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 .
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 1, 11-13, and 16 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.
The claims broadly embrace a composition and method for controlling various insects, nematode, etc. and phytopathogenic fungal and some phytopathogenic bacterial pests. Applicant’s specification demonstrates that they have achieved synergy in controlling specific insect and phytopathogenic fungal pests which are exemplified in applicant’s specification.
The specification is silent however on the claimed mixture having all possible synergies as is instantly claimed in all ratios as is instantly claimed.
The specification fails to disclose any additional types of synergy (e.g. synergistic growth or yield or control of nematodes or control of phytopathogenic bacteria) or synergistic amounts/ratios beyond those specifically exemplified in applicants specification, specifically wherein the mixtures are synergistic for controlling phytopathogenic fungi and insects. Thus, it is clear that Applicants' description of structure and activity regarding the claimed broad synergy which encompasses all known and unknown types of synergy (e.g. yields, growth, control of any and all pests including mammalian pests, rodent pests, avian pests, insect pests, nematode pests, any and all microorganisms, etc. which is much broader in scope than what is supported by applicant’s specification).
As the specification fails to describe any and all types of synergy other than the exemplified phytopathogenic fungi and insects exemplified in the specification, these examples and 4 genus disclosed in the specification do not constitute a substantial portion of the claimed entire scope of synergy that is now claimed.
Applicant's attention is also directed to In re Shokal, 113 USPQ 283 (CCPA 1957), wherein it is stated:
It appears to be well settled that a single species can rarely, if ever, afford sufficient support for a generic claim. In re Soll, 25 CCPA (Patents) 1309, 97 F2d 623, 38 USPQ 189; In re Wahlforss, 28 CCPA (Patents) 867, 117 F2d 270, 48 USPQ 397. The decisions do not however fix any definite number of species which will establish completion of a generic invention and it seems evident therefrom that such number will vary, depending on the circumstances of particular cases. Thus, in the case of small genus such as the halogens, consisting of four species, a reduction to practice of three, perhaps even two, might serve to complete the generic invention, while in the case of a genus comprising hundreds of species, a considerably larger number of reductions to practice would probably be necessary.
As stated in MPEP 2163 II: If the application as filed does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. The instant specification is devoid of a description for the obtaining any and all types of synergy with and all amounts/concentrations of the claimed mixture. The specification merely examples of synergy in controlling phytopathogenic fungi and insects. Thus, Applicants have failed to demonstrate possession of any and all types of synergy with the claimed mixtures in any and all amounts. Disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing “a result that one might achieve if one made that invention”); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”).
The disclosed examples of synergy towards controlling various phytopathogenic insect and fungal pests, do not constitute an adequate description to demonstrate possession of the numerous known and unknown types of synergy towards any and all phytopathogenic organisms or to improved yield, growth, etc., as now claimed. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail such that the Artisan can reasonably conclude that the inventor(s) had possession of the claimed invention. Such possession may be demonstrated by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and/or formulae that fully set forth the claimed invention. Possession may be shown by an actual reduction to practice, showing that the invention was “ready for patenting”, or by describing distinguishing identifying characteristics sufficient to show that Applicant was in possession of the claimed invention (January 5, 2001 Fed. Reg., Vol. 66, No. 4, pp. 1099-11).
Overall, what these statements indicate is that the Applicant must provide adequate description of such core structure and function related to that core structure such that the Artisan of skill could determine the desired effect. Hence, the analysis above demonstrates that Applicants have not described any and all types of synergy as now claimed beyond the synergistic control of various phytopathogenic insects and fungi that are demonstrated in the specification. As such, the Artisan of skill could not predict that Applicant possessed any additional types of synergy (e.g. towards growth and yield, etc. of crop plant or towards other phytopathogenic organisms including the entire scope of pests which would include avian, rodent and mammalian pests).
Therefore, the breadth of the claims as reading on any and all types of synergy in any and all amounts/ratios including those yet to be discovered; in view of the level of knowledge or skill in the art at the time of the invention, and the limited information provided in the specification, an Artisan of skill would not recognize from the disclosure that Applicant was in possession of obtaining any and all types of synergy with their claimed mixture, at the time the application was filed. Thus, it is concluded that the written description requirement is not satisfied.
Claims 1, 11-13, and 16 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 synergistically controlling various phytopathogenic insects and fungi by applying the claimed combinations of active agents in specific ratios as exemplified in the specification, the specification and claims as filed do not reasonably provide enablement for a the entire claim scope of combinations of active agents being synergistic in any and all ratios and amounts in all pests as is asserted by applicant’s newly claimed, claim scope. 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/or use the invention commensurate in scope with these claims.
