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 I, claims 1-5, 8-11, 13, 17, 19, 21, 24 and 31-34; and the species of acetyl hexapeptide-8 in the reply filed on 11/7/2025 is acknowledged.
Claims 5, 9-10, 33-35 and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/7/2025.
During the search and examination of the originally elected species, art pertinent to other non-elected species was incidentally discovered. Although examination has not been extended beyond the non-elected species identified above per MPEP § 803.02, as a courtesy to the Applicant, this art has been applied below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 11, 13, 17, 19, 21, 24 and 31-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural composition of matter without significantly more.
Claim 1 recites a formulation comprising a plant-based growth factor and a peptide, antioxidant or a botanical agent, all which are products of nature.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a natural product; thus, the answer to Step 1 is Yes.
Step 2A, Prong One, asks if a claim recites a product of nature. In this case, applicant’s claim 1 recites formulation comprising a plant-based growth factor and a peptide, antioxidant or a botanical agent, all which are products of nature.
Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”. MPEP section 2106.04 (c-I-B) states “the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart…”.
In this case, extraction of a plant to obtain growth factors only concentrates and portions the naturally occurring compounds which are already present in the plan. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant. Thus, while a growth factor itself may not be found in the nature, the compounds which are present in the plant are found in nature. The creation of an extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed; i.e., the compound is not inventive or “man-made.” Thus, each of the extracts in turn is a mixture of the naturally occurring compounds found in the plant. Thus, the claims are drawn to mixtures of naturally occurring products. Further, at least one peptide, antioxidant and botanical agent are found in nature as part of plants and animals.
There is no indication that mixing the specified plant-based growth factor together with the at least one peptide, antioxidant or botanical agent as commensurate in scope with the stated claims changes the structure, function, or other properties of the extracts in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart is a mixture of the naturally occurring compounds that are present in the plant extract. Because, as discussed above, each plant extract is only a mixture of the naturally occurring compounds found in the plant and the at least one peptide, antioxidant and botanical agent, each extract composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. In addition, there is nothing to show that mixing the ingredients produces any sort of marked distinction. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, claims 11, 13, 17, 19, 21 and 24 recite additional elements such as alcohol, preservative, etc. Thus, the answer to Step 2A, Prong Two, is Yes.
The analysis must then move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the additional element in the claims is the combination of the growth factors, at least one peptide, antioxidant or botanical agent with additional ingredients such as alcohol, preservative, etc. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Mixing specific compounds does not amount to significantly more than a combination of judicial exception because combiing the claimed growth factors, at least one peptide, antioxidant or botanical agent with additional ingredients such as alcohol, preservative, etc. is well-understood, routine, and conventional in the field for formulating cosmetics (See e.g. FR’401 discussed in the rejections below). Thus, the answer to Step 2B is No. Therefore, the claims are not directed to patent eligible subject matter.
Regarding claims 31-32, there is no evidence that altering the concentration of the particular components found in nature (i.e. growth factors, peptide, antioxidant and/or botanical agent) changes its structure or function making it markedly distinct.
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 2 and 32 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 2 and 32 recites the limitation "the plant-based growth factor”. There is insufficient antecedent basis for this limitation in the claim as the claim from which it depends recites “at least one plant-based growth factor” and it’s unclear of claim 2 is referring back to one, more than one or all the growth factors.
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.
Claim(s) 1-4, 8, 11, 13, 19, 21, 24 and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dhar (US 2017/0035687), as evidenced by Brock (US 2003/0130636) and CN116250538.
Dhar teaches dermal treatment compositions.
Examples 3 and 6 of Dhar teach formulations comprising acetyl hexapeptide-8 (Agireline) and EGF-1 (human oligopeptide-1) or EGF-1-CG-EGF.
While claims 1 and 2 recite “plant-based growth factor” or “plant-based synthetic growth factor” this is a recitation of the starting material of the growth factor and is based on the manner in which the growth factor is obtained (i.e, product-by-process). As the patentability of a product depends on the final structure and not the manner in which it was made or the starting materials of the product, as Dhar teaches human oligopeptide-1 (i.e. an epidermal growth factor) and EGF-1-CG-EGF, this anticipates the structure of plant-based growth factor and plant-based synthetic human epidermal growth factor and/or plant-based synthetic insulin growth factor.
Regarding claims 3-4 and 8: As discussed above, Ex. 3 and 6 contains acetyl hexapeptide-8.
Regarding claim 11: Examples 3 and 6 comprises capryl glycol, reading on alcohol.
Regarding claim 13: Example 6 comprises aloe vera gel, reading on humectant as evidenced by Brock, claim 22.
Regarding claim 19: Example 3 comprises sorbic acid reading on pH stabilizer as evidenced by CN’538, claim 6.
