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 01/21/2026, is acknowledged.
Applicant has previously elected without traverse the invention of Group I, claims 1-16, drawn to oral liquid suspensions comprising quetiapine fumarate in combination with pharmaceutically acceptable additives.
Claims 1-3, 5-10, 12-28 are pending in this action. Claim 4 has been cancelled. Claim 11 has been cancelled previously. Claims 17-26 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking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 1-2, 13, 16, 27-28 have been amended. Claims 1-3, 5-10, 12-16, 27-28 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn.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.
Priority
This application is a continuation of U.S. Patent Application No. 17/362,432, filed June 29, 2021 and now issued as U.S. Patent No. 11,813,269, which a continuation of U.S. Patent Application No. 17/083,497, filed October 29, 2020 and now issued as U.S. Patent No. 11,045,481, which claims benefit of provisional U.S. Application No. 62/927,153, filed October 29, 2019.
Terminal Disclaimer
The terminal disclaimers, filed on 12/16/2024, disclaiming the terminal portion of any patent granted on this application, which would extend beyond the expiration date of the prior Patent Nos. 11,045,481 and 11,813,269, have been reviewed and are accepted. The terminal disclaimers have been recorded. The nonstatutory double patenting rejection has been withdrawn.
Claim Objections
Claim 28 is objected to because of the following informalities: Claim 28 comprises the typographic error “An oral liquid suspension of claim 27” that needs to be corrected to “The oral liquid suspension of claim 27”. 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 1-3, 5-10, 12-16 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 oral liquid suspension comprising quetiapine fumarate particles, sodium benzoate powder, saccharin sodium dihydrate powder in combination with other constituents that is not reasonably clear. Does this limitation imply the presence of particles/powder of said compounds in the suspensions? Similar is applied to claim 16. Clarification is required.
Claim 1 further recites the limitation “quetiapine fumarate particles at the concentration of 28.85 mg/ml”. In the present cease, it is noted that the instant specification teaches suspensions comprising quetiapine fumarate particles at the concentration of 28.83 mg/ml (Para. 0005, 0130, 0201). Clarification is required.
Claims 2-3, 5-10, 12-15 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
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.
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Tierney et al., US 9,993,486 (cited in IDS; hereinafter referred to as Tierney).
Tierney teaches oral quetiapine fumarate suspension formulations in aqueous carrier that remain physiochemically stable for at least 24 months under the storage at 2-8 oC, have an extended shelf life and enhanced bioavailability, and wherein said formulations comprise quetiapine fumarate particles with preferred particle size distribution having the D90 of 30-60 μm (Col. 8, Lns. 36-41), and provides examples of oral suspensions with quetiapine fumarate particles having D90 of less than 300 μm; D50 of less than 100 μm, and D10 of less than 30 μm (Figs. 8 and 16 A-B; Col. 8, Lns. 36-44, Col. 15, Lns. 56-61).
Tierney further teaches that said oral quetiapine fumarate suspension may include (i) 2-40 mg/ml of quetiapine fumarate; and (ii) such pharmaceutically acceptable excipient as silicified microcrystalline cellulose, wherein said excipient should be present in concentrations providing daily intake avoiding excipient mediated toxicities based on recommendations of FDA and WHO, identifying thereby the concentrations of said excipient as result effective variables (claim 7; Title; Abstract; Col. 3, Lns. 34-50, Col. 12, Ln. 38 - Col. 15, Ln. 33).
It would be obvious to one of ordinary skill in the before the effective filing date of the claimed invention to try excipients as silicified microcrystalline cellulose at concentrations avoiding excipient mediated toxicities based on recommendations of FDA and WHO as taught Tierney preparing oral liquid suspensions comprising quetiapine fumarate, e.g., for treating mental disorders. One would do so with expectation of beneficial results, because the cited prior art teaches that said approach would allow providing oral liquid suspensions with desired drug release profile, high bioavailability, desired rheology to minimize the difficulty in swallowing, desired flavor, color, and/or other complementary properties.
With regard to the concentrations as instantly claimed, it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations/suspensions comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Response to Arguments
Applicant's arguments, filed 01/21/2026, have been fully considered, and they were found to be persuasive. Any rejection or objection not reiterated in this action is withdrawn. New objections, rejections and/or arguments have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments.
The following is a statement of reasons for the indication of allowable subject matter: The prior art teaches a large variety of additives/excipients that can be included into oral suspension formulations comprising quetiapine fumarate, i.e., poor water-soluble active agent to be used for treatment of mental disorders (e.g., US 9,993,486), and also teaches that said excipients individually suspected of causing adverse events. The prior art does not teach or suggests oral liquid suspensions comprising quetiapine fumarate particles as instantly in combination with claimed compounds/excipients present in claimed amounts. Applicant teaches that said oral liquid suspensions (i) allow improving stability of quetiapine fumarate; (ii) are free from microbial growth for at least 24 months during the storage under ambient conditions; and (iii) can be used for treatment a mental disorder by administering to a patient in need thereof. Applicant is advised to clarify the claim language, and clearly point the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the reference cited, to place the applicant in condition for allowance. Further to expedite the prosecution, it is noted that withdrawn claims 17-26 need to be amended. For instance:
Claim 17 comprises the typographic error “amount of an oral liquid suspension of claim 1” that needs to be corrected to “amount of the oral liquid suspension of claim1”.
Claim 19 comprises the typographic error “amount is 0.1 to 50.0” that needs to be corrected to “amount of from 0.1 to 50.0”. Similar is applied to claim 20.
Claims 20, 21 recite the term “sufficient” that is not reasonably clear. This term 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. Clarification is required.
Claim 22 recites the limitation “peak plasma concentrations (tmax)” should be corrected to “peak plasma concentrations (Cmax)” or clarified.
Claim 23 includes table comprising doses as used for a specific mental disorder. To this point, it is noted that claims may contain tables either if necessary to conform to 35 U.S.C. 112 or if otherwise found to be desirable. When such a patent is printed, however, the table will not be included as part of the claim, and instead the claim will contain a reference to the table number. MPEP 608. Further, it is noted that where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). MPEP § 2173.05(s). Clarification is required.
Claim 24 comprises the acronym “ALT”. The acronym should be given once in parenthesis after the first use of the full term, and then the acronym is used alone thereafter if needed.
Claim 25 recites the acronym “PK” that should be removed, because said acronym is not used in subsequent claims.
Claim 25 recites the numerical limitations for "AUC”, Cmax, Tmax, t1/2 without identification of specific method/instrument/conditions for measurements of said characteristics to be used. Said parameters of pharmacokinetic profile depend on methods of measurements, e.g., a time step for generating pharmacokinetic profile. Where a claimed value varies with its method of measurement and several alternative methods of measurement are available, 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). Therefore, the values recited by claim 25 are incomplete insofar as said claim does not specify the frame of reference used to measure them. Without knowing these parameters, the metes and bounds of the claimed subject matter are not reasonably clear. Clarification is required.
Conclusion
Claims 1-3, 5-10, 12-16 are rejected, but would be allowable if rewritten or amended 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.
Claims 27-28 are rejected.
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 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 on (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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