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 .1
Status of Claims
Claims 29 and 31-59 are pending.
Election/Restrictions
Applicant’s election of the species diabetes (disease species) and D-amino acid (modulating agent) in the reply filed on April 27, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 29, 31-35, and 42-49 read upon the elected species.
Information Disclosure Statement
The information disclosure statements (IDS)s submitted 4/18/2025 and 1/10/2024 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Relevant art US 9339482 B2 is listed on the PTO-892 form. The ‘482 patent is the issued patent of cited prior art US 20150150836 A1 (aka US 836) of the novelty rejection below.
Claim Objections
Claim(s) 29, 32, 44 and 48 is/are objected to because of the following informalities:
Line 3 of claim 29 recites “the amount of a D-amino acid. . . . “ Because this is the first occurrence of “amount” it should be preceded by “an.”
Line 2 of claim 32 recites “the glucose level in blood.“ Because this is the first occurrence of “glucose level in blood” it should be preceded by “a”.
Line 2 of claim 44 recites “the source. . . . “ Because this is the first occurrence of “source” it should be preceded by “a.”
Line 2 of claim 48 recites “the group consisting of . . . . “ Because this is the first occurrence of “group” it should be preceded by “a.” Appropriate correction is required.
Claim Interpretation
Claim 29 and dependent method claims recite functional descriptive language stating they are directed to methods of “modulating carbohydrate metabolism and/or blood pressure;” “lowering of blood pressure;” modulating blood glucose levels; “improvement in carbohydrate metabolism;” modulating section/action of insulin and/or glucagon; and modulation of diabetes and complications thereof.
The claimed method comprises the step of administering a claimed modulating agent (a D-amino acid such as D-serine) to a subject. Accordingly, prior art disclosing the administration of D-amino acid(s), such as D-serine to a subject will inherently possess the modulation of carbohydrates and blood pressure as claimed, whether such functionally descriptive limitations are explicitly taught or not.
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.
Claims 29, 31-35, and 42-49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20150150836 A1.2
US 836 is cited on the IDS dated 1/10/2024 as Ref. B2.
Regarding claims 29, 31-35, and 42-49, US 836 teaches a method of treating dysregulated blood glucose disorder (i.e. modulation of carbohydrate metabolism as claimed) in a mammal subject comprising administering an NMDA receptor activator, such as the D-amino acid, D-serine (see claims 1-2 and 4). Further, US 836 teaches the dysregulated blood glucose disorder is hyperglycemia caused by various conditions, including insulin resistance/deficiency and/or diabetes. See claims 6-9.
While US Pub 836 explicitly teaches the modulation of carbohydrate metabolism as claimed above, such limitation explicitly taught and the modulation of blood pressure not explicitly taught, both would be inherent to any prior art teaching a method of administering a D-amino acid to a subject, as all subjects would experience carbohydrate/blood pressure modulated upon administration of a D-amino acid.
Accordingly, with regard to claim 31 and independent claim 49, and the modulation/lowering of blood pressure upon administration of a D-amino acid (D-serine), as US 836 teaches the administration of D-serine to a subject, the claim is anticipated, whether or not the prior art explicitly recites lowering/modulation of blood pressure.
With regard to claim 35 requiring improvement of carbohydrate metabolism, Applicant’s specification states a type of carbohydrate metabolism in need of improvement/modulation, is diabetes, where metabolism or transport of carbohydrates in vivo is abnormal, (i.e. abnormal body glucose levels exhibited) leading a variety of related diseases. See paragraph 7 of specification. US 836 teaches the treatment of diabetes as a dysregulated blood glucose disorder. Therefore, such diabetes treatment anticipates improving carbohydrate metabolism. Additionally, the improvement of carbohydrate metabolism in a subject administered D-serine, would be inherent in the US 836 disclosure, whether explicitly recited or not.
Regarding claims 42-43, US Pub 835 teaches where the carbohydrate metabolism is by secretion and/or insulin action; insulin resistance/sensitivity; or glucose tolerance. See claims 6-9.
Regarding claim 44, that claims the source of the D-amino acid is symbiotic bacteria, this is not explicitly taught by US 836. However, if the composition (in this case the D-amino acid, D-serine) is physically the same, regardless of the source, it must have the same properties as those claimed. See MPEP 2112.01 (II). 3 As US 836 teaches D-serine, a known D-amino acid, it anticipates claim 44, regardless of the bacterial source claimed.
Regarding claims 45-48, where the subject has diabetes, complications thereof, such as neuropathy and cardiovascular disease such as arteriosclerosis, US Pub 836 teaches the treatment of diabetes, (defined at the specification’s paragraph 7 as a carbohydrate metabolism disorder), where such treatment would entail treatment of known hyperglycemic conditions, such as impaired vision, neuropathy and cardiovascular dysfunction. Id. at paragraph 3 of US 836.
Conclusion and Correspondence
In summary, no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
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, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 CONTINUING DATA
This application is a 371 of PCT/JP2022/020833 05/19/2022
FOREIGN APPLICATIONS
JAPAN 2021-084972 05/19/2021
2 Similar to the Solution of the Problem of the examined invention, starting at paragraph 8 of the Applicant’s specification noting the study of DAO -/- mice (lacking the gene to encode D-amino acid oxidase (DAO) thought to metabolize D-amino acid levels in subjects’ in vivo, paragraphs 47-52 of US 083, discuss D-Amino Acid Oxidase (DAO) to Inhibitors to raise levels of D-serine by blocking its metabolism by inhibiting the enzyme DAO.
3 II. COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES
"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
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