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 .
Status of Claims
Claims 1-8 are pending.
Priority
Instant application 18/835,946, filed 08/05/2024 claims priority as follows:
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Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
All references from IDS(s) received 08/05/2024 have been considered unless marked with a strikethrough.
Claim Objections
Claim 1 is objected to because of the following informalities: the bracketed phrases “[Chem. 1]” and “[Chem. 2]” in claim 1 are superfluous and could cause confusion. The examiner recommends removing these from the claim. Additionally, please note that line 7 of claim 1 recites an open bracket “[“ that should be removed.
Appropriate correction is required.
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 1-8 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. Specifically, this rejection concerns the scope of the Formula (1-1) and Formula (1-2) variables R1, R2, R3, R4, R5, R6, R7, R8, and R9.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, the claims at issue are drawn to a compound of Formula (1-1) or Formula (1-2):
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;
wherein Het is:
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;
and wherein the variables R1, R2, R3, R4, R5, R6, R7, R8, R9, and G are defined in the claims.
The breadth of the claims is enormous. Formula (1-1) and Formula (1-2) each contain eight independently variable positions, and the claims recite a long list of options for each variable, resulting in a compound scope encompassing well in excess of 1015 compounds. When there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See MPEP 2163.05(I)(B).
The breadth of multiple variables in Formula (1-1) and Formula (1-2) is unsupported by the disclosure. The Specification describes 436 representative species as working examples (Table 7, starting at page 310).
Claims 1-3 recite R9 as hydrogen, hydroxyl, cyano, halogen, alkyl, cycloalkyl, alkoxy, haloalkoxy, cycloalkoxy, and Rx4S(O)p-. For all 436 disclosed examples, R9 is hydrogen. No examples are disclosed where R9 falls into any of the other 10 categories recited in the claims.
Claims 1-4 recite R5 as cyano, halogen, alkoxy, haloalkoxy, cycloalkoxy, alkenyl, alkynyl, haloalkynyl, or Rx4S(O)p-. For all 436 disclosed examples, R5 is Rx4S(O)p-, and Rx4 is ethyl. No examples are disclosed where R5 falls into any of the other categories recited in the claims. And even claim 4, which recites only Rx4S(O)p-, still leaves Rx4 open to hydroxyl, halogen, cycloalkyl, alkenyl, alkynyl, and phenyl. There is no evidence in the specification that applicant possessed compounds reading on these categories.
Claims 1-3 recite R8 as hydrogen, hydroxyl, cyano, halogen, alkyl, haloalkyl, cycloalkyl, or Rx4S(O)p-. For all 436 disclosed examples, R8 is C1-C3 haloalkyl. No examples are disclosed where R8 falls into any of the other categories recited in the claims.
Claims 1-4 recite R1 in Formula (1-1) as hydrogen, alkyl, haloalkyl, cycloalkyl, alkenyl, haloalkenyl, alkynyl, haloalkynyl, phenyl, 5- or 6-membered heterocyclic, Rx1Rx2NC(=O)-, Rx3C(=O)-, Rx3OC(=O)-, or Rx4S(O)p-. Formula (1-1) recited in the claims is almost entirely unsupported by the working examples in the disclosure. In the Specification, Formula (1-1) (“Structure B” in Table 7) has 6 examples with 2 R1 values (CH2CF3, pyrimidin-5-ylmethyl). No examples are disclosed where R1 falls into any of the other categories recited in the claims.
In view of the above analysis, every working example shares unclaimed features (e.g., R9 is hydrogen; R5 is Rx4S(O)p-, and Rx4 is ethyl; R8 is C1-C3 haloalkyl), which provides evidence that applicant possessed only the feature-bearing subgenus rather than the full genus recited in the claims. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See MPEP 2163.05(I)(B). Structurally similar species that occupy one corner of the genus do not suffice.
Neither the specification nor the prior art supplies a structure-function correlation that would allow a person having ordinary skill in the art to recognize that the applicant possessed the remaining genus. The skilled artisan must rely upon applicant’s disclosure in order to predict which of the many possible compounds embraced by the claims possess the claimed function.
