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 December 15, 2022 are acknowledged and entered. Claims 1-17 are pending.
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.
Priority
This application is a 371 of PCT/US2021/014981, filed January 26, 2021, which claims benefit of 63/057,686, filed July 28, 2020 and 62/966,103, filed January 27, 2020.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statement filed on April 3, 2024. All references have been considered except where marked with a strikethrough.
Election/Restriction
Applicant’s election with traverse of Group 1, claims 1-7 and 13, drawn to a compound of formula I and the species corresponding to Compound 134 (pictured below for convenience) in the reply filed on July 11, 2025 is acknowledged. Upon further consideration, the restriction requirement has been withdrawn in part: The requirement for restriction between Groups 1-3 has been withdrawn and Groups 1-3 are presently under examination. The election of species requirement is maintained. 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)). Therefore this restriction is considered proper and thus made FINAL.
The elected species corresponds to formula I wherein
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R1 is (C6 alkanediyl)OH corresponding to
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; R5 is C1 alkyl; one X1 is N and the other three are CR2 wherein two R2 are H and the other is OC1 alkyl; m is 0; n is 1; and R3 is
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. Claims 1-2, 6-7 and 9-13 read on the elected species.
The guidelines in MPEP § 803.02 provide that upon examination if prior art is found for the elected species, the examination will be limited to the elected species. If the elected species or group of patentably indistinct species is not anticipated by or obvious over the prior art, the examiner should extend the search and examination to a non-elected species or group of species that falls within the scope of a proper Markush grouping that includes the elected species. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made.
The elected species was not found in the prior art and the search was expanded to include the subgenus of formula (I) wherein X1 is N or CR2; and m is 0. And art was found. Claims 1-17 read on the expanded subgenus.
Claims 1-17 (all in part, other than the above indicated subgenus) are additionally withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species.
Improper Markush Grouping Rejection
Claims 1, 6-7 and 9-12 are rejected on the basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of formula (I) when m is 1 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
The compounds with the scope of formula (I) recited in the instant claims are not all members of the same recognized physical or chemical class or the same art-recognized class. The possible structures of formula (I) do not overlap and are comprised of different heterocyclic groups that have different classifications. For instance, when m is 1, the claims require X2 and an additional heteroaryl or aryl ring corresponding to
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which changes the classification of the compounds included in the scope of the claims.
The claims are thus drawn to an improper Markush group, that is, the claims lack unity of invention. By vary m between 0 and 1, several patentably distinct and independent compounds are claimed. In order to have unity of invention the compounds must have “a community of chemical or physical characteristics” which justify their inclusion in a common group, and that such inclusion is not repugnant to principles of scientific classification. In re JONES (CCPA) 74 USPQ 149 (see footnote 2). In this case, there is no substantial structural feature in common between the compounds of the instant claims.
Note, the rejection may be overcome by amending claims to recite m is 0.
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 9-12 and 14-17 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 head and neck cancer comprising administration of formula (I) and an anti-PD1 antibody selected from nivolumab or pembrolizumab, does not reasonably provide enablement for treating cancer generally with the combination of formula (I) and any anti-cancer immunotherapy agent (e.g. an anti-CTLA-4 antibody).
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. In the instant case, TLR7 agonists alone or in combination with immunotherapy are not recognized as having efficacy in the broad treatment of all forms of cancer presently claimed. Applicant’s disclosure is only enabling for the treatment of cancers which Applicant has demonstrated may be treated by the instant combination, and of specific cancers which the art is aware can be treated with a TLR7 agonist and immunotherapy 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 well-established correlation between the assay and clinical efficacy. Applicants have not demonstrated nor have they alleged there is any correlation between the in vitro assays they disclose at pages 83-85 and clinical efficacy against all cancers included in the scope of the claims. Given the direction provided by Applicant, one skilled in the art could not practice the full scope of the invention without undue and unreasonable experimentation.
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)" (emphasis added). 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 principle was explicitly affirmed most recently in Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int'l, Inc. v. BMWofN. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
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:
Claims 1 and 8 are drawn to a compound of formula (I) or formula (Ib). Applicant teaches the claimed compounds are agonists of TLR7 (see Biological Activity on pages 83-85)
Claims 9 and 14 depend from claims 1 and 8, respectively, and recite a method of treating a cancer, comprising administering to a patient suffering from such cancer a therapeutically effective combination of an anti-cancer immunotherapy agent and a compound according to claims 1 or 8.
Claims 10-12 and 15-17 depend from claims 9 and 14, respectively, and recite types of anti-cancer immunotherapy agents as well as specific forms of cancer.
No limiting definition of “cancer” or “anti-cancer immunotherapy agent” is provided by Applicant. The nature of the invention is thus a method of treating cancer by administration of the combination of a TLR7 agonist and immunotherapy. The scope of the method broadly includes any form of cancer, not limited to those recited, and an immunotherapy agent.
