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
The preliminary amendment filed 12/15/2023, that amended claims 6-8, 10, 12, and 14, cancelled claim 11, and added claims 15-21, is acknowledged.
Claims 1-10 and 12-21 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Claim Objections
Claims 13, and 18-21 are objected to because of the following informalities:
-In claim 13, commas should be inserted following the 1st-3rd compounds.
-In claims 18-21, the compounds are blurry. These compounds should be replaced by clear depictions of the compounds.
Appropriate correction is required.
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 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 1-10 and 12-21 are rejected under 35 U.S.C. 103 as being unpatentable over CN 112457326 (published 03/09/2021--Original, IDS of 06/13/2024; Translation, PTO-892).
‘326 teaches compounds of:
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, wherein M1 is preferably CH, CF, or N and M2 is preferably O or S (claims 1& 6, Translation & Original), and wherein a subspecies is exemplified with a thiazole ring (pg. 24, Original).
‘326 claims R1 as
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(claim 6, Translation; pg. 5, Original).
‘326 teaches R2 as:
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(pg. 19, [0030], Original; pg. 3, last full paragraph, Description).
‘326 specifically exemplifies:
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(pg.14, Original).
Regarding claims 1, 10, and 12, while ‘326 teaches
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, it differs from that of formula (I) in that it does not teach the thiazole ring,
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.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to substitute the thiophene ring of ‘326 with a thiazole ring, to arrive at instant formula (I). One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success because:
-‘326 teaches M1 as preferably CH, CF, or N and M2 as preferably O or S,
-‘326 teaches
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as a subgenus of its compounds (pg. 24, Original).
As such, an ordinary skilled artisan would have been motivated to make such a modification/substitution since ‘326 teaches thiazole rings as within the scope of its compounds, and exemplifies such a subspecies. An ordinary skilled artisan would predictably expect such structurally similar compounds to have a similar therapeutic profile, i.e., ERK2 kinase inhibition, and thus be effective to treat solid tumors (Translation, last 2 pages of Description).
Regarding claims 2 and 3, R1 and R2 are H.
Regarding claim 4, R4 is CH3 substituted with three “F”’s.
Regarding claims 6 and 7, Rd is CH3.
Regarding claims 8-9, ring A is
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.
Regarding claims 5, 13, and 20, while ‘326 teaches
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, it differs from that of instant claims 5, 13, and 20 in that it does not teach a methyl group at the CF3 group position.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute “CF3” with “CH3,” to arrive at instant claims 5, 13, and 20. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success because:
-‘326 teaches its R2 a heteroaryl group preferably substituted by methyl (Translation, claim 2),
-‘326 exemplifies species wherein the R2 aromatic ring is substituted with “CH3” at the 2-position of the ring (Original, pgs. 10-15).
As such, an ordinary skilled artisan would have been motivated to make such a substitution, to predictably arrive at a structural similar compound with the same or similar therapeutic profile.
Regarding claim 18, while ‘326 teaches
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, it differs from that of instant claim 18, in that it does not teach
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It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the -H on the pyrimidine ring with -CH3, to arrive at instant claim 18. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success because:
-‘326 teaches R5 as H or a C1-6 alkyl and teaches R5 as preferably methyl (Translation-claims 1-3), and
-‘326 exemplifies compounds wherein R5 is methyl (Original, pgs. 10-15).
As such, an ordinary skilled artisan would have been motivated to make such a substitution, to predictably arrive at structural similar compound with the same or similar therapeutic profile.
Regarding claim 19, while ‘326 teaches
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, it differs from that of instant claim 19 in that it does not teach a tetrahydropyran ring at the instant ring A position.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the pyrazolyl ring of
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, with a tetrahydropyran ring, to arrive at instant claim 19. One of ordinary skill in the art would have been motivated to make such a substation, with a reasonable expectation of success because:
-‘326 teaches both tetrahydropyran rings and pyrazolyl rings at its R1 position,
-‘326 exemplifies compounds with both tetrahydropyran rings and pyrazolyl rings (Original pgs. 10-15),
-‘326 demonstrates that compounds with either tetrahydropyran rings or pyrazolyl rings at the R1 position as having therapeutically effective IC50 values for inhibition of ERK2 kinase and proliferation of Colo-205 cells (Original, pgs. 62-63; Translation, last two pages).
