Peter N. Coneski et al.Download PDFPatent Trials and Appeals BoardAug 30, 201913832302 - (D) (P.T.A.B. Aug. 30, 2019) 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. 13/832,302 03/15/2013 Peter N. Coneski 102109-US2 4598 26384 7590 08/30/2019 NAVAL RESEARCH LABORATORY ASSOCIATE COUNSEL (PATENTS) CODE 1008.2 4555 OVERLOOK AVENUE, S.W. WASHINGTON, DC 20375-5320 EXAMINER GULLEDGE, BRIAN M ART UNIT PAPER NUMBER 1612 MAIL DATE DELIVERY MODE 08/30/2019 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 PETER N. CONESKI, JEFFREY G. LUNDIN, PRESTON A. FULMER, and JAMES H WYNNE ____________ Appeal 2018-000520 Application 13/832,3021 Technology Center 1600 ____________ Before ULRIKE W. JENKS, RACHEL H. TOWNSEND, and DAVID COTTA, Administrative Patent Judges. COTTA, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving antimicrobial fibers. Spec. ¶ 2. The Examiner rejected the claims on appeal as obvious under 35 U.S.C. § 103(a). We affirm. 1 According to Appellants, the real party in interest is the Government of the United States of America, as represented by the Secretary of the Navy. App. Br. 2. Appeal 2018-000520 Application 13/832,302 2 STATEMENT OF THE CASE The Specification discloses that “[b]acterial contamination of clothing and other assets is of constant concern, particularly due to the emergence of antibiotic resistant bacteria. Personnel in hospitals, health care clinics, and military settings are at particular risk.” Spec. ¶ 3. According to the Specification, electrospinning, “an intricate process which utilizes electrostatic forces to create polymeric, ceramic, and sol-gel fibers with nano-scale diameters,” “has recently emerged as a promising method through which to develop novel polymeric fiber and fabric formulations for biological threat protection.” Id. ¶ 4. The Specification discloses that “[m]any approaches have been taken to develop antimicrobial polymer surfaces, of which, several can be tailored to electrospinning.” Id. ¶ 7. However, these approaches “require[] either some form of additional treatment after fabrication or reactivation of the biocidal component prior to subsequent challenges.” Id. “A different approach covalently incorporates biocides as monomers in the polymer backbone which has resulted in polymers exhibiting very promising antibacterial properties,” however this approach, “alters the physical properties of the polymer and would result in a large proportion of the biocide [being] buried within the bulk of the polymer, as opposed to at the surface where microbial interaction is likely to occur.” Id. The Specification discloses “a fiber comprising a polymeric matrix and a quaternary ammonium salt” that “contains at least one aliphatic group and no aromatic groups, is not covalently incorporated into the polymeric matrix, and is present on both the surface and in the interior of the fiber.” Id. ¶ 8. Appeal 2018-000520 Application 13/832,302 3 Claims 1, 6, 7, 9, 10, 21, 22, 25, and 26 are on appeal. Claim 1 is illustrative and reads as follows: 1. A fiber comprising: a polymeric matrix; wherein the polymeric matrix comprises a nylon or a polycarbonate; and a quaternary ammonium salt; wherein the quaternary ammonium salt has the formula: X־R-CH2-N+(CH3)2-(CH2)n-CH3; wherein X־ is an anion; wherein R is CH3-O-CH2- or H-; and wherein n is positive integer greater than 8; wherein the fiber comprises at least 5 wt% of the quaternary ammonium salt; wherein the quaternary ammonium salt is not covalently incorporated into the polymeric matrix; wherein the quaternary ammonium salt is present on both the surface and in the interior of the fiber; wherein the fiber is made by electrospinning a solution of the polymeric matrix and the quaternary ammonium salt; and wherein the concentration of the quaternary ammonium salt on the surface of the fiber is greater than the concentration of the quaternary ammonium salt in the interior of the fiber. App. Br. 8. The claims stand rejected as follows: Claims 1, 6, 9, 10, 21, 22, and 25 were rejected under 35 U.S.C. § 103(a) as obvious over the combination of Tan2 and Harney.3 2 Tan et al., Fabrication and Evaluation of Electrospun Nanofibrous Antimicrobial Nylon 6 Membranes, 305 J. MEMBRANE SCI. 287–298 (2007) (“Tan”). 