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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 24, 2026 has been entered.
In that response, claims 1, 2, 5, and 6 were amended and claims 9 and 10 were cancelled. Claims 1-8, 11, and 12 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claims 2-4, 6-8, 11, and 12 are objected to because of the following informalities: Claim” need not be capitalized within the sentence. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8, 11 and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claims 1 and 5 now recite “gel comprising amounts effective to increase serum human growth hormone levels of: dextran, a plurality of nonpeptides; aloe vera gel; vitamin E; and at least one of eucalyptol and menthol as a penetration enhancer; and at least one of somatropin, L-DOPA, and velvet bean extract”.
The methodology for determining adequacy of written description entails (1) for each claim, determining what the claim as a whole covers, (2) reviewing the entire application to understand how applicant provides support for the claimed invention including each element and/or step, and (3) determining whether there is sufficient written description to inform a skilled artisan that applicant was in possession of the claimed invention as a whole at the time the application was filed. MPEP §2163(II). Also the “written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice …, reduction to drawings …, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” MPEP §2163(II)(A)(3)(a)(ii) (citations omitted). The “Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 ‘merely by clearly describing one embodiment of the thing claimed’.” Id. (citations omitted).
1) Claims 1 and 5 respectively covers, as a whole, a composition and method comprising applying the composition, wherein the composition comprises each of dextran, nonpeptides, aloe vera gel, vitamin E, eucalyptol and/or menthol as a penetration enhancer, and at least one of somatropin, L-DOPA, and velvet bean extract. The composition comprises these components in “amounts effective to increase serum human growth hormone levels”. None of the claims recite the quantity and/or concentration of each component. In other words the “amounts” of each are described with respect to the function, i.e., effective to increase serum human growth (hGH) hormone levels.
(2) The entire application has been reviewed to understand how applicant provides support for the claimed invention. The specification discusses L-DOPA promoting increase of serum HGH levels (para.[0035]). Raising hGH is discussed generally, i.e., without specifically referencing any of the other components (see paras.[0012],[0188]). A skilled person would understand that somatropin is a recombinant hGH. L-DOPA, a precursor to dopamine, is known to stimulate the release of hGH, and velvet bean extract is known to provide natural L-DOPA. Each of these compounds could raise serum hGH level depending on the route of administration and dosage. However the effects of dextran, nonapeptides, aloe vera gel, vitamin E, eucalyptol, and menthol on raising serum hGH level is not discussed or contemplated in the disclosure. Therefore the “effective amounts” for doing so for each component is not supported by the disclosure.
(3) Therefore it is determined that there is not sufficient written description to inform a skilled artisan that applicant was in possession of the claimed invention as a whole at the time the application was filed. None of the dependent claims resolves this issue and therefore they are also rejected on this ground.
Response to Arguments
Applicant's arguments filed February 24, 2026 have been fully considered but they are not persuasive. Applicant cites a number of paragraphs in the Specification as providing relevant support. (Remarks, 4, February 24, 2026.)
However the disclosure at these paragraphs do not concern the “amounts effective to increase serum human growth hormone levels” as recited in claims 1 and 5.
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 3 and 7 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 3 and 7 recite “therapeutically effective amount of squalane”. However the current claims do not recite the target therapy, i.e., the benefit or purpose of the composition and the method. In other words the claims do not recite what condition the “therapeutically effective amount(s)” is referring to, e.g., acne, pain, etc. Only claims 11 and 12 recite, solely for the plurality of nonapeptides, “an amount effective to inhibit melanogenesis”. Consequently “therapeutically effective amount” of squalane is vague and indefinite.
For the purposes of examination now this claim term is construed as an amount.
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.
Claims 1-8, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Moy (US 10821180) in view of Dadar (Dadar, Antiinflammatory peptides: current knowledge and promising Prospects, Inflammation Research (2019) 68:125–145), Aqil (Aqil, M., et al., Status of terpenes as skin penetration enhancers, Drug Discovery Today, December 2007), and Somaderm (Somaderm, DailyMed NIH Library of Medicine, accessed 8/20/2023, available at URL dailymed.nim.nih.gov/dailymed/druginfo.cfm?setid=a7b0acae-d930-49de-bece-7fa7634220bf&audience=consumer (2018)).
Moy teaches “DNA repair skin care compositions” comprising nonapeptide-1 and hyaluronic acid (claims 7-9; see col.14 lines 46-53). “Nanopeptide-1 is a skin lightening peptide [which] works to reduce the production of melanin to prevent and lighten hyperpigmentation while restoring an even skin tone”, and it may comprise “between about 0-10%, 0-5%, about 0-1%, about 1-3%, or about 1-2 % of a dermatologic preparation” (col.15 lines 13-18). “Reduc[ing] the production of melanin to prevent and lighten hyperpigmentation while restoring an even skin tone” indicates inhibiting melanogenesis. Moy further teaches face mask containing eucalyptus whose essential oils, e.g., eucalyptol, are known to have healing properties (col.32 lines 55-57, col. 33 lines 31).
Moy teaches other skin-therapeutical components to include in the composition, including vitamin E (col.18 lines 13-29) and aloe as a hydrating fluid for the composition (col.32 line 61). Dextran can be used to apply osmotic pressure gradient for transport across the skin (col.25 lines 10-12). Squalane is a lipid substance that “can function as a barrier to serve, for example, as additional skin protection as well as to increase penetration into the skin” (col.22 lines 34-39, 55). The composition may be a gel (col.4 line 22), and is for “topical application to skin and methods for using and enhancing penetration of the same” (col.1 lines 25-27; see col.1 line 62-col.2 line 29).
Moy does not express teach a specific formulation comprising a plurality of nonapeptides, at least one of eucalyptol and menthol, and at least one of somatropin, L-DOPA, and velvet bean extract as in claims 1 and 5.
Dadar discusses nonapeptides antinflammin 1 and 2 and “topical use of antiflammin-2 as a potent phospholipase A2 (PLA2) inhibitor, in the treatment of chronic plaque psoriasis” (p.138 left col.).
Aqil discusses applications of eucalyptol or cineol and menthol as skin penetration enhancers in diverse formulations (title; abstract; pp.1061-65).
Somaderm is a homeopathic gel comprising somatropin, aloe vera, and velvet bean seed extract. Somaderm is a transdermal gel supplied in a pump bottle. Indications include “may improve bone and joint health, may increase muscle and reduce fat”, “may improve sleep”, and “may strengthen the immune system”.
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Moy, Dadar, Aqil, and Somaderm and use antiflammin-2, eucalyptol and/or menthol, and Somaderm in combination with nonapeptide-1 of Moy, i.e., a plurality of nonapeptides as recited in the instant claim(s) in combination with somatropin. “The expectation of some advantage is the strongest rationale for combining references”. MPEP § 2144(II). “Because the desire to enhance commercial opportunities by improving a product or process is universal—and even common-sensical—we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves.” MPEP § 2144(II) (citations omitted). Here the skilled person would have been motivated to combine Moy, Dadar, Aqil, and Somaderm in order to provide a topical composition that confers the benefits of the ingredients that Moy teaches for patients suffering from chronic plaque psoriasis, and further to provide the indications that Somaderm teaches such as strengthened immune system, in an enhanced form for transdermal delivery.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8, 11, and 12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
CONCLUSION
No claim is allowed.
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 H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/ Primary Examiner, Art Unit 1614