Covidien LP

Patent Trials and Appeals BoardNov 9, 2020

2020002413 (P.T.A.B. Nov. 9, 2020)

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. 15/255,263 09/02/2016 Valentino Tramontano H- US-02770.USC1(1603-88CO 9232 50855 7590 11/09/2020 Covidien LP 60 Middletown Avenue Mailstop 54, Legal Dept. North Haven, CT 06473 EXAMINER WHITE, EVERETT ART UNIT PAPER NUMBER 1623 NOTIFICATION DATE DELIVERY MODE 11/09/2020 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): docket@carterdeluca.com rs.patents.two@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ________________ Ex parte VALENTINO TRAMONTANO, PHILLIP BLASKOVICH, RACHIT OHRI, DANIEL S. COSTA, JOSHUA KENNEDY, and SAJIDA FAROOQI1 ________________ Appeal 2020-002413 Application 15/255,263 Technology Center 1600 ________________ Before FRANCISCO C. PRATS, DEBORAH KATZ, and JOHN G. NEW, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 We use the term “Appellant” to refer to the “applicant” as defined in 37 C.F.R. § 1.142. Appellant identifies Covidien LP as the real party-in- interest. App. Br. 1. Appeal 2020-002413 Application 15/255,263 2 SUMMARY Appellant files this appeal under 35 U.S.C. § 134(a) from the Examiner’s Final Rejection of claims 25–27, 32–34, 38–42, 49, and 51 as unpatentable under 35 U.S.C. § 103 as being obvious over the combination of Gehrke et al. (US 5,603,955, February 18, 1997) (“Gehrke”), Blaskovich et al. (US 8,518,440 B2, August 27, 2013) (“Blaskovich”), and Hubbard et al. (US 7,060,287 B1, June 13, 2006) (“Hubbard”). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. NATURE OF THE CLAIMED INVENTION Appellant’s claimed invention is directed to a process for dissolving modified cellulose comprising contacting modified cellulose solution with at least one non-solvent to form a plurality of modified cellulose particles. Abstr. REPRESENTATIVE CLAIM Independent claim 25 is representative of the claims on appeal and recites: 25. A process for forming a gel comprising: forming an oxidized cellulose solution; forming a precipitating composition; and contacting the oxidized cellulose solution and the precipitating composition at a tissue treatment site thereby precipitating oxidized cellulose from the oxidized cellulose solution and forming the gel. Appeal 2020-002413 Application 15/255,263 3 App. Br. 8. ISSUES AND ANALYSES We adopt the Examiner’s findings, reasoning, and conclusion that the claims on appeal are prima facie obvious over the combined cited prior art. We address the arguments raised by Appellant below. Issue Appellant argues that the Examiner erred because the combined cited prior art references neither teach nor suggest the limitation of claim 25 reciting “contacting the oxidized cellulose solution and the precipitating composition at a tissue treatment site thereby precipitating oxidized cellulose from the oxidized cellulose solution and forming the gel,” as recited in independent claim 25. App. Br. 6. Analysis The Examiner finds that Gehrke teaches preparation of cross-linked gels, in which the cross-linkers for cellulose ethers are multifunctional carboxylic acids. Final Act.4 (citing Gehrke, Abstr., col. 12, ll. 61–63). The Examiner also finds that the multifunctional carboxylic acids taught by Gehrke thus teaches the claimed cross-linkable composition, which is covalently cross-linkable with the oxidized cellulose solution, as described in Appellant’s claim 33. Id. The Examiner also finds that Gehrke teaches cephalexin as an example of an antibiotic that can be loaded into the cross- linked gels, as recited in Appellant’s claims 34 and 49. Id. (citing Gehrke col. 17, l. 47) Appeal 2020-002413 Application 15/255,263 4 The Examiner acknowledges that Appellant’s claimed process for forming a cross-linked gel differs from the cross-linked gel compositions taught by Gehrke in reciting that the polymer is oxidized cellulose, rather than Gehrke’s cellulose ethers. Final Act. 4. The Examiner reasons, however, that it would have been within the skill of an ordinary practitioner of the art to substitute oxidized cellulose for a cellulose ether, as taught by Blaskovich. Id. The Examiner finds that Blaskovich teaches hydrogel precursors including cellulose ethers such as carboxymethylcellulose, hydroxyethyl-cellulose, hydroxymethylcellulose, and oxidized cellulose. Id. at 4–5 (citing Blaskovich col. 4, ll. 54– 63). The Examiner further points out that Blaskovich teaches that these hydrogel precursors are cross-linkable. Id. at 5 (citing Blaskovich col. 5, ll. 15–16). The Examiner also notes that, prior to the Final Office Action, Appellant amended the claims to recite that the oxidized cellulose solution and cross-linkable composition are contacted at a tissue treatment site. Final Act. 5. The Examiner finds that Hubbard teaches the use of polysaccharide gels to improve the delivery of augmentation material at a tissue site. Id. The Examiner finds that Hubbard teaches that oxidized cellulose may be selected as the polysaccharide used in this method. Id. (citing Hubbard col. 10, ll. 13–16, 38). The Examiner therefore finds that Hubbard teaches that the delivery of oxidized cellulose, in gel form and combined with other materials, to a tissue site was known in the art at the time of invention. Id. