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 .
Claims 1, 2, 6, 8, 10, 15, 16, 21, 22, 27, 31, 34, 37-39, 41, 44, 47, 50, and 54 are pending.
Claims 34, 37-39, 41, 44, 47, 50, and 54 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1, 6, 10, 15, 22, 27 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over SATO (WO 2015/153772 A2) in view of KELLY (US4335095).
Regarding claim 1, SATO teaches a method of making an 89Zr-oxine complex (abstract) comprising mixing a solution of 89Zr with oxine (claim 1), sodium bicarbonate (claim 4), which reads on base, and polysorbate 80 (claim 2), which is a surfactant. The oxine concentration is directly related to the labeling efficiency (column 2, paragraph 5). The solution needs a pH of 7 to 7.2 to allow for the chelation of 89Zr by oxine, thus allowing the product to form (Page 19, paragraph 0095).
SATO does not teach using the buffer solution HEPES (4-(2-hydroxyethyl)-1- piperazineethanesulfonic acid).
KELLY teaches a complex that is created by mixing a radioactive solution of indium-111, oxine, Tween-80, also known as polysorbate 80 and which reads on a surfactant, HEPES (4-(2-hydroxyethyl)-1- piperazineethanesulfonic acid), which reads on a buffering agent (column 6, paragraph 1), bicarbonate (column 3, paragraph 2) and hydrochloric acid (column 3, paragraph 4). It is important to adjust to pH of the solution as necessary for stability of the complex and so it can be tolerated by blood cells (Column 2, paragraph 4). Tween-80 is used as a surface active agent that reduces adhesion to container walls (column 2, paragraph 4).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate the buffering agent, HEPES. The person of ordinary skill in the art would have been motivated to make those modifications, because it will create an optimal pH that is important for stability of the complex and SATO teaches that a pH of 7 to 7.2 allows for the chelation of 89Zr by oxine, thus allowing the product to form, and reasonably would have expected success because both references are in the same field of endeavor, such as radiolabeled oxine complexes created in similar methods.
Regarding claim 2 and 10, the references do not specifically teach the concentration of oxine as claimed by the Applicant. The concentration of oxine is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal concentration of oxine in order to best achieve desired results, such as a solution that can label efficiently. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the concentration of oxine would have been obvious at the time of Applicant’s invention.
Regarding claim 6, SATO teaches that the complex is with 89Zr-oxine.
Regarding claim 15, SATO teaches using polysorbate 80 (claim 2).
Regarding claim 16, the reference does not specifically teach the concentration of polysorbate 80 as claimed by the Applicant. The concentration of polysorbate 80 is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal concentration of polysorbate 80 in order to best achieve desired results, such as a solution that does not adhere to container walls. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the concentration of polysorbate 80 would have been obvious at the time of Applicant’s invention.
Regarding claim 21, KELLY teaches using HEPES (4-(2-hydroxyethyl)-1- piperazineethanesulfonic acid) (column 6, paragraph 1).
Regarding claim 22, the reference does not specifically teach the concentrations of the buffer solution as claimed by the Applicant. The concentrations of the buffer solution is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal concentration of the buffer solution in order to best achieve desired results, such as an ideal pH for formation of the complex. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the concentrations of sodium bicarbonate or the buffer solution would have been obvious at the time of Applicant’s invention.
Regarding claim 27, SATO teaches the solution needs a pH of 7 to 7.2 to allow for the chelation of 89Zr by oxine, thus allowing the product to form (Page 19, paragraph 0095).
Regarding claim 31, KELLY teaches using hydrochloric acid (column 3, paragraph 4).
Claims 1, 2, 6, 8, 10, 15, 16, 21, 22, 27 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over SATO (WO 2015/153772 A2) and KELLY (US4335095) in view of JIANG (CN 106053463 A).
SATO and KELLY teach Applicant’s invention as discussed above.
SATO and KELLY do not teach where the base is a metal hydroxide.
Regarding claim 8, JIANG teaches an oxine complex (abstract) that uses sodium hydroxide, which is a metal hydroxide, to regulate the pH of the composition (claim 9).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate sodium hydroxide. The person of ordinary skill in the art would have been motivated to make those modifications, because it helps to regulate the pH of the composition, and reasonably would have expected success because the references are in the same field of endeavor such as oxine containing pharmaceutical compositions and both SATO and KELLY use various substances to regulate pH, including a base.
Response to Arguments
Applicant argues the art does not teach adding a radioactive metal to a prepared/pre-mixed formulation comprising oxine, a surfactant, a base and a buffering agent.
Examiner does not find the argument persuasive because the list in instant claim 1 does not comprise the term “and” at the end of the list and therefor the broadest reasonable interpretation is that the list would be “or” at the end of the list. This means the radioactive metal only needs to be added to a formulation comprising one of the components listed and SATO teaches that the radioactive metal is added to a formulation comprising oxine and polysorbate 80 (claim 1 and 2).
Furthermore, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., adding the radioactive metal to a “preprepared or “pre-mixed” formulation, are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that JIANG is towards a calcium detection agent, not a cell radiolabeling agent and therefor does not have motivation to add sodium hydroxide to regulate the pH of the composition.
Examiner does not find the argument persuasive because it would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate sodium hydroxide. The person of ordinary skill in the art would have been motivated to make those modifications, because it helps to regulate the pH of the composition, and reasonably would have expected success because the references are in the same field of endeavor such as oxine containing pharmaceutical compositions and both SATO and KELLY use various substances to regulate pH, including a base.
Conclusion
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 SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618