The state of the prior art
Activation of TLR7 and cancer treatment
The state of the prior art is aware that head and neck cancer may be treated by the combination of a TLR7 agonist and anti-PD1 antibody. Sato-Kaneko et al. (JCI Insight 2017; 2(18) e93397; cited by Applicant in IDS filed April 3, 2024) teaches experiments demonstrate that combination therapy with delivery of a TLR agonist and anti-PD1 antibody may lead to the treatment of head and neck squamous carcinoma (Abstract).
The state of the prior art; however, does not appear to be aware that head and neck cancer can be treated with a TLR7 agonist and any other immunotherapy agent (e.g. an anti-CTLA-4 antibody). The state of the prior art recognized that CTLA-4 and PD1 are different protein targets and therefore one would not expect an anti-CTLA-4 and anti-PD1 antibody to be interchangeable. The prior state of the art also is not aware that a TLR7 agonist alone or in combination with an anti-immunotherapy agent is broadly applicable to treating all forms of cancer as is claimed.
Cancer treatment generally
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. As such, 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 cancer 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.
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 teaches the claimed compounds are agonists of TLR7 (see Biological Activity on pages 83-85). Applicant further cites Sato-Kaneko et al. (referenced above) which illustrates potential efficacy in the treatment of head and neck cancer.
However, no experimental or other data is provided to show the instant method treats any cancer within the scope of the claims. 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 all forms of cancer included in the scope of the method. As the Supreme Court said in Brenner v. Manson, 148 USPQ at 696: “a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” As U.S. Court of Customs and Patent Appeals stated In re Diedrich 138 USPQ at 130, quoting with approval from the decision of the board: “We do not believe that it was the intention of the statutes to require the Patent Office, the courts, or the public to play the sort of guessing game that might be involved if an applicant could satisfy the requirements of the statutes by indicating the usefulness of a claimed compound in terms of possible use so general as to be meaningless and then, after his research or that of his competitors has definitely ascertained an actual use for the compound, adducing evidence intended to show that a particular specific use would have been obvious to men skilled in the particular art to which this use relates.”
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 and unreasonable experimentation.
Claim Rejections - 35 USC § 112b
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.
Claims 1-7 and 9-17 are 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. The claims are indefinite for the reasons that follow:
Claim 1 is indefinite because it appears to have two different definitions of R1, R2, R3 and R5. On page 3 of the claims immediate after the recitation “n is 1, 2, or 3;” the claims recite:
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It is not clear if the limitations on page 3 following the phrase “wherein R1, R2, R3 and R5” are additional definitions of R1, R2, R3 and R5 or intended to be optional substituents on R1, R2, R3 and R5. Clarification is respectfully requested.
Claim 1 recites “aryl” and “heterocycle” which are indefinite because there is no closed scope of these groups provided in the specification. The definition of “Aryl” at [00186] is itself indefinite (e.g. definition recites preferably monocyclic). “Heterocycle” is not defined in the specification and includes both saturated and unsaturated rings and an unspecified number and type of heteroatom. Examiner suggests amending the claim to limit the size of “aryl” groups as well as type of heterocycle including possible heteroatoms.
Claims 2-6 and 9-13 depend from claim 1, do not cure the above deficiencies, and therefore are also indefinite.
Claims 5 and 7 include the limitations R3 is
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. There is insufficient antecedent basis for these limitations because the claims depend from claim 1 which does not provide clear support for these groups. None of the possible definitions recited in claim 1 appear to describe the above structures. For instance, the structures above do not correspond to
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nor do they correspond to NH(C1-C4 alkanediyl)0-1(C3-C6 cycloalkyl) which seem to be the closest possible definitions. Clarification is respectfully requested.
Claims 9 and 14 recite the limitation “cancer” which is indefinite because the scope of “cancer” has not been defined by the specification (see [0049]: Cancers that could be treated…include…). Cancer is a generic term that corresponds to thousands of distinct diseases, and based on the specification, one skilled in the art could not say which cancers are included in the scope of the claim. Examiner suggests amending the claim to recite specific cancers.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 11 and 16 recites the broad recitations “lung cancer”, “lymphoma”, “skin cancer” and “urothelial cancer”, and the claim also recites “including non-small cell lung cancer”, “including Hodgkin’s lymphoma”, “including melanoma and Merkel skin cancer” and “including bladder cancer” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Dependent claims 10, 12, 15 and 17 do not cure the abovementioned deficiencies in claims 9, 11, 14 and 16 and are therefore also indefinite.
Claim Rejections - 35 USC § 102
(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(s) 1-5 and 9-13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by He et al. (US 11,554,120 B2; effectively filed August 3, 2018)(hereinafter “He”) .
