DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Status
Applicant’s amendment of 10/09/2025 is acknowledged. Claims 8, 11, 17, and 19 are amended; and claims 3, 5, 12-13, 15-16, 22, 24-29, 32, and 34-39 are cancelled. Claims 1-2, 4, 6-11, 14, 17-21, 23, 30-31, and 33 are currently pending.
Election/Restrictions
An election of invention/species was required in the instant application as detailed in the Office action dated 04/18/2025. The election is maintained and claims 20-21, 23, 30-31, and 33 remain withdrawn. Accordingly, claims 1-2, 4, 6-11, 14, and 17-19 are examined on the merits herein.
Priority
The instant application is a 371 of PCT/IB2021/054710 filed on 05/28/2021 and claims foreign priority to IN202041022410 filed on 05/28/2020 as reflected in the filing receipt dated on 04/03/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/09/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Declaration Under 37 CFR 1.132
Dr. Sarma Rajeev Kumar provided a Declaration under 37 CFR 1.132, filed 10/09/2025. The Declaration meets the formal requirements. In the most relevant part,
the Declaration presents results of Applicant’s claimed composition compared to a commercial protein hydrolysate biostimulant product comprising protein component in an amount greater than the claimed amount, as well as a comparison of biostimulant effects achieved by methanotrophic bacteria-derived hydrolysate compared to non-methanotrophic-derived hydrolysate. A Declaration is due full consideration and weight for all that it discloses. Declarations are reviewed for the following considerations: 1) whether the Declaration presents a nexus such as a side-by-side or single-variable comparison (In re Huang, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996)), 2) whether the Declaration presents a comparison to the closest art, 3) whether the Declaration is commensurate in scope with the scope of the claims (In re Kulling, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)), 4) whether the Declaration shows a difference in kind rather than merely a difference in degree (In re Waymouth, 182 USPQ 290, 293 (C.C.P.A. 1974)), and 5) whether the prima facie case is sufficiently strong that allegedly superior results are insufficient to overcome the case for obviousness (Pfizer Inc. v. Apotex, Inc., 82 USPQ2d 1321, 1339 (Fed. Cir. 2007)).
The Declaration under 37 CFR 1.132 filed 10/09/2025 is insufficient to overcome
the rejection of claims 1-2, 4, 8-11, 14, 17, and 19 based upon Dyson alone or in view of Colla, Kinsey, or Woo and Sukmawati applied under 35 U.S.C. 103 as set forth in the last Office action for the following reasons:
First, as discussed in detail in the prior art rejections and responses to arguments below, Dyson anticipates Applicant’s hydrolysate based biostimulant composition as claimed, including the claimed amount of protein-derived component. Even when utilizing “high protein” hydrolysates of 90 wt.% or more, the biostimulant composition of Dyson, which comprises 0.5 wt.% to 15 wt.% total nitrogen, would necessarily comprise at least 0.45 wt.% to 13.5 wt.% protein nitrogen, which lies within and thus anticipates the instantly claimed range of 30 wt.% or less protein-derived component. As such, the Examiner is only considering Applicant’s allegedly unexpected results presented in the Declaration as they pertain to Applicant’s elected species of 4 wt.% protein-derived component, which was rendered obvious by Dyson.
The relevant criteria here are No. 1 and 2, whether the Declaration presents a nexus such as a side-by-side or single-variable comparison and whether the Declaration presents a comparison to the closest art. The Examiner has carefully reviewed the Declaration, including the data presented in the Declaration. The data show Applicant’s composition comprising 4 wt.% protein-derived component (Applicant’s Instant Specification, Pages 54-56, Example 2) having improved plant performance/yield compared to a commercial protein hydrolysate biostimulant product comprising “about 62.5 wt.% protein component” (Applicant’s Instant Specification, Pages 59-61, Example 7). The additional examples provided by Dr. Kumar allegedly demonstrate that a hydrolysate methanotrophic bacteria-derived hydrolysate achieves improved plant biostimulant effects compared to non-methanotrophic-derived hydrolysate exemplified by Dyson (Cupriavidus spp.).
In providing a side-by-side comparison of Applicant’s composition compared to a commercial protein hydrolysate biostimulant product, Applicant fails to provide sufficient evidence to establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). For example, neither Applicant’s instant specification or Declaration appear to disclose the actual composition of the commercial biostimulant product. Without demonstrating that all other components and concentrations were held constant, no definitive conclusions can be drawn about the criticality of Applicant’s claimed and/or elected amount of protein-derived component on the biostimulant’s performance.
