Ex Parte Tennenbaum et alDownload PDFPatent Trial and Appeal BoardMay 23, 201613311675 (P.T.A.B. May. 23, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/311,675 12/06/2011 49443 7590 05/25/2016 Pearl Cohen Zedek Latzer Baratz LLP 1500 Broadway 12th Floor New York, NY 10036 FIRST NAMED INVENTOR Tamar TENNENBAUM 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 ATTORNEY DOCKET NO. CONFIRMATION NO. P-78287-US4 7761 EXAMINER ALLEN, MARIANNE P ART UNIT PAPER NUMBER 1647 NOTIFICATION DATE DELIVERY MODE 05/25/2016 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@PearlCohen.com Arch-USPTO@PearlCohen.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TAMAR TENNENBAUM, SANFORD SAMPSON, TOSHIO KUROKI, ADDY ALT, and SHLOMZION SHEN1 Appeal2014-005475 Application 13/311,675 Technology Center 1600 Before FRANCISCO C. PRATS, RYAN H. FLAX, and TIMOTHY G. MAJORS, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving a claim to a method of accelerating the healing of a wound, which has been rejected as anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse the rejection of the claim as anticipated, but affirm the rejection that the claim would have been obvious. 1 Appellants identify the Real Party in Interest as Bar Ilan University. (Appeal Br. 3.) Appeal2014-005475 Application 13/311,675 STATEMENT OF THE CASE "The present invention relates to a method and a pharmaceutical composition for inducing and/or accelerating cell proliferation and/or cell differentiation and thereby accelerating the healing process of wounds." (Spec. 1, 11. 20-22.) "The primary goal in treatment of wounds is to achieve wound closure. Open cutaneous wounds represent one major category of wounds and include bum wounds, neuropathic ulcers, pressure sores, venous stasis ulcers, and diabetic ulcers." (Id. at 2, 11. 5-7.) According to the Specification, "a synergistic effect [is demonstrated when] combining insulin and platelet derived growth factor (PDGFF-BB) on wound healing in vivo." (Id. at 18, 11. 3--4.) Claim 1 is on appeal. It reads as follows: 1. A method of inducing or accelerating a healing process of a diabetic ulcer, the method comprising the step of administering to the diabetic ulcer a therapeutically effective amount of insulin and PDGF-BB to induce or accelerate the healing process of the diabetic ulcer. (Appeal Br. 14 (Claims App'x).) 2 Appeal2014-005475 Application 13/311,675 The claim is rejected as follows: Claim 1 stands rejected under 35 U.S.C. § 102(b) as anticipated by Edwards et al., (U.S. 5,770,228, issued June 23, 1998) ("Edwards"). Claim 1 stands rejected under 35 U.S.C. § 103(a) as obvious over Edwards, Utley et al., (U.S. 6,790,207, issued Sept. 14, 2004) ("Utley"), and Lindenbaum (U.S. 5,591,709, issued Jan. 7, 1997) ("Lindenbaum"). I. Anticipation Issue Has the Examiner established by a preponderance of the evidence that claim 1 is anticipated under 35 U.S.C. § 102(b) by Edwards? Findings of Fact 1. Edwards teaches "PDGF has therapeutic applications for the treatment of injuries which require the proliferation of fibroblasts or smooth muscle cells to heal ... [and] PDGF has been shown to be active in promoting wound healing in several animal models." (Edwards col. 1, 11. 34-43.) For example, Edwards cites Greenhalgh as "demonstrat[ing] enhanced healing of full-thickness skin wounds in genetically diabetic mice treated with recombinant PDGF as compared to control animals." (Id. at col. 1, 50-54.) Edwards cites Thomason as showing "that recombinant PDGF accelerates the gain in tensile strength of healing skin wounds in rats and promotes wound healing in diabetic rats." (Id. at col. 1, 11. 54-57.) Edwards further teaches that "PDGF is particularly useful in individuals who have substantially impaired wound healing capacity" and that "[ n ]ormal wound- 3 Appeal2014-005475 Application 13/311,675 healing may be retarded by a number of factors, including advanced age, diabetes, [and] cancer" among others. (Id. at col. 5, 11. 56-67.) 2. Edwards teaches "PDGF accelerates the healing process in a broad spectrum of wound conditions" where "the terms 'wound' or 'wound condition' include any disruption of the dermal layer of the skin. Examples of disruption to the dermal layer include chronic non-healing dermal ulcers (which can have a variety of causes), superficial wounds and lacerations, abrasions, surgical wounds, and some bums." (Id. at col. 6, 11. 1-8.) 3. Edwards teaches "[t]herapeutic compositions comprising a therapeutically effective amount of platelet derived growth factor [PDGF] in a hydroxyethyl cellulose gel are provided." (Id. at Abstract.) Edwards teaches that the PDGF in its composition may be PDGF-BB. (Id. at claims 3-5.) Edwards also teaches that "other growth factors, such as TGF-a, ... insulin, [and others] . . . may also work synergistically with PDGF" in a composition. (Id. at col. 7, 11. 