DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims
The amendments received on Mar. 13, 2026, have been entered. Claims 14-21 have been canceled. Claims 1-13 are pending and are examined in this Office Action. NOTE: in the future, all claims sets should include: - - Claims 14-21. Cancelled - - .
Objections and Rejections That Are Withdrawn
The objection to the specification is withdrawn in light of Applicant’s amendments to the specification.
The rejection of claims 1-13 under 35 U.S.C. 112(b) for indefiniteness is withdrawn in light of Applicant’s amendments to the claims.
The rejection of claims 1-13 under 35 USC 112(a) for lack of scope of enablement is withdrawn in light of Applicant’s amendments to the claims and their arguments regarding the ability to test the different variants to determine if they have enhancer activity (Resp 7).
The rejection of claim 3 under 35 USC 112(a) for inadequate written description is withdrawn in light of Applicant’s amendments to the claims.
The rejection of claims 1-3 and 8 under 35 U.S.C. 101 for claiming a judicial exception without significantly more is withdrawn in light of Applicant’s amendments to the claims.
The rejection of claim(s) 1, 4, 8, 9, 11, and 12 under pre-AIA 35 U.S.C. 102(b) over Callis et al is withdrawn in light of Applicant’s amendments to the claims.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.
Inadequate Written Description for Genus
Claims 1, 2, and 4-13 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 this rejection unless they include a limitation that overcomes the deficiencies of the parent claim. Applicant’s arguments in the response received on Mar. 13, 2026, have been fully considered but were not found to be persuasive.
Claim 1 is broadly drawn to a DNA molecule comprising a sequence with at least 95% identity to SEQ ID NO: 233 or comprising at least 200 contiguous nucleotides of SEQ ID NO: 233 and having intron-mediated enhancement activity, wherein the DNA sequence is operably linked to a heterologous transcribable polynucleotide molecule.
The Applicant describes analysis of genomic sequences from different plants, including Setaria italica, and identification of putative promoters, leaders, introns, and transit sequences (Id. 26) and putative introns (Id. 136-137). Applicant describes multiple sequences that are putative introns, including the claimed sequence of SEQ ID NO: 233 (Id. 137-139). Applicant discloses the relative expression level of the reporter protein, b-glucuronidase (GUS), in transient protoplast assays (Id. 137-139). The expression level is in comparison to a control intron. Table 22 (Spec 137-139) shows intron-mediated enhancement of GUS expression relative to I-Zm.DnaK-1:1:1 (Sequence ID NO: 1102). The expression level for the claimed intron (SEQ ID NO: 233) was a mean of 1.53 with standard deviation of 0.52 compared to the control that was designated as 1.0. It appears that all constructs utilized a CaMV 35S promoter with the different introns operably linked followed by the GUS coding sequence (Spec 136 and Fig. 15).
Applicant does not describe any sequences with at least 95% identity to SEQ ID NO: 233 or sequences that are 200 bp fragments of SEQ ID NO: 233 that are demonstrated to have any regulatory activity other than the enhancer of SEQ ID NO: 233 itself.
See, for example, Rose, A. B. (RNA (2002) Vol. 8; pp. 1444-1453) who teaches that deletions and mutations of nucleotides in an intron lost the ability to regulate the expression of a transgene (Rose 1444-1448). Rose teaches that none of the structural characteristics that are shared between the PAT1 intron and other dicot introns are essential for intron-mediated enhancer activity (Id. 1448). This shows that there is a high degree of unpredictability regarding which nucleotides within an intron are necessary for enhancer activity.
Part (a) allows for 5% of the nucleotides to be altered. SEQ ID NO: 233 is 1014 nucleotides in length, therefore the genus of molecules encompassed by claim 1 is more than 450 molecules. Applicant has only reduced to practice one of the molecules encompassed by this genus, and that is the full length polynucleotide of SEQ ID NO: 233.
Given the breadth encompassed by the claims, and the lack of any description of motifs (structures) associated with regulatory activity, and the lack of a representative number of species within the claimed genus having been reduced to practice, the instant specification does not provide an adequate written description to support the breadth of the claims.
Applicant argues that the specification demonstrates possession of sequences with at least 95% sequence identity to SEQ ID NO: 233 (Resp 13). The examiner agrees that the specification contemplates this genus, and this is why the inadequate written description rejection was not a new matter rejection. Instead the inadequate written description is focused on the size of the genus being claimed, the lack of a sufficient number of species having been reduced to practice, and the lack of a description of the structural features that are necessary for the species within the genus to have the required enhancer activity and the unpredictability in the art.
