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 .
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Status of the Claims
Claims 1-26 are pending in this application.
Claim Objections
Claim 1 is objected to because of the following informalities:
In the definition of L (4th to last line, page 2) applicant states: “C16 alkylene”. It is believed that applicant intended “C1-6 alkylene”
In the definition of R1 (line 2, page 3) applicant states: “( . . . ), H, , C1-6 ( . . . )”. Remove the second comma and space after “H”.
In the definition of R2 (line 4, page 3) applicant states: “C3-12 cycloalkyl, or, and is optionally ( . . .)”. Either delete the “or,” or add the missing limitation, as long as it is supported by the specification.
Appropriate correction is required.
Claims 5 and 9-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Examiner Notes
Claim 8 is free of the prior art, but stands rejected under 112(d) and 112(b).
Claim Rejections - 35 USC § 112
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 4, 7-8, and 21-22 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.
Claim 4 is indefinite because it is not clear if the claim is supposed to read: if (i) and (ii), then (iii) and/or (iv) and/or (v) and/or (vi); OR if (i) and (ii), then (iii) and (iv) and (v) and/or (vi). For the purposes of applying art, it will be assumed applicant intended: if (i) and (ii), then (iii) and/or (iv) and/or (v) and/or (vi).
Claims 4 and 7 are indefinite for being worded as provisos. Claims 4 and 7 refer to the compounds of claim 1 or 6, respectively, wherein when conditions (i) and (ii) are true, then conditions (iii) and/or (iv) and/or (v) and/or (vi) apply. However, the claims, as worded, are unclear as to what happens when limitations (i) and (ii) are not true. Examiner suggests rewording claims to read: “the compound of claim x, wherein R1 is C2 alkyl and R3 is heteroaryl; further wherein (iii) and/or (iv) and/or (v) and/or (vi)” (wherein x is 1 or 6 as appropriate) - or something to that effect.
Claim 8 is rejected for depending upon the limitations of claim 7.
Claims 21-22 is indefinite due to the recitation of “Table 1”. As stated in MPEP 2173.05(s), claims should be complete to themselves and the reference to tables renders the claims incomplete. Claims which recite figures or tables are only permitted in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into a claim. Claim 22 is indefinite for referencing compounds found in Table 1 of the specification.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 is rejected for failing to further limit claim 7, from which it depends. Claim 7 requires a compound of Formula III-d, wherein R1 is C2 alkyl and R3 is heteroaryl; further that L be -C(O)- and/or; R2 be polycyclic; and/or R3 be substituted with one or more halo, or two R3n combined to form oxo, and further optionally substituted. Claim 8, however, shows the compounds of Formula III-d-i, wherein R1 is C2 alkyl, however, R3 is broadened to encompass aryl. Furthermore, since L is not –C(O)- and R2 is not polycyclic in Formula III-d-i, then that would require that R3 (a heteroaryl) be substituted with at least a halo or two R3n combined to form an oxo (as recited in condition v-a and v-b of claim 7).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 15, 19, and 23 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Crane et al. (WO 2007/056846 A1) (“Crane”).
Regarding claims 1, 15, 19, Crane discloses the compound 1 below (page 10, line 1; and Example 15, page 46), which anticipates the instant claims when A-B is
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; X is O; Y3 is N; X1 is NH; R1 is H; L is a bond; R2 is a 6-membered heterocycle; L1 is -O-; and R3 is phenyl substituted with C1 haloalkyl.
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(1)
Regarding claim 23, Crane discloses a pharmaceutical composition comprising their compounds (Crane’s claim 11).
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.
Claims 1-2, 4, 13-18, 20-21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Crane et al. (WO 2007/056846 A1) (“Crane”); as applied to claims 1, 15, 19, and 23.
The teachings of Crane are disclosed above and incorporated herein.
