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 .
Response to Objections and Rejections:
Withdrawn in view of amendment, or claim cancellation:
Drawings Objections and Claim 47, 52 objections.
112(b) rejections: Claim 31 and 32,35,40,47,49-54; Claim 47 “healthy”; Claim 47 and 49 “corresponding segment”; Claim 47 omitting steps; Markush Group claims 31,32,35, 40,47, 49-54.
112(a) rejections: Claim 51, 52; 53,54; 31,32,35, 40 47 49-54.
Application Status
Previously, applicant’s election without traverse was to Group III claims 31,32,35 and 4 in addition to claim 47, previously amended to depend from claim 31, with claims 49-54 added prior to the last Office action, when claim 48 was withdrawn by applicant, such that claims 31,32,35,40,47 and 49-54 were pending.
Presently, the claims filed 11/6/2025 are under examination, where claims 31,40,47,48,49,50,52,53 are pending and 1-30,32-39,41-46,51 and 54 are cancelled.
Priority
This application claims priority to PRO 62/802,653 (fd 2/7/2019) and to PCT US2020/017073 (fd 2/26/20).
Support for Vitamin D treatment is not found in the provisional application, therefore support for Vitamin D administration to treat cancer related to expression of particular genes, has a priority date of 2/26/20.
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 31,40,47,48,49,50,52,53 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.
Claim 31 is indefinite in the recitation of “a small molecule that targets a master regulator” because it is unclear how to establish the metes and bounds of what small molecule does and what small molecule does not target a master regulator. The definition of small molecule is also indefinite in the recitation of “small”, which is a relative term, and without further limitation beyond molecule, since it is unclear precisely what constitutes a small molecule. The “Definitions” of the specification ([0038) do not include small molecules. Specification [00115] mentions these, but with no further limitation and [0060], [0062] reference small molecule drugs, which include but are not limited to Table A. Claims 40,47,48,49,50,52,53 depend from and as such are indefinite in the recitation for the same reason.
Claim 47 is indefinite and confusing in the recitation in the combination of steps where in step (b) “measured the expression level in the sample of VDR or VDR and HDAC7” is the followed by step (c) comparing the expression level of VDR or VDR ad HDAC2 in the sample”, which could not occur thus far since HDAC7 was measured and HDAC2 is compared. Claim 52 and 53 depends from claim 47 and is rejected for the same reason.
Claim 47 and 49 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 706.03(y).
The Markush grouping of claims 47 and 49 are improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: each of the drugs has a different function and structure than and RNAi agent or an antisense oligonucleotide, which also differ in structure from one another.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. Claim 52 and 53 depends from claim 47 and is rejected for the same reason.
Claim 48 is rejected on the basis that it contains an improper Markush grouping of alternatives, akin to the rejection above. Specifically for this claim, Vitamin D, and RNAi agent, an antisense oligonucleotide that hybridizes to a segment of VDR differ from one another chemically and structurally.
Claim 50 is indefinite in the recitation of “wherein the glioma is or brain lower grade glioma or gliobastoma multiforme” since it is not entirely clear what this means.
Claim 40 recites the limitation " second small molecule inhibitor ". There is insufficient antecedent basis for this limitation in the claim. Claim 49 depends from claim 40 and is indefinite for the same reason.
Claim Interpretation
In evaluating the patentability of the claims presented in this application, the claims will be given their broadest reasonable interpretation, in view of the specification, and as set forth at MPEP§ 2111. For clarity of the record, “small molecule” in molecular biology, according to Wikipedia (www.Wikipedia.org) is a low molecular weight (<1,000 daltons) compound that may regulate a biological process with a size on the order of 1nm. “Treating” (www.merriam-webster.com) is to care for or deal with medically or surgically. Similarly, The American Brain Tumor Association (www.abta.org/tumor types/glioma) states that “glioma” is any tumor that arises from the supportive tissue of the brain.
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 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) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanwar (US2010/0092497 A1, published April 15, 2010) in view of PubChem (2004, (pubchem.ncbi.nlm.nih.gov/#query=Vitamin+D3)).
