com/lessonplans/chapter5/lesson6 (available online Nov. 2010). 6 A. Einstein, On the Movement of Small Particles Suspended in Stationary Liquids Required by the Molecular-Kinetic Theory of Heat, 17 ANN. PHYS. 549-560 (1905). 7 http://www. sub limationscience.com/T eaching/Introduction %20to%20Lyophilization/lntroduction.html (available online Mar. 2009). 2 Appeal2017-008617 Application 14/3 71,161 Appeal Br. 15 ( emphasis added). DISCUSSION As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden ... of presenting a primafacie case ofunpatentability .... After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. In KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,415 (2007), the Supreme Court emphasized "an expansive and flexible approach" to the obviousness question, but also reaffirmed the importance of determining "whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue." Id. at 418 (emphasis added). Ultimately, therefore, "[i]n determining whether obviousness is established by combining the teachings of the prior art, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 199 5) (internal quotations omitted). In the present case, we are not persuaded that preponderant evidence supports the Examiner's conclusion that the process recited in Appellants' claim 19 would have been obvious. In particular, we are not persuaded that the cited references would have suggested a process that includes claim 19's step of maintaining frozen and dehydrated collagen at a temperature of about 40°C to about 65°C for a period of at least one week. See Appeal Br. 15. In finding that it would have been obvious to maintain frozen and dehydrated collagen at a temperature of about 40°C to about 65°C for a period of at least one week, the Examiner found that the combined teachings 3 Appeal2017-008617 Application 14/3 71,161 of Chen, Chvapil, and Noishiki suggest thermally crosslinking collagen when preparing collagen for therapeutic uses: It would be obvious to use thermal crosslinking in the method of Chen et al to increase the lifetime of the material in the body as described by Chvapil et al, while avoiding the toxicity of chemical crosslinking, as described by Noishiki et al. As N oishiki et al show that thermal crosslinking is effective, and Chen et al mentions thermal crosslinking, an artisan in this field would attempt this with a reasonable expectation of success. Ans. 5. We acknowledge Chen's disclosure of a method of preparing a collagen membrane by a process that includes freeze drying (Chen ,-J 30), as well as Chen's disclosure that the membrane "can be crosslinked by elevated thermal storage" (id. ,-i 33). We acknowledge Chvapil's disclosure that, when preparing collagen for therapeutic use as a blood vessel prosthesis, the degree of crosslinking affects how the collagen functions in vivo: Rapid [collagen] resorption may be fatal, overly slow degradation of collagen tube will slow the rate of capillary ingrowth, formation of pseudoendothelium layer, and replacement of the prosthesis by tissue components mimicking the structure of normal vessel walls .... [S]olubility, swelling and resorption by collagenase depends on the degree of crosslinking. Chvapil 298 ( citations omitted). We acknowledge Noishiki's teaching that, when preparing a vascular prosthesis that includes collagen, the collagen may be "air dried and thermally crosslinked ... at 130°C for 20 h." Nosihiki 673. We are not persuaded, however, that Noishiki's teaching of thermally crosslinking collagen at 130°C for 20 hours would have suggested that a 4 Appeal2017-008617 Application 14/3 71,161 skilled artisan should, instead, maintain the collagen at a temperature of about 40°C to about 65°C for a period of at least one week, as required by Appellants' claim 19. Even acknowledging Chvapil's teaching that the degree of crosslinking affects how the collagen functions in vivo, the Examiner identifies no evidence of record suggesting that treating collagen for the time and temperature required by Appellants' claim 19 would result in any degree of collagen crosslinking, much less a degree of crosslinking that would be desirable in the applications disclosed in the cited references. To the contrary, the sole evidence of record specifying a suitable time and temperature for crosslinking collagen for a therapeutic use, Noishiki, teaches a much higher temperature and a much shorter time than recited in Appellants' claim 19. We acknowledge, as the Examiner contends, that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or working ranges by routine experimentation." In re Aller, 220 F.2d 454, 456 (CCPA 1955). As our reviewing court has explained, where a claimed range overlaps or abuts ranges taught in the prior art, a prima facie case of obviousness based on optimization may be present. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). Again, however, in the present case the only disclosure identified by the Examiner that specifically describes conditions that produce desirable collagen crosslinking, Noishiki, teaches a much higher temperature and a much shorter time than recited in Appellants' claim 19. Given the vast difference between the time and temperature required by Appellants' claim 19, and the conditions suitable for crosslinking collagen described in the references cited by the Examiner, we are not persuaded that the cited 5 Appeal2017-008617 Application 14/3 71,161 references would have suggested a process that includes the thermal step required by claim 19. To be complete, we acknowledge that increased heat can increase the rate of dissolution, and that heat can increase the molecular motion of microscopically visible particles in suspension. See Middle School Chemistry generally; see also Einstein generally. We also acknowledge that, after freeze drying a substance, residual water can be removed by treating at from 30 to 40°C for about 4 hours. Introduction to Lyophilization 2-3. The Examiner fails to explain sufficiently, however, how these teachings suggest treating freeze-dried collagen at a temperature of about 40°C to about 65°C for a period of at least one week, as required by Appellants' claim 19, particularly in light ofNoishiki's teaching that, when preparing collagen for therapeutic uses, suitable crosslinking conditions are 130°C for 20 hours. In sum, for the reasons discussed, we are not persuaded that the Examiner has shown sufficiently that the cited references would have suggested a process having all of the steps required by Appellants' claim 19. We, therefore, reverse the Examiner's rejection claim 19, and its dependent claims, over the cited references. REVERSED 6 Copy with citationCopy as parenthetical citation