DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8 December 2025 has been entered, and the arguments presented therein have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
Claim 1 recites Biopharmaceutics Classification System (BCS) class II or class IV drugs. As best understood by the examiner, BCS class II drugs have high permeability when administered orally, but low water solubility. BCS class IV drugs have low permeability when administered orally and low water solubility. As such, the drugs recited by claim 1 are understood to have poor water-solubility.
The abbreviation “XRPD” in claim 27 refers to x-ray powder diffraction.
Note Regarding BCS Classification of Curcumin
The examiner conducted a search regarding the Biopharmaceutics Classification System (BCS) class of curcumin. This search resulted in conflicting information. Jannin et al. (International Journal of Pharmaceutics, Vol. 495, 2015, pages 385-392) teaches that curcumin is a BCS class II molecule, as of page 385, abstract. In contrast, Wahlang et al. (European Journal of Pharmaceutics and Biopharmaceutics, Vol. 77, 2011, pages 275-282) teaches that curcumin is a BCS class IV molecule, as of page 275, abstract.
For the purposes of examination under prior art, the examiner will proceed in examination with the understanding that curcumin is both a BCS class II and a BCS class IV drug.
The examiner notes that applicant does not appear to have rebutted this position in applicant’s response on 8 December 2025. As such, the examiner takes the position that applicant does not dispute the idea that curcumin is both a BCS Class II and a BCS Class IV drug.
Claim Rejections - 35 USC § 103 – Obviousness
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 26-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aditya et al. (Colloids and Surfaces B: Biointerfaces, Vol. 127, 2015, pages 114-121).
Aditya et al. (hereafter referred to as Aditya) is drawn to curcumin nano-suspensions comprising beta-lactoglobulin, as of Aditya, page 114, title and abstract. This composition is amorphous, as of Aditya, page 114, title and abstract. Curcumin is understood to be a BCS class II or IV drug; see the section above entitled “Note Regarding BCS Classification of Curcumin.” Aditya teaches that the composition has been made in the following manner, as of Aditya, page 115, left column, section 2.2, reproduced below.
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Aditya does not appear to be anticipatory because it is unclear whether the above-reproduced composition of Aditya comprises from 25% to 75% of curcumin and from 25% to 75% of beta-lactoglobulin. Nevertheless, even if, purely en arguendo, Aditya does not teach this, this difference is insufficient to overcome the prima facie case of obviousness. Generally, differences in concentration between the prior art and claimed invention will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of criticality appears to have been provided. Also, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of a composition comprising beta-lactoglobulin and a BCS Class II or IV drug such as curcumin in an amorphous form has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable ranges of beta-lactoglobulin and curcumin by routine experimentation.
As to claim 26, Aditya teaches trehalose as a cryoprotectant as of page 118, right column, section 3.4; this is understood to be an additional excipient.
As to claims 27-29, Aditya teaches stability testing, albeit at different conditions than the stability testing recited by the claims. Specifically, Aditya appears to teach good stability at 30 days in a composition with a stabilizer albeit worse stability in a composition without a stabilizer, as of Aditya, page 118, section 3.4, relevant text reproduced in part below with certain text highlighted by the examiner.
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Aditya teaches that composition comprising a stabilizer achieves superior stability, as of Aditya, page 120, left column, section 3.5, relevant text reproduced in part below.
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As such, the testing conducted by Aditya occurs at 30 days, which is only about 4-5 weeks, and is less than the amount of time that the composition is required to be stable as recited by claims 26, 27, and 28. Nevertheless, the skilled artisan would have expected that the testing conditions described by Aditya would have lent themselves to greater difficulty for the composition to remain stable as compared with the testing conditions recited by the instant claims. This is because in the testing conditions recited by the instant claims, the composition would not have been subject to degradation by hydrolysis due to the lack of water; in contrast, in the testing conditions taught by Aditya, the composition would have been subject to degradation by hydrolysis. As such, stability for 4-5 weeks under the conditions taught by Aditya in which the composition is subject to hydrolysis would likely result in the ability for the composition to remain stable for a longer period of time under water-free conditions such as those recited by the instant claims.
Therefore, with regard to claims 27-29, there would have been a reasonable expectation that the composition of Aditya would have remained stable for 5, 8, and/or 15 weeks or more under conditions in which water was not present due to the silica gel and desiccator. Something which is old (e.g. the composition of Aditya) does not become patentable upon the discovery of a new property (e.g. stability under test conditions that differ from the test conditions taught by Aditya), and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II). Additionally, the USPTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same. See MPEP 2112(V). In this case, it is the examiner’s position that because the composition of Aditya is made from the same elements as the claimed composition and achieves stability under certain test conditions taught by Aditya, this is sufficient to shift the burden to applicant in accordance with the guidelines set forth in MPEP 2112(V).
