Ex Parte Melvin et al

Patent Trials and Appeals BoardMar 26, 2019

11722726 - (D) (P.T.A.B. Mar. 26, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 11/722,726 11/04/2008 26875 7590 03/28/2019 WOOD, HERRON & EV ANS, LLP 2700 CAREW TOWER 441 VINE STREET CINCINNATI, OH 45202 UNITED ST A TES OF AMERICA FIRST NAMED INVENTOR David Boyd Melvin 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. MELV-24US 1635 EXAMINER TEMPLETON, CHRISTOPHER L ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 03/28/2019 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): usptodock@whe-law.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DAVID BOYD MEL VIN, ALAN J. MEL VIN, and MARKT. BYRNE Appeal2018-002350 Application 11/722, 726 1 Technology Center 3700 Before DANIEL S. SONG, STEFAN STAICOVICI, and NATHAN A. ENGELS, Administrative Patent Judges. STAICOVICI, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE- David Boyd Melvin et al. ("Appellants") appeal under 35 U.S.C. Â§ 134( a) from the Examiner's decision in the Final Office Action ( dated Sept. 29, 2016, hereinafter "Final Act.") rejecting claims 13, 15-24, 36, and 37.2 We have jurisdiction over this appeal under 35 U.S.C. Â§ 6(b). 1 The University of Cincinnati is identified as the real party in interest in Appellants' Appeal Brief (filed July 28, 2017, hereinafter "Appeal Br."). Appeal Br. 5. 2 Claims 1-12, 14, 25-35, 38, and 39 are canceled. Appeal Br. 20, 21, 25, and 26. Appeal2018-002350 Application 11/722,726 SUMMARY OF DECISION We AFFIRM-IN-PART and enter NEW GROUNDS of REJECTION pursuant to our authority under 37 C.F.R. Â§ 41.50(b). INVENTION Appellants' invention relates to a method "for coupling a tissue with other structures, such as another tissue, bone and prosthetic devices." Spec. para. 2. Claims 13 and 21 are independent. Claim 13 is illustrative of the claimed invention and reads as follows: 13. A method for tissue closure with a plurality of filaments, the plurality of filaments having a first tissue engaging portion and a second tissue engaging portion and the plurality of filaments being non-degradable and excluding degradable filaments, the method comprising: positioning a first living tissue substance proximate to a second living tissue substance to form a tissue boundary there between; extending the plurality of non-degradable filaments in a direction that is generally parallel to a predominant direction of known or potential tissue disrupting forces from within the first living tissue substance, across said tissue boundary, and into the second living tissue substance so as to couple the first living tissue substance with the second living tissue substance via the first and second tissue engaging portions, the plurality of non- degradable filaments being grouped into one or more bundles and extending in a generally parallel orientation within each of the one or more bundles, each of the first and second tissue engaging portions of the non-degradable filaments being all- parallel filaments; and temporarily securing the plurality of non-degradable filaments such that each one of the one or more bundles of non- degradable filaments of the plurality acts as a slender bioreactor in which the non-degradable filaments of the plurality disperse 2 Appeal2018-002350 Application 11/722,726 within the first and second living tissue substances with a proliferation of cells of the first and second living tissue substances, said dispersion of the plurality of non-degradable filaments configured to provide a scaffolding for capturing further proliferation of the cells of said first and second living tissue substances, and to increase a tissue area bearing a shear force exerted by the plurality of non-degradable filaments to result in closure of the first living tissue substance with the second living tissue substance, wherein the method excludes the use of degradable filaments. REJECTI0NS 3 I. The Examiner rejects claims 13, 16, 20-24, 36, and 37 under 35 U.S.C. Â§ I03(a) as being unpatentable over Wasson (US 3,762,418, iss. Oct. 2, 1973) and Melvin (WO 00/41631 pub. July 20, 2000). II. The Examiner rejects claim 15 under 35 U.S.C. Â§ I03(a) as being unpatentable over Wasson, Melvin, and Morency et al. (US 2003/0149447 Al, pub. Aug. 7, 2003, hereinafter "Morency"). 3 The rejections under 35 U.S.C. Â§ 112, second paragraph, of claims 13, 15- 20, and 36 as being indefinite, under 35 U.S.C. Â§ I02(b) of claims 13, 19, 20, and 36 as being anticipated by Chvapil (US 5,078,744, iss. Jan. 7, 1992), and under 35 U.S.C. Â§ I03(a) of claim 16 as being unpatentable over Chvapil and Melvin (WO 00/41631, pub. July 20, 2000) have been withdrawn by the Examiner. See Advisory Action (dated Jan. 18, 2017, hereinafter "Adv. Act."). Furthermore, as claims 1-12, 14, 25-35, 38, and 39 have been canceled, the rejections under 35 U.S.C. Â§ I03(a) based on various combinations of references are moot. See Examiner Answer ( dated Nov. 3, 2017, hereinafter "Ans.") 2. 