This rejection is based on the absence of an enabling disclosure for each and every claimed combination being synergistic in any and all amounts as claimed and against any and all pests. In determining whether Applicant’s claims are enabled, it must be found that one of skill in the art at the time of invention by Applicant would not have had to perform “undue experimentation” to make and/or use the invention claimed. Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404:
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
MPEP § 2164.04 states: “[W]hile the analysis and conclusion of a lack of enablement are based on the factors discussed in MPEP § 2164.01(a) and the evidence as a whole, it is not necessary to discuss each factor in the written enablement rejection.”
When given their broadest reasonable interpretation, in view of the as filed specification, the claims encompass compositions which when applied in specific amounts and/or ratios provide synergistic methods for controlling phytopathogenic insects and fungi. However, the specification does not provide an enabling disclosure for the claimed method wherein applying the claimed combinations in any and all amounts and ratios leads to synergistic control of the entire scope of pests.
The instant specification discloses various combinations of the claimed active agents which exhibit synergistic control of various phytopathogenic insects and fungi when used in specific ratios.
The guidance provided by the specification amounts to an invitation for the skilled Artisan to try and follow the disclosed proposed/prophetic experiments to make and use the claimed invention to synergistically control any and all pests in any and all ratios. Thus, the detail of the disclosure provided by Applicant, in view of the prior art, must encompass a wide knowledge, so that the Artisan of skill would be able to practice the invention as claimed by Applicant, without undue burden being imposed on such Artisan. This burden has not been met because it would require undue experimentation to make and/or use the method comprising applying any and all combinations claimed in any and all amounts to synergistically control any and all pests of any type, as claimed in the instant claim(s).
Therefore, in view of the art recognized high level of unpredictability for synergy in other known pesticidal mixtures, e.g. herbicidal mixtures is taught by Sukhoverkov et al. (https://www.biorxiv.org/content/10.1101/2021.02.08.430187v2.full) which teaches that many herbicidal mixtures can be antagonistic and they are rarely synergistic and that synergistic mixtures for one species of weed can be antagonistic or additive for another species (see abstract and paragraphs 1-3 of introduction). Thus, because of the large quantity of research required to define these unpredictable variables, and the lack of guidance provided in the specification regarding such synergy occurring in any and all ratios and in any and all pest types (e.g. mammalian, avian, rodent, etc.), it is the position of the examiner that it would require undue experimentation for one of skill in the art to practice the scope of the invention as broadly claimed. Hence, absent a strong showing by Applicant, in the way of specific guidance and direction, and/or working examples demonstrating the same, such invention as claimed by Applicant is not enabled.
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.
Claim(s) 1, 11-13, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2019150220 (‘220).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, ‘220 teaches pesticidal compositions which comprise applicant’s component (1) and wherein these compositions can further comprise applicant’s claimed component (2), the elected species bifenthrin (see entire document; e.g. compound 99, table 1; biology examples; pg. 52, ln. 8-17; pg. 15, ln. 16-pg. 23, ln. 3; claims, etc.).
Regarding claim 11, ‘220 teaches wherein their compositions further comprise agriculturally acceptable auxiliaries, solvents/carriers, and/or surfactants (see entire document; e.g. pg. 37, ln. 7-pg. 39, ln. 21; pg. 70, ln. 6-12; pg. 68, ln. 9-11; pg. 55, ln. 29-pg. 56, ln. 3).
Regarding claim 16, ‘220 teaches applying their compositions with amounts of active substance (e.g. component 1) of 0.1 to 1000 g per 100 kg of seeds (see entire document; e.g. pg. 63, ln. 15-22).
As applicants claims as they are currently written claim that all combinations of the claimed active agents are synergistic for pests then it is obvious that the combinations taught by ‘220 would also be achieving the claimed synergy whether or not it is recognized by the prior art as this appears to be a property of the claimed combinations which are broadly taught/rendered obvious by the prior art ‘220 as discussed in this 103 rejection.
