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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 Aug. 21, 2025, has been entered.
Claims 1-17 are pending. After further consideration, the restriction requirement between groups I-XII that was mailed on April 12, 2024, is withdrawn. Because there are no art rejections, and because the rejections under 35 USC 112 will apply to all of the current claims, there is not an undue burden to examine all claims together. ALL CLAIMS are REJOINED. Claims 1-17 are examined in this Office Action.
Claim Interpretation
Claim 1 recites “… wherein the at least one nucleic acid comprises a sequence set forth in SEQ ID NO: 8 …”. The use of the article “a” before “sequence” means multiple sequences are encompassed and renders this inclusive of fragments of SEQ ID NO: 8 as small as dinucleotides. In claim 1 requires a polynucleotide “specific to event 4588.652”. This is interpreted to mean a polynucleotide that would only appear in the genomic DNA of this event and would not be available in non-related corn plants or non-related organisms. One of ordinary skill in the art would appreciate that this usually requires sequences from the junction between the inserted DNA and the genomic DNA of the maize plant at the insertion site which in this case is a particular locus on chromosome 7. The Examiner interprets “the at least one polynucleotide comprises a sequence selected from the group consisting of SEQ ID NOS: 29-31” to require one of the full length sequences of SEQ ID NO: 29, 30, or 31. In this context the article “a” is used because there are three choices for the required sequence.
Grounds of Rejection That Are Withdrawn
In the previous Office Action mailed on April 22, 2025, the claims were rejected for indefiniteness for lack of antecedent basis for “the sequence” in line six of claim 1. Applicant correctly pointed out that this language had already been amended in the amendments received on Jan. 24, 2025. This ground of rejection should have been withdrawn in the last Office Action. The Examiner apologizes for any confusion.
Claim Objections
Claims 10, 12, and 17 are objected to because of the following informalities:
Claim 10 recites “comprses” in line two, and this is a typographical error. Applicant is advised to replace with - - comprises - - .
Claim 10 recites “ … one or more exogenous enzymes selected from the group consisting of: a hydrolytic enzyme selected from the group consisting of: … “, and this is not proper Markush structure. There should only be one “group consisting of” recitation. Applicant is advised to replace with - - one or more exogenous hydrolytic enzymes selected from the group consisting of: - - .
Claim 12 includes “and” within the list for the Markush group and this is not proper because “and” should only be at the end between the last two items of the list; Applicant is advised to replace “fat and vermiculite” with - - fat, vermiculite - - .
Claim 17 includes improper conjunctions within the list for the Markush group. Applicant is advised to replace “fat and vermiculite” with - - fat, vermiculite - - and to replace “and one or more exogenous enzymes” with - - one exogenous enzyme, and more than one exogenous enzymes - - .
Appropriate correction is requested.
Claim Rejections - 35 USC § 112
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.
Indefiniteness
Claims 1-17 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim. Applicant’s arguments in the response received on Aug. 21, 2025, have been fully considered but were not found to be persuasive.
Claim 1 requires the claimed maize plant, part, or seed thereof to comprise a polynucleotide “specific to event 4588.652”, and “event 4588.652” and comprising a sequence selected from the group consisting of SEQ ID NOs: 29-31. Because an event requires that the transgene remains the same and the insertion site remains the same, it is unclear how a sequence comprising only a small fragment of SEQ ID NO: 8 would be considered the same as the transgene encoding glucanase that was inserted in event 4588.652 and it is unclear how a nucleic acid comprising only a small fragment of SEQ ID NO: 8 would satisfy the art accepted definition of “event” or the non-limiting examples of “event” from the instant specification.
It is also unclear if the claimed maize plant, part or seed thereof is required to actually comprise Event 4588.652, or if it is only required to comprise a sequence specific to the event. Is this event required in the claimed product? Or does it just need a sequence with a fragment of SEQ ID NO: 8 encoding a glucanase and a polynucleotide comprising SEQ ID NO: 29, 30, or 31?