3 Harney et al., Surface Self-Concentrating Amphiphilic Quaternary Ammonium Biocides as Coating Additives, APPLIED MATERIALS & INTERFACES (1) 39–41 (2009) (“Harney”). Appeal 2018-000520 Application 13/832,302 4 Claims 1, 7, 9, 10, and 26 were rejected under 35 U.S.C. § 103(a) as obvious over the combination of Tan and Gannon.4 OBVIOUSNESS OVER TAN AND HARNEY Appellants argue claims 1, 6, 9–10, 21, 22, and 25 together. We designate claim 1 as representative. In finding claim 1 obvious, the Examiner finds that Tan discloses electrospun nylon nanofibers comprising antimicrobial N-halamine additives. Ans. 2. The Examiner acknowledges that Tan does not disclose antimicrobial quaternary ammonium salts or that the concentration of the quaternary ammonium salt on the surface of the fiber is greater than the concentration in the interior of the fiber. Id. However, the Examiner finds that this element is disclosed in Harney, which discloses self-concentrating amphiphilic quaternary ammonium biocides. Id. The Examiner finds that it would have been obvious to incorporate Harney’s quaternary ammonium biocides into the fibers taught by Tan because they are taught to be useful for the same purpose as Tam’s antimicrobial N-halamine additives. Id. at 3. Appellants do not challenge the Examiner’s prima facie case, but argue that “[t]he unexpected results in this case overcome any prima facie case of obviousness.” App. Br. 4. Appellants contend that it was unexpected that the quaternary ammonium salt would concentrate on the surface of the claimed nanofibers. Id. at 3. Relying on the Wynne Declaration,5 Appellants explain that the ability of an additive to surface 4 Gannon et al., US Patent No. 4,978,685, issued Dec. 18, 1990 (“Gannon”). 5 Declaration Under 37 C.F.R. § 1.132 of James H. Wynne, signed on September 28, 2015 (“Wynne Decl.”). Appeal 2018-000520 Application 13/832,302 5 concentrate is dependent on drying time, and that electrospun fiber dries so fast that surface concentration would not be expected. Id. at 4. Appellants also argue that while Harney teaches that quaternary ammonium salts migrate to the surface, Harney also teaches that this ability is “partially dependent on the presence of polyurethane and that this is a unique property.” Id. Appellants further argue that Harney teaches that migration stops once the film is cured and there is “no evidence that a compound that surface migrates in uncured polyurethane will do so in cured nylon or polycarbonate.” Id. Thus, according to Appellants, Harney does not provide reason to expect quaternary ammonium salts to surface migrate in electrospun nylon fibers. Id. Appellants have the burden of demonstrating unexpected results. We are not persuaded that the current record supports a finding of unexpected results sufficient to demonstrate the non-obviousness of the claimed fiber. Appellants contend that the surface concentration of quaternary ammonium salts in the claims is unexpected as compared to the N-halamine antimicrobial in Tan. However, Appellants do not identify any teaching in Tan to support that the N-halamine did not exhibit greater surface than interior concentration,6 nor do they provide experimental data comparing the 6 The Examiner acknowledged that Tan did not teach that its N-halamine additives surface concentrate to a greater extent than the concentration of the N-halamine that remains in the interior of the fiber. Ans. 2. However, the absence of a teaching regarding the relative surface concentration of N- halamine does not establish that the N-halamine additive in Tan lacks the claimed relative surface concentration. In this regard, we note that Tan states that “X-ray mapping showed that N-halamine additives were uniformly distributed on the electrospun membrane surface providing a potentially potent antimicrobial surface.” Tan, 293 (emphasis added). While this statement does not address the concentration of N-halamine on Appeal 2018-000520 Application 13/832,302 6 surface concentration of N-halamine additives of Tan to that of the claimed quaternary ammonium salts. Appellants do provide the testimony of Dr. Wynne that Tan’s halamines “did not demonstrate enhanced concentration at the surface (surface migration),” however Dr. Wynne does not provide evidentiary support or otherwise explain the basis for this opinion. Wynne Decl. ¶ 8. We find that the lack of factual corroboration warrants discounting this opinion. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroborations warrants discounting the opinions expressed in the declarations.”). Accordingly, we find that Appellants have not persuasively demonstrated that the results obtained using a quaternary ammonium salt were unexpected as compared to the closest prior art. In addition, unexpected results must be “commensurate in scope with the degree of protection sought by the claimed subject matter.” In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005). Here, claim 1 encompasses quaternary ammonium salts having the formula: X־R-CH2-N+(CH3)2-(CH2)n- CH3, “wherein n is a positive integer greater than 8.” App. Br. 8. Claim 1 also encompasses quaternary ammonium salts comprising “at least 5 wt%” of the fiber. The claim thus defines two genera: quaternary ammonium salts the surface of the nanofiber as compared to the concentration on the interior, it suggests that a significant quantity of the N-halamine additives were present on the membrane surface. Moreover, as it is Appellants’ burden to demonstrate unexpected results, In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972) (“the burden of showing unexpected results rests on he who asserts them”), it falls upon Appellants to demonstrate that the claimed fibers are unexpectedly different from