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 .
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/EP2021/052593 filed 02/04/2021, which claims the benefit of the priority of European Patent Application No. EP 20305101.6 filed 02/05/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements submitted on 08/03/2022 has been considered by the examiner.
Election/Restrictions
Claims 5, 12, 15-16 are withdrawn from further consideration pursuant to 37 CFR
1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant’s election of the species of CDYL2 is a small organic molecule, cancer is a solid tumor, and cancer type is lung cancer in the reply filed on 08/21/2025 is acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP 818.01 (a))
Claim Status
Claims 1-4, 6-11, and 13-14 are being examined on the merits in this office action.
Claim Objections
Claims 1, 6, and 13 are objected to for the following minor informality: claim 1 contains the acronym “CDYL2”, and an acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, i.e., Chromodomain on Y-like 2 (CDYL2). The abbreviations can be used thereafter.
Claim 6 and 13 should be amended to recite “….wherein said cancer is a solid tumor, lymphoma or leukemia.”
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.
Claims 1-4, 6, 8-11, and 13 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 a method of treating prostate cancer, ovarian cancer, lung cancer, colorectal cancer, and breast cancer, does not reasonably provide enablement for a method of treating and preventing all cancers. 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. This is a scope of enablement rejection.
To be enabling, the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1561 (Fed. Cir., 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558,1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547, the court recited eight factors to consider when assessing whether or not a disclosure would require undue experimentation. These factors are:
1) the quantity of experimentation necessary
2) the amount of direction or guidance provided
3) the presence or absence of working examples
4) the nature of the invention
5) the state of the art
6) the relative skill of those in the art
7) the predictability of the art
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099,1108,427 F.2d 833, 839,166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The breadth of the claims and the nature of the invention
The invention is drawn to a method of preventing or treating cancer comprising administering to the patient a therapeutically effective amount of a CDYL2 antagonist. The invention is further drawn to a method of activating the anti-tumoral immune response of a patient affected with a cancer comprising administering to the patient a therapeutically effective amount of a CDYL2 antagonist.
Cancer is a broad term and encompasses cancers occurring in various hard and soft tissues. The main categories include: Carcinoma (cancers that begin in the skin or tissues that line or cover organs), Sarcoma (Cancers in bone, cartilage, muscles or connective tissues), Leukemia (Cancers that form in the blood forming tissues), Lymphoma and myeloma (Cancers that begin in the immune system) and Central nervous system cancer (cancers of the brain or spinal cord). The claims of the instant application do not limit the cancer being treated, prevented to any particular type of cancer, for example lung cancer or breast cancer.
Secondly, the term “preventing” is a potent and absolute term indicating that the method of prevention will necessarily prevent the onset of any cancer, regardless of the cause and in every instance by the administration of the CDYL2 antagonist.
Since the instant specification does not provide a limiting definition of the term “preventing”, the term has been interpreted expansively. The term “preventing” encompasses a wide range of situations, from preventing a disease from occurring to preventing it from progressing, and in addition, the term is not limited by any time frame.
The applicant is claiming a “method of preventing” in claim 1. Prevention, as defined by Merriam-Webster dictionary, is to keep from happening or existing, which implies taking advance measure against something possible or probable. In addition, preventing embraces complete 100% inhibition. Therefore, the evidence of 100% prevention would be more challenging to obtain than the evidence of treatment since one would have to show that the administration of any CDYL2 antagonist of claim 1 a subject would never develop any cancer.
The instant specification is bereft of evidence of treating and prevention of any cancers in general. Since absolute success in treating and preventing cancers is not reasonably possible based on the state of the art at the earliest effective filing date of the instant application, the specification, which lacks an objective showing that all cancers can be actually treated and prevented, is viewed as lacking.
The claims are thus broad insofar as to suggest that the claimed method can treat and prevent all cancers generally and that the method can activate the anti-tumoral immune response of a patient affected with any cancer. In addition, the claims are broad insofar as to suggest that after the administration of any CDYL2 antagonist, one will not experience or develop any form of cancer.
