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 1, 10, 12, 13, 15, 21-28, 31-33, 36, 38, 40, 41 and 51-54 are pending in the application. Claims 1, 10, 13, 40 and 54 are rejected. Claims 12, 15, 21-28, 31-33, 36, 38, 41 and 51-53 are withdrawn
Response to Amendments
Objections and rejections made in the Office Action mailed August 22, 2025 that do not appear below have been overcome by Applicant’s amendments to the claims and have been withdrawn. The newly applied objection and rejection under 35 U.S.C. § 102 has been necessitated by Applicant’s amendment filed on August 22, 2025.
Election/Restriction
Previously, claims 1, 13, 21-28, 31-33, 36, 38, 40 and 41 were withdrawn from further consideration as being drawn to a non-elected invention/species while claims 10, 12 and 15 were examined with respect to Applicant’s elected species shown below (see Office Action mailed August 22, 2025).
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Upon examination, Applicant’s elected species was found to be anticipated by prior art; therefore, the Markush claim and claims to the elected species were rejected. However, as a result of Applicant’s amendment filed on August 22, 2025, claims 10, 12 and 15 no longer read on Applicant’s elected species. Therefore, the examination of the Markush claims will be extended. The prior art search will be extended to cover non-elected species or group of species that fall within the scope of a proper Markush grouping which includes the elected species. The prior art search will not be extended unnecessarily to cover all nonelected species, and need not be extended beyond a proper Markush grouping. However, if prior art is found that anticipates or renders obvious the Markush claims with respect to a nonelected species, the Markush claims shall be rejected and claims to the nonelected species held withdrawn from further consideration. Consequently, the prior art search was extended to include the following non-elected species:
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The claim(s) and subject matter that do not read on Applicant’s elected species and the expanded species above have NOT been examined and searched and are withdrawn from further consideration by the examiner. Accordingly, claims 12 and 15 are withdrawn from further consideration by the examiner as being drawn to a non-elected/expanded species. In addition, claims 1, 13 and 40 previously withdrawn from consideration are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Claims 1, 10, 13, 40 and 54 read on the expanded species. Claims 12, 15, 21-28, 31-33, 36, 38, 41 and 51-53 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention/species.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on December 22, 2025 is 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 13 is objected to because of the following informalities:
Claim 13 should be amended to replace the word “and” (shown below) with the word -or- for sake of clarity.
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Appropriate correction is required.
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, 13 and 40 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.
Claims 1 and 13 recite “...polymorph...or clathrate thereof” and are rejected as indefinite. Neither the terms “polymorph” nor “clathrate” are defined by the claims or in the specification. With respect to these terms, 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. Therefore, it is unclear how one of ordinary skill could reasonably determine the objective boundaries of the scope of the claims based on these terms. For instance, a clathrate is formed when a compound is physically trapped in another chemical substance, and the identity of this other chemical substances is not defined in the instant disclosure. Similarly, the instant specification is silent with respect to any particular crystalline form(s) of the claimed compound; therefore, the scope of the term “polymorph” is ambiguous. 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 Applicant cancel both terms (i.e., polymorph and clathrate) from both claims as these terms do not provide clear boundaries with respect to the scope of the claimed invention. Dependent claim 40 does not correct this issue of indefiniteness and is likewise rejected.
Claim 40 recites the limitation “comprising at least one of astemizole and one or more compounds of claim 1, 15, 22, 28 or 33” and is rejected as indefinite. It is unclear whether Applicant intended claim 40 to be drawn towards a pharmaceutical composition comprising a) at least one selected from the group consisting of “astemizole” and “one or more compounds of claim 1, 15, 22, 28 or 33” or b) at least one “astemizole” and at least one compound of claim 1, 15, 22, 28 or 33. For examination purposes, claim 40 is being interpreted under option a) (i.e., encompasses pharmaceutical composition comprising solely either astemizole or a compound of claim 1, 15, 22, 28 or 33). It is suggested Applicant amend claim 40 to, for instance, recite: “...comprising or one or more compounds of claim 1, 15, 22, 28 or 33...” to overcome this issue of indefiniteness.
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.
Claims 1, 10, 13, 40 and 54 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Chinese Application No. CN107556318 A (January 9, 2018).
The prior art teach Compound (I-a14) having the following chemical nomenclature: “1-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-(4-bromophenyl)propan-1-one.” See e.g., page 42 of attached machine translation. The above prior art nomenclature correlates to the following chemical structure:
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.
Regarding instant claims 1 and 54, the above prior art Compound (I-a14) is encompassed by variable definitions of the instantly claimed compound of formula (I), wherein R4 is hydrogen; R5 is heteroaryl; X1 is alkyl (i.e., methyl); X2 is CH; R1 is aryl substituted with Br and R2 is H. Note: the instant specification defines the term aryl as “substituted or unsubstituted univalent groups” examples of which include “phenyl.” See paragraph [0068]. Furthermore, the instant specification states “[t]he term ‘substituted’ as used herein refers to a group that is substituted with one or more groups including...[inter alia] halogen (e.g., F, Cl, Br, and I).” See paragraph [0089].
Regarding instant claim 40, the prior art teaches “a pharmaceutical composition suitable for oral or parenteral administration.” See e.g., page 26 of attached machine translation. Note that claim 40 is being interpreted as being drawn towards a pharmaceutical composition comprising “at least one” selected from the group consisting of “astemizole” and “compounds of claim 1, 15, 22, 28 or 33.” See discussion above under 35 U.S.C. § 112(b).
Regarding instant claim 10, the above prior art Compound (I-a14) is encompassed by variable definitions of the instantly claimed compound of formula (Ic), wherein R4 is hydrogen; R5 is heteroaryl; n is 1; and R6 is aryl substituted with Br. Note: the instant specification defines the term aryl as “substituted or unsubstituted univalent groups” examples of which include “phenyl.” See paragraph [0068]. Furthermore, the instant specification states “[t]he term ‘substituted’ as used herein refers to a group that is substituted with one or more groups including...[inter alia] halogen (e.g., F, Cl, Br, and I).” See paragraph [0089].
Regarding instant claim 13, the above prior art Compound (I-a14) is encompassed by variable definitions of the instantly claimed formula of
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, wherein R6 heteroaryl; X1 is alkyl (i.e., methyl); X2 is CH; R1 is aryl substituted with Br and R2 is H. Note: the instant specification defines the term aryl as “substituted or unsubstituted univalent groups” examples of which include “phenyl.” See paragraph [0068]. Furthermore, the instant specification states “[t]he term ‘substituted’ as used herein refers to a group that is substituted with one or more groups including...[inter alia] halogen (e.g., F, Cl, Br, and I).” See paragraph [0089].
Conclusion
No claims are allowed.
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID SHIM whose telephone number is (571)270-1205. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM EST.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
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