3 Appeal2018-002350 Application 11/722,726 III. The Examiner rejects claim 17 under 35 U.S.C. Â§ I03(a) as being unpatentable over Wasson, Melvin, and Burrell et al. (US 6,017,553, iss. Jan. 25, 2000, hereinafter "Burrell"). IV. The Examiner rejects claim 18 under 35 U.S.C. Â§ I03(a) as being unpatentable over Wasson, Melvin, and Leung et al. (US 2004/0060409 Al, pub. Apr. 1, 2004, hereinafter "Leung"). V. The Examiner rejects claim 19 under 35 U.S.C. Â§ I03(a) as being unpatentable over Wasson, Melvin, and Kaplan et al. (US 2003/0074023 Al, pub. Apr. 17, 2003, hereinafter "Kaplan"). ANALYSIS Rejection I Claims 13, 16, 20, and 36 Independent claim 13 recites, inter alia, "[a] method for tissue closure with a plurality of filaments ... wherein the method excludes the use of degradable filaments." Appeal Br. 20-21 (Claims App.). The Examiner finds that Wasson discloses such a method in column 4, lines 1-19. See Adv. Act. 2. According to the Examiner, "Wasson discloses excluding degradable filaments ('may be made of any one of usual suture materials ... silver, silk, polyethylene, nylon, ... synthetic materials presently used for making sutures')." Ans. 6 (citing to Wasson, col 4, 11. 2-5). The Examiner further finds that "Melvin [also] teaches excluding degradable filaments ('filaments 14 are preferably made of a material that does not dissolve'.[)]" Id. ( citing Melvin, p. 14) ( emphasis added). In response, Appellants argue that just because Wasson and Melvin disclose a list of non-degradable filament materials does not mean that each 4 Appeal2018-002350 Application 11/722,726 of Wasson and Melvin discloses excluding degradable materials. See Reply Brief (filed Jan. 3, 2018, hereinafter "Reply Br.") 5---6. Independent claim 13 does not require a tissue closure method with non-degradable filaments (as per independent claim 21 ), but rather a method "excluding degradable filaments," that is, a method that "bar[ s J from ... inclusfon'q degradable filaments. We agree with Appellants that "the Examiner stretches the relied upon passage of Wasson too far," and, thus, Wasson's list of some non-degradable filament materials "fails to disclose the exclusion of degradable filaments." Reply Br. 6. We further agree with Appellants that "[t]he Examiner also stretches the relied-upon passage from Melvin" because the passage discloses that non-degradable filaments are merely "preferred," which "does not support the inference that Melvin excludes the use of degradable filaments," that is, bars from inclusion degradable filaments. Id. (emphasis added); see also Appeal Br. 15. In conclusion, as neither Wasson nor Melvin discloses the limitation "wherein the method excludes the use of degradable filaments," as called for by independent claim 13, we do not sustain the rejection under 35 U.S.C. Â§ 103(a) of independent claim 13, and its dependent claims 16, 20, and 36, as unpatentable over Wasson and Melvin. Claims 21-24 and 37 Appellants do not present arguments for the patentability of claims 22-24 and 3 7 apart from claim 21. See Appeal Br. 9-13. Therefore, in accordance with 37 C.F.R. Â§ 41.37(c)(l)(iv), we select claim 21 as the 4 See MERRIAM-WEBSTER, https://www.merriam- webster.com/dictionary/excluding (last visited March 15, 2019). 5 Appeal2018-002350 Application 11/722,726 representative claim to decide the appeal of the rejection of these claims, with claims 22-24 and 37 standing or falling with claim 21. We first note that claim 21 does not include a limitation excluding degradable materials. See Appeal Br. 23-24. Hence, the Examiner finds that Wasson discloses most of the limitations of independent claim 21, but "does not expressly disclose all-parallel filaments." Final Act. 18-19. Nonetheless, the Examiner finds that Melvin discloses a method employing "all-parallel filaments 12, 14 (Fig. 1) comprising a few hundred to several thousand filaments (page 13) that are configured to disperse (page 1 7) so as to provide a scaffolding and capture proliferating cells within tissue substances and forming a mechanical bond (pages 13, 14)." Id. at 19. Thus, the Examiner concludes that Id. