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.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c). Specifically, the specification on page 5, lines 6-9, lines 22-25, page 17, lines 26-27, line 30, page 18, lines 15, 26, 28, page 26, lines 6-7, 17, 20-21. Also, see claims 8-10.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Claim Objections
Claim 1 objected to because of the following informalities. Claim 1 refers to a “first tetrapeptide” and a “second peptide”. For consistency, it would be better to write “a first peptide wherein the peptide is a tetrapeptide”. Appropriate correction is required.
Claims 2 is objected to because of the following informalities. MPEP 608.01(n)(IV) provides the following format for dependent claims: “A singular dependent claim 2 could read as follows: 2. The product of claim 1 in which . . . .”. Claim 2 currently uses the article “A”, not “The”. Appropriate correction is required.
Claims 3-12 are objected to because of the following informalities. MPEP 608.01(n)(IV) provides the following format for dependent claims: “A singular dependent claim 2 could read as follows: 2. The product of claim 1 in which . . . .”. These claims follow the same pattern as claim 2, which is objected to above. Appropriate correction is required.
Claim 16 is objected to because of the following informalities. MPEP 608.01(n)(IV) provides the following format for dependent claims: “A singular dependent claim 2 could read as follows: 2. The product of claim 1 in which . . . .”. Claim 16 recites “a peptide combination”, not “the peptide combination”. Appropriate correction is required.
Claim 17 is objected to because of the following informalities. MPEP 608.01(n)(IV) provides the following format for dependent claims: “A singular dependent claim 2 could read as follows: 2. The product of claim 1 in which . . . .”. Claim 16 recites “a tetrapeptide”, not “the tetrapeptide”. Appropriate correction is required.
Claims 8-10 are objected to because of the following informalities. As noted above, claims 8-10 lack a sequence identifier (i.e., “SEQ ID NO:X” or the like). MPEP 1.831(b)(1) states: “An unbranched sequence or linear region of a branched sequence containing 4 or more specifically defined amino acids, wherein the amino acids form a single peptide backbone; …” Appropriate correction is required.
Claims 2, 3, and 7 are objected to because of the following informalities. These claims do not have the correct capitalization for the phrase “SEQ ID NO:X”. These phrases should not have a lower case “o” present. Appropriate correction is required.
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 1-17 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.
Regarding claim 1, claim 1 recites the term “said groups” on lines 12 and 25. It is not clear to which groups this term refers. This could refer back to R1, R2, the structural groups recited, or even the group consisting of tetrapeptides. This term is therefore indefinite.
Furthermore, claim 1 recites “being capable of including one or more hetero atoms O, S and/or N” on lines 13 and 26. It is not clear under what circumstances 1 to 24 carbon atoms would be incapable of including heteroatoms. It is not clear what scientific principle is referred to by “being capable of including one or more hetero atoms O, S and/or N”.
Consequently, claim 1 is indefinite and rejected.
Regarding claims 2-17, claim 1 is rejected as described above. Claims 2-17 fail to clarify the indefiniteness in claim 1 and therefore these claims are also rejected as indefinite because they ultimately depend from claim 1.
Regarding claim 2, claim 2 recites the limitation "A peptide" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites “a peptide combination”, “a first tetrapeptide”, and “a second peptide”, but does not reference “A peptide”. Furthermore, it is not clear to which peptide claim 2 is referring: “a peptide combination”, “a first tetrapeptide”, or “a second peptide”. Based off context, this most likely is referring to “a peptide combination”. Therefore, amendment of “A peptide” to “The peptide combination” is recommended.
Also, claim 2 references “the tetrapeptide a)”. It is not clear which tetrapeptide specifically is being referenced from claim 1 and therefore indefinite. If the first tetrapeptide is intended, amending to “a first peptide wherein the peptide is a tetrapeptide” in accordance with the above objection would remedy this issue.
Claim 2 is rejected.
Regarding claims 3-12, claims 3-12 recite the limitation "A peptide" in line 1. There is insufficient antecedent basis for this limitation in these claims. Furthermore, it is not clear to which peptide these claims are referring: “a peptide combination”, “a first tetrapeptide”, or “a second peptide”. Based off context, this most likely is referring to “a peptide combination”. Therefore, amendment of “A peptide” to “The peptide combination” is recommended. Claims 3-12 are rejected.
Regarding claim 7, claim 7 recites “the tetrapeptide b)”. However, in claim 1, b) is “a peptide”. It is not clear which tetrapeptide claim 7 is referencing, rendering this claim indefinite. Claim 7 is rejected.
