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 .
Election/Restrictions
Applicant’s election without traverse of compound PS004 in the reply filed on November 18, 2025 is acknowledged.
The elected species has the following structural formula
RN 2707408-94-2 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one,
8-(1R,2R,4S)-bicyclo[2.2.1]hept-2-yl-2-[[4-[4-(3-hydroxybutyl)-1-piperidinyl]phenyl]amino]- (CA INDEX NAME)
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.
Claims 2-20 are withdrawn from prior art consideration because art was found (see MPEP 803.02.).
Applicants are advised of MPEP 803.02 Restriction - Markush Claims [R - 2], fourth and fifth paragraph, where is stated:
“As an example, in the case of an application with a Markush - type claim drawn to the compound C - R, wherein R is a radical selected from the group consisting of A, B, C, D, and E, the examiner may require a provisional election of a single species, CA, CB, CC, CD, or CE. The Markush - type claim would then be examined fully with respect to the elected species and any species considered to be clearly unpatentable over the elected species. If on examination the elected species is found to be anticipated or rendered obvious by prior art, the Markush - type claim and claims to the elected species shall be rejected, and claims to the non - elected species would be held withdrawn from further consideration. As in the prevailing practice, a second action on the rejected claims would be made final.” (emphasis added).
On the other hand, should no prior art be found that anticipates or renders obvious the elected species, the search of the Markush-type claim will be extended. If prior art is found that anticipates or renders obvious the Markush-type claim with respect to a non-elected species, the Markush-type claim shall be rejected and claims to the nonelected species held withdrawn from further consideration. The prior art search, however, will not be extended unnecessarily to cover all nonelected species. Should applicant, in response to this rejection of the Markush-type claim, overcome the rejection, as by amending the Markush-type claim to exclude the species anticipated or rendered obvious by the prior art, the amended Markush-type claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during the reexamination that anticipates or renders obvious the amended Markush-type claim, the claim will be rejected and the action made final. Amendments submitted after the final rejection further restricting the scope of the claim may be denied entry.
The search was limited to compounds of claim 1 wherein A is phenylene and D
is 1-piperidinyl. Copious amount of art was found that anticipates claim 1.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Boschelli et al. (US 6,498,163). The reference teaches a generic group of pyrido[2,3-d]pyrimidn-7(8H)-one derivatives which embraces Applicant’s claimed and elected compounds (See cols 3-4, compounds of formula (I) and definitions of the variables). The claims and the elected species differ from the reference by reciting specific species and a more limited genus than the reference. However, it would have been obvious to one having ordinary skill in the art at the time of the invention to select any of the species of the genus taught by the reference, including those instantly claimed, because the skilled chemist would have the reasonable expectation that any of the species of the genus would have similar properties and, thus, the same use as taught for the genus as a whole. One of ordinary skill in the art would have been motivated to select the claimed compounds from the genus in the reference since such compounds would have been suggested by the reference as a whole. It has been held that a prior art disclosed genus of useful compounds is sufficient to render prima facie obvious a species falling within a genus. In re Susi, 440 F.2d 442, 169 USPQ 423, 425 (CCPA 1971), followed by the Federal Circuit in Merck & Co. v. Biocraft Laboratories, 847 F.2d 804, 10 USPQ 2d 1843, 1846 (Fed. Cir. 1989).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boschelli et al. (US 6,498,163). The claim reads on the compounds depicted below (see Examples).
