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
Newly submitted Claims 237-238 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Newly added Claims 237-238 are drawn to a method of manufacturing a hybrid cereal plant line by translocation of an alien addition from a disomic alien addition chromosome and selecting for a disomic alien chromosome [steps (b) and (d)] and a hybrid cereal line produced thereof, which would have been classified in A01H 1/024, which would have been subject to the restriction requirement set forth in the Office Action dated 05/19/2025. The inventive concept encompassed by Claims 237-238 are deemed distinct from the inventive concepts of elected invention I, encompassing Claims 232-233, because the inventions as claimed have a materially different design, mode of operation, function, or effect. In the instant case, when comparing elected invention I (Claims 232-233) to newly added Claims 237-238, while they have the same starting materials, the methodology of Claims 237-238 do not select for any monosomic chromosome as in step b) or d) of the method of invention I but rather selects for a disomic chromosome, which would require searching multiple inventions and would require separate considerations under 112(a) enablement and written description. Additionally, when compared to Claims 237-238, based on the selection for any monosomic chromosome recited in Claims 232-233, the claims of elected invention I would be classified in A01H 1/023. Furthermore, there is nothing of record to show that Claims 237-238 and Claims 232-233 are obvious variants.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, Claims 237-238 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Priority
This application is a divisional of U.S. Application No. 16/643,277, filed February 28, 2020, which is a U.S. National Phase of International Patent Application No. PCT/EP2018/073282, filed on August 29, 2018, which claims priority to United States Provisional Application No. 62/551,599, filed August 29, 2017 and United States Provisional Application No. 62/610,727, filed December 27, 2017. Acknowledgment is made of Applicant' s claim for domestic benefit under 35 U.S.C. 119(e). As such, the effective filing date of Claims 323-238 is August 29, 2017.
Status of the Claims
Amendments dated 02/26/2026 have been entered.
Claims 237-238 are newly added.
Claims 232-238 are pending.
Claims 234-238 are withdrawn from consideration for being directed to nonelected inventions.
Claims 232-233 are examined herein.
Drawings
The drawings are objected to for the following reasons:
37 CFR 1.84 (u)(1) states “View numbers must be preceded by the abbreviation "FIG."”
In the current case, the view number for Figures 1-16C are preceded by the word “Figure” instead
of the abbreviation “FIG.”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office
action to avoid abandonment of the application. Any amended replacement drawing sheet should
include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is
being amended. The figure or figure number of an amended drawing should not be labeled as
“amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the
replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate
changes made to the brief description of the several views of the drawings for consistency. Additional
replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing
sheet submitted after the filing date of an application must be labeled in the top margin as either
“Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next
Office action. The objection to the drawings will not be held in abeyance.
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.
---This is a new rejection from those set forth in the Office Action dated 10/31/2025 made in view of Applicant’s amendments to the claims dated 02/26/2026, which reopens prosecution.---
Claims 232-233 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.
While it is noted that Claim 232 step (f) has been newly added, reciting “determining whether the self-fertilized cereal plant produced in step e) comprises an intact monosomic alien addition chromosome and whether the monosomic alien addition chromosome was successfully translocated in the self-fertilized cereal plant produced in step e)…”, the amendment to Claim 232 renders the claim indefinite because it is unclear if the recitation of Claim 323, step (f) includes or omits a “selecting” step [such as those in Claim 232, steps (b) and (d)] where any of the progeny following the second selfing [i.e. method step (e)] must comprise an intact alien addition chromosome; wherein the method of step (f) actually produces a successful translocation of the alien addition chromosome or portion thereof comprising the restorer of fertility and the blue marker genes.
It should be noted that the specification requires the presence of 42 chromosomes in the self-fertilized plants, not merely the detection of the presence/absence of 42 chromosomes:
“In order to determine successful translocation of the monosomic chromosome into the genome plants grown from these seeds, they were self-fertilized for a second time and segregation into blue and white seeds (F2) and analyzed. The change in the segregation showed a successful translocation of the monosomic chromosome into the genome. A successful rearrangement was proven by a segregation of blue seeds to white seeds from 3: 1 or a ratio significantly deviated from 1 :3 and by determination of the presence of 42 chromosomes” (see pg. 93 in Example 3.1).
In contrast to the instant specification, it appears that newly added step (f) only determines the presence or absence of an “intact monosomic alien addition chromosome” and “whether the monosomic alien addition chromosome was successfully translocated” in the self-fertilized cereal plant. As such, all of the self-fertilized cereal plants produced by step (e) could potentially be absent of an intact monosomic alien addition chromosome and absent of a successfully translocated monosomic chromosome.
In addition, Claim 233, that is dependent upon Claim 232 as a product by process claim, is included in this rejection because it cannot and does not resolve this issue and as such does not set forth the metes and bounds of Applicants’ invention. Claim 233 is drawn to any plant obtained from ‘a method’ of claim 232 that does not have a mis-division; or the cereal plant does not comprise a breakage of the alien addition chromosome.
