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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-10 in the reply filed on 12/4/25 is acknowledged. The traversal is on the ground(s) that there is no undue burden to examine all claims. This is not found persuasive because there are 3 groups of inventions drawn to distinct inventions with different classifications and keywords needed to examine the inventions. See the restriction requirement for details.
The requirement is still deemed proper and is therefore made FINAL.
Claim 11-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/4/25.
Priority
Application claims priority to 63/419,803 provisional application with an effective filing date of 10/27/22. Claims of the instant application are supported by the provisional application and thus have a priority date of 10/27/22.
Drawings
The drawings are objected to because the figures are not properly labeled.
37 CFR 1.84 (u)(1) states “The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear.”
In the instant case, the view numbers for Figures are preceded by the word "Figure" instead of the abbreviation "FIG.".
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 3 is rejected under 35 U.S.C. 112(a) as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ novel biological materials, Trichoderma hazianum PTA-125914. Since the biological materials are essential to the claimed invention they must be obtainable by a reproducible method set forth in the specification or otherwise readily available to the public. No detail are given in the specification as how to create the claimed strain. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
From the specification it is not apparent if the biological materials are readily available to the public. It is noted that Applicant has deposited Trichoderma hazianum PTA-125914 but there is no indication in the specification as to public availability. If the deposit is made under the Budapest Treaty, then an affidavit or declaration by applicant or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature and registration number, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant’s attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that “the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination.” The specification should be amended to include this information, however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
Claims 1-2 and 4-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
To show possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus (MPEP 2163). The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species sufficient to show the applicant was in possession of the claimed genus (Id.). A “representative number of species” means that the species which are adequately described are representative of the entire genus (Id.). The specification describes water-based extracts of Trichoderma harzianum with the deposit ATCC PTA-125914. Claim 1 is not limited to the specific deposited strain. As evidenced by Cai, there are currently 468 species of Trichoderma (“The Numerical State of Trichoderma Taxonomy and Species Identification” section), and the claims thus encompass a large and varied genus of microorganisms. The specification further fails to disclose any common mechanism or structure-function relationship that would allow one skilled in the art to identify Trichoderma strains having properties that yield extracts suitable for foliar application and having the specific properties recited in claims 4-10. As such, the specification fails to describe a representative number of species that would evidence possession of the full scope of any extract from any culture media of any Trichoderma species for foliar application.
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 1-6 and 9-10 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 an extract obtained from the culture media of Trichoderma. This judicial exception is not integrated into a practical application because there are no elements beyond the culture media produced by the microbe. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the cultivation and separation of microbes from media is routine and conventional in the arts.
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any
statutory category. MPEP 2106.03. The claim recites an extract from Trichoderma. Thus, the claim is to a product, which is one of the statutory categories of invention. As defined by instant specification [0053], the extract can simply be the culture media separated from the microbes. (Step 1: YES).
Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim
recites a judicial exception. As explained in MPEP 2106.04(II) and the October 2019
Update, a claim “recites” a judicial exception when the judicial exception is “set forth” or
“described” in the claim. In addition, the limitation of a formulation for foliar application does not provide any details on how to do this and therefore does not structurally limit the claims beyond the product of nature. Per the definition provide in the specification [0053], the extract can be a cell free supernatant. This could likewise be accomplished naturally upon the natural death of the cells yielding a cell free liquid. Further, the claimed components found in claims 4-10 are naturally a product of the cultivation of the microbe as shown in instant example 5 where the components were simply identified as being present and were not added exogenously. Accordingly, the claims recites a judicial exception (natural product). Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong
Two.
Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a
whole integrates the recited judicial exception into a practical application of the
exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating
those additional elements individually and in combination to determine whether the
claim as a whole integrates the exception into a practical application. 2019 PEG Section
III(A)(2), 84 Fed. Reg. at 54-55. The claimed product does not require any additional
elements that render the claimed product markedly different from the natural
counterpart. The limitation of a formulation for foliar application does not provide any details on how to do this and therefore does not structurally limit the claims beyond the product of nature. Accordingly, the limitations laid out in claim 1 do not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception. See MPEP 2106.05(h), discussing the administration step in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 78
(2012) (Step 2A: YES).
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole
amounts to significantly more than the recited exception, i.e., whether any additional
element, or combination of additional elements, adds an inventive concept to the claim.
MPEP 2106.05. As discussed with Step 2A prong 2, the addition of the intended formulation in claim 1 of the product is at best the equivalent of merely adding the words “apply it” as the
claimed process does not require any additional elements that are sufficient to amount to
significantly more than the judicial exception. Mere instructions to apply an exception cannot
provide an inventive concept (Step 2B: NO).
Claims 1-6 and 9-10 are not eligible.
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.
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 1-4 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Vargas (US20200048157A1). While Vargas shares common inventors and assignees as instant application it was published more than 1 year before the filing date of instant invention and therefore is valid prior art under 35 U.S.C. 102(a)(1). Claims 9 and 10 are further evidenced by Zhang ("Putative Trichoderma harzianum mutant promotes cucumber growth by enhanced production of indole acetic acid and plant colonization." Plant and soil 368.1 (2013): 433-444).
