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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-4 and 7-10 in the reply filed on June 16, 2026 is acknowledged.
The traversal is on the following ground(s):
1. The non-elected claims of groups II-IV depend directly on and incorporate the limitations of, the elected claims.
2. Claim 13 was placed into two different groups simultaneously. Applicant urges that claim 13 requires detecting the same sequences recited in claim 1 of elected Group I and therefore the inventions share a special technical feature.
3. The Examiner alleges that the methods of Group IV “can detect any INHT26 locus comprising a deletion including those that differ from those of SEQ ID NOs: 69-72”, however this statement directly contradicts the actual language of claim 13, which explicitly requires “detecting DNA molecule comprising “SEQ ID NO: 69, 70, 71, or 72” and does not permit detection of sequences that differ from SEQ ID NOs: 69-72.
The grounds of traversal summarized above are not found to be persuasive. This is because while the non-elected claims of groups II-IV do depend on claim 1 they are distinct from the invention of this claim for the reasons provided in the restriction requirement. Specifically, while these groups of claims depend on the claims of group I they do so to refer to a molecule which is either a target for a separate molecule to detect, selected for in breeding steps, or selected against in a different method. This is important to the analysis of the different groups of inventions because while they may depend on one another the different groups of inventions are related as sub-combinations disclosed as usable together, products and process of using and related processes. Using the appropriate analysis for the relationship between each group of inventions the Examiner demonstrated that these groups of inventions are distinct, see restriction requirement.
Further, while claim 13 was separated into two distinct groups of invention Applicant’s argument that the inventions of group I and IV share a special technical feature is not found to be persuasive because the instant Application is not a U.S. National Stage Application filed under 35 U.S.C. 371 and therefore rather than use the unity standard which relies on special technical features the standard applied to this restriction requirement is the independent and distinct standard.
Finally, the invention of Group IV described in claim 13, is drawn to a method of detecting a soybean plant cell comprising an INHT26 transgenic locus wherein a DNA element is deleted, comprising the step of detecting DNA molecule comprising SEQ ID NO: 69, 70, 71, or 72. The claimed sequences are produced by deletions in the DAS44406-6 transgenic event locus. While the claimed sequences comprise two specific deletions as compared to the wild type sequences, the claim is not limited to detecting only those two deletions, rather the claim is drawn to “A method of detecting a soybean plant cell comprising an INHT26 transgenic locus wherein a DNA element is deleted”. While this claim has the enumerated step of “detecting DNA molecule comprising SEQ ID NO: 69, 70, 71, or 72” the claim does not say where this molecule is detected, whether the detected soybean plant cell comprising the deletion is detected when the claimed DNA molecule is detected or rather when it is not detected, or any of the other steps which would make clear that the methods are drawn to detecting the two specific deletions found in the claimed sequences.
While Applicant urges the claim does not permit detecting other DNA molecules the language used in the claim is “comprising”. This indicates that while the claimed invention must include some step of “detecting DNA molecule comprising SEQ ID NO: 69, 70, 71, or 72” in some sample, at some point, although it is not clear how this relates to methods of detecting soybean plant cells comprising an INHT26 transgenic locus comprising a deletion of a DNA element, the claim may include many other non-enumerated steps and given that it is not clear how “the step of detecting DNA molecule comprising SEQ ID NO: 69, 70, 71, or 72” relates to the “method of detecting a soybean plant cell comprising an INHT26 transgenic locus wherein a DNA element is deleted” Applicant’s argument that because the claim includes the detecting the claimed nucleic acid sequence step that the claim is not drawn to a method of detecting any INHT26 locus having an element deleted is not found to be persuasive.
For at least these reasons, Applicant’s arguments are not found to be persuasive.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Claims 1-13 are pending.
Claims 5-6 and 11-13 are withdrawn as drawn to an unelected invention.
Claims 1-4 and 7-10 are examined on the merits.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim language is awkward, in order to improve syntax the claim should be amended to indicate that the DNA molecule comprises the sequence of SEQ ID NO: 60, 70, 71 or 72. An example of the amended claim is “A DNA Molecule comprising the sequence of SEQ ID NO: 69, 70, 71 , or 72”.
Appropriate correction is required.
Specification
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some unclear, inexact or verbose terms used in the specification are: in paragraph 14 “5’ junction sequences” should be singular, in at least paragraphs 14 and 15 “double underling” is misspelled and should be corrected to “double underlining” and in at least the last line of paragraph 75 on page 31 and the second line of paragraph 75 on page 32 there is no space between “the” and “INHT26”.
