DETAILED ACTION
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 .
Response to RCE
A request for continued examination under 37 CFR 1.114, including the fee set forth in
37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible
for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has
been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37
CFR 1.114.
Priority
The instant application is a continuation of 371 National Stage Entry of PCT/EP2021/066725 filed on June 21, 2021 which claims priority to foreign application No. EP20181341.7 filed on June 22, 2020.
Status of Claims
Acknowledgement is made of amended (1, 25, 48, 55), previously presented (29, 34-35, 40, 49, 51), cancelled (2-24, 26-28, 30-33, 36-39, 41-47, 50, 52-54, 56-61), and new (62-65) claims filed June 30, 2026. Claims 1, 25, 29, 34-35, 40, 48-49, 51, 55, 62-65 are pending. Claims 48-49, 55 and 64 are withdrawn. Claims 1, 25, 29, 34-35, 40, 51, 62-63, 65 are presently examined.
Examiner Note
The Examiner notes numerous issues (objections, 35 USC 112, withdrawn claims) have risen due to improper amendments.
Per MPEP § 714(II)(C):
Each amendment document that includes a change to an existing claim, including the deletion of an existing claim, or submission of a new claim, must include a complete listing of all claims ever presented (including previously canceled and non-entered claims) in the application. After each claim number, the status identifier of the claim must be presented in a parenthetical expression, and the text of each claim under examination as well as all withdrawn claims (each with markings if any, to show current changes) must be presented. The listing will serve to replace all prior versions of the claims in the application.
(A) Status Identifiers: The current status of all of the claims in the application, including any previously canceled or withdrawn claims, must be given. Status is indicated in a parenthetical expression following the claim number by one of the following status identifiers: (original), (currently amended), (previously presented), (canceled), (withdrawn), (new), or (not entered). The status identifier (withdrawn – currently amended) is also acceptable for a withdrawn claim that is being currently amended. See paragraph (E) below for acceptable alternative status identifiers.
(B) Markings to Show the Changes: All claims being currently amended must be presented with markings to indicate the changes that have been made relative to the immediate prior version. The changes in any amended claim must be shown by strike-through (for deleted matter) or underlining (for added matter) with 2 exceptions: (1) for deletion of five or fewer consecutive characters, double brackets may be used (e.g., [[eroor]]); (2) if strike-through cannot be easily perceived (e.g., deletion of number "4" or certain punctuation marks), double brackets must be used (e.g., [[4]]). As an alternative to using double brackets, however, extra portions of text may be included before and after text being deleted, all in strike-through, followed by including and underlining the extra text with the desired change (e.g., number 4 as number 14 as ). An accompanying clean version is not required and should not be presented. Only claims of the status "currently amended" or "withdrawn" will include markings.
Any claims added by amendment must be indicated as "new" and the text of the claim must not be underlined.
(C) Claim Text: The text of all pending claims under examination and withdrawn claims must be submitted each time any claim is amended. The text of pending claims not being currently amended, including withdrawn claims, must be presented in clean version, i.e., without any markings. Any claim presented in clean version will constitute an assertion that it has not been changed relative to the immediate prior version except to omit markings that may have been present in the immediate prior version of the claims. A claim being canceled must be indicated as "canceled;" the text of the claim must not be presented. Providing an instruction to cancel is optional. Canceled and not entered claims must be listed by only the claim number and status identifier, without presenting the text of the claims. When applicant submits the text of canceled or not-entered claims in the amendment, the Office may accept such an amendment, if the amendment otherwise complies with 37 CFR 1.121, instead of sending out a notice of non-compliant amendment to reduce the processing time.
(D) Claim Numbering: All of the claims in each amendment paper must be presented in ascending numerical order. Consecutive canceled or not entered claims may be aggregated into one statement (e.g., Claims 1 – 5 (canceled)).
37 CFR 1.530(d)(2) requires that:
(A) for each claim that is proposed to be amended by the amendment paper being submitted (the current amendment paper), the entire text of the claim must be presented with appropriate markings showing the changes to the claim;
(B) for each proposed new claim which is added in the reexamination by the amendment paper being submitted (the current amendment paper), the entire text of the proposed new claim must be presented and it must be underlined throughout;
(C) a patent claim is canceled by a direction to cancel that claim, there is no need to present the text of the patent claim surrounded by brackets; and
(D) a proposed new claim (previously added in the reexamination) is canceled by a direction to cancel that claim.
Applicant did not properly amend the claims, either by omitting strikethroughs, not including prior or original text, not indicating new text, or improper claim status in multiple instances.
Response to Arguments
Applicant’s amendments filed June 30, 2026 have overcome the following:
The 35 USC 102(a)(1) and 102(a)(2) rejection of claim(s) 1, 21, 25, 29, 34-35, 40, 51 over WO 2020/123395 A1 to Alam et. al.1
The above have been withdrawn.
