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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 24, 2026 has been entered.
DETAILED ACTION
Claims 1, 21, 61, 84, 90, 104, 121, 123, 128, 134, 148, 186, 196 – 198, and 205 – 210 are pending in this application, wherein claims 206 – 210 are new, claim 186 is withdrawn, and claims 2 – 20, 22 – 60, 62 – 83, 85 – 89, 91 – 103, 105 – 120, 122, 124 – 127, 129 – 133, 135 – 147, 149 – 185, 187 – 195, and 199 – 204 are canceled.
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Withdrawn Rejections
The rejection of claims 1, 21, 61, 84, 90, 104, 121, 123, 128, 134, 148, 196 – 197, and 205 in the previous Office Action, dated February 24, 2026, under 35 U.S.C. 103 as being unpatentable over Vergnault et al. with evidence provided by FDA and Jaimini has been considered and is withdrawn in favor of the new grounds of rejection set forth below.
The rejection of claim 198 in the previous Office Action, dated February 24, 2026, under 35 U.S.C. 103 as being unpatentable over Vergnault et al. with evidence provided by FDA 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104, 121, 123, 128, 134, 148, 196 – 197, and 205 above, and further in view of Mahalingam has been considered and is withdrawn in favor of the new grounds of rejection set forth below.
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:
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, 61, 84, 121, 148, and 207 – 210 are rejected under 35 U.S.C. 103 as being unpatentable over Messer-Schmid et al. (WO2009/147220A1).
Messer-Schmid et al. teach a pharmaceutical dosage form delivering an immediate release profile containing the active substance 3-Z-[1-(4-(N-((4-methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-anilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulphonate (page 1, para. 1). The pharmaceutical dosage form is an orally deliverable dosage form (page 5, para. 5). Thus, Messer-Schmid et al. teach an immediate release pharmaceutical composition comprising an active ingredient, which reads on the limitations “immediate release” and “active ingredient” of claim 1, “active pharmaceutical ingredient” of claim 84, and “formulated for oral” of claim 148.
Messer-Schmid et al. teach that the pharmaceutical dosage form may be formulated as a lipid suspension formulation, wherein the formulation comprises the active substance in a lipid carrier, a thickener, and a glidant/solubilizing agent (page 17, para. 4; page 18, para. 1). Messer-Schmid et al. teach that the most preferred lipid carrier is medium chain triglycerides (page 18, para. 6). Thus, Messer-Schmid et al. teach the pharmaceutical composition comprising the active ingredient, medium chain triglycerides, and solubilizing agent, which corresponds to the limitations “active ingredient”, “edible oil”, and “solubilizing agent” of claim 1. Messer-Schmid et al. further teach that the thickener adjusts the viscosity of the suspension and stabilizes the suspension system. Suitable thickeners to be used for the suspension formulation include oleogel forming excipients, such as colloidal silica(page 19, para. 2). Thus, the Messer-Schmid et al. teach the use of an oleogel forming excipients as the thickening/gelling component of the lipid suspension formulation, which reads on “gelling agent” of claim 1. Messer-Schmid et al. also explicitly teach the composition comprising the active ingredient in medium chain triglycerides, hard fat, and lecithin (page 20, para. 5). Thus, the disclosure of lecithin reads on the limitation of claim 61 because lecithin is a lipophilic surfactant. Messer-Schmid et al. further characterize that resulting formulation as a semisolid (page 21, para. 2), which corresponds to “semisolid dosage form” of claim 1. Messer-Schmid et al. further exemplify these components together in the example, which is described as a lipid-based carrier system with additional surfactant. Example 2 contains 42.19 wt.% active substance, 41.77 wt.% medium chain triglycerides, 12.66 wt.% hard fat, 2.95 wt.% Cremophor RH40, and 0.42 wt.% lecithin (page 24, lines 10 – 14). Messer-Schmid et al. teach that such lipid-based carrier system may comprise additional surfactant (page 24, Example 2). The disclosure reads on the composition further comprises “a surfactant” of claim 121 and the disclosure exemplifies an active substance, lipid carrier, thickener, surfactant, and lecithin together in a lipid-based formulation.
