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, 4, 9, 10, 17, 45, 46, 48, 61-63, 65-69, and 75-93, submitted 20 March 2024, represent all claims currently under consideration.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
This application claims priority to provisional US 63/515,031, filed 21 July 2023, and provisional US 63/430,918, filed 7 December 2022. The effective filing date is 7 December 2022.
Information Disclosure Statement
Three Information Disclosure Statements (IDSs), submitted on 23 July 2024, 26 March 2025, and 18 July 2025, are acknowledged and have been considered.
Claim Objections
Claim 4 is objected to because of the following informalities: Claim 4 has the limitation of “wherein at least one R1 is C1-6 alkyl”. The Examiner believes this should be amended to “wherein R1 is C1-6 alkyl” as there can be a maximum of one R1 group. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 9 is 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 9 is indefinite as there is on “or” or “and” prior to the final compound I-g of the Markush group.
Claim 17 is 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 17 is indefinite as there is on “or” or “and” prior to the final compound I-n of the Markush group.
Claim 61 is 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 61 recites the limitation "
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" as a substituent for variable R2. Claim 1, which Claim 61 ultimately depends on, states that variable R2 can only be cyclopropyl. There is insufficient antecedent basis for this limitation in the claim.
Claim 65 is 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 65 is indefinite as there is on “or” or “and” prior to the final compound I-cb of the Markush group.
Claim 66 is 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 66 is indefinite as there is on “or” or “and” prior to the final compound I-cf of the Markush group.
Claim 75 is 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 75 references a table. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only 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 the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
Claims 89-93 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. Claims 88-93 recite the limitation "the pharmaceutical composition" in Line 1. There is insufficient antecedent basis for this limitation in the claim as pharmaceutical compositions are not referenced in Claims 85-88, which these claims depend on.
Claim Rejections - 35 USC § 112(d)
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 61 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 61 has the limitation that variable R2 can be
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; however, Claim 1, which Claim 61 depends on, states that variable R2 can only be an optionally substituted cyclopropyl group, causing Claim 61 to be more broad 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.
Claims 1, 4, 9, 10, 45, and 76-83 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yeh (WO 2013/033070; Publication Date: 7 March 2013).
Yeh (See IDS, 23 July 2024) discloses compounds and compositions thereof, which are useful as protein kinase inhibitors, as well as methods for using such compounds to treat, ameliorate, or prevent a condition associated with abnormal or deregulated kinase activity. One compound disclosed is F85 (Page 159)
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, which has variable R1 as methyl, variable R2 as cyclopropyl substituted with fluorine, and variable R3 as -C(R)2OR with R as H and CH2CF3. In some embodiments, the invention provides methods for using such compounds to treat, ameliorate, or prevent disorders that involve abnormal activation of c-kit (Abstract). Another aspect provided herein are pharmaceutical compositions that include a therapeutically effective amount of a compound of the invention and a pharmaceutically acceptable carrier (Page 26, Line 25- Page 27, Line 2). Another aspect provided herein are medicaments for treating a patient with a disease or disorder associated with c-kit kinase activity, and such medicaments include a therapeutically effective amount of a compound of the invention. In certain embodiments, the disease is a mast-cell associated disease, a respiratory disease, an inflammatory disorder, irritable bowel syndrome, inflammatory bowel disease, an autoimmune disorder, a metabolic disease, a fibrosis disease, a dermatological disease, pulmonary arterial hypertension, or primary pulmonary hypertension. In other embodiments, the disease is asthma, allergic rhinitis, pulmonary fibrosis, hepatic fibrosis, cardiac fibrosis, scleroderma, urticaria, dermatosis, type I diabetes, or type II diabetes (Page 27, Lines 17-30).
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, 4, 9, 10, 17, 45, 46, 48, 61-63, 65-69, and 75-93 are rejected under 35 U.S.C. 103 as being unpatentable over Yeh (WO 2013/033070; Publication Date: 7 March 2013) in view of Thornber (Chemical Society Reviews, 4, 1979).
