DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions. Preliminary amendment filed on 01/28/2025 has been entered. Claims 18-27, 30-39, 42-49, 51, 52, 54, and 59-64 are cancelled. Claims 1-17, 28, 29, 40, 41, 50, 53, and 55-58 are pending in this application and are currently under examination.
Priority
This application is a CON of 17/810,313 filed on 06/30/2022, now ABN, which is a CON of 16/996,090 filed on 08/18/2020, now ABN, which is a CON of 16/012,379 filed on 06/19/2018, now ABN, which is a CON of 15/008,994 filed on 01/28/2016, now ABN, which is a DIV of 13/828,285 filed on 03/14/2013, now PAT 9296741, which is a CON of PCT/CN2012/086357 filed on 03/14/2013 (Note: The date is different from the filing date of 12/11/2012 indicated in the WO 2013/097601), which is a CIP of PCT/CN2011/002224 filed on 12/30/2011.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. PCT/CN2011/002224, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 1, 3-17, 28, 29, 40, 41, 50, 53, and 55-58 recite “L1 is… C(H)(OH)”, “G1 is C1-C6 alkyl, alkoxyalkyl”, “4-[5-amino-2-(2,4-difluorophenoxy)phenyl]-6-methyl-l,6-dihydro-7H-pyrrolo[2,3-d]pyridazin-7-one; N-[4-(2,4-difluorophenoxy)-3-(6-methyl-7-oxo-6,7-dihydro-1H-pyrrolo[2,3-d]pyridazin-4-yl)phenyl] methanesulfonamide; N-[4-(2,4-difluorophenoxy)-3-(6-methyl-7-oxo-6,7-dihydro-1H-pyrrolo[2,3-d]pyridazin-4-yl)phenyl]ethanesulfonamide; and 4-[2-(cyclopropylmethoxy)-5-(ethylsulfonyl)phenyl ]-6-methyl-1,6-dihydro-7Hpyrrolo[2,3-d]pyridazin-7-one”, “2-fluoro-N-[3-(6-methyl-7-oxo-6, 7-dihydro-1H-pyrrolo[2,3-c]pyridin-4-yl)-4-(tetrahydrofuran-3-yloxy )phenyl ]ethanesulfonamide; N-[3-(6-methyl-7-oxo-6,7-dihydro-1H-pyrrolo[2,3-c]pyridin-4-yl)-4-(tetrahydrofuran-3-yloxy)phenyl]propane-1-sulfonamide; N-[4-(4-cyanophenoxy)-3-(6-methyl-7-oxo-6,7-dihydro-1H-pyrrolo[2,3-c]pyridin-4-yl)phenyl]propane-1-sulfonamide; N-[3-(6-methyl-7-oxo-6,7-dihydro-1H-pyrrolo[2,3-c]pyridin-4-yl)-4-(2,4,6-trifluorophenoxy)phenyl]propane-1-sulfonamide”, “N-[4-(2,4-difluorophenoxy)-3-( 6-methyl-7-oxo-6,7-dihydro-1H-pyrazolo[3,4-c]pyridin-4-yl)phenyl ]ethanesulfonamide; 4-{2-(2,4-difluorophenoxy)-5-[(methylsulfonyl)methyl]phenyl}-6-methyl-1,6-dihydro-7H-pyrazolo[3,4-c]pyridin-7-one; 4-[2-(2,4-difluorophenoxy)-5-(ethylsulfonyl)phenyl]-6-methyl-1,6-dihydro-7Hpyrazolo[3,4-c ]pyridin-7-one; and 4-[2-(cyclopropylmethoxy)-5-(ethylsulfonyl)phenyl]-6-methyl-1,6-dihydro-7H-pyrazolo[3,4-c]pyridin-7-one; or a pharmaceutically acceptable salt thereof”, which are not disclosed or supported by the prior-filed Application No. PCT/CN2011/002224. Thus, the priority date of claims 1, 3-17, 28, 29, 40, 41, 50, 53, and 55-58 is 03/14/2013.
