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
2. This Office Action is responsive to Applicant’s Amendment and Remarks, filed December 9, 2025. The amendment, filed December 9, 2025, is entered, wherein claims 1 and 198 are amended, claims 2 – 20, 22 – 60, 62 – 83, 85 – 89, 91 – 103, 105 – 120, 122, 124 – 127, 129 – 133, 135 – 147, 149 – 185, 188, 191, 193 – 195, and 199 – 204 are canceled, claims 186 – 187, 189 – 190, and 192 are withdrawn, and claim 205 is new.
Priority
This application is a national stage application of PCT/US2021/032428, filed May 14, 2021, which claims benefit of domestic application 63/025,488, filed May 15, 2020.
Withdrawn Objections
4. The objection of the disclosure in the previous Office Action, mailed September 9, 2025, is withdrawn in view of the amended specification.
The objection of claim 198 in the previous Office Action, mailed September 9, 2025, is withdrawn in view of the amended claim 198.
The following are maintained / modified grounds of rejection necessitated by Applicant’s Amendment and Remarks, filed December 9, 2025, wherein claims 1 and 198 are amended, claims 2 – 20, 22 – 60, 62 – 83, 85 – 89, 91 – 103, 105 – 120, 122, 124 – 127, 129 – 133, 135 – 147, 149 – 185, 188, 191, 193 – 195, and 199 – 204 are canceled, claims 186 – 187, 189 – 190, and 192 are withdrawn, and claim 205 is new. Previously cited references have been used to establish the maintained / modified grounds of rejection.
Maintained / Modified Claim Rejections - 35 USC § 103
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:
i. Determining the scope and contents of the prior art.
ii. Ascertaining the differences between the prior art and the claims at issue.
iii. Resolving the level of ordinary skill in the pertinent art.
iv. 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, 21, 61, 84, 90, 104, 121, 123, 128, 134, 148, 196 – 197, and 205 are rejected under 35 U.S.C. 103 as being unpatentable over Vergnault et al. (WO2016/066256A1, cited in the previous Office Action) with evidence provided by FDA (Patient Labeling Resources, 2022, cited in the previous Office Action) and Jaimini (Research Journal of Pharmaceutical, Biological, and Chemical Sciences, 2013, Vol. 4, Issue 2, page 1721 – 1730, Reference included with PTO-892).
Regarding claims 1, 21, 61, 84, 90, 104, 121, 123, 128, 134, 148, 196 – 197, and 205, Vergnault et al. disclose a gastric retentive gel composition comprising a hydrophobic or amphiphilic liquid gelled with an organogelator; an active agent; and a hard wax or wax-link additive. An organogelator is a gelling agent which is capable of forming a linked network, typically a crosslinked network, through a liquid organic phase to yield a stable gel. The gel may be an oleogel (page 2, para. 4; page 3, para. 1). The hydrophobic or amphiphilic liquid may comprise an oil fraction including a fatty acid fraction. The oil must be non-toxic or edible (page 12, para. 3). The organogelator may comprise a polymeric component, wherein the polymeric component may comprise a cellulose polymer (page 11, para. 2). In other embodiments, the polymeric component may comprises xanthan gum (page 11, para. 4). The gel composition may comprise additional ingredients and additives and the composition may include a surfactant, such as lecithin (page 40, para. 5). Vergnault et al. disclose that the active agent may comprise praziquantel (page 40, para. 2) and it is formulated as nanoparticle (page 40, para. 1). Moreover, the composition may comprise antioxidative agent, such as BHA, and flavoring agent (page 40, para. 5; page 41, para. 1). The gel composition is gastric retentive, which means that, on oral administration to patient, the composition is retained in stomach for a period of time exceeding normal gastric retention time of conventional dosage forms (page 3, para. 4; page 4, para. 1). The active agent in the gel composition may be conventionally formulated for immediate absorption of the active ingredient upon release from the gel composition (page 39, para. 3). Furthermore, Vergnault et al. teach the manufacturing process (page 59, Table 9):
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200
400
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wherein the process includes mixing, heating, and cooling.
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date to combine the components with additional antioxidant and flavoring agent as taught by Vergnault et al. to achieve the claimed invention because it is known in the art that antioxidants are routinely used in pharmaceutical formulation to improve shelf life and that flavoring agent are recognized excipients added to make formulations more palatable. One would have been motivated to combine the components with additional antioxidant and flavoring agent as taught by Vergnault et al. because both are well-known excipients used for their predictable results. For the limitation “immediate release”, Jaimini teaches that the term “immediate release” pharmaceutical formulation includes any formulation in which the rate of release of drug from the formulation and/or the absorption of drug is neither appreciably, nor intentionally, retarded by galenic manipulations (page 1723, para. 5). Vergnault et al. disclose the claimed composition and teach that the gel composition may be conventionally formulated for immediate absorption of the active ingredient upon release from the gel composition. The disclosure is consistent with the definition of “immediate release” and it reads on the “immediate release” limitation. According to FDA, the Instructions for Use (IFU) is patient labeling that is part of FDA-approved prescription drug labeling. The IFU has complicated or detailed patient-use instructions. It also contains information, such as instructions on preparation, administration, handling, storage, and disposal (page 6, para. 1). Therefore, one of the ordinary skill in the art would have had a reasonable expectation of success to combine the components with additional antioxidant and flavoring agent as taught by Vergnault et al. because it is well known in the art to add excipients, such as antioxidant and flavoring agent, to improve the properties of the formulation.
