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 .
DETAILED ACTION
Claims 2 and 21-31 are pending in the application. Claims 2 and 21-26 are rejected. Claims 2, 21 and 25 are objected to. Claims 27-31 are withdrawn.
Restriction/Election of Species
Applicant’s election without traverse of Group I, claims 2 and 21-26, in the reply filed on December 3, 2025 is acknowledged.
Claims 27-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 December 3, 2025.
Priority
This application is a continuation of U.S. Application No. 17/624,970, filed on January 5, 2022, which is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2020/040881, filed on July 6, 2020, which claims benefit of Provisional Application No. 62/871,965, filed on July 9, 2019.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on October 18, 2023 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Claim Objections
Claim 2, 21 and 25 are objected to because of the following informalities:
Claim 2 should be amended to recite, “...in chlorobenzene to obtain 1-methylpiperidine-4-carboxylic acid chloride” in the second reaction step of the claim for sake of clarity and consistency.
Claim 2 should be amended to cancel the word “of” in the last line of the claim for sake of clarity.
Claim 21 should be amended to recite, “...wherein the reaction steps
Claim 25 should be amended to recite, “...wherein the organic solvent of reaction step (v) is n-butanol” to avoid ambiguity.
Appropriate correction is required.
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 2 and 21-26 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 Scope) MPEP § 2163 outlines the methodology for determining adequacy of written description. MPEP § 2163(II)(A)(1) instructs “For Each Claim, Determine What the Claim as a Whole Covers”. Applicant filed a preliminary amendment for the instant claims on October 18, 2023 in this continuation application of U.S. Application No. 17/624,970. Newly amended claim 2 is drawn towards a process for preparing a compound of the formula as recited in the claim.
(Disclosed Support) MPEP § 2163(II)(A)(2) instructs “Review the Entire Application to Understand How Applicant Provides Support for the Claimed Invention Including Each Element and/or Step”. The instant specification provides support for a process for preparing a compound of the formula as recited in claims 2. For instance, see synthetic “Route II” as disclosed on pages 8-10 of the specification. The instant specification, however, does not provide support for Applicant’s amendments to claim 2 with respect to the following reaction steps (see e.g., pages 9 and 10):
Regarding reaction step iv.), the instant disclosure provides support for treatment with a mineral base (as shown below) but does not disclose support for the present treatment with a “base” in general:
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Regarding reaction step v.), the instant disclosure provides support (as shown below) for treatment with a non-polar organic solvent but does not disclose support for the present treatment with a “non-polar solvent” in general:
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Regarding reaction step vii.), the instant disclosure provides support for treatment with solid KOH specifically (as shown below) but does not disclose support for the present treatment with a “base” in general:
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Regarding reaction step viii.), the instant disclosure provides support for treatment with thiourea-modified silica gel (as shown below) but does not disclose support for the present treatment with “thiourea” in general:
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(Determination of Sufficient Support) MPEP § 2163(II)(A)(3) instructs “Determine Whether There is Sufficient Written Description to Inform a Skilled Artisan That Inventor was in Possession of the Claimed Invention as a Whole at the Time the Application Was Filed”. This section of the MPEP further provides the following guidance:
Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that inventor had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention.
In this situation and as discussed above, Applicant has disclosed support for a process for preparing a compound of the formula as recited in claim 2 (see e.g., synthetic “Route II” as disclosed on pages 8-10 of the specification). However, the instant disclosure is limited in scope relative to present claim 2 which provides for a broader scope with respect to the aforementioned reaction steps (i.e., reaction steps iv, v, vii and viii). Therefore, the instant disclosure does not demonstrate that Applicant was in possession of the process of claim 2 as presented in the preliminary amendment filed on October 18, 2023. Applicant may overcome this issue of lack of written description, for instance, by reversing the preliminary amendments made with respect to the aforementioned reaction steps. If Applicant chooses to proceed in this manner, then newly amended claims 23 and 24 would also need to be revised to avoid potential issues under 35 USC § 112. Dependent claims 21-26 do not correct for the lack of written description as discussed above and are likewise rejected.
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 2 and 21-26 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.
Regarding claim 2, the expression “such as aqueous NaOH” in reaction step iv, renders the claim indefinite because it is unclear whether this expression is further limiting of the “base.” It is suggested Applicant either cancel this expression from the claim or- alternatively- cancel “a base such as” to overcome this issue of indefiniteness. See MPEP § 2173.05(d).
In addition, the term “about” as recited in claim 2 (see reaction steps vii, viii and ix) is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how one of ordinary skill could reasonably determine the objective boundaries of the scope of the claim based on the aforementioned terms. A claim that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970). It is suggested, for instance, that Applicant cancel the term “about” from reaction steps vii, viii and ix as recited in claim 2 to overcome this issue of indefiniteness. Dependent claims 21-26 do not correct the above issues and are hence rejected.
Claim 26 recites “the polar alcoholic solvent” and is rejected as indefinite. There is insufficient antecedent basis for this limitation in the claim as neither claim 26 nor parent claim 2 provides for a polar alcoholic solvent.
Conclusion
No claims are allowed.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
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