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 54-60 are pending and examined on the merits.
Claim 54 is currently amended.
Response to Arguments - Indefiniteness
Applicant's amendments filed 28 August 2026 have overcome the rejection of record.
Claim Rejections - 35 USC § 112
Indefiniteness
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.
Claim 60 is 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 pre-AIA the applicant regards as the invention.
Claim 60 recites, “mature explant.” It is unclear what is meant by this, because explants exist outside the context of normal developmental programs. The specification fails to provide additional guidance. Accordingly, the metes and bounds of the claim cannot be determined.
Response to Arguments - 35 USC § 102
Applicant's arguments filed 28 August 2026 have been fully considered and are persuasive. The claims are rejected over other prior art. See rejection below.
Claim Rejections - 35 USC § 102
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.
Claim(s) 54 and 56-60 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Gordon-Kamm et al (US 2005/0257289 A1).
Gordon-Kamm et al teach that transient expression of a babyboom polypeptide (which they refer to as ODP2) is useful to "kick start" somatic embryogenesis, a process which is useful in increasing transformation efficiency (Example 11 p 28). The expression of ODP2 must be transient, because if constitutively expressed the plant would not be able to transition past the embryonic state into the vegetative stage of the plant life cycle (Example 11 and 15 p 28 and 30). The Cre (site-specific recombinase) /loxp (recombination sites) system has been used extensively in molecular biological systems to allow for a removal of a gene which is temporarily needed, but is not wanted in the final organism which is produced. Gordon-Kamm et al also teach that this system in conjunction with other elements is useful in providing a temporary burst of ODP2 and Wuschel activity to produce double haploid germplasm from maize inbred line (See Example 16 p 29-30). They teach a complicated method of producing double haploid maize germplasm using a T-DNA construct which comprises several genes including the ODP2 transcription factor and the Cre site-specific recombinase which is under control of the Lec1 embryo specific promoter, wherein the construct is flanked by loxp sites immediately inside the T-DNA borders. In this method, there is also a second site-specific recombinase (FLP) which is under control of an inducible promoter and its sites (frt) which in conjunction with a YFP encoding polynucleotide are interrupting the UBI (maize ubiquitin) promoter from the ODP2. The method of inducing also requires a cell proliferation factor WUS(chel)2 which is operably linked to the maize oleosin promoter and in this case is introduced on a separate T-DNA molecule such that it can be later segregated away. In this system, anthers from maize plants which have been transformed with both of the above constructs are cultured and treated with a compound to induce expression of the FLP recombinase, which in turn recombines out the segment of the construct interrupting the UBI promoter from the ODP2 transgene, thus allowing for ODP2 expression. Upon ODP2 expression, embryogenesis has been induced and WUS2 and Cre are then expressed, because they are both under the control of embryo-specific promoters. The WUS2 expression further drives embryogenesis and the Cre excises the expression cassette which comprises the ODP2 and the Cre encoding polynucleotides from the plant genome. The overall result of this system is that embryogenesis is temporarily induced and then halted by using the Cre/lox system to excise the expression cassette which comprises the site-specific recombinase and ODP2 (babyboom) which is used to induce embryogenesis. Accordingly, claims 54 and 56-60 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Gordon-Kamm et al.
Claim Rejections - 35 USC § 103
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.
Claim(s) 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gordon-Kamm et al (US 2005/0257289 A1) as applied to claim 54 above.
Claim 55 is drawn to the method of claim 54 wherein recombination sites flank a first promoter linked to a wuschel transgene and a second promoter linked to a babyboom transgene.
Gordon-Kamm et al teach all the limitation of claim 54.
It would have been an obvious design choice for a person of ordinary skill in the art to modify the double haploid generation method to provide both the wuschel and babyboom transgenes within the cassette flanked by recombination sites allowing for excision. This modification would have been recognized as modification that would allow for temporary expression of both the wuschel and babyboom transgenes without having the need to later segregate the wuschel transgene out of the transformed line. Accordingly, claim 55 is rejected as being obvious over Gordon-Kamm.
Response to Arguments - Double Patenting
Applicant's arguments filed 28 August 2026 have been fully considered but they are not persuasive.
Applicant’s request to defer to respond to the rejections.
This is not persuasive, because the rejections still apply.
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 54 and 57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24 of U.S. Patent No. 8704041 B1. Although the claims at issue are not identical, they are not patentably distinct from each other, because they are claiming more specific embodiments within the scope of the instant claims.
Claim 54 and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. 10443064 B2. Although the claims at issue are not identical, they are not patentably distinct from each other, because they are claiming more specific embodiments within the scope of the instant claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R KEOGH whose telephone number is (571)272-2960. The examiner can normally be reached M-Th 7-4:30, half day on Fridays.
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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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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
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