Further regarding claims 1-2, 4, 14 and 21, Crane discloses the compounds of Formula I below (claim 1), and teaches their compounds are useful for the treatment of cancers, among other conditions – which is the same intended use as the claimed invention (page 1, para. 1; and page 14, para. 3). Crane’s compounds render the instant compounds obvious when: Z (corresponding to instant X1) is N, S, or O; R13 (corresponding to instant H and R1) is independently H or C1-6 alkyl; R5-12 (corresponding to instant Rn2) can independently be H, F, or C1-3 alkyl; X-Y can be N-C(O)-, N-CH2- or CH-C(O)- (corresponding to instant L1 being -C(O)- or -CH2- and R2 being piperidine or piperazine); and Ar (corresponding to instant R3) can be phenyl or heteroaryl substituted with 1-5 R3 (corresponding to instant R3n) wherein R3 can be C1-6 alkyl, halogen, -OH, or -C(O)N(R4)2, wherein R4 can be independently selected from H or C1-6 alkyl (reading on -C(O)NH-alkyl).
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, wherein HetAr is
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Crane discloses their preferred embodiment compound 1, shown in the 102-section above. While this preferred embodiment shows: (i) N in the position corresponding to instant X1, Crane teaches this position can also be S or O; (ii) a piperidine in the position corresponding to R2, their general Formula I shows this position can also be a piperazine; (iii) a -O- linkage in the position corresponding to L1, their general formula I shows this position can be C1 alkylne or carbonyl; (iv) a phenyl in the position corresponding to R3, Formula I discloses this position can be a heteroaryl, which includes pyridyl, pyrazolyl, etc. (page 11, para. 3); (v) H in the position corresponding to R1, their general Formula I shows this position can be C1-6 alkyl (reading on C1-2 alkyl).
Thus, Crane discloses a subgenus of compounds which is encompassed by the instantly claimed broad genus of compounds.
Therefore, regarding instant claims 1-2, 4, 14 and 21, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Crane’s disclosed formula I and preferred embodiments; In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2144.08. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by Crane. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Further regarding claims 14 and 21, Crane’s disclosure above renders the claimed compounds obvious, particularly, for example, compounds 65-67 shown below (bottom of page 102 of the spec.). While Crane’s compounds don’t show a C1-2 alkylene in the position corresponding to L (as required by claim 14) and shows only a bond in this position, Applicant is advised that compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
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Furthermore, the courts have found that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. In re Norris, 179 F.2d. 970, 84 USPQ 458 (CCPA 1970). Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results. In re Finely, 81 USPQ 383 (CCPA 1949); 84 USPQ 458 (CCPA 1950).
Regarding claim 13, Crane discloses their compounds above wherein the group corresponding to instant R1 can be C1-6 alkyl (reading on methyl or ethyl).
Regarding claims 15-16, Crane discloses their compounds above wherein the group corresponding to instant R2 is piperidine or piperazine (reading on
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) (when X is C or N, respectively) substituted with R5-12 (corresponding to instant Rn2), wherein R5-12 can independently be H, F, or C1-3 alkyl.
Regarding claim 17, Crane discloses their compounds above wherein the group corresponding to instant R3 can be heteroaryl substituted with 1-5 R3 (corresponding to instant R3n) wherein R3 can be C1-6 alkyl, halogen, or -C(O)N(R4)2, wherein R4 can be independently selected from H or C1-6 alkyl.
Regarding claims 18 and 20, Crane discloses their compounds above wherein the group corresponding to instant R3 can be phenyl or heteroaryl substituted with 1-5 R3 (corresponding to instant R3n) wherein R3 can be C1-6 alkyl, halogen, or -C(O)N(R4)2, wherein R4 can be independently selected from H or C1-6 alkyl.
Therefore, one having ordinary skill in the art prior to the effective filing date of the claimed invention would have been motivated to prepare the claimed compounds with a reasonable expectation of success because Crane discloses their compounds of Formula I as useful for the treatment of cancers and other conditions; further because Crane teaches that their Ar group can be phenyl or heteroaryl (pyridyl) (corresponding to instant R3), and substituted with 1-5 substituents selected from a limited number of options, including halogen or -C(O)N(R4)2, wherein R4 can be independently selected from H or C1-6 alkyl. Thus, one of ordinary skill would have been able to prepare any of the claimed substitution patterns.
Regarding claim 24, Crane teaches their compounds are useful for the treatment of cancers (page 1, para. 1; and page 14, para. 3).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer Crane’s compounds to a subject in need thereof for the treatment of cancer. One of ordinary skill would have been motivated to do so because Crane teaches their compounds are useful for the treatment of cancers. One of ordinary skill would have had a reasonable expectation of success in view of Crane’s disclosure of their SDC1 inhibitor compounds of Formula I and pharmaceutical compositions thereof for administration to subjects suffering from conditions associated with lipid metabolism (abstract), such as cancer.
Applicant is advised that similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972) (see MPEP 2144.08(d)).
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Crane et al. (WO 2007/056846 A1) (“Crane”); as applied to claims 1-2, 13-18, 20-21, and 23-24; in view of Zhao et al. (Oncology Reports, 2017, 38, 2105-2115) (“Zhao”); further in view of Ali et al. (Genes Chromosomes Cancer, 2021, 60: 358–372) (“Ali”).
The teachings of Crane are disclosed above and incorporated herein.
While Crane does not specifically teach treatment of breast cancer or treatment of an HR-deficient cancer (claims 25-26); the teachings of Zhao and Ali are relied upon for these disclosures.
Zhao teaches that SCD1 inhibition leads to the anti-proliferation effect of breast cancer cells through induction of apoptosis, cell cycle arrest and migration prevention (abstract). Zhao concludes that SCD1 may control the overall rate of lipid synthesis and then affect cell proliferation in breast cancer cells and that SCD1 may be a promising molecular target for cancer therapy (page 2114, col. 1, last para.).
Ali teaches that mutations in a number of genes encoding HR proteins are a well-studied cause of HR deficiency (HRD), and, at the germline level, can confer risk to breast cancer but also occur somatically, contributing to sporadic breast cancer development, progression and response to therapy (abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to treat an HR-deficient breast cancer with Crane’s SCD1 inhibitors, in view of Zhao and Ali. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Crane discloses their SCD1 compounds and pharmaceutical compositions thereof as being effective for the treatment of cancers; further because Zhao teaches that SCD1 inhibition leads to the anti-proliferation effect of breast cancer and may be a promising cancer therapy; and because Ali teaches mutations that lead to HR-deficiency also lead to breast cancer development or progression.
Claims 1, 4, 14-17, 19, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Kennis et al. (WO 2006/003148 A1) (“Kennis”).
Regarding claims 1, 4, 14-15, 17, and 19, Kennis discloses their compounds of Formula I below (page 7, line 22) and discloses their compounds as PARP inhibitors for the treatment of cancer (page 1, para. 1; and page 5, last para) – which is the same intended use of the instant compounds. Kennis’ compounds read on the instant claims when Z is
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or
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, etc. (reading on instant R3 being aryl or heteroaryl); L2 (corresponding to instant L1) is a bond, C1-6 alkyl, -C(O)-, etc.; X and Y are independently N or CH; L1 (corresponding to instant L) is a bond or C1-6 alkyl; and R1 (corresponding to instant R2n) is H or -OH.
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Kennis specifically discloses the compounds 12, 13, and 4 below (page 7 and Table F-1, page 22), which read on the instant compounds when A-B is
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, wherein Y1-3 are CH; X is O; R1 is H; L is C2-3 alkyl; R2 is 6-membered heterocycle; L1 is -C(O)-, -OH substituted methylene, or a bond; and R3 is phenyl, substituted with Cl or F.
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(12)
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While Kennis’ compounds show substitution on the nitrogens instead of on the phenyl ring of the A-B bicyclic core, Kennis teaches their compounds are PARP inhibitors for the treatment of cancer, including breast cancer (page 18, lines 20-25), which is the same intended use as the instant application (instant spec, page 1, [2]-[3]). Thus, Kennis discloses a narrow genus of structures, which are encompassed by the broad genus of the claims.
