DETAILED ACTION
Applicants’ arguments, filed 17 April 2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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.
Withdrawn Obviousness Rejection
Previously in the prosecution history of the instant application, the examiner rejected the instant claims as being obvious over Aditya et al. (Colloids and Surfaces B: Biointerfaces, Vol. 127, 2015, pages 114-121). This rejection has been withdrawn at least in view of the evidence provided as per the declaration submitted on 17 April 2026 (hereafter referred to as the declaration). The examiner presents the following rationale in support of this decision.
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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The previously applied rejection over Aditya has been withdrawn for at least the following reasons.
First, it appears that the composition of Aditya would not appear to be a single amorphous phase. In contrast, Aditya appears to teach curcumin particles in a beta-lactoglobulin structure, which is not understood to be a homogeneous amorphous phase. See paragraphs #10-13 of the declaration.
Secondly, the declaration indicates that Aditya teaches a maximum of about 17% drug loading. This is less than the minimum 25% drug loading. See paragraphs 14-15 of the declaration.
Third, the claimed invention appears to have unexpectedly higher solubility as compared with the prior art. The declaration indicated a solubility of 31 μg/mL for curcumin in the prior art, as of paragraph #16 of the declaration, and a solubility of curcumin of 138.5 μg/mL for the claimed invention, as of paragraph #22 of the declaration. This appears to be an unexpected improvement, and is of statistical and practical significance, as it is useful for improving delivery of a poorly water-soluble drug, which is crucial for various modes of drug administration and delivery.
As such, the previously applied rejection over Aditya has been withdrawn for at least the above-discussed reasons. Applicant’s arguments regarding the previously applied obviousness rejection have not been substantively addressed by the examiner as it is moot in view of the withdrawal of the previously applied obviousness rejection over Aditya.
Withdrawn Provisional Non-Statutory Double Patenting Rejection
Previously in the prosecution history, the examiner rejected the instant claims on the grounds of provisional non-statutory double patenting over the claims of US application serial number 18/713,118. This rejection has been withdrawn. The examiner provides the following explanation for withdrawing this rejection.
The claims of the ‘118 application are drawn to a co-amorphous form comprising a drug and beta-lactoglobulin, as of claim 1 of the ‘118 application. Claim 15 of the ‘118 application recites BCS class II or IV, which are water-insoluble drugs.
With that being said, the instant claims require that the co-amorphous form comprises from 25% to 75% of the therapeutically active substance. This is not recited by the copending claims. In contrast, the copending claims appear to be silent regarding the amount of drug. It is the examiner’s position that, in view of the lack of a claim requirement regarding the amount of drug in the claims of the ‘118 application, it would not have been prima facie obvious for the skilled artisan to have achieved 25% to 75% of drug, and the modifications to achieve this would not have been routine optimization. The examiner presents the following arguments in support of this position.
In order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See MPEP 2144.05(II)(B). In this case, it does not appear to be the case that the skilled artisan would have had a reasonable expectation of successfully modifying the amount of therapeutically active substance to have successfully been in the claimed range. The examiner presents the following arguments in support of this position.
The examiner notes that optimization of concentration is frequently prima facie obvious, as per MPEP 2144.05(II)(A). The skilled artisan could also have increased the percentage of active agent by weighing a larger quantity of active agent and a smaller quantity of beta-lactoglobulin when preparing the composition. However, there would have been no reasonable expectation that doing so would have resulted in formulation of the claimed composition.
In contrast, the skilled artisan would have expected that had the amount of therapeutic active agent been increased, the therapeutic active agent would have either formed a particle of the therapeutic agent by itself (as in Aditya), precipitated from the homogeneous amorphous phase, or formed a crystal rather than having been present in a single homogeneous amorphous phase with the beta-lactoglobulin. As such, there would have been no reasonable expectation that the composition of the claims of the ‘118 application could have been successfully increased to have been in the 25-75% range with the active agent remaining in the form of a single homogeneous amorphous phase with a reasonable expectation of success, rather than changing to a different phase such as particles comprising active agent by itself, a crystal, or a precipitate.
In further support of this position, the examiner notes Vergauwen et al. (WO 2017/186889 A1). The instant claims were previously rejected over Vergauwen et al. (WO 2017/186889 A1); however, the previously applied rejection was withdrawn in the prior office action mailed on 9 September 2025. In that office action, the examiner took the following position on page 5, second to last paragraph, reproduced below.
As best understood by the examiner, the excipients in the table; [Examiner Note: this table was reproduced by examiner on page 5 of the office action mailed on 9 September 2025 and was taken from Vergauwen] labeled as “50PS30”, “75PS18”, and “225LB30”, are gelatin excipients. The data in the above-reproduced table appears to show successful formation of amorphous particles at 10% and 20% drug load in the case of 50PS30 and 75PS18, but failure to form amorphous particles at 30% and 40% drug load. The 225LB30 particle successfully formed an amorphous particle only at 10% drug load, but not at higher drug load.
