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 .
DETAILED ACTION
Claims 1-4, 6-7, 9-12, 14-15, 17-20, and 23-26 are pending in the instant application.
Claims 27 and 28 are new.
Claims 23-26 and 28 are withdrawn from consideration.
Claims 1-4, 6-7, 9-12, 14-15, 17-20, and 27 are examined herein.
Priority
The instant application claims benefit of foreign priority to GB2019622.6, filed on 11 December 2020, and the benefit of priority to PCT/GB21/53252, filed on 10 December 2021. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 11 December 2020.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 09 June 2023, 02 January 2024, 23 February 2024, 20 June 2024, 20 June 2024, 18 October 2024, 18 October 2024, 03 December 2024, 03 December 2024, 06 January 2025, 06 January 2025, 12 February 2025, 18 April 2025, 18 April 2025, 20 August 2025, and 21 May 2026, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Election/Restrictions
Applicant’s election of Group I, with traverse, originally claims 1-4, 6-7, 9-12, 14-15, 17-20, now amended claims 1-4, 6-7, 9-12, 14-15, 17-20 and 27, in the reply filed on 11 May 2026, is acknowledged. Applicant further elects species 2-(3-Cyanophenyl)-3-(2,6-dimethyl-4-pyridyl)-N-(2-hydroxy-2-methyl-propyl)imidazo[1,2-b]pyridazine-6-carboxamide. The traversal is on the grounds that the instant application is drawn to one of the recited combination of categories in 37 C.F.R. § 1.475(b), namely category (2), a product and process of use of said product.
Applicant’s arguments have been considered but are not persuasive. The instant application must be drawn to one of the recited combinations of categories and possess a technical relationship among the claimed inventions involving a special technical feature. As defined in PCT Rule 13.2 a “special technical feature” is a technical feature that that each invention makes over the prior art. As the instant invention claims a formula known in the prior art no special technical feature exist and therefore no unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 23-26 and 28 are withdrawn from consideration for not reading on the elected group.
If the elected species is not identified in the art, the search will be expanded to additional species per MPEP 802.03.
The elected species was not identified in the art and the search was expanded to all species of Formula (I).
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 12, 15, 17, and 27 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 12 recited the limitation of Q being “…aryl, (3-8)cycloalkyl, (3-8C)cycloalkenyl…” The “(3-8)cycloalkyl” does not define that 3-8 refers to the number or carbon atoms. It is the Examiner’s opinion it should read “(3-8C)cycloalkyl.”
Claims 15 and 17 recite that A is CR4 and N. This is unclear, as A cannot be both at one time.
Claim 27 recites the limitations of R200, R201, and R202. There is insufficient antecedent basis for this limitation in the claim, as R200, R201, and R202 are not found in claim 1. It is the Examiner’s opinion claim 27 should depend on claim 10.
Claim Rejections - 35 USC § 103
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.
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, 7, 9-12, 15, 17-20, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Atkinson et al. (EP2635578B1).
Regarding claims 1 and 18, Atkinson discloses compounds of Formula (I) (pictured below) which overlaps with the instant genus of Formulas (I), (Ib), (Id), (Ig), (Ih), (Ih2), and (Ij), when the reference
R1 is pyridyl, optionally substituted (corresponds to the instant R3 where R3 is -L-Y-Lq-Q, L and Y are absent and Lq is heteroaryl)
R2 is hydrogen or C1-4 alkyl (corresponding to one of the R1B or R1C- substituents)
R3 is C1-4 alkyl (corresponding to an instant R1Z substituent)
R5 is hydrogen, halo, CN, C1-6 alkyl, C1-6 haloalkyl, aryl, heteroaryl, cycloalkyl, and heterocyclyl (corresponds to instant R0 and R2)
A is -C(O)N(R7)- or -S(O2)N(R7)-, where R7 is hydrogen or C1-4 alkyl (corresponding to one of the R1Z substituents)
Z is N or CR-6, where R6 is hydrogen (corresponds to the instant R1 being aryl or heteroaryl)
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Atkinson fails to teach an anticipatory specie; however the preferred embodiments would have guided the skilled artisan to certain substitutions seen in the instant invention. Atkinson teaches cyanophenyl substituents in embodiments such as examples 44, 296, and 545, while a bromo substituent for the reference R5 is seen in examples 9, 13, and 14. And carboxamide substituents are seen in many of the preferred embodiments. Guided by the teaching of Atkinson it would have been prima facie obvious to pick groups within the genus because structurally similar compounds are expected to have similar properties. In this case, the genus links the structures therein as having similar properties, so substitutions within the genus would also be expected to have similar properties.
