DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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 for the cited rejections 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.
3. Response to Election/Restriction filed on 2/26/2026 is acknowledged.
4. Claim filed on 2/26/2026 is acknowledged.
5. Claims 10 and 14 have been cancelled.
6. New claims 15-17 have been added.
7. Claims 1-9, 11-13 and 15-17 are pending in this application.
8. Claim 13 is withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/26/2026. Claims 3-5, 7 and 15-17 are withdrawn from consideration as being drawn to non-elected species.
Please note: With regards to the newly added claims 15-17, in the instant case, in the Requirement for Restriction/Election dated 11/26/2025, the Examiner explicitly states that Applicant is required to elect a single disclosed species of cosmetic composition wherein ALL the variables are elected. Since the elected species of cosmetic composition does not include any of the variables recited in the newly added claims 15-17, claims 15-17 are hereby withdrawn from consideration as being drawn to non-elected species.
9. Claims 1, 2, 6, 8, 9, 11 and 12 are under examination.
Priority
10. The application is a 371 of PCT/EP2021/025444 filed on 11/16/2021, which claims foreign priority to EPO application 20020537.5 filed on 11/17/2020. The EPO application provides support to instant claims 1, 2, 6, 8, 9, 11 and 12. Therefore, the effective filing date of instant claims 1, 2, 6, 8, 9, 11 and 12 is 11/17/2020.
Claim Interpretations
11. With regards to the term “cosmetic composition” recited in instant claims, the instant specification discloses that “A cosmetic composition is a product designed for use by a consumer and is preferably a facial skincare cosmetic composition.” ( see page 9, lines 16-17 of instant specification). First, the Examiner would like to point out that the preferred embodiment is not a definition. Furthermore, the only active component in the cosmetic composition recited in instant claims 1, 2, 6, 8, 9 and 11 is the recited tetrapeptide. Therefore, in the instant case, in view of the disclosure of instant specification and in the broadest reasonable interpretation, the Examiner is interpretating the term “cosmetic composition” recited in instant claims 1, 2, 6, 8, 9 and 11 broadly includes only the instant claimed tetrapeptide itself; and the term “cosmetic composition” recited in instant claim 12 broadly includes a combination of the instant claimed tetrapeptide and additional peptide selection from any dipeptide, tripeptide, other tetrapeptide, pentapeptide and mixture thereof. Such interpretation applies to all the rejections set forth below.
Election/Restrictions
12. Applicant’s election with traverse of Group 2 (claims 1-9, 11, 12 and 15-17) and election with traverse of a combination of palmitoyl-LKGD-OH and an ALAMCAT tetrapeptide as species of cosmetic composition in the reply filed on 2/26/2026 is acknowledged.
The traverse is on the ground that “neither Ostuni nor Peers discloses or remotely suggests a cosmetic composition as claimed, let alone that such compositions are capable of stimulating the production of dermal extracellular proteins in humans.”; and “even if Ostuni and Peers were combined as proposed, neither document discloses or suggests specifically selecting the combination of U and Z groups recited in all pending claims.” This is not found to be persuasive because: In the instant case, as stated in Section 6 of the Requirement for Restriction/Election dated 11/26/2025, in view of the combined teachings of Ostuni et al and Peers et al, it would have been obvious to one of ordinary skilled in the art to develop a peptide consisting of the amino acid sequence REGD (identical to the tetrapeptide of instant SEQ ID NO: 21) with acetyl group as a N-terminal protecting group that can be used for inducing in vivo vasorelaxation. The peptide developed from the combined teachings of Ostuni et al and Peers et al meets all the structural limitations of the tetrapeptide recited in instant claims 1 and 2. And the peptide developed from the combined teachings of Ostuni et al and Peers et al is a product designed for use by a consumer, therefore, it is a cosmetic composition. Furthermore, with regards to the limitation “capable of inducing dermal extracellular matrix protein upregulation” recited in instant claim 2, since the peptide developed from the combined teachings of Ostuni et al and Peers et al meets all the structural limitations of the tetrapeptide recited in instant claim 2, the peptide developed from the combined teachings of Ostuni et al and Peers et al would necessarily have the same properties and functionality of the tetrapeptide recited in instant claim 2. Therefore, the peptide developed from the combined teachings of Ostuni et al and Peers et al is capable of inducing dermal extracellular matrix protein upregulation. And the MPEP states “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).” (see MPEP § 2112.01 I). And since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise. In the instant case, other than statements/arguments, Applicant fails to provide any data and/or evidence to prove otherwise. With regards to the species election, Applicant fails to point out the supposed errors in the species election requirement. Therefore, the species election has been treated as an election without traverse. Taken all these together, the requirement is still deemed proper and is made Final in this office action.
