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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 5/17/2023, 4/25/2025, and 10/17/2025, before the mailing of a first office action. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-19, filed 4/16/2026, are pending. Claims 1-19 are under examination.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
The specification and claims were previously objected to for lacking amino acid sequence identifiers.
Response to Arguments
Applicant’s arguments, see Applicant Reply, page 6, para. 6, filed 4/16/2026, with respect to sequence requirements have been fully considered and are persuasive. The objections to the specification and claims have been withdrawn.
Claim Objections
Claims 1-12, 16, and 17 were previously objected to for informalities.
Response to Arguments
Applicant’s arguments, see Applicant Reply, page 6, para. 6, with respect to claims 1-12, 16, and 17 have been fully considered and are persuasive. The objections to claims 1-12, 16, and 17 have been withdrawn.
New Claim Objections
Claims 18 and 19 are 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.
Claim Rejections - 35 USC § 112
Claims 1-17 were previously 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.
Response to Arguments
Applicant’s arguments, see Applicant Reply, page 7, para. 1, with respect to claims 1-17 have been fully considered and are persuasive. The rejection of claims 1-17 has been withdrawn.
Claims 1-3 and 7-17 were previously 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.
Response to Arguments
Applicant’s arguments, see Applicant Reply, page 10, para. 3, with respect to claims 1-3 and 7-17 have been fully considered and are persuasive. The rejection of claims 1-3 and 7-17 has been withdrawn.
Maintained 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 1-17 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 claims contain 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.
Regarding claim 1, claim 1 recites a peptide combination capable of inducing dermal extracellular matrix protein upregulation wherein each peptide in the combination has flanking “U” and “Z” groups defined as: “U is selected from the group consisting of H, -CO-R1, -S02-R1 or a biotinyl group, at the C-terminal end, Z is selected from the group consisting of OH, OR1, NHR1 or NR1 R2; R1 and R2 are independently selected from the group consisting of alkyl, aryl, aralkyl, alkylaryl, alkoxy, saccharide and aryloxy group, which may be linear, branched, cyclical, polycyclic, unsaturated, hydroxylates, carbonylated, phosphorylated and/or sulphurous, said groups comprising from 1 to 24 carbon atoms and being capable of including one or more heteroatoms O,S and/or N”. The R1 and R2 groups may have up to 24 carbon atoms in a multitude of arrangements, giving rise to an extremely large genus that is referenced up to four times when describing the peptide combination.
In this case, 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 inventor was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. (MPEP § 2163 (II.A.3.a.ii.))
According to MPEP § 2163 (II.A.3.a.ii.), a "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
As described above, claim 1 recites four independent, extremely large genera.
MPEP § 2163 (II.A.3.a.ii.) states that “for inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’”
Even when several species are disclosed, these are not necessarily representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, as here, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. Since each genus recited in the instant claims is large, it would be very challenging to describe sufficient species to cover the structures of the entire genus.
Applicant discloses several working examples all of which feature palmitoyl as “U” and a hydroxyl group as “Z”. Palmitoyl is known in the art to enhance skin penetration of peptide products: ” For example, the palmitoyl derivative of the polypeptide interferon a has been shown to penetrate across human skin five- to six-fold greater than the underivatized peptide [3]. Thus, Lintner [4] and Mas-Chamberlin et al. [5] prepared the palmitoyl- KTTKS (pal-KTTKS) and demonstrated improved delivery across skin relative to KTTKS. They also reported [5,6] facial skin improvement effects in small base size testing of topical pal-KTTKS.” (Robinson et al., International journal of cosmetic science 27.3: 155-160 (2005), page 156, col. 1., para. 2).
However, a somewhat fine line exists between penetration enhancer and retardant as shown by Hadgraft et al. (Hadgraft, et al. International Journal of Pharmaceutics 141.1-2: 17-25. (1996)). Hadgraft describes Azone, and N-0915, which are superficially similar but have opposite skin penetration effects (Hadgraft, et al., pages 18 and 21, Figs. 1 and 5).
Consequently, since only a limited number of species of peptide combinations, specifically the “U” and “Z” components, are taught within the claimed genus above, the instant claim above fails the written description requirement. Given this unpredictability of skin penetration effects, the skilled artisan would not have been in possession of the substantial repertoire of “U” and “Z” species encompassed by the claimed invention; one of skill in the art would conclude that applicant was not in possession of the structural attributes of a representative number of species possessed by the members of the genus of every peptide combination recited by claim 1. One of skill in the art would conclude that the specification fails to disclose a representative number of species to describe the claimed genera. Therefore, claim 1 is rejected.
