Ex Parte Hardy et alDownload PDFPatent Trial and Appeal BoardAug 21, 201813063891 (P.T.A.B. Aug. 21, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/063,891 05/27/2011 3017 7590 08/22/2018 BARLOW, JOSEPHS & HOLMES, LTD. 101 DYER STREET 5THFLOOR PROVIDENCE, RI 02903 FIRST NAMED INVENTOR Craig Hardy 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. W004 P02217-US 6783 EXAMINER LAZARO, DOMINIC ART UNIT PAPER NUMBER 1611 MAIL DATE DELIVERY MODE 08/22/2018 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 CRAIG HARDY and STEWART ANDREW DARBY Appeal2017-008136 Application 13/063,891 1 Technology Center 1600 Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and RICHARD J. SMITH, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify Medtrade Products Limited as the real party in interest. App. Br. 1. Appeal2017-008136 Application 13/063,891 STATEMENT OF CASE The following claim is representative. 44. A non-gelled wound care device comprising a first material and a second material, which materials individually do not substantially gel when exposed to a fluid, the wound care device does not gel when it has not been exposed to a fluid, and the wound care device does gel when exposed to a fluid, wherein the first material is in a dry fibrous form and comprises a polysaccharide or a polysaccharide derivative, and wherein the second material is in a dry fibrous form and has an acid absorbed therein without permanent bonding occurring between the acid and the second material, and further wherein the first material has not been pre-treated with the acid. Cited References Saferstein Court Grounds of Rejection us 5,134,229 US 6,268,544 B 1 July 28, 1992 July 31, 2001 Claims 44--47, 49-54, 58-62, and 64---69 are rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Court in view of Saferstein. FINDINGS OF FACT The Examiner's findings of fact are set forth in the Final Action at pages 5-13. The following facts are highlighted. 1. Court discloses wound dressings comprised of a mixture of gel-forming fibres and textile fibres. Col 1, 11. 40-43. 2. Court teaches a wound dressing (Court, abstract) including an exemplary embodiment, wherein the inlaid yam is 2 Appeal2017-008136 Application 13/063,891 composed of alginate fibres and viscose fibres. Court, col. 4, ln. 35-39, Ex. 2; Final Act 7. 3. Court discloses chitosan (Court, col. 2, In. 39) and alginate fibres (Court, col. 4, In. 37, Ex. 2) are equivalent gel- forming fibres (Court, col. 2, ln. 34 & 38-39; Court, col. 2, ln. 39 & claim 11 ). 4. Court discloses regenerated cellulose (Court, col. 2, ln. 17) and viscose fibres (Court, col. 4, ln. 38, Ex. 2) as equivalent textile fibres (Court, col. 2, ln. 14-17). 5. Court discloses that the textile fibers are not hygroscopic. Col. 2, 11. 19-23; Col. 4, Ex. 3; Ans. 5. 6. Court discloses that the textile fibres can be cellulosic fibres, such as viscose, cotton, or regenerated cellulose. Col. 2, 11. 14-23; Ans. 3. 7. Court further discloses that the gel forming fibres can be carboxymethylated cellulose, alginate, chitosan fibers. Col. 2, 11. 34-40. 8. Court does not disclose that the gel forming fibers are gelled at the time of manufacture of the wound care device. 9. Court does not expressly teach a second material (i.e., Court's textile fibre) with an acid absorbed therein (claims 44, 46, 52, 58- 59, 61 and 67); Final Act 8. 10. The Examiner finds that Saferstein teaches: "[an] Oxidized cellulose material [which] is neutralized, by contacting an acidic oxidized cellulose material with a water and alcohol solution of a basic salt of a weak organic acid, e.g. sodium acetate, to elevate the pH of the cellulosic 3 Appeal2017-008136 Application 13/063,891 material to between 5 and 8," wherein "The resulting neutralized product is storage stable and has therapeutic applications, including hemostasis and adhesion prevention," and "may be impregnated with acid-sensitive hemostatic agents, such as thrombin, to enhance its hemostatic properties, or with acid-sensitive adhesion- preventive agents, such as t-PA, to enhance its adhesion- prevention properties." Saferstein, title & abstract; similarly at Saferstein, col. 2, ln. 25-32. Final Act. 8. 11. Saferstein teaches: "The neutralized cloth provides a scaffold of fibers to reinforce the clot, and make it stronger" wherein "The neutralized cloth being bioabsorbable will dissolve in 7-14 days" (Saferstein, col. 6, ln. 47-50), and teaches used of the neutralized cloth for covering a wound or as a hemostat (Saferstein, col. 3, ln. 45-53). Saferstein described the properties of the oxidized cellulose: . . . . Saferstein, col. 4, ln. 43-65. Final Act. 8. PRINCIPLES OF LAW In making our determination, we apply the preponderance of the evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F .2d 1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Office). "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). 4 Appeal2017-008136 Application 13/063,891 Where ... the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. ... Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on "prima facie obviousness" under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (emphasis added.) Obviousness Rejection The Examiner finds that Court discloses wound dressings comprised of a mixture of gel-forming fibres and textile fibres. Col 1, 11. 40-43. Court teaches a wound dressing (Court, abstract) including an exemplary embodiment, wherein the inlaid yam is composed of alginate fibres and viscose fibres. Court, col. 4, ln. 35-39, Ex. 2. Court discloses chitosan (Court, col. 2, In. 39) and alginate fibres (Court, col. 4, In. 37, Ex. 2) are equivalent gel-forming fibres (Court, col. 2, ln. 34 & 38-39; Court, col. 2, ln. 39 & claim 11 ). Court discloses regenerated cellulose (Court, col. 2, ln. 17) and viscose fibres (Court, col. 4, ln. 38, Ex. 2) as equivalent textile fibres (Court, col. 2, ln. 14-17). Court discloses that the textile fibers are not hygroscopic. Col. 2, 11. 19-23; Col. 4, Ex. 3; Ans. 5. Court does not disclose that the gel forming fibers are gelled at the time of manufacture of the wound care device. The Examiner admits that Court does not expressly teach a second material (i.e., Court's textile fibre) with an acid absorbed therein (claims 44, 5 Appeal2017-008136 Application 13/063,891 46, 52, 58-59, 61 and 67). To make up for this deficiency in the cited prior art, the Examiner finds that Saferstein teaches: "[an] Oxidized cellulose material [which] is neutralized, by contacting an acidic oxidized cellulose material with a water and alcohol solution of a basic salt of a weak organic acid, e.g. sodium acetate, to elevate the pH of the cellulosic material to between 5 and 8," wherein "The resulting neutralized product is storage stable and has therapeutic applications, including hemostasis and adhesion prevention," and "may be impregnated with acid-sensitive hemostatic agents, such as thrombin, to enhance its hemostatic properties, or with acid-sensitive adhesion-preventive agents, such as t-PA, to enhance its adhesion-prevention properties." Saferstein, title & abstract; similarly at Saferstein, col. 2, In. 25-32. In this regard, Saferstein teaches: "The neutralized cloth provides a scaffold of fibers to reinforce the clot, and make it stronger" wherein "The neutralized cloth being bioabsorbable will dissolve in 7-14 days" (Saferstein, col. 6, In. 47-50), and teaches used of the neutralized cloth for covering a wound or as a hemostat (Saferstein, col. 3, In. 45-53). Saferstein described the properties of the oxidized cellulose: . . . . Saferstein, col. 4, In. 43-65. Final Act. 8-9. The Examiner concludes that it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to rearrange Court's wound dressing (Court, col. 4, In. 36-38, Ex. 2) by substituting alginate fibres (Court, col. 4, ln. 37, Ex. 2), for chitosan (Court, col. 2, ln. 39) and viscose fibres (Court, col. 4, ln. 38, Ex. 2) for regenerated cellulose (Court, col. 2, ln. 17), and to have used oxidized regenerated cellulose, as taught by Saferstein (Saferstein, col. 2, ln. 25-32), as the regenerated cellulose (Court, col. 2, ln. 17). One would have been motivated to do so with a high expectation of success since both Court and Saferstein are concerned with similar problems in the art, namely the preparation of wound care devices (Court abstract) or the materials suitable for incorporation into wound car 6 Appeal2017-008136 Application 13/063,891 devices (Saferstein, col. 2, ln. 25- 32). Further, it is well within the skill of the ordinary artisan to select a suitable regenerated cellulose. Court, col. 2, ln. 17. Doing so amounts to no more than combining prior art elements according to known methods to yield predictable results, namely the preparation of Court's wound care device (Court, abstract) with regenerated cellulose (Court, col. 2, ln. 17) in order to obtain the advantage of an oxidized cellulose, which behaves as an ion exchanger (Saferstein, col. 4,1. 43-48) and a buffered solution that maintains a fairly constant pH (i.e., at a pH between 5 and 8, Saferstein, col.. 3, ln. 36-38), thereby preventing complete neutralization that renders the fiber weak and swollen when exposed to water (Saferstein, col. 4, ln. 53-65). Final Act. 10. Appellants contend that Saferstein creates a buffered, solution that is pH balanced at neutral. Saferstein explicitly states that the acid is bound to the cellulose cloth, which is expressly excluded from the claimed subject matter. The Applicant has expressly claimed that the acid is not permanently bonded to the second material, such as cellulose material. Therefore, Saferstein does not teach the claimed invention, even if combined with Court. In any event, Court teaches that one of the fibres is gel- forming which, upon the uptake of wound exudate, becomes moist and slippery or gelatinous. Conversely, the first material of the present invention [] individually does not gel when exposed to a fluid. Court therefore