Ex Parte Lockwood et al

Patent Trial and Appeal BoardNov 29, 2018

13177438 (P.T.A.B. Nov. 29, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/177,438 07/06/2011 Jeffrey S. Lockwood 60402 7590 12/03/2018 KINETIC CONCEPTS, INC. c/o Harness Dickey & Pierce 5445 Corporate Drive Suite 200 Troy, MI 48098 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. HLR.0101C2N2 6471 EXAMINER TREYGER, IL YA Y ART UNIT PAPER NUMBER 3781 NOTIFICATION DATE DELIVERY MODE 12/03/2018 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): dgodzisz@hdp.com troymailroom@hdp.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JEFFREYS. LOCKWOOD, ROBERT PETROSENKO, and JAMES R. RISK, JR. Appeal2017-010339 Application 13/177 ,43 8 Technology Center 3700 Before BRANDON J. WARNER, LISA M. GUIJT, and LEE L. STEPINA, Administrative Patent Judges. GUIJT, Administrative Patent Judge. DECISION ON APPEAL Appellants 1 appeal under 35 U.S.C. Â§ 134(a) from the Examiner's rejection2 of claims 20, 22, 24--28, 30, 33-37, and 40-42. We have jurisdiction under 35 U.S.C. Â§ 6(b). We AFFIRM-IN-PART. 1 Appellants identify the real party in interest as "KCI Medical Resources Unlimited, Company (assignee); KCI International, Inc.; KCI Holding Co., Inc.; Kinetic Concepts, Inc.; Chiron Holdings, Inc.; Chiron Topco, Inc.; and, Acelity L.P. Inc." Appeal Br. 2. 2 Appeal is taken from the Non-Final Office Action dated July 28, 2016. Appeal2017-010339 Application 13/177,438 STATEMENT OF THE CASE The sole independent claim on appeal, claim 20, reproduced below, is exemplary of the subject matter on appeal. 20. A bandage for use with a vacuum source, the bandage compnsmg: a flexible wound dressing member formed from a generally non-porous material and having a sheet-like configuration including a wound-facing surface and an opposite surface including a plurality of channels formed therein with a plurality of discrete holes extending from the channels through the wound dressing member; and a flexible cover having a sheet-like configuration and a port configured to be coupled to a vacuum source, the flexible cover coupled to the opposite surface to cover the plurality of channels and cooperate therewith to form passageways in fluid communication between the port and the plurality of holes in the wound dressing member; wherein the bandage is configured so that the wound- facing surface can be disposed over a wound such that a vacuum source can be fluidly coupled to the port to apply negative pressure to the wound through the passageways and the holes. THE REJECTIONS I. Claims 20, 22, 24--28, 30, 33-37, and 40-42 stand rejected under 35 U.S.C. Â§ 112, first paragraph, as failing to comply with the written description requirement. II. Claims 20, 22, 24--28, 30, 33-37, and 40-42 stand rejected under 35 U.S.C. Â§ 112, second paragraph, as indefinite. III. Claims 20, 22, 24, 26-28, 30, 33, 35-37, and 40-42 stand rejected under 35 U.S.C. Â§ 103(a) as unpatentable over the embodiments depicted in Figures 1 and 2 of Argenta (US 5,636,643; issued June 10, 1997). 2 Appeal2017-010339 Application 13/177,438 IV. Claims 25 and 34 stand rejected under 35 U.S.C. Â§ 103(a) as unpatentable over the embodiments depicted in Figures 1 and 2 of Argenta and Augustine (US 6,013,097; issued Jan. 11, 2000). ANALYSIS Rejection I Regarding independent claim 20, the Examiner finds that the Specification, as originally filed, discloses "generally transparent and non- porous material," but not "generally non-porous material," as claimed. Non- Final Act. 5 ( citing Spec. ,r 8); Ans. 8. Appellants correctly submit that the Specification, as originally filed, need not describe the invention using the same words as recited in the claims to provide written description support. Appeal Br. 8-9 ( citing Martin v. Johnson, 454 F.2d 746, 751 (CCPA 1972) (stating "the description need not be in ipsis verbis [(i.e., "in the same words")] to be sufficient."); see also MPEP Â§ 2163; Reply Br. 2-3. Appellants maintain that the Specification's disclosure of "generally transparent and non-porous material" is interpreted as meaning that the wound dressing member is "both generally transparent and generally non-porous." Id. at 9 (emphasis added). Appellants also argue that the Specification discloses that "[i]t is within the scope of this disclosure ... to include a wound dressing member made of any type of thin, flexible material that is non-porous ... such as polyvinylchloride (PVC), PVC free of diethylehexyl phthalate (DEHP-free PVC), polyurethane, or polyethylene," and that these examples "would have been recognizable by those of ordinary skill in the art at the time the application was filed as 'generally non-porous."' Id. at 9-10. 