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
Election of Species and Status of the Claims
Applicant’s amendments to the claims in the response filed on May 29th 2026 are acknowledged. Applicant’s amendment excludes applicant’s elected species of I-35, from the genus of claim 1. See MPEP § 803.02:
Should applicant, in response to a rejection of a Markush claim, overcome the rejection by amending the Markush claim to exclude the species anticipated or rendered obvious by the prior art, the amended Markush claim will be examined again. The examination will be extended to the extent necessary to determine patentability of the Markush claim. In the event prior art is found during this examination that anticipates or renders obvious the amended Markush claim, the claim will be rejected and the action can be made final unless the examiner introduces a new ground of rejection that is neither necessitated by applicant’s amendment of the claims nor based on information submitted in an information disclosure statement filed during the period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p). See MPEP § 706.07(a). Amendments submitted after the final rejection further restricting the scope of the claim may be denied entry if they do not comply with the requirements of 37 CFR 1.116. See MPEP § 714.13.
Claims 1-2, 4-7, 15-19, and 21-26 are pending and are examined on their merits.
Information Disclosure Statement
The Information Disclosure Statement filed on May 29th 2026 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
35 U.S.C. § 112(b) Rejections Overcome by Amendment
Applicant’s amendments in the response filed on May 29th 2026 are acknowledged. Applicant has amended claim 15 to recite a portion of the compounds from Table 1, and has amended claim 19 to recite the treatment of cancer rather than “an CDK2-mediated disorder…” Applicant has overcome all 112(b) rejections and the rejections are thereby withdrawn.
35 U.S.C. § 101 Rejections Overcome by Amendment
Applicant’s amendments in the response filed on May 29th 2026 are acknowledged. Applicant has amended claim 18 to no longer recite the judicial exception of “inhibiting CDK2 in a biological sample.” Applicant has thereby overcome the 101 rejection over claim 18 and the rejection is consequently withdrawn.
35 U.S.C. § 102 Rejections Overcome by Amendment
Applicant’s amendments in the response filed on May 29th 2026 are acknowledged. Applicant has amended claim 1 to further limit X, W, and Y rings. The compounds of Winterton no longer anticipate applicant’s compound genus, and the 102 rejections over Winterton are thereby withdrawn.
35 U.S.C. § 112(b) Rejections Necessitated by Amendment
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 15 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 15 is indefinite for reciting subject matter outside the scope of claim 1, upon which it depends. Claim 1 requires:
PNG
media_image1.png
56
640
media_image1.png
Greyscale
.
Claim 15 recites compound I-235, which includes a piperidine ring in the Ring Y location:
PNG
media_image2.png
109
460
media_image2.png
Greyscale
.
Claim 15 is thereby not further limiting to claim 1, upon which it depends.
35 U.S.C. § 102 Rejections Necessitated by Amendment
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 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.
Claims 1, 2, 4-7, and 24-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lach (Lach et al., A general route to unsubstituted N-aryl and heteroarylaminobenzenesulfonamides, Tetrahedron Letters, Volume 52, Issue 16, 2011, Pages 1882-1887).
Claims 1, 2, 4-7, and 24-26 are directed towards the compound,
PNG
media_image3.png
125
245
media_image3.png
Greyscale
,
Wherein Ring W is
PNG
media_image4.png
65
106
media_image4.png
Greyscale
.
Lach teaches the compound,
PNG
media_image5.png
204
500
media_image5.png
Greyscale
(Lach, pg. 1886).
Lach’s compound is anticipatory of claims 1, 2, 4-7, and 24-26.
Claims 1, 2, 4, 5, 6, 7, 16-18, and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Booth (WO 01/55148 A1 published on August 2nd 2001).
Claims 1, 2, 4, 5, 6, 7, and 22-23 are directed towards the compound,
PNG
media_image3.png
125
245
media_image3.png
Greyscale
,
Wherein Ring W is
PNG
media_image6.png
67
112
media_image6.png
Greyscale
.
Booth teaches the compound,
PNG
media_image7.png
252
500
media_image7.png
Greyscale
(Booth, pg. 133, Example 295).
Booth’s compound is anticipatory of claims 1, 2, 4, 5, 6, 7, and 22-23.
Claim 16 is directed towards a pharmaceutical composition comprising the compound of claim 1 and a carrier. Booth teaches such compositions (Booth, pg. 13), anticipating claim 16.
Claim 17 is directed towards the composition of claim 16, wherein the composition comprises additional therapeutic agents. Booth teaches a composition comprising additional therapeutic agents (Booth, pg. 15), anticipating claim 17.
