DETAILED ACTION
The receipt is acknowledged of applicant’s election and IDS filed 6/10/2025; and IDS filed 07/10/2023.
Claims 1, 16-27, 33-42, 56-57, 78, 82, 83, 86, 100-105 are pending.
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 .
Election/Restrictions
Applicant’s election without traverse of invention I and species (a), claims 1, and 16-19, in the reply filed on 06/10/2025 is acknowledged.
Claims 20-27, 33-42, 56-57, 78, 82, 83, 86, 100-105 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions II and III, and species (b) through (l), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/10/2025.
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, 16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 57, 111-113 of copending Application No. 17/809,191 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed and claimed in the referenced copending applications and would be covered by any patent granted on the copending applications since the referenced copending applications and the instant application are claiming common subject matter as follows: transdermal delivery system, comprising: a backing layer; a separating layer, wherein the separating layer has a top surface and a bottom surface such that the top surface is in contact with the backing layer; a drug matrix layer comprising donepezil hydrochloride (HCl) and donepezil free base wherein the drug matrix layer has a top surface and a bottom surface such that the top surface is in contact with the bottom surface of the separating layer; a membrane layer comprising a microporous membrane, wherein the membrane layer has a top surface and a bottom surface such that the top surface is in contact with the bottom surface of the drug matrix layer; and a contact adhesive layer having a top surface and a bottom surface such that the top surface is in contact with the bottom surface of the membrane layer, wherein the contact adhesive layer comprises donepezil free base in an amount of from 0.1 to 10% (w/w) of the total weight of the contact adhesive layer. Combination of donepezil HCL and donepezil base currently claimed by claim 1, is claimed by claims 111-112 of the copending application. The presence of donepezil base in the skin contact adhesive as currently claimed by claim 1, is claimed by claim 113 of the copending application. The currently pending claims and the copending claims anticipate each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 16 and 17 recite “at least 10%” and “at least 20%”, respectively, without upper limit to the claimed amount that may mount to 99+%. Claims 18 and 19 are rejected by dependency of rejected claim 16.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wen et al. (US 2009/0291127), cited in the IDS filed 07/10/2023.
Claim 1 is directed to a transdermal delivery system, comprising:
(1) a backing layer;
(2) a separating layer, wherein the separating layer has a top surface and a bottom surface such that the top surface is in contact with the backing layer;
(3) a drug matrix layer comprising donepezil HCl and donepezil free base, wherein the drug matrix layer has a top surface and a bottom surface such that the top surface is in contact with the bottom surface of the separating layer;
(4) a membrane layer comprising a microporous membrane, wherein the membrane layer has a top surface and a bottom surface such that the top surface is in contact with the bottom surface of the drug matrix layer; and
(5) a contact adhesive layer having a top surface and a bottom surface such that the top surface is in contact with the bottom surface of the membrane layer, wherein the contact adhesive layer comprises donepezil free base in an amount of from 0.1 to 10% (w/w) of the total weight of the contact adhesive layer.
Wen discloses transdermal formulation to treat dementia comprising combination of donepezil in its free form base and donepezil HCl. The formulation is provided in a multilayered transdermal patch comprising backing layer (2), reservoir/matrix (3), skin contact adhesive layer (4), rate controlling membrane (6) and a release liner (5) (abstract; claims; figures 1 and 2; ¶¶ 0005, 0025-0030). The matrix/reservoir comprising the donepezil free base and donepezil HCl in a polymer to facilitate permeation of active agent through the skin (¶¶ 0030, 0032, 0040-0041, 0057). The backing layer does not absorb the active agent from the reservoir and formed from a laminate (¶ 0036) that implies more than one layer, i.e. one of the layers of the laminate contact the reservoir reads on the separating layer. The reference disclosed overlay covering the patch over the backing layer (¶ 0059) that also read represents two layer backing: the backing itself reads on the separating layer, and the overlay reads on the backing, absence claiming materials of the layers. The adhesive layer facilitate the adhesion of the reservoir/matrix to the skin and separated from the reservoir/matrix by rate controlling membrane and comprises donepezil base to provide excellent percutaneous absorbability (¶¶ 0049, 0050). The rate controlling membrane is microporous (¶¶ 0055, 0056). The active agent reservoir layer contains donepezil freebase in an amount ranging from 1% to 25% (w/w), such as from 2% to 20% (w/w), including from 5% to 20% (w/w), and donepezil HCl in an amount ranging from 2% to 30% (w/w), such as from 5% to 25% (w/w), including from 5% to 20% (w/w). In certain cases, the active agent reservoir layer contains donepezil freebase in an amount of 6% (w/w) and donepezil HCl in an amount of 15% (w/w) (example 1; ¶ 0060). The contact adhesive layer contains donepezil freebase in an amount ranging from 1% to 25% (w/w), such as from 2% to 10% (w/w), including from 5% to 7% (w/w) (¶¶ 0061, 0075; examples). Example 2 shows the adhesive layer comprises 6% donepezil base that falls within the claimed amount of 0.1-10% claimed by claim 1.