Regarding claim 21: Example 6 comprises dimethicone, reading on polymer.
Regarding claim 24: Examples 3 and 6 comprise phenoxyethanol reading on preservative.
Regarding claim 31: Example 6 comprises 5-10% of the peptide.
Claim(s) 1-4, 8, 11, 13, 17, 19, 21 and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN109260116, as evidenced by SaNogueira (US 2003/0059383) and CN104188827. CN’116 is cited on the 1/11/2024, however, the Examiner is providing a copy of the English translation relied upon below.
CN’116 teaches peptide-based serums comprising plant extracts.
A formulation of CN’116 comprises acetyl hexapeptide-8, glycerin, oligopeptide-1, oligopeptide-2, triethanolamine, phenoxyethanol, carbomer, methyl paraben and other plant extracts [0012]. CN’116 teaches oligopeptide-1 which is an epidermal growth factor which is an active substance in the human body [0122].
While claims 1 and 2 recite “plant-based growth factor” or “plant-based synthetic growth factor” this is a recitation of the starting material of the growth factor and is based on the manner in which the growth factor is obtained (i.e, product-by-process). As the patentability of a product depends on the final structure and not the manner in which it was made or the starting materials of the product, as Dhar teaches oligopeptide-1 (i.e. an human epidermal growth factor), this anticipates the structure of plant-based growth factor and plant-based synthetic human epidermal growth factor.
Regarding claims 3-4 and 8: As discussed above, Ex. 3 and 6 contains acetyl hexapeptide-8.
Regarding claim 11: The formulation comprises capryl glycol, reading on alcohol.
Regarding claim 13: The formulation comprises glycerin, reading on humectant.
Regarding claim 17: The formulation comprises triethanolamine, reading on chelating agent as evidenced by SaNogueira, claim 26.
Regarding claim 19: The formulation comprises triethanolamine, reading on pH stabilizer as evidenced by CN’827, claim 7.
Regarding claim 21: The formulation comprises carbomer, reading on polymer.
Regarding claim 24: The formulation comprises phenoxyethanol reading on preservative.
Claim(s) 1-3, 13, 17, 19, 24 and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN104873409, as evidenced by CN104188827.
CN’409 teaches a skin activating and protecting lotion comprising 1-6% of hexapeptide-9, 0.8-5.8% of oligopeptide-1, ethylhexylglycerin, citric acid, EDTA dosidium [0009-0018].
While claims 1 and 2 recite “plant-based growth factor” or “plant-based synthetic growth factor” this is a recitation of the starting material of the growth factor and is based on the manner in which the growth factor is obtained (i.e., product-by-process). As the patentability of a product depends on the final structure and not the manner in which it was made or the starting materials of the product, as CN’409 teaches oligopeptide-1 (i.e. an epidermal growth factor), this anticipates the structure of plant-based growth factor and plant-based synthetic human epidermal growth factor.
Regarding claims 3: The composition comprises a hexapeptide.
Regarding claim 13: The formulation comprises glycerin, reading on humectant.
Regarding claim 17: The formulation comprises EDTA, reading on chelating agent.
Regarding claim 19: The formulation comprises citric acid, reading on pH stabilizer as evidenced by CN’827, claim 7.
Regarding claim 24: The formulation comprises citric acid reading on preservative.
Regarding claim 32: The formulation comprises 0.8-5.8% of the growth factor.
Claim(s) 1-2, 11, 13, 17, 19, 21, 24 and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by FR2828401, as evidenced by CN104188827 and SaNogueira (US 2003/0059383).
FR’401 teaches cosmetic compositions comprising a combination of IGH-1 and/or IGF-1 mimetic compounds and ascorbic acid (Abs). FR’409 describes a mimetic compound as one that promotes the release and/or synthesis of IGFI or any substance of plant or bacterial origin that selectively binds to the IGF1 receptor of IGF and mimics its cutaneous effects (pg. 3). The composition comprises IGFI and/or a compound and/or an extract of plant or bacterial origin mimicking IGFI, and b) ascorbic acid and/or at least one of its derivatives (pg. 4, lines 1-2).
FR’401 teaches a W/O cream comprising 5% IGFI mimetic compound; Vitamin C (ascorbic acid,reading on antioxidant); glycerin, polymer, preservative, triethanolamine, etc.
While claims 1 and 2 recite “plant-based growth factor” or “plant-based synthetic growth factor” this is a recitation of the starting material of the growth factor and is based on the manner in which the growth factor is obtained (i.e., product-by-process). As the patentability of a product depends on the final structure and not the manner in which it was made or the starting materials of the product, as FR’401 teaches an IGFI mimetic (i.e. compound that mimicks IGFI, also known as insulin like growth factor), this anticipates the structure of plant-based growth factor and plant-based synthetic insulin growth factor.