also contains contradictory teaching to the requirements of the claims and does not provide a suitable basis for an obviousness objection. App. Br. 6. Appellants argue that the combined teachings of Court and Saferstein do not arrive at the wound care device having all of the essential features of the independent claims. Specifically, the first and second material must not gel individually, and then, only together in the 7 Appeal2017-008136 Application 13/063,891 presence of liquid. And further, the second material must absorb an acid, but the acid must not bond with the second material. Therefore, the combination fails. App. Br. 6. ANALYSIS Appellants do not argue individual claims separately in the Appeal Brief, therefore we select claim 44 as representative claim. We adopt the Examiner's findings of fact, reasoning on scope and content of the claims and prior art (e.g., what was well known, routine, and/or conventional in the field), and conclusions set out in the Final Action and Answer. See Final Act. 5-13; Ans. 3-12. Only those arguments made by Appellants in the Appeal Brief and properly presented in the Reply Brief have been considered in this Decision. Arguments not so presented in the Briefs are waived. See 3 7 C.F .R. § 41.3 7 ( 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."). We find that the Examiner has set forth a prima facie case of obviousness on the evidence before us. In particular, the Examiner found that Court clearly teaches a wound dressing ( Court, abstract) including an exemplary embodiment, wherein the inlaid yam is composed of alginate fibres and viscose fibres. Court, col. 4, ln. 35-39, Ex. 2. In light of Court's teachings, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to rearrange Court's exemplary embodiment (Court, col. 4, ln. 35-39, Ex. 2) according to Court's disclosure. 8 Appeal2017-008136 Application 13/063,891 Ans. 3--4. The Examiner argues that one of ordinary skill in the art would have substituted chitosan (Court, col. 2, ln. 39) for alginate fibres (Court, col. 4, ln. 37, Ex. 2) since Court discloses chitosan and alginate as equivalent gel- forming fibres (Court, col. 2, ln. 34 & 38-39). The Examiner argues that one of ordinary skill in the art would have substituted regenerated cellulose (Court, col. 2, ln. 17) for viscose fibres (Court, col. 4, ln. 38, Ex. 2) since Court discloses regenerated cellulose and viscose fibres as equivalent textile fibres (Court, col. 2, ln. 14-17). Ans. 3--4. Court discloses that the textile fibers are not hygroscopic. Col. 2, 11. 19-23; Col. 4, Ex. 3; Ans. 5. Court does not disclose that the gel forming fibers are gelled at the time of manufacture of the wound care device. Appellants argue that Court and Saferstein do not teach that each of the first and second materials, individually, must not gel, and that the materials must gel only together in the presence of liquid. App. Br. 6. Appellants argue in the Reply Brief that the chitosan fibre of the present application "would not gel on contact with wound exudate." Reply Br. 3, underline omitted. However, the limitation that the chitosan fiber would not gel on contact with wound exudate is not claimed. The pending claim 44 requires that, "materials individually do not substantially gel when exposed to a fluid, the wound care device does not gel when it has not been exposed to a fluid, and the wound care device does gel when exposed to a fluid." Claim 44, italicized emphasis added. The Examiner argues that, in this case, the prior art teaches the identical chemical structure, namely chitosan fibers (Court, col. 2, In. 34- 9 Appeal2017-008136 Application 13/063,891 40), and oxidized regenerated cellulose with acetic acid (Saferstein, col. 4, In. 43-65 & col. 8, In. 35 to col. 9, In. 3-15, Ex. 1). Ans. 9. These fibers may be mixed. FF 1. The Examiner finds that the properties applicant discloses and/or claims (e.g., "which [first and second] materials individually do not substantially gel when exposed to a fluid, the wound care device does not gel when it has not been exposed to a fluid, and the wound care device does gel when exposed to a fluid" of claim 44, ... ) are necessarily (inherently) present since the materials are the same or substantially the same as those claimed. The wound care device of Court does not gel when it has not been exposed to a fluid, but does gel when exposed to a fluid Ans. 9. Appellants have not provided evidence showing an error in the Examiner's technical and/or legal analysis, and have not shown that the fibers of Court and Saferstein are in a gelled state at the time of manufacture of the wound care dressing/device. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). See also, Advisory Action dated, July 31, 2016, p. 2. 