In providing additional examples allegedly demonstrating that a hydrolysate methanotrophic bacteria-derived hydrolysate achieves improved plant biostimulant effects compared to non-methanotrophic-derived hydrolysate exemplified by Dyson (Cupriavidus spp.), Applicant merely compares 5 mL of each microbe-derived protein hydrolysate without conveying, at the least, the protein content of each hydrolysate, or comparing the claimed composition to an actual disclosed embodiment of Dyson representing the closest prior art which is commensurate in scope with the claims. Furthermore, Applicant fails to provide any showing that there is a statistically significant difference between the values achieved by each composition. As such no definitive conclusions can be drawn about the criticality of Applicant’s claimed and/or elected amount of protein-derived component as compared the closest prior art.
In view of the foregoing, when all of the evidence is considered, the totality of the
rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Withdrawn Objections and Rejections
Applicant’s amendments to the specification and drawings have overcome the previous objections to the disclosure. Thus, the objection is hereby withdrawn.
Applicant’s amendments to the claims have overcome the previous objections to the claims. Thus, the objections are hereby withdrawn.
Applicant’s amendments to the claims have overcome/rendered moot the previous 112(b) rejections. Thus, the rejections are hereby withdrawn.
The 102, 103, and non-statutory double patenting rejections over claim 38 have been withdrawn due to Applicant’s cancellation of the claim.
Claim Interpretation
In claims 2, 4, 11, and 14, recitations of the alternative “or” language immediately preceding “wherein” clauses are interpreted by the Examiner to mean that the limitations set forth within the “wherein” clauses are alternative limitations. Therefore, the claim is met by the teaching of at least one alternative by the prior art.
Claim 8 recites the Markush grouping “polypeptides, oligopeptides, and a combination thereof” followed by a “wherein” clause narrowing the scope of the oligopeptide. The Examiner notes that the oligopeptide is not required by the claim.
Claim 14 recites the limitation “optionally at least one agriculturally acceptable excipient”. The Examiner notes that the at least one agriculturally acceptable excipient is not required by the claim.
Claim 17 is interpreted to depend from claim 14 as discussed above and recites a “wherein” clause narrowing the scope of the at least one agriculturally acceptable excipient. The Examiner notes that the at least one agriculturally acceptable excipient is not required by the claim from which claim 17 depends.
Claim 19 recites the limitations a-d as alternative limitations as indicated by the inclusion of the alternative “or” language. Therefore, the claim is met by the teaching of at least one alternative by the prior art.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 1-2, 4, 8, 11, 14, 17, and 19 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Dyson (US20190390158A1; 12/26/2019; IDS of 12/21/2022) as evidenced by Biomolecules 101 (10/11/2018; PTO-892 of 07/10/2025).
Dyson discloses an increased interest in microbially derived biostimulants and biofertilizers (Paragraph 0017). Protein hydrolysates are an important category of biostimulants comprising a mixture of polypeptides, oligopeptides, and amino acids (Paragraph 0018), which read on the elected species of protein derived component comprising peptides and amino acids recited in instant claims 1, 4, 14, and 17. The term “oligopeptide” refers to those amino acid polymers with less than 20 residues, as evidenced by Biomolecules 101 (Page 1, Paragraph 1). Therefore, the oligopeptides of protein hydrolysate of Dyson would necessarily comprise at least some of the oligopeptide species recited in instant claim 8.
Dyson highlights a need to augment current animal and plant derived protein hydrolysates with those which are not derived from animals or plants and suggests microbial-derived nutrients as a viable alternative (Paragraphs 0036-0037). Specifically, Dyson identifies microorganisms that can convert low cost syngas, CO2, and/or methane into higher value organic chemicals, including amino acids, proteins, vitamins, fertilizers, biostimulants, and other biological nutrients, which in some embodiments include a methanotrophic microorganism (Paragraph 0051). Dyson further discloses methods for producing plant biostimulants and/or fertilizer, including hydrolyzing bacterial cells to obtain a hydrolysate as a plant biostimulant and/or fertilizer for foliar application, application as a soil adjuvant, and/or application as a soil fertilizer (Paragraph 0067). These hydrolysate components are used directly by plants for protein synthesis and other essential nitrogen compounds or metabolized, thereby contributing to horticulture crop productivity and quality (Paragraph 0021), which reads on at least the intended uses of improving or enhancing performance of the plant and increasing the availability of nitrogen recited in instant claim 19.
