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 23-25, 37 and 39 have been amended.
Claim 40 has been added.
Claims 23-27, 30-31, and 34-40 are pending.
Claims 1-22, 28-29 and 32-33 are cancelled.
Claims 30, 31, and 34 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn.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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 23-27 and 35-40 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 23 recites “the composition to which the pH regulator is added has a pH of 6 to 8.”. It is unclear if the limitation of a pH of 6 to 8 is the composition before the pH regulator is added or after the addition of a pH regulator. For the purposes of compact prosecution, it is interpreted to mean after the pH regulator is added.
The dependent claims fall therewith.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/05/2026 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, 24-27, 35-37 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over CHEN (US 20070269375 A1) in view of USACH (Subcutaneous Injection of Drugs: Literature Review of Factors Influencing Pain Sensation at the Injection Site. Adv. Ther. 2019.).
Regarding claim 1, CHEN teaches a method of making a stabilized radiopharmaceutical that comprises (abstract):
Adding thiamine hydrochloride, which is vitamin B1 (page 27, paragraph 0297).
A buffer solution was added which reads on a pH regulator ((page 27, paragraph 0297).
Additional disclosures: The composition is designed for administration into a patient such as subcutaneous injection (page 11, paragraph 0140).
USACH teaches a pH of 7 for pharmaceutical injection prevents pain upon subcutaneous injection (page 2993, 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 a pH of 7. The person of ordinary skill in the art would have been motivated to make those modifications, because it prevents pain upon injection, and reasonably would have expected success because the references are in the same field of endeavor, such an pharmaceutical subcutaneous injections.
Regarding claims 1, 24 and 25, Note, the prior art’s composition/method of making would have the same chemical/physical properties of “wherein the stabilizing agent maintains the radiochemical purity of the radiopharmaceutical in the composition to which the pH regulator is added”, “wherein the stabilized radiopharmaceutical composition has a radiochemical purity of at least 90% for 2 to 6 hours after the preparation of the radiopharmaceutical composition. as measured at conditions of a temperature of 40°C and pH of 6 to 8.” and “wherein the stabilized radiopharmaceutical composition has a radiochemical purity of at least 90% for 2 to 4 hours after preparation of the radiopharmaceutical composition, as measured at conditions of room temperature and pH of 6 to 7” as claimed by Applicant, because the prior art has the same ingredients as claimed by Applicant, unless proven otherwise.
Regarding claim 26, CHEN teaches vitamin B1 is added in 10 mg/mL concentration (page 27, paragraph 0297).
Regarding claim 27, CHEN teaches the composition can be in a liquid formulation (page 13, paragraph 0158).
Regarding claim 35, CHEN teaches the composition is designed to inhibit radiolysis (page 2, paragraph 0019).
Regarding claim 36, CHEN teaches the radiochemical purity was measured (page 17, paragraph 0178).
Regarding claim 37, CHEN teaches a phosphate buffer can be added (page 3, paragraph 0027).
Regarding claim 40, CHEN teaches the radioisotope can be 18F (page 6, paraph 0058) and is in a liquid formulation (page 13, paragraph 0158).
Claims 1, 24-27, 35-38 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over CHEN (US 20070269375 A1) and USACH (Subcutaneous Injection of Drugs: Literature Review of Factors Influencing Pain Sensation at the Injection Site. Adv. Ther. 2019.) in view of MUELLER (Simplified NaCl Based 68Ga Concentration and Labeling Procedure for Rapid Synthesis of 68Ga Radiopharmaceuticals in High Radiochemical Purity. Bioconjugate Chemistry. 2012).
CHEN and USACH teach Applicant’s invention as discussed above.
CHEN and USACH do not specifically teach a sodium phosphate buffer, which comprises NaH2PO4 and Na2HPO4.
Regarding claim 38, MUELLER teaches using a sodium phosphate buffer for a stabilized radiopharmaceutical that has a high radiochemical purity of >99% (page 1714, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a sodium phosphate buffer. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because a sodium phosphate buffer and a phosphate buffer are functional equivalents of buffers commonly used in the pharmaceutical industry. Furthermore, both references are towards stabilized radiopharmaceuticals.
Claims 1, 24-27, and 35-40 are rejected under 35 U.S.C. 103 as being unpatentable over CHEN (US 20070269375 A1) and USACH (Subcutaneous Injection of Drugs: Literature Review of Factors Influencing Pain Sensation at the Injection Site. Adv. Ther. 2019.) and MUELLER (Simplified NaCl Based 68Ga Concentration and Labeling Procedure for Rapid Synthesis of 68Ga Radiopharmaceuticals in High Radiochemical Purity. Bioconjugate Chemistry. 2012) in view of EDWARDS (US 6,869,590 B2).
CHEN, USACH and MUELLER teach Applicant’s invention as discussed above.
CHEN, USACH and MUELLER do not teach adding 18F-fluorodeoxyglucose.
Regarding claim 39, EDWARDS teaches that 18F-fluorodeoxyglucose (18F-FDG) can be used in radiopharmaceuticals and the isotope can be readily prepared and has a long half-life which allows for a long shelf life (column 24, 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 18F-FDG. The person of ordinary skill in the art would have been motivated to make those modifications, because it can be readily prepared and has a long half-life which allows for a long shelf life, and reasonably would have expected success because the references are in the same field of endeavor such as radiopharmaceuticals. Furthermore, 18F-FDG is a specific version of the 18F taught in CHEN.
Response to Arguments
Applicant’s arguments regarding CHARLESON and ROED with respect to claim(s) 1, 24-27, and 35-40 have been considered but are moot because Applicant’s amendments have necessitated new grounds of rejection.
Applicant argues, that USACH is towards minimizing pain and preventing tissue damage and is unrelated to the stability of the radiopharmaceutical composition, the maintenance of purity, or the inhibition of radiolysis.
The examiner does not find the argument persuasive because, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the reasoning to add the pH stabilizer does not need to be related to the stability of the radiopharmaceutical composition just a reasoning that is taught by the prior art. As discussed above, it would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a pH of 7. The person of ordinary skill in the art would have been motivated to make those modifications, because it prevents pain upon injection, and reasonably would have expected success because the references are in the same field of endeavor, such an pharmaceutical subcutaneous injections.
Applicant argues that EDWARDS does not disclose any experimental data regarding what effect the use of a stabilizing agent has on radiolysis or on the purity of a radiopharmaceutical.
Examiner does not find the argument persuasive because obviousness does not require complete predictability and less preferred embodiments do not constitute a teaching away. Furthermore, the prior art teaches the composition claimed by applicant as discussed above.
Conclusion
No claims are allowable.
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.
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, MICHAEL HARTLEY can be reached at (571) 272-0616. 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.
/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
Prosecution Insights