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.
Response to Amendment
The amendment filed July 28, 2026 has been entered. Claims 1-5, 7-10, 12, 16-17, 23-26 have been amended, claims 6, 15, and 22 have been cancelled, and claims 27-28 have been added. Applicant’s amendments to the claims have overcome the objections to the claims, drawings, and specification, as well as the 112(a), 112(b), and 112 (d) rejections previously set forth in the Non-Final Office Action mailed April 28, 2026. Applicant’s statement of ownership over Wei (WO2021/258053, cited in previous action) and Wei (US2023/0233644, cited in previous action) satisfies the 102(b)(2) exception and have thus overcome the respective 102 and 103 rejections. Applicant’s amendments to the claims have overcome the 102 rejections over Favel (Phytother. Res., 2005, cited in previous action). Applicants cancellation of claims 6, 15, and 22 have rendered the corresponding rejections/objections moot. As such, these rejections and objections are hereby withdrawn.
Applicant’s arguments filed July 28, 2026 were fully considered but they were not persuasive. Modified/New rejections necessitated by Applicant’s amendment are addressed below.
Claims 1-5, 7-14, 16-21, 23-28 are pending in this application.
Priority
This office action is a response to applicant’s communication submitted December 19, 2023. This application is a 371 of PCT/US21/38279 filed 06/21/2021.
Information Disclosure Statement
The information disclosure statement filed July 28, 2026 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of a reference listed that is not in the English language (
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). It has been placed in the application file, but the information referred to therein has not been considered.
Claim Interpretation
With respect to instant claim 1, which is directed to a pharmaceutical composition and recites the phrase “antifungal composition”. The Examiner notes that it is well settled that “intended use” of a composition or product, e.g., “antifungal”, will not further limit claims drawn to a composition, so long as the prior art discloses the same composition comprising the same ingredients in an effective amount, as the instantly claimed (See MPEP 2111.02 (II)).
Maintained/New Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 7-14, 16, and 28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
The claims are directed to compositions comprising saponins selected from 25(27)-dehydrofucreastatin, 5(6),25(27)-disdehydroyuccaloisideC, 5(6)- disdehydroyuccaloiside C, furcreastatin and yuccaloiside C, extracted from a non-woody plant of the genus Hesperaloe Claim 1 is drawn to an antifungal composition comprising a saponin having the formula
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which corresponds to 25(27)-dehydrofucreastatin, and a carrier, wherein the saponin is present in amount effective to inhibit the growth of a fungal organism. Claim 2 is drawn to the composition of claim 1 and specifies genii of fungal organisms to be inhibited. Claims 3-4 are drawn to the composition of claim 1 and specify fungal species. These claims are interpreted as reciting the functional properties necessarily possessed by the compound itself and therefore encompass the compound itself. Claim 5 recites inclusion of a liquid carrier and specified the concentration of the concentration of saponins, implying unspecified other material in the composition in order to result in such a concentration, however this does not possess “markedly different characteristics” because the implied unspecified other material is unspecified and the composition or compounds possesses the same functional properties necessarily possessed by the compound itself, implying this activity is the same characteristic possessed the compound itself. Moreover, there is no evidence in the specification that the concentration “about 10 to about 100 mg of saponins per mililiter of composition” of the composition has markedly different characteristics from its natural state. Claims 7-8 merely recite a source of the saponins, reciting extracted from non-woody plant of Hesperaloe genus or species, lending evidence that this a compound of nature.
Claim 9 recites the composition of claim 1 further comprising a saponin having the formula
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corresponding to 5(6),25(27)-disdehydroyuccaloiside C. Claim 10 recites the composition of claim 1 further comprising the a saponin having the formula
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corresponding to 5(6)- disdehydroyuccaloiside C. Claim 11 recites the composition of claim 1 further comprising furcreastatin and yuccaloiside C. However, as described below, the compounds recited claims 9-11 are present in the same plant species. Claim 12 recites an antifungal composition comprising one or more saponins selected from the group consisting of 25(27)-dehydrofucreastatin, 5(6),25(27)-disdehydroyuccaloisideC, 5(6)- disdehydroyuccaloiside C, furcreastatin and yuccaloiside C, extracted from a non-woody plant of the genus Hesperaloe, which is described in a generic level of detail so as to link the composition to field of use. Claim 13 recites the composition of claim 12 and specifies the non-woody plant to be extracted from, which merely recites a source of the saponins and providing evidence that the compounds are all natural products. Claim 14 recites further inclusion of a pharmaceutically acceptable carrier, which is described in a generic level of detail that would have been well-understood, routine, or conventional activity in the pertinent field of art concerning compounds or agents having a biological activity. Additionally, this does not possess “markedly different characteristics” because the implied unspecified other material is unspecified and the composition or compounds possesses the same functional properties necessarily possessed by the compound itself, implying this activity is the same characteristic possessed the compound itself. Moreover, there is no evidence in the specification that the concentration “are provided in an amount” of the composition has markedly different characteristics from its natural state. Claim 16 recites the composition of claim 12 and specifies fungal infections to be treated, which is interpreted as merely reciting properties of the compounds in the composition itself.