However, applicant has not explored and disclosed a representative number of species to adequately establish such a correlation. Additionally, applicant’s results with the compounds disclosed in the working examples underscore the unpredictability associated with structural changes to Formula (1-1) and (1-2). For example, Test Example 1 (Specification, page 358-359, [0915]), omits 87 of the 436 exemplified compounds. The silence of the Specification as to whether these compounds were tested (and failed to meet the threshold), or simply were not tested, leaves the skilled artisan unable to determine which genus members possess the disclosed activity. And Test Example 1 is the example with the largest number of listed active compounds; for Test Example 4, only 9 compounds are listed.
The closest prior art IKISHIMA (WO 2022250069 A1; cited in IDS; see also the appended machine translation obtained from worldwide.espacenet.com) fails to disclose a structure-function correlation to justify the breadth of the instant genus.
IKISHIMA discloses pest control compounds having the formulas: (pages 451-452 of Ikishima):
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The above formulas differ from instant Formulas (1-1) and (1-2) by the “Het” ring: Ikishima’s compounds are imidazopyridines having 3 ring nitrogen atoms, whereas the claimed compounds (depending on the identity of G) possess 3 or 4 ring nitrogen atoms at different positions within the ring. Additionally, Ikishima fails to teach or suggest modifying the “Het” ring to change the arrangement of the nitrogen atoms within the ring.
Despite the structural differences in the “Het” ring, Ikishima’s Table 5 reveals similar shared features comparable to those in the instant application’s Table 7. For all of the disclosed examples in Ikishima’s Table 5, R3 is a trifluoromethyl group (comparable to instant R8’s C1-C3 haloalkyl); the group comparable to instant R5 is explicitly defined as R8-S(O)m- (and every example has R8 = ethyl); and the group comparable to instant R9 is explicitly defined as hydrogen. Ikishima’s disclosed examples bear the same variable scope identified for the subgenus considered to be supported by the present disclosure (e.g., where R9 is hydrogen; R5 is Rx4S(O)p-, and Rx4 is ethyl; R8 is C1-C3 haloalkyl). Ikishima’s disclosed examples fail to provide evidence of possession for the broader variable scope recited by the instant claims.
The pesticidal activity of compounds generally cannot be readily predicted based on their structure. See, for example, JESCHKE (Pest Management Science, vol. 66, no. 1, Jan. 2010, pp. 10–27). Jeschke is drawn to the unique role of halogen substituents in the design of modern agrochemicals, and states that “the complex structure-activity relationships associated with biologically active molecules mean that the introduction of halogens can lead to either an increase or decrease in the efficacy of a compound”. Jeschke further teaches that “it is still difficult to predict the sites in a molecule at which halogen substitution will result in optimal desired effects” (abstract). See also PETER (Pest Management Science, vol. 77, no. 1, Jan. 2021, pp. 64–76). Peter is a review drawn to an overview of agrochemicals launched over the past 8 years. On page 67, in a discussion on the meta-diamide insecticide Broflanilide, Peter states: “Surprisingly, the change in the amide group from an ortho- to meta-position resulted in a shift in the [mode of action] (from RyR modulator to a GABA-gated chloride channel allosteric modulator).” Peter therefore provides evidence that even mere position isomers of the same pesticidal compound can have completely different targets and modes of action.
There is no prior art teaching to demonstrate that the claimed compounds possess the claimed function when R9 is hydroxyl, cyano, halogen, alkyl, cycloalkyl, alkoxy, haloalkoxy, cycloalkoxy, or Rx4S(O)p-; R5 is cyano, halogen, alkoxy, haloalkoxy, cycloalkoxy, alkenyl, alkynyl, or haloalkynyl; or R8 is hydrogen, hydroxyl, cyano, halogen, alkyl, cycloalkyl, or Rx4S(O)p-. Therefore, there is no art-recognized correlation between the disclosed function (arthropod pest control) and the claimed genus comprising the full variable scope.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”)
Accordingly, the specification fails to provide adequate written description for the genus of claims 1-8 and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the entire scope of the claimed invention.
Conclusion
Claims 1-8 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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