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art to substitute the cellulose ether used as the polymer in the cross-linked gels taught by Gehrke, with oxidized cellulose as taught by Blaskovich, at a tissue treatment site, as taught by Hubbard. Appeal 2020-002413 Application 15/255,263 5 Final Act. 5. The Examiner further concludes that a skilled artisan would have been motivated to use the hydrogel precursors at the treatment site because they possess biologically inert and water soluble cores that increase the effectiveness of the polymers as gels. Id. Appellant argues that, in the Final Office Action, the Examiner allegedly failed to establish that any of the cited references teach or suggest the disputed limitation of claim 25. App. Br. 4. Rather, argues Appellant, all of the reasoning articulated by the Examiner pertains solely to the cross- linked gel recited in claims 33 and 34. Id. Appellant asserts that the Final Office Action does not mention the claim term “precipitating composition,” nor do any of the cited references teach or suggest such a composition for contacting oxidized cellulose, as recited in claim 25. Id. Appellant points to the Advisory Action, filed July 22, 2019, in which the Examiner stated: Applicant argue [sic] that “precipitation composition” is not mentioned in the Final rejection of the claims. This argument is not persuasive since it is not clear what the precipitation composition is comprises [sic]. Withdrawn Claim 28 recite that the precipitating composition may be selected as water, saline, buffered saline, which appears to [be] any salt containing solution, which is mentioned in the Gehrke et al patent. App. Br. 5 (quoting Adv. Act. 2). Appellant notes that the Examiner did not make any rejections with respect to the definiteness of the claims, such as under 35 U.S.C. § 112, second paragraph. Id. Appellant therefore argues that, absent any such rejection by the Examiner, the recitation “precipitation composition” is definite. Id. Appellant asserts that, in applying the broadest reasonable interpretation of the claim term, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the Appeal 2020-002413 Application 15/255,263 6 Specification. Id. According to Appellant, the plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the time of the invention. Id. (citing In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997) (holding that “the USPTO looks to the ordinary use of the claim terms taking into account definitions or other ‘enlightenment’ contained in the written description”). Furthermore, argues Appellant, the disclosures of the Specification are consistent with the ordinary and customary meaning of the claim term “precipitation composition” and provide sufficient description of the term in paragraphs [0280]–[0283] of the Specification. App. Br. 5. Appellant points in particular to paragraph [0283], which discloses: Upon contact of the oxidized cellulose solution with the precipitating composition, the gel is formed in situ by the dilution of the solvent used to form the oxidized cellulose solution and the subsequent precipitation of the oxidized cellulose. Since the polar solvent of the oxidized cellulose solution is miscible with water and/or organic solvents described above, oxidized cellulose precipitates out in the form of a gel due to the dilution of the solvent. Appellant contends that the Examiner’s finding that Gehrke teaches a “precipitation composition,” because Gehrke teaches the use of saline, which is recited in claim 28 as one possible precipitation composition, is also improper. Final Act. 5. According to Appellant, Gehrke teaches saline as one of the “substances which can serve as pharmaceutically-acceptable carriers,” rather than as a substance “contacting the oxidized cellulose solution and the precipitating composition at a tissue treatment site thereby precipitating oxidized cellulose from the oxidized cellulose solution and forming the gel,” as recited in claim 25. Id. Appeal 2020-002413 Application 15/255,263 7 Appellant argues further that that independent claim 33 is patentable over the combination of Gehrke, Blaskovich, and Hubbard, because none of these references, alone or in combination, teaches or suggests the limitation reciting “contacting the