As such, an ordinary skilled artisan would have been motivated to make such a substitution, to predictably arrive at structural similar compound with the same or similar therapeutic profile.
Regarding claim 21, while ‘326 teaches
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, it differs from that of instant claim 21, in that it does not teach
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.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the -H on the pyrimidine ring with -CH2CH3, to arrive at instant claim 21. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success because ‘326 teaches R5 as H or a C1-6 alkyl (Translation-claims 1-3).
As such, an ordinary skilled artisan would have been motivated to make such a substitution, to predictably arrive at structural similar compound with the same or similar therapeutic profile.
Regarding claims 14-17, ‘326 teaches these composition in pharmaceutical compositions and teaches methods of treating tumors by administering to individuals, therapeutically effective amounts of these compounds or compositions comprising these compounds (claims 10-13, Translation).
Claims 1-10 and 12-21 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/110169 to Li (published 06/10/2021, IDS of 06/13/2024; citations to English equivalent US 2023/0072937, IDS of 07/05/2024) in view of CN 112457326 (published 03/09/2021--Original, IDS of 06/13/2024; Translation, PTO-892) and Cannon (Analog Design, Burger’s Medicine Chem and Drug Discovery, published 2003, PTO-892).
Li teaches compounds that exhibit excellent inhibitory activity against ERK2 kinase ([0083]; pg. 22, Table 2):
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(abstract; pg. 24, claim 1).
Li teaches the following subgenera:
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(pg. 25, claim 14).
Li exemplifies the following species:
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(pg. 26, claim 15).
Regarding claims 1-10 and 12, while Li teaches the above species, they differ from that of claims 1-10 and 12, in that they do not teach a pyridine ring at the phenyl ring position of the above species.
CN ‘326 is applied as discussed above and incorporated herein. CN ‘326 teaches its compounds as EKR kinase inhibitors for the treatment of cancer, and specifically teaches its compounds as ERK2 kinase inhibitors (pg. 1 and last two pages, Description).
Cannon teaches bioisosteres as groups or molecules which have chemical and physical properties producing broadly similar biological properties (pg. 690).
Cannon teaches benzene and pyridine as bioisosteric ring equivalents (pg. 690, Table 16.1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to substitute the phenyl rings of Li with the pyridine rings of ‘CN 326, to arrive at instant claims 1-10 and 12. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-both Li and CN ‘326 are directed to structurally similar compounds that are both ERK2 kinase inhibitors,
-Cannon teaches phenyl and pyridine rings as bioisosteres that produce biologically similar properties,
-CN ‘326 teaches compounds with either a phenyl or pyridine ring, such as
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, as effective ERK2 kinase inhibitors (see pgs. 62-63, Original).
As such, an ordinary skilled artisan would have been motivated to make such a substitution to predictably arrive at a functionally equivalent ERK2 kinase inhibitor for the treatment of solid tumors.
Regarding claims 13, 18 and 20, the combination of Li, CN ‘326, and Cannon differ from that of instant claims 13, 18, and 20 in that they teach F or Cl and not methyl groups at the two position of the rings,
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,
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.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the F or Cl for CH3, to arrive at instant claims 13, 18, and 20. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because Li teaches that it’s R4 position can be F, Cl, or CH3 (pg. 24, claims 7-9).
As such, an ordinary skilled artisan would have been motivated to make such a substitution, to predictably arrive at a structurally and functionally equivalent compound.
Regarding claims 13 and 19, the combination of Li, CN ‘326, and Cannon differ from that of instant claims 13 and 9 in that they teach F or Cl and not methyl groups at the two position of the pyridine ring, and they do not teach a methyl group on the pyrimidine ring
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.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the F or Cl for CH3 on the pyridine ring, and to substitute a H for a CH3 on the pyrimidine ring, to arrive at instant claims 13 and 19. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Li teaches that its R4 position can be F, Cl, or CH3 (pg. 24, claims 6-7), and
-Li teaches that its R5 can be CH3 (pg. 24, claim 8-9).
As such, an ordinary skilled artisan would have been motivated to make such a substitution, to predictably arrive at a structurally and functionally equivalent compound.
