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
This action is FINAL.
Status of Claims
Claims 1-10 are pending.
Priority
Instant application 17914515, filed 09/26/2022 claims benefit as follows:
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Response to Applicant Amendment/Argument
In view of Applicant arguments and amendments all rejections and objections are withdrawn.
In view of Applicant’s approved terminal disclaimer, the double patenting rejection is withdrawn.
New Rejection Necessitated by Amendment
Claim Rejection – 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-10 are rejected under 35 U.S.C. 103(a) as being unpatentable over the article to Hall (“Hall”, Tet Let. 1984, 25(33), 3537-3538, made of record on the IDS) as evidenced by the article to Coppins (made of record in the non-final) in view of Sato et al (“Sato”, made of record on the IDS) and in view of Laycock (“Laycock”, made of record on the IDS, 1995).
With respect to claim 1, Hall teaches hydrolyzing 10 and 12 using 0.1 M HCl, at 100 degrees C for 5 minutes). Here using the broadest reasonable interpretation 0.1 M HCl is viewed as mild acid. Evidence for this interpretation is provided for example in the specification at page 6, “[p]referably, the mild hydrolysis is by contacting the quantity of GTX6 with a dilute strong acid…[m]ore preferably, the strong acid is hydrochloric acid”. Since 0.1 M HCl is dilute strong acid it meets the claim limitation since this concentration is viewed as a mild acid. Claims 7-8 are given weight since they involve the hydrolysis step. However, Hall teaches 0.1 M HCl which is hydrochloric acid and is a dilute strong acid.
Further, Hall teaches that these conditions are sufficient to hydrolyze the R4 group of Hall from -SO3 to H. Thus, the skilled artisan is aware that these conditions will hydrolyze the N-S bond. Hall teaches chromatographic separation using some acetic acid under neutral or weakly acidic conditions (3538 bottom) using BioGel P-2.
Hall fails to teach an example where GTX6 is converted to neoSTX. It should be noted that newSTX (neosaxitoxin) is a final product with utility as an inhibitor (see evidentiary reference). Thus, there is motivation to choose to modify this compound.
Sato teaches the formation of neosaxitoxin from GTX1 and GTX4 (abstract). Sato teaches reductive desulphonation and performing the reaction at pH 7.4 in a phosphate buffer using glutathione as the thiol reagent. Sato teaches acetic acid as a solvent (see for example col 1, 1787).
Applying KSR prong A one could combine the teachings of Hall with Sato both teaching a different step of independent claim 1 – hydrolysis and desulfonation. One skilled in the art would predict success combining known steps to known compounds.
The combination fails to teach or suggest a dithiol.
Laycok teaches an alternative thiol reagent to glutathione, that being dithiothreitol at page 123 for example.
Applying KSR prong B, it would have been prima facie obvious to substitute one known thiol reagent for another both know to desulfonate molecules having similar structure.
With respect to the dependent claims 2-10, Hall teaches acids, buffers are taught, overlapping pH’s are taught, heating is taught as well as strong acid – see Hall, HCl is taught (see for example Hall). With respect to conversions, times, and temperatures at least these are result effective variables and it would be routine experimentation to optimize these variables absent a showing of criticality.
Claim Objection
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Hall teaches a size exclusion resin, as does Laycock.
Conclusion
No claims allowed.
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.
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/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621