Furthermore, Messer-Schmid et al. teach that the active substance is within the range of 1 to 90 weight % of the lipid suspension formulation (page 18, para. 2). The medium chain triglycerides is within the range of 1 to 90 weight % of the lipid suspension formulation (page 18, para. 6; page 19, para. 1). The thickener is within the range of 1 to 30 weight % of the suspension formulation (page 19, para. 3). The amount of lecithin is within the range of 0.1 to 10 weight % of the lipid suspension formulation (page 20, para. 1). Thus Messer-Schmid et al. teach the amounts of each component in the composition, which reads on the limitations of claims 207 – 210. In view of these teachings, it would have been obvious to formulate the claimed immediate release composition using the components taught and exemplified by Messer-Schmid et al. because Messer-Schmid et al. exemplify the active substance, medium chain triglycerides, hard fat, surfactant, and lecithin together in a lipid-base formulation, thereby providing a reason to select these components together. To the extent the claimed composition requires selection of a particular thickener from the thickeners disclosed by Messer-Schmid et al., it would have been obvious to select a disclosed thickener for its taught function of adjusting the viscosity and stabilizing the suspension. Such selection would have constituted use of a known component for its known function and would have been expected to predictably provide a thickened and stabilized composition. Accordingly, one of ordinary skill in the art would have had a reasonable expectation of success in formulating the claimed immediate release composition using the components and amounts taught by Messer-Schmid et al.
However, Messer-Schmid et al. do not explicitly characterize the disclosed semisolid dosage form as an oleogel or an oleopaste.
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 select oleogel-forming excipient disclose by Messer-Schmid et al. as the suitable thickener for the lipid suspension formulation and to select an amount of the thickener within the disclosed range of 1 to 30 wt/% to provide the immediate release semisolid dosage form in the form of an oleogel because Messer-Schmid et al. teach a semisolid lipid suspension comprising the active ingredient, lipid carrier, thickener, and solubilizing agent, identify oleogel-forming excipients as suitable thickeners for the lipid suspension, and teach that the thickener may be present in an amount of 1 to 30 wt.% of the suspension formulation. Thus, selecting the disclosed oleogel-forming excipient in an amount within the disclosed thickener range appropriate to form an oleogel would have predictably provided the claimed immediate release composition in the form of a semisolid oleogel . One of ordinary skill in the art would have been motivated to select an oleogel-forming excipient as the thickener because Messer-Schmid et al. explicitly teach that the thickener is used for adjusting viscosity and stabilizing the lipid suspension and explicitly identify oleogel-forming excipients as suitable thickeners for accomplishing those functions. Accordingly, the skilled artisan would have had a reason to select an oleogel-forming excipient for the disclosed thickening and stabilizing functions. One of ordinary skill in the art would have had a reasonable expectation of success to obtain a semisolid oleogel because Messer-Schmid et al. identify the selected excipients as oleogel-forming, teach that such excipients are suitable for use as thickeners in the lipid suspension formulation, and demonstrate semisolid lipid suspension formulations comprising the other recited formulation components. Therefore, the teachings of Messer-Schmid et al. provide a reasonable expectation that use of the disclosed oleogel-forming excipient in the disclosed lipid formulation would successfully produce the claimed semisolid oleogel.
Regarding claims 207 – 210, Messer-Schmid et al. teach the relative amounts of the components of the lipid suspension formulation. Messer-Schmid et al. teach that the lipid carrier may be present in an amount of about 1 to about 90wt.%, the thickener may be present in an amount of about 1 to about 30 wt.%, and lecithin may be present in an amount of about 0.1 to about 10 wt.% of the lipid suspension formulation. Messer-Schmid et al. further teach that the active substance may be present in an amount of about 1 to about 90 wt.%. The claimed ranges overlap or fall within the ranges disclosed by Messer-Schmid et al. Specifically, the claimed edible oil range of about 75 to about 99.5 wt.% overlaps the disclosed lipid-carrier range at about 75 to about 90 wt.%; the claimed gelling agent ranges of about 4 to about 10 wt.% in claim 207 and about 6 to 8 wt.% in claim 209 fall within the disclosed thickener range of about 1 to 30 wt.%; and the claimed solubilizing agent range of about 9 to about 11 wt.% overlaps the disclosed lecithin range at about 9 to about 10 wt.%. Claim 208 further requires about 0.4 to about 4 wt.% active ingredient, which overlaps the disclosed active substance range, and claim 210 further requires about 1 to about 2 wt.% active ingredient, which falls within the disclosed active-substance range. Therefore, it would have been obvious for one of ordinary skill in the art to select the amounts of the respective components within the ranges recited in claims 207 – 210 because the claimed ranges either overlap or fall within the corresponding ranges disclosed by Messer-Schmid et al. The claimed amounts would therefore have represented selections of amounts already contemplated by Messer-Schmid et al. for the respective components of the formulation.
