DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 16 December 2025 has been entered.
Claim Status
Claims 1, 3-7, and 9-20 are pending.
Claims 1, 4, 10, 12, 18 and 20 are currently amended.
Claim 11 is withdrawn.
Claims 1, 3-7, 9-10, and 12-20 are examined on the merits.
Priority
The instantly claimed subject matter is supported in the provisional application field 21 January 2010.
Response to Arguments - Failure to Further Limit
The cancelation of claim 8 in the claim set filed 16 December 2025 has obviated 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.
Claims 18-19 remain 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.
Claims 18-19 directly or indirectly recite “wherein the plant is used in germplasm improvement activities…” It is unclear if this recitation is intended to add an active method step as it is recited as a “use.” As such, the metes and bounds of the claims cannot be determined.
It is suggested that if applicant intended this recitation to require a further step in the method of claim 12 that the claim be amended as such: “The method of claim 12, wherein the method further comprises the step of using the plant [[is used]] in germplasm improvement activities…”
Response to Arguments - 35 USC § 103
Applicant's amendments filed 16 December 2025 have overcome the rejections of record. The claims are all newly rejected over new different prior art references.
Response to Arguments - Indefiniteness
Applicant's amendments filed 16 December 2025 have overcome the indefiniteness rejection regarding the phrase “proximal to.”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 3, 6, 7, 12, 13, and 16-18 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Lyznik et al (WO2009006297A2).
Lyznik et al disclose modifying maize using an engineered from the LAGLIDADG endonuclease I-CreI which was named LIG3-4SC which cut at a locus of interest (Example 6). PCR and sequencing was conducted to characterized the modified locus in the generated maize lines and alleles comprising deletions of different lengths were observed at where the LIG3-4SC target site had been (Example 6 and Figure 10). T0 plants were regenerated from the modified cell lines and crossed to wild-type plants to determine stability of the newly formed deletion allele across generations (Example 6). The resultant T1 were subjected to PCR analysis to determine presence of the mutant allele. Accordingly, claims 1, 3, 6, 7, 12, 13, and 16-18 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Lyznik et al.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1, 3-4, 6-7, 9-10, and 12-18, and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bull et al 2006 (US 2006/0282911 B1), and further in view of Smith et al (US 2007/0117128 A1).
Bull et al teach methods of making stacks of genomic regions including transgene stacks in crop species (See entire document, paragraphs 23, 24, 33, 38 and 41 are of particular interest). Bull et al also teach the use of methods known in the art to provide for site-specific integration or removal of transgenes to facilitate formation and modification of what they term a T-region of the genome, including the use of custom zinc finger nucleases (paragraphs 96-103). The T-region comprising stacked transgenes can be formed by transformation or breeding or a combination thereof (paragraph 38). Transgenes taught by Bull et al included herbicide resistance genes which can be used in transgenic event selection (paragraphs 39-40). They also teach methods of identifying and characterizing the modification (paragraphs 54-67).
Bull et al do not teach to use one of the types of custom endonucleases recited in the claims nor do they that the modification needs to be within 1000bp of the cut site.
Smith et al teach LAGLIDADG endonucleases (meganuclease) rationally-designed to cleave specific predetermined sites and methods associated with making and using said endonucleases (see entire document). Smith et al further suggest that their meganucleases would be useful in maize (paragraph 0146 p 20).
At the time of filing, it would have been prima facie obvious to one of ordinary skill in the art to practice the invention as claimed. Bull et al provide a general teaching of methods making a plant comprising a T-region of the genome which comprises stacked transgenes and arriving at the instant claims would have required nothing more than obvious design choices. As Bull et al suggest that the traits may be brought together by breeding, this suggests that the transgenes are far enough apart to later be separated without the use of a custom nuclease and possibly in incomplete linkage with one another. Bull et al also teach the use of Cre/Lox and Flp/FRT systems which are not custom endonucleases but could be used to remove a transgene. It would have been any obvious design choice to have custom recombination sites flanking the locus of interest as this would provide flexibility in the system for later modifications or the sites may have even been recreated upon insertion of the transgene if a non-homologous end joining based targeting method was used. Moreover, the steps of introducing the transgene into a first plant using a custom endonuclease would occur if the additional custom endonuclease sites introduced with a transgene were used as taught in paragraph 96-103 of Bull et al. Using the custom endonuclease of Smith in the method of a Bull et al would have only require a substitution of functional equivalents that were both known in the art, the LAGLIDADG nucleases of Smith et al for the zinc finger nucleases and recombinases of Bull et al. Further, it would have been obvious to attempt that the modification be made within 1000bp of the cut site as modifications occur more efficiently closer to the double strand break. As such, claims 1, 3-4, 6-7, 9-10, and 12-18, and 20 are rejected as being obvious under 35 U.S.C. 103(a).
Claims 5 and 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bull et al 2006 (US 2006/0282911 B1), and Smith et al (US 2007/0117128 A1), as applied to claims 1, 3-4, 6-7, 9-10, and 12-18, and 20 above, and further in view of Wijnker and DeJong 2008 (Trends in Plant Science 13:12, p. 640-646).
The claims are drawn to the methods of claim 1 and 12 further comprising inhibiting recombination of meiosis in said cell or progeny cell thereof.
Bull et al and Smith et al collectively teach all the limitations of claims 1 and 12.
Bull et al and Smith et al do not collectively teach inhibiting recombination of meiosis in said cell or progeny cell thereof.
Wijnker and Jong teach that in certain cases it is desirable to suppress recombination (crossing-over) when breeding elite cultivars and that such suppression of recombination can be achieve through RNAi suppression of early meiotic genes, such as DMC1 (preserving elite genotypes p 643).
One of ordinary skill in the art would have been motivated to combine the teachings of Bull et al, Smith et al, and Wijnker and Jong to specifically transfer a specific locus of interest which comprises a transgene of interest into an elite cultivar while inhibiting recombination otherwise. In this method, the plant which comprises the herbicide tolerance trait functions as a donor plant to integrate the herbicide tolerance trait into the elite cultivar.
One of ordinary skill in the would have been motivated to practice such a method to minimize the need for back-crossing the progeny the elite parent variety such the line maintains all the characteristics of the elite variety. Further one of ordinary skill in the art would be motivated to minimize back-cross to expedite the breeding scheme in order to speed the time required to bring new varieties to market.
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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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663