LABORATOIRES URGO

Patent Trials and Appeals BoardMar 13, 2020

15183310 - (D) (P.T.A.B. Mar. 13, 2020)

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. 15/183,310 06/15/2016 Christelle LAURENSOU 20010.0049USD1 1084 52835 7590 03/13/2020 HAMRE, SCHUMANN, MUELLER & LARSON, P.C. 45 South Seventh Street Suite 2700 Minneapolis, MN 55402-1683 EXAMINER GHALI, ISIS A D ART UNIT PAPER NUMBER 1611 NOTIFICATION DATE DELIVERY MODE 03/13/2020 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): PTOMail@hsml.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CHRISTELLE LAURENSOU Appeal 2019-0020181 Application 15/183,310 Technology Center 1600 Before JOHN E. SCHNEIDER, RYAN H. FLAX, and CYNTHIA M. HARDMAN, Administrative Patent Judges. HARDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims related to a method for promoting and/or accelerating fibroblast proliferation. The Examiner rejected the claims as obvious under 35 U.S.C. § 103(a). We heard Appellant’s oral argument on March 2, 2020. 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. Appellant identifies the real party in interest as LABORATOIRES URGO. Appeal Br. 2. Appeal 2019-002018 Application 15/183,310 2 CLAIMED SUBJECT MATTER Claims 13–20 are on appeal. Non-Final Act. 3; Appeal Br. 1. The claims are directed to a method for promoting and/or accelerating fibroblast proliferation comprising providing a composition comprising an effective amount of a specific copolymer. Claim 13, the only independent claim on appeal, is illustrative of the claimed subject matter. Claim 13 reads: 13. A method for promoting and/or accelerating fibroblast proliferation in vivo or ex vivo, comprising: providing a composition comprising an effective amount of a copolymer of a salt of 2-methyl-2-[(l-oxo-2-propenyl)amino]-l- propanesulfonic acid and of 2-hydroxyethylpropenoate ester. Appeal Br. 10 (Claims Appendix). REFERENCES The Examiner relied upon the following prior art references: Name Reference Date Laskey US 3,929,741 Dec. 30, 1975 Michaeli US 4,912,093 Mar. 27, 1990 Freeman US 5,968,001 Oct. 19, 1999 Lipman US 2004/0241215 A1 Dec. 2, 2004 D. W. Brett, A Review of Moisture-Control Dressing in Wound Care, 33 J. Wound Ostomy Continence Nurs., S3–S8 (2006) (“Brett”) Seppic, Sepinov™ EMT 10, New ‘2-in-1’ powder polymer, 1–31 (2005) (Doc. XP-002463431) (“Sepinov”) REJECTIONS Claims 13–15 and 17 stand rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Freeman, Brett, and Laskey. Non-Final Act. 4. Claims 16, 18, and 19 stand rejected under pre-AIA 35 U.S.C. § 103(a) as being obvious over Freeman, Brett, Laskey, and Michaeli. Non- Final Act. 7. Appeal 2019-002018 Application 15/183,310 3 Claim 20 stands rejected under pre-AIA 35 U.S.C. § 103(a) as being obvious over Freeman, Brett, Laskey, Lipman, and Sepinov. Non-Final Act. 9. OPINION Appellant focuses its arguments on independent claim 13. See generally Appeal Br.; see also id. at 8 (Appellant did not offer separate arguments for the rejections of claims 16 and 18–20). Accordingly, the dependent claims stand or fall with claim 13. 37 C.F.R. § 41.37(c)(1)(iv) (2017). The Examiner found that Freeman teaches a wound dressing that provides a moist wound environment. Non-Final Act. 4 (citing Freeman Abstract, 1:9–14, 1:55–65, 2:10–16, 2:53–61). The dressing includes layers comprising a thermoplastic material with a hydrocolloid and/or superabsorbent dispersed therein to entrap fluids. Id. (citing Freeman 4:35– 57; 5:33–40). The superabsorbent includes copolymers of acrylate salts and polyacrylate salts. Id. at 5 (citing Freeman 6:28–35). The Examiner found that, as evidenced Brett, a moist wound environment promotes healing, including by enhancing fibroblast proliferation and wound contraction. Non-Final Act. 6; Brett S4. Accordingly, the Examiner found that “it is inevitable that Freeman[’s] wound dressing[, which] maintains moist wound environment would encourage and accelerate fibroblast proliferation, absent evidence to the contrary.” Non-Final Act. 10. The Examiner further found that while Freeman does not teach the claimed copolymer, Laskey teaches this copolymer, and teaches that it is a Appeal 2019-002018 Application 15/183,310 4 superabsorbent that can be used in wound and burn dressings. Non-Final Act. 5–6, 12. The Examiner found that at the time of the invention it would have been obvious to a skilled artisan to provide a wound dressing comprising an acrylate/polyacrylate superabsorbent, where the dressing was designed to remove wound