Claim Objections
Claim 57 is objected to because of the following informalities: In claim 57, insert the missing comma “,” immediately before the recitation “wherein” (line 1) to be consistent with preceding claim; change the incorrect recitation “(monocytic, myeloblastic, adenocarcinoma, angiosarcoma, astrocytoma, myelomonocytic and promyelocytic),” (lines 3 to 4) to “(monocytic, myeloblastic, myelomonocytic or promyelocytic ), adenocarcinoma, angiosarcoma, astrocytoma,” because the “adenocarcinoma, angiosarcoma, astrocytoma” are not leukemia, and the conjunction “and”, not part of Markush group format, combines all recited subgroups; replace the incorrect conjunction “and” (line 9, 16, 17, and 24), which combines all recited subgroups, with “or”. Appropriate correction is required.
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 56-58 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 treating bromodomain-mediated cancer (defined as: A "bromodomain-mediated disorder or condition" is characterized by the participation of one or more bromodomains (e.g., BRD4) in the inception, manifestation of one or more symptoms or disease markers, severity, or progression of a disorder or condition, p. 71/318, lines 25-27), does not reasonably provide enablement for treating any cancer (claims 56 and 58) or listed cancers (claim 57). 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/or to use the invention commensurate in scope with these claims.
The Applicant's attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention: The rejected invention is drawn to A method for treating cancer in a subject comprising administering a therapeutically effective amount of a compound of formula (I) according to claim 1 or a pharmaceutically acceptable salt thereof, to a subject in need thereof (claims 56 and 58), wherein the cancer is selected from the group consisting of: acoustic neuroma, acute leukemia, acute lymphocytic leukemia, acute myelocytic leukemia… uterine cancer and Wilms' tumor (claim 57).
Relative skill of those in the art: The relative skill of those in the art is from biomedical field (see the cited reference below).
Breadth of claims: The claim is extremely broad in that it encompasses the treatment of any cancer or wide range of listed cancers in a subject in need thereof using the instantly claimed method, regardless of the status of Bromodomain and Extra-Terminal motif (BET) proteins.
State of the prior art/Predictability or unpredictability of the art: There is no teaching or suggestion in the state of the prior art that application of certain pharmaceutical method can treat any cancer or listed cancers in a subject in need thereof regardless of the status of Bromodomain and Extra-Terminal motif (BET) proteins. Andrieu et al. (Drug Discovery Today: Technologies, vol 19, p. 45-50, 2016) disclosed that mixed lineage leukemia (MLL) driven by MLL chromosomal translocation was shown to be susceptible to inhibition with a related compound I-BET151, fulfilling early prediction that BET proteins drive MLL. The involvement of BET gene translocations in deadly and incurable cancers of the midline, called NUT midline carcinomas, provided a sound rationale for the first cancer clinical trial for a BET bromodomain inhibitor, I-BET762. Other BET bromodomain inhibitors are in trials for treatment-refractory acute myeloid leukemia and myelodysplastic syndrome (NCT02308761), lymphoma (NCT01949883) and multiple myeloma (NCT02157636). Trials are also open for triple negative- and estrogen receptor- positive breast cancers, small cell and non-small cell lung cancers, castration resistant prostate cancer, pancreatic ductal adenocarcinoma, colorectal cancer, neuroblastoma and MYCN-driven solid tumors. The rationale to use BET inhibitors is shaky because BRD2, BRD3 or BRD4 translocations are not involved in tumorigenesis. Sometimes the justification appears to rely on MYC inhibition. An inducible Brd4 RNAi animal model shows that BET protein ablation causes widespread toxicities, including stem cell depletion (page 46, left col., para. 2 to 3; right col., para. 1 to 2). One of skilled artisan would understand that contemporary treatment using BET inhibitor targets bromodomain-mediated cancers, not any cancer or listed cancers, if BET protein does not play a role.