Applicant is reminded that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
Therefore, regarding instant claims 1, 4, 14-15, 17, and 19, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Kennis’ disclosed formula I and preferred embodiments. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by Kennis. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Regarding claim 16, Kennis discloses their compounds of Formula I above wherein X and Y can be N, reading on instant R2 being
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.
Regarding claim 23, Kennis discloses a pharmaceutical composition comprising their compounds and acceptable carriers (Kennis’ claim 6).
Regarding claims 24 and 25, Kennis teaches their compounds as anti-cancer agents for the treatment of cancers including breast cancer.
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer Kennis’ compounds to a subject in need thereof for the treatment of breast cancer. One of ordinary skill would have been motivated to do so because Kennis teaches their compounds are useful for the treatment of cancers, including breast cancer. One of ordinary skill would have had a reasonable expectation of success in view of Kennis’ disclosure of their PARP inhibitor compounds of Formula I and pharmaceutical compositions thereof.
Applicant is reminded that similar properties may normally be presumed when compounds are very close in structure. (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Kennis et al. (WO 2006/003148 A1) (“Kennis”); 1, 4, 14-17, 19, and 23-25; in view of Ali et al. (Genes Chromosomes Cancer, 2021, 60: 358–372) (“Ali”).
The teachings of Kennis are disclosed above and incorporated herein.
While Kennis does not specifically teach treatment of a cancer with an HR-deficiency, the teachings of Ali are relied upon for these disclosures.
Ali teaches that mutations in a number of genes encoding HR proteins are a well-studied cause of HR deficiency (HRD), and, at the germline level, can confer risk to breast cancer but also occur somatically, contributing to sporadic breast cancer development, progression and response to therapy (abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to treat an HR-deficient breast cancer with Kennis’ PARP inhibitors, in view of Ali. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Kennis discloses their PARP inhibitor compounds and pharmaceutical compositions thereof as being effective for the treatment of cancers, including breast cancer; and because Ali teaches mutations that lead to HR-deficiency also lead to breast cancer development or progression.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Kennis et al. (WO 2006/003148 A1) (“Kennis”); 1, 4, 14-17, 19, and 23-25; in view of Morita et al. (Obtained From gousei.f.u-tokyo.ac.jp [Retrieved on September 11th, 2025] <URL: https://gousei.f.u-tokyo.ac.jp/seminar/index.html#2012> - Published May 2012) ("Morita").
The teachings of Kennis are disclosed above and incorporated herein.
While Kennis does not specifically teach their compounds wherein the group corresponding to instant R3 has more than one substituents; the teachings of Morita are relied upon for these disclosures.
Morita teaches the design of bioisosteres introduces structural changes that can be beneficial in the context of drug and lead design by allowing modulation of polarization, dipole, polarity, lipophilicity, etc., which can help improve potency, selectivity, physical properties, metabolism, etc. (page 3, bottom). Morita discloses that H and F are classical monovalent bioisosteres.
Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Kennis’ disclosed formula in view of Morita. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of PARP inhibitors disclosed Kennis, in view of Morita’s teaching that bioisosteric modifications, such as replacing one of the hydrogens in the phenyl corresponding to instant R3 for F, may help improve potency, selectivity, physical properties, and metabolism, etc. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, particularly the compounds 230 and 231 shown below:
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Claims 1-3, 6-7, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Cheshire et al. (US 6,342,502 B1) (“Cheshire”); in view of Ratni et al. (RSC Med. Chem., 2021, 12, 758-766) (“Ratni”).
Regarding claims 1-3, Cheshire discloses the IL-2 modulator compounds of Formula I with immunosuppressive activity for the treatment of proliferative and hyperproliferative conditions (abstract; and col. 1, lines 15-20) – reading on cancer, which is the intended use claimed in the instant application. Cheshire’s compounds render the instant compounds obvious when A-B is
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, wherein X is O, Y1 is CRf, and X1 is S. Cheshire discloses their R1 and R2 can be independently H or C1-6 alkyl; R3 (corresponding to instant Rf) can be H; and R can be -C(O)Ar1, -CH2Ar1, or -Ar1 (corresponding to instant L being -C(O)-, C1 alkylene, or a bond, respectively, and to R2 being Ar1) wherein Ar1 can be phenyl substituted with phenoxy (corresponding to instant L1 being -O- and R3 being aryl) (Cheshire’s claim 1).