exudate and keep the wound moist, as taught in Freeman. Non-Final Act. 6. The Examiner further found that the skilled artisan would have been motivated to replace Freeman’s acrylate/polyacrylate superabsorbent with Laskey’s copolymer, because Freeman teaches having an absorbent dressing, and Laskey teaches that the copolymer is useful for wound and burn dressings because it is capable of absorbing large amounts of liquid. Id. The Examiner concluded that “[o]ne having ordinary skill in the art would have used the superabsorbent of Laskey in the wound dressing of Freeman, with [a] reasonable expectation of maintaining the wound moist, and hence encourag[ing] fibroblast proliferation.” Non-Final Act. 18. We agree with, and adopt, the Examiner’s reasoning that the claims are prima facie obvious over the combined cited prior art. We address Appellant’s arguments below. Appellant argues that it has “newly discovered” that the claimed copolymer “leads to superior promotion and acceleration of fibroblast proliferation,” as demonstrated by experimental work reported in the Specification. Appeal Br. 4. Appellant describes this experimental work as follows: In the experimental work, different amounts of the copolymer were applied to a plate containing seeded fibroblast cells (see pages 8-12 of Appellant’s disclosure). As shown in the results on pages 12 and 13 of Appellant’s disclosure, the claimed Appeal 2019-002018 Application 15/183,310 5 method promoted significantly more proliferation of fibroblast cells as compared to that of the control (compare proliferation amounts of Control and working examples 2-5). Id. at 4–5. If Appellant means to argue, even impliedly, that the claimed method demonstrates surprising or unexpected results, we are not persuaded. Unexpected results “must be shown to be unexpected compared with the closest prior art.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). Appellant adduced no persuasive evidence to demonstrate that the allegedly unexpected and beneficial properties of its method would have been unexpected and different in kind from those properties of methods taught by the prior art. See Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (holding that unexpected results that are probative of nonobviousness are those that are “different in kind and not merely in degree from the results of the prior art”). Here, as Appellant concedes, Laskey taught use of the claimed copolymer, and its use in wound and burn dressings (Laskey 3:36–50; Hr’g Tr. 3:11–16), such as the wound dressing of Freeman. Appellant has adduced no persuasive evidence to demonstrate that the claimed method results in fibroblast proliferation, whereas use of compositions suggested by the combined prior art does not. Absent such evidence, Appellant has not met the burden of demonstrating unexpected results. Appellant additionally argues that Freeman is silent as to a method for promoting and/or accelerating fibroblast proliferation, and as to the claimed copolymer. Appeal Br. 5. We are not persuaded by this argument, which overlooks the contributions of Brett and Laskey to the Examiner’s rejection. The test for obviousness is not whether the claimed invention is expressly Appeal 2019-002018 Application 15/183,310 6 identified in any one of the references, but whether the claimed subject matter would have been obvious to those of ordinary skill in the art in light of the combined teachings of the prior art. See In re Keller, 642 F.2d 413, 425 (CCPA 1981). Appellant cannot show nonobviousness by attacking references individually as failing to teach all of the claimed limitations where, as here, the rejection is based on a combination of references, whose teachings together render obvious the claimed invention. Id. We also note that Appellant has not argued that the “effective amount” limitation recited in the appealed claims distinguishes the claims from the amounts of the copolymer that would have been employed in the uses of the copolymer taught in the prior art. See, e.g., Hr’g Tr. 3:11–4:26. Appellant also argues that moisture per se does not necessarily improve fibroblast proliferation. Appeal Br. 5. Appellant cites Hehenberger,2 arguing that it “establishes that chronic wounds in diabetes patients do not show enhanced proliferation of fibroblasts, even in a moist environment.” Appeal Br. 5. We are not persuaded. Hehenberger does not address the effect of moisture on wound healing. Rather, it establishes that fibroblast proliferation is inhibited