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 .
Election/Restrictions
Applicant’s election without traverse Group I (drawn to compounds/pharmaceutical compositions), in the reply filed on 02/04/2025 is acknowledged.
Claims 38, 40-53, and 57-61 are pending of which, claims 57-61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected INVENTION, there being no allowable generic or linking claim. The restriction requirement is still deemed proper and is made Final.
Please note, for clarity of the record, Applicant elected compound 304 recited in claims 38, 40-42, and 44-48, as shown below:
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Pending claims 38, 40-42, 45-46, 48, and 50-53 have been examined on the merits.
Notice of Claim Withdrawal
Per MPEP 803.02, the Examiner determined that the elected species is allowable over the prior art, therefore, the examination of the Markush claim was extended. Prior art was then found that anticipates or renders obvious the Markush claim with respect to a nonelected species, therefore, the Markush claim is rejected. Additionally, claims 43-44, 47, and 49-50 drawn to nonelected species, are withdrawn from further consideration.
Objection
The specification is objected because paragraph [0222] improperly incorporated by reference essential material from WO 2021/055747, a foreign publication. For example, paragraph [0222] discloses compounds of Example 2 can be synthesized using methods described in WO 2021/055747, including the general synthesis schemes and Examples 1-3, and explicitly indicates that those disclosures “are incorporated by reference herein.” Therefore, an incorporation by reference of essential material to an unpublished U.S. patent application, a foreign application or patent, or to a publication is improper under 37 CFR 1.57(d) (see MPEP 608.01(p)).
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 38,40-42,45-46,48 and 51-53 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 38 recites a compound having a formula: (FCB)a-(L)b-(CLM)c, wherein the FCB moiety is defined structurally, while “CLM” is defined functionally as a covalent linking modality, and more particularly, as “any covalent binding modality” capable of forming a covalent bond with a biological target (specification, page 29, [0021] bridged [0022]). The specification also discloses that a CLM may comprise one or more electrophilic or nucleophilic chemical moieties and yet fails to describe the full scope of the claimed genus or provide sufficient representative species. In particular, the specification does not disclose representative species of covalent linking modalities across the breadth of the genus encompassed by “any covalent modality,” capable of covalently binding to distinct and unrelated biological targets. Therefore, merely defining CLM by its desired function does not demonstrate possession of the full claimed genus. Furthermore, the specification defines a biological target as “any target to which an FCB binds noncovalently to produce a therapeutic effect,” while also stating that a “CLM binds to the biological target covalently.” The specification does not describe the required functional relationship between the two binding modalities, including whether they bind to the same or distinct sites, whether FCB binding positions the CLM for noncovalent reaction with its target, or what structural or spatial relationship is required between the FCB, linker, CLM, and a target. The specification clearly fails to reasonably demonstrate possession of the full scope of the claimed FCB/CLM combination and biological target.
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.
Claims 41 and 51-52 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.
Claim 41 discloses FCB structure having a “substituent Y,” but neither claim 41 nor independent claim 38 defines or identifies the meaning and scope of substituent Y. Therefore, it is unclear which chemical group(s) are encompassed by “substituent Y,” which renders the claim indefinite.
Claims 51-52 identify the claimed compounds using internal numerical identifiers including Compound 1-201 through 1-272, 1-301 through 1-322, and 1-324 through 1-333. The instant claims also recite “1-129” and 1-130” within a sequence comprising Compounds 1-201 through 1-333. Therefore, the phrase “1-129” and “1-130” in this sequence is ambiguous as to the compounds intended to be claimed, or whether they are typographical errors intended to recite “1-229” and 1-230.” This is because, the specification, Table 1, provides a corresponding structure for the disclosed numerical compound designations, including 1-229 and 1-230; except for compounds “1-129” and 1-130,” which renders the claim indefinite.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 38, 40-42, and 53 are rejected under 35 U.S.C. 102(a)(l) as being anticipated by Yang et al. US Patent No. 9,447,101 B2.
Regarding claim 38, 40-42, and 53, Yang (abstract; col. 1) teaches P13K kinase inhibitors or pharmaceutically acceptable salts thereof, for treating phosphatidylinositol 3-kinase related diseases, such as cancer. Yang (col. 45, lines 12-21) teaches a pharmaceutical composition comprising a therapeutically effective amount of the compound of general formula I, and the
pharmaceutical composition may also include other ingredients, such as carrier, excipient.
Yang (col. 27-28 and 80, lines 37-60) discloses compound I-33, methyl(5-( 6-(( 4-(methylsulfonyl)piperazin-1-yl)methyl)-4-morpholinopyrrolo[2, 1-f] [1,2,4 ]triazin-2-yl)-4-(trifluoromethyl)pyridin-2-yl)carbamate:
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Yang does not explicitly describe I-33 using the claimed nomenclature “(FCB)a-(L)b-(CLM)c.” Nevertheless, it would have been clear to a person of ordinary skill in the art (POSITA) that compound I-33 corresponds to the claimed formula wherein a, b and c are each 1; R4 is
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; R14 is
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; L is
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; and CLM is MeO2S.
Therefore, claims 38, 40-42, and 53 are anticipated.
Subject Matter Free of the Art of Record
The subject matter of claims 45-46, 48, and 51-52, are free of the art of record. The closest prior art is the Yang et al. US Patent No. 9,447,101B2. Yang teaches P13K kinase inhibitors or pharmaceutically acceptable salts thereof. Although Yang describes compound I-33, Yang fails to disclose the diverse L-CLM moieties disclosed in the claimed invention. Therefore, there is no motivation for a POSITA to modify the teaching of Yang to arrive at the claimed compounds. These claims are not allowable until the objection, 112, and 102 rejections are overcome.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES H ALSTRUM-ACEVEDO can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.P.E./
Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/
Supervisory Patent Examiner, Art Unit 1622
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