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
He teaches compound 840 (see col 25; pictured below for convenience) which corresponds to instant formula (I) wherein R1 is (C6 alkanediyl)OH corresponding to
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; R5 is H; each X1 is CR2 wherein three R2 are H and the fourth is O(C1 alkyl); m is 0; n is 1; and R3 is
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.
He further teaches compound 856 (see col 28; pictured below for convenience) which corresponds to instant formula (I) wherein R1 is C4 alkyl; R5 is H; one X1 is N and the other X1 are each CR2 wherein two R2 are H and the third is O(C1 alkyl); m is 0; n is 1; and R3 is
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.
He teaches the compounds may be used in a combination therapy with an anti-cancer immunotherapy agent such as an anti-PD1 agent or nivolumab to treat cancers including head and neck cancer (col 51-52; Table A).
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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.
A non-statutory obviousness-type 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); and In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985).
Obviousness-type double patenting requires rejection of an application claim when the claimed subject matter is not patentably distinct from the subject matter claimed in a commonly owned patent, or a non-commonly owned patent but subject to a joint research agreement as set forth in 35 U.S.C. 103 (c)(2) and (3), when the issuance of a second patent would provide unjustified extension of the term of the right to exclude granted by a patent. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 58 USPQ2d 1869 (Fed. Cir. 2001); Ex parte Davis, 56 USPQ2d 1434, 1435-36 (Bd. Pat. App. & Inter. 2000).
One having ordinary skill in the art at the time of the invention would have noted that subject matter exists in both the instant invention and the below mentioned copending applications or issued patent that is not patentably distinct from each other. It has also been held that a prior art disclosed genus of useful compounds is sufficient to render prima facie obvious a species falling within a genus. In re Susi, 440 F.2d 442, 169 USPQ 423, 425 (CCPA 1971), followed by the Federal Circuit in Merck & Co. v. Biocraft Laboratories, 847 F.2d 804, 10 USPQ 2d 1843, 1846 (Fed. Cir. 1989).
Claims 1-5 and 9-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-13 of U.S. Patent No. 11,554,120. 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 recites a compound of Formula (I) (genus pictured below). In the patented genus, R5 is H as is required by the instant claims; m is 0-1 and n is 1-3.
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Patent claim 2 provides that R1 can be
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.
Patent claim 4 provides that
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can be
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or
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.
Patent claim 6 provides that R3 can be
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One skilled in the art can very clearly see that the instant genus claim, and therefore compounds, are already covered by the patent claims and thus the claims are obvious. One would have been motivated to obtain the patented compounds, which includes the instant claims, as a matter of practicing the patented invention. One would have had a reasonable expectation of success because all claim limitations were disclosed in the patent claims.
Claim 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 17/793,155 or claims 1-20 of copending Application No. 17/793,162 or claims 1-20 of copending Applicant No. 17/793,174 (reference applications), all of which have the same effective filing date, January 27, 2020, as the instant claims. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Application No. 17/793,155
Reference claim 1 is drawn to formula (I) wherein W is
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; R1 includes the instant claims (e.g.
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); R3 includes the instant claims (e.g.
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); R5 includes the instant claims (e.g. H, C1-C5 alkyl….).
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Reference claim 6 is explicitly drawn to formula (Ia) which corresponds to the insant claims wherein R5 is H.
Reference claims 10-12 recite a method of treating cancer.
Application No. 17/793,162
Reference claim 1 is drawn to formula (I) wherein W is
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; R1 includes the instant claims (e.g. C1-C5 alkyl) ); R3 includes the instant claims (e.g.
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); R5 includes the instant claims (e.g. H, C1-C5 alkyl….).
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Reference claim 10 is explicitly drawn to formula (Ib) which corresponds to instant formula (Ib) when R2 is OCH3.
Reference claims 15-18 recite a method of treating cancer.
Application No. 17/793,174
Reference claim 1 is drawn to formula (I) wherein W is
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; R1 includes the instant claims (e.g. C1-C5 alkyl) ); R3
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which corresponds to the instant claims when instant R3 is
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; R5 includes the instant claims (e.g. H, C1-C5 alkyl….).
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Reference claim 10 is explicitly drawn to formula (Ib) which corresponds to instant formula (Ib) when R2 is OCH3.
Reference claims 13-20 recite a method of treating cancer.
As above regarding the patent, one skilled in the art can very clearly see that the instant genus claim, and therefore compounds, are already covered by the reference claims and thus the claims are obvious. One would have been motivated to obtain the reference compounds, which includes the instant claims, as a matter of practicing the invention. One would have had a reasonable expectation of success because all claim limitations were disclosed in the reference claims.
Conclusion
No claim is allowed.
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July 29, 2025
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624