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 .
Applicant’s amendment and reply filed March 17, 2026 have been received and entered into the case. Claim 21 is added; claims 1 – 21 are pending; claims 13 – 20 are withdrawn; claims 1 – 12 and 21 have been considered on the merits. All arguments have been fully considered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 17, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
Previous rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn due to clarifying the botulinum toxin in claim 3; and deleting previously identified indefinite phrases in claims 5 and 8.
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.
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 – 12 and 21 are/remain rejected under 35 U.S.C. 103 as being unpatentable over Villani (US 2010/0297095) and Dake et al. (US 2005/0196414).
Regarding claim 1, Villani teaches a method for treating skin conditions in a subject comprising applying to the skin a composition comprising Spongilla (abstract, 0035 – 0036) wherein the Spongilla particles are ground to particles having a size of 1 mm, 0.5 mm or 0.2 mm (0091 – 0094) or 200 – 500 μm, which significantly overlaps with the claimed range of “an average length of about 200 um – 350 um.”
Dake teaches a method for treating skin conditions in a subject comprising applying to the skin a composition comprising botulinum toxins (abstract, 0014).
At the time the claims were filed, it would have been obvious to one of ordinary skill in the art to administered both ingredients for their known benefit of treating skin conditions, as disclosed by the cited references above, since each is well known in the art for their claimed purpose. This rejection is based on the well established proposition of patent law that no invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. (MPEP 2144.06 I) The idea for combining them flows logically from their having been used individually in the prior art.
Regarding claims 2 – 4, Dake teaches the botulinum toxin may be selected from types A, B, C (interpreted to include C1 and C2), D, E, F and G, such as BOTOX™ (onabotulinumtoxinA) (0044).
Regarding claims 5 and 8, Villani teaches the methods may treat acne, excessive sebum production, inflammation; stimulate cell growth, elastin, and collagen; improve skin tone, texture and hyperpigmentation (luminosity, brightness, overall skin quality) (0035, 0060, 0065, examples 2 - 9); while Dake teaches the methods may treat acne, sebaceous glands, fine lines and wrinkles (0019, 0047, 0055, 0156). These are interpreted as negative skin conditions.
Regarding claims 6 and 7, the references do not teach the claimed results. However, the method steps obtained by the teachings of the combined references are the same as that claimed by applicant, e.g., applying Spongilla and botulinum toxin to the skin of a subject. In this regard, when practicing the method obtained by the combined teachings, one would also achieve the claimed results.
Regarding claims 9 – 10, Villani teaches administering Spongilla monthly (once per month) or weekly (or once per week) (0035); while Dake teaches administering botulinum toxin in a series of periodic treatments at a rate and frequency that produces desired results (0058). Since both references indicate these components as the active, they are considered result effective variables. As such, when practicing the method obtained by the combined teachings of Villani and Dake, one of ordinary skill in the art would have been motivated to optimize the application frequency to obtain the desired result as a matter of routine practice and as indicated by Dake.
Regarding claims 11 – 12, Villani teaches the Spongilla composition may include 0.1 – 100% or 1 – 1.5 grams of Spongilla; 0.001 – 50% of excipients such as 0.1 – 10% hydrogen peroxide; 5 ml of 3% hydrogen peroxide; or saline (0042 – 0045, 0096 – 0097, example 4), which overlap with the claimed amounts of “about” 2 grams or 6 mL.
Regarding claim 21, since the particles of Villani may ultimately be sieved to particles with a maximum of 0.2 mm, it would follow that any particles smaller than 0.2 mm are included in the product as they are not sieved out. In this regard, one of ordinary skill in the art would have concluded that the average diameter would be less than 0.2 mm. As such, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to optimize the diameter of the particles as a matter of routine practice and experimentation, and with a reasonable expectation for successfully obtaining an effective composition to treat skin conditions.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Double Patenting
Previous rejections under 35 U.S.C. 101 as claiming the same invention as that of claims 1 – 12 of copending Application No. 17/546 001 are withdrawn due to cancellation of the claims in the reference application.
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 – 12 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 6, 8 – 12 of copending Application No. 18/954 103 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treating skin conditions by applying Spongilla and botulinum toxin to the skin of a subject. The toxins are the same type, both methods require improvements in the condition, require weekly treatment and administer the same amount of Spongilla in the same carriers.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 5 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 2 of copending Application No. 17/298 918 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treating skin conditions by applying Spongilla and botulinum toxin (a protein) to the skin of a subject. Because the methods are administering the same components to the skin, they are both treating at least luminosity, brightness, skin pore size, skin pore count, sebum production, sebum composition and overall skin quality.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 5, 11 – 12 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 – 17 and 23 – 27 of copending Application No. 17/546 001 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compositions comprising Spongilla having the same particle length and diameter and the same botulinum toxin. The compositions are for treating the same conditions and include the actives at the same amount.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant argues that the prior art does not teach Spongilla particles with an average length of 200 – 350 μm but particles with a maximum of 0.2 mm (200 μm) thereby teaching away from the claimed range.
However, the claimed range includes an average length of 200 μm which may include particles larger and smaller than the specific length. Villani teaches grinding particles to 0.2 mm (200 um) (0093 – 0094) which is interpreted as an “average” of 200 μm as claimed. In addition, Villani specifically teaches particles having 1 mm, 0.5 mm and 0.2 mm (or 1000, 500 or 200 μm), which further overlaps with the claimed range average.
Applicant argues that the claimed particle size and characteristics are necessary for the intended use of the composition. Specifically, particles with longer spicules are more beneficial in delivering botulinum toxin, as supported by Meng. Applicant argues that since Meng teaches the average epidermal thickness is about 0.2 mm (200 μm), the particle size of Villani (not higher than 200 μm) would not penetrate the dermis, rendering the particles inoperable for their intended use.
However, rather than applicant providing objective evidence that the claimed size of Spongilla is critical to its function of delivering botulinum toxin, applicant relies on a document that merely investigates epidermal thickness. The reference fails to link epidermal thickness to penetration of any therapeutic let alone Spongilla, botulinum toxin or the combination thereof. In this regard, the reference fails to provide objective evidence that the claimed size of Spongilla particles is critical to delivering botulinum toxin. Nor does the reference render Villani inoperable as argued.
Applicant argues that Dake does not cure the deficiencies of Villani, in that it does not use Spongilla to deliver botulinum toxin; does not disclose a successfully treatment with topical botulinum toxin; and that the prior art does not deliver a commercial product.
However, these arguments fail to persuade in that the rejection is not based on a single reference, but the combination of both Villani and Dake. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references (MPEP 2145 IV). In addition, Dake exemplifies successful delivery of topical delivery of botulinum toxin. Lastly, the teachings of the prior art are not dependent on whether a commercial product is available, but are valid for all of the teachings therein.
Applicant requests that the obvious double patenting rejections be held in abeyance until allowable subject matter is indicated.
No claims are allowed.
Conclusion
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 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 at 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
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