Group 2 is drawn to a cosmetic composition comprising tetrapeptide, capable of inducing dermal extracellular matrix protein upregulation, the tetrapeptide having an amino acid sequence U-XXGD-Z wherein G is used to denote amino acid Glycine and D is used to denote amino acid Aspartic acid, as per the internationally recognised single letter code for amino acids, X denotes an amino acid selected from the group consisting of Glutamic acid (E), Lysine (K), Leucine (L), Alanine (A), Isoleucine (I), Arginine (R) and mixtures thereof; wherein at the N-terminal end, U is selected from the group consisting of CO-R1, -SO2-R1 or a biotinyl group; and at the C-terminal end, Z is selected from the group consisting of OH, OR1, NHR1 or NR1R2, wherein 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. A search was conducted on the elected species; and this appears to be free of prior art. A search was extended to the genus in claim 2; and prior art was found. Claims 3-5, 7 and 15-17 are withdrawn from consideration as being drawn to non-elected species. Claims 1, 2, 6, 8, 9, 11 and 12 are examined on the merits in this office action.
Sequence Non-Compliance
13. This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below. All sequences disclosed in the application must comply with the requirements of 37 C.F.R. 1.821-1.825, not only those recited in the claims.
In the instant case, both claims and instant specification disclose various peptides. As an example, the peptides recited in instant claims 4-7; and the peptides disclosed on page 2, lines 16 and 18, page 5, lines 7-15, and many others of instant specification. However, these peptides are not disclosed in the filed sequence listing.
All such sequences are relevant for the purposes of building a comprehensive database and properly assessing prior art. It is therefore essential that all sequences, whether only disclosed or also claimed, be included in the database.
Objections
14. The specification is objected to for the following minor informality: The specification discloses various peptides on page 2, lines 16 and 18, page 5, lines 7-15, and many others of instant specification. As an example, Pal-KKTKS, Pal-GQPR, U-EKGD-Z and many others. However, these peptides are not disclosed in the filed sequence listing; and they are missing their respective sequence identifier. In addition, the instant specification discloses the peptide Glu-Gln-Pro-Arg and many others throughout the specification. However, they are missing their respective sequence identifier. Applicant is required to amend the specification to comply with 37 CFR 1.821(c) and 1.821(d).
15. The use of trademarks has been noted in this application, for example, Matrixyl and many others throughout instant specification. Each letter of the trademarks should be capitalized wherever it appears and be accompanied by the generic terminology. Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks.
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 (see MPEP § 608.01).
16. Claim 1 is objected to for the following minor informality: Applicant is suggested to amend claim 1 as “The cosmetic composition according to claim 2, wherein the amino acid sequence XXGD in the tetrapeptide is selected from the group consisting of SEQ ID NOs: 1-9 and 11-29”.
17. Claim 2 is objected to for the following minor informality: Applicant is suggested to amend claim 2 as “A cosmetic composition comprising a tetrapeptide capable of inducing dermal extracellular matrix protein upregulation, wherein the tetrapeptide consists of the amino acid sequence U-XXGD-Z, wherein G is Gly; D is Asp; each X is independently an amino acid selected from the group consisting of Glu (E), Lys (K), Leu (L), Ala (A), Ile (I) and Arg (R); U is selected from H, -CO-R1, -SO2-R1 or a biotinoyl group; Z is selected from OH, OR1, NHR1 or NR1R2; and R1 and R2 are independently selected from alkyl, aryl, aralkyl, alkylaryl, alkoxy, saccharide, or aryloxy group, wherein said group is linear, branched, cyclic, polycyclic, unsaturated, hydroxylated, carbonylated, and/or phosphorylated, wherein said group has no more than 24 carbon atoms, and wherein said group optionally comprises one or more heteroatoms selected from O, S and/or N”.
