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 .
DETAIL ACTION
This office action is a response to the following:
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As filed, claims 23-42 are pending; and claims 1-22 are cancelled, wherein claims 23 and 42 are independent claims.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/26/2024 has been considered by the Examiner.
Priority
The instant application is continuation application of PCT/EP2022/056585 filed 3/15/2022, which claims for foreign priority based on an application No. EP21163258.3 filed in Europe on 3/17/2021.
It is noted that the requirement for support is evaluated for each claim individually such that different claims may be examined with different effective filing dates. In the instant case, the instant application, the PCT application, and the EP21163258.3 application only provided support for the C3-8 cycloalkyl for instant variables R1, R2, and R4. Accordingly, the compound of instant formula (I), as shown in claims 23-36 and 39-42, are examined with an effective filing date of 4/26/2024 (the filing date of the claim amendment; i.e. earliest filing date) because the compound of instant formula (I), wherein the entire scope of C3-10 cycloalkyl, as shown in claims 23-36 and 39-42, are not disclosed and supported by the instant application, the PCT application, and the EP21163258.3 application. As for claims 37 and 38, these claims are examined with an effective filing date of 3/17/2021 (the filing date of the EP application; i.e. earliest filing date) because the entire scope of these two claims are disclosed and supported by the instant application, the PCT application, and the EP21163258.3 application.
Should applicant desire that the benefit of an earlier effective filing date be according any of the instant claims, the claims must be amended such that they are fully supported by the instant application, the PCT application and the EP21163258.3 application.
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(instant application, pg. 1, lines 8-12; pg. 2, lines 1-12; and pg. 5, lines 14-16)
(PCT application, pg. 1, lines 1-18; and pg. 4, lines 20-23)
(EP21163258.3 application, pg. 1, lines 1-5, 8-13 and 15-18; and pg. 4, lines 20-23)
Claim Rejections - 35 USC § 112(a)
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.
Claims 23-36 and 39-42 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant’s amendment with respect to amended claims 23 and 42 herein has been fully considered but is deemed to insert new matter into the claims since the specification as originally filed does not provide support for the newly added limitation of “C3-10 cycloalkyl”, for instant variables R1, R2, and R4, as instantly claimed.
The instant specification and the originally filed claim (i.e. filed 9/15/2023) only provide support for C3-C8 cycloalkyl (see snapshots below).
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(pg. 1 lines 5-13)
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(pg. 2, lines 3-12)
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(pg. 5, lines 14-16)
Accordingly, C9 cycloalkyl and C10 cycloalkyl are considered new matter.
Adequate written description means that, in the specification, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 [19 USPQ2d 1111] (Fed. Cir. 1991).
See MPEP 2163 regarding the guidelines for the written description requirement: "The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
See MPEP § 2163.06 through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).”
Applicant’s amendment with respect to amended claims 40 and 41 herein has been fully considered but is deemed to insert new matter into the claims since the specification as originally filed does not provide support for the newly added limitation of “subject”, as instantly claimed.
The instant specification and the originally filed claim (i.e. filed 9/15/2023) only provide support for “patient” (see snapshots below).
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(pg. 4, lines 17-19)
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(pg. 17, lines 4-6)
Accordingly, “subject” can include cells, etc. which are outside of patient, and that is considered new matter.
Adequate written description means that, in the specification, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 [19 USPQ2d 1111] (Fed. Cir. 1991).
See MPEP 2163 regarding the guidelines for the written description requirement: "The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
See MPEP § 2163.06 through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).”
Regarding claims 24-36 and 39-41, these claims are directly or indirect dependent of claim 23, which failed to correct the defective issue in claim 23, which rendered these claims improper.
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 42 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 42, the claim recite the following formulas, which contains instant variable GP, but failed to provide any definition for GP. Accordingly, the metes and bounds of this claim is unclear, which rendered the claim indefinite.
In addition, the claim recites the following definition, “PG is a protecting group”, but instant formulas (I), (B1), and (B2) failed to recite instant variable PG. Accordingly, the metes and bounds of this claim is unclear, which rendered the claim indefinite.
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and
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Claim Rejections - 35 USC § 102
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 23, 24, 26-29, 31-36, and 39-41 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Foreign Patent Application Publication No. WO2023/064879, hereinafter Reynolds, as evidenced by “Huntington’s Disease: Mechanisms of Pathogenesis and Therapeutic Strategies”, hereinafter Jimenez-Sanchez.
Regarding claims 23, 24, 26-29, 31-36, and 39-41, Reynolds, for instance, teaches the following compounds or pharmaceutical composition thereof for treating Huntington’s disease. All of which meet all the limitations of these claims.
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(pg. 3, lines 8-13)
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(pg. 157, lines 17-19)
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(pg. 81, compound No. 296 and 297)
Wherein instant variable R1 is 6-membered heterocyclyl; instant variable X is a bond; instant variables R2 and R3 are methyl.
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(pg. 280, lines 1-3)
As for claims 35 and 36, the claims do not require instant variable R1 to be substituted by instant variable R4 and thus, the instant compounds are anticipated by the compounds of Reynolds.
As for the limitation in claim 40, wherein the compound can reduce a protein level of HTT in a brain of a subject, the Examiner finds such limitation as an inherent feature that is embedded in the structure of compound of instant formula (I). Any prior art compound (e.g. abovementioned compound of Reynolds) having the same structure as the compound of instant formula (I) would be capable of performing the same feature. In addition, according to MPEP 2112(II), such inherent feature does not have to be recognized at the time of the invention.
Evidentiary reference Jimenez-Sanchez teaches that HD is caused by mutations in the HTT gene encoding huntingtin, which is a ubiquitously expressed protein of 350 kDa. This information established the pathogenic link between HTT and Huntington’s disease, thereby demonstrated that the compounds of Reynolds can inherently reduce a protein level of HTT when the compounds of Reynolds are used to treat Huntington’s disease, and need not be recognized at the time of invention, according to MPEP 2112(II).
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(pg. 2, left column, 2nd paragraph)
Claim Objections
Claim 42 is objected to because of the following informalities:
Regarding claim 42, the claim recites the phrase, “the method comprising at least one step selected from”.
Such expression can be clarified by reciting -- the method comprising
Regarding claim 42, the claim recites the phrase, “with a suitable base in the presence”.
Such expression can be clarified by reciting -- with a suitable base in
Regarding claim 42, instant variable n is too far away from the parenthesis that it corresponds in instant formulas (B1) and (B2) and thus, correction is needed.
Appropriate correction is required.
Allowable Subject Matter
Claims 37 and 38 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.
Conclusion
Claims 23-36 and 39-42 are rejected.
Claims 37, 38, and 42 are objected.
Claims 1-22 are cancelled.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621