Note that the claimed residues themselves have sufficient written description support. This rejection is directed towards the multitudinous possible organic structures that could potentially be added onto said claimed residues. Also, the U group palmitoyl and Z group -OH have full support in the specification.
Regarding claim 2, claim 1 is rejected as described above. Claim 2 does not reduce the relevant genera sizes and therefore that the specification fails to disclose a representative number of species to describe the claimed genera and claim 2 is rejected.
Regarding claim 3, claim 1 is rejected as described above. Claim 3 does not reduce the relevant genera sizes and therefore that the specification fails to disclose a representative number of species to describe the claimed genera and claim 3 is rejected.
Regarding claim 4, claim 1 is rejected as described above. Claim 4 does not reduce the relevant genera sizes and therefore that the specification fails to disclose a representative number of species to describe the claimed genera and claim 4 is rejected.
Regarding claim 5, claim 1 is rejected as described above. Claim 5 does not reduce the relevant genera sizes and therefore that the specification fails to disclose a representative number of species to describe the claimed genera and claim 5 is rejected.
Regarding claim 6, claim 1 is rejected as described above. Claim 6 does not reduce the relevant genera sizes and therefore that the specification fails to disclose a representative number of species to describe the claimed genera and claim 6 is rejected.
Regarding claim 7, claim 1 is rejected as described above. Claim 7 does not reduce the relevant genera sizes and therefore that the specification fails to disclose a representative number of species to describe the claimed genera and claim 7 is rejected.
Regarding claim 8, claim 1 is rejected as described above. Claim 8 does not reduce the relevant genera sizes and therefore that the specification fails to disclose a representative number of species to describe the claimed genera and claim 8 is rejected.
Regarding claim 9, claim 1 is rejected as described above. Claim 9 does not reduce the relevant genera sizes and therefore that the specification fails to disclose a representative number of species to describe the claimed genera and claim 9 is rejected.
Regarding claim 10, claim 1 is rejected as described above. Claim 10 does not reduce the relevant genera sizes and therefore that the specification fails to disclose a representative number of species to describe the claimed genera and claim 10 is rejected.
Regarding claim 11, claim 1 is rejected as described above. Claim 11 does reduce the genera size for “U”, but does not alter the size of the “Z” genera. Therefore, the specification fails to disclose a representative number of species to describe the claimed genera and claim 11 is rejected.
Regarding claim 12, claim 1 is rejected as described above. Claim 12 does reduce the genera size for “U”, but does not alter the size of the “Z” genera. Therefore, the specification fails to disclose a representative number of species to describe the claimed genera and claim 12 is rejected.
Regarding claim 13, claim 1 is rejected as described above. Claim 13 does not reduce the relevant genera sizes and therefore that the specification fails to disclose a representative number of species to describe the claimed genera and claim 13 is rejected.
Regarding claim 14, claim 1 is rejected as described above. Claim 14 does not reduce the relevant genera sizes and therefore that the specification fails to disclose a representative number of species to describe the claimed genera and claim 14 is rejected.
Regarding claim 15, claim 1 is rejected as described above. Claim 15 does not reduce the relevant genera sizes and therefore that the specification fails to disclose a representative number of species to describe the claimed genera and claim 15 is rejected.
Regarding claim 16, claim 1 is rejected as described above. Claim 16 does not reduce the relevant genera sizes and therefore that the specification fails to disclose a representative number of species to describe the claimed genera and claim 16 is rejected.
Regarding claim 17, claim 1 is rejected as described above. Claim 17 does not reduce the relevant genera sizes and therefore that the specification fails to disclose a representative number of species to describe the claimed genera and claim 17 is rejected.
Examiner Note: Claims 18 and 19 are not subject to this rejection because these claims reduce the size of the claimed genus tremendously. Claims 18 and 19 are limited to a set group of peptides, a fixed Z motif, and U is a series of structurally similar carboxylic acid derivatives.
Response to Arguments
Applicant's arguments filed 4/16/2026 have been fully considered but they are not persuasive.
Applicant asserts:
“The specification teaches a clear structure-function relationship for the U and Z groups, explaining that derivatization of the peptide can increase bioavailability of the peptide by improving the ability of the peptide to pass through the skin. See the specification at p. 5, II. 28-30. The specification explicitly discloses that the first and second peptides are preferably modified to include U and/or Z groups with R1 and/or R2 being an alkyl chain of from 1 to 24 carbon atoms, preferably a lipophilic alkyl chain of 3 to 24 carbon atoms. Id. at p. 6, II. 3-4. The specification further discloses that U is preferably an acyl group -CO-R1 and Z is selected from OH, methoxy, ethoxy and NH2, preferably OH. The specification specifically identifies U as preferably selected from octanoyl (C8), decanoyl (C10), lauroyl (C12), myristoyl (C14), palmitoyl (C16), stearoyl (C18), biotinoyl, elaidoyl, oleoyl, and lipoyl, with a preferred embodiment selecting U from lauroyl (C12), myristoyl (C14) and palmitoyl (C16). Id. at p. 6, II. 5-12.” (Applicant Reply, page 8, para. 6).
