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 1-5 and 44 are pending.
Claims 1-5 and 44 are examined on the merits.
Claim Objections
Claims 1 is objected to because of the following informalities: in the final three lines of section a), claim 1 recites “a FEA3 polypeptide comprising an amino acid sequence that is at least 95% identical to one of SEQ ID NO: 23”. Given that the claim only recites one sequence the recitation of “to one” is unnecessary and “one” should be removed to improve syntax.
Appropriate correction is required.
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.
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 1-5 and 44 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.
Claim 1 recites “A method of producing a modified maize plant with an increase in kernel number”. This phrase is indefinite because the claim requires an increase in kernel number as compared to some reference but the reference is not provided. Does the modified maize plant have increased kernel number as compared to an otherwise identical maize plant not comprising the modification? Instead, does the maize plant have an increase in kernel number as compared to all other maize plants? Given that the reference state is not clear the modified maize plants produced by the claimed method are not clear and the claim is rejected as indefinite. In order to ensure compact prosecution the claim is being interpreted to be drawn to methods of producing modified maize plants having an increase in kernel number as compared to an otherwise identical plant not comprising the modification.
Claims 2-5 and 44 are rejected for depending on an indefinite claim and failing to limit the claim scope to definite subject matter.
Claim 1, in the final two lines of the claim, recites “wherein the site-specific mutation is introduced at the fea3 genomic locus such that the amino acid position C435 of SEQ ID NO: 23 is mutated”. Earlier in the claim, in section a), states that the endogenous fea3 locus encodes a FEA3 polypeptide comprising an amino acid sequence that is at least 95% identical to one of SEQ ID NO: 23. The recitation in part a) makes clear that the claim is drawn to any endogenous fea3 locus that encodes a FEA3 polypeptide having a sequence that is at least 95% identical to the sequence of instant SEQ ID NO: 23. SEQ ID NO: 23 is 505 amino acids in length, as such the claim is drawn to FEA3 polypeptides that differ from reference sequence SEQ ID NO: 23 by as many as 25 amino acids and these differences can occur anywhere in the sequence.
In contrast the language of the last two lines of the claim, specifically, that “such that the amino acid position C435 of SEQ ID NO: 23 is mutated” indicates that the claim is drawn only to sequence of SEQ ID NO: 23 comprising a single site-specific modification at position C435. Alternatively, this limitation could be interpreted to mean that “the site-specific mutation is introduced at the fea3 genomic locus such that the amino acid corresponding to position C435 of SEQ ID NO: 23 is mutated”.
While the plain meaning of the language is drawn to the former interpretation, given that part a) of the claim states that the FEA3 polypeptide can be an sequence having at least 95% sequence identity to SEQ ID NO: 23 is included in this method the second interpretation also appears to be a reasonable interpretation of the claim. As such the recitation of “wherein the site-specific mutation is introduced at the fea3 genomic locus such that the amino acid position C435 of SEQ ID NO: 23 is mutated” imparts more than one scope to the claim and claim 1 is rejected as indefinite. In order to ensure compact prosecution the claim is being interpreted to be drawn to methods wherein the site-specific mutation is introduced at the fea3 genomic locus such that the amino acid position corresponding to C435 of SEQ ID NO: 23 is mutated.
Claims 2-5 and 44 are rejected for depending on an indefinite claim and failing to limit the scope to definite subject matter.
Claim 44, in the final two lines of the claim, recites “wherein the site-specific mutation is introduced at the fea3 genomic locus such that the activity and/or expression of the locus is altered”. This limitation is drawn to a genomic locus which encodes a polypeptide rather than a polypeptide which performs a function as such it is not clear what activity the genomic locus possess and how this activity would be altered. As such the scope of the claim is not clear and claim 44 is rejected as indefinite.