Claim 6 is specifically indefinite, because it requires the transgenic plant to be wheat, maize, barley, or sorghum. If Event 4588.652 is required, it is unclear what this would mean in wheat, barley, or sorghum. Would it still be on chromosome 7? How could one find the equivalent locus which is described relative to a known maize genome?
Applicant argues that the specification provides a description of the event in the specification and points to Example 5 and paragraphs 204-211 (Resp 5). Applicant provides a table with nucleotide positions of different elements of maize event 4588.652 and points to “Exhibit B” which includes a diagram and a nucleotide sequence labeled “transgene_4588_652” (Id. 6). Applicant reiterates the descriptions of the event provided in the specification that were also included in the previous Office Action (Id. 6-7). The Examiner agrees with all of this. The issue remains that it is unclear if the claim requires the claimed transgenic maize plant to comprise event 4588.652. It claim 1 were to be amended to recite - - A transgenic maize plant comprising event 4588.652, or a part or seed thereof comprising the event, wherein the event comprises the sequence set forth in SEQ ID NO: 8 and comprises a sequence selected from the group consisting of SEQ ID NOs: 29, 30, and 31. - - , then this indefiniteness rejection would be overcome.
The problem is the current claim language makes it unclear if the plant is required to comprise the event, or if it is merely required to comprise a few nucleotides from the event.
Failure to Further Limit
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which each claim depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 requires that the glucanase is capable of degrading one or more of beta-glucan, cellulose, cellobiose, pNP-D-glycopyranoside, or xylan. There is no glucanase that would be covered by claim 1 that would not be capable of degrading at least one of these substrates. In addition, if the claim is actually intended to require the transgenic maize plant to comprise event 4588.652, then the identity of the substrates the glucanase is capable of degrading is an inherent property of that particular glucanase, therefore, defining an inherent property in a dependent claim is not further limiting.
Claim 3 requires that the glucanase is active upon expression in the plant and exposure to a pH between 5.0 and 10.0. There is no glucanase that would be covered by claim 1 that would not be active under these conditions. In addition, if the claim is actually intended to require the transgenic maize plant to comprise event 4588.652, then the identity of the pH range in which the glucanase is active is an inherent property of that particular glucanase, therefore, defining an inherent property in a dependent claim is not further limiting.
Claim 4 requires that the glucanase is active upon expression in the plant and exposure to a temperature in the range from 25-130 degrees Celsius. There is no glucanase that would be covered by claim 1 that would not be active at a temperature within the recited broad range. In addition, if the claim is actually intended to require the transgenic maize plant to comprise event 4588.652, then the temperature range in which the enzyme is active is an inherent property of that particular glucanase, therefore, defining an inherent property in a dependent claim is not further limiting.
Claim 5 requires that the glucanase activity has improved stability upon expression in the plant compared to the activity of a glucanase having an identical amino acid sequence and expressed in a bacterial cell. The data in the specification shows this is an inherent property of the glucanase expressed in event 4588.652; therefore, if the claimed transgenic plant is required to comprise this event, then this is an inherent property of the claimed plant and is not a further limitation. If claim 1 does not actually require the plant to comprise event 4588.652, then this might actually be a further limitation, but because of the indefiniteness, it is unknown if the event if required.
Claim 6 is broader than claim 1 because it allows the plant to be a wheat, maize, barley, or sorghum plant, whereas, claim 1 requires a maize plant.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Inadequate Written Description
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 1-17 are 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim. Applicant’s arguments in the response received on Aug. 21, 2025, have been fully considered but were not found to be persuasive.
The claims are broadly drawn to a transgenic maize plant, part or seed thereof comprising at least one synthetic nucleic acid encoding a glucanase and at least one polynucleotide specific to event 4588.652, wherein the at least one nucleic acid comprises a sequence set forth in SEQ ID NO: 8, and the at least one polynucleotide comprises a sequence selected from the group consisting of SEQ ID NOs: 29-31; and to animal feedstock comprising the maize plant, part or seed thereof and methods that utilize the maize plant.
