SMITH & NEPHEW, INC.

Patent Trials and Appeals Board

Feb 17, 2022

2021002699 (P.T.A.B. Feb. 17, 2022)

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. 14/769,754 08/21/2015 Lei SHI SMIT.P0014US/1000340790 2402 32425 7590 02/17/2022 NORTON ROSE FULBRIGHT US LLP 98 SAN JACINTO BOULEVARD SUITE 1100 AUSTIN, TX 78701-4255 EXAMINER BOWERS, ERIN M ART UNIT PAPER NUMBER 1653 NOTIFICATION DATE DELIVERY MODE 02/17/2022 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): aoipdocket@nortonrosefulbright.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte LEI SHI, ALEKSA JOVANOVIC, and DENNIS CARSON1 Appeal 2021-002699 Application 14/769,754 Technology Center 1600 Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and JOHN E. SCHNEIDER, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a gel- forming film, which have been rejected for obviousness and provisionally rejected for obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM the provisional double patenting rejection. 1 Appellant identifies the real party in interest as Smith & Nephew, Inc. Appeal Br. 1. “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appeal 2021-002699 Application 14/769,754 2 STATEMENT OF THE CASE The Specification discloses “a dissolvable, gel-forming film for delivering active agents, such as those used to treat wounds. The film is solid and non-flowable, but has the ability to dissolve upon contact with water or other aqueous medium . . . to form a hydrogel that remains on the wound.” Spec. ¶ 6. For example, “a dissolvable, gel-forming film comprising a water- soluble ether, a hydrophilic rheological modifying agent, and a proteolytic enzyme (e.g., thermolysin)” can be “applied to a wound as a dry film, which is then dissolved with water or other aqueous medium to form a hydrogel and release the enzymes.” Id. “The viscosities of the hydrogels formed after hydration of the films are generally in the range of 5,000-100,000 [cps] when approximately 1g of dry film is solubilized in 20 ml of aqueous medium.” Id. ¶ 51. “Viscosity was measured using a Brookfield RV Model Viscometer using small sample adapter with spindle # SC4-14 and chamber #SC4-6R, at 10 rpm at room temperature, reading taken at 1 minute.” Id. Claims 1, 2, 5-22, and 34-36 on appeal. Claims 1 and 34, the independent claims, are reproduced below: 1. A dissolvable, gel-forming film comprising: (a) a water-soluble cellulose ether; (b) a hydrophilic rheological modifying agent; and (c) a thermolysin or collagenase proteolytic enzyme, wherein the dissolvable, gel-forming film has a water content of less than 15% w/w, and the dissolvable, gel-forming film is capable of forming a hydrogel having a viscosity of 1,000 to 100,000 cps, as measured using a Brookfield RV Model Appeal 2021-002699 Application 14/769,754 3 Viscometer using small sample adapter with spindle # SC4-l 4 and chamber #SC4-6R, at 10 rpm at room temperature, reading taken at 1 minute, when 1 gm of gel-forming film is contacted with 20 ml of water or other aqueous medium. 34. A dissolvable, gel-forming film comprising: (a) 25 to 35% w/w of hydroxyethylcellulose and 25 to 35% w/w of hydroxypropylmethyl cellulose; (b) 15 to 25% w/w of a polyethylene glycol; and (c) 5 to 15% w/w of thermolysin, wherein the dissolvable, gel-forming film has a water content of less than 15% w/w, and the dissolvable, gel-forming film is capable of forming a hydrogel when 1 gm of gel-forming film is contacted with 20 ml of water or other aqueous medium. The claims stand rejected as follows: Claims 1, 2, 5-22, and 34-36 under 35 U.S.C. § 103(a) as obvious based on Barnhart,2 Shi,3 and Reibert4 (Final Action5 3) and Claims 1, 2, 5-22, and 34-36, provisionally, for obviousness-type double patenting based on claims 1-3, 7-14, and 16-19 of Application 14/441,135 (Final Action 10). 2 Barnhart (US 2008/0124381 A1; published May 29, 2008). 3 Shi (US 2003/0198632 A1; published Oct. 23, 2003). 4 Reibert (US 6,235,893 B1; issued May 22, 2001). 