DETAILED ACTION
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 the Application
Receipt is acknowledged of Applicants’ preliminary amendment, filed on 09/02/2025, in which claims 1 and 4-5 are amended.
Claims 1-13 are pending and are examined on the merits herein.
Priority
The instant application is a CON of 17/533,069 filed on 11/22/2021, which is a CIP of 17/242,495 04/28/2021, which is a CIP of 16/338,547 04/01/2019, which is a 371 of PCT/US2017/054874 10/03/2017, which claims domestic benefit to 62/404,036 filed on 10/04/2016, 62/412,414 filed on 10/25/2016, 62/433,988 filed on 12/14/2016, 62/440,636 filed on 12/30/2016, 62/441,076 filed on 12/30/2016, 62/420,578 filed on 11/11/2016, and 62/442,478 filed on 01/05/2017. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 112(a) as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed applications, Application Nos. 62/404,036, 62/412,414, 62/433,988, 62/440,636, 62/441,076, 62/420,578, and 62/442,47, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provisional applications fail to provide support for each of TPR-1, OR 1, MR 1, TCY1, PT150, PT155, PT156, PT157, PT158, PT159, PT160, PT162, PT163, PT164, PT165, PT166, and PT167 for treating a disease or disorder in a plant. Accordingly, claims 1-13 are not entitled to the benefit of the prior application and receive the filing date of 10/03/2017, which is the filing date of PCT/US2017/054874 which provides support for these claims.
Rejections Withdrawn
Applicant’s amendment and remarks, filed 09/02/2025, with respect that the drawings are objected to because they contain color without a corresponding petition has been fully considered and is persuasive, as replacement drawings in black and white have been submitted. This objection has been withdrawn.
Applicant’s amendment and remarks, filed 09/02/2025, with respect that claims 1 and 4-5 are objected to because agents OR 1, MR 1, and TCY1 lack a hyphen to be consistent with the instant specification has been fully considered and is persuasive, as claims 1 and 4-5 have been amended to read TCY-1 and to remove OR 1 and MR 1 from the scope of the claim. This objection has been withdrawn.
Applicant’s amendment and remarks, filed 09/02/2025, with respect that claims 1-13 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention has been fully considered and is persuasive, as claims 1 and 4-5 have been amended to remove PT156 from the scope of the claim. This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 09/02/2025, with respect that claims 1-9 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Cricchio has been fully considered and is persuasive, as the scope of the claims have been amended to exclude the agents MR-1 and OR-1. This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 09/02/2025, with respect that claims 1-7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Perez-de-Luque in view of He and Cricchio has been fully considered and is persuasive, as the scope of the claims have been amended to exclude the agents MR-1 and OR-1. This rejection has been withdrawn.
The following are new and modified grounds of objection and rejection.
Objection to the Specification
The disclosure is objected to because of the following informalities: The chemical structures, especially those on pages 107, 109, both structures on 116, 117, 119-120, 122, 129, 132, 133, 134, 140, 142, 146, 165, 166, 167, the lower structure on page 173, 185, and the upper structure on page 186, are of poor resolution and cannot be easily read. Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 09/02/2025 have been fully considered but they are not persuasive. Applicant argues that higher resolution versions of the objection formulas have been included (remarks, page 7, paragraph 2). However, the amended specification submitted does not provide sufficiently legible drawings.
Because Applicant’s arguments are not persuasive, the instant specification is objected to for the reasons of record with modifications made to account for the new page numbers in the amended specification filed 09/02/2025.
Claim Objections
Claim 1 objected to because of the following informalities: there is incorrect capitalization in “oF” on line 4 of claim 1. Appropriate correction is required.
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 1-13 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.
Claims 1 and 4-5 recite “an active agent selected from the group consisting of: TPR-1, TCY1, PT150, PT155, PT157, PT158, PT159, PT160, PT162, PT163, PT164, PT165, PT166, PT167”. These agents are tradenames not defined in the prior art such that it is unclear what structure is encompassed by these agents, thereby rendering the claims indefinite. The claims must be amended to include the chemical structures of the recited agents. For purposes of compact prosecution, these claims are interpreted in light of the instant specification, including the structures on pages 104, 106-107, 113-114, 117-119, 126, 129, 10-131, 133, and 137.
