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 and 2 have been amended.
Claims 21 and 22 have been added.
Claims 1-17 and 20-22 are pending.
Claims 18-19 are cancelled.
Claims 9 and 17 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn.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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/02/2025 has been entered.
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 1-8, 10-16 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over ASTI (Development of a simple kit-based method for preparation of pharmaceutical-grade 68Ga-DOTATOC. Nuclear Medicine Communications. 2014.) in view of WOUTERS (US 11,027,031 B2).
Regarding claim 1, ASTI teaches a kit based method for preparation of 68Ga-DOTATOC (abstract) that comprises: DOTATOC (page 503, paragraph 2), which is a chelating agent, DOTA, linked to a somatostatin receptor, also known as edotreotide; ascorbic acid (page 503, paragraph 6), which reads on stabilizer; sodium acetate (page 503, paragraph 6), which reads on a buffer. The composition does not list any sequestering agent or metal inhibitor. The kit is designed to be lyophilized (abstract).
Regarding claim 2, ASTI teaches the composition comprises DOTATOC (page 503, paragraph 2), also known as edotreotide; ascorbic acid (page 503, paragraph 6), which reads on stabilizer; sodium acetate (page 503, paragraph 6), which reads on a buffer. The composition does not list any co-chelating agents capable of inactivating contaminating metals other than the desired radioisotope. The pH of the solution was 3.3 (page 503, paragraph 6). The composition is radiolabeled with gallium-68 (page 503, paragraph 6). The radiochemical purity is 99% (page 507, paragraph 3).
Regarding claim 3, ASTI teaches the chelating agent is DOTA (page 503, paragraph 2).
Regarding claim 4 and 20, the composition is a single vial kit (Figure 1).
Regarding claim 6, ASTI teaches sodium acetate is used as a buffer (page 503, paragraph 6).
Regarding claim 7, ASTI teaches the pH of the solution was 3.3 (page 503, paragraph 6).
Regarding claim 10 and 11, ASTI teaches the composition is radiolabeled with gallium-68 (page 503, paragraph 6).
Regarding claims 12-16, ASTI teaches the radiochemical purity is 99% (page 507, paragraph 3), radiochemical purity is the percentage of total radioactivity in a radiopharmaceutical that is in the desired chemical form, this would mean at most only 1% of gallium-68 in colloidal form and gallium-68 (III) iron would be present.
Regarding claim 21, ASTI teaches a kit based method for preparation of 68Ga-DOTATOC (abstract) that comprises: DOTATOC (page 503, paragraph 2), which is a chelating agent, DOTA, linked to a somatostatin receptor; ascorbic acid (page 503, paragraph 6), which reads on stabilizer; sodium acetate (page 503, paragraph 6), which reads on a buffer. The composition does not list any co-chelating agents capable of inactivating contaminating metals other than the desired radioisotope. The composition is further radiolabeled with gallium-68 (page 503, paragraph 6).
Regarding claim 22, ASTI teaches the composition comprises DOTATOC (page 503, paragraph 2), also known as edotreotide; ascorbic acid (page 503, paragraph 6), which reads on stabilizer; sodium acetate (page 503, paragraph 6), which reads on a buffer. The composition does not list any sequestering agents or metal inhibitors. The pH of the solution was 3.3 (page 503, paragraph 6). The composition is radiolabeled with gallium-68 (page 503, paragraph 6). The radiochemical purity is 99% (page 507, paragraph 3).
ASTI does not teach adding mannitol.
WOUTERS teaches a vial kit composition that comprises DOTA, a buffer and gallium-68 with a pH of 3-5 (claim 1). The components are lyophilized (claim 1). The composition further comprises mannitol, which is used as a cryoprotectant to stabilize the composition during lyophilization (column 12, paragraph 7). Multiple vials are used for the composition (claim 1). The buffer is kept in a second vial for balancing the gallium-68 labeled mixture to a pH value ranging from 3 to 5 (column 11, paragraph 6).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate mannitol. The person of ordinary skill in the art would have been motivated to make those modifications, because it acts as a cryoprotectant to stabilize the composition during lyophilization and reasonably would have expected success because the references are in the same field of endeavor such as vial kits of lyophilized components that include DOTA, a buffer and gallium-68.
Regarding claim 5, WOUTERS teaches using multiple vials.
Regarding claim 8, the buffer is in a second vial for balancing the gallium-68 labeled mixture to a pH value ranging from 3 to 5 (column 11, paragraph 6). The pH of the labelling solution needs to be in a range where it is possible to ensure both the chelating reaction and the gallium-68 reaction and the gallium-68 solubility, a buffering medium is generally used and added in between reactions to allow both reactions to occur (column 2, paragraph 10 and claim 1).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate having the buffer is in a second vial. The person of ordinary skill in the art would have been motivated to make those modifications, because changing the pH in between reactions allows both reactions to occur successfully, and reasonably would have expected success because the references are in the same field of endeavor such as vial kits of lyophilized components that include DOTA, a buffer and gallium-68.
The reference does not specifically teach the amounts of components, such as DOTATOC, ascorbic acid, sodium acetate, mannitol or gallium-68, as claimed by the Applicant. The amounts of components are 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 amounts of the listed components in order to best achieve desired results, such as chelating enough gallium-68, having a stable compound, that is buffered to the correct pH, protected from lyophilization via a cryoprotectant, and enough radioisotope for clear labeling. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of amounts of the listed components would have been obvious at the time of Applicant’s invention.
Conclusion
No clams are allowed.
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/S.L.M./Examiner, Art Unit 1618 /Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618