Claims 21 and 205 are rejected under 35 U.S.C. 103 as being unpatentable over Messer-Schmid et al. (WO2009/147220A1) as applied to claims 1, 61, 84, 121, 148, and 207 – 210 above, further in view of Gómez-Estaca et al. (Food Hydrocolloids, 2019, Vol. 87, page 960 – 969, PTO-892).
Messer-Schmid et al. teach the limitations discussed above. Messer-Schmid et al. further teach that lipophilic or amphiphilic excipients of high viscosity, including beeswax, may be used as thickeners (page 19, para. 2). Thus, Messer-Schmid et al. identify both oleogel-forming excipients and beeswax as suitable thickeners for the disclosed formulation.
However, Messer-Schmid et al. do not explicitly teach that the gelling agent is a wax as recited in claim 21 in combination with formation of the composition as an oleogel, or that the gelling agent is beeswax as recited in claim 205.
Gómez-Estaca et al. teach that beeswax may be used to prepare oleogel of olive, linseed, and fish oils (Abstract). Thus, Gómez-Estaca et al. establish that beeswax is known to function as an oleogelator capable of structuring an edible oil into an oleogel. Accordingly, Gómez-Estaca et al. teach that beeswax is a wax capable of providing the oleogel-forming function required by the claimed composition.
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 select beeswax as the gelling agent in the formulation of Messer-Schmid et al. and to employ beeswax in an amount sufficient to form an oleogel because Messer-Schmid et al. teach that thickeners are used to adjust the viscosity and stabilize the lipid suspension, identify oleogel-forming excipients as suitable thickeners, and separately identify beeswax as a suitable thickener and Gómez-Estaca et al. further teach that beeswax functions as an oleogelator capable of structuring edible oils into oleogels. In view of these teachings, one of ordinary skill in the art would have found it obvious to select the disclosed beeswax thickener as the gelling agent and to use it for its known oleogel-forming function, thereby obtaining the claimed semisolid composition in the form of an oleogel. One of ordinary skill in the art would have been motivated to select beeswax from the suitable thickeners disclosed by Messer-Schmid et al. because Messer-Schmid et al. contemplate the use of oleogel-forming excipients as thickeners for adjusting viscosity and stabilizing the suspension, and Gómez-Estaca et al. teach that beeswax possesses the desired oleogel-forming capability in edible oils. Accordingly, the teaching of Gómez-Estaca et al. would have provided a reason to select beeswax as the thickener as disclosed by Messer-Schmid et al. when an oleogel-forming thickener is desired. One of ordinary skill in the art would have had a reasonable expectation of success in forming an oleogel using beeswax because Messer-Schmid et al. identify beeswax as a suitable thickener for the lipid suspension formulation and Gómez-Estaca et al. demonstrate that beeswax is capable of structuring edible oils into oleogels. Thus, one of ordinary skill in the art would reasonably have expected that employing the disclosed beeswax thickener in an amount sufficient to provide its known oleogel-forming function would produce a semisolid oleogel while providing the thickening and stabilization taught by Messer-Schmid et al.
Claim 196 is rejected under 35 U.S.C. 103 as being unpatentable over Messer-Schmid et al. (WO2009/147220A1) as applied to claims 1, 61, 84, 121, 148, and 207 – 210 above, further in view of Food and Drug Administration (Content and Format Guidance for Industry, 2014, PTO-892).
Messer-Schmid et al. teach the limitations discussed above.
However, Messer-Schmid et al. do not explicitly teach a kit comprising the composition and instructions for administration.
Food and Drug Administration teaches that prescription drug labeling includes a patient counseling information section containing information necessary for patients to use the drug safely and effectively and further teaches that FDA-approved patient labeling, including Instructions for Use, is references in that section. FDA further recommends advising the patient to read the FDA-approved Instructions for Use (pages 3 – 4, Section IIIA).