The state of the prior art and the level of predictability in the art and the relative skill of those in the art
The state of the art is such that there is evidence and established literature on the many types of cancers (National Cancer Institute-https://www.cancer.gov/about-cancer/understanding/what-is-cancer (NCI), page 6, paragraph 1) and each cancer has its own causative factor and different cellular behaviors (National Cancer Institute, https://www.cancer.gov/about-cancer/causes-prevention/patient-prevention-overview-pdq (NCI2) page 2 and 3). Examples of the numerous forms of cancers include Breast cancer, uterine corpus endometrial carcinoma, Bladder Urothelial carcinoma, Lung cancer, cervical cancer, pancreatic cancer, Prostate cancer, ovarian cancer, Blood cancer or Brain and nervous system cancers. These are further subdivided to include carcinomas like Basal cell carcinoma, squamous cell carcinoma, renal cell carcinoma and Adenocarcinoma. There are also other forms of malignant melanoma, cylindroma, germ cell tumors and many more. Treatment of cancer is complex and usually takes into consideration the type of cancer including location, its stage and genetic characteristics. Therefore treatment for one type of cancer, may not be useful in treating other types of cancers (Merck Manual - Cancer treatment Principles By Robert Gale, page 1, paragraph 1 and 2).
Further, Peng et al. (Cellular & Molecular Immunology (2025) 22:840 – 868) teaches that antitumoral response in all cancer is challenging since most cancer patients either fail to respond or experience acquired resistance, underscoring the urgent need for new cancer immunotherapy strategies (Introduction section).
Given that there is no evidence in the art of a compound that has been found to generally treat and prevent all cancers, the treatment or prevention of cancer generally is not considered enabled. Most cancer drugs are known to be effective against a limited or closely related cancers (Merck Manual - Cancer therapy, By Robert Gale, page 1, and paragraph 1, 2). Therefore a compound that is effective against cancer or cancerous tumors generally would be an exception and more proof of the claimed invention would be required. Merck teaches the median 5-year survival rates of various types of cancer as shown below (Merck - cancer therapy, page 3).
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581
1009
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Medical News Today (https://www.medicalnewstoday.com/articles/322700 - By Christina Chun) teaches that a 5- year survival rate does not indicate whether or not treatment has removed all signs of cancer, but is useful for comparing relative severity of different types of cancer (Medical News Today, Page 1, paragraph 8).
One of ordinary skill in the art would not be able to use the claimed invention to treat all cancers generally or activate antitumoral immune response in all cancer patients and achieve a reasonable level of success in doing so due to the absence in the art of a compound that is able to treat and prevent cancer generally. It is well established that a utility rejection is therefore proper when the scope of enablement is not reasonably correlated to the scope of the claim.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)”. The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.”
The instant specification discloses that high CDYL2 expression level in breast cancer is associated with poor prognosis (Fig. 1-3), that CDYL2 expression was inhibited by RNAi, which diminishes the Expression of EMT markers and inhibits migration, invasion, and mammosphere formation (Fig. 4-6) and that CDYL2 inhibition can reduce the tumorigenicity of breast cancer cells (Fig. 10).
With regards to cancer, Ex parte Kranz, 19 USPQ2d 1216, 1219 notes the “general unpredictability of the field [of] ... anti-cancer treatment.” In re Application of Hozumi et al., 226 USPQ 353 notes the “fact that the art of cancer chemotherapy is highly unpredictable”. It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved” and physiological activity is generally considered to be an unpredictable factor.
See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.).
As a result, the specification needs to have more details on how to make and/or use the invention in order to be enabling.
The relative skill of those in the art is high. However, the art of cancer treatment or and prevention is highly unpredictable.
The examiner cites Ma et al. (Available at SSRN 3454674, Sep. 13, 2019), in view of Ye et al., (Pharmacology & Therapeutics 204 (2019) 107406) and Gu et al. ( Cancer Lett. 2025 Aug 12;632:217987) as evidentiary references to illustrate the state of the art.
Ma teaches that small organic molecule UNC3866 significantly suppresses tumor cell growth and CSC properties, particularly in SR cells (page 5, 1st paragraph) and that the compounds exerted a strong antitumor effect in vivo against SR HCC cells (Abstract). Ma does not disclose that the small organic molecule UNC3866 was used to treat and prevent all types of cancers.
Further, Ye teaches the small organic molecule UNC3866 and that it is a potent antagonist against CBX7 and CBX4 chromodomain with 6- to 18-fold selectivity as against other CBX and CDY chromodomains (Page 10, left col.). Ye teaches that UNC3866 antagonizes engagement of PRC2 to chromatin and is effective in inhibiting proliferation of PC3 prostate cell (Page 10, left col.). Ye does not disclose that the small organic molecule UNC3866 was used to treat and prevent all types of cancers.