18. Claim 6 is objected to for the following minor informality: Applicant is required to amend claim 6 to comply with 37 CFR 1.821(c) and 1.821(d). Furthermore, Applicant is suggested to amend claim 6 as “The cosmetic composition according to claim 2, wherein the tetrapeptide is Pal-LKGD-OH (SEQ ID NO: #)".
In addition, claim 6 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.
19. Claims 8 and 9 are objected to for the following minor informality: Applicant is suggested to amend claims 8 and 9 as “The cosmetic composition according to claim 2, wherein U is selected from the group consisting of…".
20. Claim 11 is objected to for the following minor informality: Applicant is suggested to amend claim 11 as “The cosmetic composition according to claim 2, wherein the tetrapeptide is present at a concentration from 0.1 to 10,000 ppm by weight of…".
21. Claim 12 is objected to for the following minor informality: Applicant is suggested to amend claim 12 as “The cosmetic composition according to claim 2, wherein the cosmetic composition further comprises additional peptides selected from the group consisting of dipeptides, tripeptides, tetrapeptides that are different from the tetrapeptide recited in claim 2, pentapeptides and mixtures thereof”.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
22. 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.
23. Claims 1, 2, 8, 9, 11 and 12 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 pre-AIA the applicant regards as the invention.
24. Claim 2 recites “…X denotes an amino acid selected from the group consisting of Glutamic acid (E), Lysine (K), Leucine (L), Alanine (A), Isoleucine (I), Arginine (R) and mixtures thereof…wherein 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”. First, since X is an amino acid, it is unclear how X can be any mixture of the recited Markush group of amino acids. Second, with regards to the term “sulphurous”, the instant specification fails to define it. According to the Sulfurous Definition & Meaning document (2026, from https://www.merriam-webster.com/dictionary/sulfurous, enclosed pages 1-5), the term “sulfurous” (same as sulphurous) means of, relating to, or containing sulfur especially with a lower valence than sulfuric compounds, or resembling or emanating from sulfur and especially burning sulfur (see page 1). Therefore, it is unclear what is encompassed within the recited “sulphurous”. Third, with regards to the recited “said groups comprising from 1 to 24 carbon atoms and being capable of including one or more heteroatoms O, S and/or N”, it is unclear what is encompassed within the recited “being capable of including one or more heteroatoms O, S and/or N”. Taken all these together, the metes and bounds of instant claim 2 is vague and indefinite. Because claims 1, 8, 9, 11 and 12 depend from indefinite claim 2, and none of the dependent claims clarifies the point of confusion, they must also be rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Claim Rejections - 35 U.S.C. § 102(a)(1)
25. 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.
26. Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ali et al (US 5849690 A, filed with IDS).
The instant claim 2 is drawn to a cosmetic composition comprising tetrapeptide, capable of inducing dermal extracellular matrix protein upregulation, the tetrapeptide having an amino acid sequence U-XXGD-Z wherein G is used to denote amino acid Glycine and D is used to denote amino acid Aspartic acid, as per the internationally recognised single letter code for amino acids, X denotes an amino acid selected from the group consisting of Glutamic acid (E), Lysine (K), Leucine (L), Alanine (A), Isoleucine (I), Arginine (R) and mixtures thereof; wherein at the N-terminal end, U is selected from the group consisting of CO-R1, -SO2-R1 or a biotinyl group; and at the C-terminal end, Z is selected from the group consisting of OH, OR1, NHR1 or NR1R2, wherein 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.
