Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 6, 2026 has been entered.
DETAILED ACTION
3. Claims 1 – 25 are pending in this application, wherein claims 1, 3, 7, 12, 14, 16 – 17, and 21 are amended and claims 12 – 25 are withdrawn.
Claims 1 – 11 are examined on the merits herein.
Priority
This application is a national stage application of PCT/US21/38278, filed June 21, 2021, which claims benefit of domestic application 63/041,224, filed June 19, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/08/2026 was filed after the mailing date of the previous Office Action on March 6, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Objections
6. The objection of claim 3 in the previous Office Action, mailed March 6, 2026, is withdrawn in view of the amended claim 3.
Withdrawn Rejections
7. The rejection of claims 1, 3 – 8, and 10 – 11 in the previous Office Action, mailed March 6, 2026, under 35 U.S.C. 103 as being unpatentable over McNeff et al. in view of Wooton has been fully considered and is withdrawn in view of the amended claim 1, wherein furcreastatin and yuccaloiside are being excluded and the examiner determined that the combination of McNeff et al. in view of Wooton is not sufficient to reject claims 5 – 6.
The rejection of claims 2 and 9 in the previous Office Action, mailed March 6, 2026, under 35 U.S.C. 103 as being unpatentable over McNeff et al. in view of Wooton as applied to claims 1, 3 – 8, and 10 – 11 above, and further in view of Zhan has been fully considered and is withdrawn due to the withdrawn of the previous rejection.
Claim Interpretation
The phrase “substantially free” does not necessarily require absolute absence. Instead, it allows for trace or incidental amounts that would reasonably be expected in the art. Therefore, under broadest reasonable interpretation, “substantially free” is interpreted to encompass any amount that is in trace or incidental amounts, but not in complete absence.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
i. Determining the scope and contents of the prior art.
ii. Ascertaining the differences between the prior art and the claims at issue.
iii. Resolving the level of ordinary skill in the pertinent art.
iv. Considering objective evidence present in the application indicating obviousness or
nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 11 are rejected under 35 U.S.C. 103 as being unpatentable over McNeff et al. (US2018/0333450A1, cited in the PTO-892 on September 24, 2025) in view of Wooton (US Department of Agriculture, 1918, cited in the PTO-892 on September 24, 2025), Marker (Journal of the American Chemical Society, 1943, Vol. 65, Issue 6, page 1199 – 1209, PTO-892), and Majinda (Methods in Molecular Biology, 2012, page 415 – 426, See PTO-892).
a. McNeff et al. teach a composition that includes a saponin composition including saponins and at least one medium chain fatty acid (MCFA) or ester or salt thereof, McNeff et al. also teach a method of processing animal fed using the compositions herein (Abstract). In some embodiments, compositions included herein can be mixed in with animal feed material (para. [0010]). Thus, McNeff et al. teach an animal feed composition that comprises a composition that includes a saponin composition, wherein the saponin composition includes saponins and at least one MCFA, which reads on the limitations “an animal feed composition comprising a basal animal feed” of claim 1 and “the extract further comprises lipids” of claim 3. The saponins and at least one MCFA can prevent or reduce methanogenesis by bacteria within the animal (para. [0034]). Thus, McNeff et al. support that saponins will help reducing gaseous emission from an animal, which reads on the limitation “reduces gaseous emissions from a non-human animal” of claim 1. Saponins useful in the invention can be extracted from plants of the family: Lilaecase, genus: Yucca and family: Amaryllidaccase, genus: Agave, or others (para. [0016]). In some embodiments, the composition can include at least 0.1% by weight of saponins as measured by HPLC (para. [0019]). In some embodiments, the composition can include at least about 0.1% by weight of MCFAs (para. [0027]). Saponins and the MCFAs can be included in a composition in a molar ratio of about 30:1 (para. [0026]). In some embodiments, the composition can include less than about 2.0% by weight of the MCFAs (para. [0027 – 0028]). McNeff et al. also teach that Yucca extract is usually in the range of about 5 – 20 % saponins content by weight as measured by the butanol extract method (para. [0018]). Moreover, McNeff et al. teach that the composition may comprise at least 10.0% by weight saponins as measured by HPLC (para. [0019]).
However, McNeff et al. do not teach an extract from Hesperaloe.