Regarding claim 11: The formulation comprises stearyl alcohol.
Regarding claim 13: The formulation comprises glycerin, reading on humectant.
Regarding claim 17: The formulation comprises triethanolamine, reading on chelating agent as evidenced by SaNogueira, claim 26.
Regarding claim 19: The formulation comprises triethanolamine, reading on pH stabilizer as evidenced by CN’827, claim 7.
Regarding claim 21: The formulation comprises a polymer.
Regarding claim 24: The formulation comprises a preservative.
Regarding claim 32: The IGFI is present in amounts of 5%.
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.
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.
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.
Claim(s) 1-4, 8, 11, 13, 17, 19, 21, 24 and 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over FR2828401 and Dilallo (US 2006/0198800), as evidenced by CN104188827, SaNogueira (US 2003/0059383) and SciFinder (Acetyl Hexapeptide-8).
FR’401 teaches cosmetic compositions comprising a combination of IGH-1 and/or IGF-1 mimetic compounds and ascorbic acid (Abs). FR’409 describes a mimetic compound as one that promoting the release and/or synthesis of IGFI or any substance of plant or bacterial origin that selectively binds to the IGF1 receptor of IGF and mimics its cutaneous effects (pg. 3). The composition comprises IGFI and/or a compound and/or an extract of plant or bacterial origin mimicking IGFI, and b) ascorbic acid and/or at least one of its derivatives (pg. 4, lines 1-2). The compositions are taught to be used to treating the signs in skin aging such as wrinkles [0005].
FR’401 teaches a W/O cream comprising 5% IGFI mimetic compound; Vitamin C (ascorbic acid,reading on antioxidant); glycerin, polymer, preservative, triethanolamine, etc.
While claims 1 and 2 recite “plant-based growth factor” or “plant-based synthetic growth factor” this is a recitation of the starting material of the growth factor and is based on the manner in which the growth factor is obtained (i.e., product-by-process). As the patentability of a product depends on the final structure and not the manner in which it was made or the starting materials of the product, as FR’401 teaches an IGFI mimetic (i.e. compound that mimics IGFI, also known as insuline like growth factor) which, this makes obvious the structure of plant-based growth factor and plant-based synthetic insulin growth factor. FR’401 also teaches the use of a compound and/or extract of plant origin that mimics IGFI, thus the use of a plant based IGFI mimetic is prima facie obvious and reads on the limitations claimed.
Regarding claim 11: The formulation comprises stearyl alcohol.
Regarding claim 13: The formulation comprises glycerin, reading on humectant.
Regarding claim 19: The formulation comprises triethanolamine, reading on pH stabilizer as evidenced by CN’827, claim 7.
Regarding claims 21: The formulation comprises a polymer.
Regarding claim 24: The formulation comprises a preservative.
Regarding claim 32: The IGFI is present in amounts of 5%.
However, FR’401 does not teach the composition to comprise acetyl-hexapeptide-8 as elected and as recited by instant claims 3-4 and 8.
Dilallo teaches skin care compositions including effective amounts of an wrinkle reduction agent which is a hexapeptide. The skin care compositions provide natural skin exfoliation, reduce fine lines and wrinkles, and improve skin elasticity and firmness. (Abs).
Regarding claim 3-4, 8 and 31: Dilallo teaches the preferred hexapeptide is acetyl hexapeptide-3, sold under the name Argireline, also known as acetyl hexapeptide-8 as evidenced by SciFinder. This hexapeptide can be used in amounts ranging from 0.00001-15% [0023], which overlaps with the ranges of instant claim 31.
It would have been prima facie obvious to a person of skill in the art before the effective filing date of the claimed invention to modify the teachings of FR’401 with those of Dilallo. One of skill in the art would have been motivated to add 0.00001-15% of Argireline to the formulation of FR’401 as Dilallo teaches this agent to be effective at reducing fine lines and wrinkles. One of skill in the art would have a reasonable expectation of success as both FR’401 and Dilallo teaches composition for improving and treating wrinkles and its prima facie obvious to combine two composition which are individually taught to be used for the same purpose (i.e. reduce wrinkles) to create a new composition for the same purpose.
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-3, 13 and 31-32 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1-3, 13 and 31-32 of copending Application No. 19/110630 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Non-Statutory 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 1-4, 8, 11, 13, 17, 19, 21, 24 and 31-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-4, 9-11, 13, 16, 30-34 of copending Application No. 19/110630 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both teaches formulations comprising the same plant-based growth factors and peptides such as acetyl hexapeptide-8, in the same amounts. Both formulations also comprise alcohols, humectants, chelating agents, pH stabilizers, polymers and preservatives.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowable.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613