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 .
Status of the Claims
Claims 1-7 and 10-21 are pending.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Instant application is a U.S. National Stage Entry of PCT/CN2021/134071, filed 11/29/2021. PCT/CN2021/134071 claims priority of foreign application CN202011414870.5, filed 12/02/2020. Therefore, the effective filing date is 12/02/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/29/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Restriction/Election Requirement
Applicant's election with traverse of Group I, directed to compounds of Formula I, claims 1-7, 10-15, 20, and 21, in the reply filed on 12/29/2025 is acknowledged. The traversal is on the grounds that there is not a “clear case” of lacking unity, and that the examination of the full scope of the claims would not impose a serious search burden upon the examiner. This is not found persuasive because Formula I, shown below, only has a single amino group as the core structure/technical feature, since the rings around the amino group contain the variables B1, B2, B3, D1, D2, and D3. This would constitute a serious search burden in the case of the restriction requirement and the election of species requirement. Additionally, the invention was proven to lack a unity of invention with the prior art, which showed that the technical feature did not constitute a special technical feature.
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The requirement is still deemed proper and is therefore made FINAL.
Applicant further elected the species of Example 2, shown below, which reads on instant claims 1-7, 10-15, 20, and 21 of Group I.
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The scope of the search has been limited to include the elected species and any 35 U.S.C. 102 art found in the search of the elected species.
Claims 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/29/2025.
Improper Markush Grouping
Claims 1-5, 10-15, and 21 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the 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 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 various permutations of variables A, R0, B1, B2, B3, -D1, D2, D3, R7, and R8 results in compounds that only require a structure of an amine in common, which is not a significant structural similarity. The varying permutations are not recognized to belong to the same physical or chemical class or to be the same art-recognized class. For example, both exemplary compounds shown below read on instant Formula I, and only have an amino group in common.
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To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. The scope of Formula I (inclusive of the elected species) that would form a proper Markush grouping would be D1, D2, and D3 are all defined. There would appear to be several different ways in which a proper Markush grouping could be derived from the scope instantly claimed. However, defining the D1, D2, and D3 variables to constitute a common core structure would appear to be a minimum requirement.
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 1-7, 10-15, and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, claims 1-7, 10-15, and 21 are drawn to compounds/methods of Formula (I) and/or a “prodrug thereof”.
The compounds of Formula (I) are structurally defined. However, the genus of “a prodrug” of Formula (I) is not fully structurally defined. It is unclear what is encompassed by the term “prodrug”. The specification does not provide a definition of the term “prodrug”, but teaches, in paragraph [0071] that examples include: “simple esters of carboxylic acid-containing compounds (e.g., those obtained by condensation with a C1-C4 alcohol according to methods known in the art); esters of hydroxy containing compounds (e.g., those obtained by condensation with a C1-C4 carboxylic acid, C3-C6 diacid or anhydride thereof, such as succinic anhydride and fumaric anhydride according to methods known in the art); imines of amino containing compounds (e.g., those obtained by condensation with a C1-C4 aldehyde or ketone according to methods known in the art); carbamate of amino containing compounds, such as those described by Leu, et al., (J. Med. Chem. 42:3623-3628 (1999)) and Greenwald, et al., (J. Med. Chem. 42:3657-3667 (1999)); and acetals and ketals of alcohol-containing compounds (e.g., those obtained by condensation with chloromethyl methyl ether or chloronethyl ethyl ether according to methods known in the art)”.
Prodrugs are derivatives or precursors of therapeutically active molecules which undergo bioconversion into their active form inside the body. See, for example, Walther et al. (“Prodrugs in Medicinal Chemistry and Enzyme Prodrug Therapies.” Advanced Drug Delivery Reviews, vol. 118, Sept. 2017, pp. 65–77), which discusses prodrugs in medicinal chemistry and enzyme prodrug therapies. Prodrugs are typically employed when, for example, the parent drug compound has poor aqueous solubility, poor absorption from the gastro-intestinal tract into the blood, poor rates of cell entry, or various other reasons (see Table 1 of Walther). Design strategy for a prodrug depends on the structural features of the parent drug molecule and availability of the appropriate chemical functionalities that can be used to mask pharmacodynamic activity of the drug through an attachment of a modifying group. Typically, an enzymatic process is relied upon for drug release.
In particular, Walther notes that esters are commonly used as prodrugs due to the ubiquity of esterases in the body and the abundance of hydroxyl and carboxylic acid functionalities in drug compounds (see pg. 67, “Esterases: a “universal tool for drug recovery”).
However, a person having ordinary skill would not readily envisage a prodrug of Formula (I) having an ester, because there is no hydroxyl or carboxylic acid functionality in the compounds. Walther discloses other common prodrugs for bioconversion, such as phosphate prodrugs, nitrophenyl prodrugs, glycoside prodrugs, and others. However, these various strategies are relied upon typically to release free hydroxyl or amino groups, which are not present in the compounds of Formula (I).
