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 .
Status of Claims
The amendments to the claims filed August 6, 2024 are acknowledged and entered. Claims 1-23 are pending.
Priority
This application is a 371 of PCT/US2023/012982, filed February 14, 2023, which claims benefit of 63/310,697, filed February 16, 2022.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statements filed on September 8, 2025 and February 6, 2026. All references have been considered except where marked with a strikethrough.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Claim Objections
Claims 8, 11 and 13-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112a
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 17 and 19-22 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 melanoma, head & neck cancer, classical Hodgkin lymphoma, urothelial carcinoma, gastric cancer, cervical cancer, primary mediastinal large-B-cell lymphoma, microsatellite instability- high cancer, lung cancer, non-small cell lung cancer, hepatocellular carcinoma, clear cell kidney cancer, colorectal cancer, breast cancer, squamous cell lung cancer, basal carcinoma, sarcoma, bladder cancer, endometrial cancer, pancreatic cancer, liver cancer, gastrointestinal cancer, multiple myeloma, renal cancer, mesothelioma, ovarian cancer, anal cancer, biliary tract cancer, esophageal cancer, salivary cancer, prostate cancer, and metastatic castration resistant prostate cancer comprising administration of an effective amount of a compound of claim 1 to a person in need thereof, does not reasonably provide enablement for
A general method of treating cancer
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.
Applicant teaches that a compound of Formula (I) is an inhibitor the adenosine A2a receptor and/or the adenosine A2b receptor (page 4 of specification, Summary of Invention). However, these receptors are not known to be associated with all forms of cancer embraced by the claims. Applicant’s disclosure is only enabling for the treatment of cancers which Applicant has demonstrated may be treated by the instant compound, and of conditions which the prior art is already aware may be treated by a compound with the disclosed activity and for which Applicant has written support. Case law is clear on this point. In an unpredictable art, such as drug therapy to treat disease, models may be used for enablement only if there is a reasonable correlation between the activity in question and the asserted utility. Given the guidance provided by Applicant, one skilled in the art would not be able to practice the full scope of the invention without undue experimentation.
In evaluating the enablement question, several factors are to be considered. Note In re Wands, 8 USPQ2d 1400 and Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed. The determination that “undue experimentation” would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations.
The nature of the invention & breadth of claims:
Claim 1 is drawn to a compound of Formula (I).
Claim 17 depends from claim 1 and recites a method of treating cancer comprising administering an effective amount of a compound of claim 1 to a person in need thereof.
Claims 19-22 depend directly or indirectly from claim 17 and include the full scope of cancer claimed.
A closed definition of conditions embraced by “cancer” is not provided in the specification.
The nature of the invention is a method of treating cancer with a compound having the activity of Formula (I). Because no complete definition of conditions embraced by “cancer” is provided, the method is very broadly drawn to the treatment of cancer generally which would include distinct forms of the disease which have no known association with the adenosine A2a receptor and/or the adenosine A2b receptor.
The state of the prior art
State of the prior art reference Zhang et al. (US 12,263,171 B2, effectively filed in 2018) teaches melanoma, head & neck cancer, classical Hodgkin lymphoma, urothelial carcinoma, gastric cancer, cervical cancer, primary mediastinal large-B-cell lymphoma, microsatellite instability- high cancer, non-small cell lung cancer, hepatocellular carcinoma, clear cell kidney cancer, colorectal cancer, breast cancer, squamous cell lung cancer, basal carcinoma, sarcoma, bladder cancer, endometrial cancer, pancreatic cancer, liver cancer, gastrointestinal cancer, multiple myeloma, renal cancer, mesothelioma, ovarian cancer, anal cancer, biliary tract cancer, esophageal cancer, salivary cancer, prostate cancer, and metastatic castration resistant prostate cancer are cancers which are associated with the adenosine A2a receptor and/or adenosine A2b receptor (see claims 15-16). The state of the prior art; however, is not aware that the adenosine A2a receptor and/or adenosine A2b receptor is associated with all forms of cancer embraced by the claim.
As per the broad treatment of cancer, no compound has ever been found to 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 any pharmaceutical agents that are useful in the treatment of cancer generally. 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” (see the enclosed article, page 1004). 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 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.
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 Cortright, 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 applicants’ 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.”
