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 .
Claims 1, 3, 7, 10-16, 19-22, 24, 30, 32-34 and 39 are pending in this application.
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, 3, 7, 10-16, 19-22, 24, 30, 32-34 and 39 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 salt forms, does not reasonably provide enablement for solvates. 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. The claims are drawn to solvates. But the numerous examples presented all failed to produce a solvate. These cannot be simply willed into existence. As was stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190 “The specification purports to teach, with over fifty examples, the preparation of the claimed compounds with the required connectivity. Hence, applicants must show that solvates can be made, or limit the claims accordingly.
Claims1, 3, 7, 10-16, 19-22, 24, 30, 32-34 and 39 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. It is the Wands factors, which are used to evaluate the enablement question. In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988); 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 nature of the invention in the instant case, has claims which embrace compounds. The scope of “prodrug” is not adequately enabled. Applicants provide no guidance as how the compounds are made more active in vivo. The choice of a “prodrug” will vary from drug to drug. Therefore, more than minimal routine experimentation would be required to determine which prodrug will be suitable for the instant invention.
The instant compounds of formula (I) wherein the prodrugs are not described in the disclosure in such a way the one of ordinary skill in the art would know how to prepare the various compounds suggested by claim 30. In view of the lack of direction provided in the specification regarding starting materials, the lack of working examples, and the general unpredictability of chemical reactions, it would take an undue amount of experimentation for one skilled in the art to make the claimed compounds and therefore practice the invention.
Claims 33 and 39 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 non-small cell lung cancer, does not reasonably provide enablement for preventing and/or treating a disease mediated by SOS1 or a disease caused by RAS mutations. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The nature of the instant invention has claims, which embrace substituted fused pyrimidine compounds.
HOW TO USE: Claims 33 and 39 are drawn to the method of preventing and/or treating a disease or disorder, which is associated with SOS1 or RAS mutation activity. Any evidence presented must be commensurate in scope with the claims and must clearly demonstrate the effectiveness of the claimed compounds. 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. The scope of claims 33 and 39 includes diseases and/or conditions not even known at this time, which may be associated with SOS1 or RAS mutation activity. While the treatment of non-small cell lung cancer has been linked with SOS1 or RAS mutation the art does not recognize use of such inhibitors as broad-based drugs for treating all disorders instantly embraced.
The treatment of cancer generally cannot possibly be considered enabled.
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. BMW of N. 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).
By way of background, four cases are of particular relevance to the question of enablement of a method of treating cancers broadly or even generally:
In In re Buting, 57 CCPA 777, 418 F.2d 540, 163 USPQ 689, the claim was drawn to “The method of treating a malignant condition selected from the group consisting of leukemias, sarcomas, adenocarcinomas, lymphosarcomas, melanomas, myelomas, and ascitic tumors” using a small genus of compounds. The Court decided that human testing “limited to one compound and two types of cancer” was not “commensurate with the broad scope of utility asserted and claimed”.
. In Ex parte Jovanovics, 211 USPQ 907 the claims were drawn to “the treatment of certain specified cancers in humans” by the use of a genus of exactly two compounds, the N-formyl or N-desmethyl derivative of leurosine. Applicants submitted “affidavits, publications and data” for one of the compounds, and a dependent claim drawn to the use of that species was allowed. For the other, no data was presented, applicants said only that the other derivative would be expected to be less effective; claims to the genus were refused.
In Ex parte Busse, et al., 1 USPQ2d 1908, claims were drawn to “A therapeutic method for reducing metastasis and neoplastic growth in a mammal” using a single species. The decision notes that such utility “is no longer considered to be “incredible”, but that “the utility in question is sufficiently unusual to justify the examiner's requirement for substantiating evidence. Note also that there is also a dependent claim 5 which specified “wherein metastasis and neoplastic growth is adenocarcinoma, squamous cell carcinoma, melanoma, cell small lung or glioma.” The decision notes that “even within the specific group recited in claim 5 some of the individual terms used actually encompass a relatively broad class of specific types of cancer, which specific types are known to respond quite differently to various modes of therapy.”