3 Appeal2017-010339 Application 13/177,438 The written description requirement of 35 U.S.C. Â§ 112 requires that the disclosure of the application relied upon reasonably convey that the inventor had possession of the claimed subject matter as of the filing date. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) ( en bane). "[T]he written description requirement is satisfied by the patentee's disclosure of 'such descriptive means as words, structures, figures, diagrams, formulas, etc., that fully set forth the claimed invention,"' (Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 969 (Fed. Cir. 2002) (quoting Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997)) ), and also when the disclosure "allow[ s] one skilled in the art to visualize or recognize the identity of the subject matter purportedly described." Enzo Biochem, at 968. We do not agree with Appellants that the term "generally" necessarily modifies both "transparent" and "non-porous" in the sentence, "the material is generally transparent and non-porous material." Spec., p. 3. Further, Appellants have not presented evidence that one skilled in the art would recognize the materials listed in the disclosure (i.e., PVC, DEHP-free PVC, polyurethane, or polyethylene (Spec., p. 9)) as "generally non-porous," as opposed to "non-porous" as stated in the disclosure. Thus, the Specification fails to reasonably convey that the inventor had possession of "a flexible wound dressing member formed from a generally non-porous material," as claimed. 3 Notably, the Specification does not provide a definition for the 3 Regarding claims 24 and 33, which recite in relevant part, "where the cover is generally non-porous" and "where the wound dressing member and the cover are each generally non-porous," respectively (Appeal Br. 33 (Claims App'x)), we cannot find written description support in the Specification for a "generally non-porous" cover; rather, the Specification 4 Appeal2017-010339 Application 13/177,438 claim term "generally." An ordinary meaning of the claim term "generally" is "in a general manner" or "as a whole." WEBSTER'S THIRD NEW INT'L DICTIONARY 945 (1993). We construe "generally non-porous material," as recited in claim 20, to mean that the material comprising the wound dressing member is, in a general manner or as a whole, non-porous. To the extent Appellants interpret the meaning of "generally" as akin to "substantially," it would seem that a material is either porous or non-porous. The Examiner also finds that the Specification, as originally filed, discloses "an adhesive sheet," but not "a sheet-like configuration," as claimed. Non-Final Act. 5 (citing Spec. ,r 5); see also Ans. 8 (determining that "'sheet-like' is much broader than a 'sheet'"). Appellants submit that the claim term "sheet-like" is "an adjective used to describe a noun having the form of a 'sheet,"' and that an ordinary definition of the term "sheet" is "' a broad stretch or surface of something."' Appeal Br. 10 ( citing Merriam- Webster's online dictionary). Appellants also submit that Figure 3 of the Specification "clearly illustrates both the 'wound dressing member 20' and the 'cover 52' in the form of a sheet, that is, having a broad stretch or surface,"' and also that "the Specification discloses the 'wound dressing member 20' as comprising a 'thin, flexible material."' Id. at 10-11 ( citing, e.g., Spec. 3:5-11, 12:8-15, 13:1-7, Fig. 3). We agree with Appellants that Figure 3 of the Specification depicts the flexible wound dressing member 20 and the flexible cover 52 as having discloses "molding a cover from a semi-cured silicone." Spec., p. 6; see also id. at 20 ("cover 52 ... may be ... formed from semi-cured silicone," which "may be bought and pre-molded from a manufacturer such as NuSil Technology"). 