Claim 31 recites, A method for treating cancer in a human comprising administering a small molecule that targets a master regulator of poor prognosis wherein the cancer is glioma or AML and wherein the master regulator of poor prognosis is VDR
Kanwar discloses a method of inhibiting tumor formation or growth and treating or preventing cancer (Title) through use of Vitamin D and lactoferrin to inhibit tumor formation (Abstract), noting Vitamin D has anti-cancer properties ([0116]), and that anticancer activity of Vitamin D ligands had been demonstrated in glioma models [0116]. Kanwar disclosed the cancer of interest in their work comprises AML, where additional cancers may include brain tumors ([0170]).
Kanwar’s claim 2 addressed a method of treating as increasing responsiveness of a subject to a cancer therapy, comprising administration to a subject in need, of one or more lactoferrin variants and vitamin D. Kanwar includes vitamin D3 as a vitamin D ([0086]). Kanwar’s disclosed the term “subject” references, preferably a mammalian companion animal or human ([0079]). Kanwar disclosed that vitamin D targets VDR ([0886], “any compound that will bind and activate VDR).
Kanwar did not speak directly to the size of Vitamin D.
PubChem demonstrates that Vitamin D3 (calciferol) is a small molecule, given a MW of 384.6 g/mol or Daltons.
Response to Remarks:
Applicant’s remarks (Pg 12, 14-17) are directed to rejections that have been withdrawn in view of amendments, except for the issue related to IDS (below).
IDS (Pg 12): In the Office action of 2025-07-09, Examiner noted there was no information disclosure statements submitted.
Regarding applicant remarks at page 12 of the paper filed 11/06/2025, stating that:
Applicant notes that an IDS was filed on September 23, 2021 (see below). Applicant notes the references disclosed in the IDS were the references cited in the search report for the corresponding PCT application.
However, applicants’ attention is directed to the Electronic Acknowledge Receipt, a copy of the important section is reproduced below which indicates that the IDS form was not scannable.
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Since the IDS form submitted by applicant was not a USPTO supplied IDS fillable form it was not loaded into the application and thus was not available to the examiner. If the applicants desire that the references submitted to be considered and listed on the face of the patent if one so develops during prosecution, then applicant must comply with 37 CFR. 1.98 requires as to the content of the IDS statement contain:
1.98 Content of information disclosure statement.
(a) Any information disclosure statement filed under § 1.97 shall include the items listed in paragraphs (a)(1), (a)(2) and (a)(3) of this section.
(1) A list of all patents, publications, applications, or other information submitted for consideration by the Office. U.S. patents and U.S. patent application publications must be listed in a section separately from citations of other documents. Each page of the list must include:
(i) The application number of the application in which the information disclosure statement is being submitted;
(ii) A column that provides a space, next to each document to be considered, for the examiner’s initials; and
(iii) A heading that clearly indicates that the list is an information disclosure statement.
(2) A legible copy of:
(i) Each foreign patent;
(ii) Each publication or that portion which caused it to be listed, other than U.S. patents and U.S. patent application publications unless required by the Office;
(iii) For each cited pending unpublished U.S. application, the application specification including the claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion [but see 1287 OG 163 (October 19, 2004) discussed in MPEP § 609.04(a), subsection II]; and
(iv) All other information or that portion which caused it to be listed.
(3)
(i) A concise explanation of the relevance, as it is presently understood by the individual designated in § 1.56(c) most knowledgeable about the content of the information, of each patent, publication, or other information listed that is not in the English language. The concise explanation may be either separate from applicant’s specification or incorporated therein.
(ii) A copy of the translation if a written English-language translation of a non-English-language document, or portion thereof, is within the possession, custody, or control of, or is readily available to any individual designated in § 1.56(c).
Conclusion
All claims rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lisa Horth whose telephone number is (703)756-4557. The examiner can normally be reached Monday-Friday 8-4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at (571) 272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LISA HORTH/Examiner, Art Unit 1681
/GARY BENZION/Supervisory Patent Examiner, Art Unit 1681