Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The Applicant’s reply filed on 9/8/25 is acknowledged. Claims 1-3, 5-9 and 11 are pending. Claims 5, 7 and 8 have been withdrawn. Claim 1 has been amended. Claims 1-3, 6, 9, and 11 are under consideration.
Rejections Withdrawn
The rejection of Claims 1-3, 6, 9 and 11 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of the amended claim.
The rejection of Claims 1-3, 6, 9 and 11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite are withdrawn in view of the amended claims.
Rejections Maintained and New Grounds of Rejections
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Sapre et al. (WO 2014/111790; cited in IDS) in view of Liao et al. (US 2014/0276478; previously cited).
Sapre et al. teach a stable transdermal pharmaceutical drug delivery system of rivastigmine or a pharmaceutically acceptable salt thereof, which provides an enhanced absorption of drug through skin, and remains stable during a longer storage period (e.g. abstract).
Sapre et al. teach that the transdermal drug delivery system comprises a backing layer, rivastigmine or a pharmaceutically acceptable salt thereof, an adhesive material, one or more pharmaceutically acceptable excipients and a release liner (e.g. Claim 1 and Examples). Sapre et al. teach that the dosage amount of rivastigmine or a pharmaceutically acceptable salt thereof in the composition may present from about 2 mg to about 25 mg, and that the surface area is 2-30 cm2 and the patch comprises, resulting in 0.07-12.5 mg/cm2, which overlaps the claimed range (e.g. page 6, lines 6-8 and page 12, lines 1-2). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I). Sapre et al. teach that the system may comprise the filler magnesium aluminometasilicate in an amount of about 1-10% by weight, which overlaps the claimed range (e.g. page 8, lines 18-23). Sapre et al. teach that the adhesive material may contain silicones or rubber, but also teach numerous alternatives and rubber is not present in the Examples, therefore Sapre et al. teach embodiments wherein the self-adhesive matrix layer comprises a silicone adhesive and does not include a rubber-based adhesive polymer (e.g. page 6, line 28 - page 7, line 29).
Sapre et al. teach the inclusion of a release controlling membrane (e.g. page 10, lines 16-23), but are silent as to the material. This is made up for by the teachings of Liao et al.
Liao et al. teach transdermal drug delivery systems for the transdermal administration of tertiary amine drugs, such as rivastigmine, comprising a polymer drug matrix, a rate-controlling membrane and a skin-contacting face adhesive apart from the polymer matrix (e.g. abstract). Liao et al. teach that the rate controlling membrane comprises an ethylene vinyl acetate film (e.g. paragraphs 0125-0127; Claim 23).
Regarding Claims 1-3, it would have been obvious to one of ordinary skill in the art at the time of filing to select the ethylene vinyl acetate rate-controlling membrane of Liao et al. for use in the patch of Sapre et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. Sapre et al. suggest the inclusion of rate-controlling membranes but do not provide examples thereof. One of ordinary skill in the art would have been motivated to seek out additional guidance on an membrane material. One of ordinary skill in the art would have predicted success in selecting the ethylene vinyl acetate taught by Liao et al., because both of Liao and Sapre are directed to transdermal patches comprising rivastigmine.
Regarding Claim 6, Sapre et al. teach that the system may comprise 1-40 wt% rivastigmine and the filler magnesium aluminometasilicate in an amount of about 1-10% by weight, which overlaps the claimed range (e.g. page 6, lines 4-8, and page 8, lines 18-23). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I).
Regarding Claim 11, Sapre et al. teach that in some embodiments, the transdermal drug delivery system includes silicone-based polymer adhesives, including those commercially available as BIO-PSA® X7-4301 and BIO-PSA® X7-4303 (e.g. page 7, lines 25-29) (i.e. a mixture of two or more having different properties).
Claims 1-3, 6, 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Liao et al. (US 2014/0276478; previously cited) in view of Sapre et al. (WO 2014/111790; cited in IDS).
Liao et al. teach transdermal drug delivery systems for the transdermal administration of tertiary amine drugs, such as rivastigmine, fentanyl or rotigotine, comprising a polymer matrix comprising a free base form of the drug and at least one carboxyl group-containing compound. In some embodiments, the systems include a rate-controlling membrane and a skin-contacting face adhesive apart from the polymer matrix. (e.g. abstract).
Liao et al. teach that the transdermal drug delivery system comprises a backing layer, rivastigmine or a pharmaceutically acceptable salt thereof, an adhesive material, one or more pharmaceutically acceptable excipients and a release liner (e.g. paragraph 0048 and 0049). Liao et al. exemplify 10-15 mg/cm2 rivastigmine (e.g. Examples). Liao et al. teach that the rate controlling membrane comprises an ethylene vinyl acetate film (e.g. paragraphs 0125-0127; Claim 23). Liao et al. teach that the adhesive material may contain silicones or rubber, but also teach numerous alternatives and rubber is not present in the Examples, therefore Liao et al. teach embodiments wherein the self-adhesive matrix layer comprises a silicone adhesive and does not include a rubber-based adhesive polymer (e.g. paragraphs 0052-0055 and 0083-0087).
