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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 19, 2026 has been entered.
Applicant’s amendment and reply filed February 19, 2026 have been received and entered into the case. Claims 1, 3 – 5, 11, 14, 16 – 17, 19 – 21, 25, 27 – 32 and 35 are pending and have been considered on the merits. All arguments have been fully considered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on February 19.,2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3 – 5, 11, 16 – 17, 19, 25, 27 – 32 and 35 remain rejected under 35 U.S.C. 102a1 and 102a2 as being anticipated by Jacky et al. (US 2019/0185523).
Regarding claims 1 and 3 – 5, Jacky teaches a method for treating a skin condition such as underactive sebaceous gland (skin conditions caused by reduced level of one or more sebaceous lipids on epidermal layer compared to a person without the condition) (abstract, 0269, claims), for cosmetic treatment (0007) and promoting skin rejuvenation (0003), the methods comprising administering a clostridial neurotoxin intradermally (0041, 0097, 0122, example 8, 9, 12) in therapeutically effective amounts of toxin (0131) such as 1 – 1000 pg/ml (0.000001 – 0.001 ng/ml) and 1 ng/ml (0245), which overlaps with and encompasses the claimed range. Although the reference does not teach the claimed function of inducing secretion of one or more sebaceous lipids to an epidermal layer of skin, e.g., squalene, fatty acid, cholesterol or wax ester, the method steps are in the prior art are administering the same neurotoxin to the same treating population as claimed. Thus, the methods of the prior art inherently also induce secretion of one or more sebaceous lipids to an epidermal layer of skin as claimed. Notwithstanding, Jacky teaches the method changes production of lipids (0194).
Regarding claim 11, the Jacky teaches the methods for treating patients with psoriasis or atopic dermatitis (0271) which are skin conditions associated with reduced levels of one or more sebaceous lipids compared to a subject that does not have the conditions, as defined by applicant (p.4 of the instant specification, via Sahle et al.).
Regarding claims 16, 17 and 19, skin conditions include acne, seborrheic dermatitis, rosacea, psoriasis, atopic dermatitis (AD) (0271), dry skin (0133, 0255), cellulitis (0272), aged skin (example 8).
Regarding claim 25, although the reference does not teach the claimed function of inducing retention of a tachykinin peptide in the dermis, the method steps are in the prior art are administering the same neurotoxin to the same treating population as claimed. Thus, the methods of the prior art inherently also induce retention of a tachykinin peptide in the dermis as claimed.
Regarding claims 27 - 31, the neurotoxin is a BoNT/A (0181), chimeric (0204), BoNT/DC, BotNT/X (0201) or a toxin that has a light chain from one botulinum toxin serotype (such as serotype A), and a heavy chain from a different botulinum toxin serotype (such as serotype B) (0117).
Regarding claim 32, Jacky teaches administering therapeutically effective amounts of toxin (0131) such as 1 – 1000 pg/ml (0.000001 – 0.001 ng/ml) and 1 ng/ml (0245), which overlaps with and encompasses the claimed range.
Regarding claim 35, although the reference does not teach the claimed function of inducing secretion of lipids into the stratum corneum, the method steps are in the prior art are administering the same neurotoxin to the same treating population as claimed. Thus, the methods of the prior art inherently also induce secretion of lipids into the stratum corneum as claimed.
Thus, the reference anticipates the claimed subject matter.
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.
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, 14 and 20 – 21 remain rejected under 35 U.S.C. 103 as being unpatentable over Jacky et al. (US 2019/0185523) in view of Picardo (2009).
Regarding claim 1, Jacky teaches a method for treating a skin condition such as underactive sebaceous gland (skin conditions caused by reduced level of one or more sebaceous lipids on epidermal layer compared to a person without the condition) (abstract, 0269, claims), the method comprising administering a clostridial neurotoxin intradermally (0041, 0097, 0122, example 8, 9, 12) in therapeutically effective amounts of toxin (0131) such as 1 – 1000 pg/ml (0.000001 – 0.001 ng/ml) and 1 ng/ml (0245), which overlaps with and encompasses the claimed range. Although the reference does not teach the claimed function of inducing secretion of one or more sebaceous lipids to an epidermal layer of skin, e.g., squalene, fatty acid, cholesterol or wax ester, the method steps are in the prior art are administering the same neurotoxin to the same treating population as claimed. Thus, the method of the prior art inherently also induces secretion of one or more sebaceous lipids to an epidermal layer of skin as claimed. Notwithstanding, Jacky teaches the method changes production of lipids (0194).