the fibers in Tan, which comprises the closest prior art. Appeal 2018-000520 Application 13/832,302 7 where n is greater than 8, and quaternary ammonium salts comprising at least 5 wt% of the fiber. Appellants present evidence that two species of the claimed quaternary ammonium salt exhibited surface migration at concentrations of 5% and 10%. Wynne Decl. ¶ 8. We are not persuaded that evidence from two species of salt at two concentrations is sufficient to demonstrate unexpected results over the entire range of compounds encompassed by “n” greater than 8 and over the entire range of concentrations greater than 5 wt%. We recognize that Dr. Wynne testifies that based on this data “in [his] expert opinion, an alkyl chain greater than C8 in such [QAS] compounds at any concentration of at least 5 wt% in nylons and polycarbonates will promote surface migration.” Id. ¶ 7. However, the persuasiveness of this testimony is diminished because it is conclusory and lacks an explanation as to why the results from these limited data points can be extend to cover the entire genus. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d at 1368. We acknowledge Appellants’ argument that Harney does not create an expectation that the claimed quaternary ammonium salts would demonstrate enhanced surface migrate in electrospun nylon or polycarbonate. App. Br. 4. However, regardless of any expectation fostered by Harney, it was Appellants burden to demonstrate unexpected results commensurate with the scope of the claim as compared to the closest prior art. Moreover, while Appellants’ argument that the ordinary artisan would not expect Harney’s observed surface migration of QAS in slow-drying polyurethane to extend to a fast drying process like electrospinning is appealing, the factual contentions supporting this position are opinion testimony without underlying experimental data, which diminishes the persuasiveness of Appeal 2018-000520 Application 13/832,302 8 Appellants’ argument. See Wynne Dec. ¶¶ 4, 6. With respect to Appellants’ argument that the surface migration described in Harney is unique to polyurethane (App. Br. 4), Harney appears to attribute the surface migration of its quaternary ammonium salt not to the polyurethane itself, but to the hydrophilicity of the polyurethane. Harney Abstract (“The migration to the surface is a consequence of the hydrophobicity of the additive within the hydrophobic polyurethane resin”). Appellants do not persuasively explain how or why the polymers claimed, i.e., nylon or polycarbonate fibers, would differ from polyurethane with respect to this property so as to cause one of ordinary skill in the art to expect the quaternary ammonium salt to interact differently with the claimed polymers. Accordingly, we affirm the Examiner’s rejection of claims 1, 6, 9, 10, 21, 22, and 25 as obvious over the combination of Tan and Harney. OBVIOUSNESS OVER TAN AND GANNON In finding claim 1 obvious, the Examiner finds that Tan discloses electrospun nylon nanofibers comprising antimicrobial N-halamine additives. Ans. 4. The Examiner acknowledges that Tan does not disclose antimicrobial quaternary ammonium salts or that the concentration of the quaternary ammonium salt on the surface of the fiber is greater than the concentration in the interior of the fiber. Id. However, the Examiner finds that this element is disclosed in Gannon, which discloses the use of quaternary ammonium halides as biocides, including specifically cetyltrimethylammonium bromide. Id. at 5. The Examiner finds that it would have been obvious to “have incorporated cetyltrimethylammonium bromide into the fibers taught by Tan” because “it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be Appeal 2018-000520 Application 13/832,302 9 useful for same purpose, in order to form a third composition to be used for the very same purpose.” Id. Appellants do not challenge the Examiner’s prima facie case, but contend that “the Tan and Gannon references contain no evidence of surface concentration, and it has been shown above that Applicants’ data showing this is an unexpected result.” App. Br. 6. Appellants argue that the unexpected results arguments presented with respect to the rejection over the combination of Tan and Harney “apply to this rejection as well.” Id. We addressed Appellants’ arguments regarding unexpected results and found them unpersuasive supra. Accordingly, we affirm the Examiner’s rejection of claims 1, 7, 9, 10, and 26 as obvious over the combination of Tan and Gannon for the reasons discussed above. SUMMARY For the reasons set forth herein, and those set forth in the Examiner’s Answer and Final Office Action, we affirm the Examiner’s rejection of claims 1, 6, 9, 10, 21, 22, and 25 under 35 U.S.C. § 103(a) as obvious over the combination of Tan and Harney and the Examiner’s rejection of claims 1, 7, 9, 10, and 26 under 35 U.S.C. § 103(a) as obvious over the combination of Tan and Gannon. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation