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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/12/2026 has been entered.
Priority
Instant application 17/615,037 filed on 11/29/2021 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 1-10, 21-23, 25 and 30-32 are pending.
Response to Arguments/Amendments
The amendment filled on 03/12/2026 has been entered.
Applicant amended claims 1.
Applicant cancelled claim 17.
Applicant added new claims 30-32.
Applicant's arguments filed 03/12/2026 have been fully considered and are persuasive. Therefore, all double patenting rejections of record are withdrawn.
However, upon further consideration, new grounds of rejections are made below.
Claim Interpretation
Applicant amended claim 1 to recite a method of treating pain, the method comprising administering to a subject in need thereof an effective amount of Compound 100, wherein the Compound 100 shows reduced nephrotoxicity compared to administration of an equivalent dose of non-deuterated D-serine”.
The newly adder clause recite a result to be achieved. The recited “reduced nephrotoxicity compared to administration of an equivalent dose of non-deuterated D-serine” accrue from a process step of administering compound 100 and is considered a characteristic feature of the claimed therapeutic method.
It should be noted that claims of US Patent 10,668036, claims of US Patent 12,029712, and claims of Application No. 18/731,580 recite the same compound and/or methods of using the same compound as instant claims (compound 100). Further the previous patents recite the same therapeutically effective amount of compound 100 as recited in instant claims.
It is noted that MPEP 2112 discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
Election/Restrictions
Claim 10 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/15/2025.
Regarding species election, Applicant’s election, without traverse, of
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in the reply filed on 04/15/2025 is acknowledged.
Claims 3, 5, 6 and 7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/15/2025.
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, 2, 4, 21-23, 25 and 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of US Patent 10668036 in view of Ito (Ito et al., J Anesth (2014) 28:228–234) and in view of Kaur (Sukhninder Kaur and Monika Gupta, Glob J Pharmaceu Sci 1(4): GJPPS.MS.ID.555566 (2017)).
The claims of US Patent 10668036 recite the elected species (compound 100) for treating schizophrenia:
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Regarding instant claim 31, the claims of US Patent 10668036 recite that compound 100 is at least about 90% stereomerically pure (see claim 1).
Regarding instant claims 30, the claims of US Patent 10668036 recite the same amounts of compound 100 as recited in instant claims (see claims 7 and 9):
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Regarding instant claims 32, the claims of US Patent 10668036 recite:
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The claims of US Patent 10668036 are silent about treating pain.
Ito teaches that activation of the glycine sites of NMDA receptors by an administration of D-serine reduces pain sensations on both acute and tonic pain in rats (see the last paragraph on page 233 and Figures 1 and 2):
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Ito is using formalin test that mimics the type of pain that naturally occurs following damage to or injury of tissue (see page 229, last paragraph).
Since the claims of US Patent 10668036 recite the elected species (compound 100) for treating schizophrenia and Ito teaches a method of treating pain comprising administering to a subject in need D-serine - Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace schizophrenia for pain to arrive at the instant method.
In addition, since Ito teaches a method of treating pain comprising administering D-serine, a skilled person would have been motivated to substitute D-serine used by Ito for the deuterated compound 100 recited in claims of US Patent 10668036 because Kaur teaches that deuteration “is an effective tool for the enhancement of drug’s metabolic profile. Selective replacement of hydrogen with deuterium leads to increased bond strength which in turn increases the biological half-life and thus metabolic stability of the drug. Apart, deuterium substitution may also result in metabolic shunting leading to reduced exposure of vital organs to undesirable/toxic metabolites or increased exposure to desired active metabolites.” (see abstract)
Further, since the claims of US Patent 10668036 recite effective amounts of compound 100 for treating schizophrenia, a person of ordinary skill in the art would be motivated to use the same amounts for treatments of pain because a skilled artisan would start with the dose that is known to be both safe and effective.
