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 .
Priority
This application, filed 6 November, 2024, is a national stage application of PCT/CN2023/088517, filed 14 April, 2023, which claims foreign benefit of application CN202210486129.2, filed 6 May, 2022.
Information Disclosure Statement
Four information disclosure statements (IDS) submitted on 6 November, 2024; 30 September, 2025; 26 March, 2026; and 18 June, 2026, are acknowledged and have been considered.
Status of the Application
Receipt is acknowledged of Applicant's claimed invention, filed 6 November, 2024, in the matter of Application N° 18/863,519. Said documents have been entered on the record.
Claims 6-10 have been amended. Claims 11-16 are new. No new matter was introduced.
Thus, Claims 1-16 represent all claims currently under consideration.
Specification
The abstract of the disclosure is objected to because of undue length (i.e., exceeds 150 words). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 2, 4, 10-11 and 13 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 2, 4, 11 and 13 recite one or more broadly defined classes of salts and thereafter recite that a narrower class or group of salts is “preferably” selected from specific alternatives. The use of the term “preferably” renders the scope of these claims unclear because it cannot be determined whether the subject matter following “preferably” constitutes a limitation of the claim or merely identifies a preferred embodiment that does not limit the preceding broader recitation. Accordingly, it is unclear whether the claims encompass the broader class of salts recited before “preferably,” or are instead limited to the specifically identified salts recited thereafter.
Claim 10 recites “A method for the preparation of a medicament which is a histamine Hl receptor antagonist or treating and/or preventing an allergic disease, comprising administering to a subject an effective amount of the salt of carebastine according to claim 1.” It is unclear how the phrase “or treating and/or preventing an allergic disease” relates grammatically and substantively to the preceding recitation of “a method for the preparation of a medicament.” In particular, the claim appears to alternatively recite (i) a method for the preparation of a medicament and (ii) a method for treating and/or preventing an allergic disease by administration to a subject; however, the claim does not clearly delineate these alternatives or identify what steps constitute the recited method of preparing a medicament. Accordingly, one of ordinary skill in the art cannot determine with reasonable certainty the acts or steps required by claim 10.
Claim 10 is further indefinite because the terms “more preferably,” “still more preferably,” and “even more preferably” in reciting successively narrower disease embodiments. It is unclear which, if any, of these preferred embodiments constitutes an affirmative limitation of the claimed method. Thus, it cannot be determined whether the claimed method broadly encompasses treatment or prevention of any allergic disease, is limited to an acute allergic disease, is limited to the subsequently listed diseases, or is further limited to acute urticaria or acute allergic rhinitis. The claim therefore fails to distinctly define the scope of the claimed method.
For purposes of prior-art searching and examination, and in view of the indefiniteness discussed above, the Examiner interprets the recitations introduced by the terms “preferably,” “more preferably,” “still more preferably,” and “even more preferably” as statements of preference rather than affirmative limitations of the claims. Accordingly, such preferred embodiments are not treated as limiting the scope of the claims for purposes of applying prior art. With respect to Claim 10, because the claim alternatively recites a method for the preparation of a medicament and a method for treating and/or preventing an allergic disease, and does not clearly recite the acts or steps required by the former alternative, the Examiner has searched and examined Claim 10 based on the latter alternative, namely, a method of treating or preventing an allergic disease, comprising administering to a subject an effective amount of the recited salt of carebastine. This interpretation is made solely for purposes of examination in view of the present indefinite claim language and should not be construed as resolving the deficiencies above.
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.
Claims 1-5, 7, 9-14 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by D’ambra (WO 9709983 A1, cited in IDS and ISR).
Regarding Claims 1-2 and 11, D’ambra teaches 4-[4-[4-(diphenylmethoxy)-1-piperidinyl]-l-oxobutyl]-a,adimethylbenzeneacetic acid, known as carebastine (‘983, Pg. 12, Lines 11-12), and their pharmaceutically acceptable salts in the form of inorganic or organic acid or base addition salts (‘983, Pg. 15, Lines 3-4).
Regarding Claims 3 and 12, D’ambra teaches suitable acids, such as methanesulfonic (‘983, Pg. 15, Line 10).
Regarding Claims 4-5, 7, 13-14 and 16 D’ambra teaches inorganic and organic bases include alkali metals, such as, sodium, potassium, and lithium, alkaline earth metals, for example, calcium and magnesium, light metals of group IHA, for example, aluminum, organic amines, such as, primary, secondary, or tertiary amines, for example, cyclohexylamine, ethylamine, pyridine, methylaminoethanol, and piperazine (‘983, Pg. 15, Lines 12-17).
Regarding Claim 9, D’ambra teaches pharmaceutical compositions with suitable carriers (‘983, Pg. 17, Para 1).
Regarding Claim 10, D’ambra teaches carebastine possesses potent selective histamine H 1-receptor blocking and calcium antagonist properties and should prove useful in the treatment of a variety of respiratory, allergic, and cardiovascular disease states and can be used as antihistamines, antiallergy agents, and bronchodilators, and more specifically as a method of treating allergic reactions in a patient comprising administering to the patient and effective amount of the pharmaceutical composition (‘983, Pg. 2, Lines 34-37, Pg. 3, Lines 1-2, Pg. 17, Lines 3-4, Claim 27).
As such, D’ambra anticipates Claims 1-5, 7, 9-14 and 16
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6, 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over D’ambra (WO 9709983 A1, cited in IDS and ISR).
The teachings of D’ambra are set forth in the above 35 U.S.C. 102 Rejections and are incorporated herein. D’ambra teaches pharmaceutically acceptable acid- and base-addition salts of carebastine and expressly identifies suitable acids and bases for formation thereof.
Regarding Claims 6 and 15, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to prepare the disclosed carebastine salts using an amount of the selected acid or base appropriate to the available ionizable functionality of carebastine, including formation of single or double salts depending upon the selected counterion and stoichiometric amount employed. Selection of the relative molar amounts of carebastine and the salt-forming acid or base would have involved no more than routine optimization of the expressly taught salt-forming reaction, with the resulting salt stoichiometry being the predictable consequence of the number of available ionizable sites, valence of the selected counterion, and relative amounts of the reactants. Accordingly, absent evidence of an unexpected property associated with the claimed salt form or molar ratio, the claimed single/double salt and corresponding molar ratio would have been obvious over D’ambra.
Regarding Claim 8, D’ambra teaches preparation of pharmaceutically acceptable acid- and base-addition salts of carebastine by treating the piperidine derivative with an appropriate acid or base. D’ambra further teaches conducting reactions involving the disclosed piperidine derivatives in suitable organic solvents, including alcohol solvents and at elevated temperatures up to the reflux temperature of the solvent (‘983, Pg. 27, Para 1).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to carry out the expressly taught reaction of carebastine with an appropriate acid or base in a suitable organic solvent and with heating, as taught by D’ambra, in order to facilitate dissolution and reaction of the reactants and formation of the desired salt. Selection of a suitable organic solvent and reaction temperature would have constituted no more than routine selection of known reaction conditions, with a reasonable expectation of successfully obtaining the expressly contemplated carebastine salt.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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/D.M.N./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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