DETAILED ACTION
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 .
Acknowledgement of Receipt
Applicant’s Response, filed 12/3/2025, in reply to the Office Action mailed 9/5/2025, is acknowledged and has been entered. Claims 1-7 and 11-19 are pending and are examined herein on the merits for patentability.
Response to Arguments
Applicant’s arguments have been fully considered. The Examiner’s response to Applicant’s arguments is incorporated below.
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.
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.
Claim(s) 1-7 and 11-19 are rejected under 35 U.S.C. 103 as being unpatentable over McBride et al. (US 2015/0217006) in view of Garrison et al. (US 2020/0316233), for reasons set forth in the previous Office Action.
Response to arguments
Applicant argues that McBride describes a method for detecting or imaging prostate cancer using a GRPR receptor antagonist, specifically JMV4168, with the formula [DOTA-(B-Ala)₂-H-d-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH₂]. The chelator DOTA is specifically used with radionuclides such as fluorine-18 (¹⁸F) or gallium-68 (⁶⁸Ga). Applicant submits that although both chelators are noted, Garrison never uses TCMC; rather Garrison uses only DOTA with a peptide-targeting NTSR1 (a particular subtype of neurotensin receptor.
Applicant’s arguments have been fully considered but are not found to be persuasive. It is respectfully submitted that patents are relevant as prior art for all they contain, see MPEP 2123. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed."). In the instant case, it is submitted that one of ordinary skill in the art would have found it obvious to use either the TCMC or DOTA chelator, as either are taught be suitable for use in conjugation to peptide, including SEQ ID. 10 containing d-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH₂.
Applicant further argues that the subject matter of claim 1 was not expected by the cited art, and that unexpected results are a secondary consideration that support a finding of nonobviousness. Applicant asserts that the studies detailed in Section IV.1 ("Impact of a change of chelator on the biodistribution in xenograft-bearing mice") clearly demonstrate the surprising advantages of replacing DOTA with DOTAM for treating or diagnosing cancers in which GRPR is overexpressed. In particular, Figure 5 shows that the claimed conjugate incorporating DOTAM exhibits: i. a superior biodistribution profile: The 212Pb-DOTAM conjugate exhibits higher tumor retention compared to the 212Pb-DOTA conjugate within the first 24 hours; and ii. a higher initial uptake in the pancreas. Applicant submits that the superior biodistribution profile and higher GRPR-binding affinity achieved by using DOTAM to chelate lead radionuclides (2¹²Pb) represents an unexpected effect that could not have been predicted from the teachings of McBride, Garrison or the combination of these references.
Applicant's arguments have been fully considered. With regard to arguments directed to biodistribution and GRPR-binding, see MPEP 2145. "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc.v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished - not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").
Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected). In In re Waymouth, 499 F.2d 1273, 1276, 182 USPQ 290, 293 (CCPA 1974), the court held that unexpected results for a claimed range as compared with the range disclosed in the prior art had been shown by a demonstration of "a marked improvement, over the results achieved under other ratios, as to be classified as a difference in kind, rather than one of degree." Further, differences in tumor retention between TCMA and DOTA-based chelate conjugates are known in the art. See for example, Larsen, US 20190177345, provided in rebuttal to Applicant’s arguments directed to advantages of replacing DOTA with DOTAM for treating or diagnosing cancers, such as observation of
higher tumor retention. For example, comparison of tumor binding and kidney uptake of 212Pb-Labeled p-SCN-Bn-TCMC-PSMA 177Lu-Labeled PSMA-617(DOTA) is shown such that tumor-to-kidney ratios at the 4-hour timepoint were as follows: 212Pb-p-SCN-Bn-TCMC-PSMA ligand 1, 1.7 and 177Lu-PSMA-617, 0.8 in Example 12. Accordingly, it is considered that observation of differences in tumor uptake and biodistribution between DOTA and DOTAM/TCMC conjugates with the claimed peptide are not unexpected as improved tumor uptake over time using TCMC conjugates compared to DOTA conjugates has been shown. Applicant’s arguments have been fully considered, but the rejection is maintained at this time.
Conclusion
No claims are allowed at this time.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH H SCHLIENTZ whose telephone number is (571)272-9928. The examiner can normally be reached Monday-Friday, 8:30am - 12:30pm EST.
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/LHS/
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618