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 .
Claim Status
Claims 1-14 are pending and presently considered.
Election/Restriction
The claims are directed to products, not methods. The products comprise the tripeptide of SEQ ID NO: 1. Accordingly, an election/restriction requirement has not been set forth on record at this time1. However, Applicant is directed to MPEP §§ 818, 818.02(a), 819, and 821.
Priority
The priority claim to PCT/KR2020/016907 (filed 11/26/2020) is acknowledged.
Examiner notes that no certified translation of the Foreign Application KR10-2020-0159848 (filed 11/25/2020) has been placed on record. If applicant wants the application to be accorded benefit of the non-English language application, a certified translation is required (see 35 U.S.C. 119(b)(3), 37 CFR 1.55(g)(1)-(4)). Applicant is advised that any showing of priority that relies on a non-English language application is prima facie insufficient if no certified translation of the application is on file. See 37 CFR 41.154(b).
Information Disclosure Statement
The IDS filed 05/24/2023; 02/07/2024; 8/13/2024; 12/06/2024; 03/12/2025; and 10/01/2025 are each acknowledged and presently considered.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
The pending claims are directed to products, not methods. Claim 1 is representative of the pending claim scope and presently recites:
1. A peptide consisting of the amino acid sequence of SEQ ID NO: 1.
Instant claims 2, 7, and 10 differ from instant claim 1 because they further require a pharmaceutical or cosmetic formulation that comprise SEQ ID NO: 1 (i.e., the tripeptide of Trp-Tyr-Met, CAS NO: 1247010-03-2).
Regarding the preamble of claims 2-6 (reciting “composition for preventing cell damage caused by particulate matter”), 7-9 (reciting “cosmetic composition for preventing skin cell damage caused by particulate matter”), and claims 10-14 (reciting “pharmaceutical composition for treating or preventing a disease caused by particulate matter”), , per MPEP § 2111.02, “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”. Here, the body of claims 2, 7, and 10 are understood to recite a structurally complete invention (i.e., SEQ ID NO: 1 in a pharmaceutically acceptable carrier), and therefore the preamble is deemed fully satisfied by prior art that satisfies the steps and structures recited in the body of the claim (see also MPEP § 2111.04(I), noting that “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”).
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
“Consisting of” excludes any elements, step, or ingredient not specified (see, e.g., MPEP § 2111.03(II)). When the phrase "consists of" appears in a clause of the body of a claim, rather than immediately following the preamble, the "consisting of" phrase limits only the element set forth in that clause; other elements are not excluded from the claim as a whole (see, e.g., MPEP § 2111.03(II)).
Claims 2, 7, and 10 recites that SEQ ID NO: 1 is present “as an active ingredient”. This limitation is understood to be fully satisfied by any composition comprising SEQ ID NO: 1, because SEQ ID NO: 1 will inherently and necessarily exhibit bioactivity attributable to its structure because a “chemical composition and its properties are inseparable” per MPEP § 2112.01.
Claims 2, 7, and 10 recite a “composition”, “cosmetic composition”, and “pharmaceutical composition”, respectively. These phrases are understood to require the presence of a cosmetically or pharmaceutically acceptable excipient (e.g., water, aqueous solutions, etc.) in addition to instant SEQ ID NO: 1. Aqueous solutions (e.g., saline) are understood to satisfy the requirements of claim 9.
Regarding the “wherein” clauses at claims 3-6, 8, and 11-14: Here, the claimed product comprises SEQ ID NO: 1 in a pharmaceutically or cosmetically acceptable excipient. Per MPEP § 2111.04(I), “Claim scope is not limited by claim language that . . . . does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and further states that a “whereby clause” in a claim “is not given weight when it simply expresses the intended result of a process step positively recited”. Here, the “wherein” clause does not unambiguously correspond to a clear structure/function relationship in the original disclosure, and therefore is not a functional limitation. Rather, the “wherein” clause is understood to merely recite an intended or expected result fully satisfied by the positively recited steps and/or structures set forth in the body of the claim. Therefore, the “wherein” clauses of at claims 3-6, 8, and 11-14 are each understood to be fully satisfied by all prior art embodiments that satisfy the structural requirements of claims 2, 7, and 10 (i.e., a composition comprising SEQ ID NO: 1 and a pharmaceutically and cosmetically acceptable excipient).
Additional claim interpretations are set forth below.
Specification
The disclosure is objected to because of the following informalities:
The specification lacks a brief summary of the drawings as required in Applications with drawings (see, e.g., MPEP § 608.01(f)). Per 37 C.F.R. §1.74, “When there are drawings, there shall be a brief description of the several views of the drawings”. The general guidelines for sections and order of sections within a utility application is set forth at 37 CFR 1.77(b).
