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 .
DETAILED ACTION
Claim Status
Claims 26-28 and 30-39 are pending. Claims 1, 11, 21-22 and 29 have been canceled. Claims 26, 28 and 30 have been amended. Claims 26-28 and 30-31 are being examined in this application. In the response to the restriction requirement, Applicants elected Group I and ascorbic acid. Claims 32-39 are withdrawn as being drawn to a nonelected invention.
Claim Objections
Claim 26 is objected to because of the following informalities: Claim 26 should be rewritten as follows: “A pharmaceutical composition, comprising:
(i) a radiopeptide comprising:
(a) a radionuclide, wherein the radionuclide is terbium-161;
(b) dodecane tetraacetic acid (DOTA) which is a chelator of terbium-161;
(c) [Tyr*]-octreotide (TOC), which is covalently coupled to (b);
(ii) 0.5 mM to 0.5 M ascorbic acid/ascorbate; and
(iii) water”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The rejection of claims 26-31 under 35 USC 112(b) is withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 102
The rejection of claims 1, 11 and 21 under 35 U.S.C. 102(a)(1) as being anticipated by Cassells et al. is withdrawn in view of the amendments to the claims.
The rejection of claims 1, 11, 21-22, 26 and 28-29 under 35 U.S.C. 102(a)(1) as being anticipated by Gracheva et al. is withdrawn in view of the amendments to the claims.
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.
This rejection has been modified.
Claims 26-28 and 30-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gracheva et al. (EJNMMI Radiopharm Chem. 2019 Jul 10;4(1):12).
Gracheva et al. teach the compound [161Tb] Tb-DOTATOC (abstract; passim), which corresponds to the instantly claimed radiopeptide comprising the radionuclides terbium-161, DOTA and TOC.
Gracheva et al. also teach that composition further comprises ascorbic acid or gentisic acid (page 11, 2nd para).
Gracheva et al. further teach that DOTATOC is a radiopharmaceutical (page 11, 2nd para). Therefore, one of ordinary skill in the art would have at once envisaged a pharmaceutical composition comprising the radiopeptide and a pharmaceutically acceptable excipient such as water.
Gracheva et al. do not teach the claimed pH and amount of the radio peptide and ascorbate.
However, the MPEP 2144.05 A states that “[G]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum pH and amount of the radio peptide and ascorbate by normal optimization procedures known in the pharmaceutical art.
Response to Arguments
Applicant’s arguments filed on 11/19/2025 have been fully considered but they are not persuasive.
Applicant argues that “[c]laim 26 is hereby amended to include aspects previously included in dependent claims 28 and 30, namely pharmaceutical compositions of claim 26 include "0.5 mM to 0.5 M ascorbic acid/ascorbate". Applicant submits that the cited references do not teach, or even suggest, the subject matter of the present claims”.
Applicant also argues that “[p]harmaceutical compositions of the present claims which include "0.5 mM to 0.5 M ascorbic acid/ascorbate" provide unexpectedly beneficial properties. For example, Applicant notes that the present application describes assessment of stability of pharmaceutical compositions of the present claims against radiolysis”.
Applicant’s arguments are not persuasive.
As discussed above, Gracheva et al. teach a composition comprising the compound [161Tb] Tb-DOTATOC (abstract; passim), which corresponds to the instantly claimed radiopeptide comprising the radionuclides terbium-161, DOTA and TOC, wherein the composition further comprises ascorbic acid or gentisic acid.
Gracheva et al. also teach that ascorbic acid is a stabilizer used to inhibit peptide autoradiolysis (page 11, 2nd para).
Thus, one of ordinary skill in the art would have reasonably expected ascorbic acid to increase the stability of the pharmaceutical composition of Gracheva et al. against radiolysis.
For the reasons stated above the rejection is maintained.
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.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658