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 with traverse of Group II in the reply filed on 7/16/2026 is acknowledged. The traversal is on the ground(s) that Group I has been amended to recite technetium-94m. Applicant’s arguments have been fully considered but are not found persuasive because applicant has not explained why amending the claims to recite the above makes the restriction improper.
The requirement is still deemed proper and is therefore made FINAL.
Notes and Comments
Claims 25-33 have the status modifier “(Previously Pending).” This is not a proper status modifier. Proper claim modifiers are (Original), (Currently Amended), (Canceled), (Withdrawn), (Previously Presented) and (New) (see § 714, II.C(E)). For the sake of compact prosecution, the examiner is considering the reply to be proper, but applicant in their next response is required to correct the status modifiers of claims 25-33.
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 24-33 are rejected under 35 U.S.C. § 103 as being unpatentable over Kannan (Dendrimer-Based Postnatal Therapy for Neuroinflammation and Cerebral Palsy in a Rabbit Model, Sci Transl Med. 2012 April 18; 4(130) in view of Nickles (Technetium-94m-Teboroxime: Synthesis,
Dosimetry and Initial PET Imaging Studies, The Journal of Nuclear Medicine • Vol. 34 • No. 7, July 1993).
Kannan teaches a method of targeting and detecting neuroinflammation in a mammalian subject by systemically administering a composition containing a hydroxyl-terminated poly(amidoamine) (PAMAM) generation 4 (G4-OH) dendrimer (Abstract; Discussion). Systemic and intravenous administration are taught (abstract; Discussion). Imaging of Alzheimers and multiple sclerosis are taught (abstract; Discussion). Kannan establishes that these neutral, hydroxyl-functionalized dendrimers cleanly cross an impaired or compromised blood-brain barrier (BBB) at sites of injury (Discussion). Once inside the central nervous system (CNS) tissue, the dendrimers are selectively internalized by activated microglia and reactive astrocytes via upregulated endocytosis (Discussion). Kannan tracks and detects this localization in CNS tissue by attaching an imaging tracer to the dendrimer core/surface, noting that the localization serves as a quantitative diagnostic metric for neuroinflammation severity (Discussion). This targeting mechanism is an intrinsic property of the G4-OH PAMAM dendrimer shell itself (Discussion). The composition does not comprise or require an active targeting ligand or agent (such as an antibody or peptide) to localize in the inflamed microglial cells (Discussion).
Kannan fails to teach use of Technetium-94m as a tracer.
Nickles teaches Technetium-94m as a tracer used in nuclear medicine and radiochemistry and details the production, chelation, and use of Technetium-94m, a positron-emitting radionuclide, as a specialized tracer for Positron Emission Tomography (PET) scanning (Materials and Methods).
It would have been obvious to one or ordinary skill in the art at the time the invention was filed to transition the diagnostic principles taught by Kannan into a high-resolution, clinically quantitative PET imaging protocol. The artisan would have been motivated to look to established radiochemical substitutions. Because Nickles teaches that {94\Tc functions as a high-fidelity PET alternative to common SPECT isotopes using the exact same well-characterized metal-chelation configurations, it would have been obvious to swap the imaging payload of Kannan with Technetium-94m with the motivation of detecting neuroinflammation in a subject.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
August 31, 2026
Prosecution Insights