Claims 1, 2, 4, 8, 9, 21-23, 25 and 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of US Patent 10668036 in view of Ito (Ito et al., J Anesth (2014) 28:228–234 ) and in view of Kaur (Sukhninder Kaur and Monika Gupta, Glob J Pharmaceu Sci 1(4): GJPPS.MS.ID.555566 (2017)) and further in view of Apkarin (Apkarin (US-20140213621-A1).
The recitation of claims of US Patent 10668036 and the teachings of Ito and Kaur have been discussed above and those teachings are incorporated herein by reference.
Regarding instant claim 8 and 9, the claims of US Patent 10668036 and the teachings of Ito and Kaur are silent about a combination with tramadol.
The deficiencies are cured by Apkarin.
Apkarin teaches a method of treating pain (paragraph 0003):
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Apkarin teaches D-serine may be used:
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Apkarin teaches combination therapies including opiates, NSAIDs, and cox-2 inhibitors (see paragraphs [0037] and [0038]):
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Since the claims of US Patent 10668036 recite the elected species (compound 100) for treating schizophrenia and Ito teaches a method of treating pain comprising administering to a subject in need D-serine - Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace schizophrenia for pain to arrive at the instant method.
In addition, since Ito teaches a method of treating pain comprising administering D-serine, a skilled person would have been motivated to substitute D-serine used by Ito for the deuterated compound 100 recited in claims of US Patent 10668036 because Kaur teaches that deuteration “is an effective tool for the enhancement of drug’s metabolic profile. Selective replacement of hydrogen with deuterium leads to increased bond strength which in turn increases the biological half-life and thus metabolic stability of the drug. Apart, deuterium substitution may also result in metabolic shunting leading to reduced exposure of vital organs to undesirable/toxic metabolites or increased exposure to desired active metabolites.” (see abstract).
Further, since the claims of US Patent 10668036 recite effective amounts of compound 100 for treating schizophrenia, a person of ordinary skill in the art would be motivated to use the same amounts for treatments of pain because a skilled artisan would start with the dose that is known to be both safe and effective.
Furthermore, regarding instant claims 8 and 9, since Apkarin teaches combination therapies - Applying KSR prong (A) - Combining prior art elements according to known methods to yield predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine 2-deutero-D-serine with tramadol, a known analgesic, and use it for treating pain. A person of ordinary skill in the art would expect a cumulative effect.
Claims 1, 2, 4, 21-23, 25 and 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-25 of US Patent 12029712 in view of Ito (Ito et al., J Anesth (2014) 28:228–234) and in view of Kaur (Sukhninder Kaur and Monika Gupta, Glob J Pharmaceu Sci 1(4): GJPPS.MS.ID.555566 (2017)).
The claims of US Patent 12029712 recite:
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and
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Regarding instant claim 31, the claims of US Patent 12029712 recite that compound 100 is at least about 90% stereomerically pure (see claim 1).
Regarding instant claim 30, the claims of US Patent 12029712 recite overlapping ranges:
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Regarding instant claim 32, the claims of US Patent 12029712 recite:
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The claims of US Patent 12029712 are silent about treating pain.
Ito teaches that activation of the glycine sites of NMDA receptors by an administration of D-serine reduces pain sensations on both acute and tonic pain in rats (see conclusion and Figures 1 and 2):
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Ito is using formalin test that mimics the type of pain that naturally occurs following damage to or injury of tissue (see page 229, last paragraph).
Since the claims of US Patent 12029712 recite the elected species (compound 100) for treatments and enhancing NMDA receptor function, and Ito teaches a method of treating pain comprising administering to a subject in need D-serine - Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace schizophrenia for pain to arrive at the instant method.
