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 .
DETAILED ACTION
1. Applicant’s preliminary amendment filed on December 23, 2024 is acknowledged. Claims 1, 4, 8, 13, 20, 24-54, 56-60 and 62-71 have been canceled. Claims 7, 9-12, 14-16, 19, 21 and 22 have been amended. Claims 2, 3, 5-7, 9-12, 14-19, 21-23, 55 and 61 are currently pending and under examination.
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on February 21, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy is attached hereto.
Claim Objections
3. Claims 2 and 55 are objected to because of the following informalities:
As it pertains to claim 2, on first sight, PKC should be accompanied by ‘Protein Kinase C’. As it pertains to claim 55. , on first sight, SNP should be accompanied by ‘single-nucleotide-polymorphisms’ and PRKCD should be accompanied by ‘protein kinase C delta’.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
4. Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Said claim is rendered vague and indefinite by the use of the phrase “an analog or derivative thereof”. It is unclear what is meant by said phrase, as it is not explicitly defined in the specification. What constitutes “an analog or derivative”? What core features/structures must be maintained? As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim Rejections - 35 USC § 112
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.
5. Claims 2, 3, 5-7, 9-12, 14-19, 21-23, 55 and 61 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.
Independent claim 2 is drawn to a method treating a subject for cancer comprising administering to the subject a therapeutically effective amount of a PKC-delta inhibitor and an immunotherapy.
Independent claim 55 is drawn to a method of treating a subject for cancer comprising administering an immunotherapy to a subject determined to have a SNP in the PRKCD gene, wherein the SNP is rs1483185, rs1483186, or rs750170.
Independent claim 61 is drawn to a method of treating a subject for RAS wild-type cancer comprising administering to the subject an effective amount of a PKC-delta inhibitor.
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must 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 fully describe the method as claimed. In the instant case, to fulfill the written description requirement, the genus of cancer to be treated in a subject must be adequately described. The claim overall is an extremely broad claim in terms of patient population.
The specification describes instances where the combination of anti-PD-L1/anti-PD-1 therapies in conjunction with PKC-δ inhibitors (i.e. Prkcd -/- BM) providing greater T-cell infiltration, improved spontaneous immune-mediated tumor control and increased accumulation of CD8+ T cells resulting in an improved overall survival. The specification, however, does not adequately describe a representative number of species for the genus of cancer. Cancer is not a single disease, or cluster of closely related disorders. There are hundreds of cancers, which have in common only some loss of controlled cell growth. Cancers are highly heterogeneous at both the molecular and clinical level, something seen especially in, for example, the cancers of the breast, brain and salivary glands. They can occur in pretty much every part of the body. Types of cancer include, but certainly are not limited to: CNS cancers which cover a very diverse range of cancers in many categories and subcategories. They include an immense range of neuroepithelial tumors, which include gliomas, the most common subtype of primary brain tumors. Other neuroepithelial tumors include astrocytic tumors (e.g. astrocytomas) oligodendroglial tumors, ependymal cell tumors (e.g. myxopapillary ependymoma), mixed gliomas (e.g. mixed oligoastrocytoma and ependyma-astrocytomas) tumors of the choroid plexus(choroid plexus papilloma, choroid plexus carcinoma), assorted neuronal and neuroblastic tumors (e.g. gangliocytoma, central neurocytoma, dysembryoplastic neuroepithelial tumor, esthesioneuroblastoma, olfactory neuroblastoma, olfactory neuroepithelioma, and neuroblastomas of the adrenal gland), pineal parenchyma tumors (e.g. pineocytoma, pineoblastoma, and pineal parenchymal tumor of intermediate differentiation), embryonal tumors (e.g. medulloepithelioma, neuroblastoma, ependymoblastoma, atypical teratoid/rhabdoid tumor, desmoplastic medulloblastoma, large cell medulloblastoma, medullomyoblastoma, and melanotic medulloblastoma) and others such as polar spongioblastoma and gliomatosis cerebri. There are vascular brain Tumors e.g., the hemangioblastomas, there is CNS Lymphoma (which can be primary or secondary) and Meningeal Carcinomatosis. There are lymphoma and haemopoietic neoplasms including malignant lymphomas (which can be primary or secondary), plasmacytoma, and granulocytic sarcoma. And there are many, many others.
The state of art recognizes that there never has been a compound capable of treating cancers generally. “The cancer therapy art remains highly unpredictable, and no example exists for efficacy of a single product against tumors generally. In re Application of Hozumi et al., 226 USPQ 353 states: “In spite of the vast expenditure of human and capital resources in recent years, no one drug has been found which is effective in treating all types of cancer. Cancer is not a simple disease, nor is it even a single disease, but a complex of a multitude of different entities, each behaving in a different way”. There are compounds that treat a modest range of cancers, but no one has ever been able to figure out how to get a compound to be effective against cancer generally, or even a majority of cancers.