Claim Rejections - 35 USC § 112 (Written Description)
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claim 44 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim is drawn to a method of producing a modified maize plant with an increase in kernel number by introducing into an endogenous fea3 locus encoding a FEA3 polypeptide having a sequence that is at least 95% identical to SEQ ID NO: 23 a site-specific nucleotide mutation at the position corresponding to position C435 of SEQ ID NO: 23 wherein the mutation is introduced such that the activity or expression of the locus is altered.
Applicant has described methods of introducing modifications to specific sites in endogenous maize fea3 genomic loci, suggests making modifications at cysteine residues including C435Y and suggests how this modification would affect FEA3 activity (Specification, Example 4, First Paragraph). Further, Applicant has described how mutating one or more of the regulatory elements in the fea3 genomic locus may reduce the expression of the fea3 polynucleotide (Specification, Example 2, Second Paragraph). Applicant also describes position 435 of endogenous fea3 genomic loci as comprising a Cysteine residue which has a conserved disulfide bond that secures the N-terminal CAP, this demonstrates that position 435 is not in a regulatory region (Specification, Example 4, First Paragraph).
However, Applicant has not described nor does the art describe how modifications at a position corresponding to C435 of SEQ ID NO: 23 would affect the expression of endogenous fea3 genomic loci having sequences which are at least 95% identical to the sequence of SEQ ID NO: 23.
The Federal Circuit has recently clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In summary, the court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. The court goes on to say, “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
Even given the scope of the claim which is drawn to a site-specific mutation at a specific locus in an endogenous fea3 genomic locus the relationship between these mutations and the expression of the locus is not clear.
Applicant does not adequately describe what structures or other features must exist at position in the genomic locus corresponding to C435 of the polypeptide sequence of SEQ ID NO: 23. As stated above, applicant does not appear to provide any description of modifications in the same region as the claimed site-specific mutation which affect gene expression, all of Applicant’s description drawn to modified gene expression appears drawn to mutations in regulatory elements and the position corresponding to position C435 of SEQ ID NO: 23 appears to be a conserved a Cysteine residue involved in a disulfide bond that secures the N-terminal CAP of the polypeptide, this demonstrates that position 435 has functions other than regulatory functions and Applicant does not provide any description of the regulatory role of this region (Specification, Example 4, First Paragraph).
Hence, Applicants fail to meet either prong of the two-prong test set forth by Eli Lilly. Given the lack of description of the necessary features or structures essential for site-specific mutations corresponding to position C435 of SEQ ID NO: 23 to modify the expression of the locus.
Maize FEA3 was known in the prior art, see Je, Signaling from maize organ primordia via FACIATED EAR3 regulates stem cell proliferation and yield traits, Nature Genetics, May 16, 2016. However, the art is focused on several alleles found in maize and a specific fasciated ear phenotype that flows from that phenotype and fails to draw a structure function relationship between the claimed mutations in the FEA3 gene and modified expression of the fea3 genomic locus (Je, Page 786, Figure 1; Je, Page 789, Figure 6). Specifically, the fea3 mutant alleles described in Je are weak alleles that can increase ear lengths, kernel row numbers, kernel numbers per ear, and ear weights (Je, Page 790, First Full Paragraph).
The prior art and the specification fail to disclose a correlation between the structure of the claimed fea3 genomic loci comprising site-specific mutations and the recited function of altering the expression of the fea3 genomic locus. Since the genus of mutated endogenous genomic loci has not been described by specific structural features, the specification fails to provide an adequate written description to support the breath of the claim.
Claim 44 is rejected as lacking written description.
Claim Rejections - 35 USC § 112 (Scope of Enablement)
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.
Claim 44 is 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 methods of producing a modified maize plant with an increase in kernel number by introducing a site-specific mutation at a target site corresponding to position C435 of SEQ ID NO: 23 in an endogenous genomic locus having at least 95% sequence identity to SEQ ID NO: 23 which alters the activity of the polypeptide encoded by the locus, does not reasonably provide enabled guidance for methods comprising all of the same steps as previously described, but where instead of the activity of the polypeptide encoded by the genomic locus being altered it is the expression of the locus itself that is altered.
