3M INNOVATIVE PROPERTIES COMPANY

Patent Trials and Appeals BoardMay 13, 2021

2020003953 (P.T.A.B. May. 13, 2021)

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. 15/313,081 11/21/2016 Philip A. Jinks 0625.075007US01 3170 170876 7590 05/13/2021 MRG/Kindeva c/o Mueting Raasch Group 111 Washington Ave. S., Suite 700 Minneapolis, MN 55401 EXAMINER BROOKS, KREGG T ART UNIT PAPER NUMBER 1764 NOTIFICATION DATE DELIVERY MODE 05/13/2021 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): ptodocketing@mrgs.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte PHILIP A. JINKS and FRANS A. AUDENAERT ____________ Appeal 2020-003953 Application 15/313,081 Technology Center 1700 ____________ Before LILAN REN, SHELDON M. MCGEE, and JANE E. INGLESE, Administrative Patent Judges. INGLESE, Administrative Patent Judge. DECISION ON APPEAL Appellant1 requests review under 35 U.S.C. § 134(a) of the Examiner’s final rejection of claims 1, 3–5, 8–10, and 12–23.2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 “Appellant” refers to the “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies 3M Innovative Properties Company as the real party in interest. Appeal Brief filed February 3, 2020 (“Appeal Br.”), 2. 2 Final Office Action entered May 3, 2019 (“Final Act.”), 1. Appeal 2020-003953 Application 15/313,081 2 CLAIMED SUBJECT MATTER Appellant claims a method of making a component for a medicinal delivery device. Appeal Br. 3–4. Claim 1, the sole pending independent claim, illustrates the subject matter on appeal, and reads as follows: 1. A method of making a component for a medicinal delivery device, the method comprising a) providing a component of a medicinal delivery device, b) providing a primer composition comprising a silane having two or more reactive silane groups wherein the silane is of the formula: X3-m(R1)mSi–Q–Si(R2)kX3-k wherein R1 and R2 are independently selected univalent groups, X is a hydrolysable or hydroxyl group, m and k are independently 0, 1, or 2 and Q is a divalent organic linking group, c) providing a coating composition comprising an at least partially fluorinated compound, d) applying the primer composition to at least a portion of the surface of the component, e) applying the coating composition to the portion of the surface of the component after application of the primer composition. Appeal Br. 9 (Claims Appendix). REJECTIONS The Examiner maintains the following rejections in the Examiner’s Answer entered March 5, 2020 (“Ans.”): I. claims 1, 3–5, 8–10, and 12–23 under 35 U.S.C. § 103 as unpatentable over Jinks3 in view of Corsaro4; 3 US 2010/0242958 A1; published September 30, 2010. 4 US 2009/0305051 A1; published December 10, 2009. Appeal 2020-003953 Application 15/313,081 3 II. claims 1, 3–5, 8–10, and 12 provisionally rejected for nonstatutory obviousness-type double patenting over claims 14–18 of copending application 15/762,350 in view of Jinks; and III. claims 1, 3–5, 8–10, and 12 provisionally rejected for nonstatutory obviousness-type double patenting over claims 1–11 and 21 of copending application 15/126,655 in view of Jinks.5 FACTUAL FINDINGS AND ANALYSIS Upon consideration of the evidence relied upon in this appeal and each of Appellant’s timely contentions,6 we affirm the Examiner’s rejection of claims 1, 3–5, 8–10, and 12–23 under 35 U.S.C. § 103 for reasons set forth in the Final Action, the Answer, and below. We decline to reach the Examiner’s provisional obviousness-type double patenting rejections for reasons discussed below. We review appealed rejections for reversible error based on the arguments and evidence the Appellant provides for each issue the Appellant identifies. 37 C.F.R. § 41.37(c)(1)(iv) (2019); Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential) (cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (explaining that even if the Examiner had failed to make a prima facie case, “it has long been the Board’s practice 5 The Examiner does not set forth the rejections in the Final Action, but refers to the statement of the rejections provided in the Non-Final Office Action entered November 13, 2018. Final Act. 2–5. 6 We do not consider the argument Appellant presents on page 2 of the Reply Brief because Appellant does not show good cause for raising the arguments for the first time in the Reply Brief. 37 C.F.R. § 41.37(c)(1)(iv); 37 C.F.R. § 41.41(b)(2) (arguments raised for the first time in the Reply Brief that could have been raised in the Appeal Brief will not be considered by the Board unless good cause is shown). Appeal 2020-003953 Application 15/313,081 4 to require an applicant to identify the alleged error in the examiner’s rejections”)). Rejection I We turn first to the Examiner’s rejection of claims 1, 3–5, 8–10, and 12–23 under 35 U.S.C. § 103 as unpatentable over Jinks in view of Corsaro. Appellant’s arguments for this rejection are not directed to any particular claim. Appeal Br. 4–6. We, therefore, select claim 1 as representative, and decide the appeal as to claims 1, 3–5, 8–10, and 12–23 based on claim 1 alone. 