The attempts to find compounds to treat the various cancers arguably constitute the single most massive enterprise in all of pharmacology. This has not resulted in finding any treatment for tumors generally. Indeed, the existence of such a "silver bullet" is contrary to our present understanding in oncology. This is because it is now understood that there is no “master switch” for cancers generally; cancers arise from a bewildering variety of differing mechanisms. Even the most broadly effective antitumor agents are only effective against a small fraction of the vast number of different cancers known. This is true in part because cancers arise from a wide variety of sources, primarily a wide variety of failures of the body's cell growth regulatory mechanisms, but also such external factors such as viruses (an estimated at least 20% are of viral origin e.g. Human papillomavirus, EBV, Hepatitis B and C, HHV-8, HTLV-1 and other retroviruses, and quite possibly Merkel cell polyomavirus, and there is some evidence that CMV is a causative agent in glioblastoma), exposure to chemicals such as tobacco tars, excess alcohol consumption (which causes hepatic cirrhosis, an important cause of HCC), ionizing radiation, and unknown environment factors.
Different types of cancers affect different organs and have different methods of growth and harm to the body, and different vulnerabilities. The skill thus depends on the particular cancer involved. Given the fact that, historically, the development of new cancerous drugs has been difficult and time consuming the quantity of experimentation needed is expected to be great.
The genus encompasses too many species and the specification has not at all demonstrated a representative number of species to show which methods Applicant is truly in possession of. As supported by the state of the art, the description is extremely important to ensure the method functions as intended. The written description requirement may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or teach correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the claimed invention.
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that: ...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2datl966.
Written description requirement must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the "written description" inquiry, whatever is now claimed. The Guidelines further state, "[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus" (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus.
Therefore, absent a detailed and particular description the skilled artisan could not immediately recognize or distinguish members of the claimed method. Therefore, because the art is unpredictable, in accordance with the Guidelines, the description do not meet the written description requirements.
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.
(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.
6. Claim(s) 2, 3 and 15-19 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Klijn et al., US 2019/0218618 A1; Published: 7/18/19.
Independent claim 2 is drawn to a method treating a subject for cancer comprising administering to the subject a therapeutically effective amount of a PKC-delta inhibitor and an immunotherapy.
Klijn discloses compositions and methods for treating cancer, for example, lung cancer (e.g., non-small cell lung cancer (NSCLC)) and head and neck carcinoma (see paragraph 0005; meets claims 2 and 19). In some embodiments, the method further comprises administering to the subject a therapeutically effective amount of an anti-cancer agent. In other embodiments, the method comprises administering an anti-cancer agent and a NRF2 pathway antagonist. In some embodiments, the anti-cancer agent and the NRF2 pathway antagonist are co-administered. In other embodiments, the anti-cancer agent and the NRF2 pathway antagonist are sequentially administered (meets claim 16). In some embodiments, the anti-cancer agent is selected from the group consisting of an anti-angiogenic agent, a chemotherapeutic agent, a growth inhibitory agent, a cytotoxic agent, and an immunotherapy (meets claim 2). In some embodiments, the NRF2 pathway antagonist is a protein kinase C (PKC) antagonist (see paragraph 0021; meets claim 2).
Moreover, Klijn discloses that the immunotherapy is a PD-1 axis binding antagonist (e.g., YW243.55.570, MDX-1105, MPDL3280A (atezolizumab), MED14736 (druvalumab), MSB0010718C (avelumab), MDX-1106 (nivolumab), MK-3475 (pembrolizumab), CT-011 (pidilizumab), MEDI-0680 (AMP-514), PDR001, REGN2810, BGB-108 or AMP-224) (see paragraph 0215; meets claim 3). Such combination therapies noted above encompass combined administration (where two or more therapeutic agents (e.g., a NRF2 pathway antagonist and an anti-cancer agent) are included in the same or separate formulations), and separate administration, in which case, administration of a NRF2 pathway antagonist can occur prior to, simultaneously, and/or following, administration of the additional anti-cancer agent or agents (see paragraph 0219; meets claim 15-16). Lastly, Klijin discloses that the level in a sample previously obtained from the individual at a prior time; or the level in a sample from a patient who received prior treatment with a NRF2 pathway antagonist in a primary tumor setting, and who now may be experiencing metastasis (see paragraph 0128; meets claim 17-18).
7. Claim(s) 61 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gualberto, WO 2020/092720 A2; Published: 5/7/20.
Independent claim 61 is drawn to a method of treating a subject for RAS wild-type cancer comprising administering to the subject an effective amount of a PKC-delta inhibitor.
Gualberto discloses methods of treating a KRAS wild-type cancer in a subject comprising GSK690693 and an anti-PD1/anti-PDL1 antibody (see paragraphs 0004, 39, 44; meets claim 61).
Conclusion
8. No claim is allowed.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571) 272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 June 23, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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