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
Regarding claims 12-13, and 16, ‘220 does not teach wherein the ratio of component (1) to component (2) are within the claimed ratios, nor does ‘220 teach wherein the combination of active agents are applied in the claimed amounts to seeds. However, it would have been obvious to one of ordinary skill in the art at the time of the instant filing to have optimized the ratio of component (1) and (2) as taught by ‘220 in order to develop the claimed combinations/compositions in the claimed ratio. Specifically, it would have been obvious to at the very least try the simplest ratio of 1:1 for component (1) and component (2) because this is the easiest ratio for one of ordinary skill in the art to try and this ratio also falls within the claimed broad ranges of ratios especially since it was known to be obvious in the art to combine known known insecticides, e.g. applicant’s component (1) and (2), in order to form an effective insecticide combination. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It also would have been obvious to one of ordinary skill in the art at the time of the instant filing to have optimized the amount of active agent being applied to seeds to be the claimed amounts because it would have been obvious to apply the actives to the seeds in a 1:1 ratio and it was already known in the art to use at least 0.1 g of component 1 to 100 kg of seeds and as such it would be obvious that at least 0.1g of the combination would be useful for treating 100 kg of seeds. “[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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding the newly added synergistic limitation, the claimed synergy appears to be a property which results from forming the claimed combinations in any ratios, etc. e.g. it is a property of the combination the two actives in any amount and against any pests. Thus, this claimed synergistic effect is/would be achieved in all combinations at all amounts/ratios and in all pests with the claimed combination(s) and as such this synergy would obviously be occurring in the prior art combinations of ‘220 which teach the same active agents can be combined together, Thus, upon their combination/formation the synergy always occurs as per applicants specification and claims and as such the synergy appears to be a property of the claimed combinations and/or a result effective of forming the claimed combinations which are rendered obvious by the prior art for the reasons discussed above and herein.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments/Remarks
Applicant’s amendments to the claims have prompted the new grounds of rejection under 112(a) and revised/new grounds of rejection under 103 presented herein. Applicant’s argue that nothing in the prior art teaches that the claimed combinations would produce a synergistic effect as is now required by applicant’s claims and that there is no teaching, suggestion and motivation in ‘220 to make the claimed combinations synergistic as is now required. The examiner agrees that the prior art does not recognize that the claimed combinations are synergistic. However, based on applicant’s claims as they are written and as asserted by applicants arguments and specification this synergy is a property which results from the claimed combinations in any ratios, etc. e.g. it is a property of the combination the two actives in any amount and against any pests. Thus, this claimed synergistic effect is/would be achieved in all combinations at all amounts/ratios and in all pests with the claimed combination and as such this synergy would obviously be occurring in the prior art combinations the same active agents upon their formation and the synergy as per applicants specification and claims and as such they synergy appears to be a property of the claimed combinations and/or a result effective of forming the claimed combinations which are rendered obvious by the prior art.
As discussed above the specification is not enabled for the entire scope of synergy that is now claimed with all of the claimed mixtures in any and all amounts/ratios of the claimed active agents achieving synergy against any and all pests as is now instantly claimed. For instance applicant’s own specification does not appear to fully support the instant claims as they are currently written that any and all combinations of the claimed compound I-1 with each of the claimed actives is clearly synergistic in all amounts and ratios as is instantly claimed for all pests, e.g. the dinotefuran and acephate examples in the declaration for instance it is unclear to the examiner if this percentage difference is actually statistically significant, e.g. that the argued synergy is actually statistically significant from the expected results since they are so close to each other and it is known, “The evidence relied upon should 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).
Further, if the examiner were to consider rejoining the withdrawn method claims, these claims do not require synergistic control or synergistic amounts/ratios of the mixture of claim 1 for controlling the claimed pests which are necessary for achieving the asserted synergy. Thus, for these reasons the instant claims remain rejected.
Declaration under 1.132
Vijay Thakur provided a declaration under 1.132, filed 11/25/25. The Declaration meets the formal requirements. In the most relevant part, the Declaration presents computational data which compares data which demonstrates that applicant’s I-1 with the claimed second active agents in specific ratios achieves synergy in controlling specific phytopathogenic insects and fungi. However, applicant’s claims are that all combinations of the claimed active agents achieve synergy in all ratios/amounts in/for all pests.
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 relevant criterion here is No. 3) whether the Declaration is commensurate in scope with the scope of the claims (In re Kulling, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)). The examiner has carefully reviewed the Declaration, including the data presented in the Declaration.
In the most relevant part, the Declaration presents computational data which compares data which demonstrates that applicant’s I-1 with the claimed second active agents in specific ratios achieves synergy in controlling specific phytopathogenic insects and fungi. However, applicant’s claims are that all combinations of the claimed active agents achieve synergy in all ratios/amounts in/for all pests. However, applicant’s data does not necessarily support their claims that all combinations of actives in all amounts, etc. are synergistic because for instance acephate or dinotefuran with compound 1 in ratios of 4:1 as in tables in the declaration the argued synergistic results do not appear to be clearly statistically significant as these result(s) are very close to the expected additive result via the Colby equation. Thus, it appears that applicants claims are not commensurate in scope with the results presented in the declaration and the argued unexpected results from the specification. And as such, it would be obvious to try the claimed combination with expectation that the claimed combinations which are taught by ‘220 for instance would have led to the claimed synergistic results because applicants claims seem to assert that all combinations of the claimed compounds in any and all amounts and ratios are synergistic for any and all scope of pests which does not appear to be commensurate in scope with applicants claims for the reasons discussed herein. Thus, the examiner is not persuaded by this evidence at this time.
Thus for the above reasons, the examiner maintains that it would have been obvious to one of ordinary skill in the art at the time of the instant filing to have developed the claimed invention when looking to the prior art references as combined at this time.
Conclusion
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 Erin E Hirt whose telephone number is (571)270-1077. The examiner can normally be reached 10:30-7:30 ET M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERIN E HIRT/Primary Examiner, Art Unit 1616
Prosecution Insights