681DETAILED 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 .
Applicants’ arguments, filed 03/04/2026, have been fully considered. Rejections and/or objections not reiterated from previous office action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112 – Indefiniteness; New by Amendment
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.
Claims 1, 9, 25, 26, and 28-38 are 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.
The term “insecticidally effective amount” in claim 1 is a relative term which renders the claim indefinite. The term “insecticidally effective amount” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear from the disclosure and originally filled what amount can be considered insecticidally effective. In addressing the issue of the limitation “effective amount” the MPEP states at § 2173.05(c) III:
The common phrase "an effective amount" may or may not be indefinite. The proper test is whether or not one skilled in the art could determine specific values for the amount based on the disclosure. See In re Mattison, 509 F.2d 563, 184 USPQ 484 (CCPA 1975). The phrase "an effective amount . . . for growth stimulation" was held to be definite where the amount was not critical and those skilled in the art would be able to determine from the written disclosure, including the examples, what an effective amount is. In re Halleck, 422 F.2d 911, 164 USPQ 647 (CCPA 1970). The phrase "an effective amount" has been held to be indefinite when the claim fails to state the function which is to be achieved and more than one effect can be implied from the specification or the relevant art. In re Fredericksen, 213 F.2d 547, 102 USPQ 35 (CCPA 1954). The more recent cases have tended to accept a limitation such as "an effective amount" as being definite when read in light of the supporting disclosure and in the absence of any prior art which would give rise to uncertainty about the scope of the claim.
In the present case, even though the specification discloses specific amounts which demonstrate insecticidal activity, it is not clear at what amount the instantly claimed compounds are no longer insecticidally effective, i.e., no longer “elicits insecticidal activity and/or repels the insect pest and/or deters the insect pest from laying eggs and/or influences the position of egg laying and/or deters the insect pest from feeding on a plant” (see instant specification at page 4, [0037]). For example, the instant specification discloses a range of the instantly claimed compounds of less than 0.25% w/v as well as from about 0.25% w/v to about 20% w/v at paragraphs 71-72 on page 9. In the examples, the instant specification discloses amounts as low as 0.0625% of the podopyrone demonstrate 100% mortality and a 32.14 % mortality rate 24 days after treatment with 0.00625% w/v podopyrones (see instant specification on page 62 at [0335] & Table 10). However, the instantly specification does not define when an amount would no longer be considered insecticidally effective. As such, a skilled artisan would not have understood the metes and bounds of the instantly claimed “insecticidally effective amount.” For the purposes of examination, an “insecticidally effective amount will be interpreted as at least 0.00625% w/v. Support for this can be found in the instant specification at Table 10 of page 62 which discloses 0.00625% w/v of a combination of compound #42 (i.e., elected species) and compound #44 result in a mortality rate of 40.78%, 48 hours after treatment. According to the instant specification at paragraph [0037] the amount of disclosed in Table 10 can be considered an insecticidally effective amount because it “elicits insecticidal activity” (e.g., causes insect mortality).
New claim 35 recites the limitation "the one or more suitable agronomically-acceptable…" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102--Previous
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
1) Claims 1, 9, 25, 26, 28-34 and 36-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kanazawa et al. (Chemical and Pharmaceutical Bulletin, 1997, vol. 45, no. 6, pages 1046-1051), as evidenced by Wagner (EPA Office of Prevention, Pesticides and Toxic Substances, 2006).
Kanazawa relates to the extraction of gamma-pyrone compounds from Gonystylus [title]. In the extraction process, Kanazawa discloses the solution comprising 15mL of methanol and about 1.3 mg of “compound 2” (i.e., 0.0087 g compound 2 per 1 mL methanol or 0.87% w/v) [p. 1049, left col., para. 3]. Compound 2 is defined in line 2 of Figure 1 on page 1046 (see below) and is the elected species.
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Additionally, methanol is a known solvent and cosolvent in pesticides (i.e., agronomically-acceptable carrier or diluent) as evidenced by Wagner at page 3, Section II A.
The prior art anticipates claims 1, 9, 25, 26, 28-33 because it discloses a composition comprising an agronomically acceptable carrier (methanol) and the elected compound in an insecticidally effective amount (i.e., more than 0.00625% w/v), wherein the compound is an extract of Gonystylus and the composition is a solvent based solution. Additionally, the composition would inherently possess the properties recited by claims 1, 34 and 36-38 because a “chemical composition and its properties are inseparable” [MPEP 2112.01 II].
2) Claims 1, 9, 25, 26, 28, 30, 31, 33, 34 and 36-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muller-Kuhrt et al. (WO 1992/013850 A1, publication date 08/20/1992; citing English machine translation).
Muller-Kuhrt disclose “compound 4” obtained from Australian Podolepis herakioides by extraction [p. 11, last para.]. Compound 4 is defined by Formula II and Table 1 (row 4) on page 5 and 6 (see below), and is the elected compound.
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Muller-Kuhrt also discloses 10mM solutions of the compounds in table 1 [p. 12, first two para.]
A 10mM solution of compound 4 (i.e., the elected species) represents about 3.36 grams per L, or 0.0036 grams compound 4 per 1 mL solvent, or 0.36% w/v compound 4.
Muller-Kuhrt anticipates instant claims 1, 9, 25, 26, 28, 30 31, and 33 because it discloses a solution of an insecticidally effective amount of the elected compound, wherein the compound is an extract of Podolepis. Additionally, the composition would inherently possess the properties recited by claim 1, 34 and 36-38 because a “chemical composition and its properties are inseparable” [MPEP 2112.01 II].