In addition, since Ito teaches a method of treating pain comprising administering D-serine, a skilled person would have been motivated to substitute D-serine used by Ito for the deuterated compound 100 recited in claims of US Patent 12029712 because Kaur (Sukhninder Kaur and Monika Gupta, Glob J Pharmaceu Sci 1(4): GJPPS.MS.ID.555566 (2017)) teaches that deuteration “is an effective tool for the enhancement of drug’s metabolic profile. Selective replacement of hydrogen with deuterium leads to increased bond strength which in turn increases the biological half-life and thus metabolic stability of the drug. Apart, deuterium substitution may also result in metabolic shunting leading to reduced exposure of vital organs to undesirable/toxic metabolites or increased exposure to desired active metabolites.” (see abstract).
Further, since the claims of US Patent 12029712 recite effective amounts of compound 100 for treatments and enhancing NMDA receptor function, a person of ordinary skill in the art would be motivated to use the same amounts for treatments of pain because a skilled artisan would start with the dose that is known to be both safe and effective.
Claims 1, 2, 4, 8, 9, 21-23, 25 and 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-25 of US Patent 12029712 in view of Ito (Ito et al., J Anesth (2014) 28:228–234) and in view of Kaur (Sukhninder Kaur and Monika Gupta, Glob J Pharmaceu Sci 1(4): GJPPS.MS.ID.555566 (2017)) and further in view of Apkarin (US-20140213621-A1).
The recitation of claims of US Patent 12029712 and the teachings of Ito and Kaur have been discussed above and those teachings are incorporated herein by reference.
Regarding instant claim 8 and 9, the claims of US Patent 12029712 and the teachings of Ito and Kaur are silent about a combination with tramadol.
The deficiencies are cured by Apkarin.
Apkarin teaches a method of treating pain (paragraph 0003):
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Apkarin teaches D-serine may be used:
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Apkarin teaches combination therapies including opiates, NSAIDs, and cox-2 inhibitors (see paragraphs [0037] and [0038]):
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Since the claims of US Patent 12029712 recite the elected species (compound 100) for treatments and enhancing NMDA receptor function, and Ito teaches a method of treating pain comprising administering to a subject in need D-serine - Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace schizophrenia for pain to arrive at the instant method.
In addition, since Ito teaches a method of treating pain comprising administering D-serine, a skilled person would have been motivated to substitute D-serine used by Ito for the deuterated compound 100 recited in claims of US Patent 12029712 because Kaur teaches that deuteration “is an effective tool for the enhancement of drug’s metabolic profile. Selective replacement of hydrogen with deuterium leads to increased bond strength which in turn increases the biological half-life and thus metabolic stability of the drug. Apart, deuterium substitution may also result in metabolic shunting leading to reduced exposure of vital organs to undesirable/toxic metabolites or increased exposure to desired active metabolites.” (see abstract).
Further, since the claims of US Patent 12029712 recite effective amounts of compound 100 for treatments and enhancing NMDA receptor function, a person of ordinary skill in the art would be motivated to use the same amounts for treatments of pain because a skilled artisan would start with the dose that is known to be both safe and effective.
Furthermore, regarding instant claims 8 and 9, since Apkarin teaches combination therapies - Applying KSR prong (A) - Combining prior art elements according to known methods to yield predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine 2-deutero-D-serine with tramadol, a known analgesic, and use it for treating pain. A person of ordinary skill in the art would expect a cumulative effect.
Claims 1, 2, 4, 21-23, 25 and 30-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 9-13, 21-28 of copending Application No. 18/731,580 (reference application) Ito (Ito et al., J Anesth (2014) 28:228–234) and in view of Kaur (Sukhninder Kaur and Monika Gupta, Glob J Pharmaceu Sci 1(4): GJPPS.MS.ID.555566 (2017)).
The claims of Application No. 18/731,580 recite a pharmaceutical composition comprising compound 100 (the instant elected species):
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wherein
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Regarding instant claim 30, the claims of Application No. 18/731,580 recite overlapping ranges:
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Regarding instant claim 31, the claims of Application No. 18/731,580 recite that compound 100 is at least about 90% thermometrically pure (see claim 1).