Recently, Wu (Journal of Hematology & Oncology 2022 (15) 143) discloses that between 1991 and 2021 there have been 228 new cancer drugs approved by the U.S. Food and Drug Administration of which 120 of these are drawn to the treatment of solid tumors alone (Abstract). Wu teaches that there are 21 different approved drugs for treating lung cancers, some of which have different cellular targets (Table 1, page 5). Similarly, breast cancer (see Table 2, page 10) has 22 different drugs that have varied cellular targets and are indicated for different types of breast cancer. More still, Table 4 (page 17) indicates that there are 17 different drugs available to treat different forms of gastrointestinal cancers. See also Table 6 (page 25), drugs approved for urologic cancers, Table 7 (page 28), drugs approved for skin cancers, and Table 8 (page 33), drugs approved for thyroid cancer. Wu further provides an illustration summarizing the protein structure of some cellular targets and the binding site of their respective drugs (Fig 12, page 38). Taken as a whole, Wu teaches that no single therapeutic has ever been identified as a treatment for all forms of cancer; and closer examination of Fig 12 provides a logical explanation: As highlighted in Fig 12, molecular protein targets implicated in different cancers (e.g. EGFR for lung cancer (see Table 1), VEGFR2 for gastric cancer (see Table 4)) have different three-dimensional protein structures, different active sites, and therefore require different drugs with the right shape and chemical groups in order to bind the target active site and have an effect in treating the cancer. In other words, there is no one size fits all approach to treating cancer simply for the reason that no single molecule will have the shape and chemical functional groups necessary to bind and modulate all molecular targets of cancer, all of which all have varied shapes. 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 (e.g. EGFR and VEGFR2), 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.
In view of the above, the state of the prior art and current state of the art are not aware of any “silver bullet” drug therapy to treat all forms of cancers as is claimed presently, at least for the reason that persons skilled in the art recognize that different forms of cancer have different treatment requirements and therefore require different drug therapies.
The Level of One of Ordinary Skill
The level of skill in the art is high. The artisan using the claimed invention would be a person with medical training such as a medical doctor or physician with an MD degree or the equivalent.
Predictability in the art
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved”. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Amount of guidance/working examples
Applicant provides evidence showing that a compound of Formula (I) is an inhibitor of the adenosine A2a receptor and/or adenosine A2b receptor (see Biological Assays at pages 191-198). This activity in view of the knowledge of which cancers are known to be associated with these receptors (see state of the prior art reference Zhang above) demonstrates that Applicant is enabled for treating those cancers recited in instant claims 18 and 23.
However, no experimental or other data is provided to show the instant compounds may have use in the treatment of the full scope of diseases claimed, and least of all those disorders for which there is no known association with the adenosine A2a receptor and/or adenosine A2b receptor. The specification does not provide any guidance to one of ordinary skill in the art to extrapolate the in vitro data provided by Applicant to the treatment of the many different forms of disease included in the scope of the method.
The quantity of experimentation needed:
MPEP 2164.01(a) states, "A conclusion of lack of enablement means that, based on theevidence 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. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)."
That conclusion is clearly justified here and one skilled in the art could not practice the full scope of the claimed invention without undue experimentation.
This rejection could be overcome by amending the claims to require that the cancer is selected from those recited in claims 18 and 23.
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.
Claim(s) 1-7, 9, 12 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ali et al. (US10,822,338 B2)(hereinafter “Ali”).
Ali teaches a generic group of compounds of formula (I) which embraces applicants’ claimed compounds (See claim 1) for use as pharmaceuticals and compositions (claim 17) for the treatment of diseases in which the A2A receptor is involved (see Abstract). Ali teaches many individual compounds which differ from the claims only with regard to variable A of instant Formula (I). For instance, Ali teaches 7-methoxy-2-(3-(3,3,3-trifluoropropyl)cyclohexyl)-[1,2,4]triazolo[1,5-c]quinazolin-5-amine (col 56, Example 29; pictured below for convenience) which corresponds to the instant claims wherein R1 is -OC1alkyl; R2 and R3 are each hydrogen; and the group corresponding to A of instant Formula (I) is a C6 cycloalkyl substituted with C3 haloalkyl. See also examples 1-27, 30-35 and 43-58 disclosed throughout the specification which teach Formula (I) wherein the ring corresponding to A of the claims is a heterocycloalkyl. Examples 29 and 50 are pictured below for convenience (see also col 56 and 71).
