DETAILED ACTION
1. 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 04/04/2026, is acknowledged.
3. Claims 1-20 are pending.
4. Applicant’s election without traverse of Groups I and III, claims 1-8,13-19 and 10-12 directed to an anti-OX40 antibody and a method of treating or preventing T cell-related diseases with an anti-OX40 antibody and the species of AB35 comprising VH CDR1-3 (a16) of SEQ ID NO: 21, 63, 107 and VL CDR1-3 of SEQ ID NO: 134, 148, 168, filed on 4/4/2026, is acknowledged.
5. It is noted that Applicant fail to elect a particular OX40-mediated disease.
6. Claims 1-3, 9, 13-18 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
7. Claims 4, 6-8, 10-12 and 19 are under examination as they read on an anti-OX40 antibody and a method of treating or preventing T cell-related diseases with an anti-OX40 antibody and the species of AB35 comprising VH CDR1-3 (a16) of SEQ ID NO: 21, 63, 107 and VL CDR1-3 of SEQ ID NO: 134, 148, 168.
8. Applicant’s IDS, filed 02/27/2023, is acknowledged.
9. The following is a quotation of 35 U.S.C. 112(b) (Pre AIA , 35 U.S.C. 112, second paragraph):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
10. Claim 4 is rejected under 35 U.S.C. 112(b), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
(a) the recitation “HCDR1 as set forth in SEQ ID NO: 134, HCDR2 as set forth in SEQ ID NO: 148, and HCDR3 as set forth in SEQ ID NO: 168” in claim 4 is ambiguous because SEQ ID NOs: 134, 148 and 168 are LCDRs not HCDRs.
11. The following is a quotation of 35 U.S.C. 112(a) (Pre-AIA 35 U.S.C. 112, first paragraph):
(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.
12. Claims 10-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not reasonably provide enablement for methods of treating or preventing T cell-related diseases with antii-OX40 antibody including T cell-related tumors or OX40-mediated diseases such as autoimmune diseases and inflammation-related diseases. 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.
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 specification used a standard immunology platform used to investigate antigen presentation, T cell activation, and clonal expansion. When combined with an OX40 agonist antibody, the OX40 receptor is ligated, triggering costimulatory signals that dramatically boost CD8+ T cell proliferation. The anti-OX40 antibody crosslinks the OX40 receptor which sends potent secondary survival signals into the T cell.
The specification fails to show the effect of the anti-OX40 antibodies on expanding tumor-reactive clones and/or OX40-mediated diseases including autoimmune diseases and inflammation-related diseases.
In re Fisher, 166 USPQ 18 indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. Since no animals were used as model system to treat T cell-related diseases such as T cell-related tumors or OX40-mediated diseases. It is not clear that reliance on the OVA-specific CD8+ T cell proliferation model paired with an OX40 agonist to activate CD8+ T cell proliferation accurately reflects the relative mammal efficacy of the claimed therapeutic strategy. The specification does not adequately teach how to effectively treat a T cell-related diseases, T cell-related tumors or OX40-mediated diseases or reach any therapeutic endpoint in patients by administrating the therapeutic composition. The specification does not teach how to extrapolate data obtained from the OVA-specific CD8+ T cell proliferation studies to the development of effective in vivo patient therapeutic treatment, commensurate in scope with the claimed invention. Therefore, it is not clear that the skilled artisan could predict the efficacy of the therapeutic package exemplified in the specification.
Given the relatively incomplete understanding in correlating OVA-specific CD8+ T cell proliferation studies to clinical treatment of T cell-related diseases involved, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims, the claims are not enabled. See MPEP 2164.08.
The burden of enabling the prevention of a disease (i.e. the need for additional testing) would be greater than that of enabling a treatment due to the need to screen those mammals susceptible to such diseases and the difficulty of proof that the administration of the drug was the agent that acted to prevent the condition. Further, the specification does not provide guidance as to how one skilled in the art would go about screening those patients susceptible to diabetic retinopathy within the scope of the presently claimed invention. Nor is sufficient guidance provided as to a specific protocol to be utilized in order to prove the efficacy of the presently claimed anti-OX40 antibody in preventing tumors or OX40-mediated diseases.
