DETAILED ACTION
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 .
Acknowledgments
The examiner acknowledges receipt of request for continued examination under 37 CFR 1.114 and IDS filed 05/01/2026 and amendment and remarks filed 04/02/2026
Claims 1 and 89 are amended.
Claims 76, 83 and 101 are canceled.
Claims 1-5, 9, 12-19, 22-48, 50-60, 89 and 157 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/01/2026 has been entered.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-10, 12-48, 50-58, 60, 76, 101 and 103, in the reply filed on 08/01/2024 was previously acknowledged. The traversal was on the ground(s) that claim 59 belongs with Group I and 76, 101 and 103 do not belong with Group I. While the examiner agrees with applicant’s removal of claims 76, 101 and 103 from Group I and the inclusion of claim 59 in Group I, the restriction is still applicable as agreed by applicant by removing claims 76, 101 and 103 from Group I, leaving claim 83 as being restricted. However, the examiner includes claim 89 in Group I as suggested by the applicant. Thus, because claims 76, 83, 101 and 103 (now canceled) have been withdrawn from consideration, the restriction requirement is maintained.
The requirement was still deemed proper and is therefore made FINAL.
Applicant also elected botulinum toxin as the specific large agent; nano-emulsion, carrier peptide as the specific non-irritating penetration enhancing agent; MSC performed before applying the composition comprising a large agent; stamp as the specific device; skin surface as the specific site; MN array that is not rotated; impressions made on overlapping sites; hyperfunctional facial lines as the specific dermatological disorder. It is noted that the claims have not been amended to recite the elected species.
Therefore, claims 1-5, 9, 12-19, 22-48, 50-60, 89 and 157 are under consideration.
Claims 76, 83 and 101 previously withdrawn, now canceled.
Priority
This application is a 371 of PCT/US19/63351 filed 11/26/2019 and which claims benefit of 62/789,407 filed 01/07/2019, 62/774,677 filed 12/03/2018 and 62/808,274 filed 02/20/2019.
Information Disclosure Statement
The IDS filed 05/01/2026 has been considered by the examiner.
Response to Arguments
Applicant argues that exclusion of enzyme overcomes the rejection under 35 USC 112.
Response: The examiner disagrees. Surfactant is a chemical penetration agent. The excludes chemical penetration agent and then contains surfactant, a chemical penetration agent. Applicant does not provide reasons or explanations why surfactant is not a chemical penetration agent or why chemical penetration enhancing agent can be excluded and surfactant which also a chemical penetration enhancing agent is present. Therefore, the rejection will be maintained below.
For the obviousness type double patenting rejections, applicant’s arguments are not persuasive as described below:
a) Applicant's argument that Burton and Kasper and Forssen do not remedy the deficiency of US 11311496 is not persuasive because, Burton teaches in paragraph [0008] that "It has now been found that the number of microneedles used and their density per unit area can produce much larger rates of delivery with virtually no pain induced. This offers for the first time the prospect for using microneedle arrays to replace hypodermic injections for rapid, painless delivery of injectable drug formulations." Kasper teaches microneedle arrays involved in the delivery of agents such as botulinum toxin (paragraphs [0090], [0093]) can have a variety of distributions of microneedles spaced at a density of from about I microneedle per square centimeter (l/cm2) to about 2500 microneedles per square centimeter (2500/cm2) (paragraph [0062]). Thus, before the effective date of the invention, the artisan would have been motivated to employ microneedle array having the density that would predictably produce desired drug delivery rates that are rapid and painless. The disclosed density range encompasses the claimed density ranges with the disclosed range allowing for about 2-50 microneedles/cm2. Therefore, the rejection over applicant's prior work, US 11311496 B2 in view of Burton, Kasper and Forssen is maintained on the ground of non-statutory double patenting.
(b) the arguments against co-pending claims of 17/610,057 and 17/696,509 are similar to the arguments presented for US 11311496 B2 in that the co-pending claims do not teach microneedle density and that Burton, Kasper and Forssen do not remedy the teachings of the co-pending claims. The examiner disagrees because Burton teaches that the number of microneedles used and their density per unit area can produce much larger rates of delivery with virtually no pain induced offering for the first time the prospect for using microneedles arrays to replace hypodermic injections for rapid, painless delivery of injectable drug formulations (paragraph [0008]). Kasper teaches delivery of botulinum toxin with microneedle arrays and (paragraphs [0090], [0093]) and densities of from about 1 microneedle per square centimeter (l/cm2) to about 2500 microneedles per square centimeter (2500/cm2) (paragraph [0062]) is envisioned. Forssen administers composition comprising botulinum toxin, surfactant and mucoadhesive (at least claim 2) using microneedle (paragraphs [0011 ], [0145], [0035]).
