DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of the invention of Group I (claims 1-3, 5-9, 11, 13-15 and 17-24) in the reply filed on 06/05/2026 is acknowledged.
Claims 17-20 and 22-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/16/2024 has been considered by the examiner.
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 1-3, 5-9, 13, 21 and 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) in vivo digestion of cactus plant by a ruminant animal. This judicial exception is not integrated into a practical application because preparing a fertilizer is nothing more than an attempt to generally link the product of nature to a particular agricultural use. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the naturally occurring digestion process prepares a fertilizer product as cow manure.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released a revised guidance on January 7, 2019 for the examination of claims reciting judicial exceptions. The revised Office guidance indicates that claims must pass an eligibility test to avoid rejection under 35 U.S.C. 101. An analysis with respect to the claims as a whole reveals that they do not include additional elements that are sufficient to amount to significantly more than the judicial exception. See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116, 106 U.S.P.Q.2d 1972 (2013); Mayo Collaborative Svcs. v. Prometheus Laboratories, Inc., 132 S. Ct. 1289, 101 U.S.P.Q.2d 1961 (2012). See also 2019 Revised Patent Subject Matter Eligibility Guidance, available at https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf, and the Office’s revised Examples to be considered in conjunction with the 2019 Revised Patent Subject Matter Eligibility Guidance in examination of abstract ideas, available online at https://www.uspto.gov/sites/default/files/documents/101_examples_37to42_20190107.pdf (“PEG Examples 37 through 42”).
Analysis of subject-matter eligibility under 35 U.S.C. § 101 requires consideration of four issues: (1) whether the claim is directed to one of the four categories recited in §101; (2A1) whether the claim recites or involves a judicial exception (i.e., a law of nature, natural phenomenon, abstract idea, or natural product); (2A2) if a judicial exception applies; whether the claim limitation is integrated into a practical application; and (2B) whether the claim as a whole recites an inventive concept, (i.e., something that amounts to significantly more than the judicial exception). (2019 Revised Patent Subject Matter Eligibility Guidance). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the analysis is as follows:
1: Statutory Category- Yes; the claims are directed to a composition claim which are composed of products of nature which are not markedly or substantially different from those that exist in nature.
2A- Prong 1: Judicial Exception- Yes; the limitations recited in independent claim 1 and subsequent dependent claims may be naturally found and appear to be natural processes and unmodified (e.g., ruminant digestion). The instant claim(s) is directed to a method of preparing a fertilizer product using ruminal fluid to digest cactus plants. Thus, the claim(s) is drawn to the judicial exception of a natural process and thus are analyzed as whole in order to determine if the claims recite something which includes a feature or structure that amounts to significantly more than a judicial exception.
2A- Prong 2: Integrated into a ‘Practical Application’- No, this judicial exception is not integrated into a practical application, because the claim(s) does not implementing a judicial exception with, or use a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim. See e.g., MPEP 2106.05(d). An ex vivo method itself is not effecting the obtained product but rather is based on the nature-based processes’ structure, function and/or other properties. However, a determination must be made as to whether the additional elements, or combination of additional elements, amount to significantly more than the judicial exception.
2B: Claim provides an Inventive Concept- No, because under the 2019 revised Guidance, a judicial exception, if not integrated into a practical application, must have additional elements that amount to significantly more than the judicial exception. See MPEP 2106.05(a)-(d). A claim may amount to significantly more by including specific limitations other than what is well-understood, routine, or conventional activity in the field, or adding unconventional steps that confine the claim to a particular useful application. See MPEP 2106.05(d)/(II).
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Here, in reviewing the claims as a whole, the method recited is no more than the natural biological process involving masticating (e.g. chewing and chewing the cud) cactus plant materials, salivation and rumen entry, the rumen and reticulum and digestion and fermentation. A cow naturally secretes saliva and continuously self-populates its rumen. In a cow, the digestate moves on to the omasum, abomasum and intestines, eventually leaving the body as manure. Therefore, the claimed method, as it pertains to preparing a fertilizer product, is carried out by a living animal. As such, the additional elements, individually and in combination, in the instant claims do not amount to significantly more than a judicial exception.
Accordingly, claims 1-3, 5-9, 13, 21 and 24 are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-9, 13, 21 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by de Waal (AgriOrbit, 2019) as evidenced by Parish et al. (Mississippi State University, 2009) and as evidenced by Rounds et al. (Texas Agricultural Extension, 2021), regarding claims 9 and 21.
