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 .
2. Applicant’s amendment filed on 08/20/2026 is acknowledged.
3. Claims 16, 23-32 and 39 are pending.
4. Claims 29-32 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/12/2025. 5. The Examiner extended the search to encompass the species of the nucleic acid of claim 25
6. Claims 16, 23-28 and newly added claim 39 are under consideration for their full scope.
7. The following rejections are necessitated by the amendment filed on 08/20/2026.
8. 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.
9. Claim 27 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: the peptide consisting of SEQ ID NO:61 and compositions and kits thereof; does not reasonably provide enablement for a kit for preventing cancer comprising the cyclic polypeptide of SEQ ID NO:61.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. The specification disclosure does not enable one skilled in the art to practice the invention without an undue amount of experimentation.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
The claims encompass polypeptides which do not inhibit tetramerization of the lactate dehydrogenase subunits. The skilled artisan cannot make and use the peptides commensurate in scope with the claims.
The claimed linear sequences comprising SEQ ID NOs:6-20 encompass an enormous number of polypeptides. In addition to each of the 8-19 amino acids in SEQ ID NOs:6-20, the peptides may comprise up to 11-22 additional amino acids added onto the N- and/or C-terminus of the peptide. Furthermore, SEQ ID Nos 18-20 comprise variable amino acids within the recited sequences. In the same way, cyclic peptides 67 and 68 comprise a variable amino acid each.
The art of Thabault et al. (PTO-892 mailed on 06/18/2025; Reference U) teaches “macrocyclic peptide 7” of Table 3 (CTLKCKLI p-tetrafluorophenyl linker) was able to inhibit the tetramerization of the lactate dehydrogenase subunits. (In particular, Figure 9, whole document). The specification does not provide sufficient guidance on how to a kit comprising the claimed peptides can be used as a type of vaccine to sufficiently prevent cancer. The first criterion in judging a vaccine is the level of antibody (humoral immune response) before and after immunization. The success of the vaccination is judged by the extent of increase in the level of antigen - specific antibody. The second criterion for a vaccine is its ability to stimulate memory T lymphocytes (cell-mediated immune response) (See Kuby; PTO-892 mailed on 05/20/2026; Reference U). As such one of ordinary skill in the art would be required to perform undue experimentation to make and use the recited genus of kits for preventing cancer.
Zhou et al. (PTO-892 mailed on 05/20/2026; Reference V) teaches that “numerous cancer vaccines have progressed to clinical evaluation, demonstrating the ability to elicit strong immune responses. However, despite some early successes, the majority have not achieved durable responses or significant clinical efficacy in large phase III trials, presenting both opportunities and challenges for future development. Decades of research have greatly deepened our understanding of cancer vaccines, and the design of an optimal vaccine remains a delicate process. This process requires careful consideration of antigen selection, adjuvant incorporation, administration methods, combination with other therapies, and identification of the appropriate patient population.” (In particular, page 20, whole document). The specification is not enabled for the use of any kits for preventing cancer.
The specification fails to provide guidance as to how to prevent disease using any of the recited agents. The art is highly unpredictable as to what will be a therapy for any of the recited diseases, so it would require an undue amount of experimentation for one of ordinary skill in the art to practice the claimed invention commensurate in the scope with the claims. The invention may encompass pharmaceutical compositions which treat cancer, but the specification does not disclose how to totally prevent cancers generally using the claimed peptides and compositions thereof.
Since no in vivo studies were used as model system to prevent any disorder it is not clear that reliance on the in vitro data accurately reflects the relative animal efficacy of the claimed therapeutic strategy. The specification does not adequately teach how to effectively treat any disorders or reach any therapeutic endpoint in animals by administrating the peptides, much less any cancer encompassed by the instant claims. The specification does not teach how to extrapolate data obtained from the in vitro studies to the development of effective in vivo animal therapeutic treatment, commensurate in scope with the claimed invention. There must be a rigorous correlation of biological activity between the disclosed in vitro activity and an in vivo effectiveness to establish a method of preventing disease.
Although, the specification describes in vitro experiments, there is no correlation on this record between the in vitro studies and the preventing cancer in currently available form for humans or animals. It is not enough to rely on in vitro studies where, as here, a person having ordinary skill in the art has no basis for perceiving those studies as constituting recognized screening procedures with clear relevance to efficacy in humans or animals (emphasis added). Ex parte Maas, 9 USPQ2d 1746
In view of the absence of a specific and detailed description in Applicant's specification of how to effectively use the genus of compositions as claimed, absence of working examples providing evidence which is reasonably predictive that the genus of claimed kits are effective for in vivo use for prevention of disease, and the lack of predictability in the art at the time the invention was made, an undue amount of experimentation would be required to practice the claimed kits with a reasonable expectation of success.
Substantiating evidence may be in the form of animal tests, which constitute recognizedscreening procedures with clear relevance to efficacy in humans. See Ex parte Krepelka, 231USPQ 746 (Board of Patent Appeals and Interferences 1986) and cases cited therein. Ex parteMaas, 9 USPQ2d 1746.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
Applicant’s argument filed on 08/20/2026 has been fully considered, but is not found persuasive.
Applicant argues:
“The Office Action rejected claims 16, 21-24, 26-28 and 33-38 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement and claims 16 and 27 under 35 U.S.C. § 112(a) as failing to comply with the enablement requirement,
Applicant notes that the Examiner acknowledged that the specification demonstrates that polypeptide of SEQ ID NO: 61 (corresponding to polypeptide MP7) inhibits tetramerization of the LDH subunits (see item 12 on page 11 of the Office Action).
Applicant thus limits the scope of claim 16 to a cyclic polypeptide having the amino acid sequence of SEQ ID NO: 61 (i.e., merging the subject-matters of claims 16 and 38).”
It is the Examiner’s position that the rejection stands for reasons of record. Claim 27 is not enabled as it reads on a kit for preventing cancer comprising the cyclic peptide of SEQ ID NO:61 for all of the reasons cited supra.
10. Claims 16, 23-26, 28 and 39 appear to be in condition for allowance.
11. 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 extension fee 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 date of this final action.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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September 14, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
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