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 .
Priority
The instant application is a continuation of US Application 17/990,656 (filed November 18, 2022, now abandoned), which is a continuation of US Application 16/636,230 (filed February 3, 2020, now US Patent 11,534,433), which is a 35 USC 371 National Stage filing of international application PCT/US2018/044619, which claims the benefit of an effective US filing date under 35 USC 119(e) from US Provisional Application 62/541,370 filed August 4, 2017.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 22, 2026 was in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS document was considered and a signed copy of the 1449 form is attached.
Status of the Claims
Currently, claims 1-4 are pending in the instant application and are under consideration herein.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roman et al. (citation 18 on 7/22/2026 IDS).
The prior art teaches the use of oral or intravenous SCY-078 (the instantly elected species) for treating vulvovaginal candidiasis, which reads on the claimed requirement for treatment of yeast infection occurring in an anatomic area (the vagina) in which the pH is lower than 7. Since the prior art teaches all the required limitations of the instant claims, the claims are anticipated.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Helou et al. (citation 9 on 7/22/2026 IDS).
The prior art teaches the use of oral or intravenous SCY-078 (the instantly elected species) for treating vulvovaginal candidiasis, which reads on the claimed requirement for treatment of yeast infection occurring in an anatomic area (the vagina) in which the pH is lower than 7. Since the prior art teaches all the required limitations of the instant claims, the claims are anticipated.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Press release (citation 17 on 7/22/2026 IDS)
The prior art teaches the use of oral SCY-078 (the instantly elected species) for treating vulvovaginal candidiasis, which reads on the claimed requirement for treatment of yeast infection occurring in an anatomic area (the vagina) in which the pH is lower than 7. Since the prior art teaches all the required limitations of the instant claims, the claims are anticipated.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2010/019203.
The prior art teaches the use of compounds of the formula
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177
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for treating mycotic (i.e. fungal) infections (see p. 2, lines 15-22). With respect to the instantly claimed compounds to be used in the method, the elected species is taught as Example 173 in the prior art, but additional anticipatory compounds are also disclosed. Further, the prior art teaches that compounds of Formula (I) are useful for the treatment of mycotic (i.e. fungal) infections in the gastrointestinal tract as well as vaginal use, both of which read on anatomic areas having a pH lower than about 7 (p. 8, lines 14-20). Finally, the topical administration required by claim 2 is taught, for example, at page 14, line 3. Regarding the limitations of instant claim 4, the claim recites a property of the active ingredient in the composition itself (whether the concentration effective to treat the low pH area infection is lower than that which would be required to treat the infection in a higher pH area). “Products of identical chemical composition can not have mutually exclusive properties" (MPEP 2112.01(II)). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure as that recited in the claim, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)). Even if that property (i.e. particle size, hydrophobicity, injectability) is not disclosed in the prior art, if the chemical structure is identical, the art need not recognize every property of the compound in order to render it unpatentable. In accordance with MPEP 2112, “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Since the prior art teaches all the required limitations of the instant claims, the claims are anticipated.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-2 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-15 of US Patent 11,534,433.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claim(s) because the examined 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).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims to a method of treating a fungal infection are anticipated by the methods claimed in the more narrowly defined formula and method recited in the claims of the ‘433 patent. In particular, the patented claims specify that the compound to be used is (IIa) (which anticipates instant Formula (I)), and the method is for treating VVC infection, which is a yeast infection, and occurring in an anatomic area having a pH of lower than about 5, which anticipates the instantly claimed lower than about 7. The topical administration recited in instant claim 2 is taught in patented claim 9. Since the instant claims are anticipated by those of the ‘433 patent, a non-statutory double patenting rejection is appropriate.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699