oxidized cellulose solution and the cross-linkable composition at a tissue treatment site thereby forming the cross-linked gel by convergently applying the oxidized cellulose solution and the cross-linkable composition onto the tissue treatment site,” as recited in independent claim 33. App. Br. 4. Similarly, Appellant contends that the combined references neither teach nor suggest “contacting the oxidized cellulose solution and the gelation composition at a tissue treatment site thereby forming the gel by convergently applying the oxidized cellulose solution and the gelation composition onto the tissue treatment site,” as recited in independent claim 38. Id. Appellant contends that, as with respect to claim 25, the Examiner did not make any indefiniteness rejection under 35 U.S.C. § 112, second paragraph, of claims 33 and 38. App. Br. 6. Appellant contends that, absent an actual rejection by the Examiner, the claim term “crosslinkable composition” and “gelation composition” are definite. Appellant asserts that the Specification is consistent with the ordinary and customary meaning of the claim terms, and provides sufficient descriptive support for the claim terms recitation in paragraphs [0273], [0279], and [0280]–[0281]. Id. We are not persuaded by Appellant’s arguments. Before proceeding to the merits of the Examiner’s rejection, we are obliged to make several initial points. First of all, Appellant does not accurately state the correct standard for construing the claim terms. In the absence of an express definition of a Appeal 2020-002413 Application 15/255,263 8 claim term in the Specification, the Board “determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’” Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Nor does Appellant correctly represent the holding of Morris, which states that: Since it would be unreasonable for the PTO to ignore any interpretive guidance afforded by the applicant’s written description, either phrasing connotes the same notion: as an initial matter, the PTO applies to the verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in the applicant’s specification. 127 F.3d at 1054. Consequently, we construe claim terms by giving them their broadest reasonable definition in light of Appellant’s Specification, and not by the “ordinary and customary meaning of the claim term,” as suggested by Appellant. See App. Br. 5. Furthermore, with respect to Appellant’s arguments concerning claims 33 and 38, and specifically, with respect to Appellant’s arguments concerning the obviousness of the claims over the combined cited prior art, our reviewing court has held that “the Board reasonably interpret[s] Rule 41.37 to require more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements were not found in the prior art.” In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011). We are currently not persuaded by Appellant’s arguments Appeal 2020-002413 Application 15/255,263 9 concerning those claims. Appellant’s arguments that certain terms in the claim are definite (or “clear” as Appellants put it), are largely irrelevant, because, as Appellant argues, the Examiner made no such rejection on the basis of indefiniteness under 35 U.S.C. § 112, second paragraph. This reasoning similarly applies to Appellant’s same arguments with respect to claim 25. Turning to the merits, Appellant’s Specification provides no express definition of the claim term “precipitating composition.” However, Appellant’s Specification discloses a number of examples of “precipitating compositions,” which, although not definitive, are instructive in our construction of the claims. Specifically, paragraphs [0106]–[0109] of the Specification disclose: According to an aspect of the above embodiment, the precipitating composition is selected from the group consisting of water, saline, phosphate buffered saline, and combinations thereof. According to an aspect of the above embodiment, the precipitating composition is an aqueous solution of carboxymethylcellulose, wherein the carboxymethylcellulose is present from about 0.5% by weight of the solution to about 5% by weight of the solution. According to an aspect of the above embodiment, the precipitating composition is a solution of an acrylic polymer based on at least one of methyl methacrylate, hydroxyethyl acrylate, hydroxyethyl methacrylate, glyceryl acrylate, glyceryl methacrylate, acrylic acid, methacrylic acid, acrylamide, or methacrylamide, and combinations thereof. According to an aspect of the above embodiment, the precipitation composition solution includes a solvent selected Appeal 2020-002413 Application 15/255,263 10 from the group consisting of acetone, ethyl acetate, dimethyl ether, and combinations thereof. (Emphasis added). Furthermore, Appellant’s