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 .
Status of the Claims
Per Applicant’s amendment to the claims, submitted on 09/19/2025, claim 8 is amended. Currently, claims 8-14 are pending in the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/19/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103 - Maintained
Claim(s) 8-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wright (previously referenced) in view of Yang (previously referenced).
Rejections of claims 8-14:
Applicant’s arguments are not persuasive, the rejections are hereby maintained. Applicant traverses the outstanding obviousness rejections of claims 8-14 over Wright in view of Yang for the following general reasons:
The combination of Wright and Yang does not teach or suggest all elements of the instant claims (Remarks page 5)
The claimed methods have superior and unexpected properties not taught by either Wright or Yang (Remarks page 6-7)
Administering R-ketamine for the treatment of Parkinson’s disease/syndrome, or Lewy body dementia proceeds contrary to the accepted wisdom of Wright (Remarks pages 7-8)
With regards to element (i), Applicant contends that the teachings of Wright and Yang are non-obvious over the instant claims because Wright does not teach all limitations of claim 8, and that Yang is directed to the use of R-ketamine as an antidepressant for depressive disorders which are distinct from the recited Parkinson’s disease, Parkinson’s syndrome, and Lewy body dementia recited in claim 8. While it is not contested that Wright alone does not suggest all limitations of claim 8, the rejection is predicated on a finding of obviousness over the combined teachings of both Wright and Yang. While Applicant is not explicitly incorrect that the teachings of Yang are directed towards use of R-ketamine for the treatment of depressive disorders, the teachings are useful, as a whole, when combined with the disclosure of Wright. As indicated in the previous Office Action, Wright essentially treats a patient having PD by administering racemic ketamine. While Yang, individually, teaches the use of R-ketamine as an antidepressant rather than a direct treatment for PD, Yang also teaches the mechanism of action by which R-ketamine functions, namely as a NMDA receptor antagonist. The teachings of Yang act as a relevant supplementary teaching to Wright who indicates that the same mechanism of action for racemic ketamine is what enables its ability to ameliorate PD symptoms such as involuntary movement. Furthermore, Wright indicates that a known drawback of such racemic ketamine are anesthetic side effects. Yang builds upon what is established in Wright by indicating that such side effects are as a result of S-ketamine having greater affinity for NMDA receptors over R-ketamine. It would logically follow, that a person of ordinary skill in the art would be able to apply the teachings of Yang to the method of Wright wherein isolated R-ketamine is administered for the treatment of PD in order to alleviate side effect burden in the patient being treated.
With regards to element (ii), Applicant contends that the instant invention provides unexpected results over the prior art. Applicant provides support from the specification indicating that R-ketamine administration, but not S-ketamine, in PD model mice improved the decrease in dopamine transporter (DAT) positive neurons in the striatum, and that administration of R-ketamine to Lewy body model mice showed improved a-synuclein performance. Applicant further indicates that the presented testing reveals that the neuroprotective effects of R-ketamine are mediated by TrkB receptors rather than NMDA receptors. While the results of presented testing within the specification are not explicitly disputed, they do not appear to provide an unexpected result in the context of claim 8. The teachings of Wright indicate the use of racemic ketamine for the treatment of PD, wherein Wright contends that the treatment is effective for treating PD motor symptoms because ketamine NMDA receptor antagonist. Yang reinforces Wright to the extent that Yang teaches that R-ketamine is an NMDA receptor antagonist. Yang, however, provides an expansion upon the teachings of Wright by suggesting that R-ketamine is preferable over S-ketamine because the use of S-ketamine confers several unwanted side effects. Even in arguendo if Wright and Yang were not aware of the particular mechanism of action of ketamine as presented in Applicant’s testing results, the combined teachings of both would still have provided a person of ordinary skill in the art ample motivation to treat PD using a composition of R-ketamine absent of S-ketamine.
With regards to item (iii), Applicant contends that the teachings of Wright would have led a person of ordinary skill in the art to the conclusion that S-ketamine would be preferable over R-ketamine because S-ketamine is a more potent NMDA receptor antagonist. However, this appears to be an overly narrow reading of the teachings of Wright. Wright explicitly provides that a general weakness of NMDA receptor antagonists are unwanted secondary side effects, including significant sedation which presents a barrier to use for long term outpatient therapy. Yang provides a remedy to such a problem by teaching that R-ketamine can be used over the stronger S-ketamine in order to avoid or lessen such side effects. Furthermore, a stronger NMDA receptor antagonist may not be universally beneficial in the preoperative setting. In the case of Wright, the patient administered ketamine was preoperative for a right-sided internal pulse generator (IPG) replacement. The operation required active managed anesthesia care using a sedative combination of cefazolin, midazolam, fentanyl, and propofol by infusion. While the use of racemic ketamine prior to the operation was reported to have no adverse consequences, a person of ordinary skill in the art would not necessarily default to the use of S-ketamine due to its higher side effect burden, greater sedative effects, and the potential of either of the aforementioned being potentially disruptive to, or exacerbating, the impending managed anesthetic treatment.
Double Patenting – Withdrawn
Rejections of claims 8-14:
In light of Applicant’s amendments, the rejections are hereby withdrawn. Claim 8 has been amended to remove Alzheimer’s disease from the conditions being treated by the method.
Conclusion
Claims 8-14 are rejected.
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.
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/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629