The application in the working example (pgs. 17, lines 24-28, pg. 20, lines 1-5) describes the isolation of a composition (i.e. fractions) containing the compounds, from Hesperaloe funifera providing evidence that these compounds are a product of nature and are all present in the same species of plant. The application demonstrates that the selected fractions comprising the compounds exhibit anti-fungal activity against Candida albicans (pg. 20, lines 5-16, pg. 21, table 5), providing evidence that the compounds are present in nature at sufficient concentration to be antifungal.
Marker (J. Am. Chem. Soc. 1947, IDS filed May 2, 2024) discloses the preparation of sapogenin fractions from Hesperaloe funifera (pg. 2403, col. 2, para. 2). Thus the disclosed compositions can be read as an sapogenin extract comprising products native to the Hesperaloe funifera plant, supporting the conclusion that the working example of the application describe the isolation of a mixture of compounds that was naturally occurring, even if not specifically known at the time of Marker. Favel (Phytother. Res., 2005, cited in previous action) discloses glycosides including saponins are known to be extracted as natural products (abstract, pg. 158, cols. 1-2, bridging para.).
This judicial exception is not integrated into a practical application because claims 1, 5, 9-12, and 14 recite an antifungal composition comprising the compound/compounds and a carrier (or liquid carrier) in a generic level of detail which is no more than generally linking the use of the natural product to a field of use. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because claims 1, 5, 9-12, and 14 implies unspecified other material in the composition and the claims recite a composition comprising a carrier or liquid carrier in a generic level of detail that would have been well-understood, routine, or conventional activity in the pertinent field of art concerning compounds or agents having a biological activity. Claims 2-4, and 16 are mere recitation of properties possessed by the compounds itself. Claims 5-8, and 13 merely describe a source of the compounds, which is from a natural source.
Therefore claims 1-5, 7-14, 16, and 28 do not integrate the judicial exception into a practical application and do not include additional elements that are sufficient to amount to significantly more than the judicial exception itself (i.e. a product/composition of nature).
Modified/New 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 1-5, 7-14, 16-21, 23-28 are rejected under 35 U.S.C. 103 as being unpatentable over Favel (Phytother. Res., 2005, cited in previous action) in view of Marker (J. Am. Chem. Soc. 1947, IDS filed May 2, 2024) and Marker (J. Am. Chem. Soc., 1943, cited in previous action) hereinafter referred to as Marker ’43 as evidenced by Aure Chemical (Aurechem.com, 2026, cited in previous action).
Regarding claims 1-5, 7-14, 16-21, 23-28: Favel teaches an antifungal composition comprising yuccaloeside C, which displays antifungal activity against Candida albicans (pg. 159, col. 2, para. 2, pg. 160, table 1). The pure compound was dissolved in DMSO from concentrations ranging from 1.9 to 2000 µg/mL ( i.e. 2 mg/mL highest, pg. 159, col. 1, para. 1). According to Aure Chemical, in pharmaceutical contexts, DMSO functions primarily as a carrier for active pharmaceutical ingredients (pg. 1, para. 1). According to the instant specification the saponins may range from about 2 to about 200 mg/mL in a liquid carrier (pg. 14, lines 3-5). Wherein Favel teaches concentration of 2 mg/mL and demonstrates antifungal activity, the composition necessarily is present in an amount to treat a fungal infection. Favel teaches the antifungal activity of a crude steroidal glycoside extract from Yucca gloriosa flowers, named alexin against Candida albicans (abstract, pg. 160, table 1). Favel teaches Yucca species is of the Agavaceae family (pg. 158, col. 1, para. 1). Favel teaches the antifungal properties of saponins are usually ascribed to their ability to complex with sterols in fungal membranes, thereby causing pore formation and loss of membrane integrity (pg. 160, col. 2, para. 1). Favel teaches Yucca gloriosa is a known source of tigogenin (pg. 158, col. 1, para. 1) Favel investigated the antifungal activity of the major tiogenyl glycosides yuccaloeisde B and yuccaloeside C (pg. 158, col. 1, para. 1).Thus, the art recognizes the general ability of saponins of tiogenin extracted from plants to exhibit antifungal activity.