As currently claimed, claim 1 recites “…wherein R1 and R2 comprise from 1 to 24 carbon atoms and optionally one or more heteroatoms O, S and/or N.” with regard to the compositions of R1 and R2.
The broadest reasonable interpretation of this claim language is any possible combination of 1 to 24 carbon atoms, not just octanoyl (C8), decanoyl (C10), lauroyl (C12), myristoyl (C14), palmitoyl (C16), stearoyl (C18), etc. Therefore, these acyl-bearing compounds are not representative of the broad genus claimed by claim 1.
Regarding the “U” position, Examiner agrees that the subset of compounds octanoyl (C8), decanoyl (C10), lauroyl (C12), myristoyl (C14), palmitoyl (C16), stearoyl (C18), biotinoyl, elaidoyl, oleoyl, and lipoyl are sufficiently supported by the specification because of their structural similarity to palmitoyl which is the working example provided by the specification.
Regarding the “Z” position, the only working example has a hydroxyl group at this position. This is not representation of any acyl-bearing compound and therefore octanoyl (C8), decanoyl (C10), lauroyl (C12), myristoyl (C14), palmitoyl (C16), stearoyl (C18), biotinoyl, elaidoyl, oleoyl, and lipoyl are not sufficiently supported by the specification at this position.
In summary, the structure-function relationship taught by the specification is not currently claimed by claim 1.
Regarding the invocation of Hadgraft, this was illustrative of seemingly small structural changes making non-trivial changes to skin permeability properties. Despite not being peptides, the compounds of Hadgraft are still composed of carbon, nitrogen, oxygen, and hydrogen and are comparable in this way.
To specifically examine peptides, peptide modifications are well-known to be unpredictable. A single point mutation can change the biophysical properties of a peptide: “In summary, we have shown that the structural changes in the fibrillar state of the Aβ42 peptide that are observed to occur upon introduction of single point mutations can be accompanied by changes in the dominance of the microscopic processes by which these aggregates are themselves formed.” (Bolognesi et al. ACS Chem Bio 9:2 (2013) page 381 col. 2 para. 3) and “In summary, while ovispirin-1 and novispirin G-10 both had solution structures that were helical and amphipathic in the presence of TFE, a relatively simple change in their primary structure (a single glycine–isoleucine exchange) had profound effects on their respective toxicities for human erythrocytes and epithelial cells.” (Sawai et al. Protein Eng. 15:3 (2002) page 232 col. 1 para. 3).
Furthermore, many sequences allowed by the current scope of the claims, result in non-functional aggregates. Wang (Wang, et al. MAbs. Vol. 1. No. 3. Taylor & Francis, (2009)) discloses a variety of aggregation prone motifs that occur in commercial antibodies (Wang, page 262, Table 2). The scope of the claims currently may incorporate such motifs and result in non-functional aggregates.
The substitution effects of peptides are not predictable in a general sense, not just in the realm of skin penetration ability.
Double Patenting
Claims 1-8 and 10-17 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Application No. 18/037,463 in view of Harris et al. (WO 2007146269, published 12/21/2007). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments, see Applicant Reply, page 12, para. 2, filed 4/16/2026, with respect to claims 1-8 and 10-17 have been fully considered and are persuasive. The provisional rejection of claims 1-8 and 10-17 has been withdrawn.
Allowable Subject Matter
Regarding claims 1-17, these are free of the prior art as described below, but are not yet allowable because of the U.S.C. 112(a) rejection described above.
Claims 18 and 19 are 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.
Regarding claim 18 and 19, these claims have full written description support and are novel and nonobvious.
There is no teaching or suggestion in the prior art to combine the claimed peptides to arrive at the claimed invention as described in more detail below.
The claimed peptides have many search hits, but the vast majority of them do not qualify as prior art. In particular, peptides appear from Applicant’s related applications which do not qualify as prior art due to filing date considerations.