Applicant’s specification provides no specific examples of a “prodrug” of the compounds of Formula (I). Additionally, no disclosure is provided which would guide a person of ordinary skill toward a particular prodrug strategy or design for the compounds of Formula (I).
Methods of synthesizing compounds are, in general, known to the person of ordinary skill, however methods of making the myriad of compounds embraced by the instant claims is beyond the skill of the artisan, particularly when certain elements, such as “a prodrug”, are merely described partially. As such, the instant specification and instant claims do not provide sufficient description such that one could anticipate what additional elements may be present in the prodrugs of Formula (I).
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
The rejection would be overcome by amending the claims to remove the term “prodrug”.
Claims 1-6, 10-15, and 21 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 compound of Formula I where D1, D2, and D3 are CH; B1, B2, and B3 are N or CH; R8 is piperazinyl optionally substituted with C1-3 alkyl; A is as defined in claim 5; and R0 is C3-8 carbocycle or a 4-7-membered heterocycle wherein the heteroatom(s) are N or O, does not reasonably provide enablement for compounds of Formula I. 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 the invention commensurate in scope with these claims.
To be enabling, the specification of the patent application 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 (Fd. 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). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth 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:
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 prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
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 nature of the invention
The nature of the invention relates to compounds of Formula (I) in claim 1. Such compounds are taught to be useful as kinase inhibitors. This invention is also directed to compositions comprising said compounds.
Predictability of the art
The hypothetical compounds in claim 1 would be unpredictable in terms of one skilled in the art being able to synthesize every possible compound claimed in instant claim 1. 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, 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.
Level of skill in the art
An ordinary artisan in the area of drug development would have experience in synthesizing and screening chemical compounds for particular activities, such as a medical doctor or chemist. Screening 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 often be employed, developing a therapeutic method, as claimed, is generally not well-known or routine, given the complexity of certain biological systems.
4. The breadth of the claims
The scope of the claims involves compounds of Formula (I), shown below.
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Claim 1 is very broad in the number of variables and the options of substituents for each variable. Substituents A, R0, D1-3, B1-3, R7, and R8 are all “optionally substituted”, with no definition of the optional substituents, which results in an infinite number of compounds encompassed by claim 1.
5. The amount of direction provided, the presence or absence of working examples, and the quantity of experimentation necessary
The specification only provides the synthesis of 41 compounds. In all of the compounds synthesized, D1, D2, and D3 are CH; B1, B2, and B3 are N or CH; R8 is piperazinyl; A is as defined in claim 5; and R0 is C3-7 carbocycle or a 6-membered heterocycle wherein the heteroatom(s) are N or O. However, it would be assumed that the inventors are also enabled for R0 being a 4, 5, or 7-membered heterocyclic ring, since these substituents would be similar in size and reactivity.
Synthesis methods are not taught in the specification to provide for the aforementioned variables to include all of the possible substituents listed in the claims. It would be expected that the varying ring sizes (e.g., A, R0, and R8-) and heteroatoms in the rings would change the reactivity of the compounds, and therefore may require alternate synthesis methods. It could also be possible that some combinations of compounds may not be able to be synthesized due to their instability (e.g., where the rings and optional substituents on these rings are large and cause steric hindrance). Due to the large scope of variables, and the optional substituents on each of these variables, it would require one skilled in the art, such as a chemist, to perform an infinite number of reactions to determine which compounds of Formula (I) can be prepared and would require synthesis methods other than those provided in the specification. This is undue experimentation given the limited guidance and direction provided by Applicants.
Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. 112(a), since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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 1-6, 10-15, and 21 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.
Regarding claims 1, 3, 4, 6, 11, 13, and 15, the phrase "optionally substituted" renders the claim indefinite because the claims include elements not actually disclosed (those encompassed by "optionally substituted"), thereby rendering the scope of the claims unascertainable. Neither the specification nor the claims define the optional substituents, which results in an indefinite number of compounds that are included in the instant claims.
Claims 2, 5, 10, 12, 14, and 21 are rejected as being dependent upon a rejected claim and failing to define all optional substituents. This rejection would be overcome by defining the optional substituents.
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.
Claims 1-6 and 10-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al. (Design, Synthesis, and Biological Evaluation of 2-Oxo-3,4-dihydropyrimido[4,5-d]pyrimidinyl Derivatives as New Irreversible Epidermal Growth Factor Receptor Inhibitors with Improved Pharmacokinetic Properties, J. of Med. Chem., 2013, Vol. 56, pages 8803-8813).
