Omoidesouzou Co., Ltd. et al.Download PDFPatent Trials and Appeals BoardMay 10, 20212020005193 (P.T.A.B. May. 10, 2021) 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. 15/518,256 04/11/2017 Hideyasu Takata HRTA:1025US 5870 34725 7590 05/10/2021 CHALKER FLORES, LLP 14951 NORTH DALLAS PARKWAY SUITE 400 DALLAS, TX 75254 EXAMINER AHMED, HASAN SYED ART UNIT PAPER NUMBER 1615 MAIL DATE DELIVERY MODE 05/10/2021 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 HIDEYASU TAKATA __________ Appeal 2020-005193 Application 15/518,256 Technology Center 1600 __________ Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and JEFFREY N. FREDMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1,2 under 35 U.S.C. § 134 involving claims to a method for treating a skin ulcer. The Examiner rejected the claims as obvious. 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 Parties in Interest as Hideyasu Takata and Omoidesouzou Co., Ltd. (see Appeal Br. 2). 2 We have considered the Specification of Apr. 11, 2017 (“Spec.”); Final Office Action of July 24, 2019 (“Final Action”); Appeal Brief of Jan. 14, 2020 (“Appeal Br.”); Examiner’s Answer of Apr. 27, 2020 (“Ans.”); and Reply Brief of June 25, 2020 (“Reply Br.”). Appeal 2020-005193 Application 15/518,256 2 Statement of the Case Background “Skin ulcers are intractable diseases in which skin tissues are deficient due to decubitus (bed sores), burns, arterial occlusive disease, diabetes, and the like” (Spec. ¶ 2). “When the skin ulcers are prolonged, they may lead to bacterial infection” (id.). “Sofratulle . . . is a patch containing as an active ingredient fradiomycin sulfate having an antibacterial action, is also used in the treatment of mild decubitus” (id. ¶ 9). “Fiblast Spray 500 . . . is a spray- type therapeutic agent for skin ulcers containing as an active ingredient trafermin having an angiogenic action and granulation promoting action” (id.). [T]he inventor has found that the intractable decubitus can be treated or ameliorated, when several sheets of Sofratulle patch are used not for its intended use as the patch but are formed into a dumpling shape or folded depending on the size of the ulcer with a pocket, sprayed with Fiblast Spray 500 until sufficiently impregnated with a trafermin solution and are packed in the ulcer with a pocket to effectively adhere and leach out fradiomycin sulfate and trafermin throughout the interior portion of the ulcers. (id. ¶ 10). The Claims Claims 1, 4–7, 16, 23, 24, 27, 29, and 31 are on appeal. Claim 1 is representative and reads as follows: 1. A method for treating a skin ulcer, comprising packing a cotton holding an antibiotic and a cell proliferation accelerator in the skin ulcer with a pocket and in a state in which a defect extending to the dermis, subcutaneous tissue, muscle or bone occurs, whereby the cotton is formed so as to contact substantially the whole of the inner surface of the skin ulcer. Appeal 2020-005193 Application 15/518,256 3 The Rejection The Examiner rejected claims 1, 4–7, 16, 23, 24, 27, 29, and 31 under U.S.C. § 103(a) as obvious over Wilcher,3 Pierce,4 Ichioka,5 Nambu,6 Frank,7 and Fonder8 (Final Act. 3–6). The issue with respect to this rejection is: Does a preponderance of the evidence of record support the Examiner’s conclusion that Wilcher, Pierce, Ichioka, Nambu, Frank, and Fonder render the claims obvious? Findings of Fact 1. Wilcher teaches “compositions and materials that react with the hemostatic system to treat or prevent bleeding” (Wilcher ¶ 13). 2. Wilcher teaches: Effective delivery of hemostatic agents to wounds is particularly desirable in the treatment of injuries characterized by arterial or venous bleeding, as well as in surgical procedures where the control of bleeding can become problematic, e.g., large surface areas, heavy arterial or venous bleeding, oozing wounds, and in organ laceration or resectioning. (Wilcher ¶ 14). 3 Wilcher et al., US 2007/0154510 A1, published July 5, 2007. 4 Pierce et al., Platelet-derived Growth Factor (BB Homodimer), Transforming Growth Factor-β1, and Basic Fibroblast Growth Factor in Dermal Wound Healing, 140 Am. J. Pathology 1375–88 (1992). 5 Ichioka et al., The positive experience of using a growth-factor product on deep wounds with exposed bone, 14 J. Wound Care 105–9 (2005). 6 Nambu, US 4,524,064, issued June 18, 1985. 7 Frank et al., Approach to infected skin ulcers, 51 Can. Family Physician 1352–59 (2005). 