5 Office Action mailed Nov. 18, 2019. Appeal 2021-002699 Application 14/769,754 4 OPINION Obviousness Claims 1, 2, 5-22, and 34-36 stand rejected as obvious based on Barnhart, Shi, and Reibert. The Examiner finds that Barnhart teaches “dissolvable adhesive films for delivery of pharmaceuticals for treatment of various conditions . . . , having cellulose ethers, a rheological agent (e.g., PVP . . .), and having a water content of less than 15% w/w, and is capable of forming a hydrogel when contacted with water.” Final Action 3. The Examiner finds that Barnhart teaches the use of papain (id.), but “do[es] not explicitly teach thermolysin.” Id. at 4. The Examiner finds, however, that Shi teaches a “wound debrider having gelatin or collagen, which employs thermolysin in combination with metal ions.” Id. The Examiner finds that Reibert teaches “methods for utilizing cellulose ethers having enhanced gel strength for the purposes of film formation, binding, adhesives, and gelation, wherein the viscosity is adjusted or manipulated.” Id. “[T]he cellulose ethers may have a viscosity of up to about 1 to about 100,000 centipoise”; thus, “the viscosity ranges overlap with those of the instant claims.” Id. at 5. The Examiner concludes that it would have been obvious to combine “the teachings of Barnhart et al. with those of Shi et al. and Reibert et al., because at least Shi et al. teach dissolvable gel materials having enzymes, and rheological modifying agents, and where Reibert et al. teach the advantages in utilizing cellulose ethers for enhancing hydrogel strength.” Id. The Examiner finds that a skilled artisan would have been motivated to combine the references “because Shi et al. teach including thermolysin in a Appeal 2021-002699 Application 14/769,754 5 ‘wound’ care composition to promote better tissue healing and improved function when paired with metal ions, and where Reibert et al. teach hydrogel formulations having effective viscosities.” Id. at 5-6. Appellant argues that “claims 1 and 34 recite a gel-forming film that is capable of forming a hydrogel when contacted with water under certain conditions. None of the cited references disclose such a film.” Appeal Br. 1. Specifically, Appellant argues, “the record evidence, including experimental data, declaration testimony by inventors of the present application, and Barnhart itself, shows that Barnhart’s films do not form hydrogels upon hydration, but instead disintegrate.” Id. at 2. Appellant points to the Shi Declaration6 as evidence that (1) Barnhart’s dry film matrix disintegrates directly into an aqueous solution-it does not form a hydrogel; (2) Barnhart explicitly states that the active ingredients are released from its dry film matrix, which further confirms that a hydrogel is not formed; (3) the rate (or speed) at which the film matrix disintegrates directly into a solution determines the disintegration profile of the film, and a slow rate of release does not indicate formation of a hydrogel. Id. at 4. Appellant also argues that “Barnhart’s films directly disintegrate rather than form hydrogels,” as “established by experiments reported by Dr. Aleksa Jovanovic . . . , in a declaration submitted to the Office on July 11, 2018 (the ‘Jovanovic Declaration’).” Id. at 5. Appellant argues that Dr. Jovanovic prepared dissolvable, enzyme-containing films according to three of Barnhart’s examples and that the films formed a liquid with no 6 Declaration under 37 C.F.R. § 1.132 of Lei Shi, filed June 26, 2019. Appeal 2021-002699 Application 14/769,754 6 measurable viscosity when mixed with water. Id. “Thus, the Examiner has failed to establish that Barnhart discloses a film that is capable of forming a hydrogel.” Id. at 6. We agree with Appellant that the Examiner has not persuasively shown that the cited references disclose or would have suggested a film that forms a hydrogel when contacted with an aqueous medium. Appellant’s Specification states that “[t]he inventors provide a dissolvable, gel-forming film for delivering active agents, such as those used to treat wounds. The film is solid and non-flowable, but has the ability to dissolve upon contact with water or other aqueous medium . . . to form a hydrogel that remains on the wound.” Spec. ¶ 6. “In certain embodiments, the hydrogel resulting from the film being dissolved in water or other aqueous medium has a viscosity of between 1,000 