in diabetic ulcer patients due to high glucose and lactate concentrations. Hehenberger Abstract; Ans. 9–10. There is no persuasive evidence of record that the claimed method would overcome this issue and promote fibroblast proliferation in chronic diabetic wounds. The in vitro study reported in the Specification used “normal 2 K. Hehenberger et al., Inhibited proliferation of fibroblasts derived from chronic diabetic wounds and normal dermal fibroblasts treated with high glucose is associated with increased formation of l-lactate, 6 Wound Repair Regen., 135–41 (Mar./Apr. 1998) (“Hehenberger”’). Appeal 2019-002018 Application 15/183,310 7 human dermal fibroblasts,” not fibroblasts biopsied from wounds of diabetic patients, as were used in Hehenberger. Spec. 11; Hehenberger Abstract. Appellant also argues that “it is a mischaracterization of the teaching of Brett to assert that ‘moisture’, i.e., the presence of water, necessarily gives ‘enhanced fibroblast proliferation,’” because Brett observes that “the optimal level of moisture has not been clearly defined.” Appeal Br. 5–6. We are not persuaded by this argument, which is contrary to the plain language of Brett. Brett expressly states that “moisture encourages fibroblast proliferation,” and that a “moist wound healing environment is associated with . . . enhanced fibroblast proliferation.” Brett S4. Accordingly, we find that it is not a mischaracterization of the teaching of Brett to assert that moisture necessarily leads to enhanced fibroblast proliferation. We also disagree with Appellant’s argument that “it appears to be mechanical features that control humidity in Freeman, not any particular choice of polymer.” Appeal Br. 6. Freeman does teach that a seal and occlusive layer form “a moisture barrier that is particularly adapted for maintaining the wound in a moist environment.” Freeman 3:12–14. But Freeman also teaches that other aspects of the dressing also maintain the moist environment, including selection of the thermoplastics, hydrocolloids, and/or superabsorbents that make up the skin-contacting and absorbent layers. See, e.g., Freeman 4:38–41 (“Alternatively, permeability can be provided through the use of hydrocolloids or similar fluid transporting materials which, by absorbing and then desorbing fluid creates discontinuities within the skin-contacting layer.”); 4:58–61 (“The combination of the upper and lower components of the skin-contacting layer allows moisture to enter the absorbent layer of the absorbent region while Appeal 2019-002018 Application 15/183,310 8 maintaining the area about the wound in a moist environment.”); 5:28–40 (absorbent layer preferably includes a matrix of polypropylene with hydrocolloids and/or superabsorbents dispersed therein, where the hydrocolloids and/or superabsorbents trap fluid within the polymeric matrix); see also Ans. 12 (addressing the dual mechanisms disclosed in Freeman to maintain a moist environment). Appellant additionally asserts that the Examiner has used hindsight in interpreting Freeman and Laskey. Appeal Br. 6. Specifically, Appellant argues that Laskey is directed to a polymer that absorbs extremely high quantities of water, such that “one would reasonably understand from Laskey that the use of the copolymer would naturally tend to give not moist, but dry wounds, which is not in accordance with the teaching of Freeman, and [is] contrary to the teaching of Brett.” Appeal Br. 6–7. We are not persuaded by this argument, because the assertion that Laskey’s copolymer would lead to a dry wound is not supported by evidence. See Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989) (noting that attorney argument is “no substitute for evidence”); Ans. 14 (noting that Appellant has not identified any persuasive evidence or teaching that the copolymer of Laskey provides dry wounds). We also note that Freeman specifically teaches use of superabsorbents in a wound dressing that is designed to maintain a most environment, indicating that the mere use of a superabsorbent does not alone create a dry wound. Freeman 4:11–14 (“It is an essential feature of the present invention that the wound dressing be capable of absorbing body fluids in a designated absorbent region while maintaining the wound area in a moist environment.”); 5:27–31 (teaching use of superabsorbents in the absorbent layer). Further, Freeman Appeal 2019-002018 Application 15/183,310 9 teaches that “[t]he amount of the body fluid absorbing materials within the absorbent