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 .
Claim Status
Claims 1-2, 4-5, 7-8, 10-12, 22-32, 35, 37-40, and 43-46 are pending. Claims 12, 26-29, 37-40 and 43-46 are withdrawn. Claims 1-2, 4-5, 7-8, 10-11, 22-25, 30-32 and 35 are rejected.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to compounds and the elected species of Compound 101 in the reply filed on December 2nd, 2025 is acknowledged.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicant’s elected species appears free of the art. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the non-elected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the scope of claims 1-2, 4-5, 7-8, 10-11, 22-25, 30-32 and 35 where the compound is one of the following:
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These species of which are anticipated and not allowable under 35 USC 102. Any subject matter discussed outside this scope was discovered incidental to the expanded search and is presented in the interest of compact prosecution.
As a non-elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention are held withdrawn from further consideration. Examination has been limited to claims embracing the elected species which are claims 1-2, 4-5, 7-8, 10-11, 22-25, 30-32 and 35. Claims 1-2, 4-5, 7-8, 10-11, 22-25, 30-32 and 35 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since the nonelected species has not been found allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 12, 26-29, 37-40 and 43-46 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Priority
Applicant’s claim for the benefit of a prior-filled application under U.S.C. 119(e) or under 35 U.S.C. 120, 121 or 365(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. 119(e) 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 of 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., 35 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed applications, Application No. 62/983,541, No. 63/007,333, No. 63/040,484, and No. 63/072,790 fail 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.
Applications ‘541, ‘333, and ‘484 disclose the following genus (page 2):
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The priority documents only provide support for compounds where ring A is directly linked to W whereas instant claims 1-2, 4-5, 7-8, 10, 22, 30, 32 and 35 are generic to compounds where there may be a linker connecting ring A to W.
Regarding claims 11 and 23-24, Applications ‘541, ‘333, and ‘484 are narrower in scope than instant Formula (I) as the priority documents only provide support for compounds of Formula (I) wherein at least one of X, Y and Z is N, N(R3c) or O (page 2).
Regarding instant claim 31, Applications ‘541, ‘333, ‘484, ‘790 fail to disclose compounds of Table 1 such as compound 213.
For these reasons the earliest priority dates for the claims under examination are as follows:
Claims 1-2, 4-5, 7-8, 10-11, 22-24, 30, 32 and 35: August 31st, 2020.
Claim 31: December 16th, 2020.
Claim 25: February 28th, 2020.
Claim Objections
Claim 4 is objected to because of the following informalities:
The bond that connects R1 to the nitrogen heteroatom is not visible in the following embodiments,
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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.
Claims 7, 30 and 35 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.
Claim 7 recites the following moieties which include variable p that is undefined in claim 7 and not recited in base claim 1:
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It is unclear what structures would be embraced by these embodiments.
Claim 30 is rejected because it refers to Table 1 of the instant specification. A claim should particularly point out and distinctly claim the subject matter which the applicant regards as his invention and, under modern claim practice, stand alone to define the invention. MPEP 2173.05(s) states:
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)
Regarding claim 35, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 10-11, 23-24, 31-32 and 35 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by WO2011148922A1 cited in the IDS filed 08/26/2022.
On page 179, the prior art discloses the following compound which reads on claims 1-2, 10-11, 23-24, 31-32 and 35 and is embraced by formula (I) where A is heterocyclyl substituted by R1 wherein R1 is heteroaryl substituted by R6 wherein R6 is C3-alkyl, L1 is absent, B is heteroaryl substituted by two R1 wherein R1 is halo or C1-alkyl, L2 is absent, W is C, X and Z are N, Y is C(R3a) wherein R3a is hydrogen, M is C(R2) wherein R2 is hydrogen, R2 is halo and m is 1:
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Regarding instant claim 31, the prior art discloses a pharmaceutical composition comprising the compound above and a pharmaceutically acceptable carrier (page 8 of translation).
Regarding instant claims 32 and 35, a compound and its properties are inseparable therefore the instant claims are anticipated by the prior art compound which is embraced by instant formula (I).
Claims 1, 10-11, 22-25, 31-32 and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 1625630-02-5, which entered Registry on September 24th, 2014.
CAS Registry No. 1625630-02-5 is drawn to 1,5-Bis(1-dibenzothienyl)phthalazine, which has the following structure:
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The compound is embraced by instant Formula (I-c) and reads on claims 1, 10-11, 22-25, 31-32 and 35 where M is C(R2) wherein R2 is hydrogen, R2 is absent (m is 0), both A and B are aryl and L2 is absent.
Regarding instant claim 31, which is drawn to a pharmaceutical composition comprising the compound and a pharmaceutically acceptable excipient, the CAS Registry entry includes predicted properties including mass and molar solubilities at varying pH values. MPEP 2131.02 states:
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015)
In this situation, a person having ordinary skill in the art in viewing the properties of the Registry entry would envisage a composition with the compound and water, which is a pharmaceutically acceptable excipient.
Regarding instant claims 32 and 35, a compound and its properties are inseparable therefore the instant claims are anticipated by the prior art compound which is embraced by instant formula (I).
Claims 1-2, 4-5, 10-11, 23-24, 31-32 and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 1003225-26-0, which entered Registry on February 13th, 2008.
CAS Registry No. 1003225-26-0 is drawn to 4-(4-Methyl-1-piperazinyl)-8-(4-morpholinyl)-3-quinolinecarboxylic acid, which has the following structure:
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The compound is embraced by instant Formula (I-b) and reads on claims 1-2, 4-5, 10-11, 23-24, 31-32 and 35 where M is C(R2) wherein R2 is hydrogen, R2 is absent (m is 0), A is
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, B is heterocyclyl, L2 is absent, X is C(R3a) wherein R3a is -C(O)ORD, RD is hydrogen, Y is C(R3a) wherein R3a is hydrogen, and Z is N.
Regarding instant claim 31, which is are drawn to a pharmaceutical composition comprising the compound and a pharmaceutically acceptable excipient, the CAS Registry entry includes predicted properties including mass and molar solubilities at varying pH values. MPEP 2131.02 states:
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015)
In this situation, a person having ordinary skill in the art in viewing the properties of the Registry entry would envisage a composition with the compound and water, which is a pharmaceutically acceptable excipient.
Regarding instant claims 32 and 35, a compound and its properties are inseparable therefore the instant claims are anticipated by the prior art compound which is embraced by instant formula (I).
Claim(s) 1, 7-8, 10-11, 23, 31-32 and 35 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2020/123395A1 BY Alam et al.
The prior art discloses (page 93):
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The compound is embraced by instant Formula (I-a) and reads on claims 1, 7-8, 10-11, 23, 31-32 and 35 where M is C(R2) wherein R2 is hydrogen, R2 is halo (m is 1), A is aryl, B is
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, L2 is absent, W is N, X is C(R3a)(R3b) wherein R3a and R3b together form an oxo group, Y is N, and Z C(R3a) wherein R3a is -NRBRC, and RB and RC are each hydrogen.
Regarding instant claim 31, the prior art teaches a pharmaceutical composition comprising the prior art compound and a pharmaceutically acceptable excipient (paragraph [0012]).
Regarding instant claims 32 and 35, a compound and its properties are inseparable therefore the instant claims are anticipated by the prior art compound which is embraced by instant formula (I).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at (571)272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626