As to claims 30-31, Aditya teaches that the composition of Aditya has a faster dissolution rate as compared with a crystalline composition, as of Aditya, page 114, right column, bottom paragraph, relevant text reproduced below with certain text highlighted by the examiner.
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With that being said, Aditya does not appear to measure dissolution rate. Nevertheless, there would have been a reasonable expectation that the composition of Aditya would have had a faster dissolution rate as compared with a hypothetical comparative crystalline composition. Something which is old (e.g. the composition of Aditya) does not become patentable upon the discovery of a new property (e.g. a dissolution rate that is faster than that of the crystalline composition in the recited amounts), and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II). Additionally, the USPTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same. See MPEP 2112(V). In this case, it is the examiner’s position that because the composition of Aditya is made from the same elements as the claimed composition and achieves an amorphous state which is known to exhibit a faster dissolution rate, this would have been sufficient to shift the burden to applicant in view of the provisions of MPEP 2112(V).
As to claims 32-33, curcumin is understood to read on both the required BCS Class II and BCS Class IV drug. See the section above entitled “Note Regarding BCS Classification of Curcumin.”
Response to Arguments Regarding Obviousness Rejections
Applicant has presented arguments in applicant’s response on 8 December 2025 related to the previously applied obviousness rejections. These arguments are moot in view of the withdrawal of the previously applied obviousness rejections. As such, applicant’s arguments presented in applicant’s response on 8 December 2025 related to the previously applied obviousness rejections have not been addressed substantively.
Non-Statutory Double Patenting
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.
Claims 1 and 26-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 and 18 of copending Application No. 17/779,566 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a co-amorphous form of a therapeutically active substance and a protein which may be beta-lactoglobulin. The therapeutically active substance is a class II or IV drug; the skilled artisan would have understood those drugs to have been water-insoluble. The claims require a particular drug load of the therapeutically active substance.
The copending claims are drawn to a co-amorphous form of an active pharmaceutical ingredient comprising beta-lactoglobulin and a class II or IV drug. Copending claim 8 recites a loading of the active pharmaceutical agent of from 15% to 95%.
The instant and copending claims differ because the copending claims require at least 92% of beta-lactoglobulin. In contrast, the instant claims are silent regarding the proportion of beta-lactoglobulin. Nevertheless, the subject matter of the copending claims appears to be within the scope of that of the instant claims, thereby effectively anticipating the subject matter of the instant claims. This results in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
Claims 1 and 26-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 35-51 of copending Application No. 18/564,552 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a co-amorphous form of a therapeutically active substance and a protein which may be beta-lactoglobulin. The therapeutically active substance is a class II or IV drug; the skilled artisan would have understood those drugs to have been water-insoluble. The claims require a particular drug load of the therapeutically active substance.
The copending claims are drawn to a co-amorphous form comprising beta-lactoglobulin and a drug selected from Olaparib or abiraterone acetate, as of copending claim 1. Copending claim 1 recites a concentration of the drug substance from 10% to 90%. Copending claim 39 further recites a corticosteroid, and copending claim 51 recites prednisone or prednisolone; the skilled artisan would have understood corticosteroids to have been class II/IV insoluble drugs.
The instant and copending claims differ because the copending claims recite specific active agents not recited by the instant claims. Nevertheless, the subject matter of the copending claims is within the scope of that of the instant claims, and thereby effectively anticipates the subject matter of the instant claims. This results in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 26-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11-19 of copending Application No. 18/713,118 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a co-amorphous form of a therapeutically active substance and a protein which may be beta-lactoglobulin. The therapeutically active substance is a class II or IV drug; the skilled artisan would have understood those drugs to have been water-insoluble.
The copending claims are drawn to a drug in combination with beta-lactoglobulin to form a co-amorphous form, as of copending claim 1. The drug is BCS Class II or IV, as of copending claim 15.
The instant and copending claims differ because the copending claims recite polymers not recited by the instant claims, such as polyvinyl pyrrolidone or polyvinyl alcohol. Nevertheless, the subject matter of the copending claims is within the scope of that of the instant claims, and thereby effectively anticipates the subject matter of the instant claims. This results in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments Regarding Double Patenting Rejections
Applicant makes arguments regarding the previously applied double patenting rejections, as of applicant’s response on 8 December 2025, pages 9-10. Applicant argues that the instant claims are allegedly in condition for allowance aside from the double patenting rejections. As such, applicant takes the position that the double patenting rejections should be withdrawn in view of the provisions of MPEP 804(I)(B)(1)(b).
This is not persuasive. The instant claims are not in condition for allowance aside from the double patenting rejections. As applicant has not presented substantive arguments as to why the double patenting rejections are incorrect, applicant’s arguments are not persuasive.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612