Ali, throughout the patent, teach compounds that are effective for inhibiting platelet aggregation and methods of using such compound in a mammal, for example, Abstract. One of such compounds in Ali is Nα-Ac-Ala-Arg-Gly-Asp-OCH3, for example, columns 37-38, Example 41. It meets all the structural limitations of the tetrapeptide recited in instant claim 2. And it is a product designed for use by a consumer, therefore, it is a cosmetic composition.
With regards to the limitation “capable of inducing dermal extracellular matrix protein upregulation” recited in instant claim 2, since the compounds Nα-Ac-Ala-Arg-Gly-Asp-OCH3 in Ali is meets all the structural limitations of the tetrapeptide recited in instant claim 2, the compounds Nα-Ac-Ala-Arg-Gly-Asp-OCH3 in Ali would necessarily have the same properties and functionality of the tetrapeptide recited in instant claim 2. Therefore, the compounds Nα-Ac-Ala-Arg-Gly-Asp-OCH3 in Ali is capable of inducing dermal extracellular matrix protein upregulation. And the MPEP states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP § 2112.01 II). And since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
Furthermore, the MPEP states the following: A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (see MPEP § 2131.02).
Since the reference teaches all the limitations of instant claim 2; the reference anticipates instant claim 2.
Claim Rejections - 35 U.S.C. § 103
27. 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 of this title, 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.
28. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
29. Claims 1, 2, 8, 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Ostuni et al (The International Journal of Biochemistry & Cell Biology, 2002, 34, pages 130-135, cited and enclosed in the previous office action) in view of the Peptide N-Terminal Modification document (from Creative Peptides, 2019, enclosed pages 1-6).
The instant claims 1, 2, 8, 9 and 11 are drawn to a cosmetic composition comprising tetrapeptide, capable of inducing dermal extracellular matrix protein upregulation, the tetrapeptide having an amino acid sequence U-XXGD-Z wherein G is used to denote amino acid Glycine and D is used to denote amino acid Aspartic acid, as per the internationally recognised single letter code for amino acids, X denotes an amino acid selected from the group consisting of Glutamic acid (E), Lysine (K), Leucine (L), Alanine (A), Isoleucine (I), Arginine (R) and mixtures thereof; wherein at the N-terminal end, U is selected from the group consisting of CO-R1, -SO2-R1 or a biotinyl group; and at the C-terminal end, Z is selected from the group consisting of OH, OR1, NHR1 or NR1R2, wherein 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. Ostuni et al, throughout the literature, teach a tetrapeptide consisting of the amino acid sequence REGD (identical to the amino acid sequence of instant SEQ ID NO: 21) induces concentration-dependent vasorelaxation in the concentration range from 10−9 to 10−5 M, for example, Abstract; and page 131, left column, the last paragraph. The molecular weight of the tetrapeptide REGD is about 475.5 Dalton. Therefore, the tetrapeptide REGD at a concentration of 10−5 M is about 4.8 mg/L or 4.8 ppm.
The difference between the reference and instant claims 1, 2, 8, 9 and 11 is that the reference does not explicitly teach modifying the N-terminus of such tetrapeptide; and the limitations recited in instant claims 1, 2, 8, 9 and 11.
However, the Peptide N-Terminal Modification document teaches N-terminal modification increases the stability of the peptide; and such N-terminal modification includes acetylation, palmitoyl, and others, for example, page 3, the 2nd and 3rd paragraphs.
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Ostuni et al and the Peptide N-Terminal Modification document to develop a tetrapeptide consisting of the amino acid sequence REGD (identical to the amino acid sequence of instant SEQ ID NO: 21) with acetyl or palmitoyl group as a N-terminal protecting group that can be used for inducing in vivo vasorelaxation. Since the tetrapeptide developed from the combined teachings of Ostuni et al and the Peptide N-Terminal Modification document is a product designed for use by a consumer, it is a cosmetic composition.
