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 27 February 2023 and is the national stage entry of PCT/IN2021/050832 filed 27 August 2021. The Applicant claims priority to foreign application IN202041037143 filed 28 August 2020. An English translated copy of the foreign document has been provided. Therefore, the effective filing date of the instant application is 28 August 2020.
Election/Restrictions
Claims 3, 4, 7-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 29 December 2025.
Applicant's election with traverse of the invention/species election in the reply filed on 29 December 2025 is acknowledged. The traversal is on the ground(s) that there is no serious search burden. This is not found persuasive because the different species, even if similar in structure, would require multiple search queries and/or classification searches.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 5 is objected to because of the following informalities: “zetapotential” as one word. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: “𝜇g/.” There is a “/” without a following unit. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 5, and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “comprising of” instead of “comprising.” Claim 1 also recites “oligomers is trehalose.” It is also unclear if the “outer sugar or carbohydrate layer” is the same as “carbohydrate or polyhydroxy oligomers is trehalose.” The Applicant is advised to correct and clarify the language, as well as any grammatical errors or missing words.
Claim 1 recites the limitation "the inorganic ceramic core." There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites a zeta potential of “less than” a negative value, such as -30 mV, to “greater than” a positive value, such as +30 mV. The claim is indefinite because it seems to claim an infinite range. The Applicant is advised to correct the language to a “zeta potential of less than -30 mV or greater than +30 mV,” for example.
Claim 10 recites “𝜇g/.” There is a “/” without a following unit. The limitation is indefinite because the metes and bounds of the limitation cannot be defined without knowing the absent unit.
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, 2, 5, 6, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (Aquasome: A Novel Drug Delivery Approach Using Nanocrystalline Biomaterial, Current Research in Pharmaceutical Sciences, 2012), Banerjee (Aquasomes: A novel nanoparticulate drug carrier, Journal of Drug Delivery Science and Technology, 2018), Malhotra (WO 2015/140569 A1), and McMillan et al. (Pharmacokinetics of a Long-Acting Nanoformulated Dolutegravir Prodrug in Rhesus Macaques, Antimicrob Agents Chemother., 2017).
Sharma teaches a composition and method for drug delivery using aquasomes (abs; entire teaching). The aquasomes may contain a calcium phosphate core (pg. 16) and trehalose as a coating for the core (pg. 19), partially addressing claim 1. Aquasomes have been used as a way of delivering therapeutics to treat Immune deficiency virus (pg. 20). Aquasomes have a particle size of 60-300 nm (pg. 18), addressing claim 2.
Sharma does not specifically teach the ratio or amounts of components in claims 1 and 6, zeta potential in claim 5, or dolutegravir in claims 1 and 10.
Banerjee teaches that aquasomes may have a core to coating ratio of 1:4 or 1:5 (pg. 448). Drug loading also varies when loaded with different carbohydrates (pg. 448).
Malhotra teaches that Dolutegravir is used to treat HIV infections (pg. 3) and is particularly useful in a nanoparticulate system for improved surface area, solubility, and bioavailability (pg. 4). The amount of Dolutegravir may be 26.3 mg (Example 1) or 50-100 mg (pg. 9).
In regards to selecting the combination of calcium phosphate and trehalose, “[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.”
Sharma teaches compositions and methods for making aquasomes with trehalose and calcium phosphate as components, whereas the claimed invention is directed towards a composition comprising calcium phosphate, trehalose, and Dolutegravir. Since Sharma 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 Sharma does not specifically teach Dolutegravir in claim 1, one of ordinary skill in the art would have been motivated to use Malhotra’s teaching of using Dolutegravir with a reasonable expectation of success. Malhotra teaches Dolutegravir in a nanoparticulate system, which helps to improve solubility, bioavailability, and surface area. A skilled artisan would have recognized the added benefit of using Dolutegravir in aquasomes, which is also described as a nanoparticulate system (pg. 1, ln. 11 of instant specification), to improve the solubility, bioavailability, and surface area, especially if the intended purpose of the skilled artisan is to treat HIV.
In regards to claim 10, antiviral activity against HSV cells is interpreted as an inherent property of Dolutegravir. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” 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 U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
In regards to the ratio and amounts of components in claims 1 and 6, as well as the zeta potential in claim 5, Banerjee teaches that aquasomes may have a core to coating ratio of 1:4 or 1:5 (pg. 448) and that in general, drug loading varies when loaded with different carbohydrates (pg. 448). McMillan teaches nanoparticles comprising dolutegravir with a zeta potential of -18.9 to -22.3 mV (pg. 2). Additionally, Malhotra teaches that the amount of Dolutegravir may be 26.3 mg (Example 1) or 50-100 mg (pg. 9) in their nanoparticulate drug delivery system. That being said and in lieu of objective evidence of unexpected results, the ratios, zeta potential, and amounts can be viewed as a variable that achieves the recognized result of successfully making the aquasome composition, which a skilled artisan would have been easily motivated to modify and adjust. The optimum or workable range of amounts, zeta potential, and ratios 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 ratios, zeta potential, and amounts of components as nonobvious.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613