Further, Examiner notes that the instant invention mainly suggests that CDYL2 is overexpressed in all cancers and thus CDYL2 inhibitors are key in treating the cancer types. However, Gu et al. teaches that CDYL2 is upregulated in breast cancer and high CDYL2 mRNA levels predict reduced survival; accordingly, overexpression of CDYL2 promoted migration, invasion and mammosphere formation of MCF7 breast cancer cells, while ablation of CDYL2 had the opposite effects in MDA-MB-231 breast cancer cells. However, in hepatocellular carcinoma, CDYL2 expression is downregulated and low CDYL2 mRNA levels correlate with reduced survival. Moreover, overexpression of CDYL2 in liver cancer cells decreased their proliferation and xenograft tumor growth, implying that CDYL2 also acts as a tumor suppressor in the liver (See Discussion section on Page 7-8). Gu further teaches that different isoforms of CDYL2 have a different effect in cancer cells and that CDYL2a reportedly is a growth promoter, whereas CDYL2b is anti-metastatic in breast cancer cells and did not affect proliferation (See Discussion section on Page 7-8). Examiner notes that the teachings of Gu add to the unpredictability of using any CDYL2 inhibitors to treat and prevent all cancer types, as well as activating antitumoral immune response, given that the use of CDYL2 inhibitors can have opposite effects in different cancer types. These teachings show how unpredictable the treatment and prevention of cancer is generally, especially in the case of a method that is used to prevent, and treat cancers in general. In light of the state of the prior art, it is apparent that the instantly claimed method is not capable of use to treat and prevent all cancers generally.
The amount of direction or guidance provided and the presence or absence of working examples
The invention is drawn to a method of preventing or treating cancer comprising administering to the patient a therapeutically effective amount of a CDYL2 antagonist as well as activating antitumoral immune response in all cancer types.
The instant Examples discloses that high CDYL2 Expression Level in Breast cancer is associated with poor prognosis (Fig. 1-3), that CDYL2 expression was inhibited by RNAi, which diminishes the Expression of EMT markers and inhibits migration, invasion, and mammosphere formation (Fig. 4-6) and that CDYL2 inhibition can reduce the tumorigenicity of breast cancer cells (Fig. 10). The instant specification does not include other examples showing effect of the claimed method to treat, prevent or activate antitumoral immune response in all cancers generally such as brain cancer.
The quantity of experimentation necessary
Given the well-known unpredictability of the art as well the incomplete experimental evidence commensurate in scope with the claims, the skilled artisan would not be able to agree that the claimed method can treat, prevent or activate antitumoral immune response in any and all cancers. In order to determine if the claimed method would treat any particular cancer, the suitable dosage as well as clinical trials or assays that can correlate to clinical efficacy of such treatment would be needed. This is undue experimentation given the limited guidance and experimentation provided by the applicant.
In view of the Wands factors discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in unduly burdensome experimentation to assess whether the claimed method would be successful in treating, preventing or activating antitumoral immune response of all cancers in general. Thus, the rejection of these claims under 35 USC 112(a) is proper.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-11, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (Available at SSRN 3454674, Sep. 13, 2019), in view of Ye et al., (Pharmacology & Therapeutics 204 (2019) 107406) and Yegnasubramanian et al. (WO2018226802A1) as evidenced by Stuckey et al. (Nat Chem Biol. 2016 Jan 25;12(3):180–187) and Iglesias et al. (Front Oncol. 2018 Jul 24;8:267).
Ma teaches that small organic molecule UNC3866 significantly suppresses tumor cell growth and CSC properties, particularly in SR cells (page 5, 1st paragraph) and that the compounds exerted a strong antitumor effect in vivo against SR HCC cells (Abstract). Ma teaches that the UNC3866 compound exerted a strong antitumor effect (Abstract).
Further, Ye teaches the small organic molecule UNC3866 and that it is a potent antagonist against CBX7 and CBX4 chromodomain with 6- to 18-fold selectivity as against other CBX and CDY chromodomains (Page 10, left col.). Ye teaches that UNC3866 antagonizes engagement of PRC2 to chromatin and is effective in inhibiting proliferation of PC3 prostate cell (Page 10, left col.). Examiner notes that as evidenced by Stuckey, UNC3866, is selective and binds to CDYL2 (Page 6, line 1-10).
Ma does not teach that the small organic molecule UNC3866 was used to treat lung cancer.