Liao et al. teach the inclusion of 0-20 wt% fillers (e.g. paragraph 0064), but do not teach the filler magnesium aluminometasilicate in an amount of about 1-10% by weight. This is made up for by the teachings of Sapre et al.
Sapre et al. teach that the transdermal drug delivery system comprises a backing layer, rivastigmine or a pharmaceutically acceptable salt thereof, an adhesive material, one or more pharmaceutically acceptable excipients and a release liner (e.g. Claim 1 and Examples). Sapre et al. teach that the dosage amount of rivastigmine or a pharmaceutically acceptable salt thereof in the composition may present from about 2 mg to about 25 mg, and that the surface area is 2-30 cm2 and the patch comprises, resulting in 0.07-12.5 mg/cm2, which overlaps the claimed range (e.g. page 6, lines 6-8 and page 12, lines 1-2). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I). Sapre et al. teach that the system may comprise the filler magnesium aluminometasilicate in an amount of about 1-10% by weight, which overlaps the claimed range (e.g. page 8, lines 18-23). Sapre et al. teach that the adhesive material may contain silicones or rubber, but also teach numerous alternatives and rubber is not present in the Examples, therefore Sapre et al. teach embodiments wherein the self-adhesive matrix layer comprises a silicone adhesive and does not include a rubber-based adhesive polymer (e.g. page 6, line 28 - page 7, line 29).
Regarding Claims 1-3, it would have been obvious to one of ordinary skill in the art at the time of filing to include the magnesium aluminometasilicate of Sapre et al. in the patch of Liao et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. Liao et al. suggest the inclusion of fillers but do not provide examples thereof. One of ordinary skill in the art would have been motivated to seek out additional guidance on an appropriate filler. One of ordinary skill in the art would have predicted success in selecting a filler taught by Sapre, because both of Liao and Sapre are directed to transdermal patches comprising rivastigmine.
Regarding Claim 6, Liao et al. teach that the system may comprise 10-40 wt% rivastigmine and Sapre et al. teach the filler magnesium aluminometasilicate in an amount of about 1-10% by weight, which overlaps the claimed range (e.g. paragraph 0014). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I).
Regarding Claim 9, Liao et al. teach 0-1wt% of an antioxidant (e.g. paragraph 0017).
Regarding Claim 11, Liao et al. teach that in some embodiments, the transdermal drug delivery system includes silicone-based polymer adhesives, including those commercially available as BIO-PSA® 7-4100, -4200 and -4300 product series (e.g. paragraph 0085) (i.e. a mixture of two or more having different properties).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 6, 9 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,318,360 in view of Sapre et al. (WO 2014/111790; cited in IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and copending claims recite a rivastigmine patch for transdermal treatment comprising a backing film; a rivastigmine matrix layer comprising rivastigmine; a self-adhesive matrix layer comprising an adhesive that adheres to the skin; and a release liner that is removed before use, wherein the content per patch area of the rivastigmine or a pharmaceutically acceptable salt thereof is 5.4 to 15 mg/cm2 based on the rivastigmine free base. Claim 10 of ‘360 recites that the rivastigmine patch comprises a release-controlling membrane that is an ethylene vinyl acetate film between the rivastigmine matrix layer and the self-adhesive matrix layer; and Claim 11 recites that the self-adhesive matrix layer comprises a mixture of two or more silicone adhesives having different physical properties.
The difference being that the instant claims recite that the matrix layer comprises 10-30 % by weight of magnesium aluminometasilicate.
However, this is obvious over the teachings of Sapre et al.
Sapre et al. teach that the transdermal drug delivery system comprises a backing layer, rivastigmine or a pharmaceutically acceptable salt thereof, an adhesive material, one or more pharmaceutically acceptable excipients and a release liner (e.g. Claim 1 and Examples). Sapre et al. teach that the system may comprise the filler magnesium aluminometasilicate in an amount of about 1-10% by weight, which overlaps the claimed range (e.g. page 8, lines 18-23).
It would have been obvious to one of ordinary skill in the art at the time of filing to include the magnesium aluminometasilicate of Sapre et al. in the patch of US 12,318,360. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success in selecting a filler taught by Sapre, because both of Sapre and ‘360 are directed to transdermal patches comprising rivastigmine.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 9/8/25 have been fully considered. However, upon further consideration and the broadening of the claims, a new ground(s) of rejection is made in view of Sapre and Liao, of record.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619