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 .
Amendments
Applicants’ amendments to the claims filed 9/16/2025 have been entered. Any objection\rejections from the previous office action filed 3/17/2025 not addressed below has been withdrawn.
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 1-12 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.
In particular in claim 1 line 11 the recitation of “therapeutically radiolabeled cancer targeting agent” and the large Markush group that follows do not agree with the earlier limitation of ”therapeutically radiolabeled chelator conjugated cancer targeting agents”, note numerous compounds in the Markush group do not contain a chelator. The examiner suggests simply deleting the large Markush group of radiolabeled cancer targeting agents.
Additionally in claim 1, the acronym “p-SCN-Bn-DOTA” is undefined in the claim and the specification rendering metes and bounds of the claim indefinite. An undefined acronym is considered indefinite as acronyms can have several meanings absent a definition defining it, at least for the first instance.
Claims 2-12 incorporate the indefiniteness by dependency.
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.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boghaert et al. (US 2007/0231333 A1) in view of Aknova et al. “Physicochemical Evaluation of Lyophilized Formulation of p-SCN-Bn-DOTA- and p-SCN-Bn-DTPA-rituximab for NHL Radio Immunotherapy”, Iranian Journal of Pharmaceutical Research (2016), 15 (3): 295-302, this new rejection was necessitated by amendment.
Boghaert teaches cancer therapy, including Non-Hodgkin’s lymphoma (NFL) compositions for human subjects including radiolabeled anti-5T4 antibody (includes alpha and beta particles, meeting claims 2-3) with chelator to mediate binding of the antibody to the radioisotope and discloses combinations of the anti-5T4 antibody with other antibodies including anti-CD47 antibodies. See entire disclosure, especially abstract, [0005], [0007], [0121], [0211]-[0215].
Boghart while teaching use of metal chelators to bind the antibody does not teach use of p-SCN-Bn-DOTA as recited in claim 1.
Ackova is used for its disclosure on use of p-SCN-Bn-DOTA immunoconjugates in radio-therapy of NHL. See entire disclosure, especially abstract, Fig 1 and conclusion on page 301.
Since Boghaert already teaches use of metal chelates to mediate binding of the antibody to the radioisotope one of ordinary skill would have a very high expectation of success in substituting the metal chelate p-SCN-Bn-DOTA of Acknova. Reason to make such a modification stems from the notion that the combination of art known elements that, when combined, do no more than serve their art-recognized functions is obvious. Thus the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Response to Arguments
Applicant's arguments filed 9/25/2025 have been fully considered but they are not persuasive in view of the new rejection above. Applicants assert that Boghart does not teach p-SCN-Bn-DOTA, however as noted above such a feature would be obvious when the primary reference is considered in view of Ackova.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618