5 Appeal2017-010339 Application 13/177,438 "a sheet-like configuration" (i.e., a configuration similar to a sheet4) and thus, provides sufficient written description support for these claim limitations. Accordingly, we sustain the Examiner's rejection of independent claim 20, and claims 22, 24--28, 30, 33-37, and 40-42 depending therefrom, as failing to comply with the written description requirement, with respect to the claim term "generally non-porous," but not with respect to the Examiner's reliance on the claim term "sheet-like." Re} ection II The Examiner determines that "[t]he phrase 'sheet-like' renders the claim( s) indefinite because the claim( s) include( s) elements not actually disclosed (those encompassed by 'or the like'), thereby rendering the scope of the claim(s) unascertainable." Non-Final Act. 6 (citing MPEP Â§ 2173.0S(d)); Ans. 8-9 ("'[s]heet-like' is a genus while a 'sheet' is a species, thus it is not clear what else can be encompassed by the 'sheet like' terminology"). The Examiner also determines that it is unclear whether the claim term "the cover" means "a flexible cover or some other structure." Non-Final Act. 6. Appellants argue that the claims do not recite "or the like," but rather, "a sheet-like configuration," which clearly means "like a sheet," wherein a sheet has limiting and identifiable characteristics: "a broad stretch or surface of something." Appeal Br. 12; Reply Br. 3. Appellants also submit that the Examiner entered Appellants' amendment, which "amended the recitation of 'the cover' in claim 20 to read 'the flexible cover,"' rendering the Examiner's rejection moot. Reply Br. 3. 4 We accept Appellants' definition of "sheet" as "a broad stretch or surface of something," as stated supra. 6 Appeal2017-010339 Application 13/177,438 We agree with Appellants that the claim term "sheet-like" is not indefinite because the claim term means "like a sheet," wherein a sheet has definable characteristics, and we accept Appellants' definition in this regard: a broad stretch or surface of something, as set forth supra. Thus, we construe the claimed flexible wound dressing member and flexible cover to be configured to be like a sheet, which has a broad stretch or surface. To the extent the claim term "the cover" appears in dependent claims, we determine that antecedent basis for "the cover" is recited as the cover specified as "a flexible cover" in independent claim 20 supra, and therefore, the claims are not indefinite based on the recitation of "the cover." See, e.g., Appeal Br. 33-34 (Claims App.) (claims 22, 24, 26, 34, 36). Accordingly, we do not sustain the Examiner's rejection of independent claim 20, and claims 22, 24--28, 30, 33-37, and 40-42 depending therefrom, under 35 U.S.C. Â§ 112, second paragraph, as indefinite. Rejection III Regarding independent claim 1, the Examiner relies on the Figure 2 embodiment of Argenta for disclosing, inter alia, a bandage comprising a wound dressing member made of "generally non-porous" (i.e., "solid") material and having "discrete holes extending through a wound dressing member ... necessarily forming channels." Non-Final Act. 7 (citing Argenta 10:4--8, Fig. 2); see also Ans. 10 (finding that Argenta's Figure 2 embodiment "discloses a plurality of discrete holes extending through the wound dressing member ... necessarily forming channels because the dressing member has a thickness"). The Examiner determines that Argenta's Figure 2 does not depict that "the cover is flexible and is coupled 7 Appeal2017-010339 Application 13/177,438 to the opposite surface and covering the plurality of channels," and the Examiner relies on the Figure 1 embodiment of Argenta for teaching a flexible cover "coupled to the opposite surface of the packing material 10 ... covering the plurality of channels necessarily formed by porous structure 10." Non-Final Act 8-9 (citing Argenta 6:46, Fig. 1). The Examiner reasons that it would have been obvious "to replace the cover of [ depicted in Argenta's Figure 2] with the flexi[b ]le cover and bring it in contact with the dressing member, as taught by Argenta embodiment on [F]ig. 1 in order to make the apparatus compact by employing the structure of the type known in the art." Id. at 9. Appellants correctly submit that claim 20 requires the opposite surface of the sheet-like wound dressing member (i.e., the surface opposite the wound-facing surface) to include a plurality of channels formed in the opposite swface with a plurality of discrete holes extending from the channels through the wound dressing member. Appeal Br. 13. Appellants emphasize that "[b ]ecause the plurality of channels are formed within the opposite surface, the plurality of channels necessarily extend along the opposite surface of the dressing member and have depth penetrating into the non-porous material of the wound dressing member." Id. Appellants also correctly submit that claim 20 