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 1-4 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Borchardt, EP 3571925 A1, Published 11/27/2019 in view of Cui, US 9,540,655 B2, patented January 10, 2017 as evidenced by Elsner, WO 2024/018016, Published January 25, 2024.
Independent claim 1 is drawn to a DNA molecule comprising the sequence of SEQ ID NO: 69, 70, 71 or 72.
These sequences are modified DAS44406-6 transgenic loci. Specifically, the sequences of SEQ ID NOs: 69 and 71 are drawn to an 114 bp deletion of insert and endogenous soybean DNA at the 3’ junction sequence of the DAS44406-6 event transgenic locus and an 8 bp deletion of endogenous soybean DNA at the 3’ junction sequence of the DAS44406-6 event transgenic locus, respectively. These deletions create new 3’ junction polynucleotides having the sequences of SEQ ID NOs: 70 and 72, respectively. (Specification, Page 5, Paragraphs 0014-0015).
In the specification on Page 27 in Paragraph 0073, Applicant describes unique deletion junctions which are created by deleting DNA elements. The Specification states that these molecules are useful for identifying these INHT26 transgenic plants comprising these deletions. Stated differently, this means that the unique deletion junctions created by deleting elements from transgenic loci can be used to identify plants comprising this deletion. Given the information provided in the specification, it does not appear that there is any specific utility related to these sequences beyond the generic marker function described above.
Therefore, the broadest reasonable interpretation of claim 1 includes a soybean chromosome comprising a DAS44406-6 soybean transgenic locus comprising a modification to introduce a generic marker sequence wherein the modified locus comprises the sequence of instant SEQ ID NO: 69 or instant SEQ ID NO: 71.
With respect to claim 1, Borchardt teaches a method for making an artificial marker allele for the identification of a nucleic acid of interest preferably encoding a polypeptide conferring a trait of interest, comprising the steps of identifying at least one genomic locus in the target genome which is genetically linked to a nucleic acid of interest and introducing at least one insertion or deletion modification into that target locus (Borchardt, Page 148, Claim 1).
Borchardt clarifies this method in claim 8 on page 148, which states that the insertion or deletion of any of the preceding methods, including the method of claim 1, comprises a deletion. In claim 10 on page 148, Borchardt provides further clarification of this method. This claims states “The method according to any preceding claim, wherein said nucleic acid of interest may be an endogenous gene, a heterologous gene, a mutated gene, a transgenic gene or a modified gene introduced or generated by gene editing or base editing”.
Further, Borchardt teaches that providing artificial marker alleles would be advantageous in plant breeding for crop improvement (Borchardt, Page 2, Paragraphs 0007 and 0002). To this end Borchardt teaches that the target plant can be selected from a group including Glycine max (Soybean) and that the trait of interest can be herbicide tolerance which is a typical trait of interest (Borchardt, Page 5, Paragraph 0032; Borchardt, Page 4, Paragraph 0020). Finally, Borchardt teaches that introducing the marker into the target locus can be carried out using CRISPR systems, preferably the CRISPR/Cas9 or CRISPR/Cpf1 systems (Borchardt, Page 7, Paragraphs 0045 and 0047).
In summary, Borchardt teaches methods for making an artificial marker allele for the identification of a transgene encoding traits including herbicide tolerance, in crop plants including soybean through the use of gene editing to introduce a deletion that is linked to the transgene encoding the trait of interest (herbicide tolerance).
With respect to claim 1, Borchardt does not teach making a deletion in the 3’ flanking region of the DAS44406-6 transgenic locus, wherein the resulting modified transgenic locus has the sequence of instant SEQ ID NO: 69 or 71 or wherein the modified junction polynucleotide has the sequence of SEQ ID NO: 70 or 72.
With respect to claim 1, Cui teaches the soybean event pDAB8264.44.06, which confers resistance to glyphosate, aryloxyalkanoate, and glufosinate herbicides (Cui, Abstract). Elsner provides evidence of an intrinsic characteristic of the teachings of Cui, specifically, Elsner makes clear that the pDAB8264.44.06.1 event of Cui is also known as DAS44406-6 (Elsner, Page 27, Line 2; Elsner, Page 26, Lines 32-33). Further, Cui teaches transgenic soybean plant cells, plant parts and seeds comprising the transgenic event (Cui, Columns 117-118, Claims 1-2 and 9).
