Dietmar SONNLEITNERDownload PDFPatent Trials and Appeals BoardDec 2, 20202020002909 (P.T.A.B. Dec. 2, 2020) Copy Citation 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. 15/227,384 08/03/2016 Dietmar SONNLEITNER 2016-1049A 7971 513 7590 12/02/2020 WENDEROTH, LIND & PONACK, L.L.P. 1025 Connecticut Avenue, NW Suite 500 Washington, DC 20036 EXAMINER HOBAN, MELISSA A ART UNIT PAPER NUMBER 3774 NOTIFICATION DATE DELIVERY MODE 12/02/2020 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): eoa@wenderoth.com kmiller@wenderoth.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte DIETMAR SONNLEITNER ____________ Appeal 2020-002909 Application 15/227,384 Technology Center 3700 ____________ Before BENJAMIN D. M. WOOD, BRETT C. MARTIN, and WILLIAM A. CAPP, Administrative Patent Judges. CAPP, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant seeks our review under 35 U.S.C. § 134(a) of the non-final rejection of claims 1–7, 12–17, 20, 21, and 24–32. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. Appeal 2020-002909 Application 15/227,384 2 THE INVENTION Appellant’s invention is a film that covers a bone defect site. Spec. ¶ 1.1 Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. A pre-bonded multilayer film for covering a bone defect site, the pre-bonded multilayer film including: a shaping molding layer for shaping the pre-bonded multilayer film to the bone defect site and at least one cover layer for covering the bone defect site, wherein: the shaping molding layer and the at least one cover layer are completely resorbable, the at least one cover layer consists essentially of a bioresorbable collagen material, and the shaping molding layer at least partially comprises a bioresorbable polymer material. THE REJECTIONS The Examiner relies upon the following as evidence in support of the rejections: Name Reference Date McKay US 2008/0044449 A1 Feb. 21, 2008 Bartee US 2010/0217392 A1 Aug. 26, 2010 Armbruster US 2012/0107407 A1 May 3, 2012 The following rejections are before us for review: 1. Claims 1–7, 12–17, 20, 21, and 24–32 are rejected under 35 U.S.C. § 112(a) for failure to comply with the written description requirement. 1 Paragraph citations to Appellant’s Specification herein shall be to the Printed Publication version of Appellant’s Disclosure US 2016/0338836 A1, pub. Nov. 24, 2016. Appeal 2020-002909 Application 15/227,384 3 2. Claims 1, 2, 5, 6, 14, 15, 17, 20, 24–27, and 30 are rejected under 35 U.S.C. § 102 as being anticipated by McKay. 3. Claim 16 is rejected over McKay under 35 U.S.C. § 102 or, in the alternative, under 35 U.S.C. § 103. 4. Claims 7, 12, and 13 are rejected under 35 U.S.C. § 103 as being unpatentable over McKay. 5. Claims 3, 4, and 31 are rejected under 35 U.S.C. § 103 as being unpatentable over McKay and Armbruster. 6. Claims 12, 13, 16, 21, 28, 29, and 32 are rejected under 35 U.S.C. § 103 as being unpatentable over McKay and Bartee. OPINION Written Description Claims 1–7, 12–17, 20, 21, and 24-32 Claim 1 recites a cover layer that “consists essentially of” a bioresorbable collagen material. Claims App. A substantially similar limitation also appears in independent claim 32. Id. As we understand the Examiner’s rejection, although Appellant’s disclosure describes a cover letter that comprises a bioresorbable collagen material, it does not do so in a manner that limits the amount of additional unclaimed elements that may accompany the claimed elements and, therefore, fails to provide disclosure that conforms to the “consists essentially of” claim language. Non-Final Act. 4. Appellant directs our attention to paragraphs 15 and 42 of the Specification as providing written description support for the claim passage in question. Appeal Br. 5. Paragraph 15, in part, provides: Appeal 2020-002909 Application 15/227,384 4 For good resorption capability of the proposed film it can be provided that the at least one cover layer at least partially and preferably substantially completely comprises a bioresorbable collagen material. Spec. ¶ 15; see also Id. ¶ 42 (“The cover layers 4a and 4b can for example comprise bioresorbable collagen membranes”). In response, the Examiner maintains that, by using the “consisting essentially of” transition phrase, Appellant bears the burden of showing that introducing additional steps or components would materially change the characteristics of the invention. Ans. 4. In reply, Appellant takes the position that the Examiner’s concerns are more properly directed to distinguishing the invention over the prior art than challenging whether there is written description support for the invention. Reply Br. 4. The phrase “consisting essentially