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 of Group I, claims 1-8; and the species of a) volatile HDAC inhibitor: (R)-gamma-undecalactone; and b) method – killing a plant, in the reply filed on 6/4/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 4-7, 9-16, 19, 22 and 25-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/4/2026. While Applicant stated that claims 5-7 read on the elected species, this is not persuasive as these claims are directed to non-elected method 1 and 2 of instant claim 1, not on the elected method 3.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/325,468, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The disclosure of US’468 fails to provide support for the claimed methods of killing plant as such all the examined claims have an effective filing date of 3/30/2023.
Specification
The disclosure is objected to because of the following informalities: The specification references Figures 1A, 1B, 4A, 4B, 4C, 4D and 3C (for example in [0153, 0155 0157, 0158] of the published application) , however the filed drawing to not include these figures. Applicant should double check that all the described Figures referenced throughout the specification are provided.
Appropriate correction is required.
Claim Objections
Claims 1-2 are objected to because of the following informalities:
Claim 1 recites multiple instances of “methyl antharanilate schiff’s base.” Applicant should make sure compounds aren’t repeated.
Claim 2iii recites “plant in need or an altered…” it should read “plant in need of an altered…”
Appropriate correction is required.
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.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. The claim recites at least one step or act, including identifying a plant or examining a plant . Thus, the claim is to a process, which is one of the statutory categories of invention (Step 1: YES).
Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. Limitation (i), (ii), (iii), (iv) and (v) in claim recite steps of identifying and examining a plant. These limitations set forth a judicial exception because the steps can be performed by a human using mental steps of basic critical thinking, which are types of activities that have been found by the court to represent abstract ideas. Thus, the claims are directed to at least one exception (Step 2A: Yes), which may be termed an abstract idea.
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. Besides the abstract idea, the claim recites the additional steps of administering an HDAC inhibitor to a plant to alter development of its tissue or to alter its response to abiotic stress. The identification step and examination step are performed with a high level of generality and are purely routine and conventional in the art. As evidenced by the rejection presented below over Bedoukian it is well-understood, routine and conventional activity for those in the field to administer gamma-undecalactone (i.e. elected HDAC inhibitor) to plants to perform the claimed method 1 and 2. As such the additional elements in the claim do not do not amount to significantly more as they are well-understood, routine and conventional activities that do not impose meaningful limits on the law of nature. Thus, the claim as a whole does not amount to significantly more than the exception itself (Step 2B: No)
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 and 8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for A) methods of altering the development of plant tissue in a plant and altering response to abiotic stress or infection in a plant by contacting a plant with a) 0.1 v/v%, 0.3 v/v% or 1v/v% of 2,3-butanedione, ethyl pyruvate, alpha-angelic lactone or 3,4-hexanedione; b) 1 v/v% of diacetyl; c) 1 v/v% propyl formate and d) (R)-gamma-undecalactone; and B) enabling for method of a) killing A.thaliana plants with 1v/v% propyl formate, does not reasonably provide enablement for the entire scope of killing plants, nor for the entire claimed scope of methods of altering the development of plant tissue in a plant and altering response to abiotic stress or infection in a plant. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
To be enabling, the specification of the patent application must teach those skilled in the
art how to make and use the full scope of the claimed invention without undue experimentation.
in re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue
experimentation," the Federal Circuit has stated that: The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the nature of the invention,
2- the breadth of the claims,
3- the state of the prior art,
4- the predictability of the art,
5- the amount of direction or guidance provided
6- the presence or absence of working examples,
7- the quantity of experimentation necessary, and
8- the relative skill of those in the art.
These factors are always applied against the background understanding that scope
of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57
CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Undue experimentation is
required by one skilled in the art to determine enablement of the instant disclosure as claimed
due to the following:
The nature of the invention (1) and the breadth of the claims (2)
The nature of the invention and breadth of claim 1 is methods of altering the development of plant tissue in a plant and altering response to abiotic stress or infection in a plant; and a method of skilling plants, by administration of effective amounts of HDAC inhibitors.
The specification defines “effective amounts” as:
“amount of a compound of the that (i) treats or prevents the particular disease,
condition, or disorder, (ii) attenuates, ameliorates, or eliminates one or more symptoms of the
particular disease, condition, or disorder, or (iii) prevents or delays the onset of one or more
symptoms of the particular disease, condition, or disorder described herein.” See page 23, lines 14-19).
The state (3) and predictability (4) of the art
Bose discusses the mechanism of action of HDAC inhibitors (HDACI) and teaches that some well-recognized mechanisms of HDACI lethality include, in addition to relaxation of DNA and de-repression of gene transcription, interference with chaperone protein function, free radical generation, induction of DNA damage, up-regulation of endogenous inhibitors of cell cycle progression, e.g., p21, and promotion of apoptosis (Abs). HDACIs interfere with multiple DNA repair processes, as well as disrupt cell cycle checkpoints, critical to the maintenance of genomic integrity in the face of diverse genotoxic insults. The clinical use of HDACIs remains restricted to certain subsets of T-cell lymphoma (Abs). While some data suggests a role for HDACIs in other malignancies (e.g., acute myeloid leukemia (AML), myelodysplastic
syndromes (MDS) and multiple myeloma (MM), there is a general sense that HDACIs have not fully realized their potential as antineoplastic agents. One of the major barriers to this goal is continuing uncertainty about the mechanism of action by which these agents in fact trigger transformed cell death. Complicating efforts to resolve this issue have been the emerging realization that HDACIs are truly pleiotropic agents which act through a wide variety of disparate and mutually interactive mechanisms (pg. 2).
