DETAILED ACTION
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 .
Priority
The instant application was filed 11 October 2023 and claims priority to provisional application 63/417,528 filed 19 October 2022. Therefore, the effective filing date of the instant application is 19 October 2022.
Examiner’s Note
The Applicant's amendments and arguments filed 26 February 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections not reiterated from previous office actions are hereby withdrawn. The
following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed
26 February 2026, it is noted that claims 1, 9, and 13 have been amended and claim 21 has been newly added. Support for the amendment(s) and/or new claim(s) can be found para. 71 of the specification. No new matter has been added.
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.
Claim(s) 1-5, 7-17, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deshpande et al. (US 11,000,480 B2), Saxena et al. (Gelucire Based In Situ Gelling Emulsions: A Potential Carrier for Sustained Stomach Specific Delivery of Gastric Irritant Drugs, BioMed Research International, 2013), and machinerylubrication.com.
Deshpande teaches a non-aqueous suspension (col. 16, ln. 56; entire teaching) that may comprise about 5-25% glyceryl distearate (claim 1), Gelucire or stearoyl polyoxyl-32 glycerides (instant specification, para. 57) in an amount of 1-20% (col. 14, lns. 7-61), and an active agent such as calcifediol in a range of 0.01-1% (col. 7, lns. 41-50), addressing 2, 4, 5, and partially claim 1. The composition comprising “about” 5% is interpreted as addressing the amount in claim 3. The composition may further comprise 35.34% mineral oil (col. 26, lns. 1-3), which is interpreted as addressing “about 40 wt. %” in claim 7, as well as a flavoring agent in an amount of 0.50% (Table 9), addressing claims 8 and 13-17. The composition in the form of a non-aqueous suspension and not requiring water is interpreted as an anhydrous suspension. The formation of a thermos-reversible gel in claim 19 is interpreted as its final form of a gel and is addressed by the incorporation of gelling agents (col. 10, lns. 49-51).
Deshpande does not teach an exact combination of an anhydrous suspension with glyceryl distearate, stearoyl polyoxyl-32 glycerides, and an active ingredient in claim 1. Deshpande does not specifically teach thixotropic properties or limitations related to the viscosity and shear stress of the suspension in claims 1, 9-13, 19, and 21.
Saxena teaches that compositions comprising Gelucire naturally and inherently result in thixotropic properties (pg, 7, section 3.4).
Machinerylubrication.com teaches that the viscosity decreases as agitation or shear rate increases and when agitation is reduced or stopped, viscosity increases, which is interpreted as inherently and necessarily occurring as a property of thixotropic suspensions (pg. 4).
In regards to selecting the combination of an anhydrous suspension with glyceryl distearate, stearoyl polyoxyl-32 glycerides, and an active ingredient, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Deshpande teaches a non-aqueous suspension with glyceryl distearate, an active ingredient, and stearoyl polyoxyl-32 glycerides, whereas the claimed invention claims an anhydrous suspension with glyceryl distearate, stearoyl polyoxyl-32 glycerides, and an active ingredient. Since Deshpande teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Since Deshpande does not specifically teach thixotropic properties or limitations related to the viscosity and shear stress of the suspension in claims 1, 9-13, 19, and 21, one of ordinary skill in the art would reasonably be able to conclude that the glyceryl distearate and Gelucire (glycerides) included in Deshpande’s composition would have thixotropic properties. Saxena teaches that Gelucire results in thixotropic properties and machinerylubrication.com teaches that the viscosity properties related to the shear rate are inherent in thixotropic compositions. Therefore, a skilled artisan would have been able to reasonably conclude that agents known in the art to form a polymer matrix and thicken compositions would have similar shear thinning properties to the claimed invention.
Claim(s) 1-17, 19, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deshpande et al. (US 11,000,480 B2), Saxena et al. (Gelucire Based In Situ Gelling Emulsions: A Potential Carrier for Sustained Stomach Specific Delivery of Gastric Irritant Drugs, BioMed Research International, 2013), machinerylubrication.com, and Gumudavelli et al (US 2017/0312226 A1).
In regards to claim(s) 1-5, 7-17, 19, Deshpande et al., as applied supra, is herein applied in its entirety for its teachings of an anhydrous suspension with glyceryl distearate, stearoyl polyoxyl-32 glycerides, and an active ingredient.
Deshpande does not teach ibuprofen in their composition in claim 6.
