CTNF 18/571,905 CTNF 98183 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-06 AIA 15-10-15 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. 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. Claims 1-26 are pending in this application. Specification 07-29 AIA The disclosure is objected to because of the following informalities: On page 3 of the instant specification, the specification states: “ PNG media_image1.png 80 596 media_image1.png Greyscale ”(pg. 3, lines 6-8). As best understood, it is believed that the figure labels are incorrect and should be FIG. 2A, FIG. 2B, and FIG. 2C respectively. The use of the terms Carbopol® (pg. 15, line 24), Diaion® (pg. 19, line 10), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks . Appropriate correction is required. Claim Objections 07-29-01 AIA Claim s 1, 9-10, 17, and 24-25 are objected to because of the following informalities: In claims 1, 9-10, 17, and 24-25 the recited structures are blurry, particularly numerical values (i.e. subscripts), rendering them illegible . Appropriate correction is required. 07-30-03-h AIA 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)). Claim Rejections - 35 USC § 112 (a) 07-30-01 AIA The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 15-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the enablement requirement. The specification, while being enabling for the treatment of a fungal infection, does not reasonably provide enablement for the prevention of the same. The specification does not enable any person skilled in the art to which is pertains, or with which it is most clear connected, to make and use the invention commensurate in scope with these claims. Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). These include: (1) breadth of the claims; (2) nature of the invention; (3) state of the prior art; (4) amount of direction provided by the inventor; (5) the level of predictability in the art; (6) the existence of working examples; (7) quantity of experimentation needed to make or use the invention based on the content of the disclosure; and (8) relative skill in the art. All of the factors have been considered with regard to the claim, with the most relevant factors discussed below: (1& 2)The breadth of the claims and nature of the invention: The claims are directed towards antifungal compositions comprising saponin compounds which can be used for the treatment or prevention of fungal infections or inhibiting the growth of fungal organisms. (3) The state of the prior art: While there are publications that describe methods of treating fungal infections with compositions comprising saponins, there is no evidence in the prior art that the claimed composition would prevent fungal infections from ever occurring. For example Favel (Phytother. Res., 2005, cited on PTO-892) teaches Yuccaloeside C exhibits antifungal activity (abstract, pg. 160, table 1). Van Dijck (WO 2015/032964, IDS filed May 2, 2024) teaches antifungal uses of plant-derived saponins which can be used for the treatment of fungal infections (abstract). Thus, in short, the art recognizes treatment including therapeutic compositions comprising saponins in the treatment of fungal infections, but not in the absolute prevention thereof. (4 & 6) The amount of direction provided by the inventor and the existence of working examples: Applicant has not provided examples that demonstrate that the composition claimed is effective at preventing fungal infections. The instant specification has demonstrated that the composition exhibits fungicidal activity against candida albicans (pg. 20, lines 9-16, pg. 21, table 5). Applicant has not demonstrated that when the composition is administered to a subject having said condition, it would prevent said condition from occurring. (5) The level of predictability in the art: The prior art does not teach a method of preventing fungal infections by administering a therapeutic composition. Although some methods may aid in the reduction of or treat fungal infections, there is nothing in the prior art that indicates that prevention is possible. (7) The quantity of experimentation: Neither the instant specification nor the state of the art have demonstrated how therapeutic compositions, such as the composition claimed, can “prevent” fungal infections from occurring. An undetermined number of experimental factors utilizing a composition and its method for preventing would have to be resolved by the practitioner and/or the patient for the following reasons: the factors are not sufficiently discussed in the specification to provide guidance to utilize