DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election without traverse of Group I, claims 1-9 and 14 in the reply filed on 7/29/2025 is acknowledged. Claims 15-18 have been amended to composition claims.
Claims 10-13 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/29/2025.
The Examiner notes that withdrawn claim 10 is missing a period.
INFORMATION DISCLOSURE STATEMENT
2. Information Disclosure Statements filed 12/12/2022, 7/6/2022 and 3/22/2024 are acknowledged.
Claim Rejections- 35 USC § 112
3. 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.
Claim 8 is 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.
Claim 8 recites a pharmaceutical solid dosage form, comprising the liquisolid pharmaceutical formulation according to claim and is missing the claim number. For the purpose of examination the Examiner is interpreting to recite claim 1.
Claim Rejections- 35 USC § 103
4. 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 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 1-5, 8-9 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Patra et al. “An Overview of liquisolid technology” in view of Grizic et al. “Propylene carbonate quantification by its derivative 3,5-diacetyl-1,4-dihydro-2,6 lutidine”, Yoshida et al. (CN 102083467), and Tiong et al. “Effects of liquisolid formulations on dissolution of naproxen”, Ahuja et al. “Porous Carriers for Controlled/Modulated Drug Delivery”.
Patra et al. “An Overview of liquisolid technology”-as cited on the IDS disclose liquidsolid technology and formulations comprising a porous carrier and an active pharmaceutical ingredient loaded onto a surface of the porous carrier, wherein the active is dispersed in a solvent such as PEG or propylene glycol. The formulations improve the solubility of poorly soluble active ingredients. Porous silica is disclosed as well as poorly water soluble drugs (Table 5.3-griseofluvin and indomethacin). The reference discloses drug venlafaxine or tramadol with liquid vehicle of solvents PEG 400, PG and Avicel 101 carrier. Patra et al. disclose the use of non-volatile solvents and while ethanol and methanol is not disclosed, these are common solvents for use in porous carrier drug delivery systems as taught by Yoshida et al. (CN 102083467) (para 0180).It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute one non-volatile solvent for another such as the PEG for ethanol. Patra et al. disclose tablets (solid dosage forms).
The reference does not disclose propylene carbonate however, Grizic et al. “Propylene carbonate quantification by its derivative 3,5-diacetyl-1,4-dihydro-2,6 lutidine” disclose that propylene carbonate is a non-toxic solvent currently used in various pharmaceutical formulations. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute one known solvent for another. One would have been motivated to do so because substitution of one solvent for another would yield predicable results as both are non-toxic solvents for use in pharmaceutical formulations.
With regards to the claimed limitation that “A liquisolid pharmaceutical formulation or pharmaceutical solid dosage form obtained by the process according to claim 10, it is noted that the patentability of a product does not depend on the process of manufacturing. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe.
While Patra et al. teaches low water insoluble drugs, it does not teach drugs such as naproxen however, Tiong et al. “Effects of liquisolid formulations on dissolution of naproxen” (hereinafter Tiong et al.) disclose liquisolid technique could be a promising strategy in improving dissolution of poorly water-soluble drugs and formulation immediate release solid dosage forms (conclusion). The naproxen showed improved dissolution profiles. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include other low water soluble drugs such as naproxen in the liquisolid dosage forms in order to improve dissolution profiles of these drugs.
Patra et al. does not disclose mesoporous silica however, Ahuja et al. “Porous Carriers for Controlled/Modulated Drug Delivery” (hereinafter Ahuja et al.) disclose that mesoporous materials offer potential means to increase the dissolution of poorly soluble drug (see improvement in dissolution). These carriers include mesoporous silica (Table 2). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute one porous carrier, the carrier Patra et al. for another , the mesoporous carriers of Ahuja et al. One would have been motivated to do so because mesoporous carriers can increase the dissolution of poorly soluble drugs.
5. Claims 6-7 and 17-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
CORRESPONDENCE
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
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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/DANAH AL-AWADI/Primary Examiner, Art Unit 1615