Example 1 shows the drug containing layer, matrix/reservoir, comprises 6% donepezil free base and 15% donepezil HCL, this form total amount of 21% donepezil. As calculated by the examiner 6% donepezil base will form 28.6% of the total amount of the base and the HCl salt of donepezil. Amount of 28.6% meets at least 10% claimed by claim 16, at least 20% claimed by claim 17, from 20% to 40% claimed by claim 18, and from 22% to 35% claimed by claim 19.
All the limitations of claims 1, 16-19 are met by the reference.
Claim Rejections - 35 USC § 103
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.
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, 16-19 are rejected under 35 U.S.C. 103 as being obvious over Lee et al. (WO 2019/023499) in view of Wen et al. (US 2009/0291127), both references are cited in IDS filed 07/10/2023.
The applied reference has a common inventor “Lee” and common assignee “Corium International” with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Applicant Claims
Claim 1 is directed to a transdermal delivery system, comprising:
(1) a backing layer;
(2) a separating layer, wherein the separating layer has a top surface and a bottom surface such that the top surface is in contact with the backing layer;
(3) a drug matrix layer comprising donepezil HCl and donepezil free base, wherein the drug matrix layer has a top surface and a bottom surface such that the top surface is in contact with the bottom surface of the separating layer;
(4) a membrane layer comprising a microporous membrane, wherein the membrane layer has a top surface and a bottom surface such that the top surface is in contact with the bottom surface of the drug matrix layer; and
(5) a contact adhesive layer having a top surface and a bottom surface such that the top surface is in contact with the bottom surface of the membrane layer, wherein the contact adhesive layer comprises donepezil free base in an amount of from 0.1 to 10% (w/w) of the total weight of the contact adhesive layer.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Lee teaches transdermal delivery system comprising reservoir layer comprising active agent, skin contact adhesive layer, microporous membrane disposed between the skin contact adhesive layer and the reservoir, backing layer separated from the reservoir by a non-rate controlling layer, and a release liner. The reservoir comprises donepezil base generated by the reaction of donepezil HCl with alkali present in the reservoir. The donepezil base is moved from the reservoir to the microporous membrane to the contact adhesive to be delivered to the skin. The reservoir comprises from 10-25% donepezil HCl, and examples 1, 2, and 3 show concentration of donepezil in the reservoir of 5.6%, 16%, and 25%, respectively (abstract; ¶¶ 0007, 0129-0134, 0140, 0145, 0153-0155, 0166, 0174-0176; examples; claims; table 9.1; figures).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Lee teaches conversion of donepezil HCl in the reservoir to donepezil base that implies that at certain point of time during the conversion process, the reservoir will comprise both the donepezil HCl and donepezil base, the reference however does not explicitly teach presence of both in the reservoir as claimed by claim 1.
While Lee teaches moving of the donepezil base from the reservoir to the contact adhesive layer, that implies at certain point of time the device will comprise the skin contact adhesive comprising donepezil base, the reference does not explicitly teach donepezil base in the skin contact adhesive layer as claimed by claim 1.
While Lee teaches amount of the donepezil in the reservoir, the reference does not teach the amount of donepezil base relative to donepezil hydrochloride as claimed by 16-19.
The missing elements from Lee are explicitly taught by Wen whose teachings are discussed under 102 rejection above.
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide transdermal device comprising reservoir comprising donepezil HCl to be converted to donepezil base in the reservoir that then moves to the skin adhesive contact layer as taught by Lee, and include both donepezil HCl and its base form in the reservoir, wherein the base form is present in amount of 28.6% donepezil free base based on the toral amount of donepezil HCl and base as taught by Wen. One would have been motivated to do so because Wen teaches both donepezil HCl and donepezil base in the reservoir treats dementia and has good skin permeability. Further one would include donepezil free base in the skin contact adhesive of Lee in amount of 6% as taught by Wen because Wen teaches this will provide good skin permeability. One would reasonably expect formulating transdermal patch having the structure of Lee and comprises both donepezil HCl and freebase in the reservoir and donepezil freebase in the skin contact adhesive wherein the patch has excellent skin permeability to effectively treat dementia.
Furthermore, one having ordinary skill in the art would have optimized the amount of donepezil free base to that taught by Wen of 28.6% of the total amount of both the base and the HCl salt of donepezil to get good skin permeation.
Amount of 28.6% reads at least 10% claimed by claim 16, at least 20% claimed by claim 17, from 20% to 40% claimed by claim 18, and from 22% to 35% claimed by claim 19. The amount of 28.6% falls within the amounts claimed by claims 16-19.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /.I.G./