Claim 198 is rejected under 35 U.S.C. 103 as being unpatentable over Vergnault et al. (WO2016/066256A1, cited in the previous Office Action) with evidence provided by FDA (Patient Labeling Resources, 2022, cited in the previous Office Action) as applied to claims 1 – 2, 21, 61, 84, 90, 104, 121, 123, 128, 134, 148, 196 – 197, and 205 above, and further in view of Mahalingam (Advanced Pharmaceutical Bulletin, 2015, Vol. 5, Issue 1, page 57 – 67, cited in the previous Office Action).
Regarding claim 198, Vergnault et al. with evidence provided by FDA teach the limitations discussed above.
However, these references do not teach the process of preparing the immediate release composition.
Mahalingam teaches that nanotechnology is a highly important area of research, in pharmaceutical industries, to develop an effective drug delivery system that can transport and deliver a drug precisely and safely to the site of action for treating a variety of diseases and disorders (page 57, Right Col., para. 2). Mahalingam explicitly discloses that nanoparticles have become an important area of research in the field of drug delivery because they have the ability to deliver a wide range of drugs to varying area of body for a sustained period of time (page 58, Left Col., para. 2). One of the very commonly used technique for preparing polymeric nanoparticles is solvent evaporation technique. The technique includes dissolving the polymer in an organic solvent into which the drug is dissolved/dispersed. The resultant solution is then added to the aqueous phase containing surfactant/emulsifying agent under high homogenization to form an emulsion. After the formation of stable emulsion, the organic solvent is evaporated/removed either by increasing the temperature under required pressure or by continuous stirring. The nanosuspension produced is freeze dried using 5% mannitol as a cryoprotectant to obtain a fine powder of nanoparticles (page 61, Right Col., para. 2).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to consider the nanoparticle formulation as taught by Vergnault et al. to be prepared by the solvent evaporation technique in view of Mahalingam because Vergnault et al. teach that the composition is in the form of nanoparticle and Mahalingam teaches the solvent evaporation technique, which is very commonly used for preparing nanoparticles. One would have been motivated to apply the solvent evaporation technique for preparing the nanoparticle composition because the technique is known in the art, thereby, yielding predictable results. Therefore, one of the ordinary skill in the art would have had a reasonable expectation of success to consider the nanoparticle formulation as taught by Vergnault et al. to be prepared by the solvent evaporation technique in view of Mahalingam because Vergnault et al. already teach that the composition may be in the form of nanoparticles and Mahalingam teaches the commonly used technique to prepare nanoparticles.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed December 9, 2025, have been fully considered and are found to be not persuasive.
Regarding Vergnault et al., Applicant argues that claim 1 has been amended to recite “an immediate release composition” comprising “an edible oil”. However, the argument is not persuasive because the maintained / modified rejection above clearly stated that Vergnault et al. teach the oil used in the composition is an edible oil. For the preamble “an immediate release composition”, Vergnault et al. disclose the claimed composition and teach that the gel composition may be conventionally formulated for immediate absorption of the active ingredient upon release from the gel composition. With the definition of “immediate release” provided by Jaimini, the disclosure of Vergnault et al. read on the “immediate release” limitation.
Applicant argues that the Office Action does not explain why a person of ordinary skill in the art would have been motivated to modify the compositions in Vergnault et al. in a way that would produce immediate release composition that comprises an edible oil nor why such a person of ordinary skill in the art would have a reasonable expectation of success in doing so. The argument is not persuasive because Vergnault et al. explicitly teach that the active agent may be “conventionally formulated for immediate absorption…upon release from the gel composition”. One of ordinary skill in the art would have considered the teaching of Vergnault et al. and would have been motivated to formulate a fast release formulation depending on the need of the patients.
Regarding FDA, Applicant argues that FDA does not disclose the release profile of any formulation. However, the argument is not persuasive because FDA is relied for the fact that pharmaceutical product is required to include patient package insert to address the limitation of claim 196.
Regarding Mahalingam, Applicant argues that Mahalingam fails to remedy the deficiencies of Vergnault et al. and FDA discussed above. Mahalingam is relied for the teaching of preparing the immediate release composition. Vergnault et al. with evidence provided by FDA teach the limitations of the claims. Responses for the arguments regarding Vergnault et al. and FDA have been provided above.
Conclusion
No claim is found to be allowable.
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.
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/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693