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 .
Detailed Action
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 30 May 2023 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Response to Restriction
2. Applicants’ election with traverse of Group I (claims 1-10, 13, 15, and 17-20) and species of long chain lipids in the reply filed on 16 December 2025 is acknowledged. The traversal is on the ground(s) that the amended claims require a dosage form for oral delivery comprising a nanocarrier formulation to be aqueous. The cubosomes of Nielson are structurally distinct as they exist as discrete particles instead of the bulk phase from which they are typically derived. In addition, the structures are spray dried. This is not found persuasive because the amendments result in a new technical feature, i.e., the presence of water in the formulation. As stated in the 35 U.S.C. 103 Rejection below, Rizwan et al. teach swelling and phase behavior of phytantriol and glyceryl monooleate matrices with varying water loadings. See abstract. The bicontinuous cubic phase, referred to as cubic phase or Q is a promising delivery system for low molecular weight drugs, proteins, peptides, amino acids, and nucleic acids. See page 4191. Samples contain FITC-Ova. See page 4194. At 20% or higher water content the phase is cubic, while water contents of 20% and 25% result in reverse hexagonal phase. See Table 1. Nielsen et al. teach cubosomes encapsulating model antigen ovalbumin via spray drying and their potential application in oral vaccine delivery. See abstract. Cubosomes were prepared with glyceryl monooleate (i.e., monoolein). See page 14, Section 2.2. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to add an enteric coating to the formulation to control the location of delivery of the active agent to increase therapeutic effectiveness.
The requirement is still deemed proper and is therefore made FINAL.
Status of Application
3. The instant application is a national stage entry of PCT/AU2021/051428 filed 30 November 2021. Claims 1-2, 4, 7-10, 13, 15, and 18-20 are currently pending. Claims 3, 5-6, 11-12, 14, 16-17, and 21-32 are cancelled. Claims 1-2, 4, 7-10, 13, 15, and 18-20 are examined on the merits within.
Claim Objections
4. Claim 1 is objected to because of the following informalities: the claim recites “an aqueous lipid nanocarrier formulation”, “the lipid nanocarrier formulation” and “the lipid aqueous nanocarrier formulation”. For consistency purposes, each reiteration of “an aqueous lipid nanocarrier formulation” should recite “the aqueous lipid nanocarrier formulation.” Appropriate correction is required. Claims 7, 18, and 19 are included in this objection for the same deficiencies.
5. Claim 2 is objected to because of the following informalities: “the non-dispersed mesophase” should instead recite “the non-dispersed bulk mesophase” for consistency purposes. Appropriate correction is required.
6. Claim 4 is objected to because of the following informalities: “wherein the the” should instead recite “wherein the”. Appropriate correction is required.
Claim Rejections – 35 U.S.C. 112(b)
7. 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.
8. Claims 4, 8-10, and 15 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.
9. Claim 4 depends from claim 3 which is currently cancelled. Therefore claim 4 is indefinite since it is unclear from where it is intended to depend.
10. Claims 8-9 recite “% weight of the formulation”. Does this phrase refer to the aqueous lipid nanocarrier formulation or the dosage form? Clarification is requested.
11. Regarding claim 10, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
12. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 10 recites the broad recitation glargine, and the claim also recites (Lantus, Basaglar, Toujeo) which is the narrower statement of the range/limitation. Claim 10 recites the broad recitation detemir, and the claim also recites (Levemir) which is the narrower statement of the range/limitation. Claim 10 recites the broad recitation degludec, and the claim also recites (Tresiba) which is the narrower statement of the range/limitation. Claim 10 recites the broad recitation NPH, and the claim also recites (Humulin No, Novolin N, Novolin ReliOn Insulin N) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
13. Claim 10 contains the trademark/trade name Lantus, Basaglar, Toujeo, Levemir, Tresiba, Humulin and Novolin. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112, second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe specific insulin prescriptions, accordingly, the identification/description is indefinite.
14. Claim 15 recites “about pH 5.0 to pH 6.0”. Since the word “about” is not defined, it is unclear what the lower limit of the range is. Does about 5.0 equate to a pH of 4? In addition, it is unclear if the word “about” refers to both the upper and lower limits, or just the lower limit. Clarification is requested.
Claim Rejections – 35 U.S.C. 103
15. 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.
16. Claim(s) 1-2, 4, 7-10, 13, 15, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rizwan et al. (Journal of Pharmaceutical Sciences, 2009) in view of Nielsen et al. (European Journal of Pharmaceutics and Biopharmaceutics, 2017).
Rizwan et al. teach swelling and phase behavior of phytantriol and glyceryl monooleate matrices with varying water loadings. See abstract. The bicontinuous cubic phase, referred to as cubic phase or Q is a promising delivery system for low molecular weight drugs, proteins, peptides, amino acids, and nucleic acids. See page 4191. Samples contain FITC-Ova. See page 4194. At 20% or higher water content the phase is cubic, while water contents of 20% and 25% result in reverse hexagonal phase. See Table 1. The release of the incorporated active is thought to be controlled partly by the unique microstructure, where the active has to diffuse through the structure to access the external solution. The pore size and tortuosity of the water channels and the stiffness and high viscosity of the cubic phase contributes to the sustained release of the entrapped active. See page 4192.
Rizwan et al. do not teach an enteric coating.
Nielsen et al. teach cubosomes encapsulating model antigen ovalbumin via spray drying and their potential application in oral vaccine delivery. See abstract. Cubosomes were prepared with glyceryl monooleate (i.e., monoolein). See page 14, Section 2.2. The cubosome powders are filled in microcontainers and spray coated with Eudragit S100. See page 15.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to add an enteric coating to the formulation to control the location of delivery of the active agent to increase therapeutic effectiveness. One would have been motivated, with a reasonable expectation of success, because Nielsen et al. teach the importance of pH dependent coatings, such as Eudragit S100, to control the location of release within the body. It would have been well within the purview of the skilled artisan to modify the amounts of long chain lipids and water to control the phase of the liquid crystalline structure which in turn affects the effectiveness of the drug delivery system. It would have been well within the purview of the skilled artisan to control the pore size to control the entrapment and release of active ingredients for therapeutic effectiveness. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to incorporate the formulation of Rizwan et al. into a capsule because Nielsen et al. teach the effective encapsulation of glyceryl monooleate cubosomes in microcontainers coated with a pH dependent coating for oral delivery.
Conclusion
17. No claims are allowed.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615