While Favel teaches a composition comprising Yucca extract, the reference does not teach use of the extract from Hesperaloe funifera. According to the instant specification, in the working example (pgs. 17, lines 24-28, pg. 20, lines 1-5) describes the isolation of a composition (i.e. fractions) containing the compounds as recited by instant claims 1, 9-12, 17, 24-26, and 28 from Hesperaloe funifera. Favel does not teach wherein the concentration of saponins ranges from about 10 to about 100 mg of saponins per mililiter of composition.
However, Marker teaches that the sapogenins manogenin, hecogenin, gitogenin, and tigogenin exist in Hesperaloe funifera (pg. 2403, col. 1, paras. 2-3, pg. 2404, col. 2, para. 2, summary). Marker teaches Agave and Hesperaloe plant extracts both comprise gitogenin and tigogenin ( pg. 2403, para. 2). Marker 43’ teaches that the sapogenins gitogenin and tigogenin exist in both Hesperaloe and Yucca (Pages 1207-1208, under tigogenin and sections 3 and 4). Similar to Yucca, thus Hesperaloe is a source of sapogenins. (Thus, it is evident that some of the sapogenin species such as gitogenin, and tigogenin are common in the extracts of Hesperaloe, Yucca and Agave, and thus by extension their corresponding saponins).
Taken together it would have been prima facie obvious to modify the method of Favel such that the Yucca extract is replaced with an extract from Hesperaloe funifera as taught by Marker and Marker ‘43 for the purpose of inhibiting a fungal organism, such as candida albicans. A person of ordinary skill in the art would have had the motivation to do so as the art establishes Hesperaloe funifera is a known source of sapogenins, and saponins of sapogenins found in plant species are generally recognized for the antifungal ability, and have demonstrated antifungal activity against candida albicans specifically. One of ordinary skill would have had a reasonable expectation of success in obtaining similar saponin to that of yucca plant extract by using Hesperaloe plant extract due to the commonality of sapogenins taught by Marker 43’. As discussed above, the instant specification in the working example (pgs. 17, lines 24-28, pg. 20, lines 1-5) describes the isolation of a composition (i.e. fractions) containing the compounds as recited by instant claims 1-11 and 17-26, from Hesperaloe funifera. Thus wherein it would have been obvious to use an extract from Hesperaloe funifera, the extract necessarily comprises the claimed compounds, absent evidence to the contrary. With respect to the claimed concentration, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” (See MPEP 2144.05 (II)). Additionally, Favel establishes 1.9 to 2000 µg/mL concentrations have been tested for antifungal activity of saponins, making concentration a result effecting variable ( i.e. 2 mg/mL highest, pg. 159, col. 1, para. 1).
Modified/New 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 1-5, 7-14, 16, 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,576,098 (cited in previous action, was US application 18/011,326). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patented claims teach
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(claim 1). The patented claims teach the composition is a liquid (claim 2). The patented claims teach wherein the non-woody plant is Hesperaloe funifera (claim 8). The patented claims teach
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(claim 18). Although the patented claims do not teach about 10 to about 100 mg of saponins per mililiter of the composition, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” (See MPEP 2144.05 (II)). Although the patented claims do not teach the antifungal acitivty of the composition, the application demonstrates that the selected fractions comprising the compounds exhibit anti-fungal activity against Candida albicans (pg. 20, lines 5-16, pg. 21, table 5) thus these are inherent properties of the composition.
Claims 17-21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,576,098 (cited in previous action, was US application 18/011,326) as applied to claims 1-5, 7-14, 16, 28 in view of Favel (Phytother. Res., 2005, cited in previous action) as evidenced by Aure Chemical (Aurechem.com, 2026, cited in previous action). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 17-21, 23-27: As discussed above the patented claims teach the composition of claims 1-5, 7-14, 16, 28. They do not teach a method of inhibiting a fungal organism that is Candida albicans.
However, Favel teaches an antifungal composition comprising yuccaloside C, which displays antifungal activity against Candida albicans (pg. 159, col. 2, para. 2, pg. 160, table 1). The pure compound was dissolved in DMSO from concentrations ranging from 1.9 to 2000 µg/mL ( i.e. 2 mg/mL highest, pg. 159, col. 1, para. 1). According to Aure Chemical, in pharmaceutical contexts, DMSO functions primarily as a carrier for active pharmaceutical ingredients (pg. 1, para. 1).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to utilize the composition of the patented claims comprising yuccaloside C for the inhibition of candida albicans as taught by Favel. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the art establishes yuccaloside C is a compound capable of doing so and patented claims demonstrates such a compound can be sourced from Hesperaloe extracts. With respect to the claimed concentration, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” (See MPEP 2144.05 (II)). Additionally, Favel establishes 1.9 to 2000 µg/mL concentrations have been tested for antifungal activity of saponins, making concentration a result effecting variable ( i.e. 2 mg/mL highest, pg. 159, col. 1, para. 1).