In some embodiments, the microorganism is in the genus Methylococcus and is preferably Methylococcus capsulatus (Paragraph 0257), which reads on the elected species of methanotrophic bacterium instant claims 1 and 11. The plant biostimulant has a total nitrogen content of about 0.5 wt.% to about 15 wt.% on a dry matter basis (Paragraph 0421). Because proteins, peptides, and amino acids are comprised of nitrogen, while other sources of nitrogen such as nucleic acids may be present in the biostimulant, at least some of the nitrogen content is necessarily attributed to these protein-derived components. Therefore, the amount of protein-derived component in the biostimulant composition of Dyson lies within the range of 0.5 wt.% to about 15 wt.% of the composition, which lies within and thus anticipates the ranges recited in instant claims 1, 2, and 14.
Because Dyson specifically teaches an embodiment wherein a methanotrophic organism, Methylococcus capsulatus, is the bacterium of choice, the plant biostimulant of Dyson reads on all limitations of the hydrolysate based biostimulant composition recited in instant claim 1.
Dyson further teaches that formulating the hydrolysate comprises separating liquid and solid fractions of the hydrolysate and retaining the liquid fraction and/or the solid fraction as the plant biostimulant and/or fertilizer (Paragraph 0413). Retaining the liquid fraction of hydrolysate as the biostimulant reads on the elected species wherein the biostimulant composition is in a liquid form as recited in instant claim 14. The nutrients obtained from the biostimulant are used to fertilize plant crops, including but not limited to rice (Paragraph 0420).
The hydrolysates contain other compounds that can contribute to the biostimulant action including lipids, vitamins, carbohydrates, and mineral elements, among others (Paragraph 0411), which read on species of the at least one non-protein metabolite recited in instant claims 14 and 17. The ratio of nucleic acid content to microbial protein content should be less than three percent (Paragraph 0037). Because nucleic acids are comprised of nitrogenous bases, while other sources of nitrogen such as proteins, peptides, and amino acids may be present in the biostimulant, at least some of the nitrogen content is necessarily attributed to these nucleic acids. Therefore, the amount of at least one non-protein metabolite in the biostimulant composition of Dyson lies within the range of 0.5 wt.% to about 15 wt.% of the composition, which lies within and thus anticipates the ranges recited in instant claim 14.
In certain embodiments a nutrient media for culture growth and production is used, comprising an aqueous solution containing suitable minerals, salts, buffers, and other components needed for microbial growth (Paragraph 0295), which read on species of the at least one culture media component recited in instant claims 14 and 17. Because the protein hydrolysate is collected as a liquid fraction, the biostimulant would necessarily comprise components of the culture media.
Taken together, the disclosure of Dyson reads on at least one alternative of instant claim 14, which does not require a specific amount of the at least one culture media component.
Further, though Applicant elected a species of biostimulant composition which does not require the optional at least one agriculturally acceptable excipient recited in instant claims 14 and 17, Dyson further discloses methods wherein additional components such as preservatives are mixed with the protein hydrolysate to obtain the plant biostimulant (Paragraph 0424), which meets the optional claim limitation.
Regarding instant claim 19, the recitations “improves…performance of plant”, “increases…potassium by the plant”, “reduces…as part of a fertilizer” are intended uses of the claimed composition and, of note, are recited using the alternative “or” language. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since the structure of the biostimulant composition of Dyson is capable of performing the intended uses, as discussed above, then it meets the claim. Note: MPEP 2111.02.
Response to Arguments
Applicant’s arguments submitted on 10/09/2025 with respect to rejections under 35 U.S.C. 102 have been fully considered but were not found to be persuasive.
Applicant argues that Dyson neither discloses nor suggests a hydrolysate based biostimulant composition comprising a protein derived component in an amount of about 30% or less and, thus, does not anticipate claim 1 or claims 2, 4, 8, 11, 14, 17, or 19, which depend from claim 1.
Specifically, Applicant argues that the total nitrogen content disclosed by Dyson does not necessarily indicate protein content and cites Lourenco, Ismail, Yang, and Atasoglu to show that protein nitrogen can range widely and unpredictably across microorganisms and growth conditions. The Examiner has fully considered Applicant’s argument in view of the cited references; however, the argument was not found to be persuasive. While protein nitrogen may vary across microbial sources, as noted by Applicant, the state of the art teaches that greater than 50% of total nitrogen is attributed to protein nitrogen. Thus, in view of Applicant’s cited references, an ordinarily skilled artisan would reasonably determine that Dyson’s biostimulant composition comprising 0.5 wt.% to 15 wt.% of total nitrogen would necessarily contain about 0.25 wt.% to about 15 wt.% protein nitrogen, which lies within and thus anticipates the instantly claimed range of less than 30 wt.%, even when accounting for the unpredictability of protein nitrogen content across microbial sources. Moreover, Applicant points out that in preferred embodiments of Dyson (e.g. Dyson, Paragraph 0413), the protein content is more than 90 wt.% of the total hydrolysate (see Page 19 of Remarks). Therefore, even when utilizing “high protein” hydrolysates, the biostimulant composition of Dyson, which comprises 0.5 wt.% to 15 wt.% total nitrogen, would necessarily comprise at least 0.45 wt.% to 13.5 wt.% protein nitrogen, which also lies within and thus anticipates the instantly claimed range.
