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 statements (IDS) submitted on 24 January 2024, 21 August 2024, 18 June 2025, and 1 December 2025 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. See attached copy of PTO-1449.
Response to Restriction
2. Applicants’ election of Cyclosporin A (claims 1-4, 6, and 11) in the reply filed on 15 June 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of Application
3. The instant application is a continuation in part of PCT/KR2022/015656 filed 14 October 2022. Claims 1-11 are currently pending. Claims 5 and 7-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 15 June 2026. Claims 1-4, 6, and 11 are examined on the merits within.
Claim Rejections – 35 U.S.C. 112(b)
4. 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.
5. Claims 1-4, 6, and 11 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.
6. Claim 1 recites “A nano-molecular association prepared by dissolving molecules of an organic material or an inorganic material in a solvent and bringing the molecules in close proximity to each other, in which an organic material or an inorganic material is physically bonded…” It is unclear what the material is physically bonded to. Does this refer to molecules of the material bound to each other or bonds between the material and another material? Clarification is requested.
7. Claim 1 recites the phrase “associated structure” which is not defined by the claim nor does the specification provide a standard for ascertaining the requisite metes and bounds, thus one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
8. Claim 1 recites “the value of dispersity (B)/solubility (A) is 1.2 or more.” The value of 1.2 or more does not contain units. What units represent this value? Is this a unitless measurement? Clarification is requested. Claim 6 is included in this rejection for the same deficiencies.
9. 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 3 recites the broad recitation “vitamin A”, and the claim also recites “(retinol)” which is the narrower statement of the range/limitation since vitamin A refers to a group of fat-soluble compounds such as retinol, retinal, retinyl esters, etc. 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.
10. Claim 4 recites “the nano-molecular association has an intermolecular distance of 10A or less.” It is unclear what this distance refers to? Does this refer to the distance between each molecule of solvent and each molecule of organic or inorganic compound? Does this refer to the distance between two organic compounds or two inorganic compounds. Or does this refer to some other distance? Clarification is requested.
Claim Rejections – 35 U.S.C. 102
11. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
12. Claim(s) 1-4, 6, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bosch et al. (U.S. Patent 6,656,504).
Regarding instant claims 1-4, 6 and 11, Bosch et al. disclose nanoparticulate amorphous cyclosporine formulations having effective average particle sizes of less than 2000 nm. See abstract. The average particle size can be less than about 50 nm. See column 6, lines 39-56. Cyclosporine particles are dispersed in a liquid dispersion medium, followed by applying mechanical means in the presence of a grinding media to reduce the particle size. See column 7, lines 5-21. Since Bosch et al. teach the same combination of ingredients, i.e., an organic material dissolved in a solvent, the properties should be the same, i.e., the value of dispersity/solubility is 2.0 or more and the intermolecular distance is 10A or less.Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Thus the instant claims are anticipated by Bosch et al.
Examiner’s Note: Claim 1 is directed to any organic or inorganic material in a solvent with a particle size of less than 50 nm. The rest of the features in the claim are functional. Thus there is numerous prior art that would read on the limitations of claim 1 as currently written.
Double Patenting
13. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
14. Claims 1-4, 6, and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2, 6-10, and 14-15 of copending Application No. 18/423812 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and Application No. 18/423812 are directed to nano-molecular associations prepared by dissolving an organic or inorganic material in a solvent wherein the average particle size is 50 nm or less. The only difference lies in the fact that Application No. 18/423812 is more specific in describing the association as noncovalent association and further defining the types of organic or inorganic material. Thus, the invention of the patent is in effect a "species” of the "generic" invention of the instant application. It has been held that the generic invention is "anticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Thus the claims are not patentably distinct. The dependent claims are included in this rejection for being directed to similar active ingredients and properties of the composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
15. Claims 1-4, 6, and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4-6 of copending Application No. 18/578902 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and Application No. 18/578902 are directed to molecular associations prepared by dissolving an organic or inorganic material in a solvent wherein the average particle size is 50 nm or less. The only difference lies in the fact that Application No. 18/578902 is more specific in describing the specific organic material as bile acid, solvent as water, and particle diameter of 1 to 10 nm. Thus, the invention of the patent is in effect a "species” of the "generic" invention of the instant application. It has been held that the generic invention is "anticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Thus the claims are not patentably distinct. The dependent claims are included in this rejection for being directed to similar active ingredients and properties of the composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
16. Claims 1-4, 6, and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-8 of copending Application No. 18/579262 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and Application No. 18/579262 are directed to molecular associations prepared with an organic or inorganic material in a solvent wherein the average particle size is 50 nm or less. The only difference lies in the fact that Application No. 18/579262 is more specific in describing the specific organic material as bile acid and solvent as water. Thus, the invention of the patent is in effect a "species” of the "generic" invention of the instant application. It has been held that the generic invention is "anticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Thus the claims are not patentably distinct. The dependent claims are included in this rejection for being directed to similar active ingredients and properties of the composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
17. No claims are allowed at this time.
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
Prosecution Insights