With regards to the limitation “capable of inducing dermal extracellular matrix protein upregulation” recited in instant claim 2, since the tetrapeptide developed from the combined teachings of Ostuni et al and the Peptide N-Terminal Modification document meets all the structural limitations of the tetrapeptide recited in instant claim 2, the tetrapeptide developed from the combined teachings of Ostuni et al and the Peptide N-Terminal Modification document would necessarily have the same properties and functionality of the tetrapeptide recited in instant claim 2. Therefore, the tetrapeptide developed from the combined teachings of Ostuni et al and the Peptide N-Terminal Modification document is capable of inducing dermal extracellular matrix protein upregulation. And the MPEP states “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).” (see MPEP § 2112.01 I). And since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
One of ordinary skilled in the art would have been motivated to combine the teachings of Ostuni et al and the Peptide N-Terminal Modification document to develop a tetrapeptide consisting of the amino acid sequence REGD (identical to the amino acid sequence of instant SEQ ID NO: 21) with acetyl or palmitoyl group as a N-terminal protecting group that can be used for inducing in vivo vasorelaxation, wherein the tetrapeptide is capable of inducing dermal extracellular matrix protein upregulation, because the Peptide N-Terminal Modification document teaches N-terminal modification increases the stability of the peptide; and such N-terminal modification includes acetylation, palmitoyl, and others.
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Ostuni et al and the Peptide N-Terminal Modification document to develop a tetrapeptide consisting of the amino acid sequence REGD (identical to the amino acid sequence of instant SEQ ID NO: 21) with acetyl or palmitoyl group as a N-terminal protecting group that can be used for inducing in vivo vasorelaxation, wherein the tetrapeptide is capable of inducing dermal extracellular matrix protein upregulation.
30. Claims 1, 2, 8, 9, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ostuni et al (The International Journal of Biochemistry & Cell Biology, 2002, 34, pages 130-135, cited and enclosed in the previous office action) in view of the Peptide N-Terminal Modification document (from Creative Peptides, 2019, enclosed pages 1-6), and further in view of Mehta et al (Am. J. Physiol., 1985, 249, pages H457-H462).
The instant claims 1, 2, 8, 9, 11 and 12 are drawn to a cosmetic composition comprising tetrapeptide, capable of inducing dermal extracellular matrix protein upregulation, the tetrapeptide having an amino acid sequence U-XXGD-Z wherein G is used to denote amino acid Glycine and D is used to denote amino acid Aspartic acid, as per the internationally recognised single letter code for amino acids, X denotes an amino acid selected from the group consisting of Glutamic acid (E), Lysine (K), Leucine (L), Alanine (A), Isoleucine (I), Arginine (R) and mixtures thereof; wherein at the N-terminal end, U is selected from the group consisting of CO-R1, -SO2-R1 or a biotinyl group; and at the C-terminal end, Z is selected from the group consisting of OH, OR1, NHR1 or NR1R2, wherein 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 rejection to claims 1, 2, 8, 9 and 11 under 35 U.S.C. 103 as being unpatentable over Ostuni et al (The International Journal of Biochemistry & Cell Biology, 2002, 34, pages 130-135, cited and enclosed in the previous office action) in view of the Peptide N-Terminal Modification document (from Creative Peptides, 2019, enclosed pages 1-6) has been set forth in Section 29 above.
The difference between the rejection set forth in Section 29 above and instant claims 1, 2, 8, 9, 11 and 12 is that the rejection set forth in Section 29 above does not teach the limitations of instant claim 12.
However, Mehta et al, throughout the literature, teach peptide 6A consisting of the amino acid sequence ARPAK (a pentapeptide) has potent vasodilator effects, in that it increases coronary blood flow and decreases coronary vascular resistance, for example, Abstract.
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Ostuni et al, the Peptide N-Terminal Modification document and Mehta et al to develop a combination comprising a tetrapeptide consisting of the amino acid sequence REGD (identical to the amino acid sequence of instant SEQ ID NO: 21) with acetyl or palmitoyl group as a N-terminal protecting group that can be used for inducing in vivo vasorelaxation, wherein the tetrapeptide is capable of inducing dermal extracellular matrix protein upregulation; and peptide 6A consisting of the amino acid sequence ARPAK (a pentapeptide). And in the instant case, the combination developed from the combined teachings of Ostuni et al, the Peptide N-Terminal Modification document and Mehta et al is a product designed for use by a consumer, therefore, it is a cosmetic composition.
