Ex Parte NyteDownload PDFPatent Trial and Appeal BoardJun 22, 201511232688 (P.T.A.B. Jun. 22, 2015) 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. 11/232,688 09/22/2005 Christopher Philip Nyte 187100/US 6287 7590 06/22/2015 WESTERN PATENT GROUP 6020 TonkowaTrail Georgetown, TX 78628 EXAMINER HOUSTON, ELIZABETH ART UNIT PAPER NUMBER 3773 MAIL DATE DELIVERY MODE 06/22/2015 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 THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte CHRISTOPHER PHILIP NYTE1 ____________________ Appeal 2012-011869 Application11/232,688 Technology Center 3700 ____________________ Before ULRIKE W. JENKS, ROBERT A. POLLOCK, and JACQUELINE T. HARLOW, Administrative Patent Judges. HARLOW, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a method and system for treatment of internal nasal valves. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 According to Appellant, the Real Party in Interest is E. Antonio Mangubat (App. Br. 3). Appeal 2012-011869 Application 11/232,688 2 STATEMENT OF THE CASE Non-surgical methods of internal nasal valve repair may “reduce morbidity, eliminate hospital stays, and shorten recovery periods” relative to prior art surgical techniques (Spec. at 2 ¶ 6). The Specification teaches a non-surgical treatment for internal nasal valve collapse that includes “injecting a biomaterial filler into the internal nasal valve of the patient” to increase the “internal nasal valve angle” (id. at 2 ¶ 7). The Specification discloses that the “biomaterial filler may be a gel cartilage matrix” (id. at 2 ¶ 9). Claims 1–7 and 10 are on appeal.2 Claim 1, the only independent claim on appeal, reads as follows (emphasis added): A method for treating an internal nasal valve of a patient comprising, injecting a biomaterial filler from a syringe and through a needle into the internal nasal valve of the patient, said biomaterial filler being present in a flowable state sufficient to enable its passage from said syringe, through said needle and into said internal nasal valve, wherein the injected biomaterial filler in the internal nasal valve increases an internal nasal valve angle. Claims 2–7 and 10, the remaining claims on appeal, each depend from claim 1. The claims stand rejected as follows: I. Claims 1–7 and 10 stand rejected under 35 U.S.C. § 112 first paragraph as failing to comply with the written description requirement. II. Claims 1–7 and 10 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Hurbis3 and Krueger.4 2 The Examiner has withdrawn the rejection with respect to claims 8, 9, and 11 (Ans. 5). Appeal 2012-011869 Application 11/232,688 3 I. Issue The Examiner has rejected claims 1–7 and 10 under 35 U.S.C. § 112 first paragraph as failing to comply with the written description requirement. The Examiner finds that the Specification does not disclose that “the biomaterial filler is in a ‘flowable state’” (Ans. 2). Appellant contends that repeated reference in the Specification to “aliquots of biomaterial filler to be injected through a syringe . . . the aliquots being expressed by volume in milliliters, and described as being injected from a syringe through a needle” (App. Br. 7) demonstrates possession of the claimed invention. The issue presented is whether the Specification satisfies the written description requirement as to the “said biomaterial filler being present in a flowable state sufficient to enable its passage from said syringe, through said needle and into said internal nasal valve” aspect of claim 1. Principles of Law The test for determining whether a specification is sufficient to support a particular claim “is whether the disclosure of the application relied upon ‘reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter.’” Ralston Purina Co. v. Far- Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375 (Fed. Cir. 1983)). 3 Hurbis, US 6,106,541, issued Aug. 22, 2000. 4 Krueger et al., US 6,899,105 B2, issued May 31, 2005 (hereinafter “Krueger”). Appeal 2012-011869 Application 11/232,688 4 “It is not necessary that the application describe the claim limitations exactly, but only so clearly that persons of ordinary skill in the art will recognize from the disclosure that appellants invented processes including those limitations.” In re Wertheim, 541 F.2d 257, 262 (CCPA 1976) (citation omitted); see also Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000) (“In order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.”). Analysis We agree with Appellant that the Examiner has not pointed to evidence or provided sound reasoning to show that the Specification fails to satisfy the written description requirement for the “said biomaterial filler being present in a flowable state sufficient to enable its passage from said syringe, through said needle and into said internal nasal valve” aspect of claim 1. During the course of prosecution, claim 1, which recited a “biomaterial filler” was amended to include the requirement “said biomaterial filler being present in a flowable state sufficient to enable its passage from said syringe, through said needle and into said internal nasal valve” (see Aug. 31, 2011, Amendment at 2). Appellant entered this amendment to traverse the Examiner’s obviousness rejection over Hurbis and Krueger (id.). We agree with Appellant that “the recitation of ‘flowable state’ in claim 1 as it now reads does not introduce any new matter into the Application, nor does the narrowing claim amendment that introduced ‘flowable state’ as a qualifier cause the specification to become lacking in its Appeal 2012-011869 Application 11/232,688 5 written description” (App. Br. 5). The Specification is replete with references to a biomaterial filler that is “present in a flowable state sufficient to enable its passage from said syringe, through said needle and into said internal nasal valve,” as recited in claim 1. For example, the Specification teaches that “[b]iomaterial fillers may include a gel cartilage matrix or calcium