Applicant further argues that Dyson does not provide an enabling disclosure of the claimed composition, asserting that Dyson merely names “a methanotroph” in a laundry list of microorganisms and fails to provide a single working example with a methanotroph, and thus argues that one would have not produced the claimed composition without undue experimentation. This argument was not found to be persuasive. As discussed in the prior art rejections of record, Dyson specifically teaches an embodiment wherein a methanotrophic organism, Methylococcus capsulatus, is the bacterium of choice (Paragraph 0257). Note: MPEP 2131.02. A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990). See also In re Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982).
Regarding Applicant’s argument of undue experimentation, the disclosure of Dyson provides examples of how to measure various parameters, including protein concentration, nitrogen content, and even the specific amino acid composition of hydrolysates (e.g., Paragraphs 0546-0557), which would easily enable an ordinarily skilled artisan to produce a biostimulant composition comprising a hydrolysate derived from any microbial source of choice, including the Methylococcus capsulatus of Dyson, having the claimed amount of protein-derived component.
In view of the foregoing, the prior art rejections above are maintained.
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.
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 1-2, 4, 8-11, 14, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Dyson (US20190390158A1; 12/26/2019; IDS of 12/21/2022), as applied to claims 1-2, 4, 8, 11, 14, 17, and 19 above, and as evidenced by Biomolecules 101 (10/11/2018; PTO-892 of 07/10/2025).
Dyson as evidenced by Biomolecules 101 discloses the hydrolysate based biostimulant composition recited in instant claims 1-2, 4, 8, 11, 14, 17, and 19 as discussed in detail above and further incorporated herein. Claims 14 and 17 are further rejected herein to demonstrate that Applicant’s elected species as it relates to instant claim 14 is obvious over the prior art.
Dyson further teaches that enzymatic hydrolysis of the microorganism yields an extract rich in proteins, mostly in the form of peptides, e.g. oligopeptides and peptides having a low molecular weight under 10 kDa, and free amino acids, which enables absorption of these molecules by plants and/or soil organisms (Paragraphs 0384-0385).
However, Dyson does not expressly teach that the biostimulant composition comprises the specific amounts of peptides recited in instant claims 9 and 10. While Dyson does teach one alternative of the biostimulant composition recited in instant claim 14, Dyson does not expressly disclose an embodiment wherein the amount of protein derived component is 4%, the amount of at least one non-protein metabolite, i.e. nucleic acids, is 1%, or the amount of at least one culture media component is 1%, by weight of the biostimulant composition as is consistent with Applicant’s elected species.
Regarding instant claims 9 and 10, while Dyson is silent as to the exact concentrations of peptides and their respective molecular weights, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the concentrations of peptides within the protein-derived component of the biostimulant composition of Dyson according to known methods in order to ensure that most of the peptides present have a molecular weight of 10 kDa or less. One of ordinary skill in the art would have been motivated to manipulate the peptide content because Dyson teaches that peptides of low molecular weight, e.g. under 10 kDa, are most readily absorbed by plants and/or soil organisms to aid in the formation of their own biomolecules.
Regarding the amounts of the protein derived component and the at least one non-protein metabolite in Applicant’s elected species of instant claim 14, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to adjust the amounts of each component within the range taught by Dyson, which overlaps the instantly claimed ranges, since the reference teaches that any amount from about 0.5 wt.% to about 15 wt.% of each component is suitable for producing a biostimulant composition. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
Regarding the amount of the at least one culture media component in Applicant’s elected species of instant claim 14, because the combined amount of the protein derived component and the nucleic acids in the biostimulant composition is a minimum of 0.5 wt.%, the amount must lie within the range of up to about 95.5 wt.%. Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to adjust the amount of culture media component(s) within the range taught by Dyson, which overlaps the instantly claimed ranges, since the reference teaches that any amount of up to about 95.5 wt.% is suitable for producing a biostimulant composition. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
It is generally noted that differences in concentrations do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Given that Applicant did not point out the criticality of each peptide or component concentration within the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of ranges is the optimum concentration. NOTE: MPEP 2144.05.
