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 .
Election/Restrictions
Applicant’s election without traverse of DOTA-ABCF3-PSMA617 in the reply filed on 3/16/2026 is acknowledged. Claims 1, 3, 8, 9, 11, 15, 16, 23, 24, 27, 29, 64-67 and 69 are pending, of which claims 8, 64 and 66 are withdrawn as being directed to a non-elected invention. Claims 1, 3, 9, 11, 15, 16, 23, 24, 27, 29, 65, 67 and 69 encompass limitations of the elected species variables and are examined herein on the merits for patentability.
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, 3, 9, 11, 15, 16, 23, 24, 27, 29, 65, 67 and 69 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. Claim 1 recites the limitation "the radionuclide is selected from the group…” in line 10 of the second page of the claim. There is insufficient antecedent basis for this limitation in the claim. For the purpose of prior art search, it is interpreted that recitation is intended to read “the radionuclide chelator is selected from the group…”, as the following list recites chelators (DOTA, NOTA, etc.), and a radionuclide chelator was recited in line 2 of the claim. Correction is requested.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 67 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim does not further limit the claim from which it depends because claim 1 lists the same chelators. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 9, 23, 24, 27, 29, 65, 67 and 69 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Babich et al. (WO 18/187631, whereby US 2021/0128757 is relied upon as equivalent).
Babich discloses trifunctional constructs that include (1) an antigen-binding domain, (2) cytotoxin-containing and/or imaging agent-containing domain; and (3) an albumin-binding moiety. The present technology also provides compositions including such compounds as well as methods of use in imaging and/or anti-tumor therapy. For example, the compounds and compositions of the present technology are useful theranostic compounds (paragraph 003).
Exemplary compounds include RPS-074 (page 57):
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or compound 25a (page 47).
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.
The metal ion of any embodiment for Tox and/or Rad may be a radionuclide, such as 177Lu3+, 75Lu3, 45Sc3+, 66Ga3+, 67G3+, 68Ga3+, 69Ga3+, 71Ga3+, 89Y3+, 86Y3+, 89Zr4+, 90Y3+, 99mTc+1, 111In3+, etc. (paragraph 0113).
The compounds are encompassed by the instant claim limitations such that X is a benzene ring; R3 is I; n1 is 3; m is 3; a linker is a bond and the remainder of the compound is a DOTA derivative.
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, 3, 9, 11, 15, 16, 23, 24, 27, 29, 65, 67 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Babich et al. (WO 18/187631, whereby US 2021/0128757 is relied upon as equivalent).
Babich teaches trifunctional constructs that include (1) an antigen-binding domain, (2) cytotoxin-containing and/or imaging agent-containing domain; and (3) an albumin-binding moiety. The present technology also provides compositions including such compounds as well as methods of use in imaging and/or anti-tumor therapy. For example, the compounds and compositions of the present technology are useful theranostic compounds (paragraph 003).
Exemplary compounds include RPS-074 (page 57):
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1168
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or compound 25a (page 47).
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478
1064
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.
The metal ion of any embodiment for Tox and/or Rad may be a radionuclide, such as 177Lu3+, 75Lu3, 45Sc3+, 66Ga3+, 67G3+, 68Ga3+, 69Ga3+, 71Ga3+, 89Y3+, 86Y3+, 89Zr4+, 90Y3+, 99mTc+1, 111In3+, etc. (paragraph 0113).
The compounds are encompassed by the instant claim limitations such that X is a benzene ring; R3 is I; n1 is 3; m is 3; a linker is a bond and the remainder of the compound is a DOTA derivative.
Babich further teaches wherein in any embodiment, the albumin binding moiety may be:
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(paragraph 0108),
Including wherein variables Y1-Y4 may be independently selected from H, halo, or alkyl.
It is noted that alkyl groups include straight chain and branched chain alkyl groups having from 1 to 12 carbon atoms.. Alkyl groups may be substituted or unsubstituted. Representative substituted alkyl groups may be substituted one or more times with substituents such as those listed above, and include without limitation haloalkyl (e.g., trifluoromethyl)… and the like (paragraph 0041).
It would have been obvious to one of ordinary skill in the art at the time of the invention to substitute fluoro or fluroalkyl such as trifluoromethyl for iodine on the albumin binding moiety portion of the compounds taught by Babich. While Babich does not specifically exemplify a compound as such, it is taught that variables Y1-Y4 may be independently selected from H, halo, or alkyl on the albumin binding moieties of paragraph 0108. Accordingly, one of ordinary skill in the art could have readily selected from among the limited number of suitable variables at the stated position with a reasonable expectation of success in providing an albumin binding moiety. Further, it is noted that the definition of alkyl includes trifluoromethyl. See MPEP 2144.09. A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990).
Conclusion
No claims are allowed at this time.
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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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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/LHS/
/Michael G. Hartley/ Supervisory Patent Examiner, Art Unit 1618
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