to 100,000 cps.” Id. ¶ 7. Consistent with the Specification, claims 1 and 34 both recite a “dissolvable, gel-forming film [that] is capable of forming a hydrogel,” when “1 gm of gel-forming film is contacted with 20 ml of water.” Claim 1 further requires that the “hydrogel ha[s] a viscosity of 1,000 to 100,000 cps,” as measured under specified conditions. Barnhart states that its “invention provides disintegratable adhesive film compositions prepared with a combination of ingredients that yield films of sufficient film strength and variable disintegration profiles.” Barnhart ¶ 10. Barnhart’s summary of its invention does not describe its compositions as “hydrogels” (see id. ¶¶ 10-14) and, although the Examiner states that Barnhart’s film “is capable of forming a hydrogel when contacted Appeal 2021-002699 Application 14/769,754 7 with water” (Final Action 3), the word “hydrogel” does not appear in any of the cited passages (i.e., Barnhart ¶¶ 22, 23; Example 2). The Examiner reasons, however, that the combination of Barnhart, Shi, and Reibert teaches or suggests making compositions that contain all of the ingredients recited in the instantly claimed compositions at the concentrations recited in the instant claims. As such, it is unclear how the compositions of the instant claims could be capable of forming hydrogels while the compositions rendered obvious by the teachings of Barnhart, Shi, and Reibert would not be capable of forming hydrogels. Ans. 10-11. We do not find this reasoning persuasive. First, Appellant’s claims 1 and 34 do not require specific concentrations of the recited components, but they do require the claimed film to be capable of forming a hydrogel when contacted with water. Second, the Examiner has not pointed to evidence of record showing that a composition with the same components in the same concentrations as disclosed by Barnhart necessarily forms a hydrogel. In addition, the Examiner’s reasoning is contradicted by Appellant’s declaratory evidence. Dr. Shi reviews Barnhart’s paragraphs 2, 10, and 41 and states that they “confirm that its dry films do not become hydrated and form hydrogels when exposed to water. Rather, the dry films, when exposed to water, directly disintegrate and release the active ingredient from the dry film matrix.” Shi Decl. ¶ 9. Dr. Shi states that “[l]onger disintegration profiles do not equate to the formation of a hydrogel-they equate to a slower rate at which the dry film directly disintegrates, thereby releasing the active.” Id. Appeal 2021-002699 Application 14/769,754 8 Dr. Shi also points to the Jovanovic Declaration as providing “[d]ata . . . confirm[ing] that Barnhart’s films, when contacted with water, directly disintegrated into liquids/solutions having viscosities of 0 cps. See paragraphs 6-10 of Dr. Aleksa Jovanovic’s declaration.” Shi Decl. ¶ 10. The Jovanovic Declaration states that the declarant “prepared the dissolvable films in Examples 30, 31, and 35 of Barnhart by following the procedures outlined in Barnhart.” Jovanovic Decl. ¶ 7. See also id. ¶ 6 (“Of [Barnhart’s] Examples, the films in Examples 30, 31, and 35 are the only films that include an enzyme. The enzyme is papain.”). Dr. Jovanovic further declares: I contacted 1 gram of each of the produced films from Examples 30, 31, and 35 of Barnhart with 20 mL of water. After contacting each film with water, a liquid formed. I measured the viscosity of each liquid using . . . the same procedure noted in the above claim 1. Each of the three liquids had a viscosity reading of 0 cps (no measurable viscosity reading). Id. ¶¶ 8, 9. Dr. Jovanovic concludes that the films of Barnhart’s Examples 30, 31, and 35 have a viscosity, when measured under the conditions recited in claim 1, that is much lower than the viscosity required by claim 1. Id. ¶ 10. We find that Appellant has provided persuasive evidence, in the form of the Shi and Jovanovic Declarations, showing that Barnhart’s films, when contacted with water, form a liquid with no measurable viscosity, rather than forming a hydrogel, as required by both claim 1 and claim 34. The Examiner finds that the experiments performed by Dr. Jovanovic were focused on three specific