In regard to claims 1 and 5, de Wall is directed to a ruminant feed source comprising cladodes and fruit from the spineless cactus pear (Opuntia ficus-indica) [pg. 1, 1st para.]. Several trials have been done with dairy cows [pg. 4, 5th para.]. Providing a feed source to ruminant animals (e.g. cows) is considered to inherently describe a method of preparing a fertilizer product because cows are ruminants, they ferment and digest fibrous feed thoroughly, excreting nutrient-rich feces which is well-for its classification as agricultural fertilizer (e.g. manure) for at least the past several thousands of years of civilization. This method of preparing a feed and feeding to a ruminant animal inherently includes the ruminant animal digestion process [described by the Parish reference, herein] comprising:
grinding the feed (e.g. cladodes as described by de Wall – see above) in the mouth of the ruminant whereby the premolars and molars of the upper and lower jaws crush and grind plant material during initial chewing and rumination [Parish, pg. 1, 4th para. from bottom];
selecting prickly pear fruits from the one or more cactus plants (e.g. the ruminant feed source comprises fruit from the spineless cactus pear) [de Wall pg. 1, 1st para.].
mixing a portion of the ground cactus and the selected prickly pear fruits with a ruminal fluid (e.g. feedstuffs are swallowed and the solid portion moves into the rumen) [Parish, pg. 2, 2nd para.] to prepare an activating fluid (the rumen inherently contains a ruminal fluid);
combining the ground cactus, the selected prickly pear fruits, water, and the activating fluid in a first container (e.g. rumen is a stomach compartment and considered a container, herein) to form a mixture (e.g. feed and ruminal fluid containing water are combined in the rumen after swallowing) [Parish, para. bridging pgs. 1-2]
storing the mixture in the first container (e.g. in the rumen) for a first time period (e.g. up to 48 hours) [Parish, para. bridging pgs. 1-2) such that the mixture reacts to form a digestate (e.g. starch and soluble sugar is digested in the rumen) [Parish, pg. 2, 7th para.]; and
storing the digestate in the first container or a second container (e.g. the small intestine) [Parish, paras. bridging pgs. 2-3] for a second time period such that the digestate (e.g. the small intestine is a tube up to 150 feet long in which digesta mixes with secretions from the pancreas and liver and bile aids in digestion) [Parish, paras. bridging pgs. 2-3] forms the fertilizer product (e.g. excretes the remaining material as feces) [Parish, pg. 3, 1st full para.].
In regard to claim 2, de Waal, with evidence from Parish, teaches the method of claim 1, wherein the first container and the second container are configured to inhibit entry of air and light (e.g. a ruminant animal’s digestive tract is inherently located completely inside the animal’s body where it is always dark and anaerobic).
In regard to claim 3, de Waal, with evidence from Parish, teaches the method of claim 1, wherein the digestate is stored at room temperature and pressure (e.g. stored in the small intestine) [Parish, paras. bridging pgs. 2-3], where the small intestine of a ruminant animal operates at a constant core body temperature and pressure, interpreted as “room” temperature and pressure.
In regard to claims 6-7, de Waal, with evidence from Parish, teaches the method of claim 1, further comprising, prior to the grinding (e.g. chewing), selecting a plurality of cladodes of the one or more cactus plants, each of the selected plurality of cladodes being between about 30 cm and about 50 cm in length (e.g. coarsely cut spineless cactus pears cladodes) [de Waal, pg. 1, fig. 1], further comprising, prior to the grinding, cleaning the cladodes with water (e.g. the cladodes are illustrated on a net exposed to the elements such as rain) [de Waal, pg. 1, fig. 1].
In regard to claim 8, de Waal, with evidence from Parish, teaches the method of claim 1, wherein the storing the mixture in the first container (e.g. the rumen) includes permitting the digestate to ferment in the first container (the rumen acts as a fermentation vat by hosting microbial fermentation) [Parish, pg. 2, 7th para.].
In regard to claims 9 and 21, de Waal, with evidence from Parish, teaches the method of claim 1, further comprising:
maintaining an internal temperature of the first container between about 25°C and about 40°C (e.g. the normal temperature of rumen fermentation ranges from 37 to 40°C) [Rounds, pg. 2, last para.] and maintaining an internal pressure of the first container within the claimed range when gases are naturally formed and belched;
and the second container having a second temperature and a second pressure, wherein the first temperature is higher than the second temperature and the first pressure is higher than the second pressure (e.g. fermentation in the rumen necessarily occurs at a higher temperature than the movement in small intestine because there is no fermentation in the second container/intestine which is reduced to body temperature).
In regard to claim 13, de Waal, with evidence from Parish, teaches the method of claim 1, wherein the ruminal fluid is a biological mixture that develops naturally inside the rumen [Parish, pg. 2]. The source recitation (wherein the ruminal fluid is extracted from one or more calves using a nasogastric tube) does not functionally limit the method steps whereby the mixture with a ruminal fluid occurs inside the animal.
In regard to claim 24, de Waal, with evidence from Parish, teaches the method of claim 1, further comprising:
a step of separating particulate matter in the digestate before storing the digestate in the second container (e.g. forage and other feedstuffs are forced back into the mouth from the rumen) [Parish, para. bridging pgs. 1-2].
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over de Waal (AgriOrbit, 2019) as evidenced by Parish et al. (Mississippi State University, 2009) and Merck (Veterinary Manual, 2022), regarding claim 15.