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Cheshire specifically discloses the preferred embodiments 58 and 73 below (col. 58; 65), which read on the instant compounds when instant X is O; X1 is S; Y1 is CRf; R1 is methyl; Rf is H; L is -CH(OH)- or -CH-2-; R2 is phenyl; L1 is -O-; and R3 is phenyl. While these preferred embodiments don’t show a hydrogen in the position corresponding to Cheshire’s R1, as required by the instant claims, Cheshire discloses their R1 group can be H.
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While Cheshire doe not teach their compounds wherein their group corresponding to instant R2 is a 6-membered heteroaryl, the teachings of Ratni are relied upon for these disclosures.
Ratni discloses a bridged piperidine (BP) moiety (see below – Figure 3) as a phenyl bioisostere, as a superior phenyl alternative since it led to strongly improved drug-like properties, in terms of solubility and lipophilicity (abstract).
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Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Cheshire’s disclosed formula I and preferred embodiments, in view of Ratni. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by Cheshire in view of Ratni’s disclosure that phenyl and the bridged piperidine BP (shown above – reading on two R2n coming together to form a cycloalkyl) are bioisosteres, with BP resulting in improved drug-like properties like solubility and lipophilicity. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Regarding claims 6-7, Applicant is reminded that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
Further regarding claim 7, since Cheshire’s compounds do not meet the provisos of: (i) R1 being C2 alkyl and (ii) R3 being a heterocycle, then conditions (iii), (iv), and (v) are not required. Therefore, Cheshire’s compounds read on the claim. (See 112(b) section).
Regarding claim 23, Cheshire discloses pharmaceutical compositions comprising their compounds and pharmaceutically acceptable adjuvants or carriers (col. 15, lines 27-35).
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, 4, 13-21 and 23-26 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of copending Application No. 18/458,039 (Copending ‘039) in view of Kennis et al. (WO 2006/003148 A1) (“Kennis”).
Regarding instant claims 1, 4, and 13-21, Copending ‘039 claims the compounds of Formula I below, which render the instant compounds obvious, wherein L can be a bond, -C(O)-, -O-, alkyl, etc.; A (corresponding to instant R2) can be heterocyclyl with at least one nitrogen; L1 can be a bond, -C(O)-, -O-, alkyl, etc.; B (corresponding to instant R3) can be aryl or heteroaryl; R3 (corresponding to instant R3n) can be halogen, alkyl, -C(O)NR4R5, etc.; R1 can be H or C1-6 alkyl; and X1 can be N.
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While Copending ‘039’s compounds show a C-R1 in the position corresponding to instant N-R1 and an N in the position corresponding to instant C=O, Applicant is reminded that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results. Furthermore, the teachings of Kennis are relied upon to leverage these differences.
Kennis discloses their compounds of Formula I below as PARP inhibitors for the treatment of cancers, which is the same intended use of the instant compounds and Copending ‘039’s compounds.
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Therefore, regarding claims 1, 4, and 13-21, one having ordinary skill would have found the claimed compounds prima facie obvious, since they are generically embraced by Copending ‘039’s disclosed formula in view of Kennis’ PARP inhibitors. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by Copending ‘039 in view of Kennis’s related structures which are also PARP inhibitors for the treatment of cancers. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Regarding instant claim 23, Copending ‘039 claims a pharmaceutical composition comprising an excipient (Copending ‘039’s claim 32).
Regarding instant claims 24-26, Copending ‘039 claims methods of treating breast and other cancers, as well as HR-deficient cancers (Copending ‘039’s claims 33-35).
Applicant is reminded that similar properties may normally be presumed when compounds are very close in structure. (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
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