What is Described
Applicant describes expression vector pAG4588 which carries a single feed glucanase expression unit (Spec 4 ¶ 21) and comprises SEQ ID NO: 8 (Spec 16 ¶ 80). pAG4588 is described as Glu:mZ27:AGR2314:SEKDEL:T35S (Id. 51 Table 1).
Applicant describes different maize “events” carrying this plasmid which produced corn flour that had dramatically different amounts of b-glucanase activity (Figure 9 Spec 5 ¶ 28).
Applicant describes Event 4588.652 as integrated in chromosome 7 of the maize genome in BxA genotype, and the T-DNA insertion occurred between nucleotides 141683320-141683357 of the publicly available reference B73 genome (Id. 5 ¶ 30, Id. 64 ¶ 204).
Applicant describes that multiple alignments of the left border specific sequences from multiple wild-type maize genotypes revealed that these 1.8 kb sequences are nearly 100% identical between all genotypes and alignments with the right border revealed the 2.2 kb sequences are also nearly 100% identical (Id. 65 ¶¶ 206-8).
Applicant describes an “advanced progeny” of 4588_652 as having a right border flanking region that comprises SEQ ID NO: 30 (Id. 66-7). SEQ ID NO: 30 has two mismatches relative to SEQ ID NO: 29 (see alignment provided in the in indefiniteness rejection mailed on Sept. 24, 2024). SEQ ID NO: 29 is described as the extended right border flank isolated from the original 4588_652 and SEQ ID NO: 31 is described as the extended left border flank for the event (Id.).
Applicant describes that PCR is used to detect events by amplifying a larger PCR product from genomic DNA containing the T-DNA insertion and a smaller PCR product for genomic DNA that does not contain the insertion (Figures 15-6 Spec 5 ¶¶ 34-5).
Applicant states that the target sequence for a diagnostic PCR test “may be” a sequence included in a junction between a genomic sequence of a transformed plant and a sequence of the T-DNA insertion and “may have” at least 70% identity to SEQ ID NOs: 29-31 (Id. 24 ¶ 103).
What is Not Described
Applicant does not describe any maize plant comprising Event 4588.652 that comprises a synthetic nucleic acid with only small fragments of SEQ ID NO: 8.
Applicant does not describe any maize plant comprising a nucleic acid encoding a glucanase and comprising a fragment of SEQ ID NO: 8, other than Event 4588.652 which comprises SEQ ID NO: 8 in its entirety.
Applicant does not describe any wheat, barley, or sorghum plant comprising Event 4588.652.
Applicant does not describe any wheat, barley, or sorghum plant comprising SEQ ID NO: 29, 30, 0r 31 and comprising a nucleic acid of SEQ ID NO: 8 (claim 6).
Analysis
As discussed, above, in the indefiniteness rejection, it is unclear if the claims require the claimed product to comprise Event 4588.652. The only plants described in the specification that would fall within the genus being claimed are the original Event 4588.652 maize plant and the “advanced progeny” plant described in the specification (Spec 64-7). Therefore Applicant was only in possession of two species that fall within the genus being claimed, each of which comprise Event 4588.652 on chromosome 7, comprise SEQ ID NO: 8, comprise SEQ ID NO: 31, and comprise either SEQ ID NO: 29 or SEQ ID NO: 30.
SEQ ID NO: 8 consists of 3292 nucleotides, therefore, nucleic acids with at least 2 contiguous nucleotides of SEQ ID NO: 8 encompass a very large genus of nucleic acids. Any nucleic acid encoding a glucanase would inherently have at least a di-nucleotide that is contained within SEQ ID NO: 8. Applicant was only in possession of plants comprising SEQ ID NO: 8 with no changes.
