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 Group I and species of [11C]8 shown in claim 19 in the reply filed on April 17, 2026 is acknowledged.
Drawings
The drawings are objected to because of ambiguity of footnote reference in FIG. 8. In FIG. 8, a footnote labeled “a” is provided at the bottom referencing “Data from Napper et al…..” However, the corresponding superscript or reference mark “a” is absent within the body of the table or the column headers. Because the reference mark “a” is not anchored to any specific part of the table, it is unclear whether the entire set of data is derived from the cited literature, or if only a specific subset of the results pertains to that reference.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities:
The use of the terms CombiFlash®, TRACERlab®, Gemini®, Sep-Pak®, Pursuit XRs®, Triumph™, DICOM®, PMOD™, and Biograph mMR® which are a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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.
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 1, 4-6, 11, 12, and 18- 20 are rejected under 35 U.S.C. 103 as being unpatentable over Napper et al. (Journal of Medicinal Chemistry, 2005; cited on IDS filed April 3, 2024) in view of Zeng et al. (ACS Medicinal Chemistry Letters, 2018; cited on IDS filed April 3, 2024).
Regarding claims 1, 4-6, 11, 12, 18, and 19, Napper discloses compounds of sirtuin 1 (SIRT1) inhibitor (abstract). Napper disclose the structure of the compound
PNG
media_image1.png
350
500
media_image1.png
Greyscale
, wherein R can be CH3, H, Cl, or Br (page 8046, Figure 2; page 8047, Scheme 2; page 8050, Table 2). The compound of Napper reads on the compound of instant claims and elected species (shown in claim 19)
PNG
media_image2.png
302
495
media_image2.png
Greyscale
, except for the radioisotope 11C at the R1 position of instant claims. The compound of Napper contains a stable methyl group (12CH3) whereas the compound of instant claims contains a radioactive methyl group (11CH3) at the same position. Napper discloses that these compounds provide a useful set of chemical tools for exploring therapeutic uses for SIRT inhibitors (page 8048, col. 2, ¶ 2). Regarding claim 20, Napper discloses a pharmaceutical composition comprising the compound and phosphate-buffered saline, which reads on pharmaceutically acceptable carrier (page 8053, col. 1, ¶ 9).
Napper does not disclose that the compound comprises a radioisotope such as 11C at the R1 position of instant claims.
Zeng discloses a radiolabeled compound ( [11C]8) for the development of positron emission tomography (PET) imaging agents for brain imaging (abstract). Zeng discloses an efficient method for the radiosynthesis of [11C]8 comprising a palladium-catalyzed coupling reaction (page 189, com. 2, ¶ 2; page 190, schemes 2 and 3), which corresponds to the radiosynthesis of [11C]8 scheme shown in FIG. 2 of instant application.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the compound of Napper by substituting the CH3 group with 11CH3 at the R position by applying the radiolabeling method of Zeng in order to prepare a radioisotope-labeled compound for PET imaging analysis. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Zeng teaches the efficient radiolabeling method using 11C-methylation for PET imaging. Further, a person of ordinary skill in the art would have been motivated to use the SIRT1 inhibitor in combination with 11C-methylation labeling in order to develop an improved PET imaging agent for neurodegenerative diseases, which expands the applications of the compound. Accordingly, applying the teachings of Zeng to the compound of Napper constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders instant claims obvious.
Claims 1, 4-6, 11, 12, and 18- 20 are rejected under 35 U.S.C. 103 as being unpatentable over Shenk et al. (US 2016 0296523; cited on IDS filed April 3, 2024) in view of Zeng et al. (ACS Medicinal Chemistry Letters, 2018; cited on IDS filed April 3, 2024).
Regarding claims 1, 4-6, 11, 12, 18, and 19, Shenk discloses a SIRT1 inhibitor, EX-527
PNG
media_image3.png
272
243
media_image3.png
Greyscale
, which can be used for medical applications such as viral infection and cancer treatments (¶ 47; ¶ 82). The compound of Shenk reads on the compound of instant claims and elected species (shown in claim 19)
PNG
media_image2.png
302
495
media_image2.png
Greyscale
, except for the 11CH3 at the R1 position of instant claims. The compound of Shenk contains a chloro group (Cl) whereas the compound of instant claims contains a radioactive methyl group (11CH3) at the same position. Regarding claim 20, Shenk discloses a pharmaceutical composition comprising the compound and pharmaceutically acceptable carrier (¶ 11).
Shenk does not disclose that the compound comprises a radioisotope group such as 11CH3 at the R1 position of instant claims.
As discussed above, Zeng discloses a radiolabeled compound ( [11C]8) for the development of positron emission tomography (PET) imaging agents for brain imaging (abstract). Zeng discloses an efficient method of radiosynthesis of [11C]8 comprising a palladium-catalyzed coupling reaction (page 189, com. 2, ¶ 2; page 190, schemes 2 and 3), which corresponds to the radiosynthesis of [11C]8 scheme shown in FIG. 2 of instant application.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the compound of Shenk by substituting the Cl group with 11CH3 by applying the radiolabeling method of Zeng in order to prepare radioisotope-labeled compound for PET imaging analysis. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Zeng teaches the efficient radiolabeling method using 11C-methylation for PET imaging. Further, a person of ordinary skill in the art would have been motivated to use the SIRT1 inhibitor in combination with 11C-methylation labeling in order to develop improved PET imaging agent for neurodegenerative diseases, which expands the applications of the compound. Accordingly, applying the teachings of Zeng to the compound of Shenk constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders instant claims obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
Prosecution Insights