A substitute specification excluding the claims is required pursuant to 37 CFR 1.125(a) because the nature of the required amendments render it difficult to consider the application in the absence of a substitute specification.
A substitute specification must not contain new matter. The substitute specification must be submitted with markings showing all the changes relative to the immediate prior version of the specification of record. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. An accompanying clean version (without markings) and a statement that the substitute specification contains no new matter must also be supplied. Numbering the paragraphs of the specification of record is not considered a change that must be shown.
Appropriate correction is required.
Claim Rejections
Claim Rejections - 35 USC § 112(b)
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 9 is 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.
Claim 9 recites “the cosmetic composition of claim 7” (i.e., a singular composition), but then states “wherein the composition has at least one formulation selected from…..”, which raises substantial and material concern regarding the metes and bounds of the claimed invention. In particular, it is unclear how a singular composition may have more than one, single formulation (i.e., it is unclear how a single composition may be simultaneously formulated as a solution, cream, foam, oil, pack, etc.). Accordingly, such language renders the claim scope indefinite because it is unclear if the claim is directed to a single composition, a mixture, or some multi-part composition. For purposes of applying prior art, the phrase “wherein the composition has at least one formulation selected from….” is reasonably inferred to be “wherein the composition has a formulation selected from…”. This is reasonable in view of the disclosed species of record, which are understood to be aqueous solutions suitable for use in cell culture (see, e.g., Spec. filed 5/24/2023 at ¶¶[0073]-[0075], [0084], [0087]).
Claim 9 recites “essence” is not defined on record; lacks a single, unique art-recognized definition; is not defined by the claim; and an artisan would therefore not be reasonably apprised of the metes and bound implied by the term. More specifically, it is unclear if the term refers to a (i) perfume or scent, (ii) an alcoholic solution of an essential oil, or (iii) a substance containing a concentrated form of an unspecified quality (e.g., taste). Because more than one distinct definition exist, no clarification is provided on record, it is unclear which is being utilized at claim 9, claim 9 is rejected as indefinite.
Accordingly, claim 9 is rejected.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-6, 8, and 11-14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 3-6, 8, and 11-14 are directed to products, and depend upon claims 2, 7, and 10, respectively. However, claims 3-6, 8, and 11-14 differ from instant claims 2, 7, and 10, respectively, only by the recitation of “wherein” clauses. Regarding these “wherein” clauses, per MPEP § 2111.04(I), “Claim scope is not limited by claim language that . . . . does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”, and further states that a “whereby clause” in a claim “is not given weight when it simply expresses the intended result of a process step positively recited”, which is reasonable because a “chemical composition and its properties are inseparable” per MPEP § 2112.01. Here, the “wherein” clauses do not unambiguously correspond to a clear structure/function relationship in the original disclosure, and therefore are not functional limitations. Rather, each “wherein” clause is understood to merely recite an intended or expected result fully satisfied by the positively recited steps and/or structures set forth in the body of claim 2, 7, or 10, respectively. Accordingly, claims 3-6, 8, and 11-14 are rejected under 35 USC § 112(d) for failing to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring peptide domain without significantly more.
The applicable claim interpretation has been discussed above in a separate section, which is incorporated into the instant rejection. Claim 1 is directed to a tripeptide of SEQ ID NO: 1; claims 2, 7, and 10 are directed to SEQ ID NO: 1 in the presence of a pharmaceutical or cosmetically acceptable excipient (e.g., aqueous media); and claims 3-6, 8-9, and 11-14 fail to further limit the scope of claims 2, 7, and 10 as explained above (see, e.g., see claim interpretation section above; see also rejection under 35 USC 112(d)).
The tripeptide naturally occurs within naturally occurring proteins, which are naturally present in a pharmaceutically acceptable carrier, namely cytoplasm (see, e.g., Govers et al.2 at title, abs, Fig. 2, showing the amino acid sequence of the ENOD12B gene, which comprises “WYM” within positions 55-68 at Fig. 2). Govers is exemplary and not exhaustive of the occurrence of WYM within natural proteins.