Therefore, the instant claims allow for any transgenic maize plant both with and without Event 4588.652, so long as they comprise any one of multitudes of sequences encoding a glucanase and at least one of the full-length polynucleotides set forth in SEQ ID NOs: 29-31, however, Applicant was only in possession of two plants that fall within this genus. Both of the two plants in Applicant’s possession were maize plants comprising Event 4588.652, SEQ ID NO: 8, SEQ ID NO: 31, and either SEQ ID NO: 29 or 30.
Given the breadth encompassed by the claims and only two species reduced to practice, the Applicant has not provided adequate written description support for the current claims.
The only transgenic plants in possession of Applicant at the time of filing were transgenic maize plants. There are no transgenic wheat, barley, or sorghum plants reduced to practice as encompassed by claim 6.
Applicant argues that in the subsection of the Office Action entitled “What is Described”, the Office Action admits that the subject matter of claim 1 was described (Resp 8). This is not persuasive, however, because the claims encompass nucleic acids encoding a glucanase wherein the nucleic acid is only required to comprise a small fragment of SEQ ID NO: 8, and the claims have not been amended to require that the claimed maize plant actually comprises Event 4588.652. For this reason, the claims are not limited to the subject matter that is described, but is broadly drawn to a genus that encompasses much more, the vast majority of which was not in Applicant’s possession at the time of filing and has not been adequately described.
Applicant provides Exhibit B and argues that it lists the complete sequence of the transgenic locus of event 4588.652 (Id.). This is not persuasive, however, for at least three reasons:
1) the table showing the nucleotide positions for the elements of the transgenic locus does not include the actual sequences for each of the elements;
2) the sequence provided after the table does not cover the total of 16158 required according to the table of nucleotide positions; and
3) any description is required to be in the originally filed specification, claims, drawings, or sequence listing.
There does not appear to be a sequence that is 16158 nucleotides in length contained in the originally filed sequence listing.
The Examiner agrees that Applicant was in possession of a transgenic maize plant comprising Event 4588.652 which comprises the nucleic acid of SEQ ID NO: 8 and comprises at least one of the polynucleotides of SEQ ID NOs: 29, 30, and 31. If seeds comprising this Event were deposited and all conditions of 37 CFR 1.801-1.809 were met, then this would be adequately described without disclosing the entirety of the 16158 nucleotides.
Lack of Enablement
Claims 1-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim. Applicant’s arguments in the response received on Aug. 21, 2025, have been fully considered but were not found to be persuasive.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the 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 claim.
The claims are broadly drawn to a transgenic maize plant, part or seed thereof comprising at least one synthetic nucleic acid encoding a glucanase and at least one polynucleotide specific to event 4588.652, wherein the at least one nucleic acid comprises a sequence set forth in SEQ ID NO: 8, and the at least one polynucleotide comprises a sequence selected from the group consisting of SEQ ID NOs: 29-31; and to animal feedstock comprising the maize plant, part or seed thereof and methods that utilize the maize plant.
What is Taught
Applicant teaches expression vector pAG4588 which carries a single feed glucanase expression unit (Spec 4 ¶ 21) and comprises SEQ ID NO: 8 (Spec 16 ¶ 80). pAG4588 is disclosed as Glu:mZ27:AGR2314:SEKDEL:T35S (Id. 51 Table 1).
Applicant teaches different maize “events” carrying this plasmid which produced corn flour that had dramatically different amounts of b-glucanase activity (Figure 9 Spec 5 ¶ 28).
Applicant teaches Event 4588.652 is integrated in chromosome 7 of the maize genome in BxA genotype, and the T-DNA insertion occurred between nucleotides 141683320-141683357 of the publicly available reference B73 genome (Id. 5 ¶ 30, Id. 64 ¶ 204).
Applicant teaches that multiple alignments of the left border specific sequences from multiple wild-type maize genotypes revealed that these 1.8 kb sequences are nearly 100% identical between all genotypes and alignments with the right border revealed the 2.2 kb sequences are also nearly 100% identical (Id. 65 ¶¶ 206-8).