the invention as claimed. (8) The level of skill in the art: The level of skill in the art would be high, mostly likely at the Ph.D. /MD level. Therefore, other than proposing an initial hypothesis, the entire burden of research involved in utilizing the compositions claimed to prevent fungal infection would fall on the shoulders of the skilled artisan attempting to practice the claimed invention, presenting an undue burden of unpredictable experimentation. Genentech, 108 F.3d at 1366, sates that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” And “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.” Therefore, in view of the Wands factors, as discussed above, particularly the state of the art and the lack of guidance or working examples, Applicant fails to provide information sufficient to practice the claimed invention without undue experimentation. It is noted that the term “prevent” does not necessarily mean that something is kept from ever occurring, but such is an interpretation available to the Examiner that falls under the “broad and reasonable” standard for claim term interpretation as set forth in the MPEP at § 2111 and thus is proper. Claim Rejections - 35 USC § 112 (b) 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 5-10, 12-16, and 22-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 5: Claim 5 recites inter alia, “The composition of claim 1 wherein the composition further comprises a liquid carrier”. The phrase “further comprises” renders the claim indefinite, because it is unclear whether the phrase is limiting the carrier recited in claim 1 to a liquid carrier specifically, or is reciting the inclusion of an additional carrier that is a liquid carrier. This conflicts with claim 17 which limits the carrier specifically for example. Regarding claims 6-8: Claim 6 recites, “The composition of claim 1 wherein the saponin is extracted from a non-woody plant of the genus Hesperaloe”. However given that the composition of claim 1 specifies a specific saponin, it is unclear how a person of ordinary skill in the art would differentiate between the saponin obtained from a plant or a synthetic saponin. Thus, a person of ordinary skill in the art would be unable to ascertain the metes and bounds of the invention rendering the claim indefinite. Claims 7-8 which depend from claim 6 are similarly rejected. Regarding claims 12-16: Claim 12 recites inter alia, “An antifungal composition comprising one or more saponins….extracted from a non-woody plant of the genus Hesperaloe.”. Claim 13 further limits the non-woody plant. However given that the composition of claim 12 specifies specific saponins, it is unclear how a person of ordinary skill in the art would differentiate between the saponin obtained from a plant or a synthetic saponin. Thus, a person of ordinary skill in the art would be unable to ascertain the metes and bounds of the invention rendering claims 12-13 indefinite. Claims 13-16 which depend from claim 12 are similarly rejected. Regarding claims 9-10, and 23-25: Claims 9-10 and 23-25 do not end in a period, thus a person of ordinary skill in the art would be unable to ascertain the metes and bounds of the invention, thereby rendering the claims indefinite. Regarding claim 15: Claim 15 recites, “The composition of claim 12, wherein the one or more saponins are provided in amount to treat or prevent a fungal infection in a plant, a non-human animal, or a human.”. However claim 12 recites “An anti-fungal composition”. It is unclear whether the claim is attempting to define a specific concentration, or to implement a method step into a claim directed towards a composition. The lack of clarity renders the claim indefinite. Regarding claims 22-23: Claim 22 recites inter alia, “wherein the saponin is extracted from a non-woody plant of the genus Hesperaloe”. Claim 23 depends from claim 22 and recites inter alia, “wherein the non-woody plant is Hesperaloe funifera, Hesperaloe nocturna, Hesperaloe parviflora”. It is unclear if this recitation requires the step of extracting the saponin or if this method is defining a saponin in terms of its method of production, similar to a product-by-process claim. See MPEP 2113. This language fails to particularly point out and distinctly claim the subject matter because the claims are drawn to the process, and it is unclear if this language is reciting further steps of the process or describing either the product made by or materials used in the process. Thus claim 22 and dependent claim 23 are rendered indefinite. Regarding claim 23: Claim 23 recites the limitation "non-woody plant". There is insufficient antecedent basis for this limitation in the claim. The claim will be interpreted such that it depends from claim 22, which recites “a non-woody plant of the genus Hesperaloe”. Regarding claims 25-26: Claims 25-26 recite inter alia, “The composition of claim 17 further comprising….”