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 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. US 9,598,459 B2. Although the claims at issue are not identical because the instant claims comprise a broader group of active agents, they are not patentably distinct from each other because claim 2 of ‘459 claims a composition comprising a therapeutically effective amount of PT155, PT156, PT157, PT158, or TCY1 and at least one pharmaceutically acceptable excipient. The specification of ‘459 indicates that the scope of a therapeutically effective amount includes a dosage of 1 mg/day (col. 162, line 9) and that the scope of acceptable excipients includes dicalcium phosphate or cellulose (col. 197, lines 33-34). The instant claims are directed to compositions comprising an effective amount of an agent selected from the group consisting of TPR-1, TCY-1, PT150, PT155, PT157, PT158, PT159, PT160, PT162, PT163, PT164, PT165, PT166, and PT167, and at least one agricultural acceptable excipient. The instant specification indicates that the scope of an effective amount in the formulations encompasses an amount of 1 mg/day (instant specification, page 38, line 15). The instant specification further indicates that the scope of acceptable excipients encompasses dicalcium phosphate or cellulose (instant specification, page 44, lines 4-5). Thus the compositions of the claims of ‘459 encompass compositions of the instant claims.
Regarding instant claims 2 and 3, claim 5 of ‘459 indicates that the composition may be in the form of a spray.
Regarding instant claim 4, the claims of ‘459 are directed toward the active agents of the claimed kit which would necessarily have to exist in a container. Inclusion of instructions in a kit is not considered a novel step in the case where no functional relationship exists between the printed matter and the product. MPEP 2111.05(b) states that in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. US 11,702,443 B2. Although the claims at issue are not identical because the instant claims comprise the scope agricultural acceptable excipients whereas the claims of ‘443 comprise pharmaceutically acceptable excipients, they are not patentably distinct from each other because claim 2 of ‘443 claims a composition comprising a therapeutically effective amount of a compound selected from the group consisting of TPR-1, TCY-1, PT150, PT155, PT157, PT158, PT159, PT160, PT162, PT163, PT164, PT165, PT166, or PT167 and at least one pharmaceutically acceptable excipient. The specification of ‘443 indicates that the scope of a therapeutically effective amount includes a dosage of 1 mg/day (col. 30, line 17) and that the scope of acceptable excipients includes dicalcium phosphate or cellulose (col. 34, lines 54-55). The instant claims are directed to compositions comprising an effective amount of an agent selected from the group consisting of TPR-1, TCY-1, PT150, PT155, PT157, PT158, PT159, PT160, PT162, PT163, PT164, PT165, PT166, and PT167, and at least one agricultural acceptable excipient. The instant specification indicates that the scope of an effective amount in the formulations encompasses an amount of 1 mg/day (instant specification, page 38, line 15). The instant specification further indicates that the scope of acceptable excipients encompasses dicalcium phosphate or cellulose (instant specification, page 44, lines 4-5). Thus the compositions of the claims of ‘443 encompass compositions of the instant claims.
Regarding instant claims 2 and 3, claim 3 of ‘443 indicates that the composition may be in the form of, among others, a capsule and a powder.
Regarding instant claim 4, the claims of ‘443 are directed toward the active agents of the claimed kit which would necessarily have to exist in a container. Inclusion of instructions in a kit is not considered a novel step in the case where no functional relationship exists between the printed matter and the product. MPEP 2111.05(b) states that in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. US 11,040,037 B2. Although the claims at issue are not identical because the instant claims comprise a different scope of active agents, they are not patentably distinct from each other because claim 2 of ‘037 claims a composition comprising a therapeutically effective amount of a compounds selected from TPR-1, OR-1, KM-1, TCY-1, PT157, PT158, PT159, PT160, PT162, PT163, PT164, PT165, PT166, or PT167, and at least one pharmaceutically acceptable excipient. The specification of ‘037 indicates that the scope of a therapeutically effective amount includes a dosage of 1 mg/day (col. 27, line 39) and that the scope of acceptable excipients includes dicalcium phosphate or cellulose (col. 32, lines 6-7). The instant claims are directed to compositions comprising an effective amount of an agent selected from the group consisting of TPR-1, TCY-1, PT150, PT155, PT157, PT158, PT159, PT160, PT162, PT163, PT164, PT165, PT166, and PT167, and at least one agricultural acceptable excipient. The instant specification indicates that the scope of an effective amount in the formulations encompasses an amount of 1 mg/day (instant specification, page 38, line 15). The instant specification further indicates that the scope of acceptable excipients encompasses dicalcium phosphate or cellulose (instant specification, page 44, lines 4-5). Thus the compositions of the claims of ‘037 encompass compositions of the instant claims.
Regarding instant claims 2 and 3, claim 3 of ‘037 indicates that the composition may be in the form of, among others, a capsule and a powder.
Regarding instant claim 4, the claims of ‘037 are directed toward the active agents of the claimed kit which would necessarily have to exist in a container. Inclusion of instructions in a kit is not considered a novel step in the case where no functional relationship exists between the printed matter and the product. MPEP 2111.05(b) states that in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals.
Conclusion
This action is made second non-final since the new grounds of rejection for the double patenting rejections were not necessitated by amendment.
No claims are allowed.
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/S.G.H./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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