The difference between the naturally occurring tripeptide within natural proteins and the instant claim scope is broken bonds such that the tripeptide is separated from the remainder of a naturally occurring protein sequence. The Court has clarified that fragmentation does not constitute a feature that renders polynucleotides markedly different from what exists in nature. Even though fragmentation or truncation structurally changes a nucleic acid from its natural state, the resultant difference (e.g., “broken” bonds) is not significant enough to render the isolated polynucleotide markedly different, because the sequence of the nucleic acid has not been altered. See, e.g., Myriad, 133 S. Ct. at 2116-18. Likewise, here, fragmentation of a natural polypeptide does not constitute a feature that renders the resulting tripeptide markedly different from what exists in nature, because the tripeptide domain would continue performing its inherent corresponding bioactivity following fragmentation or truncation, and therefore the resultant difference (e.g., broken bonds) is not significant enough to render the isolated tripeptide markedly different than the natural product.
This judicial exception is not integrated into a practical application because claims 2-14 merely attempt to combine the judicial exception with unspecified excipients, including aqueous solutions (e.g., cytoplasm, water, etc.), which would necessarily be made and be required to study the naturally occurring proteins and protein fragments. Accordingly, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the terms “composition”, “cosmetic composition”, and “pharmaceutical composition” fail to materially or meaningfully differentiate the claimed invention relative to the judicial exception (see e.g., Mayo, 132 S. Ct. at 1294 (eligibility does not “depend simply on the draftsman’s art”; see also Myriad, 133 S. Ct. at 2116-19, clarifying that not every change to a product will result in a marked difference, and that the mere recitation of particular words (e.g., “isolated”) in the claims does not automatically confer eligibility).
Therefore, claims 1-14 do not appear to recite additional elements that amount to significantly more than the judicial exception of the naturally occurring sequence of WYM as found in nature.
Summary
In sum, when the relevant considerations are analyzed, they weigh against a significant difference. Accordingly, claims 1-14 do not qualify as eligible subject matter.
“To be patent eligible, a claim that is directed to a judicial exception must include additional features to ensure that the claim describes a process or product that applies the exception in a meaningful way, such that it is more than a drafting effort designed to monopolize the exception” (79 FR 74624 col I).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Lipinski et al3.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding claims 1-14 and instant SEQ ID NO: 1, Lipinski teaches and discloses the tripeptide sequence of H-TrpTyrMet-OH (WYM) (see, e.g., Lipinski at 2 at col II at § Results and Discussions, Fig. 1 on 4, Table 1 and Fig. 2 on 5, Fig. 3 on 7). Regarding instant claims 2, 7, 9-10, and the present of a pharmaceutically or cosmetically acceptable excipient, Lipinski discloses that the tripeptide was in an aqueous solution, namely saline (PBS); and saline is a pharmaceutical and cosmetically acceptable excipient that may be placed on the skin (see, e.g., Lipinski at 10 at col II at final ¶; see e.g., MPEP § 2111.02, explaining that “If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim”). Regarding claims 3-6, 8, and 11-14, the “wherein” clauses at claims 3-6, 8, and 11 do not correspond to functional limitations, and are understood to be recitations of intended or expected results fully satisfied by any product satisfying the explicitly recited structural limitations of claims 2, 7, and 10, respectively (see, e.g., MPEP § 2111.04(I), noting that claim scope is not limited by claim language that does not limit a claim to a particular structure).
Accordingly, claims 1-14 are rejected.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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/RANDALL L BEANE/ Primary Examiner, Art Unit 1654
1 Examiner notes that only three species of the claimed product were reduced to practice (see, e.g., Spec. filed 5/24/2023 at ¶¶[0073]-[0075], [0084], [0087]), wherein SEQ ID NO: 1 is inferred to be in an undisclosed aqueous carrier suitable for use in cell culture, used at 20µM, 100µM, and 200 µM concentrations (see, e.g., MPEP § 809.02(a), noting that a species election would be by disclosed species by example number). Examiner notes that no statistical analysis is disclosed or shown for any proffered data, and that no negative tri-peptide controls were utilized to establish that proffered results are not attributable to residual synthesis impurities. No evidence of unexpected results commensurate in scope the requirements of MPEP §§ 716,716.01, and 716.02 relative to the closest prior art of record (i.e., the same sequence in PBS as discussed below) has been placed on record.
2 Govers et al., Characterization of the pea ENOD12B gene and expression analyses of the two ENOD12 genes in nodule, stem and flower tissue. Molec. Gen. Genet. 228, 160–166 (1991). https://doi.org/10.1007/BF00282461; hereafter “Govers”.
3 Lipinski et al., Fibrous Aggregates of Short Peptides Containing Two Distinct Aromatic Amino Acid Residues. Chem Biodivers. 2019 Nov;16(11):e1900339. doi: 10.1002/cbdv.201900339. Epub 2019 Oct 25. PMID: 31557397; cited in IDS filed 07/10/2025 as Cite NO: 2.