Xu et al. teaches, in Table 1, compounds 2a-2f, 2h-2l, and 2r-2v, which read on the instant claims. For example, compound 2h, shown below, reads on instant claims 1-6 and 10-15, where in Formula I of the instant claims, A is a substituted heterocyclic group, R0 is a substituted pyrrolidinyl group, B1 is N, B2 is N, B3 is CH, D1-3 are CH, R7 is methoxy, and R8- is N-methyl piperazinyl.
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Claims 1-6, 10-15, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ding et al. (CN 104418860 A).
Ding et al. teaches, in paragraph [0248], the compound shown below, which reads on instant claims 1-6 and 10-15, where in Formula I of the instant claims, A is a substituted heterocyclic group, R0 is a substituted pyrrolidinyl group, B1 is N, B2 is N, B3 is CH, D1-3 are CH, R7 is methoxy, and R8- is N-methyl piperazinyl.
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It is taught, in claims 7 and 8, that the compound is used in a pharmaceutical composition for the treatment of cancers. Ding et al. teaches, on pages 7-8 of the English translation, that the composition further comprises an anti-cancer agent which includes those listed in instant claim 21.
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 1-7, 10-15, 20, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Dobrusin et al. (WO 9961444 A2), further in view of Ding et al. (cited above).
Dobrusin et al. teaches, in claim 7, compounds having the formula shown below.
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A specific compound taught, in Example 11 of Table 5, is 1-cyclopentyl-3,4-dihydro-7-[[4-(4-methyl-1-piperazinyl)phenyl]amino]-pyrimido[4,5-d]pyrimidin-2(1H)-one, shown below.
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The compound shown above is taught, on page 5 lines 12-15, to be an inhibitor of growth factor mediated tyrosine kinases, specifically EGFR. It is taught, in claim 38 and on page 5 lines 16-19, that since this compound is an inhibitor of EGFR, it can be used to treat certain cancers.
The compound above differs from the instant elected species in that it does not contain a methoxy group on the phenyl ring.
However, it is taught in claims 1 and 8, that the phenyl group may be substituted with an alkoxy. Additionally, in view of the compounds taught by Ding et al. (see above rejection), which are taught to be EGFR inhibitors that are used to treat cancers, it would be prima facie obvious to select a methoxy substituent taught by Dobrusin et al., since similar compounds that are taught to be used for the same purpose by Ding et al. are shown to have a methoxy substituent on the phenyl group.
The close structural similarity and the same function taught by both Dobrusin et al. and Ding et al. would lead one of ordinary skill in the art to have a reasonable expectation of success in adding a methoxy substituent on the compound taught by Dobrusin et al., since it is suggested by both Dobrusin et al. and Ding et al. to do so, and it is common practice in the art to create derivatives of known compounds in order to test their biological efficacy.
Regarding claim 21, it is taught by Ding et al. that the composition can further contain the anticancer agents listed in claim 21. It is also taught by Dobrusin et al., on page 18 lines 22-23, that the composition can contain other compatible therapeutic agents. Therefore, it would be prima facie obvious to include additional anticancer agents, such as those of instant claim 21, since these are taught to be compatible in the composition to treat cancer by both Ding et al. and Dobrusin et al.
Nonstatutory 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.
Claims 1-3, 10, 11, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6 and 14-19 of copending Application No. 18/702,540 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Application ‘540 teaches compounds of Formula I, shown below, where L can be NH; A1-2, B1-5, and D2-4, can be N or CH; D1 can be CR3, wherein R3 is halogen, alkoxy, or alkyl; Cy1 can be carbocyclic or heterocyclic; and Cy2 can be carbocyclic or heterocyclic, as in instant claims 1-3 and 11.
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The instant claims differs from the copending claims because the compounds are positional isomers of the compounds of Application ‘540. It is well known in the art that compounds having the same radical at different positions on the nucleus are position isomers. Their properties are often so nearly alike as to present difficulties in identification or separation. Ex parte Mowry (POBA 1950) 91 USPQ 219. A compound which is isomeric with a compound of the prior art is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. In re Norris (CCPA 1950) 179 F2d 970, 84 USPQ 458; In re Finley (CCPA 1949) 174 F2d 130 and 135, 81 USPQ 383 and 387.
A compound need not be an adjacent homolog or position isomer of a prior art compound in order to be susceptible to a rejection based on structural obviousness; the name used to designate the structural relationship between compounds is not controlling, it is the closeness of that relationship. In re Payne et al. (CCPA 1979) 606 F2d 303, 203 USPQ 245. When chemical compounds have “very close” structural similarities…without more, a prima facie case of obviousness may be made. In re Grabiak (CAFC 1985) 769 F2d 729, 226 USPQ 870.
Claims 14 and 15 of Application ‘540 teach a pharmaceutical composition of said compounds further comprising an anticancer agent, as in instant claims 10 and 21.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-7, 10-15, 20, and 21 are rejected.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624