Further, in Rasmusson v. SmithKline Beecham Corp., 75 USPQ2d 1297-1303 (CAFC 2005), the court states “If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the 'inventor' would be rewarded the spoils instead of the party who demonstrated that the method actually worked. That scenario is not consistent with the statutory requirement that the inventor enable an invention rather than merely proposing an unproved hypothesis.”
The MPEP states that the issue of "correlation" is also dependent on the state of the prior art. In other words, if the art is such that a particular model is recognized as correlating to a specific condition, then it should be accepted as correlating unless the examiner has evidence that the model does not correlate. Even with such evidence, the examiner must weigh the evidence for and against correlation and decide whether one skilled in the art would accept the model as reasonably correlating to the condition. See MPEP 2164.02.
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.
13. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
14. Claims 4, 6-8, 10-12 and 19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20230220042 A1.
The `042 publication teaches an antibody sequence of wild-type IgG2 anti-human OX40 antibody comprising the heavy chain protein sequence SEQ ID NO: 19 comprising claimed the VH of SEQ ID NO: 231 and CDRs of SEQ ID NO: 21, 63 and 107.
Qy 1 QVQLQESGPGLVKPSGTLSLTCAVSGGSISSSIWWSWVRQPPGKGLEWIGEIHHSGNTNC 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 20 QVQLQESGPGLVKPSGTLSLTCAVSGGSISSSIWWSWVRQPPGKGLEWIGEIHHSGNTNC 79
Qy 61 NPSLKSRVTISIDKSKNQFSLKLTSVTAADTAVYYCARAGTGTTLDYWGQGTLVTVSS 118
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 80 NPSLKSRVTISIDKSKNQFSLKLTSVTAADTAVYYCARAGTGTTLDYWGQGTLVTVSS 137
And the light chain protein sequence referenced SEQ ID NO: 18 comprising claimed VL of SEQ ID NO: 231 and CDRs of SEQ ID NO: 134, 148 and 168 (see Table 6).
Qy 1 EIVLTQSPGTLSLSPGERATLSCRASQSVSGDYLAWYQQKLGQAPRLLIYGASIRATGIP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 21 EIVLTQSPGTLSLSPGERATLSCRASQSVSGDYLAWYQQKLGQAPRLLIYGASIRATGIP 80
Qy 61 DRFSGSGSGTDFTLTISKLEPEDFAVYYCQQYGSSPLTFGGGTKVEIK 108
||||||||||||||||||||||||||||||||||||||||||||||||
Db 81 DRFSGSGSGTDFTLTISKLEPEDFAVYYCQQYGSSPLTFGGGTKVEIK 128
The `042 publication teaches the antibody is a human antibody, a humanized antibody, or a chimeric antibody [0047].
The `042 publication provides proteins/antibodes with significantly enhanced agonistic activity, for the treatment of tumors, inflammatory diseases, autoimmune diseases, or a combination thereof, which have a significant application prospect.
The reference teachings anticipate the claimed invention.
15. No claim is allowed.
16. The art made of record and not relied upon is considered pertinent to applicant's disclosure:
(a) El-Khoueiry et al. Analysis of OX40 agonist antibody (PF-04518600) in patients with hepatocellular carcinoma. Journal of Clinical Oncology; 2020 Gastrointestinal Cancers Symposium, Abstract # 523.
(b) El-Khoueiry et al. A first-in-human(FIH) study of PF-04518600 (PF-8600) OX40 agonist in adult patients (pts) with select advanced malignancies. Annals of Oncology 27 (Supplement 6): vi359–vi378, 2016. Abstract # 1053PD
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM 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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May 18, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644
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