Yeh, as described previously, discloses compounds of formulae (1) and (II) and compositions thereof, which are useful as protein kinase inhibitors, as well as methods for using such compounds to treat, ameliorate, or prevent a condition associated with abnormal or deregulated kinase activity. In some embodiments, the invention provides methods for using such compounds to treat, ameliorate, or prevent disorders that involve abnormal activation of c-kit (Abstract). Compounds of the invention are of structure
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wherein
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; R1 is selected from C1-C6 alkyl and halogen; R11 is H, halo, or C1-C6 alkyl; L1 is bond, -NH-, or -C(O)NH-; R2 is R3 with R3 selected from unsubstituted C3-C8 cycloalkyl, cyclobutanone, cyclopentanone, and substituted C3-C8 cycloalkyl, wherein the cycloalkyl is substituted with 1-4 substituents selected from
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(Page 2). In certain embodiments of any of the aforementioned compounds, R3 is cyclopropyl substituted with 1 or 2 F (Page 18, Lines 12-16). In certain embodiments of any of the aforementioned compounds, m is 1 and R20 is selected from H, F, CH3, CF3, CD3, CN, OCHF2,
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(Page 18, Lines 12-16). Another aspect provided herein are pharmaceutical compositions that include a therapeutically effective amount of a compound of the invention and a pharmaceutically acceptable carrier (Page 26, Line 25- Page 27, Line 2). Another aspect provided herein are medicaments for treating a patient with a disease or disorder associated with c-kit kinase activity, and such medicaments include a therapeutically effective amount of a compound of the invention. In certain embodiments, the disease is a mast-cell associated disease, a respiratory disease, an inflammatory disorder, irritable bowel syndrome, inflammatory bowel disease, an autoimmune disorder, a metabolic disease, a fibrosis disease, a dermatological disease, pulmonary arterial hypertension, or primary pulmonary hypertension. In other embodiments, the disease is asthma, allergic rhinitis, pulmonary fibrosis, hepatic fibrosis, cardiac fibrosis, scleroderma, urticaria, dermatosis, type I diabetes, or type II diabetes (Page 27, Lines 17-30). Table 1 (Page 146) provides compounds of the invention which render the compounds claimed in the examined application obvious, and their activity in inhibiting c-Kit. Yeh discloses several compounds that demonstrate that unsubstituted or substituted cyclopropyl groups in the variable R3 position is conducive to compounds which potently inhibit c-Kit, including mono- and difluoro substitutions. Compound F20
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has an IC50 of 0.049µM. Compound F113 (Page 144)
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has an IC50 of 0.056 µM. Compounds F21 through F24 each have a cyclopropyl group substituted with -NHC(O)C(CH3)3, -NH-SO2CH3, -N(C(O)OCH3)2, and -NHC(O)CCH3, with IC50 values against c-Kit all below 0.077 µM. Compound F29
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has an IC50 of 0.058 µM. Compounds F37 through F43 provide embodiments wherein variable R20 is various groups, including CH2OH, CH2O(CH2)2OH, CH2OMe, and heteroaryl, with each compound providing an IC50 below 0.04 µM. There are numerous embodiments provided wherein R20 is selected from groups which are claimed in the examined application, with the only difference being a cyclobutyl group rather than cyclopropyl group at the variable R3 position, and these compounds retain their potent activity against c-Kit. Compounds F87 and F88
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(stereoisomers) have IC50 values of 0.066 and 0.046 µM. Compound F91
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has an IC50 of 0.02 µM, and is a stereoisomer of Compound I-142 of the examined application. Compound F101
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has an IC50 of 0.067 µM. Compound F106
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has an IC50 of 0.052 µM. Compound F110
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has an IC50 of 0.058 µM. Compound F85
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has an IC50 of 0.069 µM, and differs from I-131 by the presence of two fluorine atoms rather than one on the cyclopropyl group. Compound F104
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has an IC50 of 0.057 µM, and provides a lead compound which can be modified using the limitations set forth in Yeh for variables R20 (analogous to variable R3 of the examined application) and for substituents on the cyclopropyl group.
Yeh does not explicitly disclose compounds wherein the cyclopropyl group is substituted with halogens other than fluorine, or wherein variable R20 is a haloalkyl.
Thornber teaches the concept of bioisosterism, which describes the similarity of molecules or ions which have the same number of atoms or valence electrons. Bioisosteres are groups or molecules which have chemical and physical similarities producing broadly similar biological properties (Page 563). Table 1 lists univalent atoms and groups which function as bioisosteres of one another, and includes the halogens. Table 2 (Page 567) shows that these halogens have similar electronic properties to one another, and would not be expected to significantly alter the properties of the parent compound when replaced with one another.