Wooton discloses that the first idea to use plants, specifically yucca, for feed was in 1914. Wooton also discloses that Hesperaloe parviflora of Texas east of Del Rio could be used in animal feed because they occur in sufficient abundance (page 10, para. 1). Thus, Wooton teaches the use of Hesperaloe parviflora in animal feed, which reads on the limitation “an extract from a non-woody plant of the genus Hesperaloe” of claim 1 and “Hesperaloe parviflora” of claim 8.
Marker teaches that Hesperaloe is a natural source of steroidal sapogenins. Specifically, Marker discloses that Hesperaloe parviflora yields tigogenin and reports its occurrence among plant sources of steroidal sapogenins (page 1208, Left Col., table). Marker further teaches that Hesperaloe parviflora contains steroidal sapogenins that are isolated and identified by chemical analysis (page 1208, Left Col., para. 1), thereby establishing that Hesperaloe parviflora is recognized in the art as a plant source of naturally occurring steroidal sapogenins that may be recovered from the plant material.
Majinda discloses conventional extraction and isolation of saponins, wherein the method includes pre-treatment steps, such as particle size reduction and defatting. Defatting can also be carried out after extraction of the saponins. The efficiency of the separation is improved by using part of the plant with the highest saponin concentration (page 418, para. 3). Majinda teaches that saponins extraction are performed using methanol as extracting solvents and followed by a defatting step using n-hexane. The extracts are then dissolved or suspended in water and shaken with n-butanol saturated with water. The n-butanol aliquots are then combined and the liquid removed to give crude saponin extract to work with (page 418, para. 4).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the plant-derived saponin source, such as yucca, of McNeff et al. with Hesperaloe parviflora in view of Wooton and Marker because McNeff et al. teach the use of plant-derived saponins in animal feed compositions, Wooten teaches Hesperaloe parviflora as a plant material suitable for animal feed, and Marker further teaches that Hesperaloe parviflora is a natural source of steroidal sapogenins, specifically teaching that Hesperaloe parviflora contains the steroidal sapogenin tigogenin. Accordingly, Marker establishes that Hesperaloe parviflora is recognized in the art as a source of naturally occurring steroidal sapogenins. Therefore, one of ordinary skill in the art would have recognized Hesperaloe parviflora as an obvious alternative plant-derived saponin source to the yucca-derived saponins of McNeff et al. It would have been obvious to substitute yucca with Hesperaloe parviflora as it has been known for animal feed and the saponins in Hesperaloe parviflora is safe because they do not cause toxic effect in the animal. Therefore, one of the ordinary skill in the art would have had a reasonable expectation of success to modify the animal feed as taught by McNeff et al. with the teachings of Wooton because McNeff et al. teach that plant-derived saponins reduce methanogenesis and gaseous emissions, Wooton teaches that Hesperaloe parviflora is a suitable animal-feed plant, and Marker teaches that Hesperaloe parviflora naturally contains steroidal sapogenins. Thus, substituting one known plant-derived of steroidal sapogenins, such as yucca, with another known plant-derived source of steroidal sapogenins, which is Hesperaloe parviflora, would have represented the predictable substitution of one known equivalent plant source for another to obtain the known benefit of reducing gaseous emissions.
Regarding limitation (b) of claim 1, claims 7, and 11, Majinda teaches conventional method for extracting and isolating saponins from plant material, including methanol extraction, optional defatting, and n-butanol partitioning to recover crude saponin extracts. Marker teaches that Hesperaloe parviflora is a natural source of steroidal sapogenins, including manogenin, hecogenin, gitogenin, and tigogenin. Because these steroidal sapogenins are naturally present in the Hesperaloe plant material, one of ordinary skill in the art would have recognized that applying the conventional extraction methodology of Majinda to the Hesperaloe parviflora plant material taught by Wooton and Marker would recover the naturally occurring steroidal sapogenins present in the plant, Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in obtaining a Hesperaloe extract comprising naturally occurring steroidal sapogenins for incorporation into the animal feed composition of McNeff et al. Moreover, the extraction of Majinda involves using methanol as the extracting solvent, and then dissolving or suspending the extract in water followed by shaking with n-butanol saturated with water to recover crude saponin extract. The instant specification teaches that Hesperaloe biomass may be extracted using a simple aqueous extraction using methanol as a solvent (page 6, lines 20 – 22). The specification further teaches optional defatting with a non-polar solvent, such as hexane and further purification with a polar solvent such as butanol to isolate saponins (page 6, lines 25 – 27). The specification states that a simple water extraction of Hesperaloe biomass may yield a crude aqueous extract comprising saponins and sapogenins, and that the defatted extract may be treated with butanol to yield a mixture of saponins (page 6, line 28). Thus, Majinda teaches the same core solvent-extraction steps as the extraction embodiments described in the instant specification, including alcohol or aqueous-alcohol extraction, optional defatting with a nonpolar solvent, and butanol partitioning, for extracting saponins from Hesperaloe biomass, evidencing that the claimed Hesperaloe extract may be obtained using routine, conventional extraction techniques. Moreover, Majinda recognizes that different plant parts may contain different amounts of saponins and teaches selecting the plant part having the highest saponin concentration to maximize saponin recovery. Thus, one of ordinary skill in the art would have selected the appropriate parts of Hesperaloe plant material for extraction. Accordingly, one of ordinary skill in the art would have had a reasonable expectation that applying Majinda’s conventional saponin extraction method to Hesperaloe parviflora plant material taught by Wooton would recover the naturally occurring Hesperaloe saponins, including the saponin components recited in the limitation (b) of claim 1.