In Ex parte Stevens, 16 USPQ2d 1379 a claim to “A method for therapeutic or prophylactic treatment of cancer in mammalian hosts” was refused because there was “no actual evidence of the effectiveness of the claimed composition and process in achieving that utility.”
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
Cancer is not a single disease, or cluster of closely related disorders. There are hundreds of cancers, which have in common only some loss of controlled cell growth. Cancers are highly heterogeneous at both the molecular and clinical level, something seen especially in, for example, the cancers of the breast, brain and salivary glands. They can occur in pretty much every part of the body. Here are some assorted categories:
It is important to note that tumors can need to be treated quite differently even though they are tumors of the same organ. For example, the drugs used most often to treat Wilms tumor, the most common malignant tumor of the kidneys in children, are actinomycin D and vincristine. Such drugs are never used with clear cell renal carcinoma, which is treated, although without much success, with immunotherapy using the cytokines interleukin-2 and interferon-alpha. However, such immunotherapy has never been established as effective in non-clear cell RCC forms such as papillary renal cell carcinoma. Despite strenuous efforts over a period of decades, no chemotherapeutic agent has ever been found effective against this cancer. Cancers of the stomach can be lymphomas, GISTs, carcinoid tumors, carcinomas, or soft tissue sarcomas, and for a single agent to be effective against all or even most of these categories would be contrary to what is known in oncology.
(7) The quantity of experimentation needed: Given the fact that, historically, the development of new cancers drugs has been difficult and time consuming, and especially in view of factors 1 and 4 and 6, the quantity of experimentation needed is expected to be great.
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
In view of the lack of direction provided in the specification regarding starting materials, the lack of working examples, and the general unpredictability of chemical reaction, it would take an undue amount of experimentation for one skilled in the art to make the claimed compounds and therefore practice the invention. To be enabling, the specification of a patent must teach those skilled in the art how to make and use the scope of the claimed invention without undue experimentation. The applicants are not entitled to preempt the efforts of others. The test for determining compliance with 35 U.S.C. § 112, is whether the applicants have clearly defined their invention.
It is difficult to treat many of the disorders claimed herein. Instant claim language embraces disorders not only for treatment but the prevention, which is not remotely enabled. It is presumed in the prevention of the diseases and/or disorders claimed herein there is a way of identifying those people who may develop a tolerance to opiate analgesia, etc. There is no evidence of record, which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with the disorders claimed herein.
Where the utility is unusual or difficult to treat or speculative, the examiner has authority to require evidence that tests relied upon are reasonably predictive of in vivo efficacy by those skilled in the art. See In re Ruskin, 148 USPQ 221; Ex parte Jovanovics, 211 USPQ 907; MPEP 2164.05(a).
Patent Protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. Tossing out the mere germ of an idea does not constitute enabling disclosure. Genentech Inc. v. Novo Nordisk 42 USPQ2d 1001.
As stated in the MPEP, 2164.08 ''[t]he 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. ln re Wright, 999 F.2d 1557, 1561 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). Nevertheless, not everything necessary to practice the invention need be disclosed. In fact, what is well known is best omitted. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991). AII that is necessary is that one skilled in the art be able to practice the claimed invention, given the Ievel of knowledge and skill in the art. Further the scope of enablement must only bear a reasonable correlation to the scope of the claims. See, e.g., In re Fisher, 427 F.2d 833, 839,166 USPQ 18, 24 (CCPA 1970). As concerns the breadth of a claim relevant to enablement, the only relevant concern should be whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). See also Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003) (alleged pioneer status of invention irrelevant to enablement determination.''
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 3, 13, 15, 16, 24 and 34 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 following reasons apply:
Claim 3 recites the limitation "C4-12 heterocyclyl…, C5-12 heteroaryl…, C6-12 aryl-fused C4-12 heterocyclyl" in the definition of B with respect to the size of the heterocyclyl or heteroaryl rings. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "C4-6 heterocyclyl or C5-12 heteroary" in the definition of B with respect to the size of the heterocyclyl or heteroaryl rings. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "C4-12 heterocyclyl…, C5-12 heteroaryl…, C6-12 aryl-fused C4-12 heterocyclyl" in the definition of B with respect to the size of the heterocyclyl or heteroaryl rings. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "6-membered/4-membered fused heterocyclyl" in the definition of RC with respect to the 4-membered ring. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the limitation "6-membered/4-membered fused heterocyclyl" in the definition of RC with respect to the 4-membered ring. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 24, the phrase "for example" in the definition of Rc1 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 34 is vague and indefinite in that it is not known what is meant by “as defined in formula (A), (I), or (II) where there are no definitions or formula (A), (I), or (II) in the claim.