In either case, if the cereal plant does not first comprise a breakage (and subsequent rearrangement), then it has not been translocated and no homoeologous chromosome is created; and then there is no 42-chromosome system and no improvement upon the 42 + 1 system.
Response to Arguments
Applicant’s Remarks on pg. 11 of the reply filed on 02/26/2026 does not provide any Remarks or arguments about the previous 35 U.S.C. §112(b) rejection as it related to omitted steps and does not provide any Remarks regarding the addition of step (f) to the currently amended claims.
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.
---This is a new rejection from those set forth in the Office Action dated 10/31/2025 made in view of Applicant’s amendments to the claims dated 02/26/2026. Applicant’s Remarks dated 02/26/2026 have been reviewed but are deemed inapposite to the new rejection.---
Claim 233 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 11,697,822. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of Claims 9-11 of the ‘822 Patent from which Claim 12 of the ‘822 Patent depends and instant Claim 232 from which instant Claim 233 depends have the same genetic starting materials i.e. male sterility gene ms, restorer of fertility Ms1, suppressor of homoeologous pairing ph1b, the blue aleurone selection gene BLA and the same goal i.e. “wherein the cereal plant does not comprise a mis-division of the alien addition chromosome or the cereal plant does not comprise a breakage of the alien addition chromosome”.
Instant Claim 233 is drawn to a cereal plant obtained from “a method of Claim 232” (i.e., any part of the method of Claim 232) which is a product by process claim, meaning "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). It should be noted that newly amended Claim 232 does not comprise a selecting step after step (f) for a self-fertilized cereal plant comprising successful translocation of the monosomic alien addition chromosome, wherein step (f) only determines the presence or absence of “whether the monosomic alien addition chromosome was successfully translocated” in the self-fertilized cereal plant. As such, if the cereal plant of Claim 232 is not required (“selected”) to first comprise a breakage (and subsequent rearrangement), then it has not been translocated and no homoeologous chromosome is created; and then there is no 42-chromosome system and no improvement upon the 42 + 1 system. Additionally, the method steps b) and c) of Claim 9 of the ‘822 Patent are intended outcomes resulting from the presence of homoeologous suppressor mutation ph1b and not active method steps. As such, it unclear how the structure of the cereal plants produced by instant Claim 232 and Claims 9-11 of the ‘822 Patent (as recited in instant Claim 233 and Claim 12 of ‘822) would be structurally different from each other, particularly when both are required to not comprise a mis-division of the alien addition chromosome and/or a breakage of the alien addition chromosome. Therefore, the structural requirements of instant claim 233 are recognized as being also those of Claim 12 of U.S. Patent 11,697,822 because the plant obtained from Claim 232, step (e), wherein the cereal plant does not comprise a mis-division of the alien addition chromosome and/or the cereal plant does not comprise a breakage of the alien addition chromosome is appear to be indistinguishable from the plant obtained in Claim 12 of ‘822.
Response to Arguments
Applicant’s Remarks on pg. 11 of the reply filed on 02/26/2026 are acknowledged but do not overcome the new rejection above. In particular, Applicant’s Remarks rely on the premise that the amendments to Claim 232 render the nonstatutory double patenting rejection moot.
This is not found persuasive for the reasons given in the nonstatutory double patenting rejection above.
Closest Prior Art
Claims 232-233 appear to be free of the prior art, given the failure of the prior art to teach or suggest a BLA hybrid system comprising a male fertility restorer gene and a selection marker gene that stay on the same chromosome side of the centromere, or are integrated together in the genome, which in either case leads to a reduced chance that chromosome mis-division will separate fertility from the visible marker. The prior art also fails to teaches or suggest converting the unstable alien addition chromosome (disomic to monosomic) into a rearranged or translocated form within a euploid 42-chromosome background through homoeologous pairing. The closest prior art to Claims 232 and 233 can be found in found in Smart (WO 93/13649; issued 07/22/1993) which teaches a homeologous chromosomal pair of a 1st native chromosome with a fragment that recombined from the 2nd chromosome; a 2nd chromosome that comprises an alien addition chromosome fragment having the linked male fertility restorer Ms gene and a blue marker gene from Agropyron elongatum, a genome that is euploid, a mutation for homeologous pairing suppressor that is homozygous, and a male sterility mutation, having the blue aleurone selection marker and the fertility restorer gene on opposite sides of the centromere of the homeologous restorer chromosome, such that following persistent mis-division of the homeologous chromosome the linkage between the blue marker and the male sterility restorer gene is broken. Applicants invention presents a structural change in positioning of the selection elements; where the restorer of male fertility and the blue aleurone color selection marker are on the same side of the centromere of the homeologous chromosome thereby preventing the production of unmarked seeds (i.e. unmarked for blue aleurone) that arise from mis-division of the homeologous chromosome, and thus the yield potential is significantly improved and is therefore of practical significance in large scale commercialization of the technology.
Conclusion
No claims are allowed.
This action is NON-FINAL.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY L. MCWILLIAMS whose telephone number is (703)756-4704. The examiner can normally be reached M-F 08:00-17:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, AMJAD 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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/KELSEY L MCWILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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