It would have been obvious at the time of filing to modify the method of Borchardt to generate an artificial marker allele linked to the DAS44406-6 event of Cui as evidenced by Elsner because this would be applying a known technique to a known device ready for improvement to yield predictable results.
This rationale requires resolving the following Graham factual inquiries (MPEP 2143 D):
a finding that the prior art contained a “base” device (method, or product) upon which the claimed invention can be seen as an “improvement”;
a finding that the prior art contained a known technique that is applicable to the base device (method, or product);
a finding that one of ordinary skill in the art would have recognized that applying the known technique would have yielded predictable results and resulted in an improved system; and
whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Addressing these inquiries one by one, Cui teaches a base device upon which the claimed invention can be seen as an “improvement”. Specifically Cui teaches soybeans containing the DAS44406-6. In fact the only distinction between an embodiment of the claimed invention and the soybeans of Cui is an 8 base pair deletion in the genomic soybean DNA flanking the transgene or in the case of the sequence of SEQ ID NO: 69 a 114 base pair deletion in the junction sequence. The specification states that these deletions create unique junctions which can act as a generic marker allowing sequences comprising this deletion to be identified and there is no specific utility for the specific deletions found in the claimed sequences.
At the time of filing Borchardt taught a method of creating artificial marker alleles for traits of interest which include traits carried on transgenes and herbicide tolerance. These marker alleles can be created through the introduction of deletions in sequences linked to the trait of interest. Further, Borchardt teaches that these methods are applicable to crop plants including soybean plants. Therefore, at the time of filing there was a finding that there was a known technique for creating artificial marker alleles linked to transgenes conferring traits of interest including herbicide tolerance. The base invention taught by Cui is a soybean plant comprising herbicide tolerance traits conferred by a transgene. Therefore the method of Borchardt is applicable to the base invention of Cui.
Third, at the time of filing a person having ordinary skill in the art would have recognized that applying the known technique of Borchardt to the transgenic soybean plants of Cui would have had the predictable result of producing a unique marker allele of the DAS44406-6 transgenic event that would allow for easy screening for this unique allele and correspondingly the transgenic event.
This would have had a predictable result because the techniques used in the method of Borchardt, specifically gene editing using the CRISPR/Cas system are well known in the art. These techniques are known for their applicability to a wide variety of organisms, accuracy, ease of use, and predictability in generating targeted modifications to a sequence. Given that the target sequence was taught by Cui and known in the art at the time of filing and that the unique marker alleles of Borchardt can be introduced using the CRISPR/Cas system, at the time of filing, the ordinary artisan would have recognized that applying the known technique would have yielded predictable results and resulted in an improved transgenic soybean plant.
Given, that applicant’s invention appears to be DNA sequences which encode a generic marker allele and that the combined teachings of Borchardt in view of Cui as evidenced by Elsner teach soybean plants having unique marker alleles linked to transgenes that are produced by generating deletions that are linked to transgenes encoding a trait of interest, Applicant’s marker allele having the sequence of SEQ ID NO: 69 or SEQ ID NO: 70 which are a 114 base pair deletion or an 8 base pair deletion linked to the DAS44406-6 transgene is obvious.
With respect to claim 2, Borchardt in view of Cui as evidenced by Elsner collectively teach all of the limitations of claim 1, see above.
Further, Cui as evidenced by Elsner teaches progeny plants, soybeans, seeds, and/or regenerable parts of the plants and seeds and progeny comprising soybean event pDAB8264.44.06.1 (DAS44406-6), as well as food or feed products made from any thereof (Cui, Column 4, Lines 10-14). As such Cui teaches processed (made) products (food or feed products) comprising the DNA molecule of Cui.
With respect to claim 3, Borchardt in view of Cui as evidenced by Elsner collectively teach all of the limitations of claim 2, see above.
With respect to claim 4, Borchardt in view of Cui as evidenced by Elsner collectively teach all of the limitations of claim 1, see above.
Further, Cui explicitly teaches the DNA molecules comprising the transgenic event and soybean plant cells comprising the event and therefore, Cui teaches a biological sample (Cui, Column 13, Lines 43-48; Cui, Column 117, Claims 2 and 10).
With respect to claim 7, Borchardt in view of Cui as evidenced by Elsner collectively teach all of the limitations of claim 1, see above.
Further, Cui teaches soybean plant cells comprising the transgenic event (Cui, Column 117, Claims 2 and 10).