It would have been prima facie obvious for one of ordinary skill in the art to provide the pharmaceutical composition of Messer-Schmid et al. together with instructions for administering the composition in view of Food and Drug Administration because Food and Drug Administration teaches that prescription drug labeling includes patient counseling information containing information necessary for patients to use the drug safely and effectively and further teaches that FDA-approved patient labeling may include Instruction for Use. Thus, providing the pharmaceutical composition of Messer-Schmid et al. together with instructions of its administration would have constituted the application of a known patient-labeling practice to a known pharmaceutical product. One of ordinary skill in the art would have been motivated to provide instructions for administration with the pharmaceutical composition of Messer-Schmid et al. because Food and Drug Administration teaches that patient labeling is used to communicate information necessary for the safe and effective use of a drug product and identifies Instructions for Use as a form of FDA-approved patient labeling. Accordingly, one of ordinary skill in the art would have had reason to provide administration instructions with the pharmaceutical composition of Messer-Schmid et al. so that the patient or caregiver would have the information necessary for proper use of the pharmaceutical product. One of ordinary skill in the art would have had a reasonable expectation of success because providing instructions with the pharmaceutical composition would merely involve supplying the known drug product with the type of patient-use information taught by Food and Drug Administration. Food and Drug Administration contemplates providing FDA-approved patient labeling, including Instructions for Use, in connection with prescription drug products. Therefore, providing the composition of Messer-Schmid et al. together with instructions for administration would have predictably resulted in a pharmaceutical product accompanied by information directing the patient or caregiver in its use, as recited in claim 196.
Claims 1, 90, 104, 123, 128, 134, and 197 are rejected under 35 U.S.C. 103 as being unpatentable over Vergnault et al. (WO2016/066256A1, cited in the PTO-892 on September 9, 2025) in view of Laczay (EP2662075A1) and Münster et al. (Journal of Pharmaceutical Sciences, 2017, Vol. 109, page 446 – 454, PTO-892).
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). Thus, Vergnault et al. teach a pharmaceutical composition comprising an active ingredient, an edible oil, and a gelling agent, wherein the composition is in the form of an oleogel, corresponding to the limitations of claim 1. 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 comprise xanthan gum (page 11, para. 4). Thus, the disclosure of a polymeric component reads on the limitation of claim 123 requiring that the composition further comprises a polymer. 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). Thus, the disclosure of praziquantel reads on the limitation of claim 90 requiring the active ingredient to be praziquantel, and the disclosure of the active ingredient in nanoparticle form reads on the limitation of claim 104 requiring that the active ingredient is in the form of a nanoparticle. Moreover, the composition may comprise antioxidative agent, such as BHA, and flavoring agent (page 40, para. 5; page 41, para. 1). Thus, the disclosure of BHA reads on the limitation of claim 128 requiring that the composition further comprises an antioxidant, and the disclosure of a flavoring agent reads on the limitation of claim 134 requiring that the composition further comprises a flavoring agent. Furthermore, Vergnault et al. teach the manufacturing process (page 59, Table 9):
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wherein the process includes mixing, heating, and cooling. Thus, the disclosed manufacturing process reads on the limitations of claim 197 requiring mixing the oil, gelling agent, active ingredient, and optionally solubilizing agent; heating the mixture; and cooling the mixture.
However, Vergnault et al. do not teach the pharmaceutical composition provides an immediate release profile as required by claim 1.
Laczay teaches oral pharmaceutical compositions comprising praziquantel particles associated with a lipid coating and further teaches incorporation of the lipid-containing praziquantel particles into oral pastes or gels (para. [0018]). Laczay further teaches that the coated particles break down upon contact with gastrointestinal fluid, permitting rapid dispersion and dissolution of praziquantel in the gastrointestinal tract (para. [0016]).
Münster et al. teach pharmaceutical formulations comprising praziquantel, a polymer, and a lipid and explicitly teach that immediate release of praziquantel in gastrointestinal media is desirable for efficient drug absorption. Münster et al. further demonstrate immediate release of praziquantel from the lipid-containing formulations in simulated gastric and intestinal media (Abstract).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the praziquantel-containing oleogel pharmaceutical composition of Vergnault et la. to provide an immediate release profile in view of Laczay and Münster et al. because Vergnault et al. teach an oil-based pharmaceutical composition in the form of an oleogel comprising an active ingredient, including praziquantel, and a gelling agent, Laczay teaches lipid-containing praziquantel particles incorporated into oral pastes or gels and further teaches that the particles break down upon contact with gastrointestinal fluid to permit rapid dispersion and dissolution of praziquantel, and Münster et al. explicitly teach that immediate release of praziquantel in gastrointestinal media is desirable for efficient drug absorption and demonstrate immediate release of praziquantel from lipid-containing formulations in simulated gastric and intestinal media. Thus, the combined teachings would have suggested providing the praziquantel-containing oleogel of Vergnault et al. with an immediate release profile. One of ordinary skill in the art would have been motivated to provide the praziquantel-containing oleogel pharmaceutical composition of Vergnault et al. with an immediate release profile in view of Laczay and Münster et al. because Münster et al. explicitly teach that immediate release of praziquantel in gastrointestinal media is desirable for efficient drug absorption and Laczay further teaches that lipid-containing praziquantel particles may be incorporated into oral pastes or gels and configured to break down in gastrointestinal fluid to permit rapid dispersion and dissolution of praziquantel. Accordingly, the motivation for selecting an immediate release profile arises from a known release objective for the same active ingredient, praziquantel, while Laczay provides a closely related lipid-containing paste or gel formulation in which rapid gastrointestinal dispersion and dissolution of praziquantel is contemplated. One of ordinary skill in the art would had a reasonable expectation of success because Vergnault et al. teach incorporation of praziquantel into an oil-based oleogel pharmaceutical composition, Laczay teaches lipid-containing praziquantel particles incorporated into oral pastes or gels that break down in gastrointestinal fluid to permit rapid dispersion and dissolution, and Münster et al. demonstrate that lipid-containing praziquantel formulations provide immediate release in simulated gastric and intestinal media. Accordingly, the teachings of references would have provided a reasonable basis for expecting that the praziquantel-containing oleogel composition of Vergnault et al. may be formulated to provide the immediate release profile in view of Laczay and Münster et al.