Amount of guidance/Existence of working examples: It is worth noting that there are no working examples in the instant application to show that the claimed method is effective for treating any cancer or listed cancers in a subject in need thereof regardless of the status of Bromodomain and Extra-Terminal motif (BET) proteins as recited in the claim. The exemplary embodiments of the Specification merely present: (a) A time-resolved fluorescence resonance energy transfer (TR-FRET) assay was used to determine the affinities of compounds of the Examples listed in Table 1 for each bromodomain of human BRD4, (b) The impact of compounds of the Examples on cancer cell proliferation was determined using the breast cancer cell line MX-1 (ATCC) in a 3-day proliferation assay, (c) The compounds of Examples 4 and 78 were tested for their impact on proliferation of a panel of cancer cell lines types (with specific cell line tested) as set out in (Table 2), (d) Microsome stability assays were carried out on compounds of the Examples listed in Table 3 ("test compounds"), (e) The effect of the compound of Example 36 to inhibit the growth of OPM-2 (human multiple myeloma) and MX-1 (human breast cancer) xenograft tumors implanted in mice was evaluated. Results are shown in Tables 5 and 6, and (f) Xenograft efficacy studies were conducted with additional example compounds using OPM-2 (human multiple myeloma), MX-1 (breast cancer), HT1080 (fibrosarcoma), MV4-11 (B myelomonocytic leukemia), SKM1 (myelodysplasic leukemia) and Ramos (Burkitt's lymphoma) human cancer cells. Results are shown in Table 7 (p. 309/318 to 315/318). Compounds are selected to bind human BRD4. The xenograft animal studies were carried out for 6 cancer cell types only.
Quantity of experimentation: In order to practice the full scope of the invention, one skilled in the art would need to undertake a novel and extensive research program to show that treatment of any cancer or listed cancers in a subject in need thereof regardless of the status of BET proteins can be achieved after applying the method comprising administering a therapeutically effective amount of a compound of formula (I) or a pharmaceutically acceptable salt thereof, to a subject in need thereof. Furthermore, one of ordinary skill in the art would need to test a representative number of animals before one of ordinary skill in the art would be able to conclude that any method can be used to treat any cancer or listed cancers in a subject in need thereof regardless of the status of BET proteins. Because this research would have to be exhaustive, and because it would involve such a wide and unpredictable scope of use in treatment of any cancer or listed cancers in a subject in need thereof regardless of the status of BET proteins, it would constitute an undue and unpredictable experimental burden.
Lack of a working example is a critical factor to be considered, especially in a case involving an unpredictable and undeveloped art. See MPEP § 2164. Genetech, 108 F.3d at 1366, states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "[p]atent 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".
Therefore, in view of the Wands factors as discussed above, including the amount of guidance provided and the predictability of the art and the lack of working examples to practice the full scope of the claimed invention herein, a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 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 8 recites the limitation "claim 6 or a pharmaceutically acceptable salt thereof, wherein Ru is". There is insufficient antecedent basis for this limitation in the claim. Applicant is advised to change the above recitation to “claim 7 or a pharmaceutically acceptable salt thereof, wherein Ru is" because claim 6 recites “Y1 is N”, which cannot be CRu.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1, 3-17, 28, 29, 40, 50, 53, and 55-58 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Wang et al. (WO 2013/097052, published on July 4, 2013 and PCT filed on December 30, 2011, hereinafter referred to as Wang ‘052).
The applied reference has a common Inventor with the instant application. Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 102(e) might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor or joint inventors (i.e., the inventive entity) of this application and is thus not the invention “by another,” or if the same invention is not being claimed, by an appropriate showing under 37 CFR 1.131(a).