37 C.F.R. § 41.37(c)(1)(iv). Appellant argues that “the Examiner failed to give adequate weight to the unexpected result reported by Appellant in the Specification that the claimed methods provide components which, when assembled and in use, significantly reduce dose to dose variability of medicinal delivery devices. . . [and] provide reduced unit to unit variability.” Appeal Br. 5–6. Appellant argues that results provided in the Specification for Samples 4A and 7F, in which a primer composition and coating composition were applied sequentially, and Samples 4B and 7J, in which both compositions were applied simultaneously, “demonstrate the significant improvements associated with a two-step method.” Appeal. Br. 6. The burden of analyzing and explaining Specification disclosures to establish unexpected results rests with Appellant. In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972) (“the burden of showing unexpected results rests on he who asserts them”). To meet this burden, Appellant must show that the relied-upon disclosures provide results that are commensurate in scope with the claimed subject matter, and would have been unexpected by one of ordinary skill in the art relative to the closest prior art. In re Lindner, 457 Appeal 2020-003953 Application 15/313,081 5 F.2d 506, 508 (CCPA 1972) (explaining that “objective evidence of nonobviousness must be commensurate in scope with the claims,” meaning that the relied-upon evidence must provide a reasonable basis for concluding that untested embodiments encompassed by the claims would behave in the same manner as the tested embodiments.); In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.”). Appellant’s Specification explains that the inventors discovered that deposition of a drug, such as salbutamol sulphate, on components of devices for delivering the drug, such as a metered dose inhaler, can be reduced by first applying to the surface of the components a primer composition comprising a silane having two or more reactive silane groups separated by an organic linker, and then applying a coating composition comprising an at least partially fluorinated compound to the surface of the primer composition. Spec. 7, l. 29–9, l. 13. Examples 4 and 7 in Appellant’s Specification describe experiments for assessing the extent to which deposition of salbutamol sulphate on the surface of aluminum cans was reduced by coating the surface of the cans with a primer composition, and then coating the primer composition with a coating composition comprising a partially fluorinated compound. Spec. 35–36; 39–40. As discussed above, Appellant points to samples 4A and 7F, which were prepared by pre-washing aluminum cans with a solvent (HFE72DE), contacting the inside surface of the washed cans with bis(trimethoxysilylpropyl)amine (BMSTPA) (primer), draining the cans and placing them in an oven at 60ºC for 2 hours “to complete priming,” Appeal 2020-003953 Application 15/313,081 6 contacting the inside surface of the cans with fluorosilane A (sample 4A) or fluorosilane B (sample 7F),7 draining the cans, and placing the cans in an oven at 120ºC for 15 minutes “to effect curing.” Spec. 5, ll. 21–26; 26, ll. 13–18; 27, ll. 1–17; 35, ll. 1–30. A salbutamol sulphate dispersion was then placed into each can, the cans were placed on a horizontal rolling mixer “for 3 minutes to allow the dispersion to dry to the surface,” the cans were subjected to further air drying, and the cans were then rinsed with decafluoropentane. Spec. 27, ll. 1–16. Residual salbutamol sulphate deposited on the inside surface of the cans was quantitatively assayed by UV spectrometry. Spec. 27, ll. 17–18. Appellant also points to comparative samples 4B and 7J, which were prepared and assayed using the same process described above that was used for samples 4A and 7F, except the inside surface of the aluminum cans was coated in a single step with a composition that included both the primer bis(trimethoxysilylpropyl)amine (BMSTPA) and fluorosilane B, rather than using a two-step process in which the primer and fluorosilane were applied separately. Spec. 5, ll. 21–25; 26, ll. 13–18; 27, ll. 1–17; 35, ll. 1–30. The results set forth in Tables 4, 7a, and 7b of the Specification show that little or no salbutamol sulphate was deposited on cans that had been coated using the two-step process (samples 4A and 7F), while more salbutamol sulphate deposition occurred on cans in which the coating had been applied in a single step (samples 4B and 7J). Spec. 35–37; 39–40. As the Examiner explains, however, these experiments do not provide a comparison between the method of claim 1 and that of the closest prior art, 7 The formulas of “fluorosilane A” and “fluorosilane B” are set forth on page 26 of the Specification. Appeal 2020-003953 Application 15/313,081 7 Jinks. Ans. 13–14. More specifically, as the Examiner finds, Jinks discloses a two-step process for coating a component of a medicinal inhalation device that involves