Regarding claim 11, claim 11 references “the tetrapeptide”. It is not clear which tetrapeptide specifically is being referenced from claim 1. If the first tetrapeptide is intended, amending to “a first peptide wherein the peptide is a tetrapeptide” in accordance with the above objection would remedy this issue. Claim 11 is rejected as indefinite.
Regarding claim 13, claim 13 recites the limitation "the peptides" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 13 is rejected. The term “peptides” does not appear in claim 1. Furthermore, it is not clear to which peptides this limitation is referring. It could be the peptide combination or the first tetrapeptide, or the second peptide. Claim 13 is rejected as indefinite.
Regarding claim 14, claim 13 is rejected as described above. Claim 14 recites the limitation “a peptide”. It is not clear as to which peptide from claim 13 or claim 1 is being referenced by claim 14. It could be the peptide combination or the first tetrapeptide, or the second peptide. Claim 14 is rejected as indefinite.
Regarding claim 15, claim 13 is rejected as described above. Claim 15 does not resolve the indefiniteness of claim 13, and therefore is also rejected.
Regarding claim 16, claim 16 recites the limitation "cosmetic composition" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 17, claim 17 recites “a tetrapeptide according to claim 1”. It is not clear and therefore indefinite as to which tetrapeptide is being referenced here. This might be the first tetrapeptide or one of the tetrapeptides referenced under “b)”. Claim 17 is rejected.
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 palmityol 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.
Claims 1-3 and 7-17 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 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.
Regarding claim 1, claim 1 recites: “A peptide combination, capable of inducing dermal extracellular matrix protein upregulation, comprising; a) a first tetrapeptide selected from the group consisting of tetrapeptides having the amino acid sequence U-LSXX-Z wherein L is used to denote amino acid Leucine and S is used to denote Serine, as per the internationally recognised single letter code for amino acids, X denotes an amino acid independently selected from the group consisting of Valine (V), Aspartic acid (D), Proline (P), Glycine (G), at the N-terminal end,…”
Looking at just the residues in this case (U and Z are addressed above), claim 1 encompasses a sequence space of 4^2=16 peptide sequences. This is not a particularly large genus; however, a specific activity is present in claim 1: “capable of inducing dermal extracellular matrix protein upregulation”.
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).
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.
In the instant case, Applicant reduces one peptide combination to practice. Specifically, only one “first tetrapeptide” is reduced to practice and shown to have the claimed efficacy. At the time the invention was made, the level of skill for preparing peptides with desired functional properties was high. However, even if a synthesis and selection procedure was, at the time of the invention, sufficient to enable the skilled artisan to identify peptides that yield polypeptides with the recited properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010); see also Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1876 (Fed. Cir. 2011) (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”) Absent the conserved structure (length) provided by the provided species, the skilled artisan generally would not be able to visualize or otherwise predict, a priori, what polypeptide with a particular set of properties would look like structurally.
Applicant discloses the combination of GPKG and LSVD and shows efficacy of said combination.
The provided examples only represent a limited structural diversity. Since only a limited number of species of peptides are taught within the claimed genus above, the instant claim above fails the written description requirement. A representative number of species has not been taught to describe this genus. Regarding the peptides, 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.
Given this unpredictability of protein design, the skilled artisan would not have been in possession of the substantial repertoire of peptide 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 polynucleotide molecule recited by claim 1. Because of the potential effects of even a single residue change, the structure-function relationship between the claimed genus and claimed activity is not sufficiently established. One of skill in the art would conclude that the specification fails to disclose a representative number of species of the LSXX peptide to describe the claimed genus. Therefore, claim 1 is rejected.
For clarity, the GPXG peptide is not subject to this 112(a) rejection because of its smaller genus size, known activity as disclosed by Harris SEQ ID NO: 32, GPKG (Harris et al. (WO 2007146269, published 12/21/2007)), and similarity to the collagen GXY motif.
Regarding claim 2, claim 1 is rejected as described above. As discussed above, only SEQ ID NO: 1 has an established structure-function relationship for the LSXX peptide. Claim 2 discloses eleven other sequences for which the structure-function relationship is not established. One of skill in the art would conclude that the specification fails to disclose a representative number of species to describe the claimed genus. Therefore, claim 2 is rejected.
Regarding claim 3, claim 1 is rejected as described above. As discussed above, only SEQ ID NO: 1 has an established structure-function relationship for the LSXX peptide. Claim 3 discloses two other sequences for which the structure-function relationship is not established. One of skill in the art would conclude that the specification fails to disclose a representative number of species to describe the claimed genus. Therefore, claim 3 is rejected.
Regarding claims 7-17, claim 1 is rejected as described above. None of these claims reduce the genus size of the LSXX peptide. One of skill in the art would conclude that the specification fails to disclose a representative number of species to describe the claimed genus. Therefore, claims 7-17 are rejected.