With regard to the structural limitations “a (or a pharmaceutical composition comprising a therapeutically effective amount of a) compound of formula (I):
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wherein Rx is hydrogen or C1-C3 alkyl; RY is C1-C3 alkyl, -(C2-C3 alkylenyl)-OH, or C1-C3 haloalkyl; X1 is N or CRx1 wherein… X2 is N or CRx2, wherein… Y1 is N or CRu; wherein Ru is hydrogen, C1-C6 alkyl, halogen, or C1-C6 haloalkyl; A1 is N or CR1, A2 is Nor CR2, A3 is N or CR3; and A4 is N or CR4; with the proviso that zero, one, two, or three of A1, A2, A3, and A4 are N… L1 is absent, CH2, C(O)… (CH2)mO, (CH2)mS(O)n wherein n is 0, 1, or 2; or (CH2)mN(Rz) wherein Rz is hydrogen, C1-C3 alkyl, C1-C3 haloalkyl, (C2-C3alkylenyl)-OH, or unsubstituted cyclopropyl; m is 0 or 1; G1 is… G1a or -(C1-C6 alkylenyl)-G1a, wherein each G1a is independently aryl, heteroaryl, heterocycle, cycloalkyl, or cycloalkenyl… Ri, at each occurrence, is independently C1-C6 alkyl or C1-C6 haloalkyl (or ethyl 4-(5-amino-2-phenoxyphenyl)-6-methyl-7-oxo-6,7-dihydro-1H-pyrrolo[2,3-d]pyridazine-2-carboxylate; or 6-methyl-4-(2-phenoxyphenyl)-1,6-dihydro-7H-pyrrolo[2,3-c]pyridin-7-one)” (claims 1, 3-17, 28, 29, 40, 50, 53, and 55), and “a method for treating cancer (or leukemia) in a subject comprising administering a therapeutically effective amount of a compound of formula (I) according to claim 1 to a subject in need thereof (or further administering cytarabine)” (claims 56-58):
Wang ‘052 disclosed compounds of formula (I):
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, wherein Rx is hydrogen or C1-C3 alkyl; RY is C1-C3 alkyl, -(C2-C3 alkylenyl)-OH, or C1-C3 haloalkyl; X1 is N or CRx1 wherein… X2 is N or CRx2, wherein… Y1 is N or CRu; wherein Ru is hydrogen, C1-C6 alkyl, halogen, or C1-C6 haloalkyl; A1 is N or CR1, A2 is Nor CR2, A3 is N or CR3; and A4 is N or CR4; with the proviso that zero, one, two, or three of A1, A2, A3, and A4 are N… L1 is absent, CH2, C(O), (CH2)mO, (CH2)mS(O)n wherein n is 0, 1, or 2; or (CH2)mN(Rz) wherein Rz is hydrogen, C1-C3 alkyl, C1-C3 haloalkyl, (C2-C3alkylenyl)-OH, or unsubstituted cyclopropyl; m is 0 or 1; G1 is G1a or -(C1-C6 alkylenyl)-G1a, wherein each G1a is independently aryl, heteroaryl, heterocycle, cycloalkyl, or cycloalkenyl… Ri, at each occurrence, is independently C1-C6 alkyl or C1-C6 haloalkyl. Exemplary compounds of formula (I) include, 6-methyl-4-(2-phenoxyphenyl)-1,6-dihydro-7H-pyrrolo[2,3-c ]pyridin-7-one; 6-methyl-4-(5-nitro-2-phenoxyphenyl)-1,6-dihydro-7H-pyrrolo[2,3-c ]pyridin-7-one; 4-(5-amino-2-phenoxyphenyl)-6-methyl-1,6-dihydro-7H-pyrrolo[2,3-c ]pyridin-7-one. Also, 6-methyl-4-{ 5-[(methylsulfonyl)amino ]-2-phenoxyphenyl}-7-oxo-6,7-dihydro-1H-pyrrolo[2,3-c ]pyridine-2-carboxamide;ethyl 4-(5-amino-2-phenoxyphenyl)-6-methyl-7-oxo-6, 7-dihydro-1 H-pyrrolo[2,3-d]pyridazine-2-carboxylate; ethyl 4-[5-(ethylamino )-2-phenoxyphenyl]-6-methyl-7-oxo-6,7-dihydro-1H-pyrrolo[2,3-d]pyridazine-2-carboxylate (pages 4/139 to 6/139; page 22/139 to 27/139). A pharmaceutical composition comprising a therapeutically effective amount of a compound of formula (I), or a pharmaceutically acceptable salt thereof, in combination with a pharmaceutically acceptable carrier. A method for treating cancer (selected from the group consisting of: acoustic neuroma, acute leukemia, acute lymphocytic leukemia, acute myelocytic leukemia) in a subject comprising administering a therapeutically effective amount of a compound of formula (I) or a pharmaceutically acceptable salt thereof, to a subject in need thereof. The compounds of formula (I) can be co-administered with a therapeutically effective amount of one or more agents to treat a cancer, where examples of the agents include, alkylating agents, angiogenesis inhibitors, antibodies, antimetabolites. Antimetabolites include 5-azacitidine, capecitabine, carmofur, cladribine, clofarabine, cytarabine, cytarabine ocfosfate (pages 133/139 to 134/139; pages 45/139 to 47/139). Thus, these teachings of Wang ‘052 anticipate Applicant’s claims 1, 3-17, 28, 29, 40, 50, 53, and 55-58.
