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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7 and 11-13 in the reply filed on July 24, 2026 is acknowledged.
Claims 8-10 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 24, 2026.
Specification
The use of the term “Eudragit”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1 and 12 are objected to because of the following informalities: in line 1 the comma after “composition” is unnecessary. Darolutamide (claims 1 and 12) and poloxamer should be in lower case. The “wherein” following “agent;” in line 3 should be moved to directly precede “the formulation modifying…” in the next clause, and repeated to precede “the carrier material”, i.e., “wherein the carrier material…”.
Claims 2-6, 12, and 13 are objected to because of the following informalities: the “wherein” should be moved to directly precede the phrase it introduces, without a line break.
Claim 11 is objected to because of the following informalities: the “wherein” should be moved to directly precede the phrase it introduces, without a line break, and repeated for each separate phrase.
Appropriate corrections are 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 1-7 and 11-13 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.
Independent claim 1 is lacking an “and” or “or” following the end of the group of formulation modifying agents “…castor oil;” and therefore it is ambiguous whether just one or both of the limitations (formulation modifying agent and carrier material) are required. None of the dependent claims resolves this issue and therefore they are also rejected on this ground.
Claim 11 is lacking an “and” or “or” following the end of the group of the stabilizer therefore it is ambiguous whether any of the limitations (the recited stabilizer and the recited preservative) are required
Claims 1 and 3 contain the trademark/trade name Eudragit®. 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(b) or 35 U.S.C. 112 (pre-AIA ), 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 certain acrylic and methacrylic acid copolymers and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being clearly anticipated by Stewart (WO 2022/049075A1).
Stewart teaches amorphous solid dispersions (ASDs) comprising darolutamide, a dispersion polymer (DISPPOL), and excipient (ASDEXCIP), and solid dosage forms such as tablets comprising the ASD (see entire document including title; abstract; p.1 lines 3-5). The dispersion polymer comprise the carrier materials in instant claims 1 and 3 (p.8 line 5-p.9 line 24). The excipient ASDEXCIP includes the formulation modifying agents in instant claims 1 and 2, preferably alpha tocopheryl PEG 1000 succinate in claim 3 (p.14 lines 1-34). The ASDs may comprise further excipients such as sodium bicarbonate and sodium citrate or buffer and acidifier in claim 4 (p.15 line 18-20). The ASD may be in the form of a powder (p.15 line 22).
Regarding claim 5, in one embodiment the ASD may comprise 45-55 wt% of darolutamide and 45-55 wt% of hydroxypropyl methylcellulose acetate succinate as DISPPOL (p.13 lines 27-33), which includes a ratio of 1:1.
Regarding claims 6 and 13 which recite properties of the composition in claim 1, it is notes that for product claims, “when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent”. MPEP §2112.01(I).
Regarding claim 12, the “ASD may comprise ASDEXCIP in an amount up to 40 wt¾, the wt¾ being based on the weight of the ASD” (p.14 lines 6-7), or a ratio of 1:0.4 which is within the ranges in claim 12.
Claim Rejections - 35 USC § 103
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 1-7 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart (WO 2022/049075A1) in view of Ludwig (US 2022/0002723).
Stewart does not specifically teach the excipients in claim 11.
Ludwig is drawn to methods for treating small round cell tumor(s) by administering anti-androgen receptor such as ODM-201 or darolutamide (title; abstract; para.0011). Ludwig teaches buffers and antioxidants, i.e., stabilizers or preservatives, such as methionine and others in claim 11 (para.0068).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Stewart and Ludwig as recited in the instant claim(s). The skilled person would have been motivated to do so because both are drawn to compositions comprising darolutamide and Ludwig teaches further excipients suitable for dosage forms comprising darolutamide.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/H. SARAH PARK/Primary Examiner, Art Unit 1614
Prosecution Insights