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
Response to Amendment
The amendment filed 2/10/2026 has been entered. Newly amended Claims 1, 3-4, 6, and 8-12 are pending in the application.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Response to Applicant’s Arguments
Regarding the 35 USC 103 rejection over Govil, applicant argues Production Examples 8-10 contained more methacrylate than in Example 12 and that decomposition progressed easily. Applicant then points to Table 3 in which the decomposition products were lower in Production Examples 8-10. Applicant’s argument is unclear because one on hand, applicant argues that decomposition occurred in the “harsh conditions” but also that decomposition products were significantly lower in the same examples. Applicant further argues the release rate of scopolamine is increase in Examples 8-10 as compared to Example 5. However, this result is expected in view of Govil, which teaches “protonated pharmaceutically active compounds (basic Salts) are generally relatively high in polarity…non-polar drugs, in general, are transmitted through the skin easily because of a high degree of compatibility with lipophillic [sic] layers of the skin” (Page 1, Para 4). Therefore, one of skill in the art would expect that delivery or release of scopolamine is increased with increased deprotonating agents like the copolymer in Production Examples 8-10 as compared to Example 5. Applicant’s arguments are fully considered but not persuasive.
However, a direct comparison of Production Examples 6-7 and 12 suggest the presence of PVP interacts with the copolymer and scopolamine to preserve scopolamine over 28 days:
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One would expect that the increased relative amount of copolymer in Production Examples 8-10 as compared to Example 12 would yield more decomposition products. However, the opposite is true because like Examples 6-7, Examples 8-10 possess PVP which preserves scopolamine from decomposition. Govil merely suggests PVP as a viscosity modifier and does not speak to any interaction between the methacrylate copolymer and scopolamine HBr hydrate. These results are critical and unexpected in view of the art, and Govil fails to disclose the particular amounts found in the Production Examples or instant claims. The rejection over Govil is rejected with respect to those claims reciting particular amounts of ingredients, including PVP, in accordance with Examples 8-10.
Claim 9 is an independent claim which has not since the last rejection been amended to incorporate the new limitations which serve as the basis for applicant’s arguments and the analysis written above. Therefore, Claims 9-11 are not traversed and stand rejected on the same grounds as previously rejected.
For the same reasons described above, Claims 9-11 remain subject to the double patenting rejection over Ogawa.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Govil (US20010006628, published 2001, cited in 12/28/2022 IDS) in view of Bosman (International Journal of Pharmaceutics 169 (1998) 75–82) and Jung (J. Kor. Pharm. Sci., Vol. 33, No. 2, 141-144 (2003)).
Govil teaches a transdermal patch comprising a “ba[c]king [sic] layer, a release layer, and a therapeutic adhesive formulation including both adhesive and drug” (Page 9, Para 75; Fig. 1):
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The API to be used in the patch is scopolamine-HCl (Abstract; Page 4, Para 34; Page 13, Claim 4). The formulation can include vinyl polymers “such as polyvinyl pyrrolidone” (PVP) as the adhesive polymer material, required by Claim 1 (Page 8, Para 72; Page 13, Claim 2). Govil teaches “protonated pharmaceutically active compounds (basic Salts) are generally relatively high in polarity…non-polar drugs, in general, are transmitted through the skin easily because of a high degree of compatibility with lipophillic [sic] layers of the skin”, making a deprotonating agent critical to transdermal administration of the HCl salt of scopolamine (Page 1, Para 4). Govil teaches the use of Eudragit E100, a copolymer comprising methyl, butyl, and dimethylaminoethyl methacrylate:
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, as an acceptable deprotonating agent (Page 8, Para 69). Regarding Claims 9-11, the adhesive can be further comprised of hydroxy-containing methacrylate (like hydroxyethyl acrylate or hydroxy propyl methacrylate) or long, alkyl non-polar chain-containing methacrylate (like 2-ethylhexyl acrylate, butyl acrylate, n-decyl, n-nonyl, 2-ethyloctyl, isooctyl, and dodecyl acrylate) to achieve “an acrylic polymeric adhesive system capable of providing desirable therapeutic delivery, as well as structural integrity, for transdermal application”.
Govil fails to teach the use of a scopolamine HBr hydrate instead of scopolamine HCl and the specific permeation enhancer, isopropyl myristate (IPM), in the transdermal scopolamine patch.
Bosman teaches scopolamine hydrobromide trihydrate is stable, has a high receptor affinity, and can be transdermally administered like the scopolamine salt form of Govil (Abstract; Page 82, Conclusions).
Jung teaches IPM resulted in roughly 2-fold higher skin permeation of scopolamine compared to the control group (Abstract; Page 144, Fig 4):
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Therefore one of ordinary skill in the art seeking to form a transdermal patch described by Govil with enhanced drug permeation properties would select IPM as the permeation enhancer because Jung teaches greatly enhanced permeation of the same drug into the skin as compared to other permeation enhancers. The same artisan would select the HBr trihydrate form of scopolamine in the formation of said patch because Bosman teaches its stability and high receptor affinity. The ordinary artisan would expect successful formulation because Jung teaches enhanced permeation using IPM with respect to the same free base component of the claimed drug, scopolamine, and Govil teaches the use of permeation enhancers as acceptable excipients. Bosman also teaches Scopolamine HBr trihydrate as an acceptable API for use in transdermal patches as claimed. Therefore, one of ordinary skill in the art seeking to form a patch for scopolamine delivery via transdermal route would expect success in modifying Govil in view of the Bosman drug form and Jung IPM enhancer before the effective filing date of the claimed invention.
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 9-11 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 17-31 of copending Application No. 18023036 (hereinafter called Ogawa) in view of Bosman (International Journal of Pharmaceutics 169 (1998) 75–82) and Jung (J. Kor. Pharm. Sci., Vol. 33, No. 2, 141-144 (2003)).
Although the claims at issue are not identical, they are directed to a patch comprising a support, a drug-containing adhesive layer, and a release liner, and (0.5% to 10%) scopolamine HBr hydrate, (0.3% to 12%) polyvinyl pyrrolidone, and (0.3% to 10%) a methacrylate base, also containing an acrylic adhesive.
Ogawa is directed to a method of treatment using said patch. However, such a method necessarily requires the examined patch and composition as claimed.
Ogawa fails to teach the inclusion of a permeation enhancer, isopropyl myristate, in the transdermal scopolamine patch.
Jung teaches isopropyl myristate (IPM) resulted in roughly 2-fold higher skin permeation of scopolamine compared to the control group (Abstract; Page 144, Fig 4):
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Therefore one of ordinary skill in the art seeking to form a transdermal patch described by Ogawa with enhanced drug permeation properties would select IPM as the permeation enhancer because Jung teaches greatly enhanced permeation of the drug through a patient’s skin as compared to comparable permeation enhancers. The ordinary artisan would expect successful formulation because Jung teaches the effect with respect to the same API scopolamine as taught by Ogawa for transdermal administration.
Since both applications teach the transdermal patch comprising scopolamine HBr and compositions which comprise the patch, the examiner maintains that the aforementioned claims of the instant application are obvious over the cited claims of Ogawa.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1, 3-4, 6, 8, and 12 are allowable. Claims 9-11 are rejected.
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 mailing date of this final action.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 7:30am - 4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627