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 6/16/2023 and 2/13/2025, before the mailing of a first office action. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-20, filed 3/23/2026, are pending. Claims 15-20 are new. Claims 1-20 are under examination.
Nucleotide and/or Amino Acid Sequence Disclosures
Response to Arguments
Applicant’s arguments, see Applicant Reply page 6, section II, filed 3/23/2026, with respect to objections to the specification have been fully considered and are persuasive. The objection regarding sequence compliance has been withdrawn.
Specification
The disclosure was objected to because of various informalities.
Response to Arguments
Applicant’s arguments, see Applicant Reply page 7, section III, filed 3/23/2026, with respect to objections to the specification have been fully considered and are persuasive. The objection to the specification has been withdrawn.
Claim Objections
Claims 1-14 were objected to because of the following informalities: claim 1 refers to SEQ ID NO: 17, which is not provided by the sequence listing. Claims 2-14 ultimately refer back to claim 1 and therefore also reference SEQ ID NO: 17 and are objected to. Appropriate correction is required.
New Claim Objections
Claim 20 objected to because of the following informalities.
Regarding claim 20, claim 20 recites: “The cosmetic composition of claim 18, wherein the composition has a formulation of softening toner, nourishing toner, nourishing cream, gel, essence, soap, ointment, balm, or pack.”
The phrase “has a formulation of” is not clear because this phrase heavily implies a chemical formulation. It would be more clear to write “wherein the composition is in the form of a softening toner, a nourishing toner, a nourishing cream, gel, an essence, a soap, an ointment, a balm, or a pack.”
Appropriate correction is required.
Response to Arguments
Applicant’s arguments, see Applicant Reply page 8, section IV, filed 3/23/2026, with respect to objections to the specification have been fully considered and are persuasive. The objection to the specification has been withdrawn.
Claim Rejections - 35 USC § 112
Claims 1-14 were previously rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Response to Arguments
Applicant’s arguments, see Applicant Reply page 8, section V, filed 3/23/2026, with respect to the rejection of claims 1-14 under U.S.C. 112(b) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made.
New 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 6-8 and 15-20 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 6, amended claim 6 now recites: “A conjugate in which the according to claim 1 is conjugated with a biocompatible polymer or fatty acid at an N terminus of the peptide, wherein the biocompatible polymer is one or more polyethylene glycol (PEG) and the fatty acid is selected from the group consisting of hexanoic acid, maleimidobutyric acid, myristic acid, palmitic acid, and stearic acid.”
The phrase “wherein the biocompatible polymer is one or more polyethylene glycol (PEG)” is unclear. It is not clear if the biocompatible polymer is PEG or if one more possibilities is intended.
Consequently, claim 6 is rejected.
Regarding claim 7, claim 6 is rejected as described above. Claim 7 recites: “The conjugate of claim 6, wherein the biocompatible polymer is one or more selected from the group consisting of pullulan, chondroitin sulfate, hyaluronic acid (HA), glycol chitosan, starch, chitosan, dextran, pectin, curdlan, poly-L-lysine, poly-aspartic acid (PAA), polylactic acid (PLA), polyglycolide (PGA), poly(e-caprolactone) (PCL), poly(caprolactone-lactide) random copolymer (PCLA), poly(caprolactone-glycolide) random copolymer (PCGA), poly(lactide-glycolide) random copolymer (PLGA), polyethylene glycol (PEG), pluronic F-68, and pluronic F-127.”
Claim 7 does not remedy the indefiniteness of claim 6 and also claim 7 broadens the scope of claim 6, which is limited to PEG. This broadening creates an indefinite claim scope.
Consequently, claim 7 is rejected.
Regarding claim 8, claim 6 is rejected as described above. Claim 8 recites: “The conjugate of claim 6, wherein the fatty acid is one or more selected from the group consisting of hexanoic acid, caprylic acid, capric acid, maleimidobutyric acid, lauric acid, myristic acid, palmitic acid, stearic acid, and cholesterol.”
Claim 8 does not remedy the indefiniteness of claim 6 and also claim 8 broadens the scope of claim 6, which has a closed smaller list of possible fatty acids. This broadening creates an indefinite claim scope.
Consequently, claim 8 is rejected.
Regarding claims 15-20, claims 15-20 are dependent upon claim 6 and do not remedy the indefinite nature of claim 6.
Consequently, claims 15-20 are rejected.
Claims 2-5 and 9-14 previously rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 9-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating atopic dermatitis, does not reasonably provide enablement for preventing atopic dermatitis. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Response to Arguments
Applicant’s arguments, see Applicant Reply page 8, section V, filed 3/23/2026, with respect to the rejection of claims 2-5 and 9-14 under U.S.C. 112(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made.
New Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-8 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 inventors, at the time the application was filed, had possession of the claimed invention.
Applicant states in Applicant Reply page 6, section I, dated 3/23/2026 that amendments to the claims are fully supported by the specification, but does not cite a specific location where support is found for any of the amendments.
Regarding claim 6, “A conjugate in which the according to claim 1 is conjugated with a biocompatible polymer or fatty acid at an N terminus of the peptide, wherein the biocompatible polymer is one or more polyethylene glycol (PEG) and the fatty acid is selected from the group consisting of hexanoic acid, maleimidobutyric acid, myristic acid, palmitic acid, and stearic acid.”
This claim breadth covers any possible PEG conjugated to the N-terminus of the peptide of claim 1. However, the specification only discloses PEG2 and PEG4 molecules used in this way:
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(Specification, page 15, Table 2).
Wu et al. (Wu, et al. International journal of pharmaceutics 453.2: 533-54 (2013)) discloses that the size of PEG can change the function of peptides when conjugated to PEG molecules depending on the size of the PEG:
“In summary, M-P20K-GHA and M-P40K-GHA were prepared by N-terminal conjugation of GHA with 20 kDa and 40 kDa PEG, respectively. Our present work established the correlation between the PEG size and the PD behaviors of GHA. Preliminary in vivo PD study suggests that M-P20K-GHA exhibits enhanced pharmacological behaviors and its clinical efficacy may thus be potentially improved. In contrast, M-P40K-GHA cannot display the inhibition of in vivo GH action.” (We et al., page 539, col. 1., para. 3).
Therefore, amendments to claim 6 have introduced new matter into the application, specifically PEG molecules not recited by the specification.
Claim 6 is rejected.
Regarding claim 7, claim 7 recites: “The conjugate of claim 6, wherein the biocompatible polymer is one or more selected from the group consisting of pullulan, chondroitin sulfate, hyaluronic acid (HA), glycol chitosan, starch, chitosan, dextran, pectin, curdlan, poly-L-lysine, poly-aspartic acid (PAA), polylactic acid (PLA), polyglycolide (PGA), poly(e-caprolactone) (PCL), poly(caprolactone-lactide) random copolymer (PCLA), poly(caprolactone-glycolide) random copolymer (PCGA), poly(lactide-glycolide) random copolymer (PLGA), polyethylene glycol (PEG), pluronic F-68, and pluronic F-127.”
The specification does not disclose the breadth of these biocompatible polymers conjugated to the N-terminus:
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(Specification, page 15, Table 2).
Therefore, amendments to claim 7 have introduced new matter into the application,
Claim 7 is rejected.
Regarding claim 8, claim 8 recites: “The conjugate of claim 6, wherein the fatty acid is one or more selected from the group consisting of hexanoic acid, caprylic acid, capric acid, maleimidobutyric acid, lauric acid, myristic acid, palmitic acid, stearic acid, and cholesterol.”
The specification does not disclose the breadth of these fatty acids conjugated to the N-terminus, specifically cholesterol caprylic acid, capric acid, and lauric acid:
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(Specification, page 15, Table 2).
Therefore, amendments to claim 8 have introduced new matter into the application.
Claim 8 is rejected.
New Rejections - 35 USC § 112(d)
Claims 7 and 8 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.
Regarding claim 7, claim 7 recites a Markush group of possible biocompatible polymers selected from the group consisting of pullulan, chondroitin sulfate, hyaluronic acid (HA), glycol chitosan, starch, chitosan, dextran, pectin, curdlan, poly-L-lysine, poly-aspartic acid (PAA), polylactic acid (PLA), polyglycolide (PGA), poly(e-caprolactone) (PCL), poly(caprolactone-lactide) random copolymer (PCLA), poly(caprolactone-glycolide) random copolymer (PCGA), poly(lactide-glycolide) random copolymer (PLGA), polyethylene glycol (PEG), pluronic F-68, and pluronic F-127.”.
However, claim 6 already recites that the biocompatible polymer is PEG.
The Markush group of claim 7 broadens, rather than narrows claim 6 by reciting additional biocompatible polymers and therefore is an improper dependent claim.
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.
Regarding claim 8, claim 8 recites a Markush group of possible fatty acids selected from the group consisting of hexanoic acid, caprylic acid, capric acid, maleimidobutyric acid, lauric acid, myristic acid, palmitic acid, stearic acid, and cholesterol.
However, claim 6 already recites a Markush group of fatty acids consisting of hexanoic acid, maleimidobutyric acid, myristic acid, palmitic acid, and stearic acid.
The Markush group of claim 8 broadens, rather than narrows claim 6 because the Markush group is of claim 8 is larger than the Markush group of 6 and therefore is an improper dependent claim.
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.
Closest Prior Art
The peptides claimed by claim 1 are free of the prior art because they are novel and non-obvious. Brover et al. (US 2011167514) discloses SEQ ID NO: 20983, aligned against Applicant SEQ ID NO: 14 below:
Claim 1; SEQ ID NO 20983; 18pp; English.
XX
CC The present invention relates to novel Panicum virgatum (switchgrass) DNA
CC sequences and encoded proteins which are useful for producing transgenic
CC plants with modified growth, development, or phenotype characteristics.
CC The present sequence is one such sequence of the invention.
XX
SQ Sequence 396 AA;
Query Match 90.4%; Score 47; Length 396;
Best Local Similarity 87.5%;
Matches 7; Conservative 1; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GCLRCGEI 8
|||||||:
Db 77 GCLRCGEV 84
This sequence is from a protein found in switchgrass of 396 residues, which is completely unrelated to the present invention. The prior art does not teach or suggest a reason for a person of ordinary skill in the art to use this particular region of the switchgrass protein and make the substitution shown above. Consequently, the claimed peptides are novel and non-obvious.
Conclusion
Claims 6-8 and 15-20 are rejected.
Claim 20 is objected to.
Claims 1-5 and 9-14 are allowable.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Paul Bowles whose telephone number is (571)272-0919. The examiner can normally be reached Monday-Friday 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID PAUL BOWLES/ Examiner, Art Unit 1654
/LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654
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