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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claims 39-46) in the reply filed on December 18, 2025 is acknowledged.
Claims 34-38 and 47-53 have been withdrawn from consideration.
Claims 39-46 are examined on the merits.
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 39-46 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 39 and 40 recite concentration ranges in % without stating the basis (w/w, w/v, v/v, etc.). Although claims are construed in light of the specification, importing limitations from the disclosure of the specification is improper. See MPEP__. In this case, although the concentrations in the example formulations in the specification are expressed in % by weight, such disclosure will not be read into the claim limitation. The unit “%” as used in the claims is ambiguous, and the claims are rejected for being vague and indefinite. The remaining claims are rejected for depending on the indefinite base claim, claim 39.
For prior art consideration only, the examiner will assume that the concentration unit is % by weight based on the total weight of the composition, for the sake of compact prosecution. Applicant must amend the claims appropriately in order to overcome the present rejection under § 112 (b).
Claims 43 and 44 recite the limitation "the neurotoxin" in claim 39. There is insufficient antecedent basis for this limitation in the claim.
Claims 45 and 46 recite “agent that slows down or eliminates the enzymatic degradation of injected hyaluronic acid and other lip-plumbing agents”. The specification provides no explanation or definition as to what applicant means by such agent, and one of ordinary skill in the art would not immediately apprehend what compounds would cross the skin barrier to inhibit injected hyaluronic acid or other lip-plumbing agents.
Claims 45 and 46 are also vague and indefinite as it is not clear what applicant means by the term “other lip-plumbing agents”. The specification provides no explanation or definition as to what applicant means by such agents, and one of ordinary skill in the art would not immediately apprehend what compounds could be included in the scope of the limitation.
Claims 45 and 46 are also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: 1) injection of hyaluronic acid and other lip-plumbing agents on the skin prior to the topical method of claim 39; and 2) practicing the method of claim 39 on the injected area of the skin.
Claim 46 is also vague and indefinite as the claim depends on claim 44, which implies that the topical application is applied on the site where a neurotoxin is administered, but the claim recites that the composition affects “injected hyaluronic acid and other lip-plumping agents”, which in turn implies that the application site may be lip where hyaluronic acid and other lip-plumping agents have been injected. Isn’t this the site where the neurotoxin, not hyaluronic acid or other lip-plumping agents, has been administered? Claim 46 is confusing and it is not clear what method steps are involved and what goals are to be achieved.
Due to the ambiguity and uncertainty of the claimed subject matter, claims 45 and 46 have not been further treated for merits.
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 39-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rippke et al. (WO9515148 A1, published on June 8, 1995) (“Rippke” hereunder).
Rippke discloses a method of prophylaxis and/or treatment of dry and flaky skin and aging skin, the method comprising topical use of a composition comprising l-arginine. Example 1 discloses a sun gel comprising 10 wt % of L-arginine in Example 1; Example 11 discloses a shower milk comprising 10wt % of L-arginine hydrochloride. The reference teaches that the disclosed compositions are applied to the skin in a sufficient amount in the manner customary for cosmetics or dermatics.
Claim Rejections - 35 USC § 102/103
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.
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 39-41 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by, or in alternative, unpatentable over, Fossel (US 20100196517 A1, published on August 5, 2010, cited in IDS).
Fossel discloses a method of alleviating wrinkled, sagging or cellulite-afflicted skin, the method comprising topically applying a cream comprising l-arginine 12.5 % w/v. See Example 4, which discloses a method of lifting and firming facial skin; the treatment continued for 2 weeks. Assuming the density of the composition is 1.0 g/ml, the concentration of l-arginine is about 12.5 % w/w, unless shown otherwise.
Claim Rejections - 35 USC § 103
Claims 42 -44 are rejected under 35 U.S.C. 103 as being unpatentable over Fossel as applied to claims 39-41 as above, and further in view of Sand et al. (US 20090053290 A1, published on February 26, 2009) (“Sand” hereunder).
Fossel fails to teach application of the l-arginine composition made in concurrence with, prior to, or on a continuous basis following the administration of a composition comprising neurotoxin.
Sand discloses a method of diminishing the appearance of wrinkles caused by muscular contraction, the method comprising injection of neurotoxin such as BOTOX or other chemical denervation drug in areas such as forehead and glabellar lines. See [0284-0285].
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). In this case, both Fossel and Sand teach that topical l-arginine treatment and neurotoxin injection, topical or transdermal are used to improve the appearance of wrinkles. Combining the two methods for the same purpose of reducing wrinkles would have been prima facie obvious.
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.
U.S. Patent Application No. 18/221515
Claims 39- 44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15-20 of copending Application No. 18/221515 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a method of treating, alleviating or preventing a skin condition, comprising administering topically to the skin an effective amount of a composition, comprising l-arginine or cosmetically or pharmaceutically acceptable salts, isomers, analogs and derivatives thereof, wherein the concentration l-arginine is at least about 6 %. The present claim 39 does not necessarily require nicotinamide in the composition.
Regarding the present claim 41, the reference claim 16 discloses the same skin condition to be treated/alleviated/prevented.
Regarding the present claims 42-44, the reference claim 17 discloses a method of applying a composition comprising a neurotoxin mimetic agent in concurrence with, prior to, or following the administration of the NO donor composition; using a neurotoxin agent in place of the mimetic agent would have been an obvious variation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
U.S. Patent Application No. 18/221529
Claims 39-44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 16-20 of copending Application No.18/221529 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a method of treating, alleviating or preventing a skin condition, comprising administering topically to the skin an effective amount of a composition, comprising l-arginine or cosmetically or pharmaceutically acceptable salts, isomers, analogs and derivatives thereof; the reference claim 3 defines that the NO donor of the base claim, claim 1, is l-arginine, a salt, an isomer, an analog, or a derivative thereof, present in the concentration of at least about 6 %. The present claim 39 does not necessarily require nicotinamide in the composition.
Regarding the present claim 41, the reference claim 17 discloses the same skin condition to be treated/alleviated/prevented.
Regarding the present claims 42-44, the reference claim 18 discloses a method of applying a neurotoxin composition in concurrence with, prior to, or following the administration of the NO donor composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/GINA C JUSTICE/Primary Examiner, Art Unit 1617