DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 22-26 are objected to, because the numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Currently, there are two claims labeled “Claim 22.” The second misnumbered claim 22 has been renumbered Claim 23. All subsequent claims are renumbered appropriately (Claim 23 becomes Claim 24, Claim 24 becomes Claim 25, etc). It is interpreted that Claims 24 and 27 depend from Claim 23. The new claim numbers will be referenced in the instant office action, but appropriate correction is required.
Claim Status
Claim listing filed on October 16, 2025 is pending. Claims 1-6 and 11-20 are cancelled. Claims 7-8 are amended. Claims 21-27 are new. Claims 7-10 and 21-27 are examined upon their merits.
Withdrawn Objections and Rejections
Applicant’s cancelation of Claim 11 has rendered all previous rejections directed to this claim moot.
Applicant’s amendments to the drawings have overcome all objections of record, and the drawing objections are withdrawn.
The rejection of Claims 7-10 on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 9,737,585 is withdrawn in view of Applicant’s amendments to Claim 7. Specifically, U.S. Patent No. 9,737,585 does not teach co-administering a PIF peptide in combination with one or more anti-tuberculosis agents.
Claim Rejections - 35 USC § 112 (Maintained)
Claims 7-10 and 21-27 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 inventor(s), at the time the application was filed, had possession of the claimed invention. Note, the rejection of record applied to Claims 7-11 and now applies to Claims 7-10 and 21-27 due to Applicant’s amendments.
Note, Examiner acknowledges that “SEQ ID NO: 4” in specification paragraph [0091] was a typographical error and the working examples are instead directed to SEQ ID NO: 3 (see explanation in Remarks filed 10/16/25). Note, “or a combination thereof” in Claims 7 and 23 is interpreted as a combination of two or more PIF peptides selected from the group consisting of SEQ ID NOs: 1-3 and 5-8.
Claims 7 and 23 are directed to a method of treating tuberculosis by administering a genus of possible PIF peptides consisting of SEQ ID NOs: 1-3 and 5-8 wherein only a PIF comprising SEQ ID NO: 3 was evaluated in the working examples of the specification. The specification teaches administering a PIF peptide comprising SEQ ID NO: 3 in the treatment of tuberculosis (Example 2 and 4) and the prevention of tuberculosis (Example 3). SEQ ID NOs: 1-2 are fragments of SEQ ID NO: 3 but no evidence is provided that the fragments retain their therapeutic function. Further, SEQ ID NO: 3 shares 15% sequence identity or less to SEQ ID NOs: 5-8, and no evidence is provided that SEQ ID NOs: 5-8 have therapeutic function in tuberculosis. The specification does not convey that the inventor, at the time of filing, was in possession of a method of treating tuberculosis by administering PIF peptides comprising SEQ ID NOs: 1-2 and 5-8.
Applicant's arguments filed October 16, 2025 have been fully considered but they are not persuasive. Applicant argues that the amendments removing SEQ ID NO: 4, removing the reference to mimetics, and reciting that the intracellular infection is Mycobacterium tuberculosis overcome the 112(a) rejection of record. While these amendments appropriately narrow the scope of the claims to better encompass what is supported by the specification, the claims are still directed to a method of treating tuberculosis by administering a PIF peptide comprising SEQ ID NOs: 1-3 and/or 5-8 wherein the specification only provides adequate written description of a method of treating tuberculosis by administering a PIF peptide comprising SEQ ID NO: 3. Applicant’s arguments are not persuasive, and the rejection is maintained.
Claims 7-10 and 21-27 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 tuberculosis by administering a PIF peptide comprising SEQ ID NO: 3, does not reasonably provide enablement for treating tuberculosis by administering a PIF peptide comprising SEQ ID NOs: 1-2 or 5-8. 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. Note, the rejection of record applied to Claims 7-11 and now applies to Claims 7-10 and 21-27 due to Applicant’s amendments.