RN 211245-94-2 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cyclohexyl-2-[[4-(1-piperidinyl)phenyl]amino]- (CA
INDEX NAME)
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210
454
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RN 211246-13-8 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cyclopentyl-2-[[4-(1-
piperidinyl)phenyl]amino]- (CA INDEX NAME)
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210
445
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RN 211246-15-0 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cyclohexyl-2-[[4-(4-methyl-1-
piperidinyl)phenyl]amino]- (CA INDEX NAME)
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210
484
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Greyscale
RN 211246-16-1 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cyclohexyl-2-[[4-(1-
pyrrolidinyl)phenyl]amino]- (CA INDEX NAME)
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210
436
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Greyscale
RN 211246-19-4 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cycloheptyl-2-[[4-(1-
piperidinyl)phenyl]amino]- (CA INDEX NAME)
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219
460
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Greyscale
RN 211246-20-7 CAPLUS
CN 4-Piperidinecarboxylic acid, 1-[4-[(8-cyclohexyl-7,8-dihydro-7-
oxopyrido[2,3-d]pyrimidin-2-yl)amino]phenyl]-, ethyl ester (CA INDEX
NAME)
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321
563
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Greyscale
RN 211246-23-0 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cyclohexyl-2-[[4-(3,5-dimethyl-1-
piperidinyl)phenyl]amino]- (CA INDEX NAME)
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315
465
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RN 211246-24-1 CAPLUS
CN L-Proline, 1-[4-[(8-cyclohexyl-7,8-dihydro-7-oxopyrido[2,3-d]pyrimidin-
2-yl)amino]phenyl]-, 1,1-dimethylethyl ester (CA INDEX NAME)
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305
490
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Greyscale
RN 211246-26-3 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cyclohexyl-2-[[4-(3-methyl-1-
piperidinyl)phenyl]amino]- (CA INDEX NAME)
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285
465
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Greyscale
RN 211246-32-1 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-(1R,2R,4S)-bicyclo[2.2.1]hept-2-yl-
2-[[4-(1-piperidinyl)phenyl]amino]-, rel- (CA INDEX NAME)
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261
461
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Greyscale
RN 211246-36-5 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cyclohexyl-2-[[4-[3-(hydroxymethyl)-
1-piperidinyl]phenyl]amino]- (CA INDEX NAME)
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285
514
media_image12.png
Greyscale
RN 211246-40-1 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cyclopentyl-2-[[4-[4-(2-
hydroxyethyl)-1-piperidinyl]phenyl]amino]- (CA INDEX NAME)
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210
548
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Greyscale
RN 211246-41-2 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cyclopentyl-2-[[4-[4-(3-
hydroxypropyl)-1-piperidinyl]phenyl]amino]- (CA INDEX NAME)
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268
579
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RN 211246-42-3 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cyclopentyl-2-[[4-(4-hydroxy-1-
piperidinyl)phenyl]amino]- (CA INDEX NAME)
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210
491
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Greyscale
RN 211246-43-4 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 2-[[4-(1-piperidinyl)phenyl]amino]-8-
(tetrahydro-3-furanyl)- (CA INDEX NAME)
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210
445
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Greyscale
RN 211246-44-5 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cycloheptyl-2-[[3-(1-
piperidinyl)phenyl]amino]- (CA INDEX NAME)
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235
440
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Greyscale
RN 211246-45-6 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cyclopentyl-2-[[3-(1-
piperidinyl)phenyl]amino]- (CA INDEX NAME)
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media_image18.png
211
440
media_image18.png
Greyscale
RN 211246-46-7 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cyclohexyl-2-[[3-(1-
piperidinyl)phenyl]amino]- (CA INDEX NAME)
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229
440
media_image19.png
Greyscale
RN 211246-47-8 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cyclopentyl-2-[[4-(3-hydroxy-1-
piperidinyl)phenyl]amino]- (CA INDEX NAME)
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268
481
media_image20.png
Greyscale
RN 211246-48-9 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cyclopentyl-2-[[4-[2-
(hydroxymethyl)-1-piperidinyl]phenyl]amino]- (CA INDEX NAME)
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274
445
media_image21.png
Greyscale
RN 211246-49-0 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 2-[[4-(1-piperidinyl)phenyl]amino]-8-
(tetrahydro-2H-pyran-4-yl)- (CA INDEX NAME)
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210
454
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Greyscale
RN 211246-52-5 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-(1R,2R,4S)-bicyclo[2.2.1]hept-2-yl-
2-[[4-[4-(3-hydroxypropyl)-1-piperidinyl]phenyl]amino]-, rel- (CA INDEX
NAME)
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273
584
media_image23.png
Greyscale
RN 211246-53-6 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cyclohexyl-2-[[4-(4-hydroxy-1-