Claim 34 is vague and indefinite in that it is not known what is meant by the definition of R6 which includes the moiety bromine or iodine which is included in the moiety halogen resulting in a double inclusion.
Claim 34 is vague and indefinite in that it is not known what is meant by “as defined in formula (A) or (I) where there are no definitions or formula (A) or (I) in the claim.
Claim 34 is vague and indefinite in that it is not known what is meant by “as defined in formula (II) where there are no definitions or formula (II) in the claim.
Claim 34 is vague and indefinite in that it is not known what is meant by “as defined in formula (III) where there are no definitions or formula (III) in the claim.
Claim 34 is vague and indefinite in that it is not known what is meant by “as defined in formula (IV) where there are no definitions or formula (IV) in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 7, 10-14, 32-34 and 39 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wan et al., U.S. Patent Application Publication No. 2024/0254117. Wan teaches the compounds, compositions and method of use of the compounds of formula (A) where Z is N; Y is C which together with ring A form an imidazole ring; X is C; R1 is RC; RC is tetrahydropyran-4-yl, phenyl, pyrid-3-yl, benzofuran-5-yl, morpholin-4-yl, piperazin-1-yl, 3,8-diazabicyclo[3.2.1]oct-3-yl, piperidin-4-yl, 1,1-dioxidothiopyran-4-yl, 8-azabicyclo[3.2.1]oct-8-yl, etc.; Rc1 is absent, OH, CH3, cyclopentyl, CH(CH3)2, OCH3, C(=O)CH3, CN, C(=O)CH(CH3)2, oxo, etc.; R2 is hydrogen or CH3; R3 is methyl, etc.; R4 is CF3, NH2, NO2, CH3, etc.; w is 1 or 2; and ring B is phenyl, as set forth in examples 21-23, 30, 69-83, 85-96, etc.; or the compounds of formula (V) where Z is N; Y is C which together with ring A form an imidazole ring; X is C; R6 is Br; R5 is OH; R2 is methyl; R3 is methyl as set forth in examples 69, 75, 94, etc.; or the compounds of formula (VI), (VII), (VIII) or (IX) where Z is N; Y is C which together with ring A form an imidazole ring; X is C; R6 is Br; R2 is hydrogen; R3 is methyl; R4 is CF3, NO2, etc.; w is 2; and ring B is phenyl, as set forth in examples 69, 82, 94, etc.
Claim(s) 1, 3, 7, 10-14, 32, 33 and 39 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wang et al., WO 2022/156792. Wang teaches the compounds, compositions and method of use of the compounds of formula (A) where Z is N; Y is C which together with ring A form a triazole ring, a pyrazole ring, an imidazole ring; X is C; R1 is RC; RC is CH3, tetrazol-5-yl, etc.; Rc1 is N(CH3)2, oxo, etc.; R2 is hydrogen, CH3, CF3; R3 is methyl, etc.; R4 is CHF-CH2OH, F, CF2H, NH2, CH3, 1-hydroxycycloprop-1-yl, 1-aminocycloprop-1-yl, 1-amino-1-methylethyl, etc.; w is 2, 3 or 4; and ring B is phenyl as set forth in examples from lines 5-6 pages 89 and 90, lines 6-7 page 94, examples 219, 235, 238, etc.
Claim(s) 1, 3, 7, 10-14, 30, 32, 33 and 39 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lv et al., WO 2022/161480. Lv teaches the compounds, compositions and method of use of the compounds of formula (A) where Z is N or C; Y is N or C which together with ring A form an imidazole ring, pyrazole ring, pyrazolidine, etc.; X is C; -O-RA; RA is tetrahydrofuran3-yl, etc.; R2 is hydrogen; R3 is methyl, etc.; R4 is CF3, NH2, F, CF2-C(CH-3)2OH, CHF-CH2OH, CF-2-CH3, etc.; w is 1, 2 or 3; and ring B is phenyl, pyrid-4-yl, pyrid-2-yl, pyramid-4-yl, pyramid-2-yl, as set forth in examples on page 18, etc.