Regarding claim 90, Vergnault et al. explicitly teach that the active agent of the disclosed oil-based gel composition may comprise praziquantel. Thus, Vergnault et al. teach the additional limitation of claim 90 requiring the active ingredient to be praziquantel. Moreover, the modification discussed above is specifically supported for praziquantel because Laczay teaches lipid-containing praziquantel formulations providing rapid dispersion and dissolution in gastrointestinal fluid and Münster et al. teach immediate release of praziquantel in gastrointestinal media. Accordingly, the praziquantel-containing composition of Vergnault et al., as modified above to provide an immediate release profile, reads on the limitations of claim 90.
Regarding claim 123, Vergnault et al. further teach that the organogelator of the oil-based gel composition may comprise a polymeric component, including cellulose polymers or xanthan gum, in oil-based gel pharmaceutical compositions. Thus, Vergnault et al. teach the additional limitation of claim 123 requiring that the composition further comprise a polymer. Accordingly, the polymer is not being introduced into the composition from a separate reference, but is contemplated by Vergnault et al. as a component of the organogelator of the disclosed oil-based gel composition. Therefore, the composition of Vergnault et al., as modified above to provide the immediate release profile in view of Laczay and Münster et al. would further comprise the polymer recited in claim 123..
Regarding claims 128 and 134, Vergnault et al. further teach that the oil-based pharmaceutical gel composition may comprise an antioxidative agent, such as BHA, and a flavoring agent. Thus, Vergnault et al. teach the additional limitation of claim 128 requiring that the composition further comprises an antioxidant and the additional limitation of claim 134 requiring that the composition further comprises a flavoring agent. Accordingly, the composition of Vergnault et al., as modified above to provide the immediate release profile in view of Laczay and Münster et al., would further comprise the antioxidant and flavoring agent recited in claims 128 and 134. .
Regarding claim 197, Vergnault et al. further teach a process for preparing the disclosed oil-based pharmaceutical gel by heating the oil phase, dispersing the gelling component with mixing, incorporating the active ingredient and other formulation components, and cooling the resulting composition. Thus, Vergnault et al. teach the additional limitations of claim 197 requiring mixing the oil, gelling agent, active ingredient, and optionally solubilizing agent; heating the mixture; and cooling the mixture. Accordingly, the process disclosed by Vergnault et al. for preparing its oil-based gel composition, as modified above to provide the immediate release profile in view of Laczay and Münster et al., reads on the process limitations recited in claim 197.
Claim 198 is rejected under 35 U.S.C. 103 as being unpatentable over Vergnault et al. (WO2016/066256A1, cited in the PTO-892 on September 9, 2025) in view of Laczay (EP2662075A1) and Münster et al. (Journal of Pharmaceutical Sciences, 2017, Vol. 109, page 446 – 454, PTO-892) as applied to claims 1, 90, 104, 123, 128, 134, and 197 above, further in view of Mahalingam (Advanced Pharmaceutical Bulletin, 2015, Vol. 5, Issue 1, page 57 – 67, cited in the PTO-892 on September 9, 2025).
Vergnault et al., Laczay, and Münster et al. teach the limitations discussed above.
However, Vergnault et al. , Laczay, and Münster et al. do not teach the process of making the immediate release composition recited in claim 198.
