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 .
Response to Election/Restriction filed on January 14, 2026 is acknowledged.
Claims 2-3, 8, 11-12, 14, 16, 18, 20-22, 26 and 33 have been cancelled.
Claims 1, 9-10, 27, 29, 37, 41 and 44 are pending in this application.
Restriction
Applicant's election with traverse of Group 1 (claims 1, 9-10, 27, 41 and 44) and the election the following species of at least 10 recombinant human growth factors
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, hyaluronic acid at a concentration ranging from 0.5 wt% to 6 wt% of the overall composition with a molecular weight ranging from 150 kDA to 600 kDA, nanoencapsulating agent, C1-C6 alkylene glycol and/or lecithin, and excludes skin protecting agent(s), an anti-inflammatory agent(s) of in the reply filed on January 14, 2026 is acknowledged. The traversal is on the ground(s) that the examination of the entire application could be made without serious burden. This is not found persuasive because instant application is a 371 of a PCT and the restriction requirement was established under PCT Rule 13.1. Therefore, there is no burden involved in the 371 of a PCT application.
The requirement is still deemed proper and is therefore made FINAL. Claims 29 and 37 are withdrawn from consideration, pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Claims 1, 9-10, 27, 41 and 44 are examined on the merits in this office action.
Objections
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Claims 1, 9-10, 27, 41 and 44 are objected to for the following: Claims 1, 41 and 44 recite the sequence identifiers as “SEQ ID NO 1” for example. The correct way to recite sequence identifier is “SEQ ID NO: 1”. Applicant is required to correct these errors. Because claims 9-10 and 27 depend from claim 1, these claims are also objected to.
Rejection
35 U.S.C. 112(a)
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, 9-10, 27 and 44 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.
The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP 2163.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gostelli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618.
In the instant case, the claims are drawn to a composition for topical use on a human scalp comprising at least 10 but no more than 12 recombinant human growth factors selected from at least 90% identical to SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 1, SEQ ID NO: 5, SEQ ID NO: 11, SEQ ID NO: 12 and SEQ ID NO: 13; at least 98% identical to SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 1, SEQ ID NO: 5, SEQ ID NO: 11, SEQ ID NO: 12 and SEQ ID NO: 13. The generic statements at least 10 but no more than 12 recombinant human growth factors selected from at least 90% identical to SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 1, SEQ ID NO: 5, SEQ ID NO: 11, SEQ ID NO: 12 and SEQ ID NO: 13; at least 98% identical to SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 1, SEQ ID NO: 5, SEQ ID NO: 11, SEQ ID NO: 12 and SEQ ID NO: 13 do not provide ample written description for the compounds since the claims do not describe what amino acids are required to have the same function of each peptide. The specification does not clearly define or provide examples of what qualify as compounds of the claimed invention. For example, instant SEQ ID NO; 1 is a 463 residue protein. Thus, a protein having at least 90% sequence identity of SEQ ID NO: 1 would be 463 * 0.9 = 417; and a protein having at least 98% sequence identity of SEQ ID NO: 1 would be 463 * 0.98 = 454. This implies that for a 90% sequence identity of SEQ ID NO: 1, there can be 46 residues that can be different; for a 98% sequence identity of SEQ ID NO: 1, there can be 9 residues that can be different. However, the specification does not define what residues are required to have the same function.
As stated earlier, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable claims 1 and 44 are broad generics with respect all possible compounds encompassed by the claims. The possible structural variations are limitless to any class of peptide or a peptide-like molecule that can form peptide bonds. It must not be forgotten that the MPEP states that if a peptide is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. Here, though the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond compounds disclosed in the examples in the specification. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus since the specification does not provide variety of peptides that are encompassed with each amino acid substitutions, deletions, additions and peptide like compounds. The specification is void of organic molecules that functions as a peptide-like molecule that qualify for the functional characteristics claimed as a peptide or a peptide-like molecule and other synthetic peptide or peptide-like molecule that can be used for topical application.
The specification is limited to SEQ ID NOs: 1-13. The working example describes 100% sequence identity to SEQ ID NOs: 1-13. The specification does not describe any what amino acids are required from each SEQ ID NOs: 1-13 to maintain the function as claimed. Description of SEQ ID NOs: 1-13 is not sufficient to encompass numerous other proteins that belong to the same genus. For example, there are varying lengths, varying amino acid compositions, and numerous distinct qualities that make up the genus. There is not sufficient amount of examples provided to encompass the numerous characteristics of the whole genus claimed.
For example, Yampolsky et al (Genetics, 2005, 170: 1459-1472) teach the unpredictability of the effect of amino acid substitution on the function and/or property of peptide/protein. Yampolsky et al teach even conservative substitution can significantly affect the function of the peptide/protein (see for example, p. 165, Table 3).
Additionally, Caregen 2012 (Caregen 2012, April 26, 2012, filed with IDS) teaches the following formulation for hair care:
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. The peptides are full length sequences. Caregen 2012 does not teach what amino acid residues are important for the hair care formulation. Caregen 2012 teaches that all residues of each peptide is required for function.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
CLOSEST ART
The closest art is Caregen 2012 (Caregen 2012, April 26, 2012, filed with IDS). Caregen 2012 teaches the following:
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. For the hair care, Caregen2012 teach a composition comprising sh-Oligopeptide-2, sh-Polypeptide-31, sh-Polypeptide-1, sh-Polypeptide-2, sh-Polypeptide-3, rh-Polypeptide-4, sh-Polypeptide-9, sh-Polypeptide-10, sh-Polypeptide-11, sh-Oligopeptide-4, rh-Polypeptide-13, and rh-Polypeptide-14 (see page 7). Instant composition for topical use on a human scalp comprises at least 10 recombinant human growth factors selected from
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.
Nakhla patent (US Patent No. 12,496,266) teaches a skin care blend comprising a synthesized protein matrix comprising sh-oligopeptide-2, sh-polypeptide-1, sh-polypeptide-9, sh-polypeptide-11, sh-oligopeptide-1, acetyl hexapeptide-8, palmitoyl tripeptide-3, and palmitoyl tetrapeptide-7 (see for example, column 1, lines 49-54).
CONCLUSION
Claim 41 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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/JULIE HA/Primary Examiner, Art Unit 1654
2/5/2026