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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/13/2026 has been entered.
Status of the Claims
Claims 1-9, 11, 14, 18, 34, 39, 42, 45, 50-52 and 54-58 are currently pending. Claims 1-9, 11, 14, 18, 34, 39, 42, 45, 50-52 and 54-57 are allowed. Claim 58 is rejected.
Response to Amendment/Arguments
The amendment filed 08/13/2026 is compliant with the requirements of 37 CFR 1.121(c), accordingly the amendment has been entered. Applicant’s arguments have been fully considered and are addressed below:
Double Patenting Rejection
The rejection of the claims for nonstatutory obvious double patenting over application 17/916,773 has been overcome by abandonment of the previously copending application. The rejection has been withdrawn.
Scope of the Elected Invention
Claims 1-9, 11, 14, 18, 34, 39, 42, 45, 50-52 and 54-57 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claim 58, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, is hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 05/11/2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
New Claim Rejection - 35 USC § 112(a)
The following is a quotation 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.
Claim 58 is 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 PKMYT1 related cancers, does not reasonably provide enablement for cancer in general. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. Accordingly, the method of claim 58 is not enabled.
Nature of the invention:
The invention is drawn to a method of treating cancer comprising administration of a compound of an Myt1 inhibitor.
Breadth of the invention:
The scope of the claimed invention is very broad, as it is drawn to administration of any of the numerous compounds encompassed by a formula (I) as instantly recited to treat cancer.
State of the prior art and predictability in the art:
No compound has ever been found to prevent or treat cancers of all types generally. Since this assertion is contrary to what is known in medicine, proof must be provided that this revolutionary assertion has merits. The existence of such a “silver bullet” is contrary to our present understanding of oncology. The state of the art is not indicative of any pharmaceutical agents that are useful in the treatment of cancer generally. At Page 1004, Cecil Textbook of Medicine states that “each specific type has unique biologic and clinical features that must be appreciated for proper diagnosis, treatment and study”. Different types of cancers affect different organs and have different methods of growth and harm to the body. Also see In re Buting, 163 USPQ 689 (CCPA 1969), wherein ‘evidence involving a single compound and two types of cancer, was held insufficient to establish the utility of the claims directed to disparate types of cancers’. Thus, it is beyond the skill of oncologists today to get an agent to be effective against cancers generally.
A similar statement appears at In re Application of Hozumi et. al., 226 USPQ 353: “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 prevent or treat various cancers arguably constitute the single most massive enterprise in all of pharmacology. This has not resulted in finding any treatment for tumors generally. 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 environmental factors.
Similarly, In re Novak, 134 USPQ 335, 337-338 says “unless one with ordinary skill in the art would accept those allegations as obviously valid and correct, it is proper for the examiner to ask for evidence which substantiates them.” There is no such evidence in this case for a compound that treats all types of cancer. Likewise, In re Cartright, 49 USPQ2d 1464, states: “Moreover, we have not been shown that one of ordinary skill would necessarily conclude from the information expressly disclosed by the written description that the active ingredient” does what the specification surmises that it does. That is exactly the case here. Moreover, even if Applicant’s assertion that cancer in general could be treated with these compounds were plausible -- which it is not --, that “plausible” would not suffice, as was stated in Rasmusson v. SmithKline Beecham Corp., 75 USPQ2d 1297, 1301: “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.
It is commonly known in the pharmaceutical arts that shape dictates function wherein drugs which have a shape complimentary to the protein target will bind and have an effect (this is often referred to simplistically as a “Lock and Key” model). Given the varied shape of protein targets in cancer, it is pure fantasy to speculate that a single drug with a single three-dimensional shape will bind all protein targets implicated in cancer therapy and have an effect in treating all forms of the disease. As such, at present the “silver bullet” drug therapy to treat all forms of cancer is elusive and such a therapy is not recognized in the art where the reality is that different forms of cancer require different drug therapies.
Regarding MYT1 inhibitors specifically, in WO 2000033837 A2, Lago discloses a method for inhibiting MYT1 using compounds of Formula (I),
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, wherein the inhibition treats various forms of cancer. See Field of the Invention section on page 1 and page 2, line 16.
There do not appear to be examples in the prior art of MYT1 inhibitors that are able to prevent and/or treat all cancers, or even most cancers. Lago, for instance, demonstrated that compounds of Formula (I) were expected to inhibit the proliferation of Hela S3, HT29, and Jurkat cancer cell lines. See page 9, line 20 through page 10 line 2.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
Applicants demonstrate cancer cell death as a result of Myt1 inhibition using compound 133 in the assay on page 155, results of which are shown in Figure 4C.
No examples have been provided that would enable the instantly disclosed compounds for preventing or treating cancer generally, as claimed in instant claim 58.
Quantity of experimentation needed to use the invention
The quantity of experimentation needed is undue experimentation. A person having ordinary skill in the art would need not only to identify and/or develop metrics to be able to investigate the efficacy of the disclosed compounds in the treatment of cancer generally, but would also need to evaluate the disclosed compounds, with no assurance of success.
The Applicant has not sufficiently disclosed examples demonstrating the efficacy of the instantly claimed compounds in treating cancer generally. The utility thereof would not have been readily recognized by a person having ordinary skill in the art at the time of filing, as distinct cancers have mutually exclusive etiologies. The examples disclosed in the application are not sufficient to overcome the unpredictability of treating cancer generally.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.
Genentech Inc. V Novo Nordisk A/S (CAFC) 42 USPQ 2d 1001 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”. Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person having ordinary skill in the art would have to engage in undue experimentation to determine the efficacy of disclosed compounds in treating cancer, with no assurance of success.
Applicant may amend claim 58, for example, as follows: “A method of treating a Myt1-related cancer in a subject, the method comprising administering to the subject a therapeutically effective amount of the compound of claim 1”.
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.
Claim 58 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Lago in WO 2000033837 A1, as cited in the IDS dated 04/11/2024.
Lago discloses Myt1 inhibitors of Formula (I) for the treatment of cancer. See Field of the Invention section on page 1 and page 2, line 16. See also claim 3 and page 9, line 20 through page 10 line 2 wherein Lago recites that the compounds of Formula (I) were expected to inhibit the proliferation of Hela S3, HT29, and Jurkat cancer cell lines.
Instant claim 58 is therefore anticipated by Lago wherein a Myt1 inhibitor is used in a method of treating cancer.
Conclusion
Claims 1-9, 11, 14, 18, 34, 39, 42, 45, 50-52 and 54-57 are allowed. Claim 58 is rejected.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.H.F./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
