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 .
Receipt is acknowledged of IDS filed on 05/12/2025.
Claims 1, 2 and 13-29 are pending.
Claims 3-12 and 30-34 are cancelled.
Claims 1, 2, and 13-24 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group II and Species A-B in the reply filed on 5/4/2026 is acknowledged.
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.
Claim 25 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. The claims are dependent on a withdrawn claim. For compact prosecution purposes, the Examiner will examine claim 25 dependent on claim 1 for 103 rejections.
Claim 29 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 29 contains the terms “DOTA" and “NOTA” which is not defined by the claims. Claims must stand alone to define the invention, and should not rely on the description or the drawings to give them meaning (see Ex Parte Fressola, 27 USPQ 2d 1608). Thus, claim 29, at the very least, should define "DOTA” and “NOTA” by its formal name; once "DOTA" and “NOTA” is defined, the terms "DOTA" and “NOTA” may be subsequently recited.
In regard to claim 29, it is unclear why the term “e.g., DOTA-Gd/Mn, NOTA-Gd/Mn, etc.” is in parenthesis. Thus, it is unclear if this is a limitation in the claim or just a preferred embodiment.
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.
Claims 25-29 are rejected under 35 U.S.C. 103 as being unpatentable over NAIRN (WO 2019/126240) in view of KARANJA (A STING-based fluorescent polarization assay for monitoring activities of cyclic dinucleotide metabolizing enzymes. RSC Chemical Biology. 2020.).
Regarding claim 25 and 26, NAIRN a method of using a composition that uses STING ligands, such as GMP (table 8 and figure 12b), such as:
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(Figure 12B), that is administered to target tumors (claim 13), such as cancer (claim 189) and is used to image (claim 188 and claim 193). The imaging agent allows for diagnostic tests which can enhance the use of the therapeutic composition and aid in diagnosis (page 162, paragraph 1).
Regarding claim 27, NAIRN teaches the composition can target tumors and comprise an immuno-oncology agent (abstract). The composition has a therapeutic agent that causes a therapeutic effect (page 83, paragraph 0213) and can be further conjugated to a peptide that can enhance the therapeutic effects (page 150, paragraph 0304).
Regarding claim 28, NAIRN teaches the composition can be detected via magnetic resonance imaging (MRI) (claim 195) using a radiolabel (claim 193).
Regarding claim 29, NAIRN teaches the composition can be detected via positron emission tomography (PET), which means it has a MRI imaging moiety.
NAIRN does not teach using a compound that falls into the specific formula claimed.
KARANJA teaches the following compound,
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(figure 2), which reads on the formula of claim 1, wherein R10 is am imaging agent. The R Group shown in figure 2 is a fluorescein derivative which is a fluorescence imaging agent (page 209, paragraph 3). The composition can be used for cancer cells (page 206, paragraph 1) and GMP, which is part of the composition, can be used to target cancer (page 206, paragraph 1). The compound shows a high binding affinity to STING (page 210, paragraph 2), which would lead to a high binding of cancer.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate the compound from KARANJA. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the compound in KARANJA and the compound in NAIRN are functional equivalents of GMP compounds that are used for imaging and for cancer. Furthermore, both are structurally similar.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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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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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
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