piperidinyl)phenyl]amino]- (CA INDEX NAME)
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210
500
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Greyscale
RN 211246-54-7 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cyclohexyl-2-[[4-[4-(2-
hydroxyethyl)-1-piperidinyl]phenyl]amino]- (CA INDEX NAME)
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210
556
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Greyscale
RN 211246-55-8 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-(1R,2R,4S)-bicyclo[2.2.1]hept-2-yl-
2-[[4-[4-[3-(4-morpholinyl)propyl]-1-piperidinyl]phenyl]amino]-, rel-
(CA INDEX NAME)
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338
624
media_image26.png
Greyscale
RN 211246-65-0 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-(1R,2R,4S)-bicyclo[2.2.1]hept-2-yl-
2-[[4-(4-hydroxy-1-piperidinyl)phenyl]amino]-, rel- (CA INDEX NAME)
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261
509
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Greyscale
RN 211246-66-1 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-(1R,2R,4S)-bicyclo[2.2.1]hept-2-yl-
2-[[4-[4-(2-hydroxyethyl)-1-piperidinyl]phenyl]amino]-, rel- (CA INDEX
NAME)
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261
565
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Greyscale
RN 211246-67-2 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-(1R,2S,4S)-bicyclo[2.2.1]hept-2-yl-
2-[[4-(1-piperidinyl)phenyl]amino]-, rel- (CA INDEX NAME)
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261
461
media_image29.png
Greyscale
RN 211246-69-4 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-(1R,2R,4S)-bicyclo[2.2.1]hept-2-yl-
2-[[4-[3-(hydroxymethyl)-1-piperidinyl]phenyl]amino]-, rel- (CA INDEX
NAME)
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273
509
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Greyscale
RN 211246-73-0 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-bicyclo[2.2.1]hept-2-yl-2-[[4-[4-[3-
(4-morpholinyl)propyl]-1-piperidinyl]phenyl]amino]- (CA INDEX NAME)
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306
624
media_image31.png
Greyscale
RN 211246-74-1 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-bicyclo[2.2.1]hept-2-yl-2-[[4-[3-(3-
hydroxypropyl)-1-piperidinyl]phenyl]amino]- (CA INDEX NAME)
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290
579
media_image32.png
Greyscale
RN 211246-79-6 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-(2-hydroxycyclopentyl)-2-[[4-(1-
piperidinyl)phenyl]amino]- (CA INDEX NAME)
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210
475
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RN 211246-83-2 CAPLUS
CN 1-Piperidinecarboxylic acid, 4-[7-oxo-2-[[4-(1-
piperidinyl)phenyl]amino]pyrido[2,3-d]pyrimidin-8(7H)-yl]-, ethyl ester
(CA INDEX NAME)
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274
546
media_image34.png
Greyscale
RN 211246-87-6 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-(1R,2R,4S)-bicyclo[2.2.1]hept-2-yl-
2-[[4-[2-(hydroxymethyl)-1-piperidinyl]phenyl]amino]-, rel- (CA INDEX
NAME)
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305
461
media_image35.png
Greyscale
RN 211246-88-7 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-bicyclo[2.2.1]hept-2-yl-2-[[4-(3-
hydroxy-1-piperidinyl)phenyl]amino]- (CA INDEX NAME)
PNG
media_image36.png
290
481
media_image36.png
Greyscale
RN 211246-92-3 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-cyclohexyl-2-[[4-[4-[2-(4-
morpholinyl)ethyl]-1-piperidinyl]phenyl]amino]- (CA INDEX NAME)
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235
620
media_image37.png
Greyscale
RN 211246-93-4 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-(1R,2R,4S)-bicyclo[2.2.1]hept-2-yl-
2-[[4-[4-[2-(4-morpholinyl)ethyl]-1-piperidinyl]phenyl]amino]-, rel-
(CA INDEX NAME)
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266
629
media_image38.png
Greyscale
RN 211246-95-6 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-bicyclo[2.2.1]hept-2-yl-2-[[4-[3-[3-
(4-morpholinyl)propyl]-1-piperidinyl]phenyl]amino]- (CA INDEX NAME)
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media_image39.png
300
629
media_image39.png
Greyscale
RN 211246-96-7 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-bicyclo[2.2.1]hept-2-yl-2-[[4-[3-(4-
morpholinylmethyl)-1-piperidinyl]phenyl]amino]- (CA INDEX NAME)
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268
573
media_image40.png
Greyscale
RN 211247-21-1 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-bicyclo[2.2.1]hept-2-yl-2-[[4-(1-
piperidinyl)phenyl]amino]- (CA INDEX NAME)
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media_image41.png
225
461
media_image41.png
Greyscale
RN 211247-24-4 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-bicyclo[2.2.1]hept-2-yl-2-[[4-[4-(3-
hydroxypropyl)-1-piperidinyl]phenyl]amino]- (CA INDEX NAME)
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media_image42.png
241
584
media_image42.png
Greyscale
RN 211247-29-9 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-bicyclo[2.2.1]hept-2-yl-2-[[4-(4-hydroxy-1-piperidinyl)phenyl]amino]- (CA INDEX NAME)
PNG
media_image43.png
225
509
media_image43.png
Greyscale
RN 211247-30-2 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-bicyclo[2.2.1]hept-2-yl-2-[[4-[4-(2-hydroxyethyl)-1-piperidinyl]phenyl]amino]- (CA INDEX NAME)
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media_image44.png
225
565
media_image44.png
Greyscale
RN 211247-32-4 CAPLUS
CN Pyrido[2,3-d]pyrimidin-7(8H)-one, 8-bicyclo[2.2.1]hept-2-yl-2-[[4-[3-(hydroxymethyl)-1-piperidinyl]phenyl]amino]- (CA INDEX NAME)
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241
509
media_image45.png
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.