The only difference between Examples 1-27, 29, 30-35 and 43-58 of Ali and the instant claims is that the claims require wherein the ring corresponding to A of instant Formula (I) is a C3-5 cycloalkyl. However, Ali discloses that the group corresponding to A of the claims can alternatively be selected from a C3-10 cycloalkyl, which includes the C3-5 cycloalkyl ring of the claims, or a heterocyclyl each of which is substituted with R4, R5 or R6 as required by the claims (see claim 1, formula (I), R3 represents C3-10 cycloalkyl or C3-10 heterocyclyl substituted with Ra). Ali thus teaches that C3-10 cycloalkyl or heterocycloalkyl substituted an R4, R5 or R6 of the claims are equivalent groups at the position corresponding to A of instant Formula (I).
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It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify prior art compounds such as examples 1-27, 29, 30-35 and 43-58 into the claimed invention by exchanging the C6 cycloalkyl ring of example 29 or the heterocyclyl ring of examples 1-27, 30-35 and 43-58 for a C3-5 cycloalkyl ring because Ali disclosed that C3-10 cycloalkyl or heterocycloalkyl where equivalent groups at the position corresponding to A of the instant claims.
One would have been motivated as a matter of practicing the invention of Ali to prepare additional compounds of formula (I) for use in treating disease. One would have been especially motivated to make the modification because Ali specifically taught that the claimed compounds where embraced by formula (I).
One would have had a reasonable expectation of success because Ali disclosed that the position corresponding to A of the instant claims could alternatively be a C3-5 cycloalkyl as required by the claims. One wishing to practice the invention of Ali could have been reasonably expected to select modifications embraced by the invention.
Claim(s) 1-4, 6, 9-10, 12 and 16-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsen et al. (WO2020/112700 A1)(hereinafter “Larsen”).
Larsen teaches compounds corresponding to the instant claims wherein R1, R2 and R3 are each hydrogen, -OC1 alkyl or halogen and the group corresponding to A of instant Formula (I) is a C6 cycloalkyl substituted with -OH and heteroaryl (claim 10, page 274; pictured below for convenience). Larsen teaches a composition comprising the compounds (claim 11). Larsen teaches the compounds are useful in the treatment of cervical cancer (claims 12-13) and wherein the compounds may be administered with a PD-1 agonist wherein the agonist is pembrolizumab (claims 14-17).
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The difference between the compounds of Larsen and the instant claims is that the instant claims require wherein A is a C3-5 cycloalkyl. The compounds of Larsen and the instant claims are thus related as homologs, differing only in the number of repeating -CH2- groups. Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. See MPEP 2144.09.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Larsen into the claimed invention because homologs of Larsen would have been regarded as obvious over each other.
One would have been motivated as a matter of preparing additional compounds that may be useful for treating cervical cancer. One would have been particularly motivated to prepare the claimed compounds because homologs would have been presumed to have the same activity as the compounds disclosed in Larsen.
One would have had a reasonable expectation of success because the claims only differ from Larsen by repeating -CH2- groups.
Claim(s) 1-4, 6, 9, 12 and 16-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (WO2020112706)(hereinafter “Zhang”).
Zhang teaches compounds corresponding to the instant claims wherein R1 is OC1 alkyl; R2 and R3 are each hydrogen; and the group corresponding to A of instant Formula (I) is a C6 cycloalkyl substituted with -OH and/or heteroaryl (claim 14, page 249; pictured below for convenience). Zhang teaches a composition comprising the compounds (claim 15). Zhang teaches the compounds are useful in the treatment of cervical cancer (claims 16-17) and wherein the compounds may be administered with a PD-1 agonist wherein the agonist is pembrolizumab (claims 18-21).
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The difference between the compounds of Zhang and the instant claims is that the instant claims require wherein A is a C3-5 cycloalkyl. The compounds of Zhang and the instant claims are thus related as homologs, differing only in the number of repeating -CH2- groups. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art compounds into the claimed invention for the reasons provided above in the rejection over Larsen, the reasons of which are incorporated herein by reference.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-7, 9, 12 and 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No 10,822,338 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the patent claims.
Patent claim 1 is drawn to a compound of formula (I)
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.
