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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application on 06/08/2022.
Response to Amendment
Applicant's amendment and argument filed 03/01/2026, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 10, 13-14, 16, 19, 23, 26-27, 29, 33, 35-36, 47, 49, 51-52, 54, 56 and 61-62 are pending of which claims 23, 26-27, 29, 33, 35-36, 47, 49, 51-52, 54, 56 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/22/2022.
Claims 10, 13-14, 16, 19 and 61-62 are being examined on the merits.
Claim Rejections - 35 USC § 112
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 10, 13, 14, 19, 61 and 62-62 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 preventing and treating Macrophomina, Rhizoctonia, Pythium and Sclerotinia when in the specific ranges of claim 16, does not reasonably provide enablement for any amount of the claimed VOCs for the prevention and treatment of all plant diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The Applicant's attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention: Claim 1 recites a composition being formulated for preventing or treating a disease of a plant. The claims are to a composition and not a method of treating diseases. Broadly claiming a composition formulated to treat a disease requires more than the figuring out which of the required VOC’s being claimed and those particular amounts can treat any disease which is not limited.
The state of the prior art: The prevention and treatment of plant diseases, generally speaking is vast and there are thousands of diseases affecting plants, not merely the four fungal species which were tested (see figures 4A-4E). For instance, plants can be infected by numerous different species and genera of fungi, bacteria, mold, yeasts, algae, nematodes, parasites, etc. Plants are affected by various diseases caused by temperature fluctuations and abundance of water intake or droughts, genetic diseases and radiation. The art is not limited to merely the four fungal pathogens which have been tested.
The relative skill of those in the art: The relative skill of those in the art is high.
The predictability or unpredictability of the art: It cannot be predicted which VOC components being claimed can be preventative or used as a form of treatment for the many different species of pathogens and for the many different species of plants existing.
The breadth of the claims. The scope of the claims is broad in the sense that there are no administration routes and dosage amount that tie the activity being claimed to the composition as there are in instant claim 16. The claims should recite particular diseases or species which the applicant is intending for the composition to treat and prevent. The claimed activity is also effective when the composition ingredients are within particular working ranges as can be noted from the applicant’s own figures (see Fig 4A-4E).
The amount of direction or guidance presented, the presence or absence of working examples and quantity of experimentation necessary: The specification describes the treating of plants with specific amounts (in ppm) of particular VOCs and only for the treatment of four different fungal species (Macrophomina, Rhizoctonia, Pythium and Sclerotinia). There is no other guidance on treating any other diseases and so persons having ordinary skill in the art would have much experimentation to determine dosing ranges and particular species of organisms, such as other fungal, bacterial, algal, parasitic, viruses, and nematodes, etc., which can be killed or inhibited from affecting the plant.
Therefore, in view of the Wands factors, as discussed above, applicants fail to provide information sufficient to practice the claimed invention for preventing and treating any disease of a plant.
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 10, 13-14, 16, 19 and 61-62 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite specific volatile organic compounds (VOCs). The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since the claims are directed to a composition comprising VOCs, the claims are directed to a composition of matter. Because the claims recite the VOC’s: Butanoic acid, 2-methyl, 5-Methyl-2-hexanone, 2,3-Hexanedione, 1-Hexanol, 2-ethyl and Methyl-2-heptanone, the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within living organisms such as the bacterial species Bacillus halotolerans, as can be appreciated from the applicant’s own claims and specifications (see background 0003-0004 and summary 0006, 00011). The closest naturally occurring counterparts of those volatile compounds are indeed the same ones that come from the bacteria. The extracted volatile compounds are chemically and structurally identical to those found in the bacterial species as found in nature and therefore the applicant is merely claiming those judicial exceptions. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found within the bacteria they come from. The components which would give the activities of the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements 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. This judicial exception is not integrated into a practical application because the applicant is only claiming these judicial exceptions in specific amounts or claiming them with an antifungal agent, antibacterial agent, nematicidal agent, a fertilizer. When so broadly claimed these can be natural judicial exceptions such as the VOC’s being claimed and would require the same analysis as just discussed which would not remove the claimed composition from the judicial exceptions and would not integrate them in any practical application. Doing so would be implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature and the addition of an intended use does not impart any added benefit to the compounds or integrate the composition into a practical application.
Step 2 B 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 (see MPEP § 2106.05(b)). In the instant case the applicant merely claims the VOCs without any additional element that can be taken into consideration.
Please also note, the mere modifying the concentration and proportions of the product/composition is not sufficient to remove the claimed composition from a judicial exception.
Response to Arguments
Applicant's arguments filed 03/01/2026 have been fully considered but they are not persuasive. The applicant argues that since they have amended the claims to recite “synthetic” versions of the judicial exceptions that this limitation would help overcome the rejection. Unfortunately, this is not the case because the judicial exceptions are compared to their natural counterparts and as currently claimed they are indeed identical to those found in nature, even if made synthetically. The applicant argues that the recited claims are directed to engineered compositions and exclude naturally occurring counterparts. This statement is false as the claims currently do not exclude natural compounds. Nothing in the claim language requires an absence of naturally occurring components. Additionally, the judicial exceptions, even if made synthetically would be identical to those found in nature and thus cannot be claimed as currently recited. The claims stand rejected.
Conclusion
Currently no claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 JACOB ANDREW BOECKELMAN whose telephone number is 571-272-0043. The examiner can normally be reached Mon-Friday 8am-4pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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