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 1-8 and 10-17 are 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.
Regarding claim 1, claim of the ‘463 application recites: “A tetrapeptide, capable of inducing dermal extracellular matrix protein upregulation, selected from the group consisting of tetrapeptides having the amino acid sequence U-LSXX-Z wherein L is used to denote amino acid Leucine and S is used to denote Serine, as per the internationally recognised single letter code for amino acids, X denotes an amino acid selected from the group consisting of Valine (V), Aspartic acid (D), Proline (P), Glycine (G) and mixtures thereof, at the N-terminal end, 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, O R1, NHR1 or NR1R2, wherein if U is H then Z cannot be OH, and 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 0,S and/or N.”
The ’463 application does not disclose a second peptide as recited by claim 1 of the present application: “ b) a second peptide selected from the group consisting of tetrapeptides having the amino acid sequence U-GPXG-Z wherein G is used to denote amino acid glycine and P denotes the amino acid proline, as per the internationally recognised single letter code for amino acids, X denotes an amino acid independently selected from the group consisting of Lysine (K), Glutamic acid (E), Proline (P) and Serine (S) and mixtures thereof, or a pentapeptide having the amino acid sequence according to SEQ ID No:17, at the N-terminal end, 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.”
However, 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.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the peptide of the ‘463 application with the peptide disclosed by Harris. The peptide of the ‘463 application is claimed as being capable of inducing dermal extracellular matrix upregulation. The peptide disclosed by Harris is also associated with the extracellular matrix: “The disclosed sequences are referred to as REPLIKINES™. "REPLIKINE" is defined as a short sequence within ECM proteins that occurs multiple times (i.e., is replicated). This sequence may be present in one ECM protein (e.g., collagen IV). Preferably, the sequence is present in multiple ECM proteins (e.g., all collagens, elastin, laminin, etc.). The presence of the sequence in multiple ECM proteins increases the likelihood that the fragment may be able to promote ECM synthesis or repair.” (Harris et al, para [0029]).
A person of ordinary skill in the art would be motivated to combine these two peptides to arrive at the claimed invention because both peptides are associated with ECM and MPEP 2144.06(I) states: “"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." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).”
A person of ordinary skill in the art would have a reasonable expectation of success for similar reasons. Because both peptides are associated with ECM, and Harris discloses that: “This fact contributes to the ability of the disclosed peptides to stimulate the production of all collagen types, particularly when the peptides are used in combination.” (Harris, et al., para. [0030]), a person of ordinary skill in the art would expect this combination of peptides to have some efficacy related to ECM synthesis or repair.
Consequently, claim 1 is obvious over U.S. Application No. 18/037,463 in view of Harris et al. and provisionally rejected.
Regarding claim 2, claim 1 is obvious as described above. Claim 2 of the ‘463 application discloses: “A tetrapeptide according to claim 1 wherein the tetrapeptide is selected from the group consisting of SEQ ID No: 1, SEQ ID No: 2, SEQ ID No: 3, SEQ ID No: 4, SEQ ID No: 5, SEQ ID No: 6, SEQ ID No:7, SEQ ID No: 8, SEQ ID No: 9, SEQ ID No: 10, SEQ ID No: 11 and SEQ ID No: 12.”. These SEQ ID NOs match the SEQ ID NOs of the present application. Consequently, claim 2 is obvious over U.S. Application No. 18/037,463 in view of Harris et al. and provisionally rejected.
Regarding claim 3, claim 1 is obvious as described above. Claim 3 of the ‘463 application discloses: “A tetrapeptide according to any preceding claim wherein the tetrapeptide is selected from the group consisting of SEQ ID No: 1, SEQ ID No: 9 and SEQ ID No: 8.”. These SEQ ID NOs match the SEQ ID NOs of the present application. Consequently, claim 3 is obvious over U.S. Application No. 18/037,463 in view of Harris et al. and provisionally rejected.
Regarding claim 4, claim 1 is obvious as described above. Claim 4 of the ‘463 application discloses: “A tetrapeptide according to any preceding claim wherein the tetrapeptide is U-LSVD-Z.” Consequently, claim 4 is obvious over U.S. Application No. 18/037,463 in view of Harris et al. and provisionally rejected.
Regarding claim 5, claim 1 is obvious as described above. Claim 5 of the ‘463 application discloses: “A tetrapeptide according to any preceding claim wherein the tetrapeptide is U-LSPG-Z.” Consequently, claim 5 is obvious over U.S. Application No. 18/037,463 in view of Harris et al. and provisionally rejected.