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Regarding instant claim 32, the claims of Application No. 18/731,580 recite:
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The claims of Application 18/731,580 do not recite a method of treating pain.
Ito teaches that activation of the glycine sites of NMDA receptors by an administration of D-serine reduces pain sensations on both acute and tonic pain in rats (see conclusion and Figures 1 and 2):
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Ito is using formalin test that mimics the type of pain that naturally occurs following damage to or injury of tissue (see page 229, last paragraph).
Since the claims of Application 18/731,580 recite a pharmaceutical composition comprising compound 100 (instant elected species), and Ito teaches a method of treating pain comprising administering to a subject in need D-serine - Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute D-serine used by Ito for the deuterated compound 100 recited in claims of Application 18/731,580 because Kaur teaches that deuteration “is an effective tool for the enhancement of drug’s metabolic profile. Selective replacement of hydrogen with deuterium leads to increased bond strength which in turn increases the biological half-life and thus metabolic stability of the drug. Apart, deuterium substitution may also result in metabolic shunting leading to reduced exposure of vital organs to undesirable/toxic metabolites or increased exposure to desired active metabolites.” (see abstract).
Further, since the claims of Application 18/731,580 recite compositions comprising effective amounts of compound 100, a person of ordinary skill in the art would be motivated to use the same amounts for treatments of pain because a skilled artisan would start with the dose that is known to be both safe and effective.
Claims 1, 2, 4, 8, 9, 21-23, 25 and 30-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 9-13, 21-28 of copending Application No. 18/731,580 (reference application) Ito (Ito et al., J Anesth (2014) 28:228–234) and in view of Kaur (Sukhninder Kaur and Monika Gupta, Glob J Pharmaceu Sci 1(4): GJPPS.MS.ID.555566 (2017)) and further in view of Apkarin (US-20140213621-A1).
The recitation of claims of Application No. 18/731,580 and the teachings of Ito and Kaur have been discussed above and those teachings are incorporated herein by reference.
Regarding instant claim 8 and 9, the claims of Application 18/731,580 and the teachings of Ito and Kaur are silent about combination with tramadol.
The deficiencies are cured by Apkarin.
Apkarin teaches a method of treating pain (paragraph 0003):
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Apkarin teaches D-serine may be used:
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Apkarin teaches combination therapies including opiates, NSAIDs, and cox-2 inhibitors (see paragraphs [0037] and [0038]):
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Since the claims of 18/731,580 recite a pharmaceutical composition comprising compound 100 (instant elected species) and Ito teaches a method of treating pain comprising administering to a subject in need D-serine - Applying KSR prong (B) - Simple substitution of one known element for another to obtain predictable results, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute D-serine used by Ito for the deuterated compound 100 recited in claims of Application 18/731,580 because Kaur teaches that deuteration “is an effective tool for the enhancement of drug’s metabolic profile. Selective replacement of hydrogen with deuterium leads to increased bond strength which in turn increases the biological half-life and thus metabolic stability of the drug. Apart, deuterium substitution may also result in metabolic shunting leading to reduced exposure of vital organs to undesirable/toxic metabolites or increased exposure to desired active metabolites.” (see abstract).
Further, since the claims of Application 18/731,580 recite compositions comprising effective amounts of compound 100, a person of ordinary skill in the art would be motivated to use the same amounts for treatments of pain because a skilled artisan would start with the dose that is known to be both safe and effective.
Furthermore, regarding instant claims 8 and 9, since Apkarin teaches combination therapies Applying KSR prong (A) - Combining prior art elements according to known methods to yield predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine 2-deutero-D-serine with tramadol, a known analgesic, and use it for treating pain. A person of ordinary skill in the art would expect a cumulative effect.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/I.S./Examiner, Art Unit 1621
/GEORGE W KOSTURKO/ Primary Examiner, Art Unit 1621
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