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 techniques 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 prepare the nanoparticulate active ingredient taught by Vergnault et el. using the solvent evaporation/emulsification and freeze-drying technique in view of Mahalingam because Vergnault et al. contemplate the active ingredient in nanoparticle form, while Mahalingam teaches solvent evaporation/emulsification as a commonly used technique for preparing polymeric nanoparticles and further teaches freeze-drying the resulting nanosuspension to obtain a fine powder of nanoparticles. One of ordinary skill in the art would have been motivated to consider the nanoparticle preparation process of Mahalingam because Vergnault et al. contemplate use of the active ingredient in nanoparticle form but do not specify a particular process for preparing the nanoparticles and Mahalingam provides a known process directed to the same technical objective of preparing drug nanoparticles. Thus, Mahalingam provides an established nanoparticle manufacturing technique directly applicable to preparation of the nanoparticulate active ingredient contemplated by Vergnault et al. One of ordinary skill in the art would have had a reasonable expectation of success because Mahalingam identifies solvent evaporation/emulsification as a commonly used technique for preparing polymeric nanoparticles and teaches that the resulting nanosuspension may be freeze-dried to obtain a fine powder of nanoparticles. Accordingly, applying the demonstrated nanoparticle preparation technique of Mahalingam to prepare the nanoparticulate active ingredient taught by Vergnault et al. would have been expected to successfully produce nanoparticulate active material with predictable results.
Claim 206 is rejected under 35 U.S.C. 103 as being unpatentable over Vergnault et al. (WO2016/066256A1, cited in the PTO-892 on September 9, 2025) in view of Laczay (EP2662075A1) and Münster et al. (Journal of Pharmaceutical Sciences, 2017, Vol. 109, page 446 – 454, PTO-892)as applied to claims 1, 90, 104, 123, 128, 134, and 197 above, further in view of Jackson et al. (WO99/21908).
Vergnault et al., Laczay, and Münster et al. teach the limitations discussed above.
However, Vergnault et al., Laczay, and Münster et al. do not teach that the semisolid dosage form is an oleopaste and wherein the oleopaste is extrudable from a syringe or tube using normal hand pressure, as required by claim 206.
Jackson et al. teach that a polymeric pharmaceutical paste composition (page 2, line 28). The composition comprises an active drug, wherein the drug is paclitaxel. In some formulations, the 30:70 and 40:60 (TB:MePEG350) blends of paclitaxel could be extruded through a 22-gauge needle at room temperature using normal finger pressure on a disposable 1 mL syringe (page 52, lines 9 – 16). It further states that those compositions could be easily injected into a patient without heating (page 52, lines 11 – 13). Jackson et al. teach that other hydrophobic drug paste formulations could also be extruded through a 22-gauge needle at room temperature, and that pastes may be dispensed from an open syringe on surgically exposed areas (page 52, lines 17 – 24).
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 formulate the semisolid pharmaceutical composition of Vergnault et al., as modified in view of Laczay and Münster et al. as discussed above, as an oleopaste having a consistency suitable for extrusion from a syringe or tube using normal hand pressure because Vergnault et al. teach an oil-based semisolid pharmaceutical composition comprising an active ingredient dispersed in a liquid organic phase gelled by an organogelator to form a stable gel, including an oleogel and Laczay further teaches lipid-containing praziquantel compositions formulated as oral pastes or gels. In view of these teachings, it would have been obvious to provide the oil-based, gelled praziquantel composition of Vergnault et al. in the paste form taught by Laczay. Under the broadest reasonable interpretation consistent with the specification, such an oil-based semisolid comprising dispersed solid active within a gelling agent network corresponds to the claimed oleopaste (para. [0010]). Jackson et al. further teach pharmaceutical paste compositions, including hydrophobic drug paste formulations, that are extrudable through a syringe using normal finger pressure. Thus, the combined teachings suggest both the claimed oleopaste dosage form and the claimed syringe- or tube-extrudable consistency. One of ordinary skill in the art would have been motivated to formulate the oil-based pharmaceutical gel composition of Vergnault et al. in the paste form in view of Laczay because Laczay teaches such paste formulations in the closely related context of lipid-containing pharmaceutical composition comprising the same active ingredient, which is praziquantel. This provides a specific reason to select a paste form for the praziquantel-containing lipid composition. One of ordinary skill in the art would further have been motivated to provide the resulting oleopaste with a syringe extrudable consistency taught by because Jackson et al. teach that pharmaceutical paste compositions, including hydrophobic drug paste formulations, may be extruded from a syringe at room temperature using normal finger pressure, thereby providing a convenient and controlled mode of administration or dispensing of the semisolid composition without additional procedure. One of ordinary skill in the art would have had a reasonable expectation of success because Vergnault et al. teach an oil-based gel comprising an active ingredient and a gelling agent network, Laczay teaches lipid-containing praziquantel compositions in paste or gel form, and Jackson et al. demonstrate that pharmaceutical paste compositions, including hydrophobic drug paste formulations, may possess sufficient flowability to permit extrusion from a syringe at room temperature using normal finger pressure. Accordingly, the combined teachings would have provided a reasonable basis for expecting that the praziquantel-containing oil-based gel composition of Vergnault et al. may be provided in an oleopaste form having the claimed syringe- or tube-extrudable consistency.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed June 24, 2026, have been fully considered and are found to be not persuasive.