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 1-21 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.
i) The intended use of the compound is as a pharmaceutical. Therefore, the “salt” should be limited to “a pharmaceutically acceptable salt” to exclude salts that are not suitably for the intended utility (e.g., toxic).
ii) The term “substituted” without saying which substituents are intended is indefinite. One skilled in the art cannot say which substituents are permitted and which ones are not. The definition in the specification is open-ended. Regarding D, it is unclear whether additional substituents are intended or whether R11 is only allowed. A clarification is required.
iii) The term “heteroaryl” is indefinite because it is not known how many atoms are present, how many and what kind of heteroatoms are involved, what size ring is intended and how many rings are present.
iv) Regarding the “C1-6 hydrocarbyl,” is more than an alkyl or cycloalkyl intended? The claim already states alkyl and cycloalkyl in the definition of R1. Applicants are requested to keep this consistent.
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.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention.
The treatment of cancer somehow associated with a CDK inhibitor generally cannot possibly be considered enabled.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008). See also In re Cortright, 49 USPQ2d 1464, 1466 and Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 49 USPQ2d 1370.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
The analysis is as follows:
(1) Breadth of claims.
(a) Scope of the compounds. The scope of compound is not objected to.
(b) Scope of the diseases covered. Cancer which is somehow associated with a CDK, or cluster of closely related disorders. There are hundreds of such cancers, which have in common only some association with CDK. Such cancers are highly heterogeneous at both the molecular and clinical level, something seen especially in, for example, the cancers of the breast, brain and salivary glands. They can occur in pretty much every part of the body. For example, leukemia is any malignant neoplasm of the blood-forming tissues. Leukemia can arise from many different sources. These include viruses such as EBV, which causes Burkitt's lymphoma, and HTLV-1, linked to certain T cell leukemias. Others are linked to genetic disorders, such as Fanconi's anemia, which is a familial disorder, and Down's syndrome. Other leukemias are caused by exposure to carcinogens such as benzene, and some are actually caused by treatment with other neoplastic agents. Still other leukemias arise from ionizing radiation, and many are idiopathic. Leukemias also differ greatly in the morphology, degree of differentiation, body location (e.g., bone marrow, lymphoid organs, etc.) There are dozens of leukemias. There are B-Cell Neoplasms such as B-cell prolymphocytic leukemia and Hairy cell leukemia (HCL, a chronic Lymphoid leukemia). There are T-Cell Neoplasms such as T-cell prolymphocytic leukemia, aggressive NK cell leukemia, adult T cell leukemia/lymphoma (ATLL), and T-cell granular Lymphocytic leukemia. There are different kinds of acute myeloid leukemias (undifferentiated AML, acute myeloblastic, acute myelomonocytic leukemia, acute monocytic leukemias, acute monoblastic, acute megakaryoblastic (AmegL), acute promyelocytic leukemia (APL), and erythroleukemia). There is also lymphoblastic leukemia, hypocellular acute myeloid leukemia, Ph-/BCR- myeloid leukemia, and acute basophilic leukemia. Chromic leukemias include chronic lymphocytic leukemia (CLL, which exists in a B-cell and a T-cell type), prolymphocytic leukemia (PLL), large granular lymphocytic leukemia (LGLL, which goes under several other names as well), chronic myelogenous leukemia (CML), chronic myelomonocytic leukemia (CMML), chronic neutrophilic leukemia, chronic eosinophilic leukemia (CEL), and many others.