Thornber and Yeh are considered analogous to the claimed invention as all are involved in the study of the biological activity of pharmacological compounds. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to modify the compounds of Yeh by substitution of fluorine for other halogens such as chlorine, or the replacement of hydrogen atoms in a methyl group with fluorine as Thornber demonstrates that these are known bioisosteric substitutions that would not be expected the significantly alter the properties of the parent compound. The artisan would be motivated, and have a reasonable expectation of success to perform these modifications as Yeh shows that these compounds are potent c-Kit inhibitors, and due to the close chemical structure, the artisan would not expect these modifications to significantly alter the properties of the resultant compound (See MPEP § 2144.09 I).
Regarding Claim 75, as described previously, several compounds disclosed by Yeh are obvious variations of compounds which are claimed in Table 1. Compound I-2 is an obvious variation of F95
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(IC50 of 0.077 µM), differing by the particular heteroaryl ring in the variable R6 position, and a cyclobutyl rather than cyclopropyl group. The artisan would not expect the properties of the claimed compound to be significantly different than this compound. Compounds I-4 and I-14 are obvious over Compound F76
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(IC50 of 0.094 µM), which differs by a cyclobutyl ring rather than cyclopropyl. Compound I-6 is obvious over F76 (IC50 of 0.037 µM)
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, which has a cyclobutyl ring rather than cyclopropyl, and an additional methyl group on the alkoxy chain. Compounds I-15 and I-16 are obvious over compound F73 (IC50 of 0.025 µM)
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, which differs from by a cyclobutyl rather than cyclopropyl, and an additional CH3 prior to the cyano group. Compounds I-22 and I-23 are obvious over compound F38 (IC50 of 0.025 µM)
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, which differs by the cyclobutyl group. This is not a complete list of each obvious iteration as the table provided claims over 500 compounds.
Regarding Claim 88, the difference between this compound and those claimed by Yeh is the presence of an S(O)2Me group terminating the alkoxy, which is not disclosed by Yeh. However, the artisan would not expect this compound to have significantly different properties than what is disclosed by Yeh due to the close structural similarity, and would not expect this compound to have significantly altered inhibition against c-Kit (See MPEP § 2144.09 I).
Claim 75 is rejected under 35 U.S.C. 103 as being unpatentable over Molteni (WO 2013/033167; Publication Date: 7 March 2013).
Moletni (See IDS, 23 July 2024) provides compounds of formulae (I) and (II) and compositions thereof, which are useful as protein kinase inhibitors, as well as methods for using such compounds to treat, ameliorate, or prevent a condition associated with abnormal or deregulated kinase activity. In some embodiments, the invention provides methods for using such compounds to treat, ameliorate, or prevent diseases or disorders that involve abnormal activation of c-kit (Abstract). Compounds of the invention are of structure
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wherein
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R1 is selected from C1-C6 alkyl and halo; R11 is H, halo, and C1-C6 alkyl, L1 is bond, -NH-, or -C(O)NH-; R2 is R3 or L2R3; R3 is selected from an optionally substituted 4-6 membered heterocycloalkyl, and the optional substituents are selected from C1-C6 alkyl, halo,
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Another aspect of the invention includes methods for treating a disease or disorder where c-kit activity is implicated, comprising administering a compound of the invention (Page 32, Lines 7-16). Table 1 (Page 146) provides wherein variable R3 is a substituted or unsubstituted heterocycloalkyl such as azetindyl, as well as its activity against c-Kit. F6
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has an IC50 of 0.026 µM. F7
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has an IC50 of 0.078 µM. F8
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has an IC50 of 0.042 µM. F9
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has an IC50 of 0.035 µM. F10
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has an IC50 of 0.023µM. F17 and F18 have alkyl-heterocycloalkyl with IC50 of 0.27 of 0.064 µM
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. The table provides several other compounds with different heterocycloalkyl groups present, with different substituents, as well as different substituents on the fused ring, which result in potent inhibitors of c-Kit. While there are no compounds disclosed which are identical to those claimed in the examined application, these compounds render many of the claimed compounds obvious due to the close structural similarity to what is disclosed by Moletini (See MPEP § 2144.09 I). For example, I-87 has a propoxy group at the variable R3 postiion. Moletini shows that five-membered oxygen containing heterocycles are potent inhibitors; thus the artisan would not expect this modification to significantly alter the properties of the resultant compound. This is not a complete list of all compounds disclosed by Moletni, nor of all compounds of Claim 75 which are rendered obvious, as Moletini discloses over 150 compounds, and Claim 75 claims over 500 compounds.
Claim 75 is rejected under 35 U.S.C. 103 as being unpatentable over Liu (WO 2013/033116; Publication Date: 7 March 2013).
Liu (See IDS, 24 July 2024) discloses compounds of formulae (1) and (II) and compositions thereof, which are useful as protein kinase inhibitors, as well as methods for using such compounds to treat, ameliorate, or prevent a condition associated with abnormal or deregulated kinase activity. In some embodiments, the invention provides methods for using such compounds to treat, ameliorate, or prevent disorders that involve abnormal activation of c-kit (Abstract). Compounds of the invention are of structure
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wherein
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R1 is C1-C6 alkyl or halo, each R11 is independently H, halo, or C1-C6 alkyl; L1 is bond, -NH-, or -C(O)NH-;
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(Page 2). Compounds of the invention are useful for the treatment of diseases mediated by c-Kit kinase activity (Page 31, Lines 13-22). Table 1 (Page 162) lists compounds which render several compounds of Claim 75 obvious. This table provides compounds with various alkyl substituents in the R3 position, providing compounds with IC50 values below 100 nM. Compound F1 has an IC50 of 0.078 µM
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. F11 has an IC50 of 0.086nM
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. F12 has an IC50 of 0.049 µM
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. Compound F13 has an IC50 of 0.093 µM
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. Compound F42 has IC50 values of 0.009 µM
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. Compound F44 has an IC50 of 0.025µM
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. Compounds of the examined application such as I-25 and I-37 differ from the compounds disclosed by Liu by a chlorine group on the central phenyl ring, and addition of an alkoxy to the fused ring system. These limitations are taught by Liu, and the artisan would not expect these compounds to have significantly different properties than what is disclosed by Liu due to the close chemical structure (See MPEP § 2144.09 I). This is not an exhaustive list of each compound of Liu as Liu discloses over 150 compounds, nor is it a complete list of every compound rendered obvious as over 500 compounds are found in Table 1.
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, 9, 10, 17, 45, 46, 48, 61-63, 65-69, and 75-93 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7, 15, 17, 24, 30, 40, and 43-51 of copending Application No. 19/136,334 (Claims of 6 June 2025) (‘334) (reference application).
Claim 1 of ‘334 is directed to compounds of Formula (I)
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. Claim 4 is directed to compounds of Claim 1 wherein X is O. Claim 7 is directed to the compound of Claim 1 wherein R1 is C1-C6 alkyl. Claim 15 is directed to the compound of Claim 1 wherein the compound is of formula
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. Claim 17 is directed to a compound of formula
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. Claim 24 claims the compound of Claim 1 wherein Rb is selected from a group which includes
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. Claim 30 is directed to the compound of Claim 1 wherein at least one R2 is a 3-4 membered saturated monocyclic carbocycle. Claim 40is directed to the compound of Claim 1 wherein R2 is selected from a group which includes
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. Claim 43 claims a compound of Table 1. Claim 44 claims a pharmaceutical composition comprising a compound of the invention and a pharmaceutically acceptable carrier. Claim 45 claims a method of inhibiting c-Kit activity using a compound of the invention. Claim 46 claims a method of treating a c-Kit kinase mediated disease comprising administering a compound of the invention. Claims 47, 48, 49, and 50 specify the diseases to be treated which encompasses those claimed in the examined application. Claim 51 claims the method of claims 46-50 wherein the patient is human. Compounds claimed in the invention include II-3 (Page 105 of specification)
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, which has a
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46
47
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group rather than
PNG
media_image45.png
26
25
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group; the artisan would not expect these compounds to have significantly different properties due to the close chemical structure (See MPEP § 2144.09 I). As such, these compounds are obvious variations of what is claimed in the examined application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 4, 9, 10, 17, 45, 46, 48, 61-63, 65-69, and 75-93 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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/P.M.R./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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