Claims 1-5, 7-14, 16, 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/548,471 (cited in previous action, unpublished). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending claims teach
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(claim 1). The composition is a liquid (claim 2).
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(claim 9).
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(claim 10). The copending claims teach
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(claim 24). The copending claims teach
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(claim 27). Although the copending claims do not teach about 10 to about 100 mg of saponins per mililiter of the composition, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” (See MPEP 2144.05 (II)). Although the copending claims do not teach the antifungal acitivty of the composition, the application demonstrates that the selected fractions comprising the compounds exhibit anti-fungal activity against Candida albicans (pg. 20, lines 5-16, pg. 21, table 5) thus these are inherent properties of the composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 17-21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/548,471 (cited in previous action, unpublished) as applied to claims 1-5, 7-14, 16, 28 in view of Favel (Phytother. Res., 2005, cited in previous action) as evidenced by Aure Chemical (Aurechem.com, 2026, cited in previous action). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 17-21, 23-27: As discussed above the copending claims teach the composition of claims 1-5, 7-14, 16, 28. They do not teach a method of inhibiting a fungal organism that is Candida albicans.
However, Favel teaches an antifungal composition comprising yuccaloside C, which displays antifungal activity against Candida albicans (pg. 159, col. 2, para. 2, pg. 160, table 1). The pure compound was dissolved in DMSO from concentrations ranging from 1.9 to 2000 µg/mL ( i.e. 2 mg/mL highest, pg. 159, col. 1, para. 1). According to Aure Chemical, in pharmaceutical contexts, DMSO functions primarily as a carrier for active pharmaceutical ingredients (pg. 1, para. 1).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to utilize the composition of the copending claims comprising yuccaloside C for the inhibition of candida albicans as taught by Favel. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the art establishes yuccaloside C is a compound capable of doing so and copending claims demonstrates such a compound can be sourced from Hesperaloe extracts. With respect to the claimed concentration, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” (See MPEP 2144.05 (II)). Additionally, Favel establishes 1.9 to 2000 µg/mL concentrations have been tested for antifungal activity of saponins, making concentration a result effecting variable ( i.e. 2 mg/mL highest, pg. 159, col. 1, para. 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5, 7-14, 16, 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/011,335 (US20230302079, cited in previous action). Although the claims at issue are not identical, they are not patentably distinct from each other because: The copending claims teach
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(claim 1). The copending claims teach
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(claim 5). The copending claims teach
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(claim 6). The copending claims teach
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(claim 8). The copending claims teach
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(claim 8).The copending claims teach
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(copending claim 9). Although the copending claims do not teach about 10 to about 100 mg of saponins per mililiter of the composition, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” (See MPEP 2144.05 (II)). Although the copending claims do not teach the antifungal acitivty of the composition, the application demonstrates that the selected fractions comprising the compounds exhibit anti-fungal activity against Candida albicans (pg. 20, lines 5-16, pg. 21, table 5) thus these are inherent properties of the composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 17-21, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/011,335 (US20230302079, cited in previous action) as applied to claims 1-5, 7-14, 16, 28 in view of Favel (Phytother. Res., 2005, cited in previous action) as evidenced by Aure Chemical (Aurechem.com, 2026, cited in previous action). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 17-26: As discussed above the copending claims teach the composition of claims 1-5, 7-14, 16, 28. They do not teach a method of inhibiting a fungal organism that is Candida albicans.
However, Favel teaches an antifungal composition comprising yuccaloside C, which displays antifungal activity against Candida albicans (pg. 159, col. 2, para. 2, pg. 160, table 1). The pure compound was dissolved in DMSO from concentrations ranging from 1.9 to 2000 µg/mL ( i.e. 2 mg/mL highest, pg. 159, col. 1, para. 1). According to Aure Chemical, in pharmaceutical contexts, DMSO functions primarily as a carrier for active pharmaceutical ingredients (pg. 1, para. 1).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to utilize the composition of the copending claims comprising yuccaloside C for the inhibition of candida albicans as taught by Favel. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the art establishes yuccaloside C is a compound capable of doing so and copending claims demonstrates such a compound can be sourced from Hesperaloe extracts. With respect to the claimed concentration, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” (See MPEP 2144.05 (II)). Additionally, Favel establishes 1.9 to 2000 µg/mL concentrations have been tested for antifungal activity of saponins, making concentration a result effecting variable ( i.e. 2 mg/mL highest, pg. 159, col. 1, para. 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5, 7-14, 16, 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/011,341 (US20230263815, cited in previous action). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending claims teach
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(claim 1).