Applicant argues that the cited references fail to teach or suggest the claimed immediate release composition. Applicant contends that Vergnault et al. is directed to gastroretentive gel formulations designed to provide controlled and/or sustained release of an active agent. Applicant argues that the disclosure of “immediate absorption” in Vergnault et al. refers to immediate absorption of the active ingredient only upon release from the gel composition, rather than immediate release of the active ingredient from the composition itself. Applicant further argues that Jaimini defines immediate release as excluding formulations in which drug release is intentionally retarded and, therefore, does not cure the alleged deficiency of Vergnault et al. Applicant also contends that FDA patient labeling does not disclose a release profile or any particular pharmaceutical composition. The arguments are moot in view of the present rejection. The rejection has been modified and no longer relies on Vergnault et al., Jaimini, and FDA to establish the “immediate release composition”. Instead, Messer-Schmid et al. is relied upon for teaching an immediate-release pharmaceutical lipid formulation, as discussed above. Accordingly, Applicant’s arguments that Vergnault et al. are directed to controlled and/or sustained release, that the disclosure of “immediate absorption” does not establish immediate release from the composition, that Jaimini’s definite of immediate release does not cure the alleged deficiency of Vergnault et al., and that FDA does not disclose a particular release profile are moot because those references no longer relied upon to establish the immediate release limitation. With respect to the separate rejection over Vergnault et al. in view of Laczay and Münster et al., Applicant’s argument that Vergnault et al. do not teach an immediate release composition has been considered but is not persuasive. The rejection does not rely on Vergnault et al. to supply the immediate release limitation. Instead, Vergnault et al. is relied upon for the oil-based oleogel pharmaceutical composition comprising the active ingredient, including praziquantel, and the additional limitations discussed above. Laczay further teaches lipid-containing praziquantel compositions that may be incorporated into oral pastes or gels and teaches that the lipid-containing particles break down contact with gastrointestinal fluid to permit rapid dispersion and dissolution of praziquantel. Münster et al. explicitly teach that immediate release of praziquantel in gastrointestinal media is desirable for efficient drug absorption and demonstrate immediate release of praziquantel from lipid-containing formulations in simulated gastric and intestinal media. Thus, the claimed immediate release limitation is supplied by Münster et al.in the combination, and no longer by the disclosure “immediate absorption” by Vergnault et al. As explained in the rejection above, one of ordinary skill in the art would have been motivated to provide the praziquantel-containing oleogel pharmaceutical composition of Vergnault et la. with the immediate release profile in view of Münster et al. because Münster et al. explicitly teach, for the same active ingredient, that immediate release of praziquantel in gastrointestinal media is desirable for efficient drug absorption and Laczay further teaches lipid-containing compositions in the context of praziquantel that is suitable for incorporation into oral pastes or gels and configured to permit rapid dispersion and dissolution of praziquantel in gastrointestinal fluid. Accordingly, the reason for selecting an immediate release profile is based on a known release objective for praziquantel and is further supported by Laczay’s teaching of rapid gastrointestinal dispersion and dissolution of praziquantel in a closely related lipid-containing paste or gel formulation. Therefore, Applicant’s characterization of Vergnault et al. as directed to controlled and/or sustained release does not overcome the rejection based on the combined teachings of Vergnault et al., Laczay, and Münster et al..
