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 application was filed 14 September 2022 and claims priority to provisional applications 63/244,105, 63/321,596, 63/356,275 with the earliest filing date of 14 September 2021. Therefore, the effective filing date of the application is 14 September 2021.
Examiner’s Note
The Applicant's amendments and arguments filed 01 April 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections and objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 01 April 2026, it is noted that claims 1, 9, and 20 have been amended, claims 5-7 and 12 have been canceled, and no claims have been newly added or canceled. Support for the amendment can be found the canceled claims. 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) 1-4, 8-11, 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perumal et al. (US 20150150822 A1), Saar et al. (US 11497760 B2), 88herbs.com, Szukalska et al. (Nicotine and caffeine: influence on dopaminergic transmission, 2016), and Dionisio et al. (Locust bean gum: Exploring its potential for biopharmaceutical applications, J Pharm Bioallied Sci, 2012), as evidenced by Biswas et al. (Optimized piperine-phospholipid complex with enhanced bioavailability and hepatoprotective activity, Pharmaceutical Development and Technology, 2021).
Perumal et al. teach an oral nanoparticle drug delivery system (entire teaching; abs) that may be in the form of a suspension (para. 147), where the nanoparticles may encapsulate the active agents (para. 131). The therapeutic agents may either be encapsulated in or absorbed onto the nanoparticle, which includes hydrophobic agents (para. 103) and hydrophilic molecules (para. 124). The nanoparticles may be dispersed or combined with a vehicle, such as vegetable oil (para. 144). Since the composition may be in the form of a suspension and the vehicle may be a non-aqueous solvent, such as vegetable oil, the composition is interpreted as a non-aqueous suspension, addressing the limitation in claim 1. The particle diameter of the nanoparticles may be approximately 400 nm (para. 114), or about 50-900 nm (para. 52). Since the composition may be in the form of a non-aqueous suspension, it is interpreted that the diameter measurements would be taken in a non-aqueous suspension, addressing the limitations in claim 1. Perumal references incubating the nanoparticles in an appropriate buffer (para. 123) where it is mentioned that the use of buffers may produce particles in the same or similar diameter size (para. 109). Perumal teaches that maintaining the pH in a certain range controls the particle size (para. 110). The hydrophobic and hydrophilic active ingredients (paras. 103, 124) in the nanoparticle composition are interpreted as solubilizing in the appropriate suspensions in claim 1. For example, the hydrophobic active ingredients would be expected to solubilize in the non-aqueous portion of the composition. The composition in the form of a suspension or solution is interpreted as addressing the tincture limitation of claim 4.
The composition may be stabilized with lecithin (para. 133) and may further include alginic acid as a disintegrating agent (para. 148), cyclosporine (para. 43), and retinol (vitamin A) (para. 14), which addresses claims 16 and 17. Perumal also provides examples where the nanoparticles are stored for several months with no remarkable change in the particle size (para. 178), which is interpreted as addressing the limitations in claim 14. The nanoparticles may provide targeted drug delivery and temporal control of the release of the agent (para. 129), as well as sustained release of the drugs over time (para. 68), which is interpreted as addressing the conditions in claim 15. The particles may have a narrow polydispersity (para. 52), which is less than 0.5, as evidenced by Biswas et al. (pg. 73), addressing claim 19.
Perumal does not specifically teach a combination of a non-aqueous suspension of active ingredients and nanoparticles of a second plurality of active ingredients in claims 1 and 20. Perumal also does not teach that the locust bean gum slows the release of the second plurality of ingredients in claims 1 and 20. Perumal also does not specifically teach the enhanced properties in claims 1 and 20, or Rhodiola rosea, Ashwagandha, caffeine, nicotine, polyglycerol polyricinoleate, locust bean gum, or medium-chain triglycerides in their composition in claims 1-3, 8, 9, 11, 18, 20.
Saar et al. teach an aggregate system (col. 5, ln. 44-46) as a dietary supplement to deliver plant extracts (col. 12, ln. 63-67) and/or pharmaceutical drugs (col. 15, ln. 41-43). The particles, liposomes, micelles, or spheres are enclosed or encapsulated and may deliver the agents (col. 2, ln. 7-11). Plant extracts include Rhodiola rosea, lecithin, Ashwagandha (col. 13, ln. 16-63), pharmaceutical drugs include caffeine and nicotine (col. 23, ln. 12-19), emulsifiers include polyglycerol polyricineoleate (col. 20, ln. 4) and locust bean gum (col. 19, ln. 46-47), wax as a carrier (col. 16, ln. 64), and medium-chain triglycerides as a solubilizing agent (col. 10, ln. 48-56). The poorly water-soluble dietary supplements (abs), such as plant extracts (col. 12, lns. 63-67), are presumably in the non-aqueous portion of the composition. Agents that are more water-soluble, such as caffeine, are interpreted as being used in the particulate form in a lipophilic medium (col. 2, lns. 1-7).
88herbs.com suggests that Ashwagandha and Rhodiola rosea may have a synergistic effect when taken together as opposed to individually (pg. 1).
Szukalska et al. suggests a synergistic effect between nicotine and caffeine for pain perception, voluntary movement functions, and behavioral traits (pg. 1).
Dionisio et al. teach that locust bean gum is a commonly used excipient in oral drug delivery systems for controlled or slow release of the drug (pg. 11).
In regards to selecting a combination of Rhodiola rosea, Ashwagandha, caffeine, nicotine, polyglycerol polyricinoleate, locust bean gum, and medium-chain triglycerides, “[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
combination 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.”