With respect to claim 8, Borchardt in view of Cui as evidenced by Elsner collectively teach all of the limitations of claim 7 taught above, see above.
Further, Cui teaches a plant part of the soybean plant comprising the DAS44406-6 transgenic event (Cui, Column 118, Claim 9; Cui, Column 117, Claim 4).
With respect to claim 9, Borchardt in view of Cui as evidenced by Elsner collectively teach all of the limitations of claim 8 taught above, see above.
Further, Cui teaches that the plant part can comprise a flower, a shoot, a root, a leaf (Cui, Column 118, Claim 9). Cui also teaches soybean seeds comprising the DAS44406-6 event (Cui, Column 117, Claim 2).
With respect to claim 10, Borchardt in view of Cui as evidenced by Elsner collectively teach all of the limitations of claim 7 taught above, see above.
Further, Cui teaches soybean plants produced by growing the seed of claim 2 and further comprising the transgenic event (Cui, Column 117, Claim 4).
As noted above in the obviousness analysis with respect to claim 1, it would have been obvious to modify the method of Borchardt to generate an artificial marker allele linked to the DAS44406-6 event of Cui as evidenced by Elsner because this would be applying a known technique to a known device ready for improvement to yield predictable results. Finally, it would have been obvious to modify the method of Cui to defat the soybean seed to produce defatted soybean seed meal, because this is an obvious use of soybean seed.
This rationale requires resolving the following Graham factual inquiries (MPEP 2143 D):
a finding that the prior art contained a “base” device (method, or product) upon which the claimed invention can be seen as an “improvement”;
a finding that the prior art contained a known technique that is applicable to the base device (method, or product);
a finding that one of ordinary skill in the art would have recognized that applying the known technique would have yielded predictable results and resulted in an improved system; and
whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness.
Addressing these inquiries one by one, Cui teaches a base device upon which the claimed invention can be seen as an “improvement”. Specifically Cui teaches soybeans containing the DAS44406-6. In fact the only distinction between the claimed invention and the soybeans of Cui is a 4 base pair deletion in the genomic soybean DNA flanking the transgene. Applicant made clear in the interview on 12/12/2025 and in the remarks dated 8/25/2025 that this deletion acts as a generic marker allowing sequences comprising this deletion to be identified, further Applicant stated that by itself this sequence has no function other than as a generic marker, see attached interview summary and the paragraph spanning pages 10-11 of Applicant’s Remarks dated 8/25/2025.
At the time of filing Borchardt taught a method of creating artificial marker alleles for traits of interest which include traits carried on transgenes and herbicide tolerance. These marker alleles can be created through the introduction of 1-60 base pair deletions in sequences linked to the trait of interest. Further Borchardt teaches that these methods are applicable to crop plants including soybean plants. Therefore, at the time of filing there was a finding that there was a known technique for creating artificial marker alleles linked to transgenes conferring traits of interest including herbicide tolerance. The base invention taught by Cui is a soybean plant comprising herbicide tolerance traits conferred by a transgene. Therefore the method of Borchardt is applicable to the base invention of Cui.
Third, at the time of filing a person having ordinary skill in the art would have recognized that applying the known technique of Borchardt to the transgenic soybean plants of Cui would have had the predictable result of producing a unique marker allele of the DAS44406-6 transgenic event that would allow for easy screening for this unique allele and correspondingly the transgenic event.
This would have had a predictable result because the techniques used in the method of Borchardt, specifically gene editing using the CRISPR/Cas system are well known in the art. These techniques are known for their applicability to a wide variety of organisms, accuracy, ease of use, and predictability in generating targeted modifications to a sequence. Given that the target sequence was taught by Cui and known in the art at the time of filing and that the unique marker alleles of Borchardt can be introduced using the CRISPR/Cas system, at the time of filing, the ordinary artisan would have recognized that applying the known technique would have yielded predictable results and resulted in an improved transgenic soybean plant.
Given, that applicant’s invention is a generic marker allele and that the combined teachings of Borchardt in view of Cui as evidenced by Elsner teach soybean plants having unique marker alleles linked to transgenes that are produced by generating deletions of 1-60 contiguous nucleotides that are linked to transgenes encoding a trait of interest, applicant’s marker allele having the sequence of SEQ ID NO: 61 which is a 4 base pair deletion linked to the DAS44406-6 transgene is obvious.
As such claims 2-4 and 7-10 are rejected as obvious under Borchardt in view of Cui as evidenced by Elsner.
Conclusion
All examined 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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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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/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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