Bedoukian discuss method for killing agricultural pests and teaches application of formulations comprising gamma-undecalatone (also known as RS-gamma-undecalactone as evidenced by SciFinder and reading on elected species as (R)-gamma-undecalactone) [0056-0057]. These formulations are also effective at providing benefits to plants including helping the plant grow a better root system, helping the plant withstand stressful growing conditions, improving the health of the plant, improving tolerance to abiotic and/or biotic stress on the plant [0108].
The prior art provides enablement for method 1 and 2 of claim 1 using (R)-gamma-undecalactone. The prior art provides evidence that HDAC inhibitors have a wide variety of disparate and mutually interactive mechanisms which would require undue experimentation to determine the effective amounts necessary for all the claimed HDAC inhibitors to be capable of performing the claimed methods. This is supported by Bedoukian who teaches gamma-undecalactone to be effective at helping plants (i.e. not killing them) and the specification provides no guidance as to the what amounts would be effective to kill plants.
The amount of direction or guidance provided (5) and the presence or absence of working
examples (6)
The specification provides the following embodiments:
Testing using 2,3-butanedione, ethyl pyruvate, alpha-angelic lactone or 3,4-hexanedione which showed significant phenotypic changes on large leaf growth and lateral root growth [0033].
Data showing 1 v/v% diacetyl was both effective increasing lateral growth [0149], 0.1% solutions delaying flowering [0157], diacetyl was also effective at offering some degree of protection to plants [0158], killing plants [0161].
Data showing 1v/v% of propyl formate to be effective at killing A.thaliana plants [0161]
The specification provides enablement for A) methods of altering the development of plant tissue in a plant and altering response to abiotic stress or infection in a plant by contacting a plant with a) 0.1 v/v%, 0.3 v/v% or 1v/v% of 2,3-butanedione, ethyl pyruvate, alpha-angelic lactone or 3,4-hexanedione; b) 1 v/v% of diacetyl; c) 1 v/v% propyl formate and d) (R)-gamma-undecalactone; and B) enabling for method of killing A.thaliana plants with 1v/v% propyl formate
The specification does not explain or teach how to perform the claimed method using effective amounts of the vast HDAC inhibitors claimed. The specification itself shows unpredictability in performing the claimed methods as it teaches the same HDAC inhibitor, diacetyl to be both effective at increasing the growth of plants and killing pants when used in the same amounts.
Therefore, the full scope of treatment as claimed is not enabled.
The quantity of experimentation necessary (7) and the relative skill of those in the art (8)
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. Because of the
unknown predictability in the art (as discussed above) and the unpredictability in the specification and in the absence of experimental evidence commensurate in scope with the claims, the Examiner determined that the instant invention is not enabled as described above. It would certainly require undue
experimentation to discover the enabled embodiments encompassed by claims 1-3 and 8
Brenner v. Manson states "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and 'patent protection' is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable" (Brenner v. Manson 383 U.S. 519, 536, 148 USPQ 689, 696 (1966), cited in Genentech Inc. vs. Nova Nordisk 42 USPQ 2d 1001, Fed. Circuit 1997).
To practice the full scope of the instant claims would be undue because one of skill in the art must perform excessive experimentation to identify the effective amounts needed to perform the claimed methods for each individual HDAC inhibitor claimed. All this is undue experimentation given the limited guidance and direction provided by Applicants.
Conclusion
Accordingly, the invention of claims 1-3 and 8 does not comply with the enablement requirement
of 35 U.S.C 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "the compound" or “said compound” in sections ii, iii, iv and v. There is insufficient antecedent basis for this limitation in the claim as claim 1 only references a volatile HDAC inhibitor but does not discuss “a compound.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bedoukian (US 2019/0075793), as evidenced by SciFinder.
Bedoukian discloses formulations for killing agricultural pests (Abs) using gamma undecalactone in effective amounts (Bedoukian – claims 1, 7 and 13). As evidenced by SciFinder, gamma undecalactone, is also known as (RS-gamma-undecalactone) which reads on R-gamma-undecalactone as elected.
Bedoukian teaches the formulations can be applied where plants are growing and where there are low levels (or no levels) of pests. Applying such formulations benefits the plants being grown in such locus. Benefits include helping the plants grow a better root system, helping the plant withstand stressful growing conditions, increasing growth and/or greener leaves, improving tolerance to abiotic and/or biotic stress of the plants, etc. [0108], this reads on “altering the development of plant tissue in a plant” and “altering response to abiotic stress in a plant.”
As such it would have been prima facie obvious to administer the formulations of Bedoukian including those with gamma-undecalactone to plants, in amounts effective amounts to achieve one of the benefits discussed by Bedoukian.
Regarding claim 2: As Bedoukian teaches the composition to provide specific benefits to plants, such improving tolerance to abiotic and/or biotic stress of the plants, in order to determine which plants are to be treated a skilled artisan would necessarily need to first identify which plants need increased tolerance to abiotic and/or biotic stress of the plants prior to administration, thus it would have been prima facie obvious to first have an identification step, prior to a step of administration.
Regarding claim 3: As discussed above, the prior art makes obvious the use of the elected species R-gamma-undecalactone, it is well established that a compound and its properties are inseparable and Applicant has stated that the species reads on claim 3, as such the limitations of the claim have been met.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613
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