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 .
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
Examiner have withdrawn all previous 112 rejections and 103 rejection in the non-final office action of 05/13/2025.
Applicant canceled claims 3,4, 5,7 and 8.
Applicant provided complaint species election of
Compound of formula I: Compound 100
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104
131
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;
Species of disease: Parkinson disease.
Examiner did not find prior art on the full scope of independent claim 1.
Therefore, election of species requirement is withdrawn.
This office action is made non-final because double patenting rejection is made.
Claims 1-2,6 10,12-14, 16-18, 20-21, 28-29 and 33-34 are examined in this office action.
Current Status of 17/614,323
This Office Action is in response to the amended claims of 09/03/2025.
Claims 1, 21 are currently amended; claims 2, 6, 16-18 and 30 are withdrawn; claim 10 and 12-14 are previously presented; claims 20, and 28-29 are original; and claim 33-34 are new.
Claims 1-2,6 10,12-14, 16-18, 20-21, 28-29 and 33-34 are examined in this office action.
Priority
The effective filing date is 05/29/2019, claims find support on provisional application no. 62/854,218.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 09/03/2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Arguments
Examiner acknowledges the receipt of applicant’s claim amendment and remarks of 09/03/2025.Examiner have reviewed these remarks and amendments.
Regarding 112 (b) and (d) rejections for claims 1,3-5,7-8,10,12-14, 20-21, 28:
Applicant argues:
The specification defines “compound” as a collections of molecules will contain molecules having deuterium at each of the positions designated as deuterium in the chemical structure. The percentage of molecule having deuterium at position at each positions designated as deuterium is at least 90%.
Examiner’s response:
Examiner agrees with applicant traversal. Therefore, the 112 rejections for 1,3-5,7-8,10,12-14, 20-21, 28 and 29 are withdrawn.
Regarding 112 rejections of claim 21, applicant amended the claim thereby rendering moot the rejection. Therefore 112 rejections of claim 21 for limitation "(vascular dementia)" and "such as Creutzfeldt-Jakob Disease" are withdrawn.
Regarding 112(b) rejections of claims 1,3-5,7-8,10, 12-14, 20-21 and 29:
Applicant cancelled claims 3-5 and 7-8.
Applicant argues:
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212
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(page 2, of remarks of 09/03/2025)
Examiner’s response:
Examiner agrees; therefore 112 (b) rejection is withdrawn.
Regarding 103 rejections:
Applicant canceled claims 3-5, and 7-8.
Applicant amended claim by deleting all compounds except for compound 100 in the claims.
Applicant traverses 103 rejections as follows:
Applicant argues
Applicant argues (page 4-5 of remarks of 09/03/2025), substitution of hydrogen with deuterium can contribute positively or negatively. Thus, office arguments regarding deuterated compound increase stability of compound of 100 is not persuasive. Furthermore, applicant cites Tung et.al and Fisher et.al to demonstrates replacing hydrogen with deuterium does not always results in metabolic stability of compounds. Thus, Tung et.al and Fisher et.al teaches away from the motivation to replace hydrogen atom with deuterium.
Examiner’s reply:
There is motivation to replace hydrogen with deuterium in compounds to increase metabolic stability. However, there is no motivation to replace hydrogen with deuterium in the specific position as in compound 100 of claim 1 as amended. Moreover, there is no motivation in the prior art to reduce nephrotoxicity by replacing hydrogen with deuterium in compound 100. Thus 103 rejection is withdrawn.
Applicant argues:
Applicant claims (page 6-8 of remarks of 09/03/2025) the specification showed unexpected and surprising results; Example 3, which states as follows: "The nephrotoxicity of Compound 100 and non-deuterated D-serine were evaluated in male Sprague-Dawley Rats. Rats received 150 mg/kg of either Compound 100 or nondeuterated D-serine (PO administration). Elevated levels of blood urea nitrogen (BUN) were seen in the non-deuterated D-serine at 8 hr and 24 hr serum samples. Elevated levels of creatinine and Gamma glutamyl transferase (GGT) were seen in the non-deuterated D-serineat 24 hr serum samples. Elevated levels of blood urea nitrogen, creatinine and GGT are suggestive of nephrotoxicity. In contrast, with Compound 100, levels of urea nitrogen, creatinine, and GGT level at 4, 8, and 24 hours were similar in comparison to control values and reference values provided by Charles River Laboratory. While nondeuterated D-serine caused an increase in levels of biomarkers of nephrotoxicity, administration of Compound 100 did not increase levels of biomarkers of nephrotoxicity".
Examiner’s response:
Applicant provided surprising and unexpected results in example 3 of the specification as well in the remarks of 09/03/2025 (page 6-8) as “While nondeuterated D-serine caused an increase in levels of biomarkers of nephrotoxicity, administration of Compound 100 did not increase levels of biomarkers of nephrotoxicity". Thus, administering of Compound 100 was surprising and unexpected because compound 100 showed less nephrotoxicity. Thus 103 rejection is withdrawn.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 10,12-13, 20-21, and 28-29 rejected on the ground of anticipatory-nonstatutory double patenting as being anticipated over claims 1 and 3-9 of U.S. Patent No. 10,668,036 B2. Claims of 09/03/2025 were use to write the double patenting rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claim 1,3-5 and 8 discloses method of treating schizophrenia (same as instant claims 1, 20-21, and 28-29) with compound 100 where each designated specifically as deuterium has least 90% incorporation of deuterium (same as instant claims 1 and 10) and 90% stereomerically pure(instant claims 1, 10) thus anticipating claims 1 and 10. Reference claim 6 disclose orally administration of compound 100 (same as instant claim 10),thus anticipating instant claim 12. Reference claims 7 and 9 teaches dosage between 1g to 4g same which fall within the range of instant claim 13, thus anticipate claim 13.
Response to Amendment
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 2 and 6 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 2 dependent on claim 1, recites variables R1 and R2, but amended claim 1 does not have variables R1 and R2. There is insufficient antecedent basis for variables R1 and R2 in independent claim 1. As drafted “R1 and R2” in claim 1 renders metes and bounds of claim 2 undefined. Hence renders claim 2 indefinite.
Claim 6 dependent on claim 1, recites variables Y2a and Y2b, but amended claim 1 does not have variables Y2a and Y2b. There is insufficient antecedent basis for variables Y2a and Y2b in independent claim 1. As drafted “Y2a and Y2b” in claim 6 renders metes and bounds of claim 6 undefined. Hence renders claim 6 indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 6 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Dependent Claims 2 recites limitation “R1 and R2”, which fails to properly further limit independent claim 1, since claim 1 has no limitations drawn to deuterated compound of formula Ia. Thus claim 2 rejected under 35 U.S.C. 112(d)
Dependent Claims 6 recites limitation “Y2a and Y2b”, which fails to properly further limit independent claim 1, since claim 1 has no limitations drawn to deuterated compound of formula Ia. Thus claim 6 rejected under 35 U.S.C. 112(d)
Conclusion
Claims 1, 2, 6, 10,12-13, 20-21, and 28-29 are rejected.
Claims 14, 16-18, 30 and 33-34 and is objected for depending on rejected claims.
Claim 1 is free of prior art for the reason stated in paragraph [20] of this office action.
Grabowski (US 4582931) teaches compound 100 (2-deutero-D-serine) (col 1, In 25-32) but Grabowski does not teach the use of compound 100 (2-deutero-D-serine) to treat symptoms associated Parkinson disease. A person skilled in the art would not be able to envision using, 2-deutero-D-serine for treating diseases or disorders stated in claim 1, thus Grabowski is a close art not a prior art.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625