forming a first coating having at least one silanol functional group on a surface of the component, and then applying a composition comprising at least one partially fluorinated compound to at least a portion of the surface of the first coating. Non-Final Act. (entered November 13, 2018) 4–5; Jinks ¶¶ 6–8, 19–21. Although Jinks discloses a two-step coating process, Jinks does not disclose that the first coating used in the process includes a silane of the formula recited in claim 1. The experimental examples relied upon by Appellant, however, do not compare coatings formed using a primer composition as disclosed in Jinks to coatings formed using a primer composition as recited in claim 1. Rather, as discussed above, the relied- upon experimental examples compare a two-step coating process as recited in claim 1 to a single step coating process. The relied-upon experimental examples, therefore, do not provide a comparison to the closest prior art. Furthermore, the relied-upon experimental examples test coating compositions that include only one compound of formula I (bis(trimethoxysilylpropyl)amine (BMSTPA)), and include only two different partially fluorinated compounds (fluorosilane A and fluorosilane B). Appellant does not provide an explanation grounded in objective evidence or technical reasoning establishing that the results generated from the limited number of tested coating compositions would extend to the full scope of the compositions encompassed by claim 1. In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005) (“Even assuming that the results were unexpected, Harris needed to show results covering the scope of the claimed Appeal 2020-003953 Application 15/313,081 8 range. Alternatively Harris needed to narrow the claims.”); In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978) (“Establishing that one (or a small number of) species gives unexpected results is inadequate proof, for ‘it is the view of this court that objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support.’”) (Quoting In re Tiffin, 448 F.2d 791, 792 (CCPA 1971)). In fact, as the Examiner points out (Ans. 14), results presented in Appellant’s Table 8 show otherwise. More specifically, Table 8 shows that the level of salbutamol sulphate deposited on PET vials after coating the vials in a two-step process with bis(triethoxysilyl)ethane) (Primer B)—a primer encompassed by the formula recited in claim 1—followed by fluorosilane B (sample 8B), was significantly similar to the level of salbutamol sulphate deposition that resulted from coating unprimed vials with fluorosilane B only. Spec. 40, ll. 9–29; Ans. 14 (noting that formulation 8B “performs no better than an unprimed surface with regard to deposition.”). Appellant, therefore, does not meet the burden of establishing that the relied-upon Specification results are commensurate in scope with claim 1, and would have been unexpected relative to the closest prior art. Considering the totality of the evidence relied upon in this appeal, a preponderance of the evidence weighs in favor of the Examiner’s conclusion of obviousness. We, accordingly, sustain the Examiner’s rejection of claims 1, 3–5, 8–10, and 12–23 under 35 U.S.C. § 103. Rejections II and III We turn now to the Examiner’s provisional rejection of claims 1, 3–5, 8–10, and 12 for nonstatutory obviousness-type double patenting over claims 14–18 of copending application 15/762,350 in view of Jinks Appeal 2020-003953 Application 15/313,081 9 (Rejection II), and provisional rejection of claims 1, 3–5, 8–10, and 12 for nonstatutory obviousness-type double patenting over claims 1–11 and 21 of copending application 15/126,655 in view of Jinks (Rejection III). The copending applications applied in these rejections have now issued as patents. Because the scope of the claims in the issued patents may differ from the scope of the claims applied in the provisional obviousness- type double patenting rejections, we decline to reach the merits of these provisional rejections. We leave it to the Examiner to determine the propriety of the rejections upon return of jurisdiction to the Examiner. Ex parte Jerg, Appeal No. 2011-000044, 2012 WL 1375142, at *3 (BPAI Apr. 13, 2012) (informative) (“Panels have the flexibility to reach or not reach provisional obviousness-type double-patenting rejections.”) (citing Ex parte Moncla, 95 USPQ2d 1884 (BPAI 2010) (precedential)). CONCLUSION Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3–5, 8– 10, 12–23 103 Jinks, Corsaro 1, 3–5, 8– 10, 12–23 1, 3–5, 8– 10, 12 Provisional Nonstatutory Double Patenting, 15/762,350, Jinks8 1, 3–5, 8– 10, 12 Provisional Nonstatutory Double Patenting, 15/126,655, Jinks9 8 For reasons explained above, we do not reach this rejection. 9 For reasons explained above, we do not reach this rejection. Appeal 2020-003953 Application 15/313,081 10 Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed Overall Outcome 1, 3–5, 8– 10, 12–23 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)(iv). AFFIRMED