region 8 can vary according to the amount of body fluids which must be absorbed,” indicating that it would have been within the skill of an ordinary artisan to determine an optimal amount of a superabsorbent to use in a wound dressing designed to create a moist environment. Freeman 4:16– 19; see also Ans. 10 (“The degree of moisture in the wound can be determined by one skilled in the art based on the type of the treated wound and how much exudate is present.”). In sum, there is no persuasive evidence of record that mere presence of a superabsorbent in a wound dressing would create a dry wound environment. Appellant also argues that what is “totally lacking” in the teachings of the prior art is a “direct link between the copolymer and fibroblast proliferation,” and that “Appellant has newly discovered this direct link.” Appeal Br. 7. We are not persuaded. “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 919 F.2d 1574, 1578 (Fed. Cir. 1990) (affirming obviousness where applicant sought to rely on a new benefit not disclosed in the prior art). Here, the “direct link” between the copolymer and fibroblast proliferation on which Appellant seeks to rely is merely a latent benefit inherent in the prior art teachings. Laskey teaches use of the claimed copolymer as a superabsorbent in a wound or burn covering, and Freeman teaches use of superabsorbents in a wound dressing that maintains a moist environment. Because moist environments encourage and accelerate fibroblast proliferation as evidenced by Brett, Appellant has merely recognized a latent property resulting from the combined teachings of the Appeal 2019-002018 Application 15/183,310 10 prior art. “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” In re Baxter Travenol Labs., 952 F.2d at 392 (“Since the prior art bags plasticized with DEHP were inherently suppressing hemolysis, albeit unknown at the time of the Becker document, this hemolysis-suppressing function is not a basis for rebutting a prima facie finding of obviousness.”). At the oral hearing, Appellant stated for the first time that in order for the copolymer to be effective in promoting the fibroblast proliferation, it would have to be exposed to the fibroblasts. Hr’g Tr. 6:1–3; see also id. 11:4–10 (appearing to suggest that if one were to provide the claimed copolymer in Freeman’s dressing according to the Examiner’s rejection, the property of promoting fibroblast proliferation would not be found because in Freeman, the superabsorbent is segregated from the wound area by the skin contacting layer); id. at 12:1–3 (arguing that “in Freeman, the superabsorbent is segregated from the wound area, and therefore it is not acting in a way that it is, itself promoting the proliferation of fibroblast”). To the extent Appellant is arguing the prior art combination is deficient or would not have resulted in fibroblast proliferation because it does not teach direct exposure between the claimed polymer and fibroblasts, such argument is waived, because it was not included in Appellant’s Appeal Brief. See 37 C.F.R. § 41.37(c)(1)(iv) (2015); see also Ex Parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative) (“Any bases for asserting error, whether factual or legal, that are not raised in the principal brief are waived.”). However, even if we were to consider this argument, we find that it is not persuasive. Claim 13 merely requires “providing a composition comprising an effective amount” of the copolymer. Appeal Br. 10 (Claims Appeal 2019-002018 Application 15/183,310 11 Appendix). Because nothing in the claim requires direct exposure between the claimed polymer and fibroblasts to promote fibroblast proliferation, such direct exposure need not be demonstrated in the prior art. CONCLUSION We affirm the rejection of claims 13–15 and 17 under pre-AIA 35 U.S.C. § 103(a) as being obvious over Freeman, Brett, and Laskey. We affirm the rejection of claims 16, 18, and 19 under pre-AIA 35 U.S.C. § 103(a) as being obvious over Freeman, Brett, Laskey, and Michaeli. We affirm the rejection of claim 20 under pre-AIA 35 U.S.C. § 103(a) as being obvious over Freeman, Brett, Laskey, Lipman, and Sepinov. DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 13–15, 17 103(a) Freeman, Brett, Laskey 13–15, 17 16, 18, 19 103(a) Freeman, Brett, Laskey, Michaeli 16, 18, 19 20 103(a) Freeman, Brett, Laskey, Lipman, Sepinov 20 Overall Outcome 13–20 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). Appeal 2019-002018 Application 15/183,310 12 AFFIRMED