Applicant teaches an “advanced progeny” of 4588_652 as having a right border flanking region that comprises SEQ ID NO: 30 (Id. 66-7). SEQ ID NO: 30 has two mismatches relative to SEQ ID NO: 29 (see alignment provided in the in indefiniteness rejection mailed on Sept. 24, 2024). SEQ ID NO: 29 is described as the extended right border flank isolated from the original 4588_652 and SEQ ID NO: 31 is described as the extended left border flank for the event (Id.).
Applicant teaches that PCR is used to detect events by amplifying a larger PCR product from genomic DNA containing the T-DNA insertion and a smaller PCR product for genomic DNA that does not contain the insertion (Figures 15-6 Spec 5 ¶¶ 34-5).
Applicant states that the target sequence for the diagnostic PCR test “may be” a sequence included in a junction between a genomic sequence of a transformed plant and a sequence of the T-DNA insertion and “may have” at least 70% identity to SEQ ID NOs: 29-31 (Id. 24 ¶ 103).
What is Not Taught
Applicant does not teach any maize plant comprising Event 4588.652 that comprises a synthetic nucleic acid with only small fragments of SEQ ID NO: 8.
Applicant does not teach any maize plant comprising a nucleic acid encoding a glucanase and comprising a fragment of SEQ ID NO: 8, other than Event 4588.652 which comprises SEQ ID NO: 8 in its entirety.
Applicant does not teach any wheat, barley, or sorghum plant comprising Event 4588.652.
Applicant does not teach any wheat, barley, or sorghum plant comprising SEQ ID NO: 29, 30, 0r 31 and comprising a nucleic acid of SEQ ID NO: 8 (claim 6).
Analysis
If the claims require the claimed product to comprise Event 4588.652 (see indefiniteness rejection, above), then there needs to be a reproducible way for one of skill in the art to make such a transgenic plant. Because Event 4588.652 must be in the exact same chromosomal location on chromosome 7 of maize, according to the art accepted meaning of “event”, then Applicant would need to provide publicly available seeds of maize that comprise the event, otherwise, there would not be a way to reliably get the transgene (sequences from plasmid p4588 and T-DNA border sequences) integrated into the exact location in the chromosome. If seeds comprising the event were publicly available, then one of skill in the art would be able to take a seed that comprises the event and use a plant grown from the seed to cross pollinate with a second maize plant in order to introgress the event into the second maize plant. Applicant has not made a biological deposit to enable this (see, 37 CFR 1.801-1.809 for rules regarding biological deposits), therefore, the disclosure is not enabling for how to make the claimed plant.
Applicant argues that Exhibit B lists the complete sequence of the transgenic locus of the of the maize event 4588.652, and shows that SEQ ID NOs: 8 and 29-31 are included in the complete sequence. Applicant asserts that they believe the application as filed provides sufficient enablement for the skilled artist to make and use a transgenic maize plant that includes the event (Resp 9). This is not persuasive, however, because the originally filed application, not Exhibit B of the response, needs to provide enablement for the claimed invention.
If genomic DNA comprising the complete Event 4588.652 sequence were available, then one would be able to PCR amplify the insert using primers designed to anneal to the junction sequences, but the genomic DNA would be necessary to use as the template for the PCR amplification. Without that template and without the complete sequence of the entire insert, one would not be able to replicate the Event. Either seeds for use in introgression or genomic DNA for use as a template would be required to enable one of skill in the art to make a maize plant comprising Event 4588.652.
Summary
No claim is allowed.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHY KINGDON whose telephone number is (571)272-8784. The examiner can normally be reached M-F 9:00 - 5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shubo "Joe" Zhou can be reached on (571) 272-0724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CATHY KINGDON
Primary Examiner
Art Unit 1662
/CATHY KINGDON/Primary Examiner, Art Unit 1662