The claim is drawn to a method of producing a modified maize plant with an increase in kernel number by introducing into an endogenous fea3 locus encoding a FEA3 polypeptide having a sequence that is at least 95% identical to SEQ ID NO: 23 a site-specific nucleotide mutation at the position corresponding to position C435 of SEQ ID NO: 23 wherein the mutation is introduced such that the activity or expression of the locus is altered.
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/or use the invention commensurate in scope with these claims.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that. . . the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731,8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim.
Applicant has provided enabled guidance for methods of introducing modifications to specific sites in endogenous maize fea3 genomic loci, suggested making modifications at cysteine residues including C435Y and suggested how this modification would affect FEA3 activity (Specification, Example 4, First Paragraph). Further, Applicant has provided enabled guidance on how mutating one or more of the regulatory elements in the fea3 genomic locus may reduce the expression of the fea3 polynucleotide (Specification, Example 2, Second Paragraph). Applicant also provides enabled guidance on position 435 of endogenous fea3 genomic loci, which applicant describes as comprising a Cysteine residue which has a conserved disulfide bond that secures the N-terminal CAP, this demonstrates that position 435 is not in a regulatory region (Specification, Example 4, First Paragraph).
However, Applicant has not provided guidance on nor does the art describe how modifications at a position corresponding to C435 of SEQ ID NO: 23 would affect the expression of endogenous fea3 genomic loci having sequences which are at least 95% identical to the sequence of SEQ ID NO: 23.
In the absence of guidance from either the instant disclosure or the art, it would require trial and error experimentation for a skilled artisan to identify the modifications to endogenous genomic loci having at least 95% sequence identity to the sequence of instant SEQ ID NO: 23 that had a site-specific mutation corresponding to position C435 of instant SEQ ID NO: 23 that resulted in altered expression of the claimed endogenous genomic locus. Even the knowledge provided by applicant that position C435 was drawn to a conserved cysteine residue involved in disulfide bonds which secure the N-terminal CAP does not allow the ordinary artisan to determine the effect of any site-specific mutation at this residue on gene expression of the genomic locus and in fact there does not appear to be any evidence that this genus of mutations would modify expression of the genomic locus.
Thus, in view of the unpredictability associated with genetic mutations at the claimed position in the claimed endogenous genomic loci and the function of altering expression of that genomic locus, the lack of enabling guidance from either the instant disclosure or the art, the lack of sufficient working examples, and the level of the art at the time of the invention, one of ordinary skill in the art must rely on undue trial and error experimentation to make and test the all of the possible site-specific mutations at the claimed position in the claimed genus of endogenous genomic loci, in order to make and/or use the invention within the full scope of the claim.
For at least this reason, the Specification does not teach a person with skill in the art how to make and/or use the subject matter within the full scope of the claim and claim 44 is rejected on the grounds of lacking scope of enablement.
Claim Rejections - 35 USC § 102
Claims 1, 4-5 and 44 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Allen, WO 2013/138408 A1, September 19, 2013 as evidenced by "Caryopsis". Encyclopedia Britannica, 7 Mar. 2016.
With respect to claim 1, Allen discloses a method of producing a modified maize plant (Allen, Page 4, Line 27- Page 5, Line 14; Allen, Page 1, Abstract) with an increase in a yield related agronomic characteristic including kernel number which Allen calls seed number (Allen, Page 4, Lines 27-28; Allen, Page 5, Lines 9-14). Importantly, Caryopsis provides evidence of an inherent property of maize plants, specifically Caryopsis discloses that in the cereal grains which includes maize, there is a specialized dry, one-seeded fruit called a caryopsis where the ovary wall of the fruit is united with the seed coat fusing the seed to the fruit. In maize the caryopsis are called kernels. This evidence makes clear when Allen discloses plants having increased seed number Allen is disclosing maize plants having increased kernel number.