Claim(s) 1, 3, 7, 10-14, 30, 32-34 and 39 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al., U.S. Patent Application Publication No. 2024/0109891. Zhang teaches the compounds, compositions and method of use of the compounds of formula (A) where Z is N; Y is C which together with ring A form a triazole ring; X is C; R1 is ORA or RC; RA is tetrahydrofuran-3-yl; RC is tetrahydropyran-4-yl, pyrid-3-yl, piperidin-4-yl, pyrrolidine-3-yl, dihydropyran-4-yl, cyclohexyl, etc.; Rc1 is absent, oxo, methyl, C(=O)CH3, methylsulfonyl, C(=O)CH2OCH3, hydroxy, etc.; R2 is hydrogen; R3 is methyl; R4 is CF2-CH2OH, F, CF2H, CF3, C(CH3)2OH, NH2, etc.; w is 1 or 2; and ring B is phenyl, inden-4-yl, as set forth in examples 1-23, etc., or the compounds of formula (V) where Z is N; Y is C which together with ring A form an triazole ring; X is C; R6 is Br; R5 is OH, -O-SO2-(4-methylphenyl), etc.; R2 is methyl; R3 is methyl as set forth in examples 1, 17, 18, 23, etc.; or the compounds of formula (VI), (VII), (VIII) or (IX) where Z is N; Y is C which together with ring A form an triazole ring; X is C; R6 is Br, OH, etc.; R2 is hydrogen; R3 is methyl; R4 is F, CF3, NH2, etc.; w is 1 or 2; and ring B is indenyl, phenyl, etc., as set forth in examples 1, 17, 18, 23, etc.
Claim(s) 1, 3, 7, 10-14, 30, 32-34 and 39 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Su et al., U.S. Patent Application Publication No. 2025/0230159. Su teaches the compounds, compositions and method of use of the compounds of formula (A) where Z is N; Y is C which together with ring A form a triazole ring, tetrazole ring, imidazole ring, etc.; X is C; R1 is ORA, N(RD)RB or RC; RA is tetrahydrofuran-3-yl; RB is 1,1-dioxido-tetrahydrothiopyran; RC is methyl, piperidinyl, azetidinyl, morpholino, 1,1-dioxido-thiomorpholino, cyclohexyl, piperizinyl, pyrrolidine-3-yl, pyranyl,
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, oxazepin-4-yl, oxazol-3-yl, cyclopropyl, etc.; RD is hydrogen; Rc1 is F, oxo, ethyl, methoxy, methylsulfonyl, CF3, CF2H, hydroxy, NH(t-butyl), morpholino, 3-methylmorpholino, 3,5-dimethylmorpholino, 3,3-dimethylmoropholino, piperidin-4-yl, 4-methylpiperazinyl, N(i-propyl)2, N(CH3)2, NHCH3, NHC(=O)CH3, C(=O)CH3, C(=O)CH2OCH3, CH3, C(=O)CH(OH)(CH3), CN,
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, thiomorpolino, 1,1-dioxido-thiomorpholinyl,
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, etc.; R2 is hydrogen, methyl, CF3, etc.; R3 is hydrogen, methyl; R4 is CF3, NH2, CHF2, F, CH3, etc.; w is 2; and ring B is phenyl, as set forth in examples 1-3, 6, 7, 9-19, 27-29, 31-40, 42-60, 62-68, 72-174, etc., or the compounds of formula (VI), (VII), (VIII) or (IX) where Z is N; Y is C which together with ring A form a tetrazole ring, triazole ring, etc.; X is C; R6 is Br, etc.; R2 is CH3; R3 is hydrogen, methyl; R4 is F, CF2H, etc.; w is 1 or 2; and ring B is phenyl, etc., as set forth in examples 74, 90, 91, 100, 153, 169, 170, etc.
Specification
The disclosure is objected to because of the following informalities: compounds 107 and 112 are missing part of their structure.
Appropriate correction is required.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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