Gumudavelli et al. teach a suspension and lipophilic drug delivery system (paras. 7 and 65) that may comprise Gelucire (para. 118), glyceryl distearate (para. 211), and ibuprofen (para. 68).
Since Deshpande does not teach ibuprofen in their composition in claim 6, one of ordinary skill in the art would have been led to use Gumudavelli’s lipophilic drug delivery system and suspension with a reasonable expectation of success. A skilled artisan would have been led to combine the teachings since Deshpande’s suspension composition is for delivering hydrophobic APIs (col. 5, ln. 54) and to treat inflammatory diseases (col. 27, ln. 67-col. 28, ln. 5), and Gumudavelli’s lipophilic drug delivery system may delivery anti-inflammatory drugs, such as ibuprofen.
Claim(s) 1-19, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deshpande et al. (US 11,000,480 B2), Saxena et al. (Gelucire Based In Situ Gelling Emulsions: A Potential Carrier for Sustained Stomach Specific Delivery of Gastric Irritant Drugs, BioMed Research International, 2013), machinerylubrication.com, Gumudavelli et al. (US 2017/0312226 A1), and nebulasnacks.com.
In regards to claim(s) 1-17, 19, Deshpande et al., as applied supra, is herein applied in its entirety for its teachings of an anhydrous suspension with glyceryl distearate, stearoyl polyoxyl-32 glycerides, and an active ingredient.
Deshpande does not teach monk fruit sweetener in their composition in claim 18.
Nebulasnacks.com teaches that monk fruit sweetener has health benefits and anti-inflammatory properties (pg. 3).
Since Deshpande teaches flavoring agents but does not teach monk fruit sweetener in their composition in claim 18, one of ordinary skill in the art would have been led to use nebulasnacks.com’s teaching of monk fruit sweetener with a reasonable expectation of success. A skilled artisan would have been led to combine the teachings since Deshpande’s suspension composition may include flavoring agents and nebulasnacks.com teaches that monk fruit sweetener may have anti-inflammatory properties and other health benefits, which may be beneficial in Deshpande’s composition to address inflammatory diseases.
Response to Arguments
Applicant's arguments filed 26 February 2026 have been fully considered but they are not persuasive.
The Applicant argues unexpected results regarding the viscosity of the suspension decreasing when agitated to a shear rate of about 100 s-1 (Remarks, pgs. 7-10).
Applicant’s argument is not found persuasive. The Applicant refers to Fig. 2 of the present application. Fig. 2 allegedly shows unique properties regarding the viscosity decreasing when agitated to a shear rate of 100 s-1. The described viscosity properties appear to be an inherent property of thixotropic behavior (Anton Paar, pgs. 1-2), where the viscosity may become thinner when a constant force is applied. Additionally, the higher the force, the lower the viscosity becomes. The viscosity is expected to recover after a certain time when the applied force is removed. Therefore, the viscosity properties described by the Applicant are not seen as unexpected or unique.
The Applicant argues that the claimed invention forms unexpectedly uniform emulsions compared to other anhydrous suspensions used in the industry (Remarks, pg. 10).
Applicant’s argument is not found persuasive. It is known in the art that surfactants, such as Gelucire, contribute to the stability of emulsions and uniformity of droplets. JP 2004534832 A provides an example wherein using gelucire, with ibuprofen as an active agent (para. 32), results in a homogeneous solution or suspension (para. 28). Furthermore, the data in Figs. 3-5 are difficult to distinguish and it is not clear what the industry standards are and how they differ from the claimed invention. Without substantial and clear comparative data, is it unclear that the results are unexpected or unique.
The Applicant argues that Vu is non-analogous art (Remarks, pg. 11).
Applicant’s argument is not found persuasive. Vu has been removed as prior art and the arguments against them will not be addressed.
The Applicant argues that the art does not teach the amended limitations, as well as new claim 21 (Remarks, pgs. 11-12).
Applicant’s argument is not found persuasive. Since Deshpande does not specifically teach thixotropic properties or limitations related to the viscosity and shear stress of the suspension in claims 1, 9-13, 19, and 21, one of ordinary skill in the art would reasonably be able to conclude that the glyceryl distearate and Gelucire (glycerides) included in Deshpande’s composition would have thixotropic properties. Saxena teaches that Gelucire results in thixotropic properties and machinerylubrication.com teaches that the viscosity properties related to the shear rate are inherent in thixotropic compositions. Therefore, a skilled artisan would have been able to reasonably conclude that agents known in the art to form a polymer matrix and thicken compositions would have similar shear thinning properties to the claimed invention.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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