DETAILED ACTION
The amendment submitted on May 26, 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 Claim 19 is withdrawn.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, in the reply filed on May 26, 2026 is acknowledged. Claim 19 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 26, 2026.
Claim Rejections – 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 12 and 17-18 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for treating myeloid leukemia, does not reasonably provide enablement for preventing it. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The enablement requirement refers to the requirement of 35 U.S.C. 112(a) that the spec-ification describe how to make and how to use the claimed invention. The purpose of the requirement is to ensure that the invention is communicated to the interested public in a mean-ingful way. The information contained in the disclosure of an application must be sufficient to inform those skilled in the relevant art how to both make and use the claimed invention. The analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention. The factors relevant to consideration of questions of enablement are discussed in MPEP1 2164.
The claimed invention is in the pharmaceutical arts and is directed to a composition “for preventing or treating myeloid leukemia.” The state of the prior art is summarized in applicant’s specification (pp. 1-3). While administering chemotherapy for treating leukemia is known in the prior art (see, e.g., the references cited under § 103, below), the search of the prior art reveals that there is no known medical intervention whereby the same chemotherapy prevents leuke-mia. One of ordinary skill in the art is a person who can read and understand the relevant prior art, as well as the description of the invention in applicant’s specification. According to appli-cant’s specification (p. 3), “27-hydroxycholesterol suppressed the proliferation of hematopoietic stem cells by increasing the active oxygen of the hematopoietic stem cells and activating a cascade of endoplasmic reticulum stress, and promoted the apoptosis of blood cancer cells,” among other things. The present application (see, e.g., Fig. 3A in the drawings and the discussion thereof) includes evidence that 27-hydroxycholesterol is effective in reducing the cell counts of HL-60, KG-1a, and K562 cells, which are known in the prior art2 as in vitro models of myeloid leukemia. The examiner therefore acknowledges that the application is enabling of treating myeloid leukemia with 27-hydroxycholesterol. The application includes no evidence, however, that 27-hydroxycholesterol is actually useful in preventing myeloid leukemia. In the absence of such information, the examiner concludes that one of skill in the art would be burdened with undue experimentation when attempting to make and use the invention as claimed.
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 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5,773,431 A by Javitt.
Javitt discloses pharmaceutical compositions (col. 4, ll. 31-43) comprising 27-hydroxy-cholesterol (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 are 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 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2014/0179656 A1 by Kuang et al.
Kuang discloses functional food compositions (para. 0169) comprising 27-hydroxycholes-terol (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
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
June 3, 2026
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]
2 Information about these cell lines may be found at https://www.atcc.org/cell-products/human-cells.
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