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 .
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 21, 2026 has been entered.
The amendment filed January 21, 2026 has been entered. Claims 2-3, 9-10, 16-17, 23-24, and 27-28 remain cancelled.
The declaration of Gonzalez filed January 21, 2026 claims ownership of the Juneja reference previously applied in the final rejection mailed August 21, 2026. The reference was published 1 year or less than the effective filing date of the instant specification and is thus disqualified as a prior art reference. New rejections and response to arguments as they currently apply are addressed below.
This application is a 371 of PCT/US2020/032547 filed May 12, 2020 which claims benefit of 62/849,019 filed May 16, 2019.
Claims 1, 4-8, 11-15, 18-22, 25-26, and 29-32 are pending in this application.
Claim Interpretation
According to the instant specification, the term "decolonization" refers, in embodiments, to the reduction of a specific pathogen (e.g., Candida auris) burden in a specific body site (e.g., skin) in a sufficient magnitude that common culture techniques are no longer able to identify the pathogen (pg. 19, para. 0076).
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Although, currently a typographical error, the phrase “wvvw.cdc.gov” appears in the instant specification, which if corrected would read “www.cdc.gov” (pg. 3, para. 0008). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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.
Claims 1, 4-8, 11-15, 18-22, 25-26, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Berkow (Antimicrobial Agents of Chemotherapy, 2017, cited in previous action), in view of Schelenz et al (Antimicrobial Resistance and Infection Control, 2016, cited in previous action), and Greenlee (WO 2010/019203, cited in previous action) as evidenced by Juneja (European Congress of Clinical Microbiology and Infectious Diseases, 2019, cited in previous action).
Regarding claims 1, 4-8, 11-15, 18-22, 25-26, and 29: Berkow teaches SCY-078 is known in the art as a glucan synthase inhibitor that has in vitro activity against C. auris (pg. 1, para. 2, pg. 2, table 2). Berkow teaches SCY-078 is known in the art with both oral and intravenous formulations (pg. 2, para. 2). According to the instant specification ibrexafungerp or SCY-078 is the compound of formula (IIa), is the preferred compound of formula (I) and has the following structure:
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(pgs. 9-10, para. 0025, pg. 12, para. 0042). Berkow teaches a method of administering SCY-078, which differs from the structure in instant claim 8 by an additional defined chiral center (see image):
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. However, the pure chiral center is encompassed the racemate variant as recited by instant claims 8 and 12-13.
Berkow does not explicitly teach a method of decolonizing an anatomic area of a human subject, wherein the anatomic area is skin or mucosal tissue, and wherein the mucosal tissue is respiratory, gastrointestinal, urinary tract mucosal tissue.
However, Schelenz teaches in the majority of cases C. auris was confined to colonization of skin sites or mucosa (pg. 4, col. 1, para. 3). Colonization with C. auris was defined as culture positive skin, oropharynx, vascular line exit site, respiratory, and urinary tract without clinical signs of Candida infection (pg. 2, col. 1, para. 2). Greenlee teaches methods for inhibiting glucan synthase for treating fungal infections comprising administering enfumafungin derivatives (abstract, pg. 13, lines 24-32). The compound of formula (IIa), as recited by instant claim 30, is included as a possible compound (pg. 98, lines 5-10, compound 182). Greenlee teaches compounds/compositions can be provided as tablets for oral administration (pg. 14, lines 19-31). Greenlee teaches the compounds are useful for the treatment of mycotic infections in skin, oral mucosa, gastrointestinal tract, bronchus, and lung (i.e. respiratory, pg. 8, lines 14-20). Juneja discloses a method of treating Candida auris in a human subject comprising administering oral ibrexafungerp (col. 1, methods). The method resulted in decreasing amount C. auris in blood cultures (col. 2, results, table 2). Juneja states that a patient showed “no evidence of recurrence of the fungal infection” (i.e. decolonized, results).
Taken together it would have been prima facie obvious to one of ordinary skill in the art to apply the method of Berkow by administering SCY-078 orally or intravenously as taught by Berkow, for the treatment of a Candida auris infection, which would necessarily result in the decolonization of skin or mucosal tissues, such as respiratory tissues, as taught by Schelenz and Greenlee. One of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success as patients colonized by C. auris have culture positive skin and respiratory tissues, and the one would administer these established oral/intravenous antifungal agents for the purpose of treating the infection As disclosed by Juneja, administration of SCY-078 necessarily results in decolonizing the tissue. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant (See MPEP 2144 (IV)).
Claims 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Berkow (Antimicrobial Agents of Chemotherapy, 2017, cited in previous action), Schelenz et al (Antimicrobial Resistance and Infection Control, 2016, cited in previous action), Greenlee (WO 2010/019203, cited in previous action), and Juneja (European Congress of Clinical Microbiology and Infectious Diseases, 2019, cited in previous action) as applied to claims 1, 4-8, 11-15, 19-22, 25-26, and 29 above in view of Wring et al (Antimicrobial Agents and Chemotherapy, 2017, cited in previous action).
Regarding claims 30-32: As discussed above, the prior art teaches everything except wherein the SCY-078 is administered as a citrate salt (pharmaceutically acceptable salt) in tablet form.
However, Wring teaches the citrate salt of SCY-078 (i.e. a compound of formula (IIa)) has improved pharmacokinetic (solubility) properties in both i.v. and oral studies (pg. 6, para. 1). Greenlee teaches methods for inhibiting glucan synthase for treating fungal infections comprising administering enfumafungin derivatives (abstract, pg. 13, lines 24-32). The compound of formula (IIa), as recited by instant claim 30, is included as a possible compound (pg. 98, lines 5-10, compound 182). Greenlee teaches compounds/compositions can be provided as tablets for oral administration (pg. 14, lines 19-31). Greenlee teaches the compounds are useful for the treatment of mycotic infections in skin, oral mucosa, gastrointestinal tract, bronchus, and lung (i.e. respiratory, pg. 8, lines 14-20).
Taken together, it would have been prima facie obvious to modify the method of Juneja, Berkow, Greenlee, and Schelenz by administering the citrate salt of SCY-078 in tablet form as taught by Wring and Greenlee for decolonization of C. auris in skin or mucosal tissues. One of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success as the art recognizes tablet formulations of these compounds as a viable option for the treatment of fungal infections, the citrate salt of the compound improves pharmacokinetic properties, and these types of compounds are useful for the decolonization of fungal infections in the skin or mucosal tissue, such as respiratory tissue.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4-6, 8, 11-13, 15, 18-20, 22, 25-26, 29-30, and 31-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,534,433 in view of Kumar et al (J. Infect. Dev. Ctries., 2015, cited in previous action), Schelenz et al (Antimicrobial Resistance and Infection Control, 2016, cited in previous action), Greenlee (WO 2010/019203, cited in previous action) as evidenced by Juneja (European Congress of Clinical Microbiology and Infectious Diseases, 2019, cited in previous action).
Regarding claims 1, 4-6, 8, 11-13, 15, 18-20, 22, 25-26, 29-30, and 31-32: The patented claims teach a method of treating vulvovaginal candidiasis infection in a subject comprising administering the compound of formula (IIa):
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, or a pharmaceutically acceptable salt or hydrate thereof, wherein the infection occurs in an anatomic area (claim 1). The patented claims also teach the citrate salt of the compound can be administered (claims 11 and 14). The patented claims teach the compound can be administered orally as a tablet (claims 8 and 15).
The present claims and the patented claims differ in that the patented claims do not teach a method of decolonizing C. auris, wherein the subject is human, or wherein the anatomic area is skin or mucosal tissue, such as respiratory tissue.
However, Kumar teaches vulvovaginal candidiasis can be caused by C. auris (pg. 1, col. 1, para. 1). Schelenz teaches in the majority of cases C. auris was confined to colonization of skin sites or mucosa (pg. 4, col. 1, para. 3). Colonization with C. auris was defined as culture positive skin, oropharynx, vascular line exit site, respiratory, and urinary tract without clinical signs of Candida infection (pg. 2, col. 1, para. 2). Greenlee teaches methods for inhibiting glucan synthase for treating fungal infections comprising administering enfumafungin derivatives (abstract, pg. 13, lines 24-32). The compound is of formula (IIa), as recited by instant claim 30, is included as a possible compound is included as a possible compound and meets the structural requirements of formula (I) as recited by instant claim 1 (pg. 98, lines 5-10, compound 182). The compound differs from the structure in instant claim 8 by an additional defined chiral center (see image):
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. However, the pure chiral center is encompassed by the racemate variant as recited by instant claims 8 and 12-13. Greenlee teaches compounds/compositions can be provided as tablets for oral administration (pg. 14, lines 19-31). Greenlee teaches the compounds are useful for the treatment of mycotic infections in skin, oral mucosa, gastrointestinal tract, bronchus, and lung (i.e. respiratory, pg. 8, lines 14-20). Juneja discloses a method of treating Candida auris in a human subject comprising administering oral ibrexafungerp (col. 1, methods). The method resulted in decreasing amount C. auris in blood cultures (col. 2, results, table 2). Juneja states that a patient showed “no evidence of recurrence of the fungal infection” (i.e. decolonized, results).
Taken together it would have been prima facie obvious to one of ordinary skill in the art to apply the method of the copending claims for the decolonization of C. auris skin or mucosal tissues, such as respiratory tissues, in human subjects as taught by Kumar, Schelenz and Greenlee. One of ordinary skill in the art would have the motivation to do as vulvovaginal candidiasis can be caused by C. auris and patients colonized by C. auris have culture positive skin and respiratory tissues, and one would administer these established antifungal agents for the purpose treating the C. auris infection in tissue, thereby necessarily resulting in the decolonization of tissues in the subject, absent evidence to the contrary.