One of ordinary skill in the art would reasonably expect success in modifying the biostimulant composition of Dyson as proposed because all components and parameters are taught within the same reference as suitable approaches for formulating biostimulant compositions.
Claims 1-2, 4, 6-11, 14, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Dyson (US20190390158A1; 12/26/2019; IDS of 12/21/2022), as applied to claims 1-2, 4, 8-11, 14, 17, and 19 above, and further in view of Colla (11/10/2015; PTO-892 of 07/10/2025) and as evidenced by Biomolecules 101 (10/11/2018; PTO-892 of 07/10/2025).
Dyson as evidenced by Biomolecules 101 discloses the hydrolysate based biostimulant composition recited in instant claims 1-2, 4, 8-11, 14, 17, and 19 as discussed in detail above and further incorporated herein.
Dyson further discloses that optimization of protein production and the targeting of specific amino acid distributions can be achieved by control of bioreactor conditions and/or nutrient levels and/or through genetic modification of the bacterial cells (Paragraph 0342).
However, Dyson does not expressly teach that the protein derived component of the biostimulant composition comprises the specific amounts of amino acids recited in instant claims 6 and 7.
Colla teaches that protein hydrolysates are an important group of plant biostimulants based on a mixture of peptides and amino acids that have received increasing attention in the recent years due to their positive effects on crop performances (Abstract). When derived from various animal and plant sources, amino acid concentrations of the protein hydrolysates fall within the following ranges with respect to weight of total amino acids in the protein source: 2.9 – 8.8% lysine; 2.0 – 4.8 % threonine; 0.7 – 2.9% methionine; 0 – 1.7% tryptophan; 0.7 – 3.7% histidine; 2.9 – 7.6% valine; 2.2 – 6.0% phenylalanine; 0.9 – 5.4% isoleucine; 3.2 – 12.2% leucine; 4.8 – 13.1% proline; and 2.1 – 23.5% glycine; among other amino acids (Page 31, Table 1). The concentrations of amino acids in protein hydrolysates as taught by Colla overlap the instantly claimed ranges recited in instant claims 6 and 7, and overlap or closely approach the amounts found within Applicant’s elected species of biostimulant composition. The amino acids are sufficient for increasing amino acid and peptide availability for plant uptake and are used directly by plants for protein synthesis and other essential nitrogen compounds or metabolized (Page 31, L. Col).
Regarding instant claims 6 and 7, while Dyson is silent as to the amino acid concentrations within the protein derived component, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the amino acid concentrations of Dyson by using the concentrations taught by Colla, which overlap the instantly claimed ranges, as a starting point for routine optimization. One of ordinary skill in the art would have been motivated to manipulate the amino acid concentrations in order to mimic the effects of traditional animal and plant sourced protein hydrolysates, as desired by Dyson. Specifically, Colla teaches that these amino acid concentrations are sufficient for increasing amino acid and peptide availability for plant uptake and are used directly by plants for protein synthesis and other essential nitrogen compounds or metabolized, which Dyson teaches as the same purpose of the protein hydrolysate in its biostimulants. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
It is generally noted that differences in concentrations do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Given that applicant did not point out the criticality of each amino acid concentration within the claimed biostimulant composition, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of ranges is the optimum concentration. NOTE: MPEP 2144.05.
One of ordinary skill in the art would reasonably expect success in modifying the biostimulant composition of Dyson with the teachings of Colla as proposed because Dyson teaches microorganism derived protein hydrolysates as an advantageous alternative to animal and plant derived protein hydrolysates and specifically teaches approaches for optimizing microbial cell protein production and specific amino acid distributions.
Claims 1-2, 4, 8, 11, 14, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Dyson (US20190390158A1; 12/26/2019; IDS of 12/21/2022), as applied to claims 1-2, 4, 8, 11, 14, 17, and 19 above, and further in view of Kinsey (Oct. 2013; PTO-892 of 07/10/2025) and as evidenced by Biomolecules 101 (10/11/2018; PTO-892 of 07/10/2025).
Dyson as evidenced by Biomolecules 101 discloses the hydrolysate based biostimulant composition recited in instant claims 1-2, 4, 8, 11, 14, 17, and 19 as discussed in detail above and further incorporated herein.
As discussed above, Dyson teaches that in certain embodiments, the biostimulant is obtained by mixing in additional components (Paragraph 0424). In some embodiments, the additional component is a fertilizer and/or plant macro-nutrient comprising at least one element selected from iron, boron, calcium, and magnesium, among others (Paragraph 0424), which read on four of the five micronutrients recited in instant claim 18.