Regarding claim 14, Jacky does not teach the claimed lipid amounts in the subject prior to administration. However, as stated by applicant, these lipids express at a reduced level in conditions like psoriasis and atopic dermatitis (p.4 of applicant’s specification). In this regard, it is established that subjects with psoriasis and atopic dermatitis will have the claimed sebaceous lipids at concentrations lower than normal, or the ranges recited in claim 14. In support, Picardo teaches human sebum consists of 12 – 20% squalene, 26 – 30% wax esters, 1.5 – 2.5 cholesterol and 15 – 30% fatty acids (Table 1). As such, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to practice the methods of Jacky on a patient with the claimed reduced levels of lipids as a matter of standard practice in treating psoriasis and/or atopic dermatitis, and with a reasonable expectation for successfully treating therefor.
Regarding claims 20 and 21, Jacky does not specifically teach administering to a non-facial area such as the hands, foot, neck, scalp or back. However, Jacky teaches the methods are used to treat dandruff, acne, seborrheic dermatitis, erythema, rosacea, psoriasis, atopic dermatitis (AD), alopecia (0269, 0271) with the effect of regulating or altering sebum composition. In this regard, it would have been obvious to one practicing the methods of Jacky to administer the active toxin to the location of the condition. Specifically, to the scalp for dandruff, and any body part that exhibits the disclosed conditions. Moreover, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to administer the toxin of Jacky to the scalp, back, hands, feet or neck with a reasonable expectation of successfully treating dandruff, alopecia, acne, seborrheic dermatitis, erythema, rosacea, psoriasis or atopic dermatitis (AD).
Therefore, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
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 – 5, 25, 27 and 35 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims
33 and 35 of copending Application No. 18/549 871; and
21 and 24 of copending Application No. 18/552 599
(reference applications).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims administer the same BoNT/A to the same treating population for the same purpose of treating skin disorder or cosmetic disorder. Regarding the various claimed effects, although the reference does not teach the claimed functions, the method steps are the same. Thus, the methods would inherently achieve the claimed effects. Regarding the claimed dose, the specification states that clostridial neurotoxins are not standardized across products, wherein the same products are disclosed to have variable volumes of neurotoxin per unit (published application paragraph 0428 – 0437). Moreover, the specification indicates 500 units of DYSPORT ™ BoNT/A contains about 2.69 ng of 150 kD BoNT/A and also 100 Units of Dysport® contains about 0.65 ng of 150 kD BoNT/A (0428 – 0437 of the published application). In this regard, 1 unit of DYSPORT™ contains 0.00538 ng toxin and also 0.0065 ng toxin, which is the toxin used by application in the instant examples. Further, Scaglione teaches that LD50 units or biological units (BU) are not standardized rendering it difficult to compare unit potencies (p.2). In this regard, since the applications are each drawn to treating the same treating population for the same purposes, it would have been within the purview of one of ordinary skill in the art to adjust the effective dose as a matter of routine experimentation in order treat the same skin and cosmetic conditions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that Jacky does not teach the method wherein the “absolute” dose of neurotoxin is from 0.0005 – 1 ng, but only that the amount administered is in the context of a formulation, e.g., ng/ml; and the example show an absolute dose of 1.3 ng or 1.8 ng which are above the claimed range.
However, this argument fails to persuade because the reference teaches 1 – 1000 pg/ml (0.000001 – 0.001 ng/ml) and 1 ng/ml (0245), which overlaps with and encompasses the claimed range. As acknowledged by the instant specification, clostridium neurotoxin is typically in a fluid injection when administered intradermally as claimed (0437 - 0442) indicating some amount of fluid is included. In this regard, the claimed dose of 0.0005 – 1 ng would intrinsically include a fluid, or ml. Moreover, in following standard practices of intradermal injection, one in the art would recognize the effective amount of neurotoxin to be administered is 1 – 1000 pg, or 0.000001 – 0.001 ng and 1 ng. Additionally, regarding the argued term “absolute,” it is noted that the feature upon which applicant relies is not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that claim 11 was not previously included in the rejection under 35 U.S.C. 103 and is therefore sufficient to overcome the rejections of record.
However, this argument fails to persuade because Jacky teaches the claimed method for treating a skin condition such as underactive sebaceous gland (skin conditions caused by reduced level of one or more sebaceous lipids on epidermal layer compared to a person without the condition) (abstract, 0269, claims).
Applicant argues the provisional rejections on the ground of nonstatutory double patenting should be withdrawn due to the requirement of a particular skin condition.
The argument is persuasive in part. Regarding the applications treating conditions that are not related to cosmetic or skin conditions, the rejections are withdrawn. However, the remaining rejections above are each drawn to treating the same skin conditions as the instant application. In this regard, the rejections are maintained for the reasons stated above.
No claims are allowed.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699