. However, claim 17 is directed towards a method. This leads to a lack of clarity as it is unclear whether the claims are meant to limit the method or a composition, thereby rendering the claims indefinite. Claim Rejections - 35 USC § 112 (d) 07-36 AIA The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. 07-36-01 AIA Claim s 2-4, 6-8, 13, 15-16, 22-23 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Regarding claims 2-4: Claim 2, which depends from claim 1, recites “The composition of claim 1 wherein the fungal organism is of the genus Blastomyces, Candida, Cryptococcus, Epidermophyton, Microsporum, Trichophyton or Pityrosporum”. Claim 3 further limits the fungal organism to specific species. However, claim 1 recites an antifungal composition comprising a saponin. Claims 2-4 merely specify fungal organisms that may be inhibited, describing a property of the composition. Thus, claims 2-4 fail to further limit claim 1. Regarding claims 6-8: Claim 6, which depends from claim 1 recites, “The composition of claim 1 wherein the saponin is extracted from a non-woody plant of the genus Hesperaloe”. Claims 7-8 further limit the non-woody plant to specific species. However, the saponin in the composition would be identical regardless of source. Thus, claims 6, and dependent claims 7-8 fail to further limit claim 6. Regarding claim 13: Claim 13, which depends from claim 12, recites wherein the non-woody plant is Hesperaloe funifera, Hesperaloe nocturna, Hesperaloe parviflora, Hesperaloe chiangii or a combination thereof. However, claim 12 recites an antifungal composition comprising specific saponins. The saponins would be the same in structure regardless of source. Thus claim 13 fails to further limit claim 12. Regarding claims 15-16: Claim 15, which depends from claim 12, recites “The composition of claim 12 wherein the one or more saponins are provided in amount to treat or prevent a fungal infection in a plant, a non-human animal, or a human. However, this is an intended use and claim 12 already specifies an antifungal composition. Claim 15 further specifies specific fungal infections. Thus, claims 15-16 fail to further limit claim 12. Regarding claims 22-23: Claim 22, which depends from claim 17 recites, “The method of claim 17 wherein the saponin is extracted from a non-woody plant of the genus Hesperaloe”. Claim 23 further limits the non-woody plant to specific species. However, the saponin in the composition would be identical regardless of source. Thus, claims 22-23 fail to further limit claim 17 . Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-16 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 PNG media_image2.png 240 566 media_image2.png Greyscale 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 6-8 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 PNG media_image3.png 217 575 media_image3.png Greyscale corresponding to 5(6),25(27)-disdehydroyuccaloiside C. Claim 10 recites the composition of claim 1 further comprising the a saponin having the formula PNG media_image4.png 212 553 media_image4.png Greyscale 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. Claim 15 recites the composition of claim 12, wherein the one or more saponins are provided in an amount to treat or prevent a fungal infection in a plant, a non-human animal, or a human, which recites an intended use and is described in a generic level of detail so as to link the composition to field of use. 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 15 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 on PTO-892) 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 14-15 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 14-15 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 1-16 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). Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15-03-aia AIA Claim s 1-4 and 6-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wei (WO 2021/258053, cited on PTO-892) . 