hydroxylapatite (CaHA) filler material. . . . Biomaterial used in embodiments of the present invention are injectable through a needle.” (Spec. at 5 ¶ 22). The Specification also discloses injecting biomaterial filler in milliliter aliquots. For example, the Specification teaches, “[i]n another embodiment of the present invention, biomaterial filler, such as CaHA gel, is injected in small aliquots, e.g., 0.05 ml aliquots, at points along the upper lateral cartilage and septum junction in order to produce a stiff scaffolding effect similar to surgically placed septal or conchal cartilage grafting” (Spec. at 6 ¶ 26). We find that the Specification’s description of numerous examples of using milliliter aliquots of gels for injection via needle and syringe in performing the claimed method is sufficient to convey to a skilled artisan that the inventor had possession of the subject matter set forth in claim 1. See Ralston Purina, 772 F.2d at 1575. Conclusion of Law A preponderance of the evidence of record does not support the Examiner’s conclusion that claim 1 does not satisfy the written description requirement. Because they depend from claim 1, the rejection of claims 2–7 and 10 is also reversed. See In re Fine, 837 F.2d 1071, 1076 (Fed. Cir. 1988). Appeal 2012-011869 Application 11/232,688 6 II. Issue The Examiner has rejected claims 1–7 and 10 under § 103(a) as being obvious over Hurbis and Krueger. The Examiner finds that Hurbis discloses every aspect of claim 1, except that it “is silent regarding the filler being compressed in a needle” (Ans. 3). The Examiner finds, however, that Krueger teaches “using a needle/syringe (col. 2, ll. 36-38) with a compressed implant (Fig. 8)” to correct snoring (Ans. 3). The Examiner further finds that [i]t would have been obvious to one of ordinary skill in the art at the time the invention was made to use the needle of Krueger to implant the filler of Hubris as Hubris uses something to insert the implant/filler (col. 3, ll. 2-12) and using a needle for implantation and compression is common in the art for delivering compressed implants and aids in correct placement of the implant/filler. (Ans. 3.) Appellant contends that there is no motivation to combine Hurbis and Krueger. Appellant asserts that the Examiner failed to articulate any reasoning or rational underpinning to support combining the cited references. Appellant argues that the Hurbis “implants are in the solid, non- flowable state, and are surgically implanted (col. 1, lines 52-53),” rather than injectable (App. Br. 13). Appellant further asserts that it would be physically impossible to inject the Hurbis implants through a needle and into a patient’s internal nasal valve, and notes that “[t]he Hurbis specification is devoid of the words ‘syringe’ and ‘needle’, and Hurbis’ implants are inserted into patients using surgical techniques.” (Reply Br. 3.) Appeal 2012-011869 Application 11/232,688 7 The issue presented is whether the Examiner erred in rejecting claims 1–7 and 10 as being obvious because the combination of Hurbis and Krueger is improper. Principles of Law While the analysis under 35 U.S.C. § 103 allows flexibility in determining whether a claimed invention would have been obvious, KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418–419 (2007), it still requires showing that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” Id. at 418. Analysis We agree with Appellant that the Examiner has not pointed to evidence or provided sound reasoning that one skilled in the field at the time of invention would have been motivated to combine Hurbis and Krueger. In addressing the motivation to combine the cited references, the Examiner found that [i]t would have been obvious to one of ordinary skill in the art at the time the invention was made to use the needle of Krueger to implant the filler of Hubris as Hubris uses something to insert the implant/filler (col. 3, II. 2-12) and using a needle for implantation and compression is common in the art for delivering compressed implants and aids in correct placement of the implant/filler. (Ans. 3.) The Examiner did not offer any additional analysis regarding the motivation to combine Hurbis and Krueger in response to Appellant’s nonobviousness arguments (see Ans. 5). On this record, we agree with Appellant that the Examiner’s motivation to combine the cited references is conclusory and falls short of Appeal 2012-011869 Application 11/232,688 8 the “articulated reasoning with some rational underpinning” required to support a conclusion of obviousness. KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). The Examiner has not adequately identified the factual basis for concluding that a person having ordinary skill in the field would reasonably have expected that the Hurbis surgical implant could be inserted into a patient’s internal nasal valve using Krueger’s needle. Neither has the Examiner adequately explained how the cited teachings are to be combined to practice the claimed method. Indeed, Appellant’s argument that “[g]iven the description in Hurbis in the second paragraph of Hurbis’ Detailed Description section, [it is] apparent that the needle of [Krueger] cannot place the implant of Hurbis in a patient in the mechanically-biased fashion taught by Hurbis” stands unchallenged by the Examiner. (App. Br. 15). Conclusion of Law A preponderance of the evidence of record does not support the Examiner’s conclusion that the combination of Hurbis and Krueger renders claim 1 obvious. Because they depend from claim 1, the rejection of claims 2–7 and 10 is also reversed. See In re Fine, 837 F.2d at 1076. Appeal 2012-011869 Application 11/232,688 9 SUMMARY We reverse the rejection of claims 1–7 and 10 under 35 U.S.C. § 112 first paragraph for failure to comply with the written description requirement We reverse the rejection of claims 1–7 and 10 under 35 U.S.C. § 103 based on Hurbis and Krueger. REVERSED cdc Copy with citationCopy as parenthetical citation