Specification discloses that Dissolved oxidized cellulose may also be utilized to form in situ gels. Oxidized cellulose solution may be prepared using the methods, e.g., solvents, conditions, etc., outlined above. The oxidized cellulose solution may have a pH from about 7.0 to about 10.0, in embodiments from about 8.0 to about 9.5. The oxidized cellulose solution may be combined with a gelation composition that, upon contacting the oxidized cellulose solution, forms a gel. Spec. ¶ 272 (emphasis added). Given these disclosures, and mindful that the broadest reasonable definition of the term must be consistent with the Specification, we can define the claim term “precipitating composition” as meaning “any composition, including at least those listed in paragraphs [0106]–[0109], which, when combined with oxidized cellulose, causes it to precipitate in the form of a gel.” See, e.g., ¶ 279 (the “oxidized cellulose precipitates out in the form of a gel”), see also, e.g., ¶ 283. The Examiner states that: [T]he Blaskovich et al[.] patent teach[es] mixing of a macromolecule solution which can be oxidized cellulose and crosslinker solution to produce a hydrogel, which can be done in situ (see 6th paragraph of column 1, 3rd and 5th paragraphs of column 4), for example by injecting in two chambers of a dual syringe. The process of crosslinking the macromolecule to form a gel can reasonably be interpreted as falling under the definition of precipitating or gelation as recited in Claims 25 and 38 as well as crosslinking, since it results in the formation of a gel. Appeal 2020-002413 Application 15/255,263 11 Ans. 6. We agree. With respect to the formation of the hydrogels, Blaskovich teaches that: In embodiments, components which may be utilized for foaming hydrogels…. These precursor(s) may form “in situ”, meaning formation occurs in a living animal or human body. In general, this may be accomplished by utilizing precursors that can be activated at the time of application to tissue to form an in situ forming material, in embodiments a hydrogel. Blaskovich col. 2, ll. 2 31–39. More specifically, Blaskovich teaches that: In embodiments the hydrogel may be formed from single precursors or multiple precursors. For example, where the hydrogel is formed from multiple precursors, for example two precursors, the precursors may be referred to as a first and second hydrogel precursor. The terms “first hydrogel precursor” and “second hydrogel precursor” each mean a polymer, functional polymer, macromolecule, small molecule, or crosslinker that can take part in a reaction to form a network of crosslinked molecules, e.g., a hydrogel. Id. at col. 4, ll. 24–33 (emphasis added). We conclude that a person of ordinary skill in the art would recognize that the first or second precursor molecules that “take part in a reaction to form a network of crosslinked molecules, e.g., a hydrogel,” would correspond to a “precipitating composition” under the broadest reasonable definition of the term consistent with Appellant’s Specification, and as we have construed it supra. We acknowledge the Examiner’s finding that Gehrke neither teaches nor suggests the use of oxidized cellulose as a polymer. However, Blaskovich teaches that: The first and second hydrogel precursors may have biologically inert and water soluble cores. When the core is a polymeric region that is water soluble [i.e., a hydrogel], suitable polymers that may be used include: polyethers, for example, polyalkylene Appeal 2020-002413 Application 15/255,263 12 oxides such as polyethylene glycol (“PEG”),… carboxymethylcellulose, oxidized cellulose, hydroxyethyl- cellulose, hydroxymethylcellulose, …. Blaskovich col. 4, ll. 54–65 (emphasis added). We agree with the Examiner that a person of ordinary skill would have found it obvious to substitute oxidized cellulose for the cellulose polymer ethers taught by Gehrke. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (holding that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”; see also id. at 417 “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability”). In this instance, the substitution of oxidized cellulose for the other cellulose ethers does no more than result in a predictable end, viz., the formation of a hydrogel, a species of gel. We consequently conclude that the combined cited prior art teaches or suggests the disputed limitation, and we affirm the Examiner’s rejection of the claims. CONCLUSION The Examiner’s rejection of claims 25–27, 32–34, 38–42, 49, and 51 under 35 U.S.C. § 103 is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Appeal 2020-002413 Application 15/255,263 13 Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 25–27, 32– 34, 38–42, 49, 51 103 Gehrke, Blaskovich, Hubbard 25–27, 32–34, 38–42, 49, 51