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.
Election/Restrictions
Applicants elected group I (compounds) and SEQ ID 6 dissolved in PBS without traverse in the reply filed on 13 March, 2026 and the phone call with Hyunseok Park, applicant’s representative, on 16 April, 2026.
Information Disclosure Statement
Applicants have stated that they have submitted citations that were not found in the application file. However, the fact that applicants may have entered the references does not mean that the entry was successful, or that the references were legible, or that they displayed sufficient information to link them to a given citation.
Maintained/Modified Objections
Drawings
The drawings are objected to because of resolution details and extraneous content. Figs 1, 3b, 5a, and 9a, 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.
response to applicant’s arguments
Applicants argue that they have submitted new figures that overcome this issue.
Applicant's arguments filed 28 July, 2026 have been fully considered but they are not persuasive.
While applicants have removed the confusing characters, they have otherwise just resubmitted the same figures. This does not resolve the issue with too many lines to determine which line is which in the charts.
Claims Status
Claims 1-15 and 18-22 are pending.
Claims 1-6, 8, and 11 have been amended.
Claims 18-22 are new.
Claims 12-15, 21, and 22 are withdrawn from consideration due to an election/restriction requirement.
Withdrawn Rejections
The rejection of claim 8 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to the inability to fix damaged hair is hereby withdrawn due to amendment.
The rejection of claim 5 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is hereby withdrawn due to amendment.
The rejection of claim(s) 1-11, 16, and 17 under 35 U.S.C. 102(a)(1) as being anticipated by Roesner et al (Chem. Sci. (2019) 10:2465) is hereby withdrawn due to amendment.
The rejection of claim(s) 1-11, 16, and 17 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) is hereby withdrawn due to amendment.
The rejection of claims 1, 2, 4-11, and 16 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 8,853,164 is hereby withdrawn due to amendment.
Maintained/Modified Rejections
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 and 18-20 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. The ingredients in PBS, required by some dependent claims, are naturally occurring as ingredients in seawater, as evidenced by the Encyclopedia Britannica’s entry on that subject (downloaded 3 Aug, 2026). 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. Claims 18-20 specify counterions which are naturally occurring, and include those of PBS.
Note that in Ass’n for Molecular Pathology vs Myriad Genetics, a fragment of DNA, not the full chromosome, was determined to lack patent eligibility. The current guidance, based on this, is that fragments of naturally occurring biomolecules (such as peptides) are not patent eligible unless there is a significant difference between the fragment and the full length biomolecule.
2b) As some claims can be met with nothing other than the naturally occurring sequence, there can be nothing beyond those embodiments than the naturally occurring sequence. Other claims require PBS; however, there is no evidence of record that the claimed sequences dissolved in that solvent provide a significant difference in properties. Thus, the claims lack patent eligibility.
response to applicant’s arguments
Applicants argue that the amendment that limits the claims to polypeptides consisting of the particular sequences overcomes the rejection.
Applicant's arguments filed 28 July, 2026 have been fully considered but they are not persuasive.
The rejection has been modified to take into account applicant’s amendments.
New Rejections
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) 1-3, 9, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vasquez et al (US 2013019721).
Vasquez et al discuss antibody libraries (title), although most segment of the antibody can be removed and still read on the invention (paragraph 137). One DH (heavy chain variable) segment that can be used is AGAY (SEQ ID 5749, table 28), identical with SEQ ID 6 of the examined claims, and applicant’s elected sequence.
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 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Vasquez et al (US 2013019721) in view of the Uptima guide to dialysis (2018, previously cited) with evidentiary support from the Millipore Sigma PBS calculator web page (downloaded 4 Aug, 2026).
Vasquez et al discuss antibody libraries (title), although most segment of the antibody can be removed and still read on the invention (paragraph 137). One DH (heavy chain variable) segment that can be used is AGAY (SEQ ID 5749, table 28), identical with SEQ ID 6 of the examined claims, and applicant’s elected sequence.
As noted above, this reference anticipates claims 1-3, 9, and 10.
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 libraries of Vasquez 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.
Vasquez et al render obvious libraries comprising the peptide of SEQ ID 6. The Uptima guide renders obvious dissolving those libraries in PBS. Note that there is nothing in this formulation that would prevent medical usage of the compounds, rendering obvious claims 4-8 and 11.
As evidenced by the Millipore Sigma PBS calculator, PBS contains sodium, potassium, chloride, and phosphate salts (1st page, “PBS Solution Concentrations”). Thus, a peptide in this solution would be a salt with sodium and potassium, rendering obvious claims 18-20.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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