Saar teaches an aggregate system as a dietary supplement to deliver plant extracts and/or pharmaceutical drugs, whereas the claimed invention is directed towards a composition comprising a non-aqueous suspension of active ingredients and nanoparticles encapsulating a second plurality of active ingredients. Since Saar 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.
In regards to claim 10, Perumal teaches that the nanoparticles may comprise roughly 2-60% of an agent (para. 144). That being said and in lieu of objective evidence of unexpected results, the amount of nanoparticle can be viewed as a variable that achieves the recognized result of successfully making the non-aqueous suspension composition. The optimum or workable range of concentration or amount can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of the nanoparticles as nonobvious.
In regards to the thermal stability and improved bioavailability from the combination of ingredients in claims 1 and 20, Saar teaches an improvement in bioavailability, overall stability, and safety when using this type of core-shell based nanoparticles (para. 236). The conditions for the temperature and length of time recited in claims 1 and 20 are interpreted as routine optimization and experimentation that is obvious to a skilled artisan (see MPEP 2144.05 (II)B).
Since Perumal et al. do not teach the elected species in claims 1-3, 8, 9, 11, 18, 20,
one skilled in the art would have been motivated to use the component teachings from Saar et al. to address these deficiencies since both teachings are directed towards encapsulated particles comprising active agents and 88herbs.com suggests a synergistic effect when Ashwagandha with Rhodiola rosea and caffeine with nicotine are included together in a composition. Since the composition may be in the form of a non-aqueous suspension, it is interpreted that the diameter measurements would be taken in a non-aqueous suspension, addressing the limitations in claim 20.
Since Perumal et al. do not teach the locust bean gum slows the release of the second plurality of ingredients in claim 1, one skilled in the art would have been motivated to use the component teaching that locust bean gum controls the release and delivery of oral drugs from Dionisio et al. to address these deficiencies since Perumal and Saar teach encapsulated drug delivery systems that may comprise locust bean gum and Dionisio provides a reason and motivation to include locust bean gum as an excipient.
Claim(s) 1-4, 8-11, 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perumal et al. (US 20150150822 A1), Saar et al. (US 11497760 B2), 88herbs.com, Szukalska et al. (Nicotine and caffeine: influence on dopaminergic transmission, 2016), Dionisio et al. (Locust bean gum: Exploring its potential for biopharmaceutical applications, J Pharm Bioallied Sci, 2012), and Pateiro et al. (Nanoencapsulation of Promising Bioactive Compounds to Improve Their Absorption, Stability, Functionality and the Appearance of the Final Food Products, molecules, 2021), as evidenced by Biswas et al. (Optimized piperine-phospholipid complex with enhanced bioavailability and hepatoprotective activity, Pharmaceutical Development and Technology, 2021).
In regards to claim(s) 1-4, 8-11, 14-20, Perumal et al., as applied supra, is herein applied in its entirety for its teachings of an oral nanoparticle drug delivery system in the form of a suspension.
Perumal does not teach a wax in their composition in claim 13.
Pateiro teaches that lipid carriers such as bees wax, vegetable oils, lecithin, and medium-chain triglycerides are important carriers in nanoencapsulation compositions. Pateiro suggests that the lipids improved solubility, had higher bioavailability, and had a controlled release of active ingredients (pg. 12).
Since Perumal does not teach a wax in their composition in claim 13, one skilled in the art would have been motivated to use the teaching that beeswax, lecithin, and medium-chain triglycerides may be favorable carriers in nanoencapsulation compositions from Pateiro et al. to address these deficiencies since Perumal and Saar teach encapsulated drug delivery systems that may comprise a wax, and Pateiro provides a reason and motivation to include bees wax as a carrier to improve solubility, bioavailability, and controlled release of active agents.
Response to Arguments
Applicant's arguments filed 01 April 2026 have been fully considered but they are not persuasive.
The Applicant argues that Perumal does not teach that the vegetable oil delivery itself results in a suspension (Remarks, pg. 13).
Applicant’s argument is not found persuasive. Perumal broadly teaches an oral nanoparticle drug delivery system (entire teaching; abs) that may be in the form of a suspension (para. 147), where the nanoparticles may encapsulate the active agents (para. 131). Therefore, it is obvious to a person of ordinary skill in the art that the vegetable oil, which is used as a vehicle, creates a nanoparticle suspension. The teachings of KSR are an endorsement and expansion of the flexible and expansive approach to obviousness, which clearly invites continued reliance on such broad and flexible analyses concerning the utility of selecting alternative embodiments of components providing art-recognized utility, with no substantial change in the overall utility of a composition so formulated.
The Applicant argues against inherency in regards to the Z-average measurements in claims 1 and 20 (Remarks, pg. 14).
Applicant’s argument is not found persuasive. In regards to the thermal stability and improved bioavailability from the combination of ingredients in claims 1 and 20, Saar teaches an improvement in bioavailability, overall stability, and safety when using this type of core-shell based nanoparticles (para. 236). The conditions for the temperature and length of time recited in claims 1 and 20 are interpreted as routine optimization and experimentation that is obvious to a skilled artisan (see MPEP 2144.05 (II)B).
Furthermore, the instant claims recite a composition. Therefore, the Applicant’s argument that Z-average measurements be made is interpreted as a product-by-process limitation and the instant claims are examined for their final product. Since the limitations recite “less than 20%” changes in the nanoparticles, it is interpreted that the nanoparticles may not undergo any physical changes.
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.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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