07-15-02-aia The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. Regarding claims 1-4 and 6-16: Wei teaches “soluble extractives prepared from non-woody plants of the genus Hesperaloe and processes for preparing the same. The extracts preferably comprise at least one saponin. In certain instances, the process includes providing biomass derived from non-woody plants of the genus Hesperaloe, milling the biomass, washing the biomass with a solvent to yield a crude extract and optionally further purifying the crude extract by filtration to remove water insoluble compositions such as fibers, fines, epidermal debris and lipids. Preferably, the composition extracted from Hesperaloe comprises 25(27)-dehydrofucreastatin, 5(6),25(27)-disdehydroyuccaloiside C, 5(6)-disdehydroyuccaloiside, C, furcreastatin, yuccaloiside, or a mixture thereof.” (abstract). Wei teaches figures 4A-C illustrate various novel saponins extracted from non-woody plants of the genus Hesperaloe according to the present invention including, 25(27)-dehydrofucreastatin (FIG. 4A), 5(6),25(27)-disdehydroyuccaloiside C (FIG. 4B), and 5(6)-disdehydroyuccaloiside C (FIG. 4C); (pg. 4, lines 16-18, drawings sheets pgs. 3-5). These compounds correspond to the structures recited by instant claims 1, 9-10, and 24-25. Wei teaches In certain instances, the saponins may comprise 25(27)-dehydrofucreastatin (FIG. 4A), 5(6),25(27)-disdehydroyuccaloiside C (FIG. 4B), 5(6)disdehydroyuccaloiside C (FIG. 4C), furcreastatin and yuccaloiside C (pg. 18, lines 12-14). Wei teaches the saponins were extracted from Hesperaloe funifera (pg. 21, lines 20-25).The obtained saponins were in fractions and eluted with water (i.e. compositions comprising a carrier, pg. 23, lines 1-7, pg. 24, table, last para., F 86-95 ppt). Wei teaches this composition was labeled sample 12 (pg. 22, table 4), and was prepared identically to sample 12 of the instant specification (pg. 18, table 3). According to the instant specification, Candida Albicans activity was determined from thirty five samples derived from KC hesperaloe funifera, crude extracts and selected fractions (Table 1) (pg. 20, lines 5-7). The instant specification discloses that sample 12 demonstrated antifungal activity (pg. 21 table 5). Thus, the sample 12 of the instant specification and Wei were prepared in the same manner, pooled in combination with water, and the composition of Wei necessarily possesses antifungal activity against Candida Albicans, absent evidences to the contrary. 07-15-03-aia AIA Claim s 1-4 and 6-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wei (US 2023/0233644, cited on PTO-892) . 07-15-02-aia The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. Regarding claims 1-4 and 6-16: Wei teaches “soluble extractives prepared from non-woody plants of the genus Hesperaloe and processes for preparing the same. The extracts preferably comprise at least one saponin. In certain instances, the process includes providing biomass derived from non-woody plants of the genus Hesperaloe, milling the biomass, washing the biomass with a solvent to yield a crude extract and optionally further purifying the crude extract by filtration to remove water insoluble compositions such as fibers, fines, epidermal debris and lipids. Preferably, the composition extracted from Hesperaloe comprises 25(27)-dehydrofucreastatin, 5(6),25(27)-disdehydroyuccaloiside C, 5(6)-disdehydroyuccaloiside, C, furcreastatin, yuccaloiside, or a mixture thereof.” (abstract). Wei teaches figures 4A-C illustrate various novel saponins extracted from non-woody plants of the genus Hesperaloe according to the present invention including, 25(27)-dehydrofucreastatin (FIG. 4A), 5(6),25(27)-disdehydroyuccaloiside C (FIG. 4B), and 5(6)-disdehydroyuccaloiside C (FIG. 4C); (pg. 2, para. 0018, drawings sheets pgs. 3-5). These compounds correspond to the structures recited by instant claims 1, 9-10, and 24-25. Wei teaches In certain instances, the saponins may comprise 25(27)-dehydrofucreastatin (FIG. 4A), 5(6),25(27)-disdehydroyuccaloiside C (FIG. 4B), 5(6)disdehydroyuccaloiside C (FIG. 4C), furcreastatin and yuccaloiside C (pg. 8, para. 0082). Wei teaches the saponins were extracted from Hesperaloe funifera (pg. 10, para. 0096).The obtained saponins were in fractions and eluted with water (i.e. compositions comprising a carrier, pg. 11, paras. 0098-0100). Wei teaches this composition was labeled sample 12 (pg. 10, table 4), and was prepared identically to sample 12 of the instant specification (pg. 18, table 3). According to the instant specification, Candida Albicans activity was determined from thirty five samples derived from KC hesperaloe funifera, crude extracts and selected fractions (Table 1) (pg. 20, lines 5-7). The instant specification discloses that sample 12 demonstrated antifungal activity (pg. 21 table 5). Thus, the sample 12 of the instant specification and Wei were prepared in the same manner, pooled in combination with water, and the composition of Wei necessarily possesses antifungal activity against Candida Albicans, absent evidence to the contrary. 