DETAILED ACTION
The amendment submitted on July 13, 2026 has been entered. Claims 12 and 17-19 are pending in the application. Claim 19 is withdrawn. Claims 12 and 17-18 are rejected for the reasons set forth below. No claim is allowed.
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 . 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.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a pharmaceutical composition comprising 27-hydroxycholesterol or a health functional food comprising the same, is acknowl-edged. Claim 19 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Withdrawn Rejections
The rejection of claims 12 and 17-18 under 35 U.S.C. 112(a) for lack of enablement is withdrawn because “preventing” has been deleted from the independent claims.
Response to Arguments
Applicant argues that the references fail to teach or suggest all of the elements of the claims, particularly “none of the cited references teach or suggest the claim element of treating myeloid leukemia with 27-hydroxycholesterol.” In applicant’s view, it is improper for the exam-iner to concludes that “treating myeloid leukemia is an inherent, necessary consequence of the compositions.” See applicant’s Remarks, submitted July 13, 2026, at pp. 5-6. Applicant’s arguments have been fully considered but are not persuasive.
The examiner relies upon the principle of inherency in rejecting the claims. As explained in MPEP1 2112, “inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102.” Contrary to applicant’s assertion, “[t]here is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.” See MPEP 2112(II). For claims drawn to chemical compositions, such as in the present situation, it is Office policy that products of identical chemical composition cannot have mutually exclusive properties. This is because “a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See MPEP 2112.01(II) (composition claims — if the composition is physically the same, it must have the same properties). As explained in the rejections below, the cited references disclose compositions having the same ingredients required by the instant claims. It is therefore proper for the examiner to conclude that they have the same functional properties. That is, the “wherein” clauses at the end of claims 12 and 18 are inherent.
The rejections under § 102 are therefore maintained.
Maintained Rejections Claim Rejections – 35 USC § 102
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.
Claim 12 remains rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5,773,431 A by Javitt.
Javitt (cited in the prior action) discloses pharmaceutical compositions (col. 4, ll. 31-43) comprising 27-hydroxycholesterol (col. 4, ll. 1-7). These compositions are useful in treating “various type of cancer” (col. 3, ll. 30-31).
The instant claim appears to represent applicant’s discovery of an inherent property of the composition disclosed in the reference, namely, that it also apparently has utility in the treat-ment of myeloid cancer. The discovery, however, of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. The claiming of a new use, new function, or unknown property that is inherently present in the prior art—although not necessarily specif-ically disclosed therein—does not make the instant claim patentable. See MPEP 2112(I) (some-thing which is old does not become patentable upon the discovery of a new property). This is because products of identical chemical composition cannot have mutually exclusive properties. “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01(II) (composition claims — if the composition is physically the same, it must have the same properties).
The cited reference discloses a pharmaceutical composition comprising the same active ingredient, namely, 27-hydroxycholesterol. The properties recited in the “wherein” clause at the end of claim 12 are therefore presumed to be inherent characteristics of the prior art.
Claims 12 and 17 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5,587,368 A by Javitt.
See the table at col. 10, ll. 40-55, which discloses pharmaceutical compositions comprising 27-hydroxycholesterol at concentration of 1.0 μM, 5.0 μM, and 7.5 μM. The “wherein” clause at the end of claim 12 as not been accorded patentable weight for substantially the same reasons discussed above.
Claim 18 remains rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2014/0179656 A1 by Kuang et al.
Kuang (cited in the prior action) discloses functional food compositions (para. 0169) comprising 27-hydroxycholesterol (para. 0089). The properties recited in the “wherein” clause at the end of the claim are inherent in the compositions of the reference for the reasons discussed above.
Conclusion
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 advi-sory 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 Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
September 28, 2026
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]
