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 .
Application Status
The claim set filed on 8/24/2023 is acknowledged. Claims 1-20 are currently pending and under consideration
Information Disclosure Statement
The information disclosure statement filed on 7/17/2025 has been considered except where lined through.
Claim Interpretation
Claims 8-10 are written as an “if” “then” statement pertaining to R2, R3, n and R1, but does not define what R2, R3, n and R1 can be if the statements are not true. Accordingly, the examiner is interpreting R2, R3, n and R1 to be defined by claim 1 in the event that the “if” “then” statement is false. If Applicants are attempting to only limit R2, R3 and n to that defined in claims 8-10, the examiner suggests amending the claim to remove the “if” “then” statement.
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.
Claim 8 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.
Regarding claim 8, claim 8 recites “… then R1 is not an optionally substituted piperidine when.” In the instant case, it is unclear what “when” is referring to and therefore, is indefinite. For prior art purposes, the examiner will be ignoring the ‘when” and just consider the proviso preceding the “when”.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-2, 4-5 , 8-10 and 14-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schiltz et al. (US Patent No. 9,981,968B2, 2018-05-29). (see claim interpretations set forth above for claim 8-10 which does not specifically limit R2, R3 and n)
Schiltz et al. teach substituted pyrrolo[2,3-d]pyrimidine compounds useful for treating cancer and cell proliferative disorders having a general Formula I:
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(abstract). Specifically, Schiltz et al. teach a compound having the structure
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which reads on the instantly claimed compound, wherein R3 is a halo, R2 is a hydrogen, Alk is -CH-, and R1 is a 4 piperidine (claim 15 of US Patent). The US patent further teaches that the compounds of the invention are formulated as a pharmaceutical composition comprising a therapeutically effective amount of the compound and one or more pharmaceutically acceptable carriers, excipients or diluents (column 17, lines 13-17). Moreover, with regards to the cancer, the US Patent teaches that cancers include but are not limited to leukemia, specifically acute myeloid leukemia (e.g. K562) (column 16, line 32 and example 4).
Claim(s) 1-2, 4-5 and 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marquet et al. (Chimica Therapeutica (1971); 6 (6): 427-38). (see claim interpretations set forth above for claim 8-10 which does not specifically limit R2, R3 and n)
Marquet et al. teach compounds having the structures:
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which reads on the instantly claimed compound wherein R3 is Cl, R2 is methyl, Alk is -CH2- and R1 is a hydrogen, hydroxy, hydroxy alkyl, alkoxy, phenyl substituted with an alkoxy or halogen, or a 5 membered ring comprising either an O or S (Table 1).
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 1-2, 4-6, 8-10 and 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 14-15 and 18 of U.S. Patent No. 9,981,968B2 to Schiltz et al. (2018-05-29). Although the claims at issue are not identical, they are not patentably distinct from each other because the compound claimed in claim 15 of the US Patent having the structure:
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anticipates the instantly claimed compound of the generic formula
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wherein R3 is a halogen, R2 is a hydrogen, Alk is -CH2- and R1 is a piperidine. Moreover, the US Patent claims a pharmaceutical composition comprising the compound together with a carrier, excipient or diluent (claim 18). The US Patent does not specifically claim a method of treating cancer. However, the US patent teaches that the compounds are useful for treating cancer and are formulated as a pharmaceutical composition comprising a therapeutically effective amount of the compound and one or more pharmaceutically acceptable carriers, excipients or diluents (column 17, lines 13-17). Moreover, with regards to the cancer, the US Patent teaches that cancers include but are not limited to leukemia, specifically acute myeloid leukemia (e.g. K562) (column 16, line 32 and example 4).
Conclusion
Claims 3, 7 and 11-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The closest prior art to the objected claims appears to be U.S. Patent No. 9,981,968B2 to Schiltz et al. as described above and herein. Specifically, Schiltz et al. teach a compound having the formula
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, wherein the estimated IC50 value is >10 compared to a structurally similar compound
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which has an estimated IC50 value of 1 (see Table 2). As such, there would be no motivation to select and modify the compound with for example, a -CH2- elongation, since it has one of the weakest estimated IC50 value’s vs. the majority of the other compounds tested.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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, Joseph McKane can be reached at 571-272-0699. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626