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 .
Status of Claims
Claims 1-30 are pending in the instant application. Claim 23 is withdrawn.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed 01/13/2023, 07/23/2024 and 07/15/2025 were considered by the Examiner.
Response to Restriction/Election Requirement
Applicant’s election without traverse of the disease autism spectrum disorder and the reduced folate compound of levoleucovorin, in the reply filed on November 3rd, 2025 is acknowledged.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species is not allowable. Therefore, according to MPEP 803.02:
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability.
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.
If on examination the elected species is found to be anticipated or rendered obvious by prior art, the Markush claim and claims to the elected species will be rejected, and claims to the nonelected species will be held withdrawn from further consideration.
As the elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration.
Regarding claim 22, levoleucovorin is not indicated in the claim. However, in interest of compact prosecution the examiner considers levo-leucovorin calcium to be the elected species. Further, claim 23, further defines the reduced folate compound to be folinic acid or MTHF. As claim 23 does not indicate the elected species, the claim is withdrawn from further consideration.
Claims 1-22 and 24-30 have been examined to the extent that they are readable on the elected disease of autism spectrum disorder and the reduced folate compound, levoleucovorin. Since the elected species is not allowable, subject matter not embraced by the elected embodiment is therefore withdrawn from further consideration.
Claim Objections
Claims 9, 15, 17, 24, 27-28 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n).
Claim 9, 13, 15, 17-18, 21-22, 24 and 27 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-22 and 24-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because it is unclear whether the claims are intended to encompass a product or a process. Specifically, claim 1 recites limitations clearly directed to a product, i.e., “A composition,” but also states limitations that are clearly directed to a process, i.e., “the method comprising the step of: administering the composition.” Accordingly, it is unclear whether the claim is directed to a product or process. The overlap between these two statutory categories of invention (i.e., product and process) renders the subject matter of instant claims 1-22 and 24-30 non-statutory under 35 U.S.C. 101 because 35 U.S.C. 101 is drafted in a manner so as to set forth the statutory classes of invention in the alternative only. Please see Ex parte Lyell, 17 USPQd 1548 (Bd. Pat. App. & Inter. 1990) Id. At 1551.
Claim Rejections - 35 USC § 112(b)
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 1-22 and 24-30 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.
Claims 1-22 and 24-30 are directed to a composition comprising an effective amount of a reduced folate compound, where the composition is administered to a woman of child bearing age. It is unclear whether the claims are intending to encompass a product (i.e., a composition comprising an effective amount of a reduced folate compound) or a process of administering the preparation.
It is noted that for the purpose of applying prior art, the claims have been construed as product claims, requiring to a composition comprising an effective amount of a reduced folate compound.
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) 1-22 and 24-27 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Frye et al (US 2019/0111059 A1, published 04/18/2019)
Note, the claims are interpreted as product claims, as statements of intended use are not accorded patentable weight.
Frye teaches a composition comprising an effective amount levoleucovorin (claim 2). Frye also teaches the use of levoleucovorin to treat autism spectrum disorder (claim 12). Thus, the teachings of Frye anticipates claims 1-21 and 24-27.
Regarding claim 22, Frye also teaches levoleucovorin calcium salt (paragraph [0114]).
Claim(s) 1-21 and 24-30 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Giordano et al (US 2007/0036869 A1, published 02/15/2007).
Note, the claims are interpreted as product claims, as statements of intended use are not accorded patentable weight.
Regarding claims 1-21 and 24-27, Giordano teaches a composition comprising 5-formyl-(6S)-tetrahydrofolic acid, levoleucovorin (claim 16).
Regarding claims 28-30, Giordano teaches a composition comprising cobalamin (vitamin B12), vitamin D3, and levoleucovorin (claims 8 and 16), in a unit dosage package (paragraph [0066]). Regarding the claims “instructions for use”, see MPEP 211.05(I)(B): “For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ3d at 1864.” Therefore, the instant kit is anticipated by the prior art which is embraced by a composition of levoleucovorin, vitamin B12 and vitamin D3. Note that the claims are being construed as product claims and as such, nothing precludes the use(s) steps as claimed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Grace Kuckla whose telephone number is (703)756-5610. The examiner can normally be reached Monday-Friday 7:30-5.
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, Clinton Brooks can be reached at (571)270-7682 The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699