One of ordinary skilled in the art would have been motivated to combine the teachings of Ostuni et al, the Peptide N-Terminal Modification document and Mehta et al to develop a combination comprising a tetrapeptide consisting of the amino acid sequence REGD (identical to the amino acid sequence of instant SEQ ID NO: 21) with acetyl or palmitoyl group as a N-terminal protecting group that can be used for inducing in vivo vasorelaxation, wherein the tetrapeptide is capable of inducing dermal extracellular matrix protein upregulation; and peptide 6A consisting of the amino acid sequence ARPAK (a pentapeptide), because Mehta et al, throughout the literature, teach peptide 6A consisting of the amino acid sequence ARPAK (a pentapeptide) has potent vasodilator effects, in that it increases coronary blood flow and decreases coronary vascular resistance. And the MPEP states that “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...” (see MPEP § 2144.06 I).
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Ostuni et al, the Peptide N-Terminal Modification document and Mehta et al to develop a combination comprising a tetrapeptide consisting of the amino acid sequence REGD (identical to the amino acid sequence of instant SEQ ID NO: 21) with acetyl or palmitoyl group as a N-terminal protecting group that can be used for inducing in vivo vasorelaxation, wherein the tetrapeptide is capable of inducing dermal extracellular matrix protein upregulation; and peptide 6A consisting of the amino acid sequence ARPAK (a pentapeptide).
Obviousness Double Patenting
31. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
32. Claims 1, 2, 8, 9, 11 and 12 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 and 6-15 of co-pending Application No. 18/686955.
33. Instant claims 1, 2, 8, 9, 11 and 12 are drawn to a cosmetic composition comprising tetrapeptide, capable of inducing dermal extracellular matrix protein upregulation, the tetrapeptide having an amino acid sequence U-XXGD-Z wherein G is used to denote amino acid Glycine and D is used to denote amino acid Aspartic acid, as per the internationally recognised single letter code for amino acids, X denotes an amino acid selected from the group consisting of Glutamic acid (E), Lysine (K), Leucine (L), Alanine (A), Isoleucine (I), Arginine (R) and mixtures thereof; wherein at the N-terminal end, U is selected from the group consisting of CO-R1, -SO2-R1 or a biotinyl group; and at the C-terminal end, Z is selected from the group consisting of OH, OR1, NHR1 or NR1R2, wherein 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.
34. Claims 1-4 and 6-15 of co-pending Application No. 18/686955 are drawn to a cosmetic composition comprising: oligo-alpha-glucans; and a tetrapeptide wherein the tetrapeptide is selected from the group consisting of; a) 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 and X denotes an amino acid selected from the group consisting of Valine (V), Aspartic acid (D), Proline (P), Glycine (G) and mixtures thereof, b) 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) and Serine (S) and mixtures thereof, c) tetrapeptides having the amino acid sequence U-XXGD-Z wherein G is used to denote amino acid Glycine and D is used to denote amino acid Aspartic acid, as per the internationally recognised single letter code for amino acids and X denotes an amino acid selected from the group consisting of Glutamic acid (E), Lysine (K), Leucine (L), Alanine (A), Isoleucine (I), Arginine (R) and mixtures thereof, d) tetrapeptides having the amino acid sequence U-QTAV-Z wherein Q is used to denote amino acid Glutamine, T is used to denote amino acid Threonine, A is used to denote amino acid Alanine and V is used to denote amino acid Valine as per the internationally recognised single letter code for amino acids, and e) combinations thereof wherein at the N-terminal end of the one or more tetrapeptide, U is selected from the group consisting of H, -CO-R1, -SO2-R1 or a biotinyl group, wherein at the C-terminal end, Z is selected from the group consisting of OH, OR1, NHR1 or NR1R2, and wherein 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; a kit comprising such cosmetic composition, and methods of using such cosmetic composition.