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(claim 7). The copending claims teach
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(claim 8). Although the copending claims do not teach about 10 to about 100 mg of saponins per mililiter of the composition, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” (See MPEP 2144.05 (II)). Although the copending claims do not teach the antifungal acitivty of the composition, the application demonstrates that the selected fractions comprising the compounds exhibit anti-fungal activity against Candida albicans (pg. 20, lines 5-16, pg. 21, table 5) thus these are inherent properties of the composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5, 7-14, 16, 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/011310 (US20230233644, cited in previous action). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending claims teach
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5, 7-14, 16, 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of patented Application No. 18/571,922 (US 20240292834, cited in previous action, notice of allowance mailed April 21, 2026). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending claims teach
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(claim 12).
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(claim 16). The copending claims teach wherein the saponins further comprise furcreastatin, yuccaloside C, or mixtures thereof (claim 17). The copending claims teach wherein the non-woody plant is hesperaloe funifera (claim 18).
Response to Arguments
Applicant’s arguments filed July 28, 2026 with respect to the claims have been fully considered but they are not persuasive.
On pages 10-11 of Applicant’s response, Applicant argues the claimed invention is not directed to a natural product because an extraction process is required to obtain the plant extract, and when combined with a carrier it is significantly more than the judicial exception drawn to a natural product (bridging para.). Applicant argues that Saponins and sapogenins are different things wherein sapogenins are aglycone non-saccharide moieties of saponins, whereas saponins are steroid or triterpenoid aglycone linked to one or more oligosaccharide moieties.
However, the resulting plant extract does not change any characteristic of the compounds present in the composition. The antifungal ability of the composition is an innate characteristic of the compounds. If there is no change in any characteristic in the extract versus how they exist in the natural state, the claimed product lacks markedly different characteristics, and is a product of nature exception (See MPEP 2106.04(c) (IIC). Inclusion of a carrier, which is described in a generic level of detail that would have been well-understood, routine, or conventional activity in the pertinent field of art concerning compounds or agents having a biological activity. The claims do not integrate into a practical application as they are drawn to a product of nature and merely describe properties of said product. Applicant has not provided adequate evidence that the mere extraction from a plant source results in properties/characteristics than that already present. Additionally the art recognizes that the saponins generally are natural products.
On page 14 of Applicant’s response, Applicant argues Marker ‘47’ and Marker ’43 disclose steroidal sapogenins from Yucca and Agave, but fail to disclose any saponin (para. 2). Applicant argues the instant claims are directed towards compositions comprising saponins which are different from sapogenins. On page 15 of Applicant’s response, Applicant argues the skilled person would have no expectation of success at arriving at the composition over Favel in view of Marker ’43 and Marker ’47 (para. 1).
The Examiner acknowledges that saponins and sapogenins are different. One of ordinary skill in the art would have found it obvious to substitute the yucca extract which contains saponins as taught by Favel, in view of the sapogenins gitogenin and tigogenin from both Hesperaloe and Yucca, as taught by Marker ’43 and the sapogenins manogenin, hecogenin, gitogenin, and tigogenin from Hesperaloe, as taught by Marker ’47. Favel teaches yuccaloeside B and yuccaloeside C are from tiogenin (pg. 158, col. 1, para. 1). Favel is directed towards a crude glycoside containing extract, not a pure steroid fraction. One of ordinary skill in the art would have known that the sapogenins (i.e. tiogenin) taught by Marker ’43 and Marker ’47 are from the saponins (i.e. yuccaloeside B and yuccaloeside C) in both Hesperaloe and Yucca, as taught by Marker ’43, and from Hesperaloe, as taught by Marker ’47. A person of ordinary skill in the art would have had a reasonable expectation of success in obtaining the claimed saponins given that the corresponding sapogenins are found in both plants.
On pages 15-16 of Applicant’s response, Applicant did not argue against any of the above stated double patenting rejections.
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 § 101, 103 and double patenting rejections are maintained for reason of record and foregoing discussion.
Conclusion
No claims are allowed in this action.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/S.L.G./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693