Applicant argues that the Office failed to provide sufficient articulated reasoning to support the proposed combination. Applicant contends that the previous rationale that one of ordinary skill in the art would have formulated a fast-release formulation based on the “need of patients” is conclusory and unsupported by evidence. Applicant further argues that the Office did not explain why one of ordinary skill seeking an immediate release composition would have looked at Vergnault et al., which is directed to controlled and sustained release formulation, or why such a person would have modified Vergnault et al. to arrive at the claimed immediate release composition. The argument is moot in view of the present rejection. The present rejection does not propose modifying the controlled or sustained release formulation of Vergnault et al. to obtain immediate release, nor does the Office rely upon the previously stated “need of patients” as the reason for making such a modification. Instead, Messer-Schmid et al. teach the immediate-release pharmaceutical lipid formulation relied upon in the present rejection. Thus, there is no need to modify the release profile of Vergnault et al. to arrive at the claimed immediate release composition. In view of the separate rejection over Vergnault et al. in view of Laczay and Münster et al., the present rejection does not rely on the previously stated “need of patients” as the reason for modifying Vergnault et al. Instead, Vergnault et al. teach an oil-based pharmaceutical gel that may be an oleogel and that may comprise praziquantel as the active ingredient, Laczay teaches lipid-containing praziquantel compositions suitable for incorporation into oral pastes or gels and further teaches that the lipid-containing particles bread down up contact with gastrointestinal fluid to permit rapid dispersion and dissolution of praziquantel, and Münster et al. explicitly teach that immediate release of praziquantel in gastrointestinal media is desirable for efficient drug absorption and demonstrate immediate release of praziquantel from lipid-containing formulations in simulated gastric and intestinal media. Thus, Münster et al. provide a reason, tied to the same active ingredient, for selecting an immediate release profile for praziquantel, while Laczay provides additional support for rapid gastrointestinal release behavior in a related lipid-containing praziquantel formulation. Accordingly, one of ordinary skill in the art would have had reason to modify the praziquantel-containing oleogel pharmaceutical composition of Vergnault et al. to provide an immediate release profile because the prior art identifies immediate gastrointestinal release as a desirable release characteristic for praziquantel and demonstrates such release from lipid-containing praziquantel formulations. The proposed modification therefore is not based on the previously asserted “need of patients”, but on the teachings of the cited references and the relationship between the lipid-based pharmaceutical formulations.
Applicant argues that the rejection relies on improper hindsight reconstruction. Applicant contends that the Office selected isolated disclosures from the cited references corresponding to individual claim limitations without identifying a teaching or reason in the prior art that would have led one of ordinary skill in the art to select and combine those teachings to arrive at the claimed composition as a whole. Applicant therefore asserts that the cited references, even when combined, fail to establish a prima facie case of obviousness. However, the arguments are not persuasive. The present rejection provides articulated reasoning for the proposed modifications based on the teachings of the prior art itself. In particular, Messer-Schmid et al. teach an immediate release lipid suspension, identify oleogel-forming excipients as suitable thickeners, and separately identify beeswax as a suitable thickener for the lipid suspension. Gómez-Estaca et al. further teach that beeswax forms oleogels from edible oils. Thus, the proposed modification is not based on Applicant’s disclosure as a roadmap, but rather on the explicit teachings of the references concerning the use of oleogel-forming excipients and beeswax in lipid systems. The specific motivation for each additional modification and the corresponding reasonable expectation of success are further set forth in the rejection above. Accordingly, the present rejection is based on the teachings and suggestions available in the prior art and not on impermissible hindsight reconstruction.
Applicant argues that Mahalingam does not cure the alleged deficiencies of the other references. Applicant acknowledges that Mahalingam relates to methods of preparing polymeric nanoparticles but contends that Mahalingam does not remedy the alleged failure of Vergnault et al., Jaimini, and FDA to teach or suggest the claimed immediate release composition. However, the argument is moot in view of the present rejection. Mahalingam is not relied upon to establish or cure any deficiencies concerning immediate release. Instead, Münster et al.is relied upon for teaching that immediate release of praziquantel in gastrointestinal media is desirable for efficient drug absorption and for demonstrating immediate release of praziquantel from lipid-containing formulations, while Vergnault et al. is relied upon for teaching an active ingredient in nanoparticle form. Mahalingam is relied upon for the process of preparing nanoparticles. As discussed above, one of ordinary skill in the art would have been motivated to consider Mahalingam because Vergnault et al. contemplate the use of a nanoparticulate active ingredient but do not specify a particular process for preparing such nanoparticles, whereas Mahalingam provides an established nanoparticle preparation technique. Accordingly, Applicant’s argument concerning Mahalingam’s failure to remedy the previously alleged immediate release deficiency is moot and does not address the basis of the present rejection.
Conclusion
No claim is found to be allowable.
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/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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