(c) Applicant argues that 17/610,057 has an effective filing date of 05/12/2020 while the effective filing date for the examined claims is 11/26/2019 which make the examined claims filed before the effective date of the co-pending and as such the rejection should be withdrawn. Because there is a pending rejection over issued US 11311496 B2, the rejection over 17/610,057 will be maintained until the rejection over US 11311496 B2 is overcome and the co-pending is co-pending. Applicant also argues that 17/696,509 is a divisional of US 11311496 B2, however, 17/696,509 is not a divisional of the examined claims. There, the rejection is maintained until overcome. The decision in Ex parte Baurin does not invalidate the provisional obviousness type rejection because the co-pending claims are still co-pending and there is still a rejection of the examined claims.
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 1-5, 9, 12-19, 22-48, 50-60, 89 and 157 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.
The exclusion and inclusion of chemical penetration enhancing agent and surfactant which is a chemical penetration enhancing agent make the claims ambiguous.
It is unclear and confusing how a composition used in a method contains a surfactant which is a chemical penetration enhancing agent and chemical penetration enhancing agent.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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 1-5, 9, 12-19, 22-48, 50-60, 89 and 157 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-59 of U.S. Patent No. 11311496 B2 in view of Burton et al. (US 20110213335 A1) and Kasper et al. (US 20210301289 A1, published Sep.30. 2021 with an effective date of July 29, 2016) and Forssen et al.,(US 20150313973 A1). The issued claims 1-50 teach steps of delivering emulsion/nano-emulsion/macroemulsion composition in the form of lotion, cream, powder, ointment, liniment, gel or drops to the skin/site with microneedle skin conditioning (MSC); the composition comprises large agent such as antibody and botulinum toxin having molecular weight of 100,000 Da or greater; the microneedle have a length of about 10 mm to about 4000 mm; the microneedles are composed of biocompatible material/metal and the microneedle skin conditioning (MSC) several administrations of microneedle (MN) impressions on the same target site or different target sites; the administration treats conditions such as hyperhidrosis. The issued claims do not teach the density of the microneedle arrays. However, Burton teaches in paragraph [0008] that “It has now been found that the number of microneedles used and their density per unit area can produce much larger rates of delivery with virtually no pain induced. This offers for the first time the prospect for using microneedle arrays to replace hypodermic injections for rapid, painless delivery of injectable drug formulations.” Furthermore, Kasper teaches microneedle arrays involved in the delivery of agents such as botulinum toxin (paragraphs [0090], [0093]) can have a variety of distributions of microneedles spaced at a density of from about 1 microneedle per square centimeter (1/cm2) to about 2500 microneedles per square centimeter (2500/cm2) (paragraph [0062]). Therefore, before the effective date of the invention, the ordinary skilled artisan would have been motivated to employ microneedle array having the density that would predictably produce desired drug delivery rates that are rapid and painless. The disclosed density range encompasses the claimed density ranges with the disclosed range allowing for about 2-50 microneedles/cm2.
The issued claims do no use chemical penetration enhancing agents. The transdermally administered composition of the issued claims do not contain surfactant. However, it is known that permeability agent such as surfactant is used in the delivery of botulinum toxin, a large agent delivered by the issued method, by microneedle system. Therefore, before the effective date of the invention, the ordinary skilled artisan would have been motivated to add surfactant to add in the permeability of the botulinum large agent.