examples of Barnhart, Examples 30, 31, and 35. It Appeal 2021-002699 Application 14/769,754 9 is interesting to note that these particular examples, example 30 and 31, contained high amounts of Avicel, which is a disintegrant, whereas the example cited in the rejection was not relied upon to make the comparison. Example 35 relied upon in the Declaration did not utilize a high amount of cellulose ether. Again, the example relied upon in the rejection contains a high amount of cellulose ether. See examples 2 and 24. Ans. 11. However, the Examiner has not persuasively explained why the noted differences would lead a skilled artisan to conclude that Barnhart’s Examples 2 and 24 form hydrogels, even though the Examples cited in the Jovanovic Declaration did not. The Examiner reasons that Barnhart clearly teaches that film disintegration or dissolving rate to release the active ingredient may mean a few seconds or more than several hours or days. See Barnhart et al. at [0041]. When gelling agents such as those of Barnhart are in contact with water for several hours or days as recited by Barnhart, they will intrinsically form a gel. Ans. 12-13. The Examiner, however, does not cite any evidence or provide sound technical reasoning supporting the assertion that Barnhart’s films “intrinsically form a gel” while in the process of disintegrating, and the Shi Declaration expressly states that “[l]onger disintegration profiles do not equate to the formation of a hydrogel-they equate to a slower rate at which the dry film directly disintegrates.” Shi Decl. ¶ 9. We conclude that a preponderance of the evidence of record supports Appellant’s position that Barnhart does not disclose a dry film that forms a hydrogel upon contact with water. The Examiner has not cited any disclosure in Shi or Reibert that makes up for the deficiency in Barnhart. We Appeal 2021-002699 Application 14/769,754 10 therefore reverse the rejection of claims 1, 2, 5-22, and 34-36 under 35 U.S.C. § 103(a) based on Barnhart, Shi, and Reibert. Obviousness-type double patenting Claims 1, 2, 5-22, and 34-36 stand provisionally rejected for obviousness-type double patenting based on claims 1-3, 7-14, and 16-19 of application 14/441,135.7 Final Action 10. Appellant does not present arguments directed to the provisional double patenting rejection, instead “respectfully request[ing] deferral of this rejection until an indication that the present application is allowable.” Appeal Br. 8. Appellant indicates that, at that time, it “would consider filing an appropriate terminal disclaimer.” Id. The MPEP provides the following guidance: If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application, and that application has an effective U.S. filing date . . . that is later than the effective U.S. filing date of at least one of the reference application(s), the rejection should be maintained until applicant overcomes the rejection. . . . [A] reply that includes the filing of a compliant terminal disclaimer in the later-filed application under 37 CFR 1.321 will overcome a nonstatutory double patenting rejection. MPEP § 1490(VI)(D)(2)(c). We note that the effective filing date of the instant application is March 15, 2013 and the effective filing date of the ’135 application is November 14, 2012. 7 The ’135 application is the subject of Appeal 2021-002702, decided concurrently with the instant appeal. Appeal 2021-002699 Application 14/769,754 11 Panels of the PTAB have discretion whether or not to reach provisional rejections. Ex parte Moncla, 95 USPQ2d 1884 (BPAI 2010) (precedential). In this case, we choose to reach the provisional rejection here, based on the Director’s guidance in the MPEP and the respective filing dates of the instant application and the ’135 application. And, because Appellant has waived arguments disputing the merits of the provisional double patenting rejection, we affirm it. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 2, 5-22, 34-36 103(a) Barnhart, Shi, Reibert 1, 2, 5-22, 34-36 1, 2, 5-22, 34-36 Provisional Obviousness-type Double Patenting 1, 2, 5-22, 34-36 Overall Outcome 1, 2, 5-22, 34-36 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED