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 .
Priority
The instant application was filed 01 November 2024 and is the national stage entry of PCT/US2023/020592 filed 01 May 2023. The Applicant claims priority to provisional application 63/337,488 filed 02 May 2022. Instant claims 3-5, 7-9, 12-17 have an effective filing date of 01 May 2023. Instant claims 1, 2, 11, 18, 19, and 23 have an effective filing date of 02 May 2022.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-5, 7-9, 11-19, 23) in the reply filed on 17 July 2026 is acknowledged.
Claims 21 and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 17 July 2026.
Claim Rejections - 35 USC § 112
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 and 2 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.
Instant claims 1 and 2 recite a virus-like particle derived from Tobacco mild green mosaic virus or a “derivative” thereof optionally conjugated to an agent. The Applicant’s specification does not define or specify the derivatives for the Tobacco mild green mosaic virus and thus may vary greatly in structure and/or function. The specification also does not provide for a sufficient representative number of species that would allow for all the types of derivatives that can exist for the listed compounds.
MPEP 2163 II - A “representative number of species” means that the species which
are adequately described are representative of the entire genus. Thus, when there is substantial
variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc.,
759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
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 (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.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steinmetz et al. (WO 2020154739 A1).
Regarding claims 1 and 2, Steinmetz teaches a VLP from Tobacco mild green mosaic virus to deliver agents, such as nematicides (Example 1, paras. 109, 110).
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-5, 7-9, 11-13, 15-19, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Steinmetz et al. (WO 2020154739 A1).
Regarding claims 1 and 2, Steinmetz teaches a virus-like particle (VLP) from Tobacco mild green mosaic virus (claim 10, entire teaching). An agrochemical agent may be optionally conjugated or covalently attached to the interior or exterior of the VLP (para. 16).
Regarding claim 3 and 4, the rod-shaped particle may be 300 x 18 nm (para. 56).
Regarding claims 5, 7-9, Steinmetz teaches that the agrochemical agent may be loaded or encapsulated in the VLP with a molar excess of 500:1, 1000:1, etc. (para. 78).
Regarding claims 11-13, the agrochemical may be a pesticide (para. 20), such as abamectin (para. 20).
Regarding claims 15-17, Steinmetz teaches a plurality of virus nanoparticles (claim 1), which is broadly interpreted to a plurality of same nanoparticles.
Regarding claim 18, water may be used as a carrier (para. 19).
Regarding claim 19, a buffer may be included in the formulation (para. 78), which is an example of a stabilizer (instant specification, para. 82).
Regarding claim 23, the invention is designed to improve yield of plant products and deliver treatment to a plant with a certain dose (paras. 44, 93, 94). It is obvious to a skilled artisan that the formulation may be intended to be used as a kit with proper instructions.
Steinmetz does not specifically teach the diameters and concentrations recited in claims 3-5 and 7-9.
In regards to the diameters and concentrations recited in claims 3-5 and 7-9, Steinmetz teaches the rod-shaped particles may be 300 x 18 nm (para. 56) and that the agrochemical agent may be loaded or encapsulated in the VLP with a molar excess of 500:1, 1000:1, etc. (para. 78).
That being said and in lieu of objective evidence of unexpected results, the diameters and concentrations can be viewed as a variable that achieves the recognized result of successfully making the VLP composition, which a skilled artisan would have been easily motivated to modify and adjust based on the broad teachings of Steinmetz. The optimum or workable ranges of diameters and concentrations can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration, such as unexpected results, that would render the optimized ranges of diameters and concentrations as nonobvious.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Steinmetz et al. (WO 2020154739 A1), as applied to claim(s) 1-5, 7-9, 11-13, 15-19, 23 above, in view of isglobal.org.
In regards to claim(s) 1-5, 7-9, 11-13, 15-19, 23, Steinmetz, as applied supra, is herein applied in its entirety for its teachings of a VLP composition.
Steinmetz does not teach ivermectin in claim 14.
Isglobal.org teaches that ivermectin has been used to reduce the prevalence of parasitic worms transmitted through soil (pg. 3).
Since Steinmetz does not teach ivermectin in claim 14, one of ordinary skill in the art would have been motivated to use isglobal.org’s teaching that ivermectin can reduce the prevalence of parasitic worms found in soil with a reasonable expectation of success. A skilled artisan would have been led to combine the teachings because Steinmetz’s composition may be used to disperse agrochemical agents in soil to treat parasites (abs, paras. 5, 11). “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15-17 of U.S. Patent No. 11,654,117 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 of the reference patent recites a nanoparticle composition comprising virus-like particles with a polymer matrix, which is interpreted as a carrier, which corresponds to instant claims 1 and 18.
Claim 15 of the reference patent recites tobacco mosaic virus or virus-like particle, which corresponds to instant claim 1.
Claim 16 of the reference patent recites an agent loaded in the virus-like particle, which is interpreted as the particle comprising an agent, corresponding to instant claims 1 and 2.
Claim 17 of the reference patent recites that the agent may be a targeting or therapeutic agent, which corresponds to instant claims 1 and 2.
Claims 1, 2, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, and 17 of U.S. Patent No. 12,156,947 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 of the reference patent recites a composition comprising a virus-like particle with a polymer matrix, which is interpreted as a carrier, which corresponds to instant claims 1 and 18.
Claim 16 of the reference patent recites a virus-like particle loaded with a cargo molecule, which is interpreted as the particle comprising an agent, corresponding to instant claims 1 and 2.
Claim 17 of the reference patent recites a therapeutic or targeting agent, which corresponds to instant claims 1 and 2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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