Regarding claims 13 and 21, the combination of Li, CN ‘326, and Cannon differ from that of instant claims 13 and 9 in that they teach F or Cl and not methyl groups at the two position of the ring, and they do not teach an ethyl group on the pyrimidine ring
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.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the F or Cl for CH3 on the pyridine ring, and to substitute a H for a -CH2CH3 group on the pyrimidine ring, to arrive at instant claims 13 and 21. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Li teaches that its R4 position can be F, Cl, or CH3 (pg. 24, claims 6-7), and
-Li teaches that its R5 can be C1-3 alkyl (pg. 24, claim 1).
As such, an ordinary skilled artisan would have been motivated to make such a substitution, to predictably arrive at a structurally and functionally equivalent compound.
Regarding claims 14-17, the combination of Li, CN ‘326, and Cannon teaches a method of treating a solid tumor by administering to a subject one of its compounds, and teaches a medicament comprising its compounds (Li-pg. 27, claims 16-20).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 and 12-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,522,616 (PTO-892) in view of CN 112457326 (published 03/09/2021--Original, IDS of 06/13/2024; Translation, PTO-892) and Cannon (Analog Design, Burger’s Medicine Chem and Drug Discovery, published 2003, PTO-892).
‘616 claims the following compound
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(claim 1), and the following subspecies:
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(claim 14), wherein m and n are 0-2, R2 and R3 are a C1-3 alkyl, R4 can be H, F, Cl, Br, I or a C1-3 alkyl, and R5 can be a C1-3 alkyl.
‘616 claims the following species:
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(claim 15).
‘616 claims a method of treating colon cancer or NSCLC in a subject by administering these compounds (claims 16-17).
‘616 claims a medicament comprising these compounds (claim 18).
While ‘616 claims the above compounds, they differ from that of the instant claims, in that they do not teach a pyridine ring at the phenyl ring position.
CN ‘326 is applied as discussed above and incorporated herein.
Cannon is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to substitute the phenyl ring, in the compounds of ‘616, with the pyridine rings of ‘CN 326, to arrive at the instant claims. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-both ‘616 and CN ‘326 are directed to structurally similar compounds that are both ERK2 kinase inhibitors (see Example 1 of ‘616, beginning in line 53 of Col. 41),
-Cannon teaches phenyl and pyridine rings as bioisosteres that produce biologically similar properties,
-CN ‘326 teaches compounds with either a phenyl or pyridine, such as
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, as effective as ERK2 kinase inhibitors (see pgs. 62-63, Original).
As such, an ordinary skilled artisan would have been motivated to make such a substitution to predictably arrive at a functionally equivalent ERK2 kinase inhibitor for the treatment of cancer.
Claims 1-10 and 12-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,133,841 (PTO-892) in view of CN 112457326 (published 03/09/2021--Original, IDS of 06/13/2024; Translation, PTO-892).
‘841 claims compounds of formula:
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(claim 1), and subspecies
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, wherein Z1 and Z2 can be CH or N, R35 can be a C1 alkyl, R36 can be H, and R22b can be H or a C1-C3 alkyl.
‘841 claims the following species:
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(claim 16).
‘841 claims compositions comprising these compounds (claims 17-19).
‘841 teaches these compounds as having ERK2 inhibitory activity and as useful for the treatment of cancer (Col. 72, line 30-Col. 73, end).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
While ‘841 ‘claims
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, it differs from that of the instantly claimed compounds in that it does not teach the thiazole ring.
CN ‘326 is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to substitute the thiophene ring of ‘841 with a thiazole ring, to arrive at the instantly claimed compounds. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success because:
-‘841 and ‘326 are both directed toward compounds that inhibit ERK2 kinase for the treatment of cancer,
-‘326 teaches M1 as preferably CH, CF, or N and M2 as preferably O or S,
-‘326 teaches
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as a subgenus of its compounds (pg. 24).
As such, an ordinary skilled artisan would have been motivated to make such a modification since ‘326 teaches thiazole rings as within the scope of such compounds. An ordinary skilled artisan would predictably expect such structurally similar compounds to have a similar therapeutic profile and thus be effective to inhibit ERK2 and treat cancer.
Conclusion
No claims are allowed.
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/LAUREN WELLS/Examiner, Art Unit 1622
Prosecution Insights