DETAILED ACTION
This Office action details final action on the merits of the above referenced application No. Claims 1, 3, and 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 13 May 2026 has been entered.
Status of Claims
Claims 1 and 5 are amended. Claims 2 and 4 are canceled.
Response to Amendment
The amendments filed on 13 May 2026 have been entered.
Response to Arguments
The rejection of claims 1-5 under 35 USC 103 as being unpatentable over Jain et al. (US 2015/0250906 A1; published 10 Sep. 2015), in view of Koivistonen 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 Cell; published 2003) is withdrawn.
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 13 Feb. 2026.
Applicants Arguments
Applicants assert that Jain’s disclosure regarding fungal imaging is merely prophetic and non-enabling. Jain provides a vast list of potential substrates and pathogens but fails to provide any working examples or data showing that [18F]FDS actually accumulates in fungal lesions in a living subject. It is contradictory to assert that a disclosure deemed non-enabling for its own prosecution can provide a reasonable expectation of success to a person of ordinary skill in the art to reach the present invention. [18F]FDG-the most common PET tracer which targets glucose metabolism-showed the lowest uptake in Aspergillus fumigatus lesions compared to other pathogens. The fact that [18F]FDS failed where [18F]FDS succeeded proves that in vivo uptake and retention are governed by complex biological factors beyond the metabolic presence. Applicants assert improper hindsight bias. Applicants assert long felt need and secondary considerations. If the claimed invention were truly obvious as 2021, the medical community would not have had to wait over a decade for a definitive method to image invasive aspergillosis.
Applicant's arguments filed 13 May 2026 have been fully considered but they are not persuasive. At for example [0005], Jain teaches that the imaging agents were selected based on the following criteria: presence of prokaryotic specific metabolic pathway, absence of known host metabolism, and essentiality of the pathway for bacterial survival. At [0006], Jain teaches a method for detection of the presence of an infection microorganisms in a mammalian host comprising: a) administering to the host a therapeutically effective amount of labeled substrate, wherein the labeled substrate is a compound that is solely utilized by the metabolism of the infectious organism selected as fungi and wherein the label of the labeled substrate is a PET detectable moiety; b) allowing a sufficient period of time for the infectious organism to take up the labeled substrate, and c) determining whether the infectious organisms are present in the host by detecting the labeled substrate. Jain teaches [18F]FDS as an exemplary labeled substrate that is solely utilized by the metabolism of infectious organisms. At [0099], Jain enables the synthesis of [18F]FDS. According to Jain, [18F]FDS can be rapidly synthesized from [18F]FDG at a low cost technique. At [0100], Jain enables the administration and PET imaging of [18F]FDS. In this case, Jain enables how to make and use the [18F]FDS in methods of PET imaging including methods of PET imaging fungal infections.
Koivistoinen teaches and suggests that sorbitol is utilized in the metabolism of Asperigillus sp. and is essential for fungal survival whereby fulfilling the criteria set forth in Jain. Specifically, Koivistoinen teaches identifying a sorbitol dehydrogenase gene, sdha, in Asperigillus n. which is involved in the catabolism of sorbitol. For a sdhA deletion strain, growth on D-sorbitol was abolished. Accordingly, a person of ordinary skill in the art would have had good reason and motivation, absent hindsight analysis, to modify the teachings of Jain to arrive at a method for diagnosing a fungal infection cause by Asperigillus sp. in a subject, comprising administering an effective amount of [18F]FDS to the subject and obtain a PET image. There would have been a reasonable expectation of success since [18F]FDS meets the criteria as set forth in Jain as being suitable for the detection of infectious organisms, in this case Asperigillus sp.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, Jain alone provides teaching, suggestion and motivation to detect pathogenic fungi using a compound that is solely utilized by the metabolism of the infectious fungi. Jain alone provides criteria of imaging agents for the detection of the pathogenic fungi. Koivistoinen teaches and suggests that [18F]FDS meets the imaging agent criteria for detection of pathogenic Asperigillus sp. before the effective filing date.
Ankrah teaches that Aspergillus is one of the most common fungi causing IFIs. There is an absolute need for a sensitive non-invasive biomarker capable of monitoring the disease activity of IFIS and determining the efficacy of treatment at an early time point. Ankrah teaches that a probe for imaging Aspergillus fumigatus could be very useful for monitoring invasive pulmonary aspergillosis. 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 absent hindsight analysis to modify Jain by diagnosing a fungal infection caused by Aspergillus fumigatus in a subject comprising administering an effective amount of [18F]FDS and obtaining a PET imaging because the diagnosing of a fungal infection cause by Aspergillus fumigatus would have been expected to advantageously enable selective and sensitive diagnosing and monitoring of invasive pulmonary aspergillosis fulfilling an absolute need for disease monitoring.
A long-felt need must not have been satisfied by another before the invention by the inventor. See Newell Companies v. Kenney Mfg. Co., 864 F.2d 757, 768, 9 USPQ2d 1417, 1426 (Fed. Cir. 1988). In this case, both [18F]FDS and methods of diagnosing a fungal infection in a subject comprising administering the [18F]FDS to a subject and PET imaging was satisfied by Jain before the effective filing date. In addition, Ankrah teaches that [64Cu]DOTA labeled A. fumigatus-specific monoclonal antibody demonstrated the ability to distinguish invasive pulmonary aspergillosis to bacterial infections in mice.
The post-filing publication by Kim is not prior art. For the purpose of comparison, the closest prior art is Jain who teaches and suggest the use of [18F]FDS for the diagnosis and monitoring of fungal infections. Jain discourages the use [18F]FDG for the detection of fungal and bacterial infections since [18F]FDG is not selective and does meet the criteria as set forth above. The post-filing publication by Kim teaches and suggests some uptake of [18F]FDG in A. fumigatus.
Claim Objections
Claim 1 is objected to because of the following informalities: “Aspergillus fumgatus” should be “Aspergillus fumigatus”. Appropriate correction is required.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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
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