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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/17/2026 has been entered.
Claim Status
Claims 26-28, 30 and 32-39 are pending. Claim 31 has been canceled. Claims 26 and 38 have been amended. Claims 26-28 and 30 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 Claims 32-39 are withdrawn as being drawn to a nonelected invention.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 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 is maintained.
Claims 26-28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over 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 6/17/2026 have been fully considered but they are not persuasive.
Applicant argues that “[A]s admitted by the Office Action, "Gracheva et al. do not teach the claimed pH and amount of the radio peptide and ascorbate". (page 4, lines 7-8) Therefore, this statement does not appear to be consistent with a rejection under 35 U.S.C. 102(a)(1) as being anticipated by Gracheva et al.”.
Applicant also argues that “[G]racheva et al. is completely silent on any range of concentrations (of ascorbic acid/ascorbate) or pH in 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 3]-octreotide (TOC), which is covalently coupled to (b). Thus, the Examiner's assertion that "general conditions" of the claims are disclosed in Gracheva et al. is submitted to be incorrect. There simply is no apparent "disclosed range" of "pH and amount of the radio peptide and ascorbate" in Gracheva et al. and the Office Action has not cited to any portion of Gracheva et al. which could support an assertion to the contrary. If the Examiner believes that Gracheva et al. does disclose "the general conditions of a claim", additional information regarding this point is respectfully requested. It is therefore submitted that the teachings of MPEP 2144.05 cited by the Examiner do not support obviousness in this case. Further, as disclosed in the present application, the radiolytic stability of the radiolabeled somatostatin analogue 161Tb-DOTATOC was specifically assessed over a period of 24 hours. Without the addition of L-ascorbic acid, the intact fraction of the radiopeptides was reduced to approximately 90% and approximately 60% after 4 hours and 24 hours, respectively, due to radiolytic degradation (see [0130] of the present publication). However, the addition of ascorbic acid within the claimed concentration range was effective in stabilizing the terbium-161-labeled DOTATOC analogues over longer periods”.
Applicant’s arguments are not persuasive.
It is noted that the rejection is an obviousness rejection as the heading clearly stated “Claim Rejections - 35 USC § 103”, which was followed by a quotation of 35 U.S.C. 103. Therefore, it is clear that the recitation “…as being anticipated under 35 U.S.C. 102(a)(1)” was a typo.
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.
Although Gracheva et al. do not specifically teach the claimed pH, Gracheva et al. teach many instances where the pH is adjusted (e.g. page 4, 3rd para; page 5, 2nd-3rd paras; passim).
Furthermore, according to the MPEP 2144.05 A, it is obvious to one of ordinary skill to discover the optimum pH by normal optimization procedures known in the pharmaceutical art.
Therefore, the skilled artisan making the claimed pharmaceutical composition would have been motivated, with a reasonable expectation of success, to discover the optimum pH by normal optimization procedures known in the pharmaceutical art.
With respect to Applicant’s arguments regarding ascorbic acid, Gracheva et al. clearly teach that ascorbic acid is a stabilizer used to inhibit peptide autoradiolysis (page 11, 2nd para).
Therefore, the skilled artisan 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
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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