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 .
DETAILED ACTION
Status of the Claims
Claims 1-3, 6, 11-12, 15, 20, 24-26, 29-30, 36-37, 40, 44, 49, 53, and 56 are pending. Claims 1-3, 6, 11-12, 15, 20, 44, 49, and 53 are withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable. Claims 24-26, 29-30, and 56 are examined on their merits.
Information Disclosure Statement
The Information Disclosure Statements filed on March 30th 2026 and December 23rd 2025 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
35 U.S.C. § 102 Rejections Overcome by Amendment
Applicant’s amendment to claim 24 in the response filed on March 30th 2026 is acknowledged. Applicant has amended claim 24 to require that the patient receiving anesthesia is receiving the anesthesia for a surgical operation. As Heerdt does not explicitly teach patients undergoing surgery, the 102 rejections over claims 24-26, 29-30, and 56 are withdrawn.
35 U.S.C. § 103 Rejections Necessitated by Amendment
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 24-26, 29-30, and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Heerdt (Heerdt et al., Anesthesiology, 125(6), (2016), 1136-1143) in view of NCT01338935 (NCT01338935, Phase I Clinical Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of CW002 (CW002), Feb 4 2014) and Prabhakar (Prabhakar et al., Novel drug development for neuromuscular blockade. J Anaesthesiol Clin Pharmacol. 2016 Jul-Sep;32(3):376-8).
Claims 24-26, 29-30, and 56 are directed towards applicant’s elected method, i.e. a method of inducing paralysis or neuromuscular blockade and recover therefrom comprising:
Administering 0.14 mg/kg of RP1000 (commonly referred to as CW002 in the art) to a human patient under inhaled anesthesia
Effecting a spontaneous recovery (defined as a measured train-of-four ratio of at least 0.9) from the paralysis/NMB in the absence of an RP1000 antagonist
wherein that the patient receiving anesthesia is receiving the anesthesia for a surgical operation.
Heerdt, teaches the administration of CW002 (i.e. RP1000) to subjects anesthetized with inhaled sevoflurane/nitrous oxide, administered at a dose of 0.14 mg/kg (Heerdt, Abstract, Method).
Heerdt further teaches that the patients receiving administration spontaneously recover to a train-of-four ratio of 0.9 in a time period of 59-86 minutes without the aid of an antagonist (Heerdt, Abstract, Results).
Heerdt does not explicitly teach a patient population undergoing surgery. However, one of ordinary skill in the art would have a reasonable expectation of success in administering Heerdt’s method to a patient population undergoing surgery, because the Phase I study in which Heerdt reported the results thereof was intended to prove RP1000 (CW002)’s usefulness in effecting spontaneous recovery specifically so it could be used in a surgical setting. See NCT01338935:
This research is being done because CW002 is expected to act quickly and to provide a muscle block of intermediate (not too long, not too short) duration. The researchers would like to test increasing doses of CW002 that can be given without causing severe side effects. If shown to be both safe and effective, such a compound would be useful in surgical procedures and could improve future anesthetic care.
[NCT01338935, pg. 1-2]
Furthermore, the entire class of drugs belonging to the class of fumarates, affecting a reversible neuromuscular blockade, are intended for the sue in surgical settings (Prabhakar, pg. 376-377, Fumarates, Conclusion).
One of ordinary skill in the art would therefore have a reasonable expectation of success in using Heerdt’s method in a patient population undergoing surgery, and claims 24-26, 29-30, and 56 are prima facie obvious.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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, Jeffrey Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
Prosecution Insights