Double Patenting
Statutory type: A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-17, 28, 29, 40, 41, 50, 53, and 55 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-17, 28, 29, 40, 41, 50, 53, and 55 of prior U.S. Patent No. 9,296,741 (Wang et al., published on March 29, 2016). This is a statutory double patenting rejection.
Nonstatutory type: 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
(I) Claims 1-5, 7-11, 13-15, 28, 29, 50, and 55-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, 17 and 18 of U.S. Patent No. 9,321,765 (Same assignee: AbbVie Inc., published on April 26, 2016, also listed in IDS filed on 10/05/2018). Although the claims at issue are not identical, they are not patentably distinct from each other because Pat. ‘765 claims (a) An isolated crystalline form of N-[4-(2,4-difluorophenoxy)-3-( 6-methyl-7-oxo-6, 7-dihydro-1H-pyrrolo[2,3-c ]pyridin-4-yl)phenyl]ethanesulfonamide (
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, RN# 1445993-26-9), wherein the crystalline form has a powder X-ray diffraction pattern comprising three or more 28 peak values ±0.2 selected from the group consisting of: 6.2°, 9.0°, 12.3°, 12.6°, 15.6°, 22.1°, 25.6°, 26.3°, 27.0°, and 27.3° (claim 1), (b) A pharmaceutical composition comprising an isolated crystalline form of N-[4-(2,4-difluorophenoxy)-3-( 6-methyl-7-oxo-6, 7-dihydro-1H-pyrrolo[2,3-c ]pyridin-4-yl)phenyl]ethanesulfonamide according to claim 1, and at least one pharmaceutically acceptable carrier (claim 16), and (c) A method for treating cancer in a subject comprising administering a therapeutically effective amount of a pharmaceutical composition comprising a crystalline form of N-[4-(2,4-difluorophenoxy)-3-(6-methyl-7-oxo-6,7-dihydro-1H-pyrrolo[2,3-c]pyridin-4-yl)phenyl]ethanesulfonamide according to claim 1 and at least one pharmaceutically acceptable carrier, to a subject in need thereof” (claim 17). Claim 18 of Pat. ‘765 reads on claim 57 of this instant application. Thus, claims 1-5, 7-11, 13-15, 28, 29, 50, and 55-57 of instant application encompass or overlap with claims 1, 16, 17 and 18 of Pat. ‘765.
(II) Claims 1-5, 7-11, 13-15, 28, 50, and 55-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, and 5 of U.S. Patent No. 9,957,263 (Same assignee: AbbVie Inc., published on May 1, 2018). Although the claims at issue are not identical, they are not patentably distinct from each other because Pat. ‘263 claims (a) A compound or a pharmaceutically acceptable salt thereof, wherein the compound is selected from the group consisting of N-{3-[cyclohexyl(methyl)amino]propyl}-4-[2-(2,6-dimethylphenoxy)-5-(methylsulfonyl)phenyl]-6-methy 1-7-oxo-6, 7-dihydro-l H-pyrrolo[2,3-c ]pyridine-2-carboxamide (
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, RN# 1643749-42-1); and 4-[2-(2,4-difluorophenoxy)-5-(methylsulfonyl)phenyl]-6-methyl-2-[(4-methyl-2-phenylpiperazin-1-yl)methyl]-1,6-dihydro-7H-pyrrolo[2,3-c]pyridin-7-one (
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, RN# 1643749-44-3) (claim 1), (b) A compound or a pharmaceutically acceptable salt thereof, wherein the compound is 4-{2-[2-(2-cyclopentylethyl)-6-methylphenoxy]-5-(ethylsulfonyl)phenyl}-N-ethyl-6-methyl-7-oxo-6,7-dihydro-1H-pyrrolo[2,3-c]pyridine-2-carboxamide (
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, RN# 1643749-08-9) (claim 2), (c) A pharmaceutical composition comprising a therapeutically effective amount of a compound according to claim 1, 2, or 3, or a pharmaceutically acceptable salt thereof, in combination with a pharmaceutically acceptable carrier (claim 4), and (d) A method for treating cancer in a subject comprising administering a therapeutically effective amount of a compound according to claim 1, 2, or 3, or a pharmaceutically acceptable salt thereof, to a subject in need thereof, wherein the cancer is a bromodomain-mediated hematologic or solid cancer (claims 5). Thus, claims 1-5, 7-11, 13-15, 28, 50, and 55-57 of instant application encompass or overlap with claims 1, 2, 4, and 5 of Pat. ‘765.