Regarding claim 2, McNeff et al. teach that the animal feed composition may include at least about 0.1% by weight saponins. An amount of 0.1 wt% corresponds to 0.1 kg or 100 g of saponins per 100 kg of composition. Thus, McNeff et al. teach the upper endpoint of the claimed range of about 1 to about 100 g total saponins per 100 kg of basal animal feed. Accordingly, the claimed amount overlaps the amount taught by McNeff et al.
Regarding claim 4, the phrase “substantially free” does not require complete absence, but instead encompasses trace of incidental amounts that would reasonably be expected in the art. McNeff et al. teach compositions in which the MCFAs may be present in very small amounts, such as less than about 2.0 wt%. Accordingly, one of ordinary skill in the art would have understood that minor amounts of lipids may be presented in the animal feed composition of McNeff et al.
Regarding claims 5 – 6, the instant specification teaches that extraction of Hesperaloe biomass using aqueous or aqueous alcohol extraction, followed by optional defatting and butanol purification, produces an extract enriched in water-soluble constituents while removing insoluble materials. Majinda teaches substantially the same conventional saponin extraction methodology, including aqueous extraction, optional defatting with n-hexane, and partitioning with n-butanol to recover crude saponin extracts. Accordingly, one of ordinary skill in the art would have reasonably expected that application of Majinda’ s conventional extraction process to the Hesperaloe parviflora plant material taught by Wooton would produce an extract enriched in water-soluble solids and correspondingly reduced in water-insoluble solids, as recited in claims 5 – 6.
With respect to claim 9, Majinda teaches conventional extraction and isolation of saponins from plant material using aqueous/alcohol extraction followed by optional defatting and n-butanol partitioning, thereby recovering a crude extract comprising water-soluble saponin solids. Because Marker teaches that Hesperaloe parviflora is a natural source of steroidal saponin constituents, one of ordinary skill in the art would have reasonably expected that applying Majinda’s conventional extraction methodology to the Hesperaloe plant material taught by Marker would recover the water-soluble solids naturally present in the plant. McNeff et al. teach incorporating the resulting saponin-containing compositions comprising at least 10% by weight saponins. Accordingly, it would have obvious to incorporate the recovered water-soluble saponin solids into the animal feed composition in an amount falling within the claimed range.
Regarding claim 10, McNeff et al. teach that a typical yucca extract contains about 5 – 20% saponins by weight. The claimed range of about 5 to about 25 wt% saponin overlaps the range taught by McNeff et al. Therefore, it would have been obvious to use an extract having the claimed saponin concentration in the modified feed composition.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed May 6, 2026, have been fully considered and have been addressed in the Advisory Action mailed on June 2, 2026.
Applicant has not presented new arguments responding to the responses in the Advisory Action mailed on June 2, 2026.
Applicant should submit an argument under the heading “Remarks” pointing out disagreements with the examiner’s contentions. Applicant must also discuss the references applied against the claims, explaining how the claims avoid the references or distinguish from them.
