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 .
Claim Rejections - 35 USC § 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.
Claim(s) 8-10, 13-14 and 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over Osborn (US 2013/0266487) in view of Engell et al. (US 2019/0275182).
Regarding claim 8, Osborn discloses a method for determining optimised SPE purification conditions for the isolation of a compound from a composition, the method comprising:
(i) provision of a cassette, wherein the cassette comprises:
a flowpath comprising a first end and a second end (the cassette has an input for sample and an output); and
a plurality of valves oriented along said flowpath (valves are located at each junction, fig. 1 shows 25 three-way valves for example), wherein each of said plurality of valves is selectively fluidly connected to one of a number of components (See fig. 1-3 where a valve is located along the flow path and is at a junction), wherein said components comprise (it is noted that the cassette claimed herein is drawn to the structures and not the contents of the vials. If Applicant wishes to claim the contents of the vial then the claim should recite each individual solvent for example being contained in a vial, i.e. a solvent vial containing NaOH, a composition vial containing a dried buffer):
(1) at least one composition vial (fig. 1-3 shows a plurality of vials, 139, 158,154, or 129);
(2) 1-3 SPE cartridges (SPE columns 114,116,120);
(3) at least 4 solvent vials (4 vials shown in the middle of fig. 1-3, 164,166,168,176);
(4) a water vial (water for injection contained in a vial 174); and
(5) a transfer line (any line that is shown in fig. 1).
(ii) the cassette further comprising the composition of the compound in each of said at least one composition vials or addition of such a composition to each of said at least one composition vials (this limitation does not further limit the instant claim. Applicant has not positively claimed the contents of each vial. For example, a solvent vial is just a vial that can house a solvent. Applicant should claim a solvent vial having a solvent therein. See fig. 1-3; The Fastlab cartridge comprises all the above structures);
(iii) passing an aliquot of said composition into each of said 1-3 SPE cartridges (para 29);
(iv) passing a particular combination of aliquots of solvent from at least 4 of said 4 solvent vials into one or more of the SPE cartridges (para 29-34), wherein the solvent in each of said 4-10 solvent vials is either a different solvent or the same solvent at different concentration (para 29-34);
(v) eluting the compound to be purified from the or each SPE cartridge using different mobile phases provided from the solvent vials (para 31-32);
(vi) evaluating the eluted products of step (v) to each solvent and each cartridge (para 29-34); and
(vii) determining the optimised purification conditions by comparing the eluted products of step (v) from each cartridge and each solvent (para 29-34).
Osborn does not specifically teach comparing the eluted products of step (v) to each solvent.
Engell teaches a radiotracer composition that employs a cartridge with a plurality of vials containing various SPE cartridges, composition vials, solvent vials, water vials, transfer lines and a plurality of valves in order to process and perform detection and comparison of various optimizations (fig. 2, para 85, 62, example 4, use of FastLab procedure/cartridge). It would have been obvious to one having an ordinary skill in the art to modify Osborn to employ a comparison of the products in order to optimize the process parameters as is well known in the art as taught by Engell.
Regarding claim 9, the method of claim 8, wherein the method further comprises a step of eluting impurities (SPE removes impurities. Applicant has not defined or claimed what an impurity consists of, therefore it is any particle that is trapped by the SPE).
Regarding claim 10, the method of claim 8, wherein the at least one solvent is selected from: (i) ethanol (para 32, (ii) methanol (para 32), (iii) acetonitrile (para 31), or combinations thereof.
Regarding claim 13, the method of any of claim 8, wherein the eluting is carried out by passing organic solvent through the SPE cartridge and through the transfer line for collection (para 31-32).
Regarding claim 14, the method of claim 8, wherein the at least one composition vials (the contents of the vials are not positively recited therefore any vial is structurally capable of holding any fluid, reaction mixture, or reference standard mixture) are: (i) at least one crude reaction mixture vials; (ii) at least one single reference standard vials; or (iii) at least one reference standard mixture vials.
Regarding claim 16, the cassette of claim 8, wherein the cassette has 1-3 composition vials (“composition” vial is a label given to a vial. There is not structural different between a composition vial and a reagent vial or water vial. Applicant has not positively recited the contents of the vial as defined in claim 8 above).
Regarding claim 17, the cassette of claim 8, wherein the cassette has 2 composition vials (“composition” vial is a label given to a vial. There is not structural different between a composition vial and a reagent vial or water vial. Applicant has not positively recited the contents of the vial as defined in claim 8 above).
Regarding claim 18, the cassette of claim 8, wherein a maximum of 1 composition vial is used (“composition” vial is a label given to a vial. There is not structural different between a composition vial and a reagent vial or water vial. Applicant has not positively recited the contents of the vial as defined in claim 8 above).
Regarding claim 19, the method of claim 9, wherein the step of eluting impurities is carried out before and/or after step (v) (SPE removes impurities. Applicant has not defined or claimed what an impurity consists of, therefore it is any particle that is trapped by the SPE).
Regarding claim 20, the method of claim 13, wherein the collection is in a 96 well plate (para 30).
Regarding claim 21, the method of claim 9, wherein the compound impurities are hydroxy impurities (Engell, para 62).
Regarding claim 22, the method of claim 8, wherein the cassette is selected from cassettes (I), (II), or (III): (I) 3 SPE cartridges and 6 solvent vials; or (II) 2 SPE cartridges and 8 solvent vials; or (III) 1 SPE cartridge and 10 solvent vials (see fig. 1, FastLabs cartridge discloses the above structures).
Response to Arguments
Applicant’s arguments with respect to claim(s) 8-10, 13-14 and 16-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday-Friday 8-5.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758