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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/3/26 has been entered.
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, 4, 6, 7, 9-16, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Hernandez et al (US 2016/0199524 A1 hereafter Hernandez) in view of Williams et al (US 2016/0333114 A1 hereafter Williams) and Deri et al (p-SCN-Bn-HOP: A Superior Bifunctional Chelator for 89Zr ImmunoPET, Bioconjugate Chemistry, 2015, 26, 2579-2591 hereafter Deri).
Hernandez discloses a method for in vivo immunotherapy and imaging of bound IL-12 (claim 9). The method comprises administering a labeled antibody or antigen fragment conjugate which comprises an antibody or antigen fragment that specifically binds IL-12 and a detection label such as a radionuclide and detecting the conjugate (Figures, Examples). The radionuclide tracer is ¹⁸F (0007, 0011, 0017). The method is applied to a subject where the subject has cancer (claim 27). The subject used in the method include mice (Fig.1, 0022). The radionuclide tracer is conjugated to the antibody via a difunctional chelator such as DOTA (0010, 0042-0044). The imaging aspects of the method include PET, MRI and PECT scans (0015). The imaging can be done in real time (Fig. 10).
The reference discloses a method for in vivo imaging, the reference does not disclose prior immunotherapy therapy. Immunotherapy can be applied with in vivo immunoimaging as seen in the Williams patent.
Williams discloses a method of treatment comprising a noninvasive means of diagnosing and imaging tissues in a patient [abstract, Examples]. The compound is an antibody that binds IL-12 [0200]. The antibody can further be labeled with a radiometal such as 18F, 68Ga and 64Cu [Examples]. The compound is conjugated with DOTA [0238-0240]. The formulation can be applied after the administration of a prior immunotherapy in order to improve the treatment [0231]. It would have been obvious to apply the prior immunotherapy of Williams to the method of Hernandez to improve the overall treatment of cancers.
As discussed above, Hernandez discloses a method of immunoimaging of IL-12 as a marker in a subject. The marker composition comprises an antibody or fragment that binds IL-12 and conjugates with a detection label, where the label is a radionuclide. The conjugate is formed with the antibody with a bifunctional chelating agent. The reference does not disclose the specific chelator of claim 13, however the use of this specific compound is known in the art as seen in the Deri study.
Deri discloses a study of the use of p-SCN-Bn-HOPO and p-SCN-Bn-DFO as a bifunctional chelator for forming conjugates with ⁸⁹Zr for immunoimaging using PET (abstract). In experiments the chelator forms conjugates with anticancer drugs and shows superior tumor: blood ratio for visualization (pg. 2583). It would have been obvious to include this specific bifunctional chelator in the method of Hernandez as they solve the same problem of visualizations tumors in the body.
With these aspects in mind, it would have been obvious to combine the chelator of Deri into the method of Hernandez as they solve the same problem. It would have been obvious to include the additional immunotherapy administration of Williams in order to enhance the overall effectiveness of the treatment, as they solve the same problem of treating cancers by in vivo visualizations. The chelator of Deri provides a superior imaging ability for the types of imaging methods, where the compounds comprise conjugated anticancer compounds. One of ordinary skill in the art would have been motivated to include the chelator of Deri into the method of Hernandez with an expected result of a stable method for in vivo immunoimaging using anticancer conjugates.
Response to Arguments
Applicant’s arguments, see Remarks, filed 2/3/26, with respect to the rejection(s) of claim(s) 1, 3, 4, 6, 7, 9-16, 19 and 20 under USC 102 (a) and 103(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the above recited rejection. Williams is added to the combination to address the amended claim limitation regarding prior art immunotherapy.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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/MICAH PAUL YOUNG/ Primary Examiner, Art Unit 1618