Regarding claims 2 and 3, Atkinson discloses the A can be -C(O)N(R7)- or -S(O2)N(R7)-, where R7 is hydrogen or C1-4 alkyl, which corresponds to the instant R1Z, and R3 is C1-4 alkyl, which also corresponds to the instant R1Z, but can be H.
Regarding claim 4, Atkinson discloses Z is N or CR-6, where R6 is hydrogen, which corresponds to the instant R1 being pyridyl.
Regarding claims 7 and 9, Atkinson discloses R5 is hydrogen, halo, CN, C1-6 alkyl, C1-6 haloalkyl, aryl, heteroaryl, cycloalkyl, and heterocyclyl, which corresponds to the instant R2.
Regarding claims 10 and 11, Atkinson discloses R5 can be halo or heteroaryl, turning to the specification “heteroaryl” includes monocyclic and bicyclic rings (paragraph [0159]), optionally substituted.
Regarding claim 12, Atkinson discloses R1 is pyridyl, optionally substituted, this corresponds to the instant R3 where R3 is -L-Y-Lq-Q, L, Y, and Lq are absent and Q is heteroaryl.
Regarding claims 15 and 17, Atkinson teaches the substituent corresponding to A, wherein A is CR4, to be R5, where R5 is hydrogen, halogen, or C-1-2 alkyl.
Regarding claim 20, Atkinson discloses a pharmaceutical composition with a pharmaceutically acceptable carrier or diluent (paragraph [0011]).
Regarding claim 27, Atkinson teaches R5 can be heteroaryl, optionally substituted with one or more R10. Pyridine is one of the examples of heteroaryl groups provided in the specification (paragraph [0159]). Substituted with two R-10 substituents where R10 is C1 alkyl leads to the instant claimed moiety.
Claims 1-4, 6-7, 9-12, 14-15, 17-20, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Uchikawa et al. (US20080167314A1).
Regarding claims 1 and 18, Uchikawa discloses compounds of Formula (I) (pictured below) which overlaps with the instant genus when the reference:
X1 is N
X2 is CH, optionally substituted (corresponding to the instant R3)
X3 is N or CH, optionally substituted (corresponding to the instant A)
X4 is CH
R1 is optionally substituted phenyl or heteroaryl (corresponding to the instant R1)
R2 is optionally substituted pyridin-4-yl or pyrimidin-4-yl (corresponding to the instant R2)
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Uchikawa fails to teach an anticipatory specie; however the preferred embodiments would have guided the skilled artisan to certain substitutions seen in the instant invention. Uchikawa teaches a pyridine substituent as a preferred embodiment for the reference R2 and cyanophenyl substituents is seen in example 47-4. Guided by the teaching of Uchikawa it would have been prima facie obvious to pick groups within the genus because structurally similar compounds are expected to have similar properties. In this case, the genus links the structures therein as having similar properties, so substitutions within the genus would also be expected to have similar properties.
Regarding claims 2 and 3, Uchikawa discloses the reference R1 can be optionally substituted phenyl or heteroaryl. The optional substituents can be an optionally substituted hydrocarbon, an optionally substituted amino group, halogen, nitro, cyano, optionally substituted hydroxy group, carboxy, optionally substituted acyl group, optionally substituted alkoxycarbonyl group, optionally substituted alkoxycarbonyl group, optionally substituted aralkyloxycarbonyl group, thiocarbamoyl, substituted sulfonyl, an optionally substituted heterocyclic group, sulfo; sulfamoyl, sulfinamoyl, or sulfenamoyl (paragraph [0074]).
Regarding claims 4 and 6, Uchikawa discloses the reference R1 can be optionally substituted phenyl or heteroaryl, this includes furyl, pyridyl or oxazoyl. The ring can be substituted with alkyl, alkoxy, or cyano. Therefore Uchikawa discloses R1 can be 2-cyanophenyl.
Regarding claims 7 and 9, Uchikawa discloses the reference R2 can be pyridiny-4-yl or pyrimdin-4-yl optionally substituted with the substituents listed above.
Regarding claims 10 and 11, Uchikawa discloses the reference R2 can be optionally substituted pyridiny-4-yl which corresponds to the instant
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.