As such, the above-reproduced text would appear to indicate that increasing the drug load is not routine optimization because there would have been no reasonable expectation that, were drug load to have been increased, that the resultant composition would have successfully retained the required co-amorphous form wherein the therapeutically active substance and the beta-lactoglobulin is in a single homogeneous phase at the molecular level.
As such, the double patenting rejection over the claims of the ‘118 application has been withdrawn because the claims of that application fail to recite the claimed requirement of 25% to 75% active substance, and there would have been no reasonable expectation that this could have been achieved successfully via routine optimization.
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 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,564,554. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
As an initial matter, the examiner notes that previously in the prosecution history, as of the prior office action mailed on 26 January 2026, pages 11-12, the examiner rejected the instant claims over copending application 17/779,566. Since the mailing of the prior office action, the ‘566 application has matured into US Patent 12,564,554. As such, this rejection is the same as the previously applied rejection over the claims of the ‘566 application. Therefore, this is not a new ground of rejection.
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 conflicting claims are drawn to a co-amorphous form of an active pharmaceutical ingredient comprising beta-lactoglobulin and a class II or IV drug. Conflicting claim 8 recites a loading of the active pharmaceutical agent of from 15% to 95%. Conflicting claim 10 recites that the active agent has a water solubility at 25°C of less than 0.02 mg/mL.
The instant and conflicting claims differ because the conflicting claims, while reciting the drug-solubility in claim 10 and proportion of the co-amorphous form that comprises the pharmaceutical excipient, as of claims 8-9, does not teach these components together in the same claim. Nevertheless, the skilled artisan would have been motivated to have combined disparate features from claim 10 with those from claims 8-9 to have achieved a co-amorphous form comprising active agent in a specific percentage range, wherein the active agent was present in an amount up to 85% in claim 8 and up to 35% in claim 9. This combination would have resulted in a composition having the features required by instant claim 1. There would have been a reasonable expectation this resultant composition would have had the features required by claims 26-33 because it includes the required amorphous dispersion and the required amount of active agent.
The examiner notes that in the previous office action, the claims were rejected on the grounds of non-statutory double patenting over the claims of copending application 17/779,566; see pages 11-12 of the office action mailed on 26 January 2026. Application 17/779,566 has matured into US Patent 12,564,554. As such, this rejection is not a new ground of a rejection.
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 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 with the exception of the fact that the copending claims recite a broader range of active agent than what is recited by the instant claims.
Also, the instant and copending claims differ because the instant claims require that the co-amorphous form have from 35% to 75% of active agent. In contrast, copending claim 36 recites from 10% to 70% active agent. The amount taught by the copending claims overlaps with, but does not read on the instantly claimed invention. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
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
In applicant’s response on 17 April 2026, pages 8-9 of applicant’s response, applicant takes the following position.
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In response, the examiner takes the position that the provisions of MPEP 804(I)(B)(1)(b) apply only to provisional non-statutory double patenting rejections, which are double patenting rejections over applications that have not issued as patents. In contrast, the double patenting rejection over US Patent 12,564,554 (formerly application 17/779,566) is not a provisional double patenting rejection. As such, (a) the double patenting rejection over the ‘554 patent is not withdrawn because it is not a provisional rejection. Therefore, it is the not the case that provisional non-statutory double patenting rejections are the only rejections remaining, and the provisional non-statutory double patenting rejection over the claims of application No. 18/564,552 have also not been withdrawn. As such, no rejections have been withdrawn in view of the provisions of MPEP 804(I)(B)(1)(b).
In a verbal interview between examiner and representative of applicant, representative of applicant took the position that the double patenting rejection over US Patent No. 12,564,554 should be withdrawn because the ‘554 patent does not have a common assignee with the instant application. Specifically, representative of applicant verbally argued that the instant application is assigned to the University of Copenhagen. In contrast, the ‘554 patent is assigned to “Dispersome IP APS.”
Nevertheless, this argument is not persuasive because there is a common inventor between the instant application and the ‘554 patent; that common inventor appears to be Korbinian Lobmann. MPEP 804(I)(A) states the following, wherein relevant text reproduced below with certain text made bold by the examiner.
Double patenting may exist between an issued patent and an application which share the same inventive entity, at least one common (joint) inventor, a common applicant, and/or a common owner/assignee. See In re Hubbell, 709 F.3d 1140, 1146-47, 106 USPQ2d 1032, 1037-38 (Fed. Cir. 2013) (in the context of an application and a patent that had two common joint inventors, but different inventive entities and no common owners or assignees, the court held that complete identity of ownership or inventive entities is not a prerequisite to a nonstatutory double patenting rejection).
The examiner understands this to refute applicant’s position that the applied double patenting rejection should be withdrawn because the instant application has a different assignee as compared with that of the ‘554 patent. In contrast, because the instant application and the ‘554 patent have a common inventor, the issue of double patenting may be raised. The examiner understands that the treatment of provisional non-statutory double patenting over a copending application may also be raised in the case where there is a joint inventor but no common assignee between the instant application and the copending application. See MPEP 804(I)(B).
As such, the previously applied double patenting rejections have not been withdrawn in view of applicant’s verbal or written arguments.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
Prosecution Insights