07-15 AIA Claim s 12-16 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Favel (Phytother. Res., 2005, cited on PTO-892) as evidenced by Aure Chemical (Aurechem.com, 2026, cited on PTO-892) . Regarding claims 12-16: 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, absent evidence to the contrary, and satisfies the limitations of claim 15-16. Given the claims are directed to a composition comprising yuccaloeside C, the limitations with respect to the source of the saponin (i.e. extracted from a non-woody plant of the genus Hesperaloe, wherein the non-woody plant is Hesperaloe funifera as recited by instant claims 12-13) are non-limiting, as the compound yuccaloeside C obtained from one source would be indistinguishable from yuccaloeside obtained from another source, and the structure of the composition is identical . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 5 and 17-26 are rejected under 35 U.S.C. 103 as being unpatentable over Wei (WO 2021/258053, cited on PTO-892) as applied to claims 1-4 and 6-16 above in view of Favel (Phytother. Res., 2005, cited on PTO-892) as evidenced by Aure Chemical (Aurechem.com, 2026, cited on PTO-892) . Regarding claims 5 and 17-26: As discussed above Wei teaches the composition as recited by instant claims 1-4 and 6-16 comprising yuccaloiside C. Wei does not teach a method of inhibiting Candida albicans growth or wherein the concentration of saponins ranges from about 10 to about 100 mg of saponins per mililiter of composition. 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 Wei 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 Wei 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) . 07-21-aia AIA Claim s 1-11 and 17-26 are rejected under 35 U.S.C. 103 as being unpatentable over Favel (Phytother. Res., 2005, cited on PTO-892) and Aure Chemical (Aurechem.com, 2026, cited on PTO-892) as applied to claims 12-16 above in view of Marker (J. Am. Chem. Soc. 1947, IDS filed May 2, 2024) and Marker (J. Am. Chem. Soc., 1943, cited on PTO-892) hereinafter referred to as Marker ‘43 . Regarding claims 1-11 and 17-26: As discussed above, Favel teaches the composition of claim 12 comprising yuccaloside C. 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 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, 9-11, 17, and 24-26, 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 saponins 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 saponins 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 saponins. (Thus, it is evident that some of the saponin species such as gitogenin, and tigogenin are common in the extracts of Hesperaloe, Yucca and Agave). 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 saponins, and saponins 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 saponins 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). Double Patenting 08-33 AIA 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 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,576,098 (cited on PTO-892, 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 PNG media_image5.png 120 304 media_image5.png Greyscale (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 PNG media_image6.png 169 332 media_image6.png Greyscale (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 17-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,576,098 (cited on PTO-892, was US application 18/011,326) as applied to claims 1-16 in view of Favel (Phytother. Res., 2005, cited on PTO-892) as evidenced by Aure Chemical (Aurechem.com, 2026, cited on PTO-892). 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 patented claims teach the composition of claims 1-16. 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 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/548,471 (cited on PTO-892, unpublished). Although the claims at issue are not identical, they are not patentably distinct from each other because: The copending claims teach PNG media_image7.png 132 565 media_image7.png Greyscale (claim 1). The composition is a liquid (claim 2). PNG media_image8.png 81 552 media_image8.png Greyscale (claim 9). PNG media_image9.png 76 552 media_image9.png Greyscale (claim 10). The copending claims teach PNG media_image10.png 161 552 media_image10.png Greyscale (claim 24). The copending claims teach PNG media_image11.png 80 550 media_image11.png Greyscale (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 17-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/548,471 (cited on PTO-892, unpublished) as applied to claims 1-16 in view of Favel (Phytother. Res., 2005, cited on PTO-892) as evidenced by Aure Chemical (Aurechem.com, 2026, cited on PTO-892). 