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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/11/2025 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant elected the compound
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in the reply filed 01/15/2025. Claims 1-5, 8-11 and 15-17 require further deuteration beyond the -CH(OD)SO3Na moiety of the elected species and therefore are not drawn to the elected species.
Accordingly, claims 1-5, 8-11 and 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 01/15/2025.
Response to Arguments
Note that while claims 1, 5-7, and 11-14 were rejected in the 02/11/2025 Non-Final Rejection, claim 6 has been canceled and claims 1, 5 and 11 are withdrawn for the reasons above. Accordingly, the arguments and amendments presented in the 06/11/2025 reply have only been considered with respect to claims 7 and 12-14 which are currently under examination.
Applicant’s arguments, see p. 6-7, filed 06/11/2025, with respect to the rejection of claims 7 and 12-14 under 35 U.S.C. 112(a) and have been fully considered and are persuasive. Amendments overcome the rejections. The rejection of claims 7 and 12-14 under 35 U.S.C. 112(a) and the rejection of claims 7 and 12-14 under 35 U.S.C. 112(b) of 02/11/2025 have been withdrawn.
Applicant's arguments filed 06/11/2025 with respect to the rejection of claims 7 and 12-14 under 35 U.S.C 103 have been fully considered but they are not persuasive.
Applicant first argues that there is not a reasonable expectation of success and that the art is highly unpredictable. Unpredictability in the art and evidence to such (Di Martino et al. and Aprile et al.) is acknowledged and considered. However, obviousness does not require absolute predictability, but at least some degree of predictability is required. See MPEP 2143.02(II). The teachings of Liu et al. that deuteration of metabolically labile sites can reduce metabolism and the fact that Kim et al. teaches that the hydroxymethane sulfonate moiety of GC376 is metabolically labile is sufficient to establish that there was a reasonable expectation of success in reducing metabolism of GC376 via deuteration of the hydroxymethane sulfonate moiety. Note that Di Martino et al. and Aprile et al., while indeed providing evidence against absolute predictability regarding deuteration, provide such evidence as a caveat to what are generally considered expected metabolic effects of deuteration. For example, Di Martino et al. teaches deuteration “may improve the pharmacokinetic and/or toxicity profile of drugs” (Abstract) and Aprile et al. refers to the results relied upon by applicant as “unexpected” (Title). It is clear that both references regard deuteration as reasonably expected to have specific metabolic outcomes in line with those taught by Liu et al. and that contrary outcomes are exceptions.
With respect to alleged unexpected results, the deuterated compounds of Dampalla et al. do not include the instantly claimed compound and the results therein are therefore insufficient to establish unexpected results commensurate in scope with the claimed invention.
Accordingly, the rejection of claims 7 and 12-14 under 35 U.S.C. 103 is maintained.
Conclusion
Claims 7 and 12-14 are rejected.
Claims 1-5, 8-11 and 15-17 are withdrawn.
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 JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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 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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/JED A KUCHARCZK/ Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623