Regarding claims 12 and 14, Uchikawa discloses X2 is optionally substituted CH, X2 can be substituted with substituents from the Substituent A group (paragraph [0145]), these substituents are an optionally substituted hydrocarbon, an optionally substituted amino group, halogen, nitro, cyano, optionally substituted hydroxy group, carboxy, optionally substituted acyl group, optionally substituted alkoxycarbonyl group, optionally substituted alkoxycarbonyl group, optionally substituted aralkyloxycarbonyl group, thiocarbamoyl, substituted sulfonyl, an optionally substituted heterocyclic group, sulfo; sulfamoyl, sulfinamoyl, or sulfenamoyl (paragraph [0074]). This overlaps with many combinations of the instant R3 when R3 is -L-Y-Lq-Q. Such as, L, Y, and Lq are absent and Q is alkyl, alkenyl, alkynyl, aryl, cycloalkyl, cycloalkenyl, heteroaryl or heterocyclyl; and L and Lq are absent, Y is N(Ra) and Q is alkyl.
Regarding claims 15 and 17, Uchikawa discloses that X3 is N or optionally substituted CH. CH can be substituted with substituents of Substituent A group (above).
Regarding claim 20, Uchikawa discloses the pharmaceutical composition of a compound of Formula (I) (paragraph [0600]) and a carrier (paragraph [0604]).
Regarding claim 27, Uchikawa discloses the pyridiny-4-yl can be optionally substituted, which includes alkyl groups.
Claims 1-4, 6-7, 12, 14-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Soeberdt et al. (WO2009115321A1).
Regarding claims 1 and 18, Soeberdt discloses compounds of Formula (I) (pictured below) (claim 1) which overlaps with the instant genus when the reference:
R1 is H or C1-6 alkyl, (corresponds to the instant Ra)
R2 is H, C1-6- alkyl, or C1-6 alkylene-C3-7 cycloalkyl (corresponds to the instant Q)
R3 is –(CR8R9)n-T, where R8 is H or halogen; R9 is H or halogen; n is 1 to 4; and T is NR12R13, where R12 and R13 are H or C1-4 alkyl (corresponds to the instant R2)
A is a bond (corresponds to the instant R1)
B is CH
D is CH or N
E is N
X is phenyl or 5-6 membered heteroaryl (corresponds to the instant R1)
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Soeberdt fails to teach an anticipatory specie; however the preferred embodiments would have guided the skilled artisan to certain substitutions seen in the instant invention. Soeberdt teaches cyanophenyl substituents as a preferred embodiment in example 4 and 8 and carboxamides are a requirement of the genus. Examples 1-4 have substituent E as N, matching the core of the instant genus. Guided by the teaching of Soeberdt it would have been prima facie obvious to pick groups within the genus because structurally similar compounds are expected to have similar properties. In this case, the genus links the structures therein as having similar properties, so substitutions within the genus would also be expected to have similar properties.
Regarding claims 2 and 3, Soeberdt discloses that A can be a bond and X can be phenyl or 5-6 membered heteroaryl, corresponding to the instant R1. The phenyl or heteroaryl can then be substituted by 1-3 substituents selected from halogen, cyano, C1-6 alkyl, O-C1-6 alkyl; and/or 1 substituent selected from C(O)NH2, C(O)NH-C1-6alkyl, C(O)N-)C1-6alkyl)2, SO2-C1-6alkyl, C(O)NH-SO2-C1-6alkyl, oxo, NH2, NH-C1-6alkyl, N-(C1-6alkyl)2, NH-SO2-CH3, or NH-SO2-CF3; and/or 1 substituent selected from a 5-6 membered heteroaryl.
Regarding claims 4 and 6, Soeberdt discloses that A can be a bond and X can be phenyl or 5-6 membered heteroaryl, this includes furyl, pyridyl or oxazolyl. Soeberdt discloses X can be substituted with cyano, thereby teaching 3-cyanophenyl.
Regarding claims 7, Soeberdt discloses R3 is –(CR8R9)n-T, where R8 and R9 are H or halogen and T is NR12R13, where R12 and R13 are H or alkyl; corresponding to the instant R2 being (1-4C)alkyl substituted with (CH2)qNR2DR2E.
Regarding claims 12 and 14, Soeberdt discloses that R1 can be H or C1-6 alkyl and R2 can be H, C1-6- alkyl, or C1-6 alkylene-C3-7 cycloalkyl. This corresponds to the instant R3 where R3 is -L-Y-Lq-Q; L and Lq are absent, Y is N(Ra) where Ra is H or (1-4C)alkyl (reference R1), and Q is (1-6C)alkyl, (2-6C)alkenyl, (3-8) cycloalkyl, or (3-8C)cycloalkenyl,
Regarding claims 15 and 17, Soeberdt discloses D can be CH or N
Regarding claim 20, Soeberdt discloses a pharmaceutical composition and a pharmaceutically acceptable carrier (claim 24).
Claim Objections
Claim 19 is 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.
Conclusion
Claims 1-4, 6-7, 9-12, 14-15, 17-18, 20, and 27 are rejected.
Claim 19 is objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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