Regarding claim 1, Vargas teaches a bio-inoculant for plants (abstract). Vargas teaches that the formulation can comprise a water based extract comprising culture medium ([0023]). Vargas teaches that the inoculant comprises Trichoderma (claim 1). Vargas teaches that the Trichoderma can be in a conidial suspension (claim 4). Vargas teaches that conidial suspensions can degrade rendering the agent ineffective ([0011]). Vargas teaches that the antimicrobial compounds are soluble ([0013]).
While Vargas does not explicitly teach a water based extract of Trachoderma, It is obvious to one of ordinary skill in the arts to experiment within the inventive confines to use a water based extract of Trachoderma as a bio-inoculant. Further, Vargas teaches that conidial suspensions can degrade lending further motivation for one of ordinary skill to arrive at a water based extract. All of the claimed components were known in the arts at the time of filing of instant invention and would be yield nothing more than predictable results with a reasonable expectation of success to one of ordinary skill in the arts.
Regarding claims 2-3, Vargas teaches that Trichoderma harzianum deposited at the ATCC under Accession Number PTA-125914 can be used (claim 3).
Regarding claim 4, Vargas does not explicitly teach the claimed protein. Instant specification example 5 indicated that the protein and their quantities were simply measured from the conditioned media of the culture. “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.” See MPEP 2112.
Regarding claims 9-10, Vargas does not explicitly teach the claimed compounds. Instant specification example 5 indicated that the compounds and their quantities were simply measured from the conditioned media of the culture. “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.” See MPEP 2112.
Zhang teaches many Trichoderma species are known for their ability to promote plant growth (abstract). Zhang teaches that Trichoderma naturally produce indole acetic acid, zeatin, and gibberellin (p434 left column first full paragraph). Therefore, one of ordinary skill in the arts understand these compounds would be present in the claimed concentrations in the culture media.
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Vargas (US20200048157A1), as applied to claims 1-4 and 9-10 above, and further in view of Lopez (US20120084886A1).
Regarding claim 5 and 7, Vargas teaches that the formulation can comprise a water based extract comprising culture medium ([0023]).
Vargas does not explicitly teach the claimed amino acids. Instant specification example 5 indicated that the amino acids and their quantities were simply measured from the conditioned media of the culture. “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.” See MPEP 2112.
Lopez teaches compositions for agriculture use (abstract). Lopez teaches the compositions can comprise amino acids (abstract). Lopex teaches the composition comprises T. harzianum (table 1). Lopez teaches that the composition comprising amino acids has a series of benefits including (1) provides nutrients and elements in the soil that increase crop yields by 25-55%, (2) reduces green house gas emissions, (3) increases the efficiency of mineral fertilizers (3) reduces the use of conventional fungicides and other pesticides, (4) increases the production of plant growth regulators, (5) improves soil structure, tilth, and water penetration and retention, (6) cleans up chemical residues and (7) shifts soil pH toward neutral pH ([0041]). Lopez teaches the amino acids provided can comprise tryptophan, histidine, threonine, tyrosine, valine, methionine, isoleucine, leucine, phenylalanine, lysine, aspartic acid, cysteine, glutamic acid, glutamine, serine, glycine, alanine, proline, asparagine and arginine ([0045]). Lopez teaches the composition comprises protein hydrolysates (hydrolysis conditions) ([0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to ensure amino acids are contained in the composition of Vargas as taught by Lopez. One of ordinary skill in the art would be motivated to do so because Lopez teaches that a wide range of benefits come with the inclusion of amino acids. Further, one of ordinary skill in the art would be motivated to do so because these amino acids have been successfully used in compositions for agriculture, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. There would be a reasonable expectation of success as both Vargas and Lopez are in the same field of endeavor of agriculture compositions.
Regarding claim 6 and 8, Instant specification example 5 indicated that the amino acids and their quantities were simply measured from the conditioned media of the culture. “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.” See MPEP 2112.
Lopez teaches the concentrations of several of the claimed amino acids in table 2 in a dry composition. Lopez teaches the amino acid composition can be formulated as a spray ([0080]). One of ordinary skill in the arts understands that adding a liquid to a powder would necessarily dilute the concentration of the claimed components and that the amount of water to be used could be varied. Therefore, the concentration of the amino acids is a result effective variable and the claimed concentrations could be arrived at through routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05).
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 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 11,505,510 B2 (hereafter 510). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claim 1 requires an extract from Trichoderma as a foliar application. 510 claim 1 requires the application of Trichoderma as a biological inoculant. One of ordinary skill in the arts understands that as the biological inoculant grows it will release components (extracts).
Instant claims 2-3 require a Trichoderma harzianum, 510 claim 3 requires the Trichoderma harzianum PTA-125914.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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/TREVOR KANE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657