Accordingly, the rejections are maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 – 4, 7, and 9 – 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17 – 22 of copending Application No. 19/548,471 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘471 anticipate the claimed invention.
a. ‘471 claims a method of treating coccidiosis comprising administering thereto an anticoccidial amount of a feed composition comprising a basal animal feed and at least one saponin extracted from a non-woody plant of the genus Hesperaloe (claim 17), wherein the at least one saponin is 25(27)-dehydrofucreastatin, 5(6), 25(27)-disdehydroyuccaloiside C, 5(6)-disdehydroyuccaloiside C, furcreastatin or yuccaloiside C (claim 22). The method, wherein the at least one saponin is provided as a mixture of water soluble solids and the mass of the water soluble solids ranges from about 100 to about 1,000 g per kilogram of animal feed (claim 18). The water soluble solids further comprise saccharides, proteins, and lipids (claim 20) or the water soluble solids are substantially free from saccharides, proteins, and lipids (claim 21). The water soluble solids comprise from about 10 to about 25 wt% saponin (claim 19).
For the reasons above, ‘471 anticipates the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 5 – 6 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17 – 22 of copending Application No. 19/548,471 in view of Wooton (US Department of Agriculture, 1918, cited in the PTO-892 on September 24, 2025), Marker (Journal of the American Chemical Society, 1943, Vol. 65, Issue 6, page 1199 – 1209, PTO-892), and Majinda (Methods in Molecular Biology, 2012, page 415 – 426, See PTO-892).
b. ‘471 claims the limitations discussed above.
However, ‘471 does not claim the extract comprises at least about 90% water soluble solids and less than about 2% water insoluble solids. ‘471 also does not claim that the non-woody plant is Hesperaloe parviflora.
Wooton discloses that the first idea to use plants, specifically yucca, for feed was in 1914. Wooton also discloses that Hesperaloe parviflora of Texas east of Del Rio could be used in animal feed because they occur in sufficient abundance (page 10, para. 1). Thus, Wooton teaches the use of Hesperaloe parviflora in animal feed, which reads on the limitation “an extract from a non-woody plant of the genus Hesperaloe” of claim 1 and “Hesperaloe parviflora” of claim 8.
Marker teaches that Hesperaloe is a natural source of steroidal sapogenins. Specifically, Marker discloses that Hesperaloe parviflora yields tigogenin and reports its occurrence among plant sources of steroidal sapogenins (page 1208, Left Col., table). Marker further teaches that Hesperaloe parviflora contains steroidal sapogenins that are isolated and identified by chemical analysis (page 1208, Left Col., para. 1), thereby establishing that Hesperaloe parviflora is recognized in the art as a plant source of naturally occurring steroidal sapogenins that may be recovered from the plant material.
Majinda discloses conventional extraction and isolation of saponins, wherein the method includes pre-treatment steps, such as particle size reduction and defatting. Defatting can also be carried out after extraction of the saponins. The efficiency of the separation is improved by using part of the plant with the highest saponin concentration (page 418, para. 3). Majinda teaches that saponins extraction are performed using methanol as extracting solvents and followed by a defatting step using n-hexane. The extracts are then dissolved or suspended in water and shaken with n-butanol saturated with water. The n-butanol aliquots are then combined and the liquid removed to give crude saponin extract to work with (page 418, para. 4).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to select Hesperaloe parviflora as the Hesperaloe species recited in the animal feed composition of ‘471 because Wooton teaches that Hesperaloe parviflora is suitable for use as animal feed and Marker further teaches that Hesperaloe parviflora is a source of naturally occurring steroidal sapogenins, specifically identifying tigogenin in Hesperaloe parviflora. Therefore, one of ordinary skill in the art seeking a particular Hesperaloe species for the saponin-containing feed composition claimed in ‘471 would have found it obvious to select Hesperaloe parviflora, because it was known both as an animal feed plant and as a source of steroidal sapogenins. Such selection would have represented the predictable selection of a known species within the genus already claimed in ‘471.
Regarding claims 5 – 6, the instant specification teaches that extraction of Hesperaloe biomass using aqueous or aqueous alcohol extraction, followed by optional defatting and butanol purification, produces an extract enriched in water-soluble constituents while removing insoluble materials. Majinda teaches substantially the same conventional saponin extraction methodology, including aqueous extraction, optional defatting with n-hexane, and partitioning with n-butanol to recover crude saponin extracts. Accordingly, one of ordinary skill in the art would have reasonably expected that application of Majinda’ s conventional extraction process to the Hesperaloe parviflora plant material taught by Wooton would produce an extract enriched in water-soluble solids and correspondingly reduced in water-insoluble solids, as recited in claims 5 – 6.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOI YAN LEE whose telephone number is 571-270-0265. The examiner can normally be reached Monday - Thursday 7:30 - 17:30.
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 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.
/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
Prosecution Insights