(2) The nature of the invention and predictability in the art: With specific reference to cancer, Ex parte Kranz, 19 USPQ2d 1216, 1219 notes the “general unpredictability of the field [of] …anti-cancer treatment.” In re Application of Hozumi et al., 226 USPQ 353 notes the “fact that the art of cancer chemotherapy is highly unpredictable”. More generally, the invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
(3) Direction or Guidance: That provided is very limited. There is no dosage information.
(4) State of the Prior Art: The claimed compound is a pyridopyrimidinone. So far as the examiner is aware these have only been used against specific cancers not against cancer associated with a CDK inhibitor.
(5) Working Examples: Applicants results against the specific cell lines shown in pages 58-62 are sufficient to support those cancers.
(6) Skill of those in the art: the prior art knows that there never has been a compound capable of treating cancers generally. “The cancer therapy art remains highly unpredictable, and no example exists for efficacy of a single product against tumors generally.” (<http://www.uspto.gov/web/offices/pac/dapp/1pecba.htm#7> ENABLEMENT DECISION TREE, Example F, situation 1). A similar statement appears at In re Application of Hozumi et al., 226 USPQ 353: “In spite of the vast expenditure of human and capital resources in recent years, no one drug has been found which is effective in treating all types of cancer. Cancer is not a simple disease, nor is it even a single disease, but a complex of a multitude of different entities, each behaving in a different way.” There are compounds that treat a modest range of cancers, but no one has ever been able to figure out how to get a compound to be effective against cancer generally, or even a majority of cancers.
The attempts to find compounds to treat the various cancers arguably constitute the single most massive enterprise in all of pharmacology. This has not resulted in finding any treatment for tumors generally. Indeed, the existence of such a "silver bullet" is contrary to our present understanding in oncology. This is because it is now understood that there is no “master switch” for cancers generally; cancers arise from a bewildering variety of differing mechanisms. Even the most broadly effective antitumor agents are only effective against a small fraction of the vast number of different cancers known. This is true in part because cancers arise from a wide variety of sources, primarily a wide variety of failures of the body's cell growth regulatory mechanisms, but also such external factors such as viruses (an estimated at least 20% are of viral origin e.g. Human papillomavirus, EBV, Hepatitis B and C, HHV-8, HTLV-1 and other retroviruses, and quite possibly Merkel cell polyomavirus, and there is some evidence that CMV is a causative agent in glioblastoma), exposure to chemicals such as tobacco tars, excess alcohol consumption (which causes hepatic cirrhosis, an important cause of HCC), ionizing radiation, and unknown environment factors.
Accordingly, there is substantive “reason for one skilled in the art to question the objective truth of the statement of utility or its scope” (In re Langer, 183 USPQ 288, 297).
Similarly, In re Novak, 134 USPQ 335, 337-338, says “unless one with ordinary skill in the art would accept those allegations as obviously valid and correct, it is proper for the examiner to ask for evidence which substantiates them.” There is no such evidence in this case. Likewise, In re Cortright, 49 USPQ2d 1464, states: “Moreover, we have not been shown that one of ordinary skill would necessarily conclude from the information expressly disclosed by the written description that the active ingredient” does what the specification surmises that it does. That is exactly the case here. Even if applicants’ assertion that cancer in general could be treated with these compounds were plausible--- which it is not ---, that would not suffice, as was stated in Rasmusson v. SmithKline Beecham Corp., 75 USPQ2d 1297, 1301: “If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success.”
Different types of cancers affect different organs and have different methods of growth and harm to the body, and different vulnerabilities. The skill thus depends on the particular cancer involved. There are some cancers where the chemotherapy skill level is high and there are multiple successful chemotherapeutic treatments. The mechanism in these situations, however, is not necessarily the same as is alleged for these compounds.
(7) The quantity of experimentation needed: Given the fact that, historically, the development of new cancers drugs has been difficult and time consuming, and especially in view of factors 1 and 4 and 6, the quantity of experimentation needed is expected to be great.
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCK KIFLE whose telephone number is (571)272-0668. The examiner can normally be reached 8 AM - 6 PM, M-F.
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November 21, 2025
/BRUCK KIFLE/Primary Examiner, Art Unit 1624