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 .
This is a Final Office Action.
Election/Restrictions
Applicant’s election of Group (I) in the reply filed on January 14, 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)).
Group (I), drawn to compounds of formula (I) and compositions thereof, embraced by claims 1-11, 13 and 20 was elected by Applicant. Applicant has not pointed to any errors in the Examiner’s analysis of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Applicant elected the following species:
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117
621
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249
374
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,
and indicated claims 1-9, 11, 13-17 and 19-22 read on said species. However, claims 14-17, 19, 21 and 22 are not within Group (I).
Claims 1-5, 7-9, 11 and 13-23 are pending and claims 1-5, 7-9, 11, 13 and 20 are under examination. Claim 23 is a new claim and withdrawn based on the species election. Claims 14-19 and 21-23 are withdrawn due to the restriction requirement.
Specification
The substitute specification filed April 3, 2025 has been entered because it does conform to 37 CFR 1.125(b) and (c).
Claim Rejections - 35 USC § 112
The rejection of claims 1-9, 11, 13 and 20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the term “precursor” is withdrawn based on the amendments.
The rejection of claims 1-9, 11, 13 and 20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the term “metabolite” is withdrawn based on the amendments.
The rejection of claims 2-7, 9 and 11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the term “preferably” is withdrawn based on the amendments.
The rejection of claims 1-9, 11, 13 and 20 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description requirement for failing to provide sufficient written basis for the scope of precursors and metabolites, is withdrawn based on the amendments.
Claim Rejections - 35 USC § 102
The rejection of claim(s) 1-9, 11, 13 and 20 rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yang et al. (US 11866452) is withdrawn based on Applicant’s statement that the ‘452 patent were commonly owned by the same person or entity not later than the effective filing date of the claimed invention, see the response received on May 20, 2026, page 25 of 27.
The rejection of claim(s) 1-9, 11, 13 and 20 rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yang et al. (US 20240109919) is withdrawn based on Applicant’s statement that the ‘919 publication were commonly owned by the same person or entity not later than the effective filing date of the claimed invention, see the response received on May 20, 2026, page 25 of 27.
A declaration under 37 C.F.R. § 1.132 was submitted by inventor Qianjiao Yang, which were not considered for the 102(a)(2) rejection since the statement submitted sufficed to overcome the rejection. However, said declaration will be addressed below for the double patenting rejections.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1-5, 7-9, 11, 13 and 20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11866452. Although the conflicting claims are not identical, they are not patentably distinct from each other for the same reason provided in the previous 102 rejection, which has been added below.
The ‘452 patent teaches the following species, see columns 19-20:
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320
815
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. This compound is the same as the elected species, except for when R3= CD3 versus CH3 in the ‘452 patent. Based on natural abundance of hydrogen, the elected species is inherently present. The compositions are taught in column 116.
Claim(s) 1-5, 7-9, 11, 13 and 20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12577260 (previously over co-pending application 18240546). Although the conflicting claims are not identical, they are not patentably distinct from each other for the same reason provided in the previous double patenting rejection above.
Applicant traverses the above rejections by stating, “The double patenting rejection similarly fails because the cited prior art does not disclose or inherently disclose the claimed deuterated compounds. For the reasons set forth above, the prior art non-deuterated compounds are not the same invention, and there is no overlapping scope that would give rise to double patenting.
The claimed compounds represent a significant and non-obvious departure from the compounds of the cited patent. The high level of isotopic enrichment (at least 90%) at specific positions is not a mere "background" variation but a technical feature that requires specific synthetic intent and provides unique properties.
As supported by the attached Declaration of the First Inventor, the compounds of the cited patent do not inherently contain or teach the specific deuterated species of the present claims in a manner that would render the present claims a "double" of the prior disclosure. The background levels of deuterium in the prior art are negligible and do not provide a basis for a double patenting rejection where the claims require high-purity enriched isotopes.”
This is not persuasive.
The claims do not discriminate between the natural abundance level of deuterium versus the level which Applicant and the inventor in the declaration state is found in the elected species.
The Examiner agrees with the inventor that the NMR did not provide a singlet of 3 protons for the methoxy group at the R3 variable as compared and shown in the declaration for the deuterated compound versus the non-deuterated compound at R3. However, this is just for the elected species. The affidavit should be commensurate in scope with the claims, which it’s not.
Thus, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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