Applicant’s amendments have necessitated the following:
The withdrawal of claims 48-49.
A new objection to claim 25.
A new 35 USC 112(d) rejection of claims 25, 62-63.
A new 35 USC 112(b) rejection of claims 1, 25, 35, 40, 51, 62-63.
Applicant’s arguments filed June 30, 2026 have been considered but are not fully persuasive.
Regarding the specification, the Examiner cannot hold an objection to the specification in abeyance. The specification remains objected to for lack of proper headings.
Regarding the prior art rejections under Alam, due to Applicant’s amendments, the rejection under Alam has been modified to account for the new limitations.
Regarding the double patenting rejection, per MPEP § 1490(VI)(D)(2), Co-Pending Application Dates:
(b) Application under Examination Has the Same Patent Term Filing Date
If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application or includes a compliant terminal disclaimer in the application under 37 CFR 1.321 that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted. (emphasis added)
Election/Restriction
The elected species is understood as follows: CAS# 2756703-34-9, “4-amino-1-(2-chloropyridin-3-yl)-7-cyclopropylpyrido[2,3-d]pyrimidin-2(1H)-one”.
Amended claims 48-49 do not encompass the elected species and are withdrawn. The Examiner notes claims 48-49 no longer read on claim 1 (R1d is not halogen) and would not be eligible for rejoinder should the parent claim become allowable in the future.
In light of Applicant’s arguments, the originally elected species has been deemed free of the prior art.
Per MPEP § 803.02(III)
If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended. If prior art is then found that anticipates or renders obvious the Markush claim with respect to a nonelected species, the Markush claim shall be rejected; claims to the nonelected species would still be held withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species.
Accordingly, Examination was extended to a non-elected species. Following extensive search and examination, the non-elected species was deemed anticipated and/or obvious in view of the prior art as applied below. Per MPEP § 803.02(III), claims directed to other nonelected species have been withdrawn.
Claim Objections
Claims 25, 51 are objected to because of the following informalities:
Claim 25 has a claim status of amended, but no alterations to the text have been made.
Claim 51 recites “comprising one or more of the compound of claim 1 or pharmaceutically…” but should read “comprising one or more of a compound of claim 1 or pharmaceutically…” or “comprising one or more of the compounds of claim 1 or pharmaceutically…”
Appropriate correction is required.
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 25, 62-63 are 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 1 recites wherein R1 is pyridinyl optionally substituted with one or two R1d wherein at least one R1d is substituted in ortho and R1d is halogen.
Claim 25 depends from claim 1, and limits R1 to multiple structures not encompassed by newly amended claim 1 (e.g. 2-methylpyridin-3-yl).
Claims 62 depends from claim 1 and lists wherein R1 may be 2-(C1-C6alkyl)pyridine-3-yl, which is not encompassed by newly amended claim 1 (e.g. R1d is not a halogen).
Claim 63 depends from claim 1 and lists wherein R1 may be 2-methylpyridyn-3-yl, which is not encompassed by newly amended claim 1 (e.g. R1d is not a halogen).
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 § 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.
Claims 1, 25, 35,40, 51, 62-63 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.
Newly amended claim 1 omits the definition of R2, which is part of the claimed Formula I. Accordingly, an artisan would not understand the metes and bounds of R2. In addition, claim 1 lists the definition of R2a but R2a does not appear in Formula I’ as written. Accordingly, an artisan would not understand R2a’s relevance to Formula I’.
For the purposes of applying art, R2 is understood to be hydrogen, halogen, amino, (C1-C6)alkyl, (C1-C6)alkoxy, halo(C1-C6)alkyl, halo(C1-C6)alkoxy, (C3-C6)heterocycloalkyl or (C3-C6) cycloalkyl optionally substituted with one or more R2a substituents.
Claims 25, 35,40, 51, 62-63 depend from claim 1 and do not resolve this issue of indefiniteness and are thus included in instant rejection.
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.
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.
Claim(s) 1, 25, 29, 34-35, 40, 51, 62-63 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/123395 A1 to Alam et. al.2
Regarding claims 1, 29, 34-35, 40, 62-63 and a compound of instant Formula I’, Alam teaches MAT2A inhibitors of Formula IIId, corresponding with the cores of instant Formula I’ (see Alam at Abstract and at claim 4). Alam teaches Example 261 (see Alam at p. 73), also known as CAS# 2439272-33-8 and Example 312 also known as CAS# 2439279-93-1 (see Alam at p. 81).