The specification teaches administering a PIF peptide comprising SEQ ID NO: 3 in the treatment of tuberculosis (Examples 2 and 4) and the prevention of tuberculosis (Example 3). The PIF peptide comprising SEQ ID NO: 3 was combined with IFNγ (Example 2), a Kv1.3 inhibitor (Example 2), or an anti-CD3 antibody (Example 5). Further, combination therapy comprising up to four different anti-tuberculosis drugs was a standard treatment approach in the field prior to the effective filing date of the instant claims (Blomberg et al. Drugs 2003; abstract ant Table I).
The specification fails to teach a method of treating and preventing tuberculosis by administering a PIF peptide comprising SEQ ID NOs: 1-2 or 5-8. Given that the nature of the claims is in vivo treatment, a person having ordinary skill in the art would have to perform multiple further experiments, in human clinical trials or in animal models, that are predictive of tuberculosis treatment and prevention by administering PIF peptides comprising SEQ ID NOs: 1-2 and 5-8 in order to demonstrate the invention could be used with a reasonable expectation of success. The amount of experimentation required for enabling guidance, commensurate in scope with what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the method of treatment with a reasonable expectation of success.
Applicant's arguments filed October 16, 2025 have been fully considered but they are not persuasive. Applicant argues that the amendments removing SEQ ID NO: 4, removing the reference to mimetics, and reciting that the intracellular infection is Mycobacterium tuberculosis overcome the 112(a) rejection of record. As addressed in the written description rejection above, these amendments appropriately narrow the scope of the claims to better encompass what is supported by the specification, but the claims are still directed to a method of treating tuberculosis by administering a PIF peptide comprising SEQ ID NOs: 1-3 and/or 5-8 wherein the specification only provides enablement for a method of treating tuberculosis by administering a PIF peptide comprising SEQ ID NO: 3. Applicant’s arguments are not persuasive, and the rejection is maintained.
Double Patenting (New, necessitated by amendment)
Claims 7-10 and 21 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 and 6-13 of U.S. Patent No. 9,737,585 in view of Blomberg et al. Drugs 2003.
The instant claims recite a method of Mycobacterium tuberculosis infection comprising co-administering a PIF peptide comprising SEQ ID NO: 3, a pharmaceutically acceptable salt thereof, or a combination thereof, and one or more anti-tuberculosis agents (Claim 7). Dependent claims recite: wherein the method further comprises administering a potassium channel inhibitor (Claim 8) that could be a Kv1.3 inhibitor (Claim 9) or IFNγ (Claim 10) and wherein the agents are administered as a pharmaceutical composition (Claim 21).
The patented claims recite a method of therapeutically treating Mycobacterium tuberculosis infection comprising administering a PIF peptide comprising SEQ ID NO: 3 (Claim 1), a method of therapeutically treating tuberculosis comprising administering a PIF peptide comprising SEQ ID NO: 3 (Claim 6), and a method of decreasing dissemination of tuberculosis bacteria comprising administering a PIF peptide comprising SEQ ID NO: 3 (Claim 10). Note, instant SEQ ID NO: 3 and patented SEQ ID NO: 3 are 100% identical. Dependent claims recite wherein the method further comprises administering a potassium channel inhibitor (Claims 2, 7, and 11) that could be a Kv1.3 inhibitor (Claims 3, 8, and 12) or IFNγ (Claims 4, 9, and 13).
The patented claims do not teach co-administering the PIF peptide with one or more anti-tuberculosis agents and combining the agents in a pharmaceutical composition. Blomberg teaches that administering drug combinations comprising up to four anti-tuberculosis agents was a standard therapeutic practice before the effective filing date of the instant claims (abstract and Table I). Multiple anti-tuberculosis agents can be formulated into a single tablet for oral administration (Blomberg section 2.3, paragraph 2).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the PIF peptide taught by the Patented claims with the anti-tuberculosis agents taught by Blomberg. Blomberg teaches that combination therapy and combined pharmaceutical formulations were standard in the field of tuberculosis treatment. The motivation to combine multiple agents that have anti-tuberculosis activity is that combination therapy was a milestone development in the early 1970s that led to tuberculosis patients being fully cured (Blomberg section 2.1, paragraph 6). Thus, the instant claims are either anticipated and/or rendered obvious by the Patented claims in view of Blomberg.
Conclusion
No claim is allowed.
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 SARAH COOPER PATTERSON whose telephone number is (703)756-1991. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675