8 Fonder et al., Treating the chronic wound: A practical approach to the care of nonhealing wounds and wound care dressings, 58 J. Am. Acad. Dermatology 185–206 (2008). Appeal 2020-005193 Application 15/518,256 4 3. Wilcher teaches “a puff, e.g. cotton ball, fleece, or sponge form can be preferable for controlling the active bleeding” (Wilcher ¶ 15). Wilcher teaches “[i]n preferred embodiments, the rough surface is exposed to the wound so as to maximize contact of the fibers with the wound, resulting in an improved hemostatic effect and superior adherence to the wound” (Wilcher ¶ 21). 4. Wilcher teaches “the hemostatic devices of the invention further include a therapeutically effective amount of one or more therapeutic agents, such as an agent which promotes wound-healing” where “[a]gents that promote wound-healing include anti-inflammatory agents, agents which inhibit free radical formation, and bacteriostatic or bacteriocidal agents” (Wilcher ¶ 30). 5. Wilcher teaches “[r]epresentative bacteriostatic or bacteriocidal agents include antibacterial substances such as β-lactam antibiotics” (Wilcher ¶ 33). 6. Wilcher teaches the hemostatic article may comprise “epidermal growth factor, fibroblast growth factors, transforming growth factors” (Wilcher 6, claim 13). 7. Ichioka teaches “[t]rafermin is a human recombinant form of basic fibroblast growth factor (bFGF). It promotes tissue regeneration, and gained approval for use in Japan in 2001” (Ichioka 105, col. 1). 8. Ichioka teaches “our experience suggests that trafermin accelerates the healing of deep wounds” (Ichioka 109, col. 2). 9. Nambu teaches “wound-covering materials which, by embedding antimicrobials in the aforesaid hydrogels, have sustained- Appeal 2020-005193 Application 15/518,256 5 releasing capacity (long durable release) for the antimicrobial agent” where the antibiotic includes fradiomycin sulfate (see Nambu 1:47–50 and 11:59). 10. Frank teaches: The role of topical antibiotics in treatment of wounds that are not healing or continue to have serious exudation after 2 to 4 weeks of optimal management has been studied. A 2-week trial of topical antibiotics with Gram-negative, Gram-positive, and anaerobic coverage should be used in these circumstances, even with no other evidence of critical colonization or infection. (Frank 1356, col. 1). 11. Table I of Fonder is reproduced, in part, below: Table I discloses gauzes as useful for packing deep wounds (Fonder 192, Table I). 12. Fonder teaches: Many modern gauzes are impregnated with substances intended to optimize the healing environment . . . Gauze ribbons are ideal for treating deep wounds and sinus tracts, which must heal from the base upwards in order to eliminate dead space and prevent abscess formation. Loose packing with gauze ribbons encourages healing from the base outward. Packing should never be tight, because this may cause localized ischemia and wound enlargement. (Fonder 194, col. 1–2). 13. Fonder teaches “[t]opical antibiotics can be very effective when used against sensitive organisms” (Fonder 198, col. 2). 14. Fonder teaches the growth factor “rhPDGF-BB homodimer, becaplermin . . . clearly increases the probability that well perfused, properly debrided diabetic forefoot ulcers will heal completely and in shorter times. Appeal 2020-005193 Application 15/518,256 6 It also appears to be beneficial for the treatment of pressure ulcers” (Fonder 200, col. 2). Principles of Law “[D]uring patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.” In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989). “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’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. Analysis We adopt the Examiner’s findings of fact and conclusion of law (see Final Act. 3–6; FF 1–14) and agree that the prior art renders claim 1 obvious. We address Appellant’s arguments below. Claim Interpretation We begin with claim construction because before a claim is properly interpreted, its scope cannot be compared to the prior art. During prosecution, we interpret terms in a claim using the broadest reasonable interpretation in light of the Specification. In re Morris, 127 F.3d 1048, 1056 (Fed. Cir. 1997). The phrase at issue in claim 1 is the “cotton is formed so as to contact substantially the whole of the inner surface of the skin ulcer.” We first turn to the Specification which is, “[i]n most cases, the best source for discerning the proper context of claim terms.” Metabolite Labs., Appeal 2020-005193 Application 15/518,256 7 Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1360 (Fed. Cir. 2004). The Specification teaches using an amount of therapeutic material that can contact a part of the inner surface of the skin ulcer (preferably 50% or more of the entire inner surface) or substantially the whole of the inner surface (preferably more than 90%) when the fibrous material holding an antibiotic and a cell proliferation accelerator therein is formed into an approximately spherical shape. (Spec. ¶ 29). The Specification explains that the product may be “packed in the ulcer with a pocket to effectively adhere and leach out fradiomycin sulfate and trafermin throughout the interior portion of the ulcers” (Spec. ¶ 10). The Specification teaches “by forming Sofratulle patch into a dumpling shape, fradiomycin sulfate (antibiotic) as its active ingredient was effectively adhered and permeated throughout the base of ulcers” (Spec. ¶ 36). We, therefore, understand that “substantially the whole of the inner surface” encompasses about 90% or more of the inner surface and that this level of contact may be achieved by loosely packing the therapeutic gauze material into the ulcer. Obviousness Appellant contends “the cotton of Fonder is for covering a wound surface and is not used in a manner as claimed in the current version of claim 1, that is, by forming the cotton so that the cotton contacts substantially the whole of the inner surface of a skin ulcer” (Appeal Br. 11). Appellant notes that Fonder teaches “[p]acking should never be tight, because this may cause localized ischemia and wound enlargement” (id.; citing Fonder 194, col. 2). Appeal 2020-005193 Application 15/518,256 8 We find this argument9 unpersuasive because the full quote from Fonder states: Gauze ribbons are ideal for treating deep wounds and sinus tracts, which must heal from the base upwards in order to eliminate dead space and prevent abscess formation. Loose packing with gauze ribbons encourages healing from the base outward. Packing should never be tight, because this may cause localized ischemia and wound enlargement. (FF 12). Thus, Fonder actually prefers “to eliminate dead space” which is reasonably understood as contacting the entirety of the internal surface of deep wounds to prevent abscess formation (cf. Ans. 5). While, as Appellant correctly notes, Fonder does not prefer tight packing, Fonder encourages “loose packing . . . from the base outward” (FF 12). Appellant provides no reasoning or evidence that Fonder’s loose packing of gauze from the base outward to eliminate dead space would fail to contact substantially the whole of the inner surface of the ulcer as required by claim 1. In contrast, Wilcher reasonably supports the Examiner’s position because Wilcher explains “the rough surface is exposed to the wound so as to maximize contact of the fibers with the wound, resulting in an improved hemostatic effect and superior adherence to the wound” (FF 3). Thus, the ordinary artisan would also have expected the ordinary artisan to apply the loose packing of Fonder to adhere to the entire wound because Wilcher 9 We note that Appellant’s reference to “Reference Material 1” also suggests that packing that results in pressure is undesirable but does not address the loose packing suggested by Fonder (see Appeal Br. 11). We also note that in the Response dated Dec. 6, 2018, only a small portion of this reference was provided in a non-certified translation that was not submitted with an IDS and we are therefore unable to ascertain the complete teachings of this reference. Appeal 2020-005193 Application 15/518,256 9 teaches “to maximize contact” for “superior adherence” (FF 3). Thus, as the Examiner notes, “[p]acking a deep wound (such as a skin ulcer) with gauze will by definition result in substantial contact the whole of the inner surface of a skin ulcer since ‘packing’ of a wound is understood by artisans as gauze being pushed into the ulcer” (Ans. 5). Appellant contends Fonder does not teach that when a cotton holding an antibiotic and a cell proliferation accelerator is packed in a skin ulcer with a pocket and the cotton comes into contact with substantially the whole of the inner surface of the skin ulcer, that the antibiotic effectively adheres and permeates throughout the interior of the pocket to effectively inhibit bacterial infections in the pocket. (Appeal Br. 12; cf. Reply Br. 6). We find this argument unpersuasive because Appellant is arguing Fonder alone rather than in combination with