Patent claims 2-15 depend from claim 1 and recite further limitations to formula (I).
Patent claim 16 depends from claim 1 and recites species of formula (I) including 7-methoxy-2-(3-(3,3,3-trifluoropropyl)cyclohexyl)-[1,2,4]triazolo[1,5-c]quinazolin-5-amine and 7-methoxy-2-(1-phenylpiperidin-3-yl)-[1,2,4]triazolo[1,5-c]quinazolin-5-amine (Examples 29 and 50 noted in the rejection over Ali above).
Patent claim 17 depends from claim 1 and recites a pharmaceutical composition comprising a compound of formula (I).
The specification teaches a compound of formula (I) is useful for treating diseases in which the A2A receptor is involved (see Abstract).
The only difference between the patent claims and the instant claims is that the instant claims require wherein the ring corresponding to A of instant Formula (I) is a C3-5 cycloalkyl. However, patent claim 1 permits that the group corresponding to A of the instant claims can alternatively be selected from a C3-10 cycloalkyl or a heterocyclyl each of which is substituted with R4, R5 or R6 as required by the claims (see patent claim 1, formula (I), R3 represents C3-10 cycloalkyl or C3-10 heterocyclyl substituted with Ra).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the patented compounds into the claimed invention because the patent claims embraced C3-5 cycloalkyl at the position corresponding to A of the instant claims.
One would have been motivated as a matter of practicing the patented invention to prepare additional compounds for use in treating disease.
One would have had a reasonable expectation of success because formula (I) of the patent claims embraced compounds wherein the group corresponding to A of the instant claims could alternatively be a C3-5 cycloalkyl. It would have been reasonable to expect that one wishing to practice the patented invention would select modifications that were embraced by the patented invention.
Claim(s) 1-4, 6 , 9-10, 12 and 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 9-11 of U.S. Patent No. 11,312,719 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the patent claims.
Patent claims 1-2 and 9 are drawn to a compound of Formula (I) wherein A is a C6 cycloalkyl substituted with heteroaryl
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Patent claim 10 depends from claim 1 and is drawn to a compound having formula
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,
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wherein A is C6 cycloalkyl substituted with heteroaryl (pyrazolyl) and -OH.
Patent claim 11 depends from claim 1 and recites a pharmaceutical composition.
The patent specification teaches the compounds are useful in a method of treating cervical cancer (col 29, Oncology).
Claim(s) 1-4, 6 , 9, 12 and 16-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 13-20 of U.S. Patent No. 12,263,171 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the patent claims.
Patent claims 1-3 and 5 are drawn to a compound of Formula (I) wherein A is a C6 cycloalkyl substituted with heteroaryl
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Patent claim 13 depends from claim 1 and is drawn to a compound having formula ,
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wherein A is C6 cycloalkyl substituted with heteroaryl (pyrazolyl).
Patent claims 14 depends from patent claim 1 and recites a pharmaceutical composition.
Patent claims 15-16 depend from claim 1 and recite a method of treating cancer including cervical cancer.
Patent claims 17-20 depend from patent claim 16 and recite wherein the compound is administered with another therapeutic agent and wherein the agent is pembrolizumab.
Regarding the above double patenting rejections over U.S. Patent Nos. 11,312,719 B2 and 12,263,171 B2, the difference between the patent claims and the instant claims is that the instant claims require C3-5 cycloalkyl. The patent claims and instant claims are thus related as homologs, differing only in the number of repeating -CH2- groups, and are therefore regarded as obvious over each other as noted in the above rejection.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify the patent claims into the instant claims because the claims are homologs of the patented compounds.
One would have been motivated as a matter of preparing additional compounds that may be useful for treating cancer.
One would have had a reasonable expectation of success in preparing the claimed compounds because the claimed compounds only differ by repeating -CH2- groups.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The closest references to the instant claims are Ali et al., Larsen et al., and Zhang et al. which were discussed in the rejections herein. The references are silent regarding the limitations set forth in claims 8, 11 and 13-14. There is no teaching which would have motivated a person of ordinary skill in the art before the effective filing date of the claimed invention to selectively modify any of the references into the claimed invention with any reasonable expectation of success.
Conclusion
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July 16, 2026
/KEVIN S MARTIN/Examiner, Art Unit 1624
Prosecution Insights