DETAILED ACTION
This office action is in response to applicant’s filing dated March 4, 2026.
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 .
Status of claims
Claims 18 - 32 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 18-23, drawn to a compound of formula I and a pharmaceutical composition thereof in the reply filed on March 4, 2026 is acknowledged.
Claims 24 – 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 4, 2026.
Applicant’s election without traverse of compound AB27141:
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as a single species of compound of genus Fornmula I in the reply filed on March 4, 2026 is acknowledged.
Claims 18 – 23 are presently under examination as related to the elected species, compound AB27141.
Priority
The present application is a 371 of PCT/CN2021/139355, filed December 17, 2021 and claims the benefits of priority to Chinese patent application CN202011511391.5, filed December 18, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/18/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
Acknowledgement is made of the drawings received on June 18, 2023. These drawings are accepted.
Claim Rejections - 35 USC § 112
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.
Claim 18 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.
The claim recites the term:”[…] “preferably”, which is equivalent to phrase “such as”, renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 20 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 20, reciting the term “e.g.” which is equivalent to the phrase "for example" 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 § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 21 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 21 recites the compound AB24883 of structure:
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, which structural elements are not encompassed by genus Formula I. Compound AB24883 has an amide group
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, which is not described as possible structure of variable R1 in genus Formula I, as recited in claim 18, on which claim 21 is being dependent.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 18 – 23 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (US 2017/0305861 A1, cited in IDS, filed 06/18/2023, hereinafter Kim).
Instant claims are drawn to a compound of Formula I:
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, where Ring A is substituted or unsubstituted C6-C16 aromatic ring, substituted or unsubstituted C3-C16 cycloalkane ring, substituted or unsubstituted 3-16 membered heterocycloalkane ring, or substituted or unsubstituted 3-16 membered heteroaromatic ring; ring B is absent; R1 is
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, R4 and R5 are independently hydrogen, n is 0 – 6, R6 is substituted or unsubstituted C6-C16 aryl, substituted or unsubstituted C5-C12 heteroaryl, substituted or unsubstituted 3-16 membered cycloalkyl or substituted or unsubstituted 3-16 membered heterocycloalkyl;
R2 is hydrogen or
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, R10 and R11 are each independently hydrogen, R3 is none or hydrogen. For example compounds correspond to Formula I-2:
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. Exemplary compounds of Formula I are:
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,
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,
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. Instant claims are further drawn to a pharmaceutical composition, comprising compound of formula I and a pharmaceutically acceptable carrier. Said pharmaceutical composition is suitable for oral administration or administration by injection.
Kim teaches compound of Formula 1:
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, where
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refers to a single bond or double bond, a ring of Formula 1 comprises two to three double bonds; X is CH or N; Y is CH, N, or S; n is 1 or 2; L is C1-6 alkylene or linker (L) is -CH2-C(O)-; R1 is C6-14 aryl, such as phenyl, optionally further substituted with e.g. methyl, C5-20 heteroaryl; R2 to R4 are each independently hydrogen, amino (-NH2), substituted amino (NR’R”), R’ and R” are independently C1-6 alkyl; R2 to R4 can be a C3-8 cycloalkyl such as cyclohexyl, which is unsubstituted or substituted with halogen or oxo; R2 to R4 can also be a C3-8 heterocycloalkyl, where the term "heterocycloalkyl" refers to a non-aromatic 3-, 4-, 5-, 6-, or 7-membered ring or bi- or tri-cyclic group fused or unfused system, such as pyrrolidinyl, piperidinyl, where any of the rings may be fused to a benzene ring (pages 1-2, [008] – [0016] and [0021] – [0031]). One of the exemplary compounds taught by Kim, is compound of structure:
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(page 10, ex. 26). Kim further teaches a pharmaceutical composition, comprising compound of Formula 1 and a pharmaceutically acceptable carrier (page 5, [0050]). Said The pharmaceutical composition may be formulated in a form of a tablet, capsule, pill, granule, powder, injection etc. (page 5, [0052]).
Compounds of Formula 1 correspond to instantly claimed compounds of above examples AB24957-1 and AB24956-1 if:
X and Y are both carbons; n is 2; (L) is -CH2-C(O)-; R1 is phenyl, substituted with methyl; R2 is pyrrolidinyl or piperidinyl, fused to a benzene ring.
Compound of Formula 1 correspond to instantly claimed compounds of above example AB27141 if: X and Y are both carbons; n is 2; (L) is C1-6 alkylene (brunched); R1 is phenyl, R2 is cyclohexyl substituted with oxo and fused to a benzene ring substituted with halogen.
Thus, since Kim teaches compounds, where all the structural elements of the molecule are equivalent to those of instant claims, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention to combine structural elements of the molecule, taught by prior art, and make various compounds to arrive at claimed compounds. The one of ordinary skills would be motivated to do so in search of an active agent, possessing similar or better pharmaceutical properties for treatment of proliferative disease with the reasonable expectation of success.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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 18 – 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16 - 24, of copending Application No. 18/268,236 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims are directed to a compound of Formula I:
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, where Ring A is substituted or unsubstituted C6-C16 aromatic ring, substituted or unsubstituted C3-C16 cycloalkane ring, substituted or unsubstituted 3-16 membered heterocycloalkane ring, or substituted or unsubstituted 3-16 membered heteroaromatic ring; ring B is absent; R1 is
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, R4 and R5 are independently hydrogen, n is 0 – 6, R6 is substituted or unsubstituted C6-C16 aryl, substituted or unsubstituted C5-C12 heteroaryl, substituted or unsubstituted 3-16 membered cycloalkyl or substituted or unsubstituted 3-16 membered heterocycloalkyl;
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, R10 and R11 are each independently hydrogen, R3 is none or hydrogen. Exemplary compounds of Formula I are:
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or
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. Instant claims are further drawn to a pharmaceutical composition, comprising compound of formula I and a pharmaceutically acceptable carrier.
Claims of copending application are directed to a drawn to a compound of Formula I:
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, where Ring A is substituted or unsubstituted C6-C16 aromatic ring, substituted or unsubstituted C3-C16 cycloalkane ring, substituted or unsubstituted 3-16 membered heterocycloalkane ring, or substituted or unsubstituted 3-16 membered heteroaromatic ring; ring B is absent; R1 is
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, R4 and R5 are independently hydrogen, n is 0 – 6, R6 is substituted or unsubstituted C6-C16 aryl, substituted or unsubstituted C5-C12 heteroaryl, substituted or unsubstituted 3-16 membered cycloalkyl or substituted or unsubstituted 3-16 membered heterocycloalkyl;
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, R10 and R11 are each independently hydrogen, R3 is none or hydrogen. Exemplary compounds of Formula I are:
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or
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. Copending claims are further drawn to a pharmaceutical composition, comprising compound of Formula I and a pharmaceutically acceptable carrier.
Although exemplary compounds of instant claims and copending claims are not identical, they are structural alternatives, encompassed by genus Formula I.
Thus, the compounds of copending claims would anticipate instantly claimed compounds.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 18 – 23 are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELENA V VISHNYAKOVA whose telephone number is (571)272-3781. The examiner can normally be reached 7:30am - 5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RENEE CLAYTOR can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.V.V./Examiner, Art Unit 1691
/SAVITHA M RAO/Primary Examiner, Art Unit 1691
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