Claims 7, 14, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,534,433, Kumar et al (J. Infect. Dev. Ctries., 2015, cited on previous action), Schelenz et al (Antimicrobial Resistance and Infection Control, 2016, cited on previous action), Greenlee (WO 2010/019203, cited on previous action), and Juneja (European Congress of Clinical Microbiology and Infectious Diseases, 2019, cited in previous action) as applied to claims 1, 4-6, 8, 11-13, 15, 18-20, 22, 25-26, 29-30, and 31-32 in view of Wring et al (Antimicrobial Agents and Chemotherapy, 2017, cited in previous action).
Regarding claims 7, 14, 21: The patented claims further differ from the instant claims in that the patented claims do not teach wherein the compound is administered intravenously.
However, Wring teaches the citrate salt of SCY-078 (an antifungal compound) has improved pharmacokinetic (solubility) properties in both i.v. and oral studies (abstract, pg. 6, para. 1). According to the instant specification ibrexafungerp or SCY-078 is the compound of formula (IIa) (pgs. 9-10, para. 0025, pg. 12, para. 0042).
Taken together it would have been prima facie obvious to modify the patented claims by administering the compound intravenously as taught by Wring. One of ordinary skill would have the motivation to do so in order to treat fungal infections (C. auris) with a reasonable expectation of success given that this administration route has been demonstrated for this compound.
Response to Arguments
Applicant’s arguments filed June 6, 2025 have been fully considered but they are not persuasive.
On page 8 of Applicant’s response, Applicant argues that the declaration of Gonzalez filed January 21, 2026 disqualifies Juneja as a prior art reference under 102(b)(1).
See rejections above which rely on Juneja as an evidentiary reference, rather than a prior art reference.
On page 9 of Applicant’s response (paras. 2-3), Applicant argues that the general ability of glucan synthase inhibitors to treat skin/lung mycotic infections is not the same as decolonization, and would not have been predicted based on the prior art.
However, as discussed above in the 103 rejections, via administering the claimed antifungal agent for the purpose of eliminating/treating a Candida auris fungus infection, the method necessarily results in decolonizing that subject, as evidenced by Juneja. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant (See MPEP (IV)). In order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis – the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art (See MPEP 2112 (IV)). Wherein the prior art establishes SCY-078 as an efficacious treatment for Candida auris infections, and Schelenz teaches in the majority of cases C. auris was confined to colonization of skin sites or mucosa (pg. 4, col. 1, para. 3). Colonization with C. auris was defined as culture positive skin, oropharynx, vascular line exit site, respiratory, and urinary tract without clinical signs of Candida infection. Juneja discloses a method of treating Candida auris in a human subject comprising administering oral ibrexafungerp (col. 1, methods). The method resulted in decreasing amount C. auris in blood cultures (col. 2, results, table 2). Juneja states that a patient showed “no evidence of recurrence of the fungal infection” (i.e. decolonized, results). The ability of SCY-078 to decolonize a tissue, is an innate feature of the specific compound, thus the resulting decolonization flows naturally from practicing the method.
On page 8 of Applicant’s response, Applicant argues that the prior art does not teach or suggest that administration of SCY-078 results in decolonization from skin or mucosal tissues of a subject colonized by Candida auris (para. 2). Applicant argues that the Examiner has not provided sufficient evidence that decolonization of a person’s skin or mucosal tissues is an expected property of the composition (para. 3). Applicant argues the Examiner relies on improper hindsight to suggest a person would have expected such an outcome following practicing the method.
However, as discussed above, although the prior art does not necessarily recognize the ability to decolonize skin or mucosal tissues, this property flows naturally as a result of practicing the method. There is nothing in the prior art that teaches away from this being a capability of SCY-078. Wherein the prior art establishes SCY-078 as an efficacious treatment for Candida auris infections, and Schelenz teaches in the majority of cases C. auris was confined to colonization of skin sites or mucosa (pg. 4, col. 1, para. 3). Colonization with C. auris was defined as culture positive skin, oropharynx, vascular line exit site, respiratory, and urinary tract without clinical signs of Candida infection. Juneja discloses a method of treating Candida auris in a human subject comprising administering oral ibrexafungerp (col. 1, methods). The method resulted in decreasing amount C. auris in blood cultures (col. 2, results, table 2). Juneja states that a patient showed “no evidence of recurrence of the fungal infection” (i.e. decolonized, results). The ability of SCY-078 to decolonize a tissue, is an innate feature of the specific compound, thus the resulting decolonization flows naturally from practicing the method.
Applicant’s reply is considered to be a bona fide attempt at a response and is being accepted as a complete response. The 35 USC § 103 rejections are maintained for reason of record and foregoing discussion.
Conclusion
No claims are allowed in this action.
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/S.L.G./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693