However, Dyson does not expressly teach that the biostimulant composition comprises calcium, magnesium, boron, iron, and sodium in the amounts recited in instant claim 18.
Kinsey teaches that high-quality, high-yielding crops begin with the soil, and sufficient fertilizer is extremely important (Page 1, Paragraph 2). The physical structure and pH of soil is influenced by four key elements: calcium, magnesium, potassium, and sodium (Page 4, Paragraph 1). Boron is a trace mineral which is necessary for nitrogen utilization in the plant throughout the growing season (Page 7, Paragraph 5; Page 8, Paragraph 3). Iron is another trace mineral that should be readily available in the subsoil (Page 8, Paragraph 4).
Regarding instant claim 18, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biostimulant composition of Dyson by further including a fertilizer comprising sufficient levels of calcium, magnesium, sodium, boron, and iron, as taught by Kinsey. One of ordinary skill in the art would have been motivated to include a fertilizer comprising these micronutrients because Kinsey teaches that soil requires them in order to produce high-quality, high-yielding crops wherein each element uniquely supports the crop’s structure and health. While the combination of Dyson and Kinsey is silent as to the exact concentrations of these micronutrients, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amounts such that the key nutrients calcium, magnesium, and sodium are present in higher amounts relative to the trace elements boron and iron, according to the specific needs of the soil to which the biostimulant is applied. One of ordinary skill in the art would have been motivated to manipulate the amounts of micronutrients according to known methods in order to improve the ability of the biostimulant to enhance crop quality parameters and nutrient efficiency, increase growth rates, photosynthetic rate, crop yield, growth of plant roots and leaves, and improve cultivated soils, as desired by Dyson (Dyson, Paragraph 0016).
It is generally noted that differences in concentrations do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Given that applicant did not point out the criticality of each micronutrient concentration within the claimed biostimulant composition, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of ranges is the optimum concentration. NOTE: MPEP 2144.05.
One of ordinary skill in the art would reasonably expect success in modifying the biostimulant composition of Dyson with the teachings of Kinsey as proposed because Dyson teaches that its biostimulant compositions may further comprise a fertilizer and/or plant macro-nutrient comprising at least one element selected from iron, boron, calcium, and magnesium.
Response to Arguments
Applicant’s arguments submitted on 10/09/2025 with respect to rejections under 35 U.S.C. 103 have been fully considered but were not found to be persuasive.
Applicant again argues that Dyson neither discloses nor suggests a hydrolysate based biostimulant composition comprising a protein derived component in an amount of about 30% or less. Specifically, Applicant argues that Dyson suggests a protein content of more than 90% by weight for hydrolysate biostimulant compositions and, therefore, the “high protein” amounts taught by Dyson teach away from the claimed amount. This argument was not found to be persuasive. Applicant’s claims are directed toward a hydrolysate based biostimulant composition comprising the claimed amount of protein-derived component—wherein the open claim language “comprising” allows for the inclusion of ingredients other than the hydrolysate—rather than a hydrolysate alone comprising the claimed amount of protein-derived component. Dyson teaches hydrolysate based biostimulant formulations comprising 0.5 wt.% to 15 wt.% total nitrogen, wherein at least some of the nitrogen content is attributed to proteins in the hydrolysate. Therefore, even when utilizing “high protein” hydrolysates, the biostimulant composition of Dyson, which comprises 0.5 wt.% to 15 wt.% total nitrogen, would only comprise 0.45 wt.% to 13.5 wt.% protein nitrogen, which lies within and thus renders obvious the instantly claimed range and overlaps Applicant’s elected species of 4 wt.% protein-derived component.
Regarding Applicant’s argument of unexpected results, this argument was not found to be persuasive. As discussed at length above, Applicant’s assertion that Dyson discloses higher protein amounts than claimed is incorrect. The Examiner reiterates that, as discussed under “Declaration under 37 CFR 1.132”, to the extent the allegedly unexpected results pertain to Applicant’s elected species of 4 wt.% protein-derived component, the Declaration and examples of the instant specification are insufficient to rebut the case of prima facie obviousness. Applicant fails to provide sufficient evidence to establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992).
Applicant further argues that rejections over the dependent claims should be withdrawn because the other cited references do not remedy the deficiencies of Dyson. This argument was not found to be persuasive for the same reasons as applied to Applicant’s arguments pertaining to Dyson discussed in detail above.
In view of the foregoing, the prior art rejections of record 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.
