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 Status
Claims 1, 3, and 6-14 are pending. Claims 1, 3, and 6-14 are rejected.
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.
Claims 1, 3, and 6-14 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.
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 1 recites the broad recitation “an XRPD pattern…which is characterized by an XRPD pattern having peaks at 13.5, 13.8, 16.2 and 21.4 degrees 2-theta ± 0.2 degrees 2-theta, and also having one, two or three additional peaks selected from at 7.9, 19.4 and 23.9 degrees 2-theta ± 0.2 degrees 2-theta”, and the claim also recites “an XRPD pattern substantially as shown in Figure 1” 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. It is unclear whether the claims require the crystalline Form B of indoxacarb to be characterized by an XRPD pattern substantially as shown in Figure 1 or merely have the 5 required peaks and at least one additional peak listed in option ii.
Likewise, claim 3 recites the broad recitation “an XRPD pattern…which is characterized by an XRPD pattern having [a] peak at 5.8 degrees 2-theta ± 0.2 degrees 2-theta, and also having one, two or three additional peaks selected from 11.6, 14.1, 14.3, 16.5, 17.4, 18.8, 20.2, 21.7, 22.9 and 24.3 degrees 2-theta ± 0.2 degrees 2-theta”, and the claim also recites “an XRPD pattern substantially as shown in Figure 5” which is the narrower statement of the range/limitation. The claim is indefinite for the same reason as explained above.
Dependent claims 6-14 are rejected for failing to obviate the indefiniteness of claims 1 and 3 from which they depend.
Additionally, Claims 7 and 14 recite methods for controlling lepidopteron pests by using a crystalline form in an agrochemical formulation as an insecticide; however, the claims do not recite any active steps. It is unclear how this method would be performed.
Closest Prior Art
The closest prior art references are WO2021005549A1 by Gharda et al., CN105111164B by Zhao et al., WO2018137387A1 by Bristow, and WO2021005545A1 by Gharda et al. each cited in the IDS filed 07/30/2024.
In WO2021005549A1 Gharda et al. teach a process for isolating S-isomer crystals of indoxacarb (title) and disclose XRD values for crude Indoxacarb (page 12, Table 1), racemic Indoxacarb (page 12, Table 2), and the S-isomer of Indoxacarb (pages 12-13, Table 3). None of disclosed crystals possess peaks at 13.5, 13.8, 16.2 and 21.4 degrees 2θ ± 0.2 degrees 2θ as required by instant claim 1. Furthermore, Gharda et al. are silent to the preparation of Indoxacarb solvates such as the isopropanolate solvate having a peak at 5.8 degrees 2θ ± 0.2 degrees 2θ required by instant claim 3.
In CN105111164B, Zhao et al. state (abstract):
The invention discloses a crystal form A of (S)-7-chloro-2,5-dihydro-[[(methoxycarbonyl)[4-(trifluoromethoxy)-phenyl]amino]carbonyl]indeno[1,2-e][1,3,4] oxadiazin-4a(3H)-carboxylic acid methyl ester, and X ray powder diffraction pattern has characteristic peaks at 2theta (+-0.20 theta degrees) of 9.56, 14.33, 19.08, 19.56 and 23.90 degrees.
The disclosed crystal does not possess peaks at 13.5, 13.8, 16.2, 21.1 and 21.4 degrees 2θ ± 0.2 degrees 2θ as required by instant claim 1. Furthermore, Zhao et al. are silent to the preparation of Indoxacarb solvates such as the isopropanolate solvate having a peak at 5.8 degrees 2θ ± 0.2 degrees 2θ required by instant claim 3.
Bristow et al. disclose a crystalline polymorph of indoxacarb and x-ray powder diffraction data in paragraph [0008]. The disclosed crystal does not possess peaks at 13.5, 13.8, 16.2, and 21.4 degrees 2θ ± 0.2 degrees 2θ as required by instant claim 1. Furthermore, the reference is silent to the preparation of Indoxacarb solvates such as the isopropanolate solvate having a peak at 5.8 degrees 2θ ± 0.2 degrees 2θ required by instant claim 3.
In WO2021005545A1, Gharda et al. disclose a process for obtaining indoxacarb crystals with specific purity and enantiomeric ratio (title) and provide the following X-ray diffraction patterns for the crystalline forms (Figures 3 and 4):
PNG
media_image1.png
566
692
media_image1.png
Greyscale
PNG
media_image2.png
566
674
media_image2.png
Greyscale
The crystalline form of instant claim 1 has peaks at 13.5, 13.8, 16.2, 21.1 and 21.4 degrees 2θ ± 0.2 degrees 2θ and the diffraction pattern below:
PNG
media_image3.png
563
1191
media_image3.png
Greyscale
.
Neither of the prior art’s figures display all five of the characteristic peaks of the instant form nor do they correspond to the crystal as shown in the diffraction pattern of instant Form-B. Additionally, Gharda et al. do not prepare Indoxacarb solvates such as the isopropanolate solvate having a peak at 5.8 degrees 2θ ± 0.2 degrees 2θ required by instant claim 3.
Even if a person of ordinary skill were motivated to experiment and prepare additional polymorphs of Indoxacarb using the teachings of Gharda et al., Zhao et al., or Bristow et al., the prior art provides no guidance to suggest that a crystalline form with the specific peaks of instant claim 1 would be formed. Thus, there is no reasonable expectation of success in preparing the instant crystalline forms from the prior art disclosures. For this reason, the prior art neither anticipates nor renders obvious the instant claims.
Conclusion
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/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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