2 Attorney 2 (''Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In this regard, it is noted that in arguing that "the first material of the present invention 'individually does not gel when exposed to a fluid,"' and "therefore appears to contain contradictory teaching to the requirements of the claims" (Remarks, p. 9, par. 1 ), are mere arguments of counsel. Since the US PTO lacks the capacity of laboratory facilities to ascertain the comparative gel forming or lack thereof of Court's chitosan versus the chitosan first material of the instant claims, the burden falls on Applicant to show/demonstrate facts (i.e., comparative gelling, or lack thereof) and not to speculate about them. Applicants have not made a sufficient evidentiary showing whereby one of ordinary skill in the art would conclude that the 10 Appeal2017-008136 Application 13/063,891 argument cannot take the place of evidence. In re DeBlauwe, 736 F.2d 699, 705 (Fed. Cir. 1984). Unsupported attorney argument, presented for the first time on appeal, is an inadequate substitute for record evidence. See also, Gemtron Corp. v. Saint-Gobain Corp., 572 F.3d 1371, 1380 (Fed. Cir. 2009) ( emphasizing that "unsworn attorney argument ... is not evidence"). 3 We do not entertain Appellants' new argument and evidence presented for the first time in the Reply Brief as we do not have the benefit of the Examiner's position with respect to the new evidence. 3 7 C.F .R 41.41 (b ). Appellants argue that the claimed second material must absorb an acid, but the acid must not bond with the second material. App. Br. 6. Appellants argue that the cited references do not disclose this claim limitation. Id. that With respect to the acid treated fiber limitation, the Examiner finds Saferstein teaches: "[an] Oxidized cellulose material [which] is neutralized, by contacting an acidic oxidized cellulose material with a water and alcohol solution of a basic salt of a weak organic acid, e.g. sodium acetate, to elevate the pH of the cellulosic material to between 5 and 8." Saferstein, title & abstract. In this regard, it is noted that appellants arguments that Saferstein discloses a "neutralized product" that is "a chitosan material of Court's knitted dressing would have different gelling properties than the chitosan first material of the instant claims.") 3 In the Reply Brief, Appellants submitted new evidence from Science Direct and Wikipedia regarding the nature of chitosan. 3 7 C.F .R 41.41 (b )(1) states that a Reply Brief shall not include any new evidence filed after the date of filing of the appeal. Moreover, any argument raised in the reply brief which was not raised in the appeal brief is non-responsive to the Examiner's Answer, and will not be considered on appeal. 37 C.F.R 4I.41(b)(2). Such arguments do not have the benefit of the Examiner's response. 11 Appeal2017-008136 Application 13/063,891 buffered, solution that is pH balanced at neutral" (Appeal Brief, p. 5, par. 5, cont. on p. 6) mischaracterizes the scope of Saferstein's oxidized cellulose as a material buffered at a neutral pH of 7 (thereby excluding the presence of acid at pH's lower than pH 7), WHEREAS the scope of Saferstein's disclosure is directed to an "[ o ]xidized cellulose material [that] is neutralized, by contacting an acidic oxidized cellulose material with a water and alcohol solution of a basic salt of a weak organic acid, e.g. sodium acetate, to elevate the pH of the cellulosic material to between 5 and 8" (Saferstein, abstract). Ans. 5. Regarding the claim limitation that the acid is not permanenetly bonded to the second material, the Examiner argues that In Saferstein's material, acetate salt molecules are not "bound" to the oxidized cellulose, but instead exist in a state of equilibrium associated with the oxidized cellulose whereby "the by-product of this exchange is an acid from the salt [ ... ], a weak acid such as acetic acid is produced" (Saferstein, col. 4, ln. 45-47), which appears to be the weak acid that results in the weakly acidic pH 6.5 exhibited by oxidized regenerated cellulose after treatment with sodium acetate, washing and drying (Saferstein, col. 8, ln. 35 to col. 9, In. 3-15, Ex. 1). Ans. 7. Appellants have not provided evidence showing an error in the Examiner's technical or legal analysis, or showing that Safterstein's acetate salt molecules are bound to the cellulose. In re Best, 562 F.2d 1252, 1255 ( CCP A 1977). Where the claimed and prior art cellulose and chitosan products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Appellants have provided no such evidence. Attorney argument is not evidence, and new evidence presented 12 Appeal2017-008136 Application 13/063,891 in the Reply Brief is not timely presented nor allows for the benefit of the Examiner's position. The preponderance of the evidence supports the Examiner's position. The obviousness rejection is affirmed for the reasons of record. CONCLUSION OF LAW The cited references support the Examiner's obviousness rejections, which are affirmed for the reasons of record. All pending, rejected claims fall. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv). See 37 C.F.R. § 4I.50(f). AFFIRMED 13 Copy with citationCopy as parenthetical citation