Regarding claim 6, claim 1 is obvious as described above. Claim 6 of the ‘463 application discloses: “A tetrapeptide according to any preceding claim wherein the tetrapeptide is U-LSPD-Z.” Consequently, claim 6 is obvious over U.S. Application No. 18/037,463 in view of Harris et al. and provisionally rejected.
Regarding claim 7, claim 1 is obvious as described above. Harris discloses SEQ ID NO: 32, GPKG, which is identical to Applicant SEQ ID NO: 13 when U is -H, and Z and -OH. Consequently, claim 7 is obvious over U.S. Application No. 18/037,463 in view of Harris et al. and provisionally rejected.
Regarding claim 8, claim 1 is obvious as described above. Harris discloses SEQ ID NO: 32, GPKG, which is identical to Applicant SEQ ID NO: 13 when U is -H, and Z and -OH. Consequently, claim 8 is obvious over U.S. Application No. 18/037,463 in view of Harris et al. and provisionally rejected.
Regarding claim 10, claim 1 is obvious as described above. Harris discloses SEQ ID NO: 32, GPSG, which is identical to Applicant SEQ ID NO: 15 when U is -H, and Z and -OH. Consequently, claim 10 is obvious over U.S. Application No. 18/037,463 in view of Harris et al. and provisionally rejected.
Regarding claim 11, claim 1 is obvious as described above. Claim 7 of the ‘463 application discloses: “A tetrapeptide according to any preceding claim wherein U of the tetrapeptide is independently selected from the group consisting of octanoyl (C8), decanoyl (C10), lauroyl (C12), myristoyl (C14), palmitoyl (C16), stearoyl (C18), biotinoyl, elaidoyl, oleoyle and lipoyle.” Consequently, claim 11 is obvious over U.S. Application No. 18/037,463 in view of Harris et al. and provisionally rejected.
Regarding claim 12, claim 1 is obvious as described above. Claim 8 of the ‘463 application discloses: “A tetrapeptide according to any preceding claim wherein U of the tetrapeptide is independently selected from the group consisting of lauroyl (C12), myristoyl (C14) and palmitoyl (C16).” Consequently, claim 12 is obvious over U.S. Application No. 18/037,463 in view of Harris et al. and provisionally rejected.
Regarding claim 13, claim 1 is obvious as described above. Claim 9 of the ‘463 application discloses: “A cosmetic composition comprising the tetrapeptides of any preceding claim.” Consequently, claim 13 is obvious over U.S. Application No. 18/037,463 in view of Harris et al. and provisionally rejected.
Regarding claim 14, claim 13 is obvious as described above. Claim 10 of the ‘463 application discloses: “A cosmetic composition according to claim 9 wherein the tetrapeptide is present at from 0.1 to 10,000ppm by weight of the composition.” Consequently, claim 14 is obvious over U.S. Application No. 18/037,463 in view of Harris et al. and provisionally rejected.
Regarding claim 15, claim 13 is obvious as described above. Claim 11 of the ‘463 application discloses: “A cosmetic composition according to any of claims 9 and 10 further comprising additional further peptides selected from the group consisting of dipeptides, tripeptides, additional tetrapeptides, pentapeptides and mixtures thereof.” Consequently, claim 15 is obvious over U.S. Application No. 18/037,463 in view of Harris et al. and provisionally rejected.
Regarding claim 16, claim 1 is obvious as described above. Claim 12 of the ‘463 application discloses: “A method for stimulating the production of extra cellular proteins in humans, the method comprising administering to the skin of said human a cosmetically effective amount of a tetrapeptide or a cosmetic composition according to any preceding claim.” Consequently, claim 16 is obvious over U.S. Application No. 18/037,463 in view of Harris et al. and provisionally rejected.
Regarding claim 17, claim 1 is obvious as described above. Claim 13 of the ‘463 application discloses: “The use of a tetrapeptide according to any of claims 1 to 8 or a composition according to any of claims 9 to 11 as a non-therapeutic cosmetic treatment to improve the condition of the skin and/or lines and/or wrinkles and/or imperfections.” Consequently, claim 17 is obvious over U.S. Application No. 18/037,463 in view of Harris et al. and provisionally rejected.
Closest Prior Art
Mertens et al. (US 2006/0099689, published May 11, 2006) discloses SEQ ID NO: 52, shown below.
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
Numerous other sources also disclose variants of the LSXX formula.
The second peptide 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.
However, none of these prior art disclosures provide background or activity information sufficient to provide motivation to person of ordinary skill in the art to combine with the second peptide b) in claim 1 to arrive at the claimed invention. Consequently, claim 1 and all dependent claims are free of the prior art.
Conclusion
No claim is allowed.
Claims 1-12 and 16-17 are objected to.
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/DAVID PAUL BOWLES/ Examiner, Art Unit 1654
/LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654