DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The listing of references on pages 27 and 28 of the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 26-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 7,632,985. Although the claims at issue are not identical, they are not patentably distinct from each other because the soybean of the ‘985 Patent comprising event MON89788 would comprise instant SEQ ID NO: 1 or 2 flanking a glyphosate tolerant 5-enolpyruvyl-3-physphoshikimate synthase coding sequence (see Figure 1). Hence, the claims of the ‘985 Patent represent a species of the instantly claimed invention and would anticipate and render obvious the instantly rejected claims.
Claims 26-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9,944,945. Although the claims at issue are not identical, they are not patentably distinct from each other because SEQ ID NO: 3 of the ‘945 Patent comprises instant SEQ ID NO: 1 and SEQ ID NO: 4 (claim 5) of the ‘945 Patent comprises instant SEQ ID NO: 2. Hence, the claims of the ‘945 Patent represent a species of the instantly claimed invention and would anticipate and render obvious the instantly rejected claims.
Claims 26-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 10,738,320. Although the claims at issue are not identical, they are not patentably distinct from each other because the soybean of the ‘320 Patent comprising event MON89788 would comprise instant SEQ ID NO: 1 or 2 flanking a glyphosate tolerant 5-enolpyruvyl-3-physphoshikimate synthase coding sequence (see Figure 1). Hence, the claims of the ‘320 Patent represent a species of the instantly claimed invention and would anticipate and render obvious the instantly rejected claims.
Claim Rejections - 35 USC § 112
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 26-39 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 a soybean plant, seed or plant part comprising event MON89788 (SEQ ID NO: 9), does not reasonably provide enablement for a soybean plant, seed or plant part comprising only SEQ ID NO: 1 or 2. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Applicant claims a soybean plant, seed or plant part comprising SEQ ID NO: 1 or 2.
Applicant teaches a soybean plant, seed or plant part comprising event MON89788 which confers glyphosate resistance to a soybean plant that was produced by Agrobacterium transformation method (paragraph [0053] on pages 17-18 of the Specification).
Applicant does not teach how to use non-functional fragments SEQ ID NO: 1 or SEQ ID NO: 2.
In re Wands, 858F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988) lists eight considerations for determining whether or not undue experimentation would be necessary to practice an invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claims.
The claims are directed to a very broad genus of soybean plants, seed or plant parts comprising the non-functional portions of event MON89788, SEQ ID NO: 1 or SEQ ID NO: 2. Applicant only provides guidance on how to make and use instant SEQ ID NO: 9 which confers glyphosate tolerance upon a (soybean) plant. Applicant does not teach any specific use for the soybean genomic flanking DNA of event MON89788. The instant specification states “it is common to produce hundreds to thousands of different events and screen those events for a single event that has desired transgene expression levels and patterns” (paragraph [0007] on page 4). The chance of inserting a transgene into a specific site is highly unpredictable without the presence of a recombination site and the assistance of a recombinase protein. Hence, it would have required undue trial and error experimentation by one of skill in the art at the time of Applicants' invention to make and use the invention as broadly claimed.
Conclusion
No claims are allowed.
The claims appear free of the prior art. The closest prior art appears to be Berry et al (U.S. Patent 5,627,061) which teaches pMON1 7227 in Figure 16 having a similar structure to event MON89788, and includes a FMV promoter linked to a CTP2 coding sequence operably linked to a CP4 EPSPS coding sequence, but differs by having an E9 terminator and not a RbcS:E9 promoter as used in MON89788 of the instant invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/David H Kruse/
Primary Examiner, Art Unit 1663
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