of” is a transition that is commonly used to signal a partially open claim in a patent. PPG Industries v. Guardian Industries Corp., 156 F.3d 1351, 1354 (Fed. Cir. 1998). A “consisting essentially of” claim occupies a middle ground between closed claims that are written in a “consisting of” format and fully open claims that are drafted in a “comprising” format. Id. Typically, “consisting essentially of” precedes a list of ingredients in a composition claim or a series of steps in a process claim. By using the term “consisting essentially of,” the drafter signals that the invention necessarily includes the listed ingredients and is open to unlisted ingredients that do not materially affect the basic and novel properties of the invention. Id. Appellant provides adequate written description support for the claim limitation at issue. The Examiner errs in requiring Appellant to shoulder the burden of providing written description support for the exclusion of Appeal 2020-002909 Application 15/227,384 5 unclaimed subject matter that might affect the basic and novel properties of the invention. “In view of the ambiguous nature of the [consisting essentially of] phrase, it has long been understood to permit inclusion of components not listed in the claim, provided that they do not “materially affect the basic and novel properties of the invention.” AK Steel Corp. v. Sollac, 344 F.3d 1234, 1239 (Fed. Cir. 2003). We agree with Appellant that analysis of whether additional components materially affect the basic and novel properties of the invention is better conducted in the context of a patentability analysis under Sections 102 or 103 than under the written description provisions of Section 112. Consequently, we do not sustain the Examiner’s Section 112 rejection related to the “consisting essentially of” phrase. Claims 29 and 32 The Examiner states that there is insufficient written description support for a shaping structure that consists of individual strut-shaped elements with free ends as claimed in claims 29 and 32. Non-Final Act. 4–5. Appellant argues that the drawings disclose elements with free ends as claimed and that the Examiner has admitted as much in the Office Action under review. Appeal Br. 6. In response, the Examiner concedes that Appellant’s figures appear to show elements with free ends. Ans. 4. The Examiner contends, however, that the Specification fails to show such elements in a manner that excludes any other element, step or ingredient. Id. We agree with both Appellant and the Examiner that there is support in the figures for elements with free ends. We will not require Appellant to shoulder a burden of disproving the presence of additional unclaimed Appeal 2020-002909 Application 15/227,384 6 features. Thus, we do not sustain the Examiner’s Section 112 rejection with respect to the free ends limitation. Anticipation of Claims 1, 2, 5, 6, 14, 15, 17, 20, 24–27, and 30 by McKay Appellant argues these claims as a group. Appeal Br. 6–12. Claim 1 is representative. See 37 C.F.R. § 41.37(c)(1)(iv) . The Examiner finds that McKay discloses each and every limitation of claim 1. Non-Final Act. 5–7. Appellant first argues that McKay fails to disclose two “distinct” layers as claimed. Appeal Br. 8. In response, the Examiner identifies element 91 of McKay as corresponding to Appellant’s shape molding layer and element 92 as corresponding to Appellant’s cover layer. Ans. 5. In reply, Appellant argues that it has conducted “field tests” that show that it is not possible to embed a shaping molding layer in a cover layer that consists essentially of a bioresorbable collagen material due to the consistency of collagen. Reply Br. 7. According to Appellant, the layers of the claimed pre-bonded multilayer film are connected together mechanically or chemically such that a novel and inventive multilayer film is provided. Id. Determining whether claims are anticipated involves a two-step analysis. In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). The first step involves construction of the claims of the patent at issue. Id. “During examination, ‘claims ... are to be given their broadest reasonable interpretation consistent with the specification, and ... claim language should be read in light of the specification as it would be interpreted by one of ordinary skill in the art.”’ Id. (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004)). The second step of an anticipation Appeal 2020-002909 Application 15/227,384 7 analysis involves comparing the claims to prior art. Id. A prior art reference anticipates a patent claim under 35 U.S.C. § 102 if it discloses every claim limitation. Id. McKay is directed to a sheet form medical implant device. McKay ¶ 6. McKay’s sheet includes granules of a calcium-containing osteo- conductive material together with a web of biodegradable material that interconnects the granules. Id. ¶ 7. McKay is used to facilitate bone growth to repair a fracture or defect. Id. ¶ 8. McKay discloses implant sheet 90 comprised of a polymeric material 92 that incorporates granules 14. Id. ¶ 62. Implant sheet 90 further includes reinforcing mesh 91 that increases the rigidity and/or tensile strength of the sheet. Id. Suitable material for mesh 91 includes resorbable polymers. Id. Mesh 91 is conformable to a desired shape at the time of surgery and will retain that shape when implanted. Id. [R]einforced sheet 90 can be provided in or deformed to a shape suitable for use in cranial, maxillofacial or dento-alveolar applications in which tissue regeneration is desired. In one application, reinforced sheet 90 can be shaped and used for the augmentation of a human alveolar ridge. Id. In view of the foregoing disclosure of McKay, Appellant’s arguments are not persuasive. Claim 1 merely requires a first layer that is a shape molding layer and a second layer that is a cover layer that consists essentially of a bioresorbable collagen material. Claims App. McKay discloses a medical implant sheet that comprises two layers. McKay ¶ 62, Figs. 12–13. Appellant’s argument that the layers must be “distinct” to any particular degree entails subject matter that is not claimed. Moreover, Appellant does not articulate what it means for two layers to be “distinct” as Appeal 2020-002909 Application 15/227,384 8 opposed to less than “distinct,” much less how we are to draw a distinction between the two. Appellant does not direct us to any disclosure in the Specification that would guide such an inquiry. See generally Appeal Br. Case authority establishes that prior art cannot be distinguished on the ground that it lacks features that are not claim limitations. See, e.g., DDR Holdings, LLC, v. Hotels.com, L.P., 773 F.3d 1245, 1252–54 (Fed. Cir. 2014) (“Anticipation challenges under § 102 must focus only on the limitations actually recited in the claims”). Furthermore, Appellant’s “field test” evidence is not evidence at all. There is no evidence appendix attached to Appellant’s Appeal Brief and Appellant does not cite to any such evidence elsewhere in the record. Naked representations by an attorney as to what “field tests” allegedly show does not rise to the level of evidence that merits our consideration. In re Cole, 326 F.2d 769, 773 (CCPA 1964) (explaining that statements by counsel in a brief cannot take the place of actual evidence). Appellant next argues that McKay lacks a cover sheet consisting essentially of bioresorbable collagen material. Appeal Br. 9. In response, the Examiner directs our attention to paragraph 34 of McKay as disclosing collagen in its cover layer 92. Ans. 5. The Examiner further notes that, in the absence of Appellant providing any evidence concerning the basic and novel characteristics of a cover sheet that “consists essentially of” collagen, McKay satisfies the limitation directed to a cover layer that consists essentially of a bioresorbable collagen material. Id. We agree with the Examiner that Appellant fails to identify, much less establish, the alleged basic and novel characteristics of its collagen cover layer. PPG, 156 F.3d at 1354–55. If Appellant contends that any additional Appeal 2020-002909 Application 15/227,384 9 materials in McKay are excluded by the recitation of “consisting essentially of,” Appellant bears the burden of showing that the introduction of such, otherwise unidentified, components would materially change the characteristics of its invention. In re De Lajarte, 337 F.2d 870, 874 (CCPA 1964). Here, Appellant fails to meet its burden. Next, Appellant argues that there would have been no motivation for a person of ordinary skill in the art to modify McKay to provide a layer that consists essentially of bioresorbable collagen material and that modification to conform to the claim limitations would render McKay unsatisfactory for its intended purpose. Appeal Br. 11. These arguments are not persuasive. Arguments concerning a motivation to modify the prior art are not relevant to an anticipation analysis under Section 102. See e.g., Krippelz v. Ford Motor Co., 667 F.3d 1261, 1269 (Fed. Cir. 2012) (similarly explaining that the concept of “teaching away” is only a component of an obviousness analysis and is not relevant to an anticipation analysis). Appellant argues that McKay is not suitable for use with respect to oral surgery. Appeal Br. 11 (referring to use in oral surgery as “impossible”). This amounts to naked attorney argument that is not supported by evidence. Unsworn attorney argument is not evidence. Icon Health & Fitness, Inc. v. Strava, Inc. 894 F.3d 1034, 1043 (Fed. Cir. 2017). Similarly, attorney arguments that are unsupported by factual evidence are entitled to little probative value. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). As pointed out by the Examiner, McKay explicitly discloses that it may be used in a configuration in which a dental implant stem is received into bone in a patient’s maxillofacial area. Ans. 5 (citing McKay, ¶¶ 61–62). Appeal 2020-002909 Application 15/227,384 10 We have considered Appellant’s remaining arguments and find them to be unpersuasive. In view of the foregoing, we sustain the Examiner’s Section 102 anticipation rejection of claims 1, 2, 5, 6, 14, 15, 17, 20, 24–27, and 30. Unpatentability of Claims 7, 12, 13, and 16 over McKay Appellant does not argue for the separate patentability of these claims apart from arguments presented with respect to claim 1, which we have previously considered. Appellant’s allegations that the Examiner’s proposed modification “fails to cure” alleged deficiencies in McKay is unpersuasive as we previously determined that McKay is not deficient as alleged. Appeal Br. 12. Consequently, we sustain the Examiner’s rejection of claim 7, 12, 13, and 16. See 37 C.F.R. § 41.37(c)(1)(iv) (failure to separately argue claims constitutes a waiver of arguments for separate patentability). Unpatentability of Claims 3, 4, and 31 over McKay and Armbruster Appellant does not argue for the separate patentability of these claims apart from their dependency on claims to which we have already sustained the Examiner’s rejections. Appeal Br. 13. We sustain the Examiner’s rejection of claims 3, 4, and 31. 37 C.F.R. § 41.37(c)(1)(iv). Unpatentability of Claims 12, 13, 16, 21, 28, 29 and 32 over McKay and Bartee Claims 12, 13, 16, 21, 28, and 29 Appellant does not argue for the separate patentability of these claims apart from their dependency on claims to which we have already sustained Appeal 2020-002909 Application 15/227,384 11 the Examiner’s rejections. Appeal Br. 13. We sustain the Examiner’s rejection of claims 3, 4, and 31. 37 C.F.R. § 41.37(c)(1)(iv). Claim 32 Claim 32 is an independent claim that is narrower than claim 1 in that it contains limitations directed to a surface area of the shape molding layer being smaller than the surface area of the cover layer and a shaping structure that has strut-shaped elements with free ends. Claims App. The Examiner relies on Bartee as disclosing these limitations and concludes that it would have been obvious to modify McKay with the teachings of Bartee to achieve the claimed invention. Non-Final Act. 12–15. According to the Examiner, a person of ordinary skill in the art would have done this to facilitate placement of the device as well as comfort and ease of insertion. Id. at 15. Appellant argues that Bartee teaches a shaped structure of titanium that is arranged on a Teflon membrane. Appeal Br. 15. Appellant notes that use of such material requires a second medical procedure to remove Bartee’s device after bone reconstruction has been effected. Id. Bartee is directed to a device that is used to repair a bone defect. Bartee, Abstract. Bartee discloses physical and dimensional features that correspond to the relative size, shape and free end limitations of claim 32. Id. ¶¶ 39–42, Figs 7–10. Appellant’s argument does not apprise us of Examiner error. The argument is viewed as an individual attack on a single reference in a rejection that is based on a combination of references. It is well settled that non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986); In re Appeal 2020-002909 Application 15/227,384 12 Keller, 642 F.2d 413, 425 (CCPA 1981). It is clear from the rejection that the Examiner is relying on McKay for the use of bioresorbable materials and is merely relying on Bartee as demonstrating that it was known to use a particular physical and dimensional configuration to facilitate placement and insertion. We sustain the Examiner’s Section 103 unpatentability rejection of claim 32. CONCLUSION Claims Rejected § Reference(s) Bases Affirmed Reversed 1-7, 12-17, 20, 21, 24-32 112 Written Description 1-7, 12-17, 20, 21, 24-32 1, 2, 5, 6, 14, 15, 17, 20, 24-27, 30 102 McKay 1, 2, 5, 6, 14, 15, 17, 20, 24-27, 30 7, 12, 13, 16 103 McKay 7, 12, 13, 16 3, 4, 31 103 McKay, Armbruster 3, 4, 31 12, 13, 16, 21, 28, 29, 32 103 McKay, Bartee 12, 13, 16, 21, 28, 29, 32 Overall Outcome 1-7, 12-17, 20, 21, 24-32 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation