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 . 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.
Examiner’s Note
Prosecution of this application has passed to Fred Reynolds from Brendan Oliss.
Election/Restrictions
Applicant’s election without traverse of group I (compounds) and SEQ ID 6 dissolved in PBS in the reply filed on 13 March, 2026 and the phone call with Hyunseok Park, applicant’s representative, on 16 April, 2026 is acknowledged.
The requirement is deemed proper and is therefore made FINAL.
Applicants have elected SEQ ID 6 dissolved in PBS. A search was conducted for this embodiment, and references rendering it obvious were found. As a result, claims 1-11, 16, and 17 were examined and claims 12-15 were withdrawn from consideration.
During examination, references were found that anticipated at least one non-elected embodiment. These references are discussed below.
Information Disclosure Statement
The information disclosure statements filed 13 Nov, 2025 and 5 Feb, 2024 fail to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Each of these statements cites a reference not found in the application data file. Thus, those references were not considered.
Drawings
The drawings are objected to because of resolution details and extraneous content. Figs 1, 3b, 5a, 9a, 19a, and 19b show plots with a number of random characters (probably representing Korean characters not recognized by the graphing software) and give so many data points (different sequences) that it is not possible to see what each sequence is doing. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claims Status
Claims 1-17 are pending.
Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 13 March, 2026.
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 1-11, 16, and 17 are rejected under 35 U.S.C. 101 because they read on a judicial exemption (natural phenomenon).
The Supreme Court has given a 2 part test for patent eligibility under this statute:
Are the claims drawn to a process, machine, manufacture, or composition of matter?
2a) If the first test is passed, does a judicial exception apply?
2b) If a judicial exception applies, are there elements beyond the judicial exception?
Applying the test
The claims are drawn to polypeptide formulations, a composition of matter, passing the first test.
2a) The GenBank entry ACQ83615 describes a polypeptide called At1g14310-like protein (title) isolated from Maya temple nightshade (“source” 1st page, about a quarter down), with the sequence HYASGEAWHL PAGAYDTI (bottom of page). Note that the underlined sequence is applicant’s elected species, indicating that polypeptides comprising applicant’s elected species occur naturally. Claims 4-8 and 11 describe intended uses, which do not change the analysis. Claims 9 and 10 specify the form of the composition, but all can be met with the purified peptide, or the peptide mixed with other natural products, such as water.
2b) As the claims can be anticipated by just the naturally occurring sequence, there can be nothing beyond those embodiments than the naturally occurring sequence. Thus, the claims lack patent eligibility.
Claim 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.
Claim 8 is 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 regrowing tissue, does not reasonably provide enablement for damaged hair improvement. 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.
The MPEP states “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is ‘undue.’ These factors include, but are not limited to: 1) the breadth of the claims; 2) the nature of the invention; 3) the state of the prior art; 4) the level of one of ordinary skill; 5) the level of predictability in the art; 6) the amount of direction provided by the inventor; 7) the existence of working examples; and 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure” (MPEP 2164.01(a).
1 and 2) the breadth of the claims and the nature of the invention: Applicants are claiming a series of peptides that can regenerate tissue, and are claiming damaged hair improvement.
3) the state of the prior art: Ferreira (Healthline article of 21 April, 2023) states that, for the most part, hair damage is permanent because hair is a collection of dead cells, and the only real cure for damaged hair is a pair of shears and time, while preventing new damage (1st page, 3d and 4th paragraphs). Much of the article discusses methods to mask existing damage and to prevent further damage.
4) the level of one of ordinary skill: The level of skill in the art is high
5) the level of predictability in the art: People have been managing hair for millennia, leading to at least some level of predictability in the art.
6 and 7) the amount of direction provided by the inventor and the existence of working examples: Applicants demonstrate improved hair growth (using their own scale) and improvements in skin health (example 12, p65-68). Applicants state that the material will cause tissue regeneration (claim 6).
8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure: The prior art states that there is no living tissue in hair, and that if it is damaged, while the damage can be masked, the only way to fix the damage is to cut it off and wait for the hair to regrow. Applicants have provided no evidence that their peptides can cause dead cells to come alive and regrow, and how they state the material works (tissue regeneration) will not work to repair damaged hair. Thus, it will take undue experimentation to use the invention as claimed.
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.
Claim 5 is 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. Claim 4, from which claim 5 depends, is a method of treating an inflammatory disease, defined by applicants as a disease caused by inflammation (p18, 4th paragraph). However, most, if not all, of the disorders of claim 5 are not caused by inflammation (even if many of them have an inflammatory component to their etiology). 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 § 102
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.
Claim(s) 1-11, 16, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roesner et al (Chem. Sci. (2019) 10:2465).
Roesner et al describe a method of synthesizing cyclic peptides (title). Among the control sequences is (cyclo) Leu-Ala-Gly-Ala-Tyr (first example of scheme 6, 5th page, 2nd column, bottom of page). This sequence comprises SEQ ID 6 (Ala-Gly-Ala-Tyr), anticipating claims 1-3. While the reference is silent as to the ability of the sequence to reduce inflammation or induce tissue growth, an embodiment will anticipate a claim to an intended use so long as the embodiment is suitable for such use (MPEP 2122). Thus, the reference anticipates claims 4-8, 11, 16, and 17. Claims 9 and 10 describe the format of the material, but will be satisfied with a purified peptide, so the reference anticipates the claims.
Claim Rejections - 35 USC § 103
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, 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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-11, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Roesner et al (Chem. Sci. (2019) 10:2465). in view of the Uptima guide to dialysis (2018).
Roesner et al describe a method of synthesizing cyclic peptides (title). Among the control sequences is (cyclo) Leu-Ala-Gly-Ala-Tyr (first example of scheme 6, 5th page, 2nd column, bottom of page).
As noted above, this reference anticipates claims 1-11, 16, and 17.
The difference between this reference and applicant’s elected species is that this reference does not disclose the sequence dissolved in PBS.
The Uptima guide to dialysis discusses using dialysis for purification, contaminant removal, and concentration of compounds (2nd page, 7th paragraph). A commonly used buffer is PBS (p13, 2nd paragraph), which will generate the peptide in PBS.
Therefore, it would be obvious to dialyze the peptide of Roesner et al, to purify and concentrate the material, as described by the Uptima guide. As this is a very common procedure in biochemistry, an artisan in this field would attempt this process with a reasonable expectation of success.
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, 2, 4-11, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 8,853,164. Although the claims at issue are not identical, they are not patentably distinct from each other because the competing claim anticipates the examined claims.
Competing claim 1 describes a series of oligopeptides, including SEQ ID 1, with the sequence
PNG
media_image1.png
102
488
media_image1.png
Greyscale
. Note that this comprises Ala-Ile-Ser (residues 14-16, anticipating examined claims 1-2. Competing claim 7 specifies in-vivo use, which means that the sequence is suitable for treating diseases and anticipating examined claims 4-8, 11, and 16. Competing claims 9 and 10 specifies the format of the peptide, which is met by any formulation for in vivo use, anticipating those claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
Examiner interviews are available via telephone and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
Prosecution Insights