Applicant argues that they have narrowed the claims to a genus having 95% identity to SEQ ID NO: 233 rather than 85% identity (Resp 14). The Examiner agrees that this narrows the genus, however, this genus continues to encompass 450 molecules which is 1.27 x 1030 which is an extremely large genus of molecules. Applicant has only reduced to practice ONE molecule, the full-length of SEQ ID NO: 233 with no mismatches.
Applicant argues that the specification establishes that the inventors had actually reduced to practice the full-length reference sequence and confirmed its intron-mediated enhancement function (Resp 14-15). The Examiner agrees. It is the Examiner’s position that reducing to practice one molecule is not a sufficient number of species to provide adequate written description support of the claimed genus which comprises 1,267,650,600,228,229,401,496,703,205,376 molecules.
Applicant argues that the specification discloses the introns of SEQ ID NOs: 172-267 which were each tested for enhancement activity, and they assert that this demonstrates the inventors’ possession of the claimed invention (Resp 15). This is not persuasive, however, because SEQ ID NOs: 172-232 and 234-267 are not species that fall within the claimed genus.
Applicant argues that the claims have been amended to eliminate non-functional sequences (Resp 15-16). The Examiner agrees, and this is one of the reasons why the enablement rejection was withdrawn. This does not address the written description issue of having only one species reduced to practice within an extremely large genus, and lacking any description of the particular structures (i.e. motifs, consensus sequences, etc.) that are able to confer the required function.
Applicant argues that they have amended the claim to require a minimum fragment size of 200 contiguous nucleotides (Resp 16-17). The Examiner agrees that this narrows the claimed genus, however, the genus continues to encompass an extremely large number of molecules many of which would not retain enhancer activity and the vast majority of which were not in the Applicant’s possession at the time of filing. Limiting the fragments to a minimum of 200 nucleotides encompasses 814 200 bp fragments, 813 201 bp fragments, 812 202 bp fragments, etc. This genus encompasses 331,705 molecules. There has only been one molecule reduced to practice, and that is the full-length nucleic acid of SEQ ID NO: 233.
Applicant argues that the written description requirement for genus claims may be satisfied by a disclosure of a representative number of species falling within the scope of the genus, or by disclosure of relevant identifying characteristics such as structure, formula, chemical name, physical properties, or other properties (Resp 17). The Examiner agrees, however, the Examiner does not believe that a single molecule having been reduced to practice with zero description of the specific structural elements that confer the required activity satisfies this requirement.
The rejection is maintained because of the large size of the genus, only one molecule having been reduced to practice, no description of structures capable of confer the required function, and the unpredictability known in the art for attempting to identify which particular structures are sufficient to confer such activity (i.e. Rose reference).
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 4 and 12 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 it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 is directed to a progeny plant of the transgenic plant of claim 11, or a part thereof, wherein the progeny plant or part thereof comprises said DNA molecule. There is nothing in claim 12 to distinguish this progeny plant from the transgenic plant or part thereof that is claimed in claim 11. The two claims are identical in scope. Therefore, claim 12 does not further limit claim 11.
Claim 4 provides the limitation of: “wherein the DNA sequence comprises a regulatory element”, however, claim 4 depends from claim 1 which already requires that the DNA sequence will have intron-mediated enhancement activity, and this enhancement activity is a regulatory element. Therefore, claim 4 does not further limit claim 1 but instead it is redundant.
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.
Applicant’s arguments in the response received on Mar. 13, 2026, have been fully considered but were not found to be persuasive.
Applicant argues that claim 12 is required to be a progeny of a plant comprising the DNA molecule of claim 1, and this further limits claim 11 because claim 11 is not required to be a progeny of a plant comprising said DNA molecule (Resp 19-20). This is not persuasive, however, because being a progeny is the process by which the plant is made, and this is only given weight for the structural features conferred by the process. There is nothing structurally to distinguish the plant of claim 12 from the plant of claim 11.
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Summary
Claims 1, 2, and 4-13 are rejected. Claim 3 is objected to.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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, Amjad A Abraham can be reached at (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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CATHY KINGDON
Primary Examiner
Art Unit 1663
/CATHY KINGDON/Primary Examiner, Art Unit 1663
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