HAWEST RESEARCH AG

Patent Trials and Appeals Board

Jan 18, 2022

2021002431 (P.T.A.B. Jan. 18, 2022)

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. 14/888,259 12/22/2015 Harald K. HORCHLER HORCHLER ET AL - 3 PCT 2860 25889 7590 01/18/2022 COLLARD & ROE, P.C. 1077 NORTHERN BOULEVARD ROSLYN, NY 11576 EXAMINER PALENIK, JEFFREY T ART UNIT PAPER NUMBER 1615 NOTIFICATION DATE DELIVERY MODE 01/18/2022 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): uspto@collardroe.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte HARALD K. HORCHLER and HANS-JÜRGEN BUSCHMAN Appeal 2021-002431 Application 14/888,259 Technology Center 1600 BEFORE JOHN G. NEW, JOHN E. SCHNEIDER, and RACHEL H. TOWNSEND Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 2-4, 8, 9, 11, 12, 14-17, and 19-23. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Hawest Research AG. Appeal Br. 1. Appeal 2021-002431 Application 14/888,259 2 CLAIMED SUBJECT MATTER “Antiseptically finished materials for the clinical area, especially for wound care, but also for cosmetic and other purposes, are widely known and in use.” Spec. 1. “The invention relates to an antiseptic material, which in particular can also be used for wound dressings. It contains a carrier material and one or more antiseptics and a surfactant.” Id. Claim 23, reproduced below, is illustrative of the claimed subject matter: Claim 23. An antiseptic wound dressing, comprising: a) a carrier material; b) a composite material comprising: i) a ß-cyclodextrin comprising a wt% that is between 1-5 wt% of the carrier material, ii) a polyethyleneimine, wherein the ß-cyclodextrin is bound to the polyethyleneimine to form the composite material; c) at least one antiseptic comprising PHMB wherein the molecular ratio of ß-cyclodextrin to antiseptic lies in the range of 0.1 to 1.0; d) a surfactant comprising amidopropyl betaine wherein the dressing contains antiseptic and betaine in approximately equimolar amounts; wherein, -the ß-cyclodextrin is loaded with the antiseptic; -the composite material being applied to the carrier material via an aqueous solution; and -the composite material is bound to the carrier material via physical binding. Appeal Br. 16-17 (Claims App.). Appeal 2021-002431 Application 14/888,259 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Pegelow et al. US 2004/0031107 A1 Feb. 19, 2004 Hiltner et al. US 7,604,816 B2 Oct. 20, 2009 Schmidt et al.2 DE 102004008913 A1 Aug. 9, 2005 REJECTION The Examiner has rejected pending claims 2-4, 8, 9, 11, 12, 14-17, and 19-23 under 35 U.S.C. § 103(a) as unpatentable over Pegelow in view of Schmidt and Hiltner.3 OPINION Issue The issue before us is whether a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 2-4, 8, 9, 11, 12, 14-17, and 19-23 would have been obvious to one of ordinary skill in the art at the time the invention was made over Pegelow combined with Schmidt and Hiltner. The Examiner finds Pegelow teaches a textile cleaning material with one or more host substances chemically or physically bonded to it and which host substances contain and release one or more active compounds. Final Act. 6. The Examiner finds that Pegelow teaches that the host substance can 2 Citations are to the English translation of record. 3 In the Final Office Action, the Examiner rejected claim 4 under 35 U.S.C. (b) as indefinite. Final Act. 3. The Examiner withdrew this rejection following an Amendment After Final. Ans. 3. Appeal 2021-002431 Application 14/888,259 4 be a cyclodextrin such as ß-cyclodextrin. Id. The Examiner finds that Pegelow teaches that the active compounds include surfactants and antimicrobial agents. Id. The Examiner finds that while Pegelow teaches anchoring the ß- cyclodextrin to the fabric by binding it to triazine compounds and halogenated triazines, such as monochlorotriazine or MCT, Pegelow does not teach using polyethyleneimine as the anchoring group. Id. at 6-7. The Examiner relies on Schmidt for this teaching. Id. at 7. The Examiner finds that it would have been obvious to substitute the polyethyleneimine for MCT as the anchoring group. See id. at 7-8. The Examiner finds that while Pegelow does not specifically disclose the molar ratio of antiseptic to ß-cyclodextrin, one skilled in the art would understand from Pegelow disclosure that the molar ratio would be about .88:1, within the ratio recited in claim 23. Id. at 9-10. The Examiner concludes: Based on the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed composition. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, absent a clear showing of evidence to the contrary. Id. at 14. Appellant contends that the references do not teach or suggest all of the elements of the claims. Appeal Br. 6. Appellant contends that the references do not teach the use of amidopropyl betaine as a surfactant. Id. Appellant contends that the experimentation required to produce the claimed invention from the teachings of the references would not be routine Appeal 2021-002431 Application 14/888,259 5 and that one skilled in the art would not have a reasonable expectation of success. Id. at 7. Appellant contends that the present invention calls for the bond between the fabric and the polyethlenimine substituted ß-cyclodextrin as this bond to be substantially permanent whereas the bond in Schmidt are not. Id. at 8-9. Appellant contends that Pegelow and Schmidt are not analogous art in that they are not in the same field of endeavor nor are they reasonably pertinent to the issue faced by the inventor. Id. at 10. Appellant contends that Pegelow is directed to removing soilings from substrates and not an antiseptic wound dressing. Id. Appellant contends that Schmidt pertains to “textile washing or cleaning mediums, cosmetic skin care mediums such as deodorants, soaps, body lotions, after shaves and perfumes and not to an antiseptic wound dressing as claimed in claim 23.” Id. at 10-11. Finally, Appellant contends that the present invention has particular properties that provide specific advantages. Id. at 11. Analysis We adopt the Examiner’s findings of fact, reasoning on scope and content of the prior art, and conclusions set out in the Final Action and Answer regarding this rejection. We find the Examiner has established a prima facie showing that the subject matter of the claims would have been obvious over Pegelow combined with Schmidt and Hiltner to a person of ordinary skill in the art at the time the invention was made. Appellant has not produced evidence showing, or persuasively argued, that the Examiner’s determinations on obviousness are incorrect. Only those arguments made by Appellant in the Brief have been considered in this Decision. Arguments not presented in the Brief are waived. See 37 C.F.R. § 41.37(c)(1)(iv) (2019). Appeal 2021-002431 Application 14/888,259 6 We have identified claim 23 as representative; therefore, all claims fall with claim 23. We address Appellants’ arguments below. Appellant contends that the references fail to teach all of the elements of the claims. Appeal Br. 6. Specifically, Appellant contends that Pegelow does not teach the use of a polyvinyl amine and that neither Pegelow nor Schmidt teach the use of amidopropyl betaine. Id. We are not persuaded by this argument. While we agree with Appellant that Pegelow does not teach the use of a polyvinyl amine, Schmidt teaches their use. Schmidt 4-5. “Non- obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). With respect to betaine, Pegelow teaches their use. Pegelow ¶ 45. Thus we agree with the Examiner that the references teach all of the limitation of claim 23. See Ans. 4-5. Appellant contends that one skilled in the art, given the teachings of the references, would have to engage in experimentation that would not be routine and that one skilled in the art would not have had a reasonable expectation of success in combining the teachings of the references. Appeal Br. 6-7. In support of this contention Appellant points to the calculation made by the Examiner to show that the cited references would yield a product meeting the ranges recited in the claims. Id. Again, we are not persuaded by this argument. Appeal 2021-002431 Application 14/888,259 7 In the Final Action, the Examiner sets forth a series of calculations based on the teachings of the references to show that combining the teaching of Pegelow and Schmidt would result in a product meeting the claim limitations. See, e.g., Final Act. 11-12. The Examiner finds that preparing such a formulation would have involved routine experimentation. Id. Appellant has not put forth any evidence to contradict the Examiner’s finding. “An examiner bears the initial burden of presenting a prima facie case of obviousness. Once the examiner establishes a prima facie case of obviousness, the burden shifts to the applicant to rebut that case.” In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011). “Attorneys’ argument is no substitute for evidence.” Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989). Appellant contends that one skilled in the art would not have a reasonable expectation of success in combining the references because the present invention calls for a permanent bond between the cyclodextrin component and the carrier, whereas Schmidt only teaches a temporary bond. Appeal Br. 8-9. Again, this argument is unpersuasive. Claim 23 only calls for a physical binding between the carrier and the composite material. Appeal Br. 17 (Claims App.). We discern nothing in the claim language that calls for a permanent bond between the two elements. Appellant is arguing a limitation that is not recited in the claims. See Sjolund v. Musland, 847 F.2d 1573, 1582 (Fed. Cir. 1988)(“[T]he claims define the invention.”). Appellant contends that Pegelow and Schmidt are directed to other fields of endeavor and are not pertinent to the claimed invention. Appeal Br. 9-10. Appellant contends that Pegelow is directed to “removing soilings from substrates not for binding active ingredients to an antiseptic wound Appeal 2021-002431 Application 14/888,259 8 dressing. Therefore, according to the two prong test put forth by In re Bigio, it is respectfully submitted that one skilled in the art would not look to Pegelow when first starting with the present invention.” Id. at 10. Appellant contends that Schmidt is directed to “textile washing or cleaning mediums, cosmetic skin care mediums, such as deodorants, soaps, body lotions, after shaves and perfumes and not to an antiseptic wound dressing as claimed in claim 23.” Id. at 10-11 We have considered Appellant’s argument and are not persuaded. While the preamble of the claim refers to an antiseptic wound dressing, the term merely states an intended use and does not limit the claim. Bristol- Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001). “Where . . . a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation.” Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). Here, the structurally complete invention is a carrier material with a composite material bound thereto by a physical binding and where the composite material includes a polyethyleneimine bound to ß-cyclodextrin and there is PHMB and amidopropyl betaine present. Moreover, even if Pegelow and Schmidt derive from different fields of endeavor, they are still relevant if they are reasonably pertinent to the problem face by the inventor. In re Clay, 966 F.2d 656, 658-59 (Fed. Cir. 1992). As the Examiner points out, the test is not a “two prong test” but is satisfied if either alternative exists. Ans. 10. Pegelow relates to attachment of host materials containing an active ingredient which are bonded to a textile material. Pegelow ¶¶ 8-12. Schmidt Appeal 2021-002431 Application 14/888,259 9 is similarly directed to binding a host material to a fabric, where in the host material contains an active ingredient. See Schmidt 1 (describing equipping textiles with host molecultes that are capable of reversibly binding other substances such that those substances can be released under certain conditions). We agree with the Examiner that these references are reasonably pertinent to the problem face by the inventor, binding an antiseptic (active ingredient) to the surface of a wound dressing. Ans. 10-11. Finally, Appellant contends that the wound dressing recited in the claims possess particular properties that provide specific advantages. Appeal Br. 11. Appellant cites to the Specification where it states: Tests have shown that a carrier material that is finished with 3% polyvinylamine--cyclodextrin and is loaded with approximately equal amounts of PHMB and undecylenic amidopropyl betaine, hereinafter referred to as the PHMB/betaine complex or complex, has a series of advantageous properties: - The PHMB/betaine complex has cationic properties and binds excellently to OH bonds, such as are present in cellulose, for example. An aqueous solution of the correspondingly loaded polyvinylamine-ß-cyclodextrin complex may be used appropriately for decontamination and prevention of infection. -The complex exhibits a very good biocompatibility index with a high “killing rate” for microorganisms and a low toxicity toward human cells (tested on HaCaT cells). An accelerated wound healing and a very low infection rate have been shown. - The complex is capable of stabilizing the pH environment of a wound at 5.5 and thus of creating prerequisites for the wound conditioning. In chronic wounds, the pH is regularly in the alkaline range. At pH 5. 5, the wound healing proceeds much faster. - The combination of PHMB and betaine dissolves biofilms and thus cleans the wound. It creates an optimal Appeal 2021-002431 Application 14/888,259 10 wound environment for faster regeneration of granulation tissue. - The complex durably inhibits free radicals, which are capable of damaging cells. - The complex is capable of absorbing exudate, especially proteins, from the wound and neutralizing it. In this way microorganisms are deprived of the nutritional basis. Id. at 11, citing Spec. 9-11. Appellant’s argument is unpersuasive. While the wound dressing of the claims may possess one or more of the attributes recited in the Specification, these properties are not recited in Claim 23. In addition, as the Examiner points out, the recited properties are associated with a dressing that is not commensurate with the scope of claim 23. Ans. 12-13. Finally, we discern no evidence in the record that the properties recited in the Specification are unexpected. See Spec. 9-11; Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007)( “[B]y definition, any superior property must be unexpected to be considered evidence of non- obviousness.). Based on the foregoing we conclude that a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 2-4, 8, 9, 11, 12, 14-17, and 19-23 would have been obvious to one of ordinary skill in the art at the time the invention was made over Pegelow combined with Schmidt and Hiltner. CONCLUSION The Examiner’s rejection is affirmed Appeal 2021-002431 Application 14/888,259 11 The rejection of claims 2-4, 8, 9, 11, 12, 14-17 and 19-23 under 35 U.S.C. § 103(a) as unpatentable over Pegelow in view of Schmidt and Hiltner is affirmed. DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 2-4, 8, 9, 11, 12, 14- 17, 19-23 103(a) Pegelow, Schmidt, Hiltner 2-4, 8, 9, 11, 12, 14- 17, 19-23 TIME PERIOD FOR RESPONSE 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