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(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 10 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 10 recites the broad recitation 200ppm to 800ppm, and the claim also recites 300ppm to 600ppm which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 1-4, 7-14, 15, 17-19 and 23-26 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 controlling resistant pests by exposing pests to flavesone, leptospermone, and isoleptospermone (claims 5 and 6), does not reasonably provide enablement for practicing the claimed method with the full scope of compounds in rejected claims. 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.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to: (a) the nature of the invention; (b) the breadth of the claims; (c) the state of the prior art; (d) the amount of direction provided by the inventor; (e) the existence of working examples; (f) the relative skill of those in the art; (g) whether the quantity of experimentation needed to make or use the invention based on the content of the disclosure is "undue"; and (h) the level of predictability in the art (MPEP 2164.01 (a)).
Nature of the invention and Breadth of the claims:
Claims are directed to a method of controlling resistant pests in urban and agricultural environment. The method comprises exposing the resistant pests to compound of formula (I). The breadth of claims resides in the types of pests that are controlled, the types of pesticide resistance that the pests have acquired and scope of the active agent to which the pests are exposed. The type of pest and type of resistance is not limited in claim 1 and therefore includes hundreds of possible pests and resistance to dozens of known pesticides with varying mechanisms of actions.
State of the prior art and level of predictability in the art:
In order to have activity against resistant pests, the compound must have activity against non-resistant pests. With regards to the scope of compounds encompassed by formula (I) of claims 1 and 18 (the independent claims), art recognizes flavesone, leptospermone, and isoleptospermone as natural products that have pesticidal activity against a variety of pests (Jeong et al Pest Management Science, 2008, 65(3) 327-331). The other compounds within the scope of formula (I) have not been previously described in the art as pesticides. The practice of invention requires understanding of mechanism of action of the beta-triketones and knowledge regarding interaction of specific substituents on the triketone with the target molecule in the pest. Structures of flavesone, leptospermone, and isoleptospermone are very similar and differ only in the arrangement of carbon atoms around the non-cyclic ketone. Current claims comprise compounds that have great variability in the acidity, basicity, ionization and steric considerations where flavesone has an isopropyl ketone. Based on the structure of the three natural compounds, a skilled artisan would not assign the same pesticidal activity to other compounds within the scope of the rejected claims.
Amount of direction provided by the inventor and existence of working examples:
Examples in the specification are directed to flavesone. Flavesone is the only compound within the scope of Formula (I) that has been tested. With regards to other compounds, applicants state their intent to use them, but no pesticidal activity for anything other than flavesone has been shown.
Relative skill of those in the art and quantity of experimentation needed to make or use the invention: Although the relative level of skill in the art is high, one of ordinary skill would not be able to control the population of resistant pests according to the claimed method without engaging in undue experimentation. 1) it’s not clear if any of the compounds other than flavesone have pesticidal activity. 2) its not known what mechanism the compounds utilize to achieve pesticidal activity and therefore 3) also unknown what pests with what resistance would be susceptible to control using the compound. In order to practice the invention as claimed, a person of ordinary skill would need to undertake an undue amount of experimentation without having any certainty that any compound other than flavesone can be utilized as a pesticide.
Thus, given these considerations, one of ordinary skill in the art clearly would not be able to practice the claimed method such that it can be used as contemplated in the specification without first engaging in substantial and undue experimentation. Therefore, the claims are rejected under 35 U.S.C. §112, first paragraph, as lacking and enabling disclosure.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by May (International Pest Control, 2016, 58(6), 310-311).
In paragraph bridging pages 310 and 311 May discloses successful testing of flavesone against ticks and buffalo fly including against pyrethroid and organophosphate-resistant strains. This disclosure of May anticipates claim 1 because testing encompasses exposing the pyrethroid and organophosphate resistant strains of ticks and buffalo fly to claimed compound (flavesone). The step of exposing is the sole active step of claimed subject matter.
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.
Claim(s) 1-13, 15, 17-19 and 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jeong et al (Pest Management Science, 2009, 65, 327-331; submitted with IDS) in view of IRAC (https://croplife.org/wp-content/uploads/pdf_files/IRAC-Prevention-management-of-insecticide-resistance-in-vectors-pests-of-public-health-importance.pdf; published 2006)
Scope of prior art
Jeong et al. teach a study of natural products isolated from L. Scoparium. Jeong teaches that repeated use of synthetic chemicals as pesticides led to resistance in mites and that the study is aimed at developing natural acaricides derived from L. Scoparium which will affect the biological activity of a mite (Abstract). On page 3 of the article in Figure 1 Jeong identifies leptospermone (compound 1), which is within the scope of the claimed compound (1), as being active against three species of mites. (page 3, second column, 2nd paragraph).
Ascertaining the difference
Jeong et al. fail to teach activity of leptospermone against resistant mites.
Secondary reference
IRAC teaches that to combat resistance in pests one should identify the mechanism of action involved in resistance and to switch to an insecticide that functions through a different mechanism of action (page 41, section 8.4)
Obviousness
One skilled in the art prior to the earliest effective filing date of the instant application would have found it obvious to control mites by exposing resistant pests to leptospermone. Jeong et al teach leptospermone to be more effective than DEET (page 3, column 2, paragraph 2). In view of the disclosed activity of leptospermone and teaching of IRAC to switch pest control agents when resistance is identified, one would have found it obvious to try controlling population of pesticide resistant pests by administering to said population leptospermone. Motivation to try is provided by Jeong because is directed to identifying insecticides that are potentially effective against resistant pests. Since Jeong is successful at identifying leptospermone as a potent insecticide, it would have been obvious to try using it on resistant mites. Expectation of success is provided by the activity of leptospermone being more potent that conventional pesticides such as DEET. Since leptospermone is more effective than DEET it would have been obvious to try in controlling mites that are resistant to DEET.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1-13, 15, 17-19, 23-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,259,522. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘522 patent is directed to a method of controlling pesticide resistant pests by administering compound of formula (I). While instant claims recite “exposing pests to a compound” and claims of the ‘522 patent recite “applying to the agricultural environment compound of formula (I)”, applying the compound to agricultural environment is the same as exposing the pests to the compound. Since the compound is a pesticide, exposure to the pest is required for activity.
Claims 1-13, 15, 17-19, 23-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,712,039. Although the claims at issue are not identical, they are not patentably distinct from each other. Claims of the ‘039 patent are directed to a method of controlling resistant pests comprising exposing the pests to the currently claimed compounds. Claim 14 recites combination treatment with another pesticide, claim 7 recites the currently claimed amounts. Claim 17 recites domestic and outdoor environments.
Conclusion
Claims 1-13, 15, 17-19 and 23-26 are pending
Claims 1-13, 15, 17-19 and 23-26 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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