Mertens et al. (US 2006/0099689, published May 11, 2006) discloses SEQ ID NO: 52, shown below aligned against Applicant SEQ ID NO: 1:
Query Match 100.0%; Score 18; Length 4;
Best Local Similarity 100.0%;
Matches 4; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 LSVD 4
||||
Db 1 LSVD 4
The context of this peptide, however, is that of a caspase enzyme target. Specifically, the field of invention for this peptide is:
“The invention relates generally to the field of molecular biology, biotechnology or process engineering for the production of proteins or peptides. The invention relates to methods of producing and isolating recombinant proteins using fusion protein constructs comprising specific recognition sites for a maturating protease. The invention specifically relates to the use of caspase proteases for the maturation of engineered recombinant fusion proteins or polypeptides. These molecules are engineered using recombinant DNA technology to comprise a specific target sequence for a caspase between a first fusion part and the polypeptide of interest. After processing, the desired mature format of the protein or polypeptide is obtained.” (Mertens et al., para. [0001]).
Numerous other sources also disclose variants of the LSXX formula, but nearly all of them are not the required length or do not qualify as prior art.
Regarding Applicant SEQ ID NO: 8, no prior art exists that is the required length.
Regarding Applicant SEQ ID NO: 9, Tseng-Law et al. US 5,968,753, published 10/19/1999 discloses SEQ ID NO: 197, aligned against Applicant SEQ ID NO: 9 below:
Query Match 100.0%; Score 21; Length 4;
Best Local Similarity 100.0%;
Matches 4; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 LSPG 4
||||
Db 1 LSPG 4
However, Tseng-Law is a patent regarding CD34 antigens: “The invention relates to peptides used to mediate cell release from antibody binding, methods of isolating such peptides, and methods for the specific release of target cells captured by antibody selection from a heterogeneous cell suspension. The general field is also known as cell selection.” (Tseng-Law et al., col. 1, line 9).
Applicant SEQ ID NO: 13 is disclosed by Harris et al. (WO 2007146269, published 12/21/2007). Harris discloses SEQ ID NO: 32, GPKG, which reads on the formula above for the second peptide of instant claim 1 in the case wherein U is -H, and Z and -OH, aligned below:
Query Match 100.0%; Score 24; Length 4;
Best Local Similarity 100.0%;
Matches 4; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GPKG 4
||||
Db 1 GPKG 4
Harris discloses that this peptide is known for skin treatment:
“The invention relates to tetrapeptides with the amino acid motif GxxG or PxxP, where G (glycine) and P (proline) are maintained and x is a variable amino acid. The invention also relates to frame shift active tetrapeptides which are tetrapeptide sequences shifted one frame from a GxxG or PxxP tetrapeptide in an ECM protein. In particular, the invention relates to GxxG, PxxP, or frame shift active peptides that stimulate production of extracellular matrix proteins and enhance wound closure of the epithelial cell monolayer of scratch-wounded human skin. The peptide compositions may be used in formulations for repairing damaged skin or maintaining healthy skin.” (Harris et al., Abstract).
Applicant SEQ ID NO: 14 is disclosed by Yu et al. (CN108191969, published 6/22/2018) as shown below:
SQ Sequence 4 AA;
Query Match 100.0%; Score 24; Length 4;
Best Local Similarity 100.0%;
Matches 4; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GPEG 4
||||
Db 1 GPEG 4
Yu describes this peptide as an ACE inhibitory peptide which is derived from trout collagen. Derivation from trout collagen has some association with skin-related treatments, but it is not as clear as the peptide of Harris described above.
Applicant SEQ ID NO: 15 is disclosed by various sources; for example, Krivokrysenko et al. WO 2016014899, published 1/28/2016:
%
Result Query Filing
No. Score Match Length ID Date Dups Description
-------------------------------------------------------------------------------------------------------------
1 23 100.0 4 AOF69150 -- 21 Human ECM protein stimulation tetrapeptide SEQ ID 35.
ALIGNMENT:
Query Match 100.0%; Score 23; Length 4;
Best Local Similarity 100.0%;
Matches 4; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GPSG 4
||||
Db 1 GPSG 4
However, Krivokrysenko is using this peptide for cancer treatment, not skin care. Furthermore, none of the other instances of prior art recite a role for this peptide in skin care.
Therefore, the most relevant reference available is Harris et al. which discloses both SEQ ID NO: 13 and its usage in skin care.
Based on this analysis, the nonobviousness lies in the combination of the LSXX motif with the GPXG motif. The GPXG motif is known to be associated with skin care and treatment as described above with Harris. However, SEQ ID NOs: 1, 8, and 9 are not known or suggested to be involved with skin care or treatment by the prior art. Therefore, a person of ordinary skill in the art would lack motivation to make this particular combination and claims 18 and 19 are free of the prior art.
Conclusion
No claim is allowed.
Claims 1-17 are rejected.
Claims 18-19 are objected to.
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 David Paul Bowles whose telephone number is (571)272-0919. The examiner can normally be reached Monday-Friday 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID PAUL BOWLES/ Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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