DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the claims and applicant arguments/remarks, filed 01/12/2026, is acknowledged.
Applicant has previously elected with traverse the invention of Group I, claims 1-5, drawn to tablets or capsules comprising vicagrel or salt thereof.
Claims 1-6, 8-11, 20-26 are pending in this action. Claims 7, 12-19 have been cancelled. Claims 1-6, 8-9 have been amended. New product/tablet/capsule claims 21-22 have been added. No new matter was added. New method claims 23-26 have been added. Claims 6, 8-11, 20, 23-26 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking claim. Claims 1-5, 21-22 are currently under consideration.
To expedite the prosecution, it is noted that withdrawn claims 20, 23-26, drawn to a method of treating thrombosis, do not have any support in the original specification. Therefore, said claims constitute a new matter. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
For the record, Declaration under 37 CFR 1.130(a), filed by the applicant on 05/04/2022 in the parent application 16/975,329, showing that the subject matter disclosed in the CN 108420798A reference was obtained directly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A), is acknowledged.
Priority
This application is a continuation of U.S. Patent Application No. 17/969,972, filed October 20, 2022 and now issued as U.S. Patent No. 11,878,078, which is a continuation of U.S. Patent Application No. 16/975,329, filed August 24, 2020, and now issued as U.S. Patent No. 11,478,432, which is a 371 of PCT/CN2018/083208, filed April 16, 2018.
Terminal Disclaimer
The terminal disclaimer, filed 01/12/2026, disclaiming the terminal portion of any patent granted on this application, which would extend beyond the expiration date of the prior Patent Nos. 11,478,432B2 and 11,878,078B2, has been reviewed and is accepted. The terminal disclaimer has been recorded. The nonstatutory double patenting rejection has been withdrawn.
Claim Objections
Claims 2-3, 21-22 are objected to because of the following informalities:
Newly amended claim 2 (dependent on claim 1) comprises the typographic error “a vicagrel compound” that needs to be corrected to “the vicagrel compound”. Similar is applied to other constituents recited in claim 2 as well as to claims 3, 21-22.
Newly amended claim 21 recites the limitation “the filler is selected from microcrystalline cellulose, …, mannitol or sorbitol” that needs to be corrected to “the filler is selected from the group consisting of microcrystalline cellulose, …, mannitol and sorbitol” for clarity. Similar is applied to other constituents recited in claim 21 as well as to claim 22.
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 1-5, 21-22 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 pre-AIA the applicant regards as the invention.
Newly amended claim 1 discloses compositions comprising a vicagrel compound or a pharmaceutically acceptable salt thereof in combination with fillers, binders, disintegrants, glidants and stabilizers. First, it is noted that the instant specification does not provide a clear definition for said recited functional agents, and/or a standard for ascertaining the requisite function (i.e., to be a binder, or a disintegrant, or glidant, or a stabilizer). It is well known in the field that properties of multicomponent systems (i.e., compositions) depends on compounds included as well as on concentrations and distribution of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition. Therefore, the function of a particular compound may change and/or depend on conditions. Second, claiming a result without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation. See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Similar is applied to claims 2-3. Clarification is required.
Newly amended claim 1 recites the limitation “a vicagrel compound or a pharmaceutically acceptable salt thereof” that is not reasonably clear. In the present case, it is noted that neither the claims nor the specification provides a clear definition for “a vicagrel compound” to be used in the claimed preparations/compositions. Is it vicagrel, OR some modification thereof? To this point, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Similar is applied to claims 2-3, 21-22. Clarification is required.
Newly amended claim 1 recites the limitation “90% of particles have a diameter (D90) of less than 50 µm” that is unclear and indefinite. As stated previously, where a claimed value (i.e., particle size) varies with its method of measurement and several alternative methods of measurement are available (see Wikipedia), the value is indefinite when the claim fails to concurrently recite the method of measurement used to obtain it. Honeywell Intl. v. Intl. Trade Commn., 341 F.3d 1332, 1340 (Fed. Cir. 2003). To this point, it is noted that it is well known in the field that there is no a comprehensive standard for particle size measurements, and different methods of particle size analysis yield different estimates of particle size for the same sample (see Wikipedia and references cited wherein; “Interpretation of Particle Size Reported by Different Analytical Techniques” on labmanager.com; “Comparison of particle characterization methods” on microtrac.com), i.e., experimental estimates of particle sizes depend on methods of measurements used to obtain it. Therefore, the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. MPEP § 2173.05(c). Similar is applied to claims 4, 5. Clarification is required.
New claim 21 recites the term "low substituted hydroxypropyl cellulose" that is not reasonably clear. To this point, it is noted that the term "low-substituted" is not defined by the claim, the specification does not provide a definition and/or examples for this term, and one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Similar is applied to new claim 22. Clarification is required.
Response to Arguments
Applicant's arguments, filed 01/12/2026, have been fully considered, and they were found to be persuasive. Any rejection or objection not reiterated in this action is withdrawn. New arguments and/or rejections have been added to the record to address newly introduced amendments and/or clarify the position of the examiner.
Claims 1-5, 21-22 are rejected but would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Applicant is advised to clarify the claim language and scope and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art to place the application in condition for allowance.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The prior art teaches a large variety of pharmaceutical compositions that include structural analogs of vicagrel as active agents (i.e., antiplatelet drugs).
The prior art does not teach or suggest the claimed invention as instant release pharmaceutical compositions comprising vicagrel (i.e., a novel antiplatelet drug) or pharmaceutically acceptable salts thereof in combination with specific compounds present in specific amounts, and wherein vicagrel is in a form of particles, wherein 90% of said particles have a diameter of less than 50 µm. Applicant teaches that said instant release vicagrel compositions (i) provide a high in vivo drug bioavailability and blood drug concentration, and (ii) do not require a presence of additional active compounds (e.g., aspirin).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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