the other disclosures in the prior art. “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). The Examiner’s reasoning “takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure.” In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). The claim requires that the cotton is holding an antibiotic and a cell proliferation accelerator. Fonder teaches loosely packing gauze into wounds including ulcers (FF 14) with gauzes that “are impregnated with substances Appeal 2020-005193 Application 15/518,256 10 intended to optimize the healing environment” (FF 12). Fonder teaches that these substances can include antibiotics (FF 13) and growth factors (FF 14). We understand growth factors to be a type of cell proliferation accelerator as required by the claim. Wilcher teaches to maximize contact (FF 3) with cotton gauzes (FF 2) and to include antibiotics (FF 5) and growth factors (FF 6). Ichioka specifically teaches using the Trafermin growth factor because it accelerates healing of deep wounds (FF 7–8). Nambu teaches that antimicrobial agents including fradiomycin may be incorporated into wound-covering materials (FF 9). We therefore agree with the Examiner that it would have been obvious to loosely pack skin ulcers with antibiotic and growth factor impregnated cotton gauze and “to maximize contact of the fibers with the wound, resulting in . . . superior adherence to the wound” because antibiotics, growth factors and superior adherence will result in superior wound treatment (FF 1–14; cf. Final Act. 5–6). Appellant contends: “In Wilcher, however, the fibers are used to stop bleeding and thus, their use is completely different from that of the wound dressing of Fonder. Appellant therefore submits that the Examiner’s position in view of Wilcher represents an ex post facto analysis” (Reply Br. 6). We find this argument unpersuasive because Wilcher does teach “to maximize contact of the fibers with the wound, resulting in . . . superior adherence to the wound” (FF 3). This is an independent reason to substantially contact the entire ulcer wound surface, to improve adherence. This general reason of improved adherence is reasonably understood as applicable not only to bleeding wounds but also to non-bleeding wounds Appeal 2020-005193 Application 15/518,256 11 such as ulcers, for the same purpose in treating it. As already noted, Fonder’s loose packing alone (FF 3) would have reasonably been expected to contact substantially the entire wound surface, just as a dabbed paper towel contacts an entire bowl, Wilcher simply provides additional reasons to contact as much of the wound surface as practicable to improve adherence (FF 3). Appellant contends “a superior effect is represented by the per se fact that packing a cotton holding an antibiotic and a cell proliferation accelerator into the pocket of a skin ulcer improved the ulcer rather than made the ulcer worse or intractable” (Reply Br. 10). We are not persuaded that Appellant has provided any secondary consideration or unexpected result for the claimed method. Appellant does not identify a teaching in the Specification that contacting the entire inner surface results in an unexpected or superior result. Nor does Appellant point to a Declaration or other evidence. “[A]ny superior property must be unexpected to be considered as evidence of non-obviousness.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). “It is well settled that unexpected results must be established by factual evidence. Mere argument or conclusory statements . . . [do] not suffice.” In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). The only indication of superior results is attorney argument in the brief. But this is simply attorney argument without evidence regarding the rejection as presented by the Examiner. See In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984). We also note that Appellant has not demonstrated a result commensurate in scope with the claim and has not compared the result to the closest prior art. Conclusion of Law Appeal 2020-005193 Application 15/518,256 12 A preponderance of the evidence of record supports the Examiner’s conclusion that Wilcher, Pierce, Ichioka, Nambu, Frank, and Fonder render the claims obvious. DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 4–7, 16, 23, 24, 27, 29, 31 103 Wilcher, Pierce, Ichioka, Nambu, Frank, Fonder 1, 4–7, 16, 23, 24, 27, 29, 31 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED Copy with citationCopy as parenthetical citation