DETAILED ACTION
This Office action details a first action on the merits for the above referenced application No. Claims 1-2, 11, 13-22, 28, 30, 34-35, 41-45, 58, 60, 65, 71, 77, and 81 are pending in this application.
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 .
Priority
This application is a 35 USC 371 National Stage filing of international application No. PCT/US2022/036645 filed on 11 Jul. 2022 and claims benefit under 35 USC 119(e) to US provisional application No. 63/220,737 filed on 12 Jul. 2021.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 11 Jan. 2024 and 16 Feb. 2024 have been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-2, 11, 13-22, 28, 30, 34, and 35 in the reply filed on 20 Jul. 2026 is acknowledged.
Claims 41-45, 58, 60, 65, 71, 77, and 81 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-IV, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 20 Jul. 2026.
Applicant’s election without traverse of the elected species of formula I (see below), claims 1-2, 11, 13-15, and 34 in the reply filed on 20 Jul. 2026 is acknowledged.
Claims 16-22, 28, 30, and 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 20 Jul. 2026. Note that claim 2 is not withdrawn since formula I below is a CSR ligand of claim 1 wherein the radioisotope is selected from 18F. Claim 14 is not withdrawn since the Ia in the claim is structurally the same as formula I below. Claim 34 is not withdrawn since the elected formula I is PET probe comprising the ligand of claim 1.
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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 13, 15, and 34 are 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.
Instant claim 13 is indefinite since the R in the fragment
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is not defined in the claims and otherwise not understood. For the purpose of compact prosecution, the R is understood to mean -CF3.
Instant claim 15 is indefinite because it is not clear if “(18F-cinacalcet)” is a required limitation or alternate name or an example. In addition, the structure of 18F-cinacalcet is unclear.
Instant claim 34 is indefinite because the claim requires a fluorophore of claim 1; however, claim 1 does not mention a fluorophore but instead mentions a radioisotope directly linked to an aromatic ring. It is not clear if the recitation of “or fluorophore” further limits claim 1.
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.
The following rejection is based upon art which was found incidental to the search for the elected species. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied in an effort to promote compact prosecution of the case.
Claim(s) 1-2, 11, and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nemeth et al. (US 6,011.068; issued 4 Jan. 2000), in view of Yusof et al. (Surgery; published 2013).
Nemeth et al. teach calcium receptor molecules (see title). The preferred use of the present in invention is to treat diseases or disorders in a patient by modulating one or more inorganic ion receptor activities Preferably the disease and disorder is characterized by abnormal bone and mineral homeostasis (cols. 4 16). Such molecules can be used to treat diseases characterized by abnormal calcium homeostasis such as hyperparathyroidism and osteoporosis (col. 4). Nemeth et al. teach compounds of formulas
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and
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wherein R may be H and X may be F (cols. 38-39). Nemeth et al. claim the compound
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and teach the compound 13T
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(Fig. 36I).
Nemeth et al. do not teach a claimed radioisotope labeled CSR ligand wherein the radioisotope is directly linked to the aromatic ring or a compound or instant formula II.
Yusof et al. teach the development of calcium sensing receptor molecular imaging agents (see title). Yusof et al. teach that a molecular imaging agent with high sensitivity and specificity to MTC and parathyroid glands would not only decrease operative time but more importantly likely improve the outcomes of operative treatment (pg. 1378). Yusof et al. present the synthesis of a novel compound containing fluorine to further develop one the analogs as imaging agents. A fluorine molecule is conducive to labeling with 18F which can be imaged on PET or hand-held probe (pg. 1379). An effective imaging agent has the potential to dramatically improve the operative treatment of MTC and parathyroid disease (pg. 1383).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the compounds of Nemeth et al. (claimed compound above and 13T) by substituting their F with 18F to arrive radioisotope labeled CSR as taught by Yusof et al. because those 18F-labeled compounds would have been expected to PET imaging and in vivo evaluation and dramatically improved operative treatment of MTC and parathyroid disease. Homologues are prima facie obvious due to a general expectation of similar properties. A person of ordinary skill in the art would have been further modify the above claimed compound of Nemeth et al. by increasing the length of alkyl chain by 2 CH2 units to at a compound of instant formula II as taught by Nemeth et al. that homolog would have been expected to provide a functionally equivalent calcium receptor binding compound suitable PET imaging and diagnosis of calcium receptor associated disorders. See In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Claim(s) 1-2, 11, 13-15, and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yusof et al. (Surgery; published 2013), in view of Nemeth et al. (US 6,011.068; issued 4 Jan. 2000).
Yusof et al. teach as discussed above. Yusof et al. teach that understanding and regulating the activity of CaSR has important medical ramifications because the receptor has been implicated in numerous diseases including HDT and osteoporosis. Only one calcimimetic, cinacalcet (IC50 28 nM) is used clinically for the treatment of secondary HPT (pg. 1383).
Yusof et al. do not expressly teach the 18F-cincalcet of instant formula I or formula Ia.
Nemeth et al. teach as discussed above.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the compound of Yusof et al. (cinacalcet) by placing 18F on the naphthyl ring para to the amino alkyl substituent to arrive at 18F-cincalcet of instant formulas I, Ia, II, and III as taught by Yusof et al. because that 18F-cincalcet would have been expected to provide an equivalent calcimimetic (CaSR binding compound) and advantageously enable PET imaging of CaSR and diagnosis of CaSR associated diseases using a well-established and clinically used calcimimetic as the targeting ligand.
Technical Background Material
Pees et al. (J. Nucl. Med.; published 2020; see attached 892) is being made of record; however, it is not being used in a rejection because it is cumulative. Pees et al. teach a [18F]cinacalcet.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN R DONOHUE whose telephone number is (571)270-7441. The examiner can normally be reached on Monday - Friday, 8:00 - 5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on (571)272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN R. DONOHUE/
Examiner, Art Unit 1618
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights