DETAILED ACTION
This Office action details a final action on the merits for the above referenced application No. Claims 1-19 are pending in this application.
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 .
Status of Claims
Claims 1, 3, 11, 13, and 15-17 are amended.
Response to Amendment
The amendments filed on 29 May 2026 have been entered.
Response to Arguments
In view of Applicants amendments, the rejection of claims 11, and 16-18 under 35 USC 112(a) as failing to comply with the written description requirement is withdrawn.
In view of Applicants amendments, the rejection of claim 1-15, and 19 under 35 USC 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn.
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 16 is 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 for the reasons cited in the Office action filed on 30 Jan. 2026.
Applicants Arguments
Applicants assert that PET imaging which the claimed method is directed to is a well-known technique used for differentiating between diseased cells and healthy cells based on differences in uptake of PET compounds, for example as a result of different metabolic activity in cancer cells compared to quiescent cells.
Applicant's arguments filed 29 May 2026 have been fully considered but they are not persuasive. Differentiating between diseased and non-diseased cells based on observed differences in uptake is a mental activity or computer algorithm activity and not an activity performed by the claimed method of performing PET imaging on a subject. While the claimed method can allow for differentiating between disease or healthy cells, the method itself cannot differentiate between disease and healthy cells.
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.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rumsey et al. (J. Biol. Chem.; published 1999), in view of Kniess et al. (Med. Chem. Commun.; published 2015) and Gazivoda et al. (Carbohydrate Res.; published 2006), in further view of Yamamoto et al. (Nucl. Med. Biol.; published 1996) for the reasons cited in the Office action filed on 30 Jan. 2026.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rumsey et al. (J. Biol. Chem.; published 1999), in view of Kniess et al. (Med. Chem. Commun.; published 2015) and Gazivoda et al. (Carbohydrate Res.; published 2006), and Yamamoto et al. (Nucl. Med. Biol.; published 1996), in further view of Halliwell et al. (Annu. Rev. Nutri.; published 1996) for the reasons cited in the Office action filed on 30 Jan. 2026.
Applicants Arguments
Applicants assert that Rumsey fails to teach or suggest the use of any compounds of measuring intracellular ROS levels as recited in claim 1; for imaging/detecting/diagnosing a ROS modulated illness as recited in claim 13; or for performing PET imaging of a subject in need thereof as recited in claim 15. One of ordinary skill in the art would have been motivated to use a 6-halo substituted ascorbate as in Rumsey or Gazivoda for detecting intracellular ROS species because Rumsey teaches that transport of 6-deoxy-6-iodo-L-ascorbate is unaffected by an increased oxidation state induced by hydrogen peroxide. This is in direct contrast to the compounds of the present invention which demonstrated an increase in cellular uptake in hypoxic conditions. There is no indication in Rumsey of any advantage to using an ascorbate derivative that cannot cyclize into a hemi-ketal DHA for measuring intracellular ROS as recited in claim 1 or for imaging/detecting a ROS modulated illness as recited in claim 13 or for imaging oxidative stress in cells or for performing PET imaging of a subject in need thereof as recited in claim 15. One of ordinary skill in the art would have had no motivation based on the teachings of Yamamoto to use 18F-DFA in vivo outside of imaging for the cerebral cortex, hypothalamus, and amygdala. Halliwell fails to correct the deficiencies of Rumsey, Kniess, Gazivoda, and Yamamoto.
Applicant's arguments filed 29 May 2026 have been fully considered but they are not persuasive. Rumsey provides for and identifies the 6-deoxy-6-chloro-L-ascorbic acid as most effective inhibitor of ascorbate transport with a Ki value of 2.9 and Rumsey teaches and motivates the use of the compounds therein to study ascorbate transport while showing no activity toward DHA transport mechanisms. In addition, Rumsey teaches and motivates radiolabeled forms and non-radiolabeled forms of the compound for discriminating ascorbate uptake. At ref. 4, Yamamoto teaches one electron oxidation of 6-chloro-6-deoxy-ascorbic acid. Regarding applicants’ assertion that Rumsey teaches that transport of 6-deoxy-6-iodo-L-ascorbate is unaffected by an increase in oxidation state by hydrogen peroxide, at pg. 23221, Rumsey is actually teaching that [125I]6-deoxy-6-iodo-L-ascorbate and its oxidized product are not transported by either GLUT1 or GLUT3 mediated mechanisms of DHA transport. Yamamoto teaches that 18F-FDA can is capable of accumulating in tissues associated with oxidative stress induced by postischemic reperfusion. According to Yamamoto, oxygen derived free radicals are involved in the pathogenesis of cerebral ischemic re-perfusion. At table 1, Yamamoto teaches increased uptake 18F-FDA in the brain and non-CNS tissues such as adrenal in the ischemic group subject to 5 d recirculation achieving statistical significance. The delayed change is related to a process causing further damage. A recognized advantage is the strongest reason to combine. It would have been to a person of ordinary skill in the art before the effective filing date to modify the methods of Rumsey by contacting/administering the obvious 18F-labeled 6-deoxy-6-chloro-L-ascorbic acid derivative made obvious by Rumsey, Gazivoda, and Kniess to cells or a subject to image and/or diagnose oxidative stress as taught by Yamamoto with a reasonable expectation of success because the contacting/administering would have been expected to advantageously enable sensitive identification of oxidatively stressed tissues and/or ROS associated disease by PET. The combination of Rumsey, Gazivoda, Kniess, and Yamamoto teach and motivate all of the limitations of the pending claims. The basic technique of using an 18F-labeled 6-deoxy-6-chloro-L-ascorbic acid derivative to image oxidative stress yielded no more than an expected outcome and is therefore obvious. See Dann v. Johnston, 425 U.S. 219, 189 USPQ 257 (1976).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN R DONOHUE whose telephone number is (571)270-7441. The examiner can normally be reached on Monday - Friday, 8:00 - 5:00 EST.
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 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.
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618
Prosecution Insights