Claim Rejections - 35 USC § 103--Previous
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.
Claims 29, 32 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Muller-Kuhrt et al. (WO 1992/013850 A1, publication date 08/20/1992; citing English machine translation) as applied to claims 1, 9, 25, 26, 28, 30, 31, 33, 34 and 36-38 above, and in further view of Price (In Vitro Cellular & Developmental Biology – Animal, 2017, vol. 53, p. 673-681).
Muller-Kuhrt does not anticipate claims 28 and 32 because it does not disclose the specific diluent for the compounds in table 1 (e.g., compound 4, the elected species) and a group consisting of emulsifiers, wetting agents surfactant, stabilizers and spreaders.
However, Muller-Kuhrt does disclose the compounds are diluted with culture media [p. 12, para. 2].
Price, which relates to the best practices selecting culture mediums [title & abstract], discloses that water is a key component of culture medium [p. 674, left col., para. 3].
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have selected a culture medium comprising water as the culture medium disclosed by Muller-Kuhrt. One would have been motivated to, and had an expectation of success in selected a culture medium comprising water because Price discloses it is a key component of culture medium. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a composition comprising water (i.e., agronomically-acceptable diluent; instant claim 29) and the elected compound (i.e., a water-based composition; instant claim 32).
Regarding instant claim 35, Price discloses “zwitterion buffers (such as HEPES) are often included as buffers in a formulation” for pH balance [p. 674, col. 2, para. 3, lines 8-9].
Organic acids are stabilizing agents according to the instant specification at page 25, paragraph [0189].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the HEPES (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid) of Price with the composition taught by Muller-Kuhrt and Price. One would have been motivated to added the HEPES buffer to balance the pH of the formulation. One would have had an expectation of success because Price discloses HEPES is often included in culture medium formulations. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to formulated a composition comprising the elected species, water and a stabilizer (i.e., organic acid; (HEPES).
Response to Arguments
1) On page 14 of their remarks, Applicant argues that cited references cannot anticipate the amended claims because they do not disclose an insecticidally effective amount of the claimed compound and because they do not disclose that the compound affects two neuronal ion channels.
This argument is not persuasive. As discussed in the explanation of indefiniteness, “insecticidally effective amount” is being interpreted to require at least 0.00625% w/v of the instantly claimed compound. Both Kanazawa and Muller-Kuhrt disclose at least 0.00625% w/v of the instantly claimed compound. Furthermore, the compounds of the prior art would have inherently possessed the same properties as instantly claimed because a “chemical composition and its properties are inseparable” [MPEP 2112.01 II]. As such, Kanazawa and Muller-Kuhrt both continue to anticipate the instant claims as indicated in the anticipation rejections above.
2) On page 14 of their remarks, Applicant argues that the instant claims are not obvious over the prior art because the cited prior art documents do not teach an insecticidal composition comprising an insecticidally effective amount of a y-pyrone having the structural formula (3); and they do not disclose an insecticidal composition that affects at least two neuronal ion channels of an insect pest.
This argument is not persuasive. As discussed above, Muller-Kuhrt discloses a composition comprising an insecticidally effective amount of the instant compound which would inherently effect two ion channels. The instant claims continue to read on the prior art.
3) On pages 14 and 15 of their remarks, Applicant asserts that Example 11 (p. 62-62) demonstrates that the instantly claimed composition unexpectedly elicits potassium ion efflux and chlorine ion influx, whilst also causing sodium ion efflux which outperforms pyrethrum in both magnitude and persistence. Applicant argues that the ability to elicit multiple ion flux responses is surprising, as it suggests multiple modes-of-action and that to have the claimed effects, the claimed insecticidal composition must comprise an insecticidally effective amount of the claim-recited active compound.
This argument is not persuasive. According to MPEP 2112 (I) “the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.
In the present case the claimed composition comprising an insecticidally effective amount of the instant compound is anticipated by the prior art. Thus, even though Applicant has allegedly discovered new and unexpected properties of that composition, the composition itself remains anticipated and therefore is not patentably distinct from the prior art.
Furthermore, evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973).
Moreover, to the extent that the claims are obvious in view of the prior art, overcoming a rejection based on unexpected results requires the combination of three different elements: (i) the results must fairly compare with the prior art, (ii) the results must truly be unexpected and (iii) the claims must be commensurate in scope. MPEP §716.02. The burden rests with Applicant to establish results are unexpected and significant. MPEP §716.02(b). Applicant's showing of allegedly unexpected results does not satisfy any of these requirements. -
(i) The objective evidence has not been compared to the closes prior art. The closes prior art is the 10mM solution of substances 1-15 disclosed in Table 1, pages 13-14 of Muller-Kuhrt. See MPEP 716.02(e).
(ii) To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). (MPEP 716.02(d)). In the present case, applicant alleges that the composition must comprise the instantly claimed compound at an insecticidally effective amount to achieve the unexpected results. However, applicant as not compared results at amounts outside the range which is considered to be an insecticidally effective amount.
(iii) The "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support" (see MPEP 716.02(d) quoting In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)). In the present case, applicant has claimed a broad set of gamma-pyrone compounds, one of which has been elected and is under current examination. Example 11 discloses results from extract 68N which is the non-polar fraction of the Podolepis jaceoides (see page 60, paragraph [037]). While the 68N extract appears to comprise the elected species (see page 61, [0332]), the claims are nevertheless not commensurate in scope with the evidence because it is unclear if the elected species is solely responsible for the allegedly unexpected results. As a note, there also is no explanation as to why the 68N extract reasonably represents all the compounds of the instant claims.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612