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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 21 July 2026 has been entered.
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 21 July 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 Rejections not reiterated from previous office actions are hereby withdrawn.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 21 July 2026, it is noted that claims 1, 6, 9, 10, 12, 13, and 21 have been amended and no claims have been added. Support for the amendment(s) and/or new claim(s) can be found in at least paras. 54, 71, 120 of the instant 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.
Regarding claim 1, Deshpande teaches a non-aqueous suspension (col. 16, ln. 56; entire teaching) that may comprise about 5-25% glyceryl distearate (claim 1), Gelucire (a 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).
Regarding claim 2, the composition may comprise about 5-25% glyceryl distearate (claim 1).
Regarding claim 3, the composition may comprise about 5-25% glyceryl distearate (claim 1), wherein “about” 5% is interpreted as about 2.5-3.5%.
Regarding claim 4, the composition may comprise Gelucire (a stearoyl polyoxyl-32 glyceride, instant specification, para. 57) in an amount of 1-20% (col. 14, lns. 7-61).
Regarding claim 5, the composition may comprise an active agent such as calcifediol in a range of 0.01-1% (col. 7, lns. 41-50).
Regarding claim 7, the composition may further comprise 35.34% mineral oil (col. 26, lns. 1-3), which is interpreted as addressing “about 40 wt. %.”
Regarding claim 8, the composition may comprise a flavoring agent in an amount of 0.50% (Table 9).
Regarding claim 13, the non-aqueous composition (col. 16, ln. 56; entire teaching) may comprise medium chain triglycerides (MCT) in an amount of about 1-20% (claim 20), wherein “about” 20% is interpreted as about 40%, a flavoring agent in an amount of 0.50% (Table 9), glyceryl distearate in an amount of 5-25% (claim 1), Gelucire (a stearoyl polyoxyl-32 glyceride) in an amount of 1-20% (col. 14, lns. 7-61), and an active agent.
Regarding claim 14, the composition comprises Gelucire (a stearoyl polyoxyl-32 glyceride) in an amount of 1-20% (col. 14, lns. 7-61).
Regarding claim 15, the composition comprises Gelucire (a stearoyl polyoxyl-32 glyceride) in an amount of 1-20% (col. 14, lns. 7-61).
Regarding claim 16, the composition may comprise an active agent such as calcifediol in a range of 0.01-1% (col. 7, lns. 41-50).
Regarding claim 17, the composition may comprise medium chain triglycerides (MCT) in an amount of about 1-20% (claim 20).
Regarding claim 19, the formation of a thermos-reversible gel 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 claims 1 and 13. 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 in claims 1 and 13, “[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.
Regarding the viscosity, shear rate, and thixotropic properties of claims 1, 9, 10, 12, and 13, it is noted that the claims are evaluated in its final form. Claim 1 is interpreted as the anhydrous suspension having a lower viscosity when agitated (final product), claim 9 is interpreted as the anhydrous suspension having a higher viscosity when agitated (final product), claim 10 is interpreted as the suspension having lower viscosity with a higher shear rate (final product), claim 12 is interpreted as the suspension having a higher viscosity when not agitated (final product), and claim 13 is interpreted as the suspension having a higher viscosity when not agitated (final product). Regarding claim 11, the shear rate increasing from agitation is rendered obvious in view of Machinerylubrication.com’s teaching.
Since Deshpande does not specifically teach thixotropic properties or the limitations related to the viscosity and shear stress of the suspension in claims 1, 9-13, and 19, one of ordinary skill in the art would reasonably be able to conclude that the glyceryl distearate and Gelucire included in Deshpande’s composition would inherently and necessarily exhibit 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. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
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 claims 6 and 21.
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 claims 6 and 21, 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. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
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, and 21, 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. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Response to Arguments
Applicant's arguments filed 21 July 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. 7-9).
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.
Additionally, Tables 2 and 3 of the instant specification refer to a suspension comprising ibuprofen. However, the instant claims are broad to any active agent. Therefore, any evidence regarding the uniformity or homogeneity of the resulting emulsions do not have a causal relationship with the merits and scope of the claimed invention, which is a suspension comprising glyceryl distearate, stearoyl polyoxyl-32 glycerides, and, broadly, any active agent. As such, the data are not commensurate in scope with the claims.
“For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.” Wyers v. Master Lock Co., 616 F.3d 1231, 1246 [95 USPQ2d 1525] (Fed. Cir. 2010) (quotation omitted). Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention. Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 [97 USPQ2d 1673] (Fed. Cir. 2011) (“If commercial success is due to an element in the prior art, no nexus exists.”); Ormco Corp., 463 F.3d at 1312 (“[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent.”); In re Woodruff, 919 F.2d 1575, 1578 [16 USPQ2d 1934] (Fed. Cir. 1990).
The Applicant argues that the teachings from Saxena and machinerylubrication.com are broad (Remarks, pgs. 10-11).
Applicant’s argument is not found persuasive. 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).
Since Deshpande does not specifically teach thixotropic properties or the limitations related to the viscosity and shear stress of the suspension in claims 1, 9-13, and 19, one of ordinary skill in the art would reasonably be able to conclude that the glyceryl distearate and Gelucire included in Deshpande’s composition would inherently and necessarily exhibit 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. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
The Applicant argues that the cited references do not demonstrate the viscosity limitations and shear rate limitations in the amended claims (Remarks, pg. 11).
Applicant’s argument is not found persuasive. Regarding the viscosity, shear rate, and thixotropic properties of claims 1, 9, 10, 12, and 13, it is noted that the claims are evaluated in its final form. Claim 1 is interpreted as the anhydrous suspension having a lower viscosity when agitated (final product), claim 9 is interpreted as the anhydrous suspension having a higher viscosity when agitated (final product), claim 10 is interpreted as the suspension having lower viscosity with a higher shear rate (final product), claim 12 is interpreted as the suspension having a higher viscosity when not agitated (final product), and claim 13 is interpreted as the suspension having a higher viscosity when not agitated (final product). Regarding claim 11, the shear rate increasing from agitation is rendered obvious in view of Machinerylubrication.com’s teaching.
The Applicant argues that the claimed composition exhibits unexpectedly superior anti-flocculation behavior, uniform emulsion formation, and enhanced API dispersion stability (Remarks, pgs. 11-12).
Applicant’s argument is not found persuasive. As previously stated, 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.
Additionally, Tables 2 and 3 of the instant specification refer to a suspension comprising ibuprofen. However, the instant claims are broad to any active agent. Therefore, any evidence regarding the uniformity or homogeneity of the resulting emulsions do not have a causal relationship with the merits and scope of the claimed invention, which is a suspension comprising glyceryl distearate, stearoyl polyoxyl-32 glycerides, and, broadly, any active agent. As such, the data are not commensurate in scope with the claims.
“For objective evidence of secondary considerations to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention.” Wyers v. Master Lock Co., 616 F.3d 1231, 1246 [95 USPQ2d 1525] (Fed. Cir. 2010) (quotation omitted). Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention. Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 [97 USPQ2d 1673] (Fed. Cir. 2011) (“If commercial success is due to an element in the prior art, no nexus exists.”); Ormco Corp., 463 F.3d at 1312 (“[I]f the feature that creates the commercial success was known in the prior art, the success is not pertinent.”); In re Woodruff, 919 F.2d 1575, 1578 [16 USPQ2d 1934] (Fed. Cir. 1990).
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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