Allen discloses that the method comprises:
a. Introducing a site-specific nucleotide mutation at position C435 of an endogenous FEA3 genomic locus (Allen, Page 4, Lines 1-8; Allen, Figure 1; Allen, Page 10, Lines 3-4), wherein the endogenous FEA3 locus encodes a FEA3 polypeptide comprising an amino acid sequence that is at least 95% identical to instant SEQ ID NO: 23 (Allen teaches SEQ ID NO: 3 which is described on page 8 in Line 12 as the wild type polypeptide sequence of FEA3 further SEQ ID NO: 3 of Allen shares 100% sequence identity with instant SEQ ID NO: 23).
b. Generating a population of modified plants comprising the one or more site- specific modifications at the FEA3 genomic locus of (b) (Allen, Page 37, Claim 1b).
c. Selecting the modified plant (Allen, Page 37, Claim 1c), wherein the modified maize plant exhibits an increase in the yield related agronomic characteristic including those related to kernel number (Kernel Row Number)(Allen, Page 1, Lines 30-32; Allen, Page 3, Lines 11-17; Allen, Page 38, Claim 3c; Allen, Page 5, Lines 9-14), when compared to a control maize plant not comprising the one or more modifications (Allen, Page 38, Claim 3c).
With respect to claim 4, Allen as evidenced by Caryopsis discloses all of the limitations of claim 1, see above. Further Allen discloses that the site-specific nucleotide changes are introduced at the genomic locus such that the interaction of the FEA3 polypeptide with a ligand is modulated (Allen discloses that FEA3 interaction with FCP1 limits shoot apical meristem growth and that when FEA3 is mutated the interaction between FEA3 and its ligand FCP1 is disrupted and FEA3 embryos showed resistance)(Allen, Page 36, Example 8).
With respect to claim 5, Allen as evidenced by Caryopsis discloses all of the limitations of claim 4, see above.
With respect to claim 44, Allen as evidenced by Caryopsis discloses all of the limitations of claim 1. See above. Importantly, Allen discloses the activity of the FEA3 polypeptide is altered, see anticipation analysis with respect to claim 4 above (The interaction of FEA3 with FCP1 is disrupted) (Allen, Page 34, Lines 3-10).
Therefore claims 1, 4-5 and 44 are rejected as being anticipated by Allen as evidenced by Caryopsis.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Allen as evidenced by Caryopsis, in view of Zong, Nature biotechnology 35.5 (2017): 438-440.
With respect to claim 2, Allen as evidenced by Caryopsis teaches all of the limitations of claim 1 (See anticipation rejection above).
With respect to claim 3, Allen as evidenced by Caryopsis teaches all of the limitations of claim 1 (See anticipation rejection above). Further, Allen teaches that TILLING can be used to introduce a mutation into the endogenous ZMFCP1 gene and then detect the mutation and that this can be a site-specific mutation (Allen, Page 4, Lines 1-8).
With respect to claims 2-3, Allen as evidenced by Caryopsis does not teach the use of a RNA-guided Cas endonuclease nor does Allen as evidenced by Caryopsis teach the use of a base editor in the absence of a double strand break.
With respect to claims 2-3, Zong teaches the use of a Cas endonuclease to base edit specific amino acids in Maize (Zong, Page 438, Column 1, Abstract). Further, Zong teaches that current methods of identifying point mutations such as TILLING are time consuming and often detect a limited repertoire of point mutations, normal Cas9 approaches using homologous-recombination can be inefficient and the delivery of repair templates challenging. In contrast Zong teaches targeted base editing in plants without the need for a foreign DNA donor or double-stranded DNA cleavage through the use of a CRISPR-Cas9 nickase-cytidine deaminase fusion to achieve targeted conversion of specific cytosine residues in maize plants (Zong, Page 438, Column 1, Abstract; Zong, Page 438, First Regular Paragraph).
It would have been obvious at the time of filing to modify the method of Allen as evidenced by Caryopsis which is drawn to modifying kernel number in Maize by decreasing the function of ZmFEA3 and thereby ZMFCP1 through site-directed methods including TILLING, approaches to use the Cas based base editors of Zong. This would have been obvious because the method of Zong is a more efficient and versatile alternative to TILLING approaches. This would have been motivating to the ordinary artisan because it would allow for specific edits to be made to the ZMFCP1 gene in order to modify the yield characteristics of a maize plants in an efficient and rapid manner. Further the ability to make single specific edits would allow for a targeted approach that would allow the ordinary artisan to generate alleles with increased yield traits and without other detrimental effects.
This would have been motivating because of the ability to rapidly and specifically generate null mutants in a target plant without off target effects and the possibility of avoiding the costly regulatory process associated with traditional transgenic approaches. Therefore, claims 2-3 are rejected as being obvious under Allen as evidenced by Caryopsis in view of Zong.
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 1-5 and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. US 12,171,179 B2 patented December 24, 2024 by Gao, Hou and Meeley and Pioneer Hybrid, the Inventors and Applicant of the presently examined application in view of Allen.
With respect to instant claim 1, claim 1 of parent patent US 12,171,179 B2, referred to hereafter as ‘179, is identical with one exception.
Claim 1 of ‘179 is drawn to methods of producing modified maize plants with increases in kernel number by generating at least one-site specific nucleotide mutation in a sequence encoding a FEA3 polypeptide having at least 95% sequence identity to SEQ ID NO: 23 of ‘179 which is instant SEQ ID NO: 23, however claim 1 of ‘179 is drawn one or more site-specific nucleotide mutations such that the mutated amino acid positions are selected from the following group: C79, C89, R127, R128, R130, F134, R164, R208, R209, R242, Y244, K261, R357, F358, H363, Y384 and C417 where the instant claim is drawn to a single site-specific mutation at a different residue (‘179, Column 69).
With respect to instant claims 2-5, claims 2-5 of ‘179 are identical (‘179, Column 70).
With respect to instant claim 44, claim 6 of ‘179 is nearly identical to the claim with one exception. Instant claim 44 recites “wherein the nucleotide mutation is introduced” while claim 6 of ‘179 recites “wherein the one or more site-specific nucleotide mutations are introduced”.
With respect to claims 1-5 and 44, ‘179 does not teach a site-specific mutation such that the amino acid position C435 of SEQ ID NO: 23 is mutated.
With respect to claims 1-5 and 44, Allen teaches introducing a site-specific nucleotide mutation at position C435 of an endogenous FEA3 genomic locus (Allen, Page 4, Lines 1-8; Allen, Figure 1; Allen, Page 10, Lines 3-4).
Given that ‘179, the parent patent, teaches all of the elements of the claims except generating a site-specific mutation such that the amino acid position C435 of SEQ ID NO:23 is mutated and that Allen teaches introducing site-specific nucleotide mutations at position C435 of the sequence of instant SEQ ID NO: 23 it would have been obvious to a person having ordinary skill in the art (PHOSITA) to follow the method of ‘179 and to target C435 of Allen. This would have been obvious because ‘179 teaches methods of producing modified maize plants with increased kernel number by targeting specific residues in a polynucleotide encoding a FEA3 polypeptide having a sequence that is at least 95% identical to instant SEQ ID NO: 23 and Allen teaches generating mutations at the position corresponding to position C435 of the sequence of SEQ ID NO:23 can produce modified kernel phenotypes including increased kernel number.
The PHOSITA would have been motivated to make this modification of the method of ‘179 in order to produce maize plants having improved kernel properties as described in Allen in order to compare these plants to the plants of ‘179. This would produce another maize plant having improved kernel characteristics which represent an allelic series of fea3 mutations which would allow for does dependent optimization of kernel yield phenotypes and other maize fruit characteristics. As such the ordinary artisan would have been motivated to use the method of ‘179 to target position C435 as taught in Allen and claims 1-5 and 44 are rejected on the grounds of non-statutory double patenting of claims 1-6 of ‘179 in view of Allen.
Conclusion
All claims are rejected.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN JAMES SULLIVAN whose telephone number is (571)272-0561. The examiner can normally be reached on 7:30 to 5:00.
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/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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