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 .
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/20/2025 has been entered.
Election/Restrictions
Applicant’s election with traverse of Group I, drawn to a pharmaceutical composition, in the reply filed on 04/09/2024 is acknowledged.
Claim 1-22 are pending of which claims 14, 17-20 (Group II) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected INVENTION, there being no allowable generic or linking claim.
Applicant elects the compound numbered "(202)" recited in claim 11, namely: 5-[3-fluoro-5-{ [(1S)-1-(piperidin-4-yl)ethyl]amino }-4-(trifluoromethoxy )phenyl ]-1,3,4-oxadiazol-2(3H)-one, having the following structure:
PNG
media_image1.png
238
346
media_image1.png
Greyscale
corresponding claim 1’s genus when X4 is a carbon and R4 is a hydrogen; R3 is a hydrogen; R2 is a halogen; X1 is a carbon and R1 is trihaloalkoxy; L is L2; A is a non-aromatic heterocyclic group, reading on claims 1-11, as the species for initial examination, in the reply filed on 04/09/2024 is acknowledged.
Pending claims 1-20 have been examined on the merits.
Withdrawn Restrictions/Elections Requirement
The restriction for claims 14 and 17-20 has been withdrawn, thus claims 14 and 17-20 are now included for full examination on the merit.
Withdrawn Rejection
The rejection of claims 1-6, and 9 were rejected under 35 U.S.C. 102(a)(l) as being anticipated by Breeze et al., PubChem CID 129267460 (2017-08-04), is withdrawn due to the claim amendments.
The rejection of claim 1-9 and 12-13 were rejected under 35 U.S.C. 103 as being unpatentable over PubChem CID 129267460 in view of Desforges et al., J Comb Chem. 2008 Sep-Oct;10(5):671-80 (“Desforges”), and in further view of Nicolaou et al. (ChemMedChem) 2016 Jan 5;11(1):31-7. As evidence by Tse et al. (2020). (J of Med Chem), 63(20), 11585–11601, is withdrawn due to the Applicant’s argument.
Claim Rejections - 35 USC § 112 (Enablement)
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.
Claims 14 and 17-20 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 claim(s) contains 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.
The specification (page 181-193) provides detailed experimental data demonstrating the claimed compounds as PIM kinase inhibitors and have efficacy in GVHD and lupus models. However, the GVHD model is insufficient to enable a person of ordinary skill in the art (POSITA) to apply the claimed compounds across the vast and distinct range of diseases as described in the instant application, including but not limited to viral infection, cancers, and metabolic disorders. This is because, it would have been apparent to a POSITA that these diseases involve distinct pathological mechanism, cell types, and molecular pathway; thus, it would not be obvious to a POSITA that the same compounds effective in the GVHD model would also provide the same therapeutic efficacy or benefit across such a broad range of diseases. Therefore, a POSITA would expect that, for claims directed to a broad and distinct genus of diseases, the specification must demonstrate therapeutic efficacy in disease relevant cellular system or models, and further provide dosage guidance, formulation details, and administration appropriate to each disease class.
Consequently, because of the lack of specific data, a POSITA would not know whether the claimed compounds would be therapeutically effective for each disease class without conducting undue experimentation, including but not limited to xenografts studies, or viral suppression assays.
Therefore, the GVHD model is sufficient for systemic lupus erythematosus and lupus nephritis or other autoimmune disease related to PIM kinase, however is not sufficient to establish enablement to the whole genus of diseases as claimed. Consequently, the lack of enablement of the claimed subject matter at the time of filing, suggest that Applicant did not possess supporting data to claim the claimed compound as therapeutic agent against the vast and distinct disease as recited.
112 (Written Description)
Claims 14 and 17-20 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 claim(s) contains 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.
The specification (page 181-193) discloses Test Examples 1-3 containing detailed quantitative evidence of the claimed compounds as inhibitors of PIM1, PIM2, PIM3, as well as corresponding proliferation effects in transgenic cells and in vivo activity in GVHD animal model. Therefore, the data demonstrate possession of the claimed compound as PIM kinase inhibitors and as therapeutic agents for autoimmune diseases, such as systemic lupus erythematosus and lupus nephritis.
However, the specification does not reasonably demonstrate possession of the claimed compounds as therapeutic agents for the full scope of the diseases recited, including viral infection, cancers, and metabolic disorders, as an example. The specification demonstrates no data regarding virus-infected cells systems, viral replication assays, or relevant animal models (to support anti-viral activity); no data in relevant cancer models such as xenografts, orthotopic tumors (to support anticancer efficacy); or even relevant disease biomarkers or animal models for metabolic disorders. Furthermore, the specification contains no evidence linking PIM kinase inhibition by the claimed compounds to therapeutic efficacy in the other disease categories, as the specification demonstrates for autoimmune diseases. Therefore, simply claiming that the claimed compounds are useful for treating a broad scope of distinct disease, solely because of their association with PIM kinase, is insufficient to satisfy the written description requirement. For these reasons, while specification demonstrates possession of the claimed compounds against autoimmune diseases, however, the specification does not establish possession across the full scope claimed therapeutic application. This further supports the conclusion that the specification lacks adequate written description of the claimed subject matter.
Allowable Subject Matter
Claim 1-20 are free of the art of record. The closest prior art is PubChem CID 129267460 and Desforges. While PubChem CID 129267460 and Desforges teach 1,3,4-oxadiazolone compound (s), however there is no motivation for an ordinary skilled artisan to modify the teaching of PubChem CID 129267460 and Desforges to arrive at the claimed compounds in the instant claim 9-10. These claims are not allowable until the current issue is resolved.
Conclusion
No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
Examiner interviews are available via telephone, in-person, 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, JAMES H ALSTRUM-ACEVEDO can be reached on (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622