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 .
DETAILED ACTION
This office action is in response to applicant’s reply filed on August 15, 2025.
Restrictions/Elections.
Applicant's election with traverse of Group II (Claims 1, 3-6, 8-10 and 14 in the reply filed on August 15, 2025, is acknowledged.
The traversal is on the ground(s) that all the groups form a single inventive concept. This is not found persuasive because for example Group V relates to a method of screening substances.
The requirement is still deemed proper and is therefore made FINAL.
Applicant election of the following species:
1- Ibuprofen as the D-serine transport modulator, and
2- phenylglycine analog as the second D-serine transport modulator,
Is acknowledged.
Status of Claims
Claims 1, 3-10, 14-17, 22 and 24-29 are currently pending and are the subject of this office action.
Claim 15-17, 22 and 24-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 15, 2025.
Claims 1, 3-6, 8-10 and 14 are presently under examination.
The following species are under examination:
1- Ibuprofen as the D-serine transport modulator, and
2- phenylglycine analog as the second D-serine transport modulator.
Priority
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Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claim Objections
Claim 10 repeats several compounds. For example, the compounds: L-serine, L-threonine, L-alanine, L-cysteine and phenylglycine analog appear twice in claim 10. Correction is required.
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.
Claim 10 is 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 10 recites the following compounds:
Benzilserine, benzilcysteine and S-benzil-L-cysteine.
A search of the literature found no evidence of any structure associated with these names.
The metes and bounds of the claims are not clearly defined.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 9 and 10 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claim 9 recites “glycine and its derivatives”.
M.P.E.P. #2163 states: “An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention….one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process”.
M.P.E.P. 2163 II-A-3-a ii) states: “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i) (C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v.Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir.2004)(“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir.2004)(Claims directed to PTFE dental floss with a friction-enhancing coating were not supported by a disclosure of a microcrystalline wax coating where there was no evidence in the disclosure or anywhere else in the record showing applicant conveyed that any other coating was suitable for a PTFE dental floss.)”.
The specification does not describe nor disclose any “glycine derivative”
The prior art does not teach or disclose any “glycine derivative”.
Even though the term “derivative” is well known in the chemical art, when it comes to specific “derivatives” of a specific compound like glycine, the skilled in the art will not be able to recognize, without any guidance from the specification and the prior art, if a specific compound qualifies or not as a derivative of glycine.
The term “derivative” corresponds in some undefined way to specifically instantly disclosed chemicals. None of these meet the written description provision of USC 112, first paragraph, due to lack of chemical structural information for what they are since chemical structures are highly variant and encompass a myriad of possibilities. The skilled artisan cannot envision the detailed chemical structure encompassed by “glycine derivatives”.
Given the broad scope of the subject claimed matter, Applicant has not provided sufficient written description that would allow the skilled artisan to recognize that Applicant was in possession of the claimed structures encompassed by “glycine derivatives”.
Similar rejection is made for claim 10 for: “phenylglycine analog”, and “alpha-methyl-DL-tryptophan and its derivatives”
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.
Claim(s) 1, 3-6, 8-9 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sena (WO 2016/156647, October 6, 2016, English translation of the DESCRIPTION is provided).
NOTE: paragraph [0062] of the specification teaches that “diseases associated with an increase in D-serine levels” are among others: kidney diseases involved in benign prostatic hyperplasia. It is not clear the meaning of the word “involved”, as such in its broadest interpretation it is going to assume that benign prostatic hyperplasia is considered a kidney disease (i.e. a disease associated with an increase in D-serine levels)
For claims 1,3-6, 8-9 and 14, Sena teaches a method of treating benign prostatic hyperplasia (BPH) (a kidney disease according to paragraph [0062] of the specification, see also above NOTE) comprising the administration of a composition comprising ibuprofen (see page 2 of the translation under Object of the Invention).
The prior art is silent regarding:
“The D-serine transport modulator (i.e. ibuprofen) modulates intracellular and extracellular D-serine transport by a D-serine transport protein, wherein the D-serine transport protein comprises one or more selected from a first group of D-serine transport proteins consisting of SMCT family, GLUT5, CAT1, THTR2 and SNAT2” as in claim 1, and “wherein the D-serine transport protein further comprises one or more selected from a second group of D-serine transport proteins consisting of ASCT family, Asc1, PAT1 and ATB” as in claim 3.
The prior art is also silent regarding the following statements:
“wherein the D-serine transport modulator (i.e. ibuprofen) modulates a D-serine level in a cell, in a tissue, in an organ, or in body fluid” as in claim 4.
”wherein the D-serine transport modulator (i.e. ibuprofen) modulates a D-serine level in blood and/or in urine” as in claim 5,
“wherein the D-serine transport modulator (i.e. ibuprofen) inhibits D-serine transport into a cell by acting on the D-serine transport protein” as in claim 6, and
“wherein the D-serine transport modulator (i.e. ibuprofen) is a substrate or inhibitor of the D-serine transport protein” as in claim 8.
However, it seems like the above statements describe an inherent property of ibuprofen as evidenced by the specification (see for example Figure 13, Figure 14 and paragraph [0036]). Apparently, Applicant discovered a new and previously unknown property of ibuprofen.
MPEP 2112 I states:
“The discovery 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.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
MPEP 2112.01 I recites:
“Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
MPEP 2112.01 II states:
"Products of identical chemical composition cannot 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."
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
September 9, 2025.