Alam
Instant
CAS# 2439272-33-8
Example 261
CAS# 2439279-93-1
Example 312
Formula I’
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CAS# 2439272-33-8 and CAS# 2439279-93-1 correspond to instant Formula I when R1 is pyridinyl substituted with one ortho R1d and R1d is halogen specifically chloro, R2 is halo(C1-C6)alkyl specifically trifluoromethane, and R3 is hydrogen.
Regarding claim 25 (currently rejected under 35 USC 112(d)), Alam teaches Example 263 (see Alam at p. 73), also known as CAS# 2439279-47-5.
Alam
Instant
CAS# 2439279-47-5
Example 263
Formula I’
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CAS# 2439279-47-5 reads on instant Formula I’ when R1 is pyridinyl, substituted with one ortho R1d and R1d is (C1-C6)alkyl specifically methyl (also reading on “2-methylpyridin-3-yl”), R2 is halo(C1-C6)alkyl specifically trifluoromethyl (also reading on “trifluoromethyl”), and R3 is H.
Regarding claim 51 and a composition, Alam teaches a composition comprising a compound of Formula IIId with a pharmaceutically acceptable excipient (see Alam at claim 49).
The prior art differs from the instant claims as follows, CAS# 2439272-33-8 and CAS# 2439279-93-1 differ from instant Formula I in that the amino substituent is NHMe instead of NH2.
However,
Alam teaches NH2 is a suitable alternative to the disclosed structures through Example 263 (see Alam at p. 73).
Alam
Instant
CAS# 2439272-33-8
Example 261
CAS# 2439279-47-5
Example 263
Formula I’
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Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s):
Regarding H for Me, the prior art suggests an NH2 at the same position as instant Formula I’. It would have been obvious to substitute H for Me in either CAS# 2439272-33-8 and CAS# 2439279-93-1 as this is modification is specifically contemplated by the reference to be a suitable alternative. In addition, per MPEP § 2144.08(II)(A)(4)(c), the closer the physical and/or chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. In addition or in the alternative, per MPEP § 2144.09(I)-(II), “[a] prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities” because “[c]ompounds which are…homologs…are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties” (see, e.g., MPEP § 2144.09(I)-(II)), and the Court has stated that “[i]f a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR, 127 S.Ct. at 1740. Here, the prior art teaches highly similar structural compounds differing only by methyl of the instantly claimed invention, wherein such compounds have the same, exact utility as the instantly claimed compounds; accordingly, an artisan would readily appreciate that such compounds could be utilized in the treatment of lymphoma or leukemia, exactly as taught and suggested in view of the prior art.
Furthermore, it is well-within the ordinary skill in art to incorporate NH2 in lieu of NHMe.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
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 1, 25, 29, 34-35, 40, 51, 62-63, 65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-8, 10-11, 13-29 of copending Application No. 18/654,989 (reference application), a continuation of instant application. Although the claims at issue are not identical, they are not patentably distinct from each other.
The examiner notes the scope matching of the claims is difficult due to App’989 claim dependencies on “claim 0”. Nevertheless, “claim 0” is treated as claim 1.
The claims are drawn to compounds of the same generic formula with the same structural limitations, and compositions comprising said compounds.
Instant Formula I’
App’989 Formula I’
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The copending applications also claim same species such as 4-amino-1-(2-chloropyridin-3-yl)-7-cyclopropylpyrido[2,3-d]pyrimidin-2(1H)-one.
Instant Exemplary Species
App’989 Claims 23, 24 Species
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claim 65 is objected to as being dependent upon a rejected base claim, but would be allowable if i) rewritten in independent form including all of the limitations of the base claim and any intervening claims, ii) all 35 USC 112 issues and objections resolved, and iii) a terminal disclaimer filed over the copending application.
The closest prior art to claim 65 is Alam. Alam teaches Example 715 (see Alam at p. 138), also known as CAS# 2439275-55-3.
The prior art differs from the instant claims as follows, CAS# 2439275-55-3 differs from the instantly elected species in that X1 is CR3 and R3 is H in lieu of X1 is N, and in isomeric connectivity of the pyridine.
Alam
Instant
CAS# 2439275-55-3
Example 715
Formula IIIa and IIId
Formula I’
Elected Species
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Applicant’s arguments regarding unpredictability in function regarding in too many modifications were convincing.
Conclusion
The specification is objected to.
Claims 25, 51, 65 are objected to.
Claims 1, 25, 29, 34-35, 40, 51, 62-63, 65 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KORTNEY KLINKEL can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.R./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
1 Published June 18, 2020 and filed December 9, 2019. Cite No. 18 in the IDS filed 4/5/233. Hereinafter Alam. Cited in previous Office Action.
2 Published June 18, 2020 and filed December 9, 2019. Cite No. 18 in the IDS filed 4/5/233. Hereinafter Alam. Cited in previous Office Action.
Prosecution Insights