Claims 1-5, 9, 12-19, 22-48, 50-60, 89 and 157 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-2, 8-9, 15-16, 23-29, 32-45, 49-52, 54-55, 58-63, 65 and 68-73 of co-pending Application No. 17/610,057 in view of Burton et al. (US 20110213335 A1) and Kasper et al. (US 20210301289 A1, published Sep.30. 2021 with an effective date of July 29, 2016) and Forssen et al.,(US 20150313973 A1). The co-pending claims teach method of treating conditions/disorders such as cancer and body odor or hyperhidrosis or bromhidrosis by administering/delivering emulsion/nano-emulsion/macroemulsion composition in the form of lotion, cream, powder, ointment, liniment, gel or drops to the skin/site with microneedle skin conditioning (MSC); the composition comprises large agent such as antibody and botulinum toxin having molecular weight of 100,000 Da or greater; the microneedle have a length sufficient to project through the stratum corneum of the skin and insufficient to reach nerves in the dermis of the skin; the microneedles are composed of biocompatible material/metal/dissolving polymer and the microneedle skin conditioning (MSC) several administrations of microneedle (MN) impressions on the same target site or different target sites and can be in the form of a stamp device. The co-pending claims do not teach the density of the microneedle arrays. However, Burton teaches in paragraph [0008] that “It has now been found that the number of microneedles used and their density per unit area can produce much larger rates of delivery with virtually no pain induced. This offers for the first time the prospect for using microneedle arrays to replace hypodermic injections for rapid, painless delivery of injectable drug formulations.” Furthermore, Kasper teaches microneedle arrays involved in the delivery of agents such as botulinum toxin (paragraphs [0090], [0093]) can have a variety of distributions of microneedles spaced at a density of from about 1 microneedle per square centimeter (1/cm2) to about 2500 microneedles per square centimeter (2500/cm2) (paragraph [0062]). Therefore, at the effective date of the invention, the ordinary skilled artisan would have been motivated to employ microneedle array having the density that would predictably produce desired drug delivery rates that are rapid and painless. The disclosed density range encompasses the claimed density ranges with the disclosed range allowing for about 2-50 microneedles/cm2.
The co-pending claims do no use chemical penetration enhancing agents. The transdermally administered composition of the co-pending claims do not contain surfactant. However, it is known that permeability agent such as surfactant is used in the delivery of botulinum toxin, a large agent delivered by the issued method, by microneedle system. Therefore, before the effective date of the invention, the ordinary skilled artisan would have been motivated to add surfactant to add in the permeability of the botulinum large agent.
This is a provisional non-statutory double patenting rejection.
Claims 1-5, 12, 16-18, 22-24, 27-38, 50-60 and 89 and new claim 157 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 56-57, 59-66, 68-73 and 75-78 of co-pending Application No. 17/696,509 in view of Burton et al. (US 20110213335 A1) and Kasper et al. (US 20210301289 A1, published Sep.30. 2021 with an effective date of July 29, 2016) and Forssen et al.,(US 20150313973 A1). The co-pending claims disclose emulsion/nanoemulsion/macroemulsion comprising large agent having molecular weight of 100,000 Da (100 kDa) and plurality of microneedles that have a length sufficient to project through the stratum corneum of the skin and insufficient to reach nerves in the dermis of the skin and between 10 and 1000 mm, greater than or equal to 100 mm or 300 mm; the microneedles are composed of biocompatible material/metal/dissolving polymer; device for microneedle conditioning of a site; the composition is in the form of a lotion, cream, powder, ointment, liniment, gel or drops. The co-pending composition is used in the method of the examined claims. The co-pending claims do not teach the density of the microneedle arrays. However, Burton teaches in paragraph [0008] that “It has now been found that the number of microneedles used and their density per unit area can produce much larger rates of delivery with virtually no pain induced. This offers for the first time the prospect for using microneedle arrays to replace hypodermic injections for rapid, painless delivery of injectable drug formulations.” Furthermore, Kasper teaches microneedle arrays involved in the delivery of agents such as botulinum toxin (paragraphs [0090], [0093]) can have a variety of distributions of microneedles spaced at a density of from about 1 microneedle per square centimeter (1/cm2) to about 2500 microneedles per square centimeter (2500/cm2) (paragraph [0062]). Therefore, at the effective date of the invention, the ordinary skilled artisan would have been motivated to employ microneedle array having the density that would predictably produce desired drug delivery rates that are rapid and painless. The disclosed density range encompasses the claimed density ranges with the disclosed range allowing for about 2-50 microneedles/cm2.
The co-pending claims do no use chemical penetration enhancing agents. The transdermally administered composition of the co-pending claims do not contain surfactant. However, it is known that permeability agent such as surfactant is used in the delivery of botulinum toxin, a large agent delivered by the issued method, by microneedle system. Therefore, before the effective date of the invention, the ordinary skilled artisan would have been motivated to add surfactant to add in the permeability of the botulinum large agent.
This is a provisional non-statutory double patenting rejection.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached on 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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