However, the treatment of lung cancer using small organic molecule UNC3866 is known in the art as taught by Yegnasubramanian et al. Yegnasubramanian teaches methods of treating cancer comprising administering to a subject in need thereof an effective amount of at least one epigenetic compound (abstract; claim 2), wherein the epigenetic compound is a histone deacetylase inhibitor or a histone methyltransferase inhibitor such as UNC3866 [0094]. Yegnasubramanian teaches that wherein the cancer is chosen from prostate cancer, ovarian cancer, lung cancer, colorectal cancer, central nervous system cancer, and breast cancer (claim 13; [0016, 0022, 01128, 00130, 00132]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Ma and use the small organic molecule UNC3866 to treat lung cancer since Yegnasubramanian teaches that the small organic molecule UNC3866 was used to treat cancers including lung cancer. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in using the small organic molecule UNC3866 to treat lung cancer since Yegnasubramanian teaches that the small organic molecule UNC3866 was used to treat cancers including lung cancer. The disclosures render obvious claims 1.
Regarding claims 2, Yegnasubramanian teaches that wherein the cancer is chosen from prostate cancer, ovarian cancer, lung cancer, colorectal cancer, central nervous system cancer, and breast cancer (claim 13; [0016, 0022, 01128, 00130, 00132]). Examiner notes that as evidenced by Iglesias, lung cancer is a drug-resistant cancer (Abstract). It would have been obvious to use the small organic molecule UNC3866 to treat the drug-resistant cancer since Yegnasubramanian exemplified the epigenetic compound UNC3866 [0094], and the specific cancer reduced to practice is lung cancer (See Fig. 2) .
Regarding claim 3, Ye teaches the small organic molecule UNC3866 and that it is a potent antagonist against CBX7 and CBX4 chromodomain with 6- to 18-fold selectivity as against other CBX and CDY chromodomains (Page 10, left col.). Ye teaches that UNC3866 antagonizes engagement of PRC2 to chromatin and is effective in inhibiting proliferation of PC3 prostate cell (Page 10, left col.). Examiner notes that as evidenced by Stuckey, UNC3866, is selective and binds to CDYL2 (Page 6, line 1-10). It would have been obvious to use the small organic molecule UNC3866
Regarding claim 4, Ye teaches the small organic molecule UNC3866 and that it is a potent antagonist against CBX7 and CBX4 chromodomain with 6- to 18-fold selectivity as against other CBX and CDY chromodomains (Page 10, left col.). Ye teaches that UNC3866 antagonizes engagement of PRC2 to chromatin and is effective in inhibiting proliferation of PC3 prostate cell (Page 10, left col.). Examiner notes that UNC3866 is a small organic molecule. It would have been obvious to use the small organic molecule UNC3866 that binds to CDYL2.
Regarding claims 6-7, Yegnasubramanian teaches methods of treating cancer comprising administering to a subject in need thereof an effective amount of at least one epigenetic compound (abstract; claim 5), wherein the epigenetic compound is a histone deacetylase inhibitor or a histone methyltransferase inhibitor such as UNC3866 [0094]. Yegnasubramanian teaches that wherein the cancer is chosen from prostate cancer, ovarian cancer, lung cancer, colorectal cancer, central nervous system cancer, and breast cancer (claim 13; [0016, 0022, 01128, 00130, 00132]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Ma and use the small organic molecule UNC3866 to treat lung cancer since Yegnasubramanian teaches that the small organic molecule UNC3866 was used to treat cancers including lung cancer.
Regarding claim 8, Ma teaches that small organic molecule UNC3866 significantly suppresses tumor cell growth and CSC properties, particularly in SR cells (page 5, 1st paragraph) and that the compounds exerted a strong antitumor effect in vivo against SR HCC cells (Abstract). Ma teaches that the UNC3866 compound exerted a strong antitumor effect (Abstract). Examiner notes that it would have been obvious to one of ordinary skill in the art to use the small organic molecule UNC3866 to activate the antitumoral immune response in a subject.
Regarding claims 9, Yegnasubramanian teaches that wherein the cancer is chosen from prostate cancer, ovarian cancer, lung cancer, colorectal cancer, central nervous system cancer, and breast cancer (claim 13; [0016, 0022, 01128, 00130, 00132]). Examiner notes that it is known in the art the lung cancer is a drug-resistant cancer. It would have been obvious to use the small organic molecule UNC3866 of Ma on a drug-resistant cancer such as lung cancer.
Regarding claim 10, Ye teaches the small organic molecule UNC3866 and that it is a potent antagonist against CBX7 and CBX4 chromodomain with 6- to 18-fold selectivity as against other CBX and CDY chromodomains (Page 10, left col.). Ye teaches that UNC3866 antagonizes engagement of PRC2 to chromatin and is effective in inhibiting proliferation of PC3 prostate cell (Page 10, left col.). Examiner notes that as evidenced by Stuckey, UNC3866, is selective and binds to CDYL2 (Page 6, line 1-10). It would have been obvious to use the small organic molecule UNC3866.