1-9; see also, id. at claims 1, 13.) These compositions, according to Edwards, "may be utilized to promote wound healing in warm-blooded animals." (Id. col. 6, 11. 58-60.) Principles of Law "[U]nless a prior art reference discloses within the four comers of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim, it cannot be said to prove prior invention of the thing claimed and, thus, cannot 4 Appeal2014-005475 Application 13/311,675 anticipate under 35 U.S.C. § 102." Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). Analysis The Examiner rejected claim 1 as anticipated by Edwards. The Examiner finds that Edwards discloses A pharmaceutical composition comprising platelet derived growth factor BB (PDGF-BB) and insulin in a cellulose gel for use in wound healing . . . The wounds intended to be treated are skin wounds including those in diabetic subjects ... This would have been understood by those of ordinary skill in the art as including diabetic skin ulcers. (Ans. 2; see also, Final Act. 3--4.) According to the Examiner, Edwards thus "discloses the claimed invention and one of ordinary skill in the art would have known that treatment of diabetic ulcers was intended." (Ans. 5.) Appellants argue that Edwards does not teach "each and every limitation of claim l" and therefore cannot anticipate. (Appeal Br. 9 .) More specifically, Appellants argue "Edwards does not teach a method of inducing or accelerating a healing process of a diabetic ulcer by administering to the diabetic ulcer a therapeutically effective amount of insulin and PDGF-BB." (Id.) In support, Appellants state "[i]n fact, an electronic word search of Edwards ... did not uncover the term 'diabetic ulcer."' (Id.) We find that Edwards does not anticipate claim 1. Our issue with Edwards is not a lack of teaching of the claim limitations, it is that those limitations must be pieced together from disclosures throughout the reference to arrive at the claimed subject matter. In other words, we are unpersuaded the disclosures in Edwards are necessarily "arranged or 5 Appeal2014-005475 Application 13/311,675 combined in the same way" as the limitations of claim 1. Net Money!N, 545 F.3d at 1371. For example, Edwards teaches a composition with PDGF, and indicates that the AA, BB, and AB isoforms of PDGF may be used as the active ingredient. (See, e.g., Edwards claims 1, 5, col. 2, 11. 10-15; FF 3.) Yet the claim requires that PDGF-BB plus insulin be included, and Edwards teaches in another section of its disclosure that insulin (among a list of other ingredients) may optionally be used to "work synergistically with PDGF." (FF 3.) Thus, at a minimum, the skilled person would have to select PDGF- BB and opt to include insulin as well to obtain synergistic effects in the composition. While the reason to do so is plainly evident from the teachings of Edwards alone, Edwards does not expressly disclose a PDGF-BB plus insulin embodiment. See Net Money!N, 545 F.3d at 1371 (Anticipating reference "must clearly and unequivocally disclose the claimed [invention] or direct those skilled in the art to the [invention] without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference.") (quoting In re Arkley, 455 F.2d 586, 587 (CCPA 1972)). Edwards further teaches that PDGF is useful in individuals with "impaired wound healing capacity" - and identifies factors that retard normal wound healing like advanced age, diabetes, and cancer. (Edwards col. 5, 11. 56-65; FF 1.) In the very next paragraph, describing the types of wounds that may beneficially be treated with PDGF, Edwards lists "chronic non-healing dermal ulcers," "lacerations," and "abrasions" among others. (Edwards col. 6, 11. 1-8; FF 2.) From this, it is likely the person of ordinary skill would have predictably combined these teachings and concluded that 6 Appeal2014-005475 Application 13/311,675 PDGF is useful in treating diabetic ulcers. And, we agree with the Examiner's finding that "one of ordinary skill in the art would have known that treatment of diabetic ulcers was intended," particularly considering the discussion in the background section of Edwards about the use of PDGF to treat wounds in diabetic animals. (Ans. 5; FF 1.) But such explanations sound in obviousness over Edwards alone - a rejection not presented here. Conclusion of Law For the reasons above, we conclude the Examiner has not established by a preponderance of the evidence that claim 1 is anticipated under 35 U.S.C. § 102(b) by Edwards. II. Obviousness Issue Has the Examiner established by a preponderance of the evidence that claim 1 is obvious under 35 U.S.C. § 103(a) over Edwards in view of Utley and Lindenbaum? Findings of Fact2 4. Utley teaches the use of "commercially available Regranex, which is [a] recombinant human PDGF-BB. This material has been applied as a gel for promoting the healing of diabetic foot ulcers." (Utley col. 6, 11. 