The cosmetic composition recited in claims 1-4 and 6-15 of co-pending Application No. 18/686955 comprising the tetrapeptide having the amino acid sequence U-XXGD-Z in a mixture with other tetrapeptide meets all the structural limitations of the cosmetic composition recited in instant claims 1, 2, 8, 9, 11 and 12.
With regards to the limitation “capable of inducing dermal extracellular matrix protein upregulation” recited in instant claim 2, since the tetrapeptide having the amino acid sequence U-XXGD-Z recited in claims of co-pending Application No. 18/686955 meets all the structural limitations of the tetrapeptide recited in instant claim 2, the tetrapeptide having the amino acid sequence U-XXGD-Z recited in claims of co-pending Application No. 18/686955 would necessarily have the same properties and functionality of the tetrapeptide recited in instant claim 2. Therefore, the tetrapeptide having the amino acid sequence U-XXGD-Z recited in claims of co-pending Application No. 18/686955 is capable of inducing dermal extracellular matrix protein upregulation. And the MPEP states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01 II. Since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
35. Claims 2, 8 and 9 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 2 of co-pending Application No. 18/687338 in view of the Peptide N-Terminal Modification document (from Creative Peptides, 2019, enclosed pages 1-6).
36. Instant claims 2, 8 and 9 are drawn to a cosmetic composition comprising tetrapeptide, capable of inducing dermal extracellular matrix protein upregulation, the tetrapeptide having an amino acid sequence U-XXGD-Z wherein G is used to denote amino acid Glycine and D is used to denote amino acid Aspartic acid, as per the internationally recognised single letter code for amino acids, X denotes an amino acid selected from the group consisting of Glutamic acid (E), Lysine (K), Leucine (L), Alanine (A), Isoleucine (I), Arginine (R) and mixtures thereof; wherein at the N-terminal end, U is selected from the group consisting of CO-R1, -SO2-R1 or a biotinyl group; and at the C-terminal end, Z is selected from the group consisting of OH, OR1, NHR1 or NR1R2, wherein 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.
37. Claims 1 and 2 of co-pending Application No. 18/687338 are drawn to a computer implemented method of choosing a solvent for a matrikine, the method comprising:(a) identifying the Hansen Solubility Parameter (HSP) sphere of skin, the matrikine, and two or more test solvents for the matrikine; and (b) choosing at least one of the two or more test solvents based on the proximity of its HSP sphere to the HSP sphere of skin, and/or the proximity of its HSP sphere to the HSP sphere of the matrikine.
Claims 1 and 2 of co-pending Application No. 18/687338 are in possession of a tetrapeptide XXGD (identical to the amino acid sequence XXGD in instant claimed tetrapeptide) that can be used for skin treatment.
38. The difference between the tetrapeptide recited in claims of co-pending Application No. 18/687338 and the cosmetic composition recited in instant claims 2, 8 and 9 is that it does not teach the U and Z in the tetrapeptide recited in instant claims 2, 8 and 9.
However, in view of the teachings of the Peptide N-Terminal Modification document as set forth in Section 29 above, it would have been obvious to one of ordinary skilled in the art to modify the tetrapeptide XXGD recited in claims of co-pending Application No. 18/687338 and develop the tetrapeptide recited in instant claims 2, 8 and 9 that can be used for skin treatment. And in the instant case, since the tetrapeptide developed above is a product designed for use by a consumer, it is a cosmetic composition.
With regards to the limitation “capable of inducing dermal extracellular matrix protein upregulation” recited in instant claim 2, since the tetrapeptide developed above meets all the structural limitations of the tetrapeptide recited in instant claim 2, the tetrapeptide developed above would necessarily have the same properties and functionality of the tetrapeptide recited in instant claim 2. Therefore, the tetrapeptide developed above is capable of inducing dermal extracellular matrix protein upregulation. And the MPEP states “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).” (see MPEP § 2112.01 I). And since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Please note: Instant application and co-pending Application No. 18/687338 share the same applicant (THE BOOTS COMPANY PLC).
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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