requires the cover to be coupled to the opposite surface to cover the channels and cooperate to form passageways that provide fluid communication between the port in the cover and the discrete holes extending from the channels through the wound dressing member. Id. at 13-14. Appellants argue, inter alia, that the Examiner fails to support the conclusion that coupling a flexible cover to Argenta's screen 50 8 Appeal2017-010339 Application 13/177,438 "necessarily" results in forming the passageways, as claimed. Appeal Br. 16-17. As set forth supra, the Examiner relies on the Figure 2 embodiment of Argenta for disclosing "a plurality of discrete holes extending through the wound dressing member ... necessarily forming channels." Non-Final Act. 7 ( citing Argenta 10:4--8 ( disclosing "[ a ]n optional screen 50" 5), Fig. 2). Argenta discloses that "screen 50 may be formed of a rigid or semi-rigid perforated polymer surgical mesh such as Prolene mesh," or alternatively, "a section of honeycombed polyethylene sheet may be cut to a suitable size and shape to overlie the wound 74." Argenta 10:5-9. We agree with Appellants that the Examiner has not sufficiently explained how Argenta's perforated polymer surgical mesh or honeycombed polyethylene sheet discloses that the mesh or honeycombed sheet necessarily forms channels in an outer surface of the mesh, such that discrete holes (e.g., the perforations) extend from the channels, wherein the cover (i.e., flexible cover 18 from the Figure 1 embodiment of Argenta), when coupled to such surface, covers such channels to form passageways in fluid communication between the port in the cover and the holes. First, the Examiner has not adequately supported the finding that an exposed surface of a perforated surgical mesh or honeycombed sheet 5 Notably, optional screen 50 is an alternative to the screen disclosed with respect to the Figure 1 embodiment of Argenta, or ''porous wound screen 10." Argenta 6:46 (emphasis added); cf claim 20, supra ("a flexible wound dressing member formed from a generally non-porous material"); see also Argenta 6 :46-61 ( further disclosing that porous wound screen 10 "can be formed from a variety of porous materials," such as "open-cell polymer foam"). 9 Appeal2017-010339 Application 13/177,438 necessarily results in channels in the surface. See WEBSTER'S THIRD NEW INT'L DICTIONARY 374 (1993) (defining "a channel" as "a long gutter, groove, or furrow"). Second, assuming covering Argenta's perforated surgical mesh or honeycombed sheet would result in grooves being formed in the outer surface of the mesh or sheet, Argenta does not disclose how covering such a surface with a cover having a single port would result in all of such covered grooves forming passageways in fluid communication (directly or indirectly) with both the port and discrete holes (i.e., perforations) extending through the mesh or sheet. Rather, it would appear that only those perforations aligned with the port and intersecting with a groove defined in the mesh or honeycombed surface would meet the claim limitation. In other words, we construe claim 20 to require that each of the channels formed in the surface must be in fluid communication with the (single) port in the cover, when covered by the cover to form passageways, as claimed. Accordingly, we do not sustain the Examiner's rejection of independent claim 20, and claims 22, 24, 26-28, 30, 33, 35-37, and 40-42 depending therefrom. Re} ection IV The Examiner's reliance on Augustine does not cure the deficiencies in the Examiner's rejection of independent claim 20, and therefore, for essentially the same reasons stated supra, we also do not sustain the Examiner's rejection of claims 25 and 34, which depend from independent claim 20. 10 Appeal2017-010339 Application 13/177,438 DECISION The Examiner's decision rejecting independent claim 20, and claims 22, 25-28, 30, 34--37, and 40-42, under 35 U.S.C. Â§ 112, first paragraph, as failing to comply with the written description requirement, with respect to the claim term "generally non-porous," is AFFIRMED. The Examiner's decision rejecting claims 20, 22, 24--28, 30, 33-37, and 40-42 under 35 U.S.C. Â§ 112, second paragraph, as indefinite is REVERSED. The Examiner's decision rejecting claims 20, 22, 24--28, 30, 33-37, and 40-42 under 35 U.S.C. Â§ 103(a) is REVERSED. 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). See 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED-IN-PART 11