33- 36.) Utley further teaches that "TGF-B and PDGF are considered the most important substances for the purpose of initiating the wound healing process." (Id. at col. 6, 11. 41--43.) 2 Findings of Fact 1-3 are incorporated by reference. 7 Appeal2014-005475 Application 13/311,675 5. Lindenbaum teaches formulations useful for treating wounds by accelerating wound healing. These formulations comprise an effective amount of a non- steroidal anabolic hormone selected from insulin, triiodothyronine/thyroxine (T 3 or T 4)4, mixtures thereof, ... and optionally, at least one cellular growth factor such as insulin- like growth factor (IGF) platelet derived growth factor, epidermal growth factor (EGF) and transforming growth factor. (Lindenbaum col. 2, 1. 67 through col. 3. 1. 14.) Lindenbaum further teaches "[t]he amount of material which is to be spread on a wound for treatment will be readily apparent to one of ordinary skill in the art." (Id. at col. 13, 11. 52-54.) Principles of Law "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Analysis The Examiner rejected claim 1 under§ 103(a) as obvious over Edwards, Utley, and Lindenbaum. In response to Appellants' argument about the absence of the term "diabetic ulcer" in Edwards, the Examiner cites Utley as "explicitly disclos[ing] using compositions of PDGF-BB to treat diabetic foot ulcers." (Ans. 3.) The Examiner further cites to Lindenbaum as teaching "topical administration of insulin, growth hormone, thyroxine and platelet derived growth factor (PDGF) to a wound. Accelerated wound healing is disclosed." (Id.) According to the Examiner, "Utley[] demonstrates that it would have been well known that PDGF-BB 8 Appeal2014-005475 Application 13/311,675 could be used to treat diabetic foot ulcers and that the disclosure of Edwards [] would have been understood by those of ordinary skill in the art to include treating foot ulcers." (Id.) Moreover, the Examiner finds, based on Lindenbaum' s further disclosure of topical formulations with PDGF and insulin, "[ o ]ne would have been motivated to treat diabetic ulcers with a combination of PDGF-BB and insulin in order to produce more effective formulations." (Id.) Appellants offered no response to the§ 103(a) rejections in their appeal brief. 3 (Appeal Br. 8-9.) In the reply brief, Appellants argue "[ n ]either Utley nor Lindenbaum overcome these deficiencies [in Edwards], and the Examiner has failed to explain why in her Answer." (Reply Br. 2.) Moreover, Appellants argue that "Lindenbaum teaches a formulation containing four components, including insulin, Lindenbaum requires thyroxine and a growth factor." (Id. at 3.) The Examiner has the better position. As an initial matter, Appellants' failure to address a ground of rejection in their appeal brief constitutes a waiver, and permits the Board to summarily sustain the unaddressed rejection. MPEP § 1205.02; see also, 37 C.F.R. § 41.37(c)(l)(iv) (the appeal brief must include "the arguments of appellant with respect to each ground of rejection ... any arguments or authorities not 3 The only "grounds of rejection to be reviewed on appeal" identified by Appellants in their opening brief is the "[ fJinal rejection of claim 1 under 35 U.S.C. § 102(b) for allegedly being anticipated by US 5,770,228 (Edwards)." (Appeal Br. 8.) 9 Appeal2014-005475 Application 13/311,675 included in the appeal brief will be refused consideration by the Board for purposes of the present appeal.") In any event, even if we consider Appellants' arguments, they are unpersuasive. Whatever deficiencies may have existed based on Edwards alone, the Examiner has cured. Utley teaches "Regranex, which is a recombinant human PDGF-BB ... [that] has been applied as a gel for promoting the healing of diabetic foot ulcers." (FF 4.) Appellants' attempt to distinguish Lindenbaum because it teaches formulations to accelerate wound healing that include PDGF, insulin, and other ingredients is also flawed. (FF. 5) Claim 1 is not limited to administering a therapeutically effective amount of only insulin and PDGF-BB. The Examiner has otherwise provided reasoning with rational underpinning for combining the teachings of Edwards, Utley, and Lindenbaum to produce the method of claim 1. (Ans. 3, 5.) That reasoning is uncontested. Accordingly, we sustain the rejection under§ 103(a). Conclusion of Law We conclude the Examiner has established by a preponderance of the evidence that claim 1 would have been obvious under 35 U.S.C. § 103(a) over Edwards, Utley, and Lindenbaum. SUMMARY We reverse the rejection of claim 1under35 U.S.C. § 102(b) over Edwards. We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) over Edwards, Utley, and Lindenbaum. 10 Appeal2014-005475 Application 13/311,675 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. § l.136(a). AFFIRMED 11 Copy with citationCopy as parenthetical citation