(III) Claims 1-5, 7-11, 13-15, 28, 50, and 55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, and 13 of U.S. Patent No. 10,131,657 (Wang et al., published on November 20, 2018). Although the claims at issue are not identical, they are not patentably distinct from each other because Pat. ‘657 claims (a) A compound of formula (I), or a pharmaceutically acceptable salt thereof:
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(claim 1), wherein the compound is selected from the group consisting of… N-[4-(2,4-difluorophenoxy)-2-[(dimethylamino) methyl]-5-(6-methyl-7-oxo-6, 7-dihydro-1H-pyrrolo[2,3-c]pyridin-4-yl)phenyl]ethanesulfonamide (
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, RN# 1643669-30-0); N-[4-(2,4-difluorophenoxy)-5-(6-methyl-7-oxo-6, 7-dihydro-1H-pyrrolo[2,3-c ]pyridin-4-yl)-2-(piperidin-1-yl-methyl)phenyI]ethanesulfonamide (
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, RN# 1643669-34-4)… N-[4-(2,4-difluorophenoxy )-2-(hydroxymethyl)-5-(6-methyl-7-oxo-6,7-dihydro-1H-pyrrolo[2,3-c ]pyridin-4-yl)phenyl]ethanesulfonamide (
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, RN# 1643669-39-9) (claim 6), and (b) A pharmaceutical composition comprising a therapeutically effective amount of a compound of formula (I) according to claim 1, or a pharmaceutically acceptable salt thereof, in combination with a pharmaceutically acceptable carrier (claim 13). Thus, claims 1-5, 7-11, 13-15, 28, 50, and 55 of instant application encompass or overlap with claim 1, 6, and 13 of Pat. ‘657.
(IV) Claims 1-5, 7-11, 13, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,633,379 (Hasvold et al., Apr. 28 , 2020). Although the claims at issue are not identical, they are not patentably distinct from each other because Pat. ‘379 claims “N-ethyl-4-[2-(4-fluoro-2,6-dimethylphenoxy)-5-(2-hydroxypropan-2-yl)phenyl]-6-methyl-7-oxo-6,7-dihydro-1H-pyrrolo[2,3-c]pyridine-2-carboxamide or a pharmaceutically acceptable salt thereof (
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, RN# 2138861-99-9)” (claim 1). Thus, claims 1-5, 7-11, 13, and 28 of instant application encompass or overlap with claim 1 of Pat. ‘379.
(V) Claims 1-5, 7-11, 13-15, 28, and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/272,097 (APPLICANTS: AbbVie Inc., the claim set of 07/17/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because Appl. ‘097 claims “A compound of formula (I), or a pharmaceutically acceptable salt thereof:
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… R4 is phenyl, pyridinyl, a C3-C6 monocyclic cycloalkyl, or a C4-C6 monocyclic cycloalkenyl; wherein each R4 is optionally substituted with 1, 2, 3, or 4 independently selected RY groups… X1 and X2 are C(R5); or one of X1 and X2 is N and the other is C(R5); R5, at each occurrence, is independently hydrogen or halogen; and R6 is hydrogen, halogen, -CN, C1-C6 haloalkyl, or C1-C6 alkyl” (claim 1). Thus, claims 1-5, 7-11, 13-15, 28, and 50 of instant application encompass or overlap with claim 1 of Appl. ‘097. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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