The Examiner notes that the following nonstatutory double patenting rejections, wherein the instant claims are now rejected over newly-patented claims 1 and 19 of US 12,364,267 B2, are equivalent to the previous provisional rejections over claims 36 and 55, respectively, of copending Application No. 17/928,096. The Examiner maintains the same reasoning used in the previous provisional nonstatutory double patenting rejection.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19 of US 12,364,267 B2 (equivalent to previous provisional rejection over claims 36 and 55, respectively, of copending Application No. 17/928,096). Although the claims at issue are not identical, they are not patentably distinct from each other.
US ‘267 claim 1 recites a biostimulant composition comprising a microbial consortium of whole cells, wherein the consortium comprises at least 50% whole cells of gammaproteobacterial methanotroph. US ‘267 claim 19 recites a biostimulant product comprising: the biostimulant composition of claim 1 and the same hydrolysate based biostimulant composition as recited in instant claim 1.
Claims 1-2, 4, 8-11, 14, 17, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19 of US 12,364,267 B2 (equivalent to previous provisional rejection over claims 36 and 55, respectively, of copending Application No. 17/928,096), as applied to claim 1 above, and further in view of Dyson (US20190390158A1; 12/26/2019; IDS of 12/21/2022) and as evidenced by Biomolecules 101 (10/11/2018; PTO-892 of 07/10/2025).
US ‘267 claims recite the hydrolysate based biostimulant composition of instant claim 1 as discussed above and further incorporated herein.
However, US ‘267 claims do not recite the further limitations of instant claims 2, 4, 8-11, 14, 17, and 19.
The teachings of Dyson as evidenced by Biomolecules 101 are as set forth above and further incorporated herein.
Regarding instant claims 2, 4, 8, 11, 14, 17, and 19, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biostimulant product recited in US ‘267 claim 19 by using the plant biostimulant composition taught by Dyson as the hydrolysate based biostimulant composition. One of ordinary skill in the art would have been motivated to use the composition of Dyson because Dyson teaches hydrolysate based biostimulant is used directly by plants for protein synthesis and other essential nitrogen compounds or metabolized, thereby contributing to horticulture crop productivity and quality.
Regarding instant claims 9 and 10, while the combination of US ‘267 claims and Dyson is silent as to the exact concentrations of peptides and their respective molecular weights, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the concentrations of peptides within the protein-derived component of the biostimulant composition of US ‘267 claims and Dyson according to known methods in order to ensure that most of the peptides present have a molecular weight of 10 kDa or less. One of ordinary skill in the art would have been motivated to manipulate the peptide content because Dyson teaches that peptides of low molecular weight, e.g. under 10 kDa, are most readily absorbed by plants and/or soil organisms to aid in the formation of their own biomolecules.
It is generally noted that differences in concentrations do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Given that Applicant did not point out the criticality of each peptide or component concentration within the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of ranges is the optimum concentration. NOTE: MPEP 2144.05.
One of ordinary skill in the art would have ordinary skill in the art would reasonably expect success in modifying the hydrolysate based biostimulant composition recited in the claims of US ‘267 with the teachings of Dyson because Dyson teaches a specific hydrolysate based biostimulant composition that falls within the scope of that claimed in US ‘267, and all components and parameters are known in the art as suitable approaches for formulating biostimulant compositions.
Claims 1-2, 4, 6-11, 14, 17, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19 of US 12,364,267 B2 (equivalent to previous provisional rejection over claims 36 and 55, respectively, of copending Application No. 17/928,096) and Dyson (US20190390158A1; 12/26/2019; IDS of 12/21/2022), as applied to claims 1-2, 4, 8-11, 14, 17, and 19 above, and further in view of Colla (11/10/2015; PTO-892 of 07/10/2025) and as evidenced by Biomolecules 101 (10/11/2018; PTO-892 of 07/10/2025).
The combination of US ‘267 claims and Dyson as evidenced by Biomolecules 101 teach the hydrolysate based biostimulant composition of instant claims 1-2, 4, 8-11, 14, 17, and 19 as discussed in detail above and further incorporated herein.
However, the combination of US ‘267 claims and Dyson do not expressly teach the further limitations of instant claims 6 and 7.
The teachings of Colla are as set forth above and further incorporated herein.
Regarding instant claims 6 and 7, while the combination of US ‘267 claims and Dyson is silent as to the amino acid concentrations within the protein derived component of the hydrolysate based biostimulant composition, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the amino acid concentrations by using the concentrations taught by Colla, which overlap the instantly claimed ranges, as a starting point for routine optimization. One of ordinary skill in the art would have been motivated to manipulate the amino acid concentrations in order to mimic the effects of traditional animal and plant sourced protein hydrolysates, as desired by Dyson. Specifically, Colla teaches that these amino acid concentrations are sufficient for increasing amino acid and peptide availability for plant uptake and are used directly by plants for protein synthesis and other essential nitrogen compounds or metabolized, which Dyson teaches as the same purpose of the protein hydrolysate in its biostimulants. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
It is generally noted that differences in concentrations do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Given that applicant did not point out the criticality of each amino acid concentration within the claimed biostimulant composition, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of ranges is the optimum concentration. NOTE: MPEP 2144.05.
One of ordinary skill in the art would reasonably expect success in modifying the hydrolysate based biostimulant composition taught by the combination of US ‘267 claims and Dyson with the teachings of Colla as proposed because Dyson teaches microorganism derived protein hydrolysates as an advantageous alternative to animal and plant derived protein hydrolysates and specifically teaches approaches for optimizing microbial cell protein production and specific amino acid distributions.
Claims 1-2, 4, 8-11, 14, and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19 of US 12,364,267 B2 (equivalent to previous provisional rejection over claims 36 and 55, respectively, of copending Application No. 17/928,096) and Dyson (US20190390158A1; 12/26/2019; IDS of 12/21/2022), as applied to claims 1-2, 4, 8-11, 14, 17, and 19 above, and further in view of Kinsey (Oct. 2013; PTO-892 of 07/10/2025) and as evidenced by Biomolecules 101 (10/11/2018; PTO-892 of 07/10/2025).
The combination of US ‘267 claims and Dyson as evidenced by Biomolecules 101 teach the hydrolysate based biostimulant composition of instant claims 1-2, 4, 8-11, 14, 17, and 19 as discussed in detail above and further incorporated herein.
However, the combination of US ‘267 claims and Dyson do not expressly teach the further limitations of instant claim 18.
The teachings of Kinsey are as set forth above and further incorporated herein.
Regarding instant claim 18, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hydrolysate based biostimulant composition taught by the combination of US ‘267 claims and Dyson by further including a fertilizer comprising sufficient levels of calcium, magnesium, sodium, boron, and iron, as taught by Kinsey. One of ordinary skill in the art would have been motivated to include a fertilizer comprising these micronutrients because Kinsey teaches that soil requires them in order to produce high-quality, high-yielding crops wherein each element uniquely supports the crop’s structure and health. While the combination of US ‘267 claims, Dyson, and Kinsey is silent as to the exact concentrations of these micronutrients, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amounts such that the key nutrients calcium, magnesium, and sodium are present in higher amounts relative to the trace elements boron and iron, according to the specific needs of the soil to which the biostimulant is applied. One of ordinary skill in the art would have been motivated to manipulate the amounts of micronutrients according to known methods in order to improve the ability of the biostimulant to enhance crop quality parameters and nutrient efficiency, increase growth rates, photosynthetic rate, crop yield, growth of plant roots and leaves, and improve cultivated soils (Dyson, Paragraph 0016).
It is generally noted that differences in concentrations do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Given that applicant did not point out the criticality of each micronutrient concentration within the claimed biostimulant composition, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of ranges is the optimum concentration. NOTE: MPEP 2144.05.
One of ordinary skill in the art would reasonably expect success in modifying the hydrolysate based biostimulant composition taught by the combination of US ‘267 claims and Dyson with the teachings of Kinsey as proposed because Dyson teaches that its biostimulant compositions may further comprise a fertilizer and/or plant macro-nutrient comprising at least one element selected from iron, boron, calcium, and magnesium.
Response to Arguments
Applicant’s arguments submitted on 10/09/2025 with respect to rejections on the grounds of nonstatutory double patenting have been fully considered but were not found to be persuasive.
Applicant argues that the claims of App. ‘096 (now US ‘267) are directed to a microbial consortium comprising whole cells rather than a hydrolysate based biostimulant composition. This argument was not found to be persuasive because App. ‘096 claim 55 (now US ‘267 claim 19) recites a biostimulant product comprising the biostimulant composition of App. ‘096 claim 36 (now US ‘267 claim 1) and a hydrolysate based biostimulant composition comprising a protein-derived component in an amount of about 30% or less with respect to the weight of the composition, wherein the protein-derived component is obtained from a methanotrophic bacterium. As such, the “hydrolysate based biostimulant composition” component of the biostimulant product recited in App. ‘096 claim 55 (now US ‘267 claim 19) meets all limitations of the instantly claimed hydrolysate based biostimulant composition as recited in instant claim 1.
Therefore, the nonstatutory double patenting rejections of record are maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
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/SARAH C WISTNER/ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616