Claim 18 is directed towards a method of inhibiting CDK2 in a patient via administration of the compound of claim 1. Booth teaches the treatment of neurodegenerative diseases via administration of the compound described above (Booth, pg. 228, claim 13), and that the compound has CDK2 inhibitory activity (Booth, pg. 186, Table 4). Said administration would thereby result in the inhibition of CDK2, and Booth thereby anticipates claim 18.
35 U.S.C. § 103 Rejections Necessitated by Amendment
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.
Claims 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Booth in view of Winterton (WO2020168178 published on August 20th 2020).
Claims 19 and 21 are directed towards the treatment of cancer characterized by amplification or overexpression of CCNE1 via administration of the compound of claim 1. For the teachings of Booth as they relate to claim, see the above 102 rejection of claim 1.
Booth teaches compounds with CDK2 inhibitory activity. Booth does not explicitly teach the treatment of CCNE1 overexpressed cancers with Booth’s compounds. However, one of ordinary skill in the art would have had a reasonable expectation of success in treating CCNE1 overexpressed cancers with Booth’s compounds because CDK2 inhibitors are known in the art to be useful in the treatment of said cancers. See Winterton, who teaches the treatment of CCNE1 overexpressed cancers with CDK2 inhibitors (Winterton, pg. 181, claim 56). One of ordinary skill in the art would thereby have a reasonable expectation of success in treating CCNE1 overexpressed cancers with Booth’s CDK2 inhibitors, and claims 19 and 21 are prima facie obvious.
Claims 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Winterton (WO2020168178 published on August 20th 2020) in view of Brown (Brown, Bioisosteres in Medicinal Chemistry, 2012), and Booth 2 (WO 03/062236 A1 published on July 31 2003).
The claims are directed towards the compound:
PNG
media_image3.png
125
245
media_image3.png
Greyscale
.
One such compound is compound I-252 (encompassed by claims 1-2, 4-7, 15, and 22-23):
PNG
media_image8.png
116
217
media_image8.png
Greyscale
.
Winterton teaches the compound,
PNG
media_image9.png
139
254
media_image9.png
Greyscale
(Winterton, pg. 116, Example A1).
Winterton’s compound differs from applicant’s in just three locations:
PNG
media_image10.png
153
254
media_image10.png
Greyscale
.
Regarding locations 1 and 2, Winterton differs from applicant’s compound only in the bioisosteric replacement of a hydrogen for a methyl, or vice versa. One of ordinary skill in the art would have had a reasonable expectation in performing such a replacement, because it is one of the most common bioisosteric replacements in the field of drug discover (Brown, pg. 17).
Regarding location 3, one of ordinary skill in the art would have had a reasonable expectation in performing the replacement of the saturated ring with applicant’s unsaturated ring, because such ring forms are already very well-known in the field of potent CDK inhibitors.
See Booth 2, who teaches the compound,
PNG
media_image11.png
283
500
media_image11.png
Greyscale
(Booth 2, pg. 62, Example 36),
which is commonly known as the successful drug, ‘palbociclib.’
Palbociclib shares the core ring feature with applicant’s compound and one of ordinary skill in the art would thereby have had a reasonable expectation of success in making the substitution of this core feature when developing CDK inhibitors. Applicant’s compound I-252 and claims 1-2, 4-7, 15, and 22-23 are thereby prima facie obvious.
Claim 16 is directed towards a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutical adjuvant. Winterton teaches the compound as part of an adjuvant therapy with additional active agents (Winterton, pg. 94), and claim 16 is thereby prima facie obvious.
Claim 17 requires that the pharmaceutical composition of claim 16 comprises additional active agents. As Winterton teaches additional active agents (Winterton, pg. 94), claim 17 is prima facie obvious.
Claim 18 is directed towards a method of inhibiting CDK2 in a patient via administration of a compound of claim 1. Winterton teaches such a method (Winterton, pg. 153, claim 23), rendering claim 18 prima facie obvious.
Claim 19 is directed towards the treatment of cancer via administration of a compound of claim 1. Winterton teaches the treatment of cancer with the compounds (Winterton, pg. 180, claim 49), and claim 19 is prima facie obvious.
Claim 21 requires that the cancer of claim 19 is characterized by overexpression of CCNE1. Winterton teaches the treatment of cancer characterized by CCNE1 overexpression (Winterton, pg. 181, claim 56), and claim 21 is prima facie obvious.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
Prosecution Insights