Regarding claim 11, Ye teaches the small organic molecule UNC3866 and that it is a potent antagonist against CBX7 and CBX4 chromodomain with 6- to 18-fold selectivity as against other CBX and CDY chromodomains (Page 10, left col.). Ye teaches that UNC3866 antagonizes engagement of PRC2 to chromatin and is effective in inhibiting proliferation of PC3 prostate cell (Page 10, left col.). Examiner notes that UNC3866 is a small organic molecule. ). It would have been obvious to use the small organic molecule UNC3866 that binds to CDYL2.
Regarding claims 13-14, Yegnasubramanian teaches methods of treating cancer comprising administering to a subject in need thereof an effective amount of at least one epigenetic compound (abstract; claim 5), wherein the epigenetic compound is a histone deacetylase inhibitor or a histone methyltransferase inhibitor such as UNC3866 [0094]. Yegnasubramanian teaches that wherein the cancer is chosen from prostate cancer, ovarian cancer, lung cancer, colorectal cancer, central nervous system cancer, and breast cancer (claim 13; [0016, 0022, 01128, 00130, 00132]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Ma and use the small organic molecule UNC3866 to treat lung cancer since Yegnasubramanian teaches that the small organic molecule UNC3866 was used to treat cancers including lung cancer.
Claims 1-4, and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Yegnasubramanian et al. (WO2018226802A1) as evidenced by Stuckey et al. (Nat Chem Biol. 2016 Jan 25;12(3):180–187) and Iglesias et al. (Front Oncol. 2018 Jul 24;8:267).
Yegnasubramanian teaches methods of treating cancer comprising administering to a subject in need thereof an effective amount of at least one epigenetic compound (abstract), wherein the epigenetic compound is a histone deacetylase inhibitor or a histone methyltransferase inhibitor such as UNC3866 [0094]. Yegnasubramanian teaches that wherein the cancer is chosen from prostate cancer, ovarian cancer, lung cancer, colorectal cancer, central nervous system cancer, and breast cancer (claim 13; [0016, 0022, 01128, 00130, 00132]). Examiner notes that as evidenced by Stuckey, UNC3866, is selective and binds to CDYL2 (Page 6, line 1-10). It would have been obvious to use the small organic molecule UNC3866.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select UNC3866 and administer an effective amount to a subject in need of treatment in order to mediate repression of tumor suppressor genes and activation of oncogenes as taught by Yegnasubramanian [0004]. One of ordinary skill in the art would and would have had a reasonable expectation of success to administer UNC3866 because it is an exemplary histone methylatransferase and epigenetic compound [0094] that can suppress tumor genes and activation of oncogenes.
Regarding claims 2, Yegnasubramanian teaches that wherein the cancer is chosen from prostate cancer, ovarian cancer, lung cancer, colorectal cancer, central nervous system cancer, and breast cancer (claim 13; [0016, 0022, 01128, 00130, 00132]). Examiner notes that as evidenced by Iglesias, lung cancer is a drug-resistant cancer (Abstract). It would have been obvious to use the small organic molecule UNC3866 to treat the drug-resistant cancer.
Regarding claims 3-4, Yegnasubramanian teaches methods of treating cancer comprising administering to a subject in need thereof an effective amount of at least one epigenetic compound (abstract; claim 5), wherein the epigenetic compound is a histone deacetylase inhibitor or a histone methyltransferase inhibitor such as UNC3866 [0094]. Examiner notes that as evidenced by Stuckey, UNC3866, is selective and binds to CDYL2 (Page 6, line 1-10). It would have been obvious to use the small organic molecule UNC3866.
Regarding claims 6-7, Yegnasubramanian teaches methods of treating cancer comprising administering to a subject in need thereof an effective amount of at least one epigenetic compound (abstract; claim 5), wherein the epigenetic compound is a histone deacetylase inhibitor or a histone methyltransferase inhibitor such as UNC3866 [0094]. Yegnasubramanian teaches that wherein the cancer is chosen from prostate cancer, ovarian cancer, lung cancer, colorectal cancer, central nervous system cancer, and breast cancer (claim 13; [0016, 0022, 01128, 00130, 00132]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the small organic molecule UNC3866 to treat lung cancer.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654