In regard to claim 14, de Waal, with evidence from Parish, teaches the method of claim 13, wherein the one or more cows are provided a diet of about 41-51% cactus plants [de Waal, pg. 4, table 1]. Although de Waal does not explicitly disclose the claimed values, the reference teaches the ratio of cactus to fodder to be an art recognized result effective variable depending on the nutritional limits required by the respective feed animal [pg. 4, 2nd to last para.]. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify a cow’s diet to include 20% fodder and 80% cladodes of cactus plants because cactus usually increases animal performance and cactus can also totally replace concentrate feeding, such as corn, with no effect on milk yield [pg. 4, 2nd to last para.]. Alternatively, it would have been obvious to one of ordinary skill in the art at the time of the invention to choose the instantly claimed ranges through process optimization, since it has been held that there the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980).
In regard to claim 15, de Waal, with evidence from Parish, teaches the method of claim 13, further comprising, prior to the combining the ground cactus, the selected prickly pear fruits, water, and the ruminal fluid, storing the ruminal fluid in a third container (e.g. the reticulum) [Parish; pg. 2, 4th para.] configured to inhibit entry of air and light. (e.g. inside of a cow). The typical internal temperature of a cow is between 36.7-39.3°C [Merck, pg. 1, table]. While these values do not overlap with the claimed temperature between about 25°C and about 35°C, Merk’s range and the instant claimed range do not overlap but are close enough such that one skilled in the art would have expected them to have the same properties, a prima facie case of obviousness exists in view of Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985), absent contrary evidence of criticality or non-obviousness.
Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Calt et al. (US Patent No. 8,367,372) in view of Ouhammou et al. (Journal of the Saudi Society of Agricultural Sciences, 2019).
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In regard to claim 1, a method of preparing a fertilizer product (e.g. the embodiment depicted in Fig. 6; the dewatered and dried biomass is a dry fertilizer) [col. 11, lines 1-3], the method comprising:
grinding (e.g. grinder/mixer) [Fig. 6] organic feedstock [col. 11, lines 1-2];
mixing a portion of the ground feedstock with a ruminal fluid to prepare an activating fluid (a grinder/mixer configured to receive the organic feedstock and the rumen) [col. 12, lines 5-10; Fig. 6];
combining the ground feedstock, water, and the activating fluid in a first container to form a mixture (e.g. fermenter configured to receive the organic feedstock and the rumen) [col. 12, lines 6-65];
storing the mixture in the first container for a first time period such that the mixture reacts to form a digestate (e.g. fermenter configured to ferment the organic feedstock/digested organic feedstock) [col. 12, lines 10-15]; and
storing the digestate in the first container or a second container for a second time period such that the digestate forms the fertilizer product (e.g. a biomass drying unit configured to dry the dewatered biomass; wherein the dewatered and dried biomass is a dry fertilizer) [para. bridging pgs. 10-11].
Calt et al. is directed to processing organic feedstock comprising agricultural waste, or food processing plant waste [col. 1, lines 55-60] but does not explicitly disclose wherein the feedstock is cladodes and prickly pear fruits from cactus plants. Ouhammou et al. is directed to valorization of cellulosic waste, including old cladodes of Ficus indica cactus optunia and the residue of prickly pear seeds [abstract]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform Calt’s fertilizer preparation method using cladodes and prickly pear fruits of cactus plants. One of ordinary skill in the art would have been motivated to do so because Ouhammou describes these materials as agricultural waste (e.g. the old cladodes and the waste seeds of Opuntia ficus-indica, after oil extraction are rich in polysaccharides as cellulose wastes, which are not recoverable either in animal feed or cosmetics industry) [pg. 133, 2nd col. 1st full para.] and it is obvious to apply Calt’s known technique in the same way to provide valorization of cactus waste which is a known agricultural waste.
In regard to claim 11, Calt et al. in view of Ouhammou disclose the method of claim 1, but do not explicitly teach wherein the first time period is between about 15 days and about 22 days and the second time period is between about 6 days and about 10 days. However, Calt describes the residence time for the solids in the system will depend on particle size and other factors, such as the solids blowdown rate, used for removal of indigestible materials. Put another way, Calt teaches the first and second time (e.g. residence time) to be an art recognized result effective variable depending on the characteristics of the treated material. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the residence time of the first and second time periods to be within the claimed range. Alternatively, it would have been obvious to one of ordinary skill in the art at the time of the invention to choose the instantly claimed ranges through process optimization, since it has been held that there the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kuhry (US-20110111475-A1) describes a plant or animal material combined with fermentation medium with a mixed microbial inoculum taken from the rumen of a ruminant animal, such as cattle. Under anaerobic conditions, the microbes break down the biomass.
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JENNIFER A. SMITH
Primary Patent Examiner
Art Unit 1731
/JENNIFER A SMITH/Primary Patent Examiner, Art Unit 1731 June 16, 2026
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