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of Was son [to] include the few hundred to several thousand filaments, that are configured to disperse, as taught by Melvin, for the purpose of integrating and forming a bond with the tissue, assisting in maximizing the potential surface area of the strand, enhancing tissue integration into and around the filaments, permitting the transfer of increased power, and assisting in preventing the filaments from becoming unembedded in or detached from the tissue (page 14 ), and lessening friction between the filaments and tissue (page 17). Appellants argue that a skilled artisan would not have been "motivated to modify the methods of Wasson with the methods of Melvin" because Melvin "is not directed to a method of tissue closure as recited in ... claim 21, and, therefore, the problems addressed by Melvin ... are not the same problems addressed by Wasson or the presently claimed 6 Appeal2018-002350 Application 11/722,726 invention." Appeal Br. 10. According to Appellants, because the purpose of Melvin's method "is to connect muscle tissue to prosthetic device" "to efficiently transfer power from the muscle to the prosthetic device," the fibers of Melvin constitute "specialized fibers ... [that] join the living muscle tissue with the non-living prosthetic device." Id. at 10-11; Declaration of Alan J. Melvin filed under 37 C.F.R. 1.132 (filed Dec. 29, 2016, hereinafter "Melvin Deel."), para. 7. In contrast, the "tissue closure" method of claim 21 and of Wasson "involve[ s] bringing 'a first living tissue substance' into contact with 'a second living tissue substance' to form a 'tissue boundary"' in order to "maintain[] the apposition between [the] two tissue sections to allow those sections to grow together." Appeal Br. 11-12; see also reply Br. 7; Melvin Deel., para. 8. As such, Appellants assert that "[t]he Examiner does not provide a rational reason why one of ordinary skill in the art of sutures would look to Melvin ... and the problems addressed by Melvin ... when modifying Wasson," and, thus, the Examiner's reasoning is based on impermissible hindsight. Appeal Br. 13. We are unaware of any requirement that the references relied upon to reject claims under 35 U.S.C. Â§ 103(a) have the same objectives as the claimed invention. Rather, it is not necessary for the prior art to serve the same purpose as that disclosed in Appellant's Specification in order to support the conclusion that the claimed subject matter would have been obvious. See KSR Int'! Co. v. Teleflex, Inc., 550 U.S. 419 (2007) ("In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the [Appellant] controls."); see also In re Linter, 458 F.2d 1013, 1016 (CCPA 1972). As such, even though Wasson discloses joining living tissue, whereas Melvin 7 Appeal2018-002350 Application 11/722,726 discloses joining living tissue to a non-living prosthetic device,"[ w ]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation,Â§ 103 likely bars its patentability." KSR, 550 U.S. at 417. Here, as noted supra, the Examiner reasons that modifying Wasson's method to include Melvin's filaments would have been obvious "for the purpose of integrating and forming a bond with the tissue ... [and] assisting in preventing the filaments from becoming unembedded in or detached from the tissue." Final Act. 19. As Wasson discloses a tissue closure method and Melvin discloses bonding of filaments and muscle M (i.e., tissue), Appellants have not adequately explained why any differences in technologies between Wasson and Melvin are of such a nature as to have dissuaded a person of ordinary skill in the art from utilizing Melvin's filaments in Wasson's tissue closure method. The Examiner's modification is an improvement to Wasson's tissue closure method to employ Melvin's filaments to lead to a predictable result, namely, "preventing the filaments from becoming unembedded in or detached from the tissue" (see Ans. 3), and the modification is well within the skill of a person having ordinary skill in this art. We, thus, agree with the Examiner that because Melvin's filaments are not easily removed from muscle tissue M, employing such filaments as a suture material to close a wound (incision) in Wasson's tissue closure method would lead to the predictable result of preventing the wound from opening. See id. at 4--5 (citing Melvin, pp. 13, 14). As such, we are not persuaded by Appellants' 8 Appeal2018-002350 Application 11/722,726 argument that the Examiner's determination of obviousness is based on impermissible hindsight. Lastly, we are not persuaded by Appellants' arguments that in contrast to Appellants' invention, Wasson discloses conventional sutures that cannot "disperse into ... tissue and become integrated into the tissue such that shear forces between the filaments and the living tissue ... allow for efficient force transfer." Appeal Br. 12; see also Melvin Deel., paras. 10, 11; Reply Br. 8. "Nonobviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. [Each reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole." See In re Merck & Co. Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Here, Melvin discloses filaments 14 configured to disperse within and form a bond or integrate with muscle tissue M such that resulting shear forces on filaments 14 sustain the required tensile force. See Melvin, pp. 13, 14, 17. In conclusion, for the foregoing reasons, we sustain the rejection under 35 U.S.C. Â§ 103(a) of independent claim 21 as unpatentable over Wasson and Melvin. Claims 22-24 and 3 7 fall with claim 21. Rejections 11-V With respect to the rejection of claims 15 and 17-19, subject to Rejections II-V, depending from independent claim 13, the Examiner's use of the Morency, Burrell, Leung, and Kapalan references does not remedy the deficiency of the Wasson and Melvin combination discussed supra as to independent claim 13. See Final Act. 11, 14--1 7. Therefore, for the reasons discussed above relative to claim 13, we also do not sustain Rejections II-V. 9 Appeal2018-002350 Application 11/722,726 NEW GROUNDS OF REJECTION I. Claims 13, 15-20, and 36 are rejected under 35 U.S.C. Â§ 112(a) as failing to comply with the written description requirement. The limitation "wherein the method excludes the use of degradable filaments" was added to independent claim 13 in the After-Final amendment, filed Dec. 29, 2016, which was entered by the Examiner in the Advisory Action, dated Jan. 18, 201 7. The limitation is not supported by the original disclosure. Negative claim limitations are adequately supported when explicitly described by the Specification or when a reason to exclude the relevant limitations is provided. Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1351 (Fed. Cir. 2012). In this case, the Specification describes the use of both degradable and non-degradable filaments for tissue-to-tissue coupling, which is the method recited in claim 13. Spec. para. 41. Although the Specification limits non-degradable filament material (thereby excluding degradable filaments) to tissue-to-prosthesis coupling, this is not the type of coupling recited in claim 13. Id. II. Claim 13 is rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Wasson and Melvin. We adopt the Examiner's findings and reasoning to combine the teachings of Wasson and Melvin as noted on pages 9-10 of the Final Action. Melvin further discloses that "filaments 14 are preferably made of a material that does not dissolve when placed in the body over time." Melvin, p. 14 ( emphasis added). As such, Melvin suggests excluding the use of degradable filaments. Therefore, it would have been obvious for a person of 10 Appeal2018-002350 Application 11/722,726 ordinary skill in the art to exclude the use of degradable filaments in the tissue closure method of Wasson, as modified by Melvin, because non- degradable filaments "withstand lateral compressive and shear forces" that may result from patient movement, and, thus, would prevent a closed wound from opening. See Melvin, p. 14. Although we decline to reject dependent claims 15-20 and 36 under our discretionary authority under 3 7 C.F .R. Â§ 41. 50(b ), we emphasize that our decision does not mean the remaining claims are patentable. Rather, we merely leave the patentability determination of these claims to the Examiner. SUMMARY The Examiner's decision to reject claims 13, 15-24, 36, and 37 under 35 U.S.C. Â§ 103(a) is affirmed as to claims 21-24 and 37 and reversed as to claims 13, 15-20, and 36. We enter a new ground of rejection of claims 13, 15-20, and 36 under 35 U.S.C. Â§ 112(a) as failing to comply with the written description requirement. We enter a new ground of rejection of claim 13 under 35 U.S.C. Â§ 103(a) as unpatentable over Wasson and Melvin. This decision contains new grounds of rejection pursuant to 37 C.F.R. Â§ 41.50(b ). Section 41.50(b) provides "[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review." Section 41.50(b) also provides ( emphasis added): When the Board enters such a non-final decision, the appellant, within two months from the date of the decision, must exercise one of the following two options 11 Appeal2018-002350 Application 11/722,726 with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the [E]xaminer, in which event the prosecution will be remanded to the [E]xaminer. The new ground of rejection is binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the [E]xaminer, overcomes the new ground of rejection designated in the decision. Should the [E]xaminer reject the claims, appellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard underÂ§ 41.52 by the Board upon the same Record. The request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining ProcedureÂ§ 1214.01 (9th ed. 2018). No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED-IN-PART; 37 C.F.R. Â§ 4I.50(b) 12