DETAILED ACTION
This Office action details a final action on the merits for the above referenced application No. Claims 1-5 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 1-5 are original.
Response to Amendment
The amendments filed on 16 Jan. 2026 have been entered.
Response to Arguments
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) 1-3, and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jain et al. (US 2015/0250906 A1; published 10 Sep. 2015), in view of Koivistoinen et al. (FEBS Lett.; published 2012) and Ankrah et al. (Curr. Pharm. Des.; published 2018) for the reasons cited in the Office action filed on 18 Sep. 2025.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jain et al. (US 2015/0250906 A1; published 10 Sep. 2015), in view of Koivistoinen et al. (FEBS Lett.; published 2012) and Ankrah et al. (Curr. Pharm. Des.; published 2018), in further view of Huang et al. (Mol. Biol. Cell; published 2003) for the reasons cited in the Office action filed on 18 Sep. 2025.
Applicants Arguments
Applicants assert that as previously held, the mere naming of a compound without an enabling disclosure of how to use it does not constitute a valid prior art rejection. The prophetic lists in Jain are essentially invitations to experiments rather than a disclosure of a reasonable expectation of success. The USPTO determined that the disclosure failed to meet the written description requirement for fungi and Gram-positive bacteria, leading to claims being limited strictly to gram-negative bacteria. It is a contradiction to assert that the same non-enabling disclosure provides a reasonable expectation of success for the claimed invention. If the mere presence of an SDH pathway were sufficient to predict imaging success, then gram-positive bacteria should have been detectable. A PHOSITA would conclude that the presence of metabolic enzymes does not correlate with PET detectability. Given that [18F]FDS fails to penetrate or accumulate in Gram positive bacterial, a PHOSITA would have a negative expectation regarding fungi. The [18F]FDS successfully image fungi is an unexpected technical effect. Applicants assert hindsight combination.
Applicant's arguments filed 16 Jan. 2026 have been fully considered but they are not persuasive. The written description requirement requires that the claims contain subject matter which was described in the specification in such a way as to reasonably convey to one of ordinary skill in the art that the inventor or joint inventor had possession of the claimed invention. See 35 USC 112(a). It is well accepted that satisfactory description may be found in in originally filed claims or any other portion of the originally filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980). The written description requirement is separate and distinct from the enablement requirement. See Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010). At [0006] and several other places, Jain provides for a method for the detection of the presence of pathogenic fungi in a mammalian host comprising a) administering to the host a therapeutically effective amount of a labeled substrate therein wherein the specification describes [18F]FDS as an exemplary labeled substrate. Accordingly, the specification of Jain provides adequate written description for the detection of pathogenic fungi. Moreover, Jain provides teaching, suggestion and motivation for the detection of pathogenic fungi with a reasonable expectation of success by administering [18F]FDS to a subject in need thereof, allowing sufficient time for the fungi to take up the [18F]FDS, and PET detecting the pathogenic fungi. In this regard, Jain teaches and suggests that [18F]FDS PET detection of pathogenic fungi allows for non-invasive whole host imaging and localization and monitoring of pathogenic fungi which allows for early and effective treatment. Repeat imaging can monitor treatment efficacy or suggest the presence of a drug-resistant infection. A recognized advantage is the strongest reason to combine. It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify Jain by administering [18F]FDS to a subject suspected of having a fungal infection and obtain a PET image of the subject as taught and motivated by Jain because the administering would have been expected to advantageously enable non-invasive in vivo detection, localization and monitoring of a pathogenic fungal infection whereby enabling more effective treatment.
Koivistoinen teaches that Aspergillus sp. uptake and metabolize sorbitol. In Aspergillus sp., sorbitol dehydrogenase and fructokinase activity are induced on D-sorbitol. Obviousness only requires a reasonable expectation and some reason or motivation to modify a prior art method. Conclusive proof of efficacy is not required to show a reasonable expectation of success; nor is there a requirement for absolute predictability of success. See OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019). Regarding reason and motivation to modify the prior art [18F]FDS PET process of Jain, at abstract Ankrah teaches that there is an absolute need for a noninvasive biomarker that can monitor disease activity of invasive fungal infections (IFI). At pg. 796, Aspergillus is the most common type of mold and the mortality rate for an Aspergillus infection is reported to be 50%-90%. Ankrah provides an example where [18F]FDG PET in a child with hepatic aspergillosis helped in deciding to perform surgery during which large necrotic areas were found and encapsulation. Jain teaches [18F]FDS as an improvement over [18F]FDG for in vivo imaging of pathogens including pathogenic fungi. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Jain so that the obvious [18F]FDS PET method of detecting pathogenic fungi administers [18F]FDS to a subject suspected of having aspergillosis or invasive fungal infection caused by Aspergillus fumigatus as taught by Koivistoinen and Ankrah because it would have been expected to advantageously enable fulfilling an absolute need for non-invasive detection of invasive fungal infections including invasive A. fumigatus. Like Koivistoinen, Hwang teaches and suggest that Histoplasma capsulatum, an etiologic agent of histoplasmosis, metabolize sorbitol. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Jain so that the fungal infection is a histoplasmosis systematic infection as taught by Hwang because it would have been expected to enable non-invasive detection, localization and monitoring of a primary fungal pathogen that infects healthy as well as immunocompromised individuals.
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.
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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.
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618