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 1-16. 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 1-16 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 on PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because: The copending claims teach PNG media_image12.png 83 655 media_image12.png Greyscale (claim 1). The copending claims teach PNG media_image13.png 60 603 media_image13.png Greyscale (claim 5). The copending claims teach PNG media_image14.png 55 633 media_image14.png Greyscale (claim 6). The copending claims teach PNG media_image15.png 52 610 media_image15.png Greyscale (claim 8). The copending claims teach PNG media_image16.png 62 649 media_image16.png Greyscale (claim 8).The copending claims teach PNG media_image17.png 75 612 media_image17.png Greyscale (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 17-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/011,335 (US20230302079, cited on PTO-892) as applied to claims 1-16 in view of Favel (Phytother. Res., 2005, cited on PTO-892) as evidenced by Aure Chemical (Aurechem.com, 2026, cited on PTO-892). 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 1-16. 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 1-16 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 on PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because: The copending claims teach PNG media_image18.png 120 611 media_image18.png Greyscale (claim 1). PNG media_image19.png 82 587 media_image19.png Greyscale (claim 7). The copending claims teach PNG media_image20.png 58 607 media_image20.png Greyscale (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. 08-35 Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/011310 (US20230233644, cited on PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because: The copending claims teach PNG media_image21.png 140 640 media_image21.png Greyscale This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-16 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 on PTO-892, 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 PNG media_image22.png 137 579 media_image22.png Greyscale (claim 12). PNG media_image23.png 94 554 media_image23.png Greyscale (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). Conclusion No claims are allowed in this action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL L GALSTER whose telephone number is (571)270-0933. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Y Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /SAMUEL L GALSTER/Examiner, Art Unit 1693 Application/Control Number: 18/571,905 Page 2 Art Unit: 1693 Application/Control Number: 18/571,905 Page 3 Art Unit: 1693 Application/Control Number: 18/571,905 Page 4 Art Unit: 1693 Application/Control Number: 18/571,905 Page 5 Art Unit: 1693 Application/Control Number: 18/571,905 Page 6 Art Unit: 1693 Application/Control Number: 18/571,905 Page 7 Art Unit: 1693 Application/Control Number: 18/571,905 Page 8 Art Unit: 1693 Application/Control Number: 18/571,905 Page 9 Art Unit: 1693 Application/Control Number: 18/571,905 Page 10 Art Unit: 1693 Application/Control Number: 18/571,905 Page 11 Art Unit: 1693 Application/Control Number: 18/571,905 Page 12 Art Unit: 1693 Application/Control Number: 18/571,905 Page 13 Art Unit: 1693 Application/Control Number: 18/571,905 Page 14 Art Unit: 1693 Application/Control Number: 18/571,905 Page 15 Art Unit: 1693 Application/Control Number: 18/571,905 Page 16 Art Unit: 1693 Application/Control Number: 18/571,905 Page 17 Art Unit: 1693 Application/Control Number: 18/571,905 Page 18 Art Unit: 1693 Application/Control Number: 18/571,905 Page 19 Art Unit: 1693 Application/Control Number: 18/571,905 Page 20 Art Unit: 1693 Application/Control Number: 18/571,905 Page 21 Art Unit: 1693 Application/Control Number: 18/571,905 Page 22 Art Unit: 1693 Application/Control Number: 18/571,905 Page 23 Art Unit: 1693 Application/Control Number: 18/571,905 Page 24 Art Unit: 1693 Application/Control Number: 18/571,905 Page 25 Art Unit: 1693 Application/Control Number: 18/571,905 Page 26 Art Unit: 1693 Application/Control Number: 18/571,905 Page 27 Art Unit: 1693 Application/Control Number: 18/571,905 Page 28 Art Unit: 1693 Application/Control Number: 18/571,905 Page 29 Art Unit: 1693 Application/Control Number: 18/571,905 Page 30 Art Unit: 1693 Application/Control Number: 18/571,905 Page 31 Art Unit: 1693
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