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 II (peptides) and Omicsynin B6 in the reply filed on 6 Jan, 2026.
Claims Status
Claims 1, 4-6, 8, and 9 are pending.
Claims 1, 4, 5, and 8 have been amended.
Claims 1, 5, 6, 8, and 9 have been withdrawn due to an election/restriction requirement.
Withdrawn Objections
The objection to the specification due to the use of non-English language is hereby withdrawn due to amendment.
The objection to the drawings due to the use of non-English language is hereby withdrawn due to amendment.
New Objections
Drawings
The drawings are objected to because fig 21, as amended, constitutes new matter. The drawing, as amended, discuss a crude extraction using gradient elution of water/ethanol mixtures on a size exclusion column, followed by multiple chromatography steps and testing/identification. The spec discusses centrifugation of the bacterial ferment, then direct testing (p16, line 10-12). Pure compounds used HPLC to isolate (p26, line 29, p28, line 4-5), but there is no mention of the details of the process, certainly not matching what is in the drawing. The identification in the spec mentions high res MS, not LC/MS-MS (p28, line 13). In other words, what is described in the drawing does not match what is in the rest of the disclosure, so there is no support for the amendments to this drawing. 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.
Please note that, if the priority documents have support for the amendments to fig 21, a certified translation of the priority documents showing the support can overcome this objection.
Withdrawn Rejections
The rejection of claim 4 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertainty as to what is meant by a “group” of Omicsynins 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.
Claim 4 is rejected under 35 U.S.C. 101 because it reads on a judicial exception (natural phenomenon).
The Supreme Court has given a 3 part test for patent eligibility:
1) Is the claim 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, is there something beyond the judicial exception?
Applying the test:
Applicants are claiming peptides, a composition of matter.
2a) Applicants isolated their sequences from Streptomyces CPPC200451 (example 2, p15, line 37-p18, line 10); this bacterium was isolated from soil (p2, 6th paragraph). This means that the peptides are produced by a naturally occurring organism, and would reasonably be expected to be produced in nature.
2b) The claim can be met with just the peptides. As there is nothing else in this embodiment, there can be no feature beyond the natural product. Thus, the claim lacks eligibility.
response to applicant’s arguments
Applicants argue that they have amended the claim to include product by process limitations, and that the comparison should be to the bacterium, not the compounds.
Applicant's arguments filed 29 April, 2026 have been fully considered but they are not persuasive.
Applicants argue that they have included product by process limitations in the claim. It is not clear how this overcomes the rejection. The product by process limitations are ferment the bacterium and isolate/purify the material. There is no process step that will change the structure of the compounds formed, which is what the claim is drawn to.
Applicants argue that the proper comparison should be to the bacterium, which is not antiviral, so is markedly different. The comparison should be to the natural product. The bacterium produces these compounds, therefore, the natural product is the compounds. Applicants have provided no evidence that the bacterium does not produce these compounds except in fermentation in vats; indeed, applicant’s do not specify anything special to get the bacterium to produce the compounds.
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) 4 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kido et al (US 4,526,866).
Kido et al discuss isolating compounds produced by Streptomyces 1647 P-2 strain (column 1, line 37-38). The material was cultured, then peptides isolated with a cation exchange resin and size exclusion chromatography to get a crude mixture, then purified by HPLC (column 3, line 19-43). While the reference does not discuss the specific sequences claimed by applicants, they are isolating compounds from the same species as applicants isolated their peptides from, using a similar method (isolation from culture medium), so they will inherently be present.
response to applicant’s arguments
Applicants state that the reference does not anticipate the claimed.
Applicant's arguments filed 29 April, 2026 have been fully considered but they are not persuasive.
Applicants recite the claim limitations and state that the citation used in the rejection does not meet these limitations. However, no evidence is presented. There is no showing that, under the same culture conditions used in the prior art, the same bacterium does not produce the claimed compounds. However, the bacterium used is closely related to the one that applicants have used; it is presumed that it will produce the same compounds.
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) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Nakae et al (J. Antibiotics (2010) 63 p41-44).
Nakae et al mention antipain, a compound identical to applicant’s elected species, save that position R2 is an isopropyl instead of an isobutyl group (fig 1a). However, applicant’s elected species is an obvious variant (MPEP 2144.09(II)), rendering obvious claim 4.
response to applicant’s arguments
Applicants argue that antipan has a lower selectivity index than the omicsynin B compounds, an unexpected result that overcomes the rejection.
Applicant's arguments filed 29 April, 2026 have been fully considered but they are not persuasive.
It is not clear that antipan has a lower selectivity index. The data that applicants point to list a minimum value, so the data is presented as overlapping ranges. The burden is on applicants to show that the results are unexpected (MPEP 716.02(b)(I)); they have not met this burden. Nor is it obvious that the results are significantly different between the various compounds, or that the alleged unexpected results are commensurate in scope with the claims (MPEP 716.02).
Conclusion
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 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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