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finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/01/2026 has been entered.
Examiner Note: Examiner suggests setting up an interview to discuss the remaining rejection and suggestions to overcome the issues presented.
Status of the Claims
Amendments dated 06/01/2026 have been entered.
Claims 1-3, 10-13, and 15-20 are pending.
Claims 1-3, 10-13, and 15-20 are examined herein.
Information Disclosure Statement
The Information Disclosure Statement filed on 06/01/2026 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of the list of references cited from the IDS
is included with this Office Action.
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.
---The following are new rejections from those set forth in the Office Action dated 02/13/2026 made in view of Applicant’s amendments to the claims. Applicants Remarks in the reply filed on 06/01/2026 are acknowledged but are deemed inapposite to the new rejections.---
Claims 1-3, 10-13, and 15-20 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.
Claim 1 recites the limitation “a control barley or sugar beet plant material grown under ambient greenhouse or standard growth-cabinet conditions without the treatment with the diurnal fixed temperature setting” which renders the claim indefinite. It is unclear based on the instant claims, and Applicant’s disclosure, what these control growth conditions would be and how they would differ from the “treatment” growth conditions, as neither the claims nor the instant specification teach the control plant material growth conditions—in a growth-cabinet or greenhouse. Applicant does not explicitly state the growth temperature, duration of temperature, light/dark cycles associated with plants grown in under ambient greenhouse conditions (Specification pg. 23, lines 8-10) and Applicant does not explicitly state the growth temperature, duration of temperature, light/dark cycles associated with plants grown in a standard growth cabinet (Specification, pg. 20, lines 18-22).
The state of the art, in regard to growing barley in a greenhouse under ambient (not controlled by human intervention) conditions, discloses that barley growth conditions in a greenhouse setting within a 24-hour time period would encompass temperatures ranging from 15-25° C (See Konate et al. (2020); pg. 3, paragraph bridging left and right columns; pg. 6, Figure 2). As such, it is unclear how the control barley plant material used in the instant invention can be grown under art-recognized ambient greenhouse conditions without being grown at a temperature that is included in the range of temperatures that would be part of the instant inventions “treatment” growth conditions. Due to the lack of disclosure in the instant specification and the state of the art, one of ordinary skill in the art would not be reasonably apprised on the metes and bounds of the claimed invention because it is unclear what the growth conditions would need to be for a control barley plant material to be grown under ambient greenhouse conditions without the ambient greenhouse conditions also encompassing the “treatment” conditions.
The state of the art, in regard to growing barley under standard growth cabinet conditions, teaches that “standard” grown cabinet conditions can vary from experiment to experiment. For example, Kong et al. (2025) teaches growing barley sprouts at a constant temperature of 22° C in a growth chamber with 85% humidity (pg. 2, right column, last paragraph). However, Hemming et al. (2012) teaches growing barley in a growth chamber under constant temperatures of 5°C or 25°C plus or minus 0.2°C and either a short-day treatment of 8-h light/16-h dark or a long-day treatment of 16-h light/8-h dark (paragraph bridging pgs. 1448-1449, left column, pg. 1449). Based on the state of the art, and without further disclosure from Applicant, it is unclear what “standard growth cabinet conditions” would be, as the conditions appear to vary in the state of the art, and even seem to overlap with the “treatment” conditions of the instant invention. As such, one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the claimed invention, because it is unclear based on the disclosure of the instant specification and the state of the art, what the growth conditions are for a barley plant being grown under standard growth-cabinet conditions.
Even though Claim 13 adds a further limitation, wherein the control barley or sugar beet plant material has not been treated according to Claim 1, step (d), this recitation does not actually define what conditions the control barley or sugar beet plant material is actually grown in to make the standard of comparison necessary to make determinations such as “increased meiotic recombination” in the treated barley or sugar beet plant material. Without a clearly defined control, one of ordinary skill in the art cannot readily visualize the metes and bounds of the standard of comparison necessary to make determinations such as “increased meiotic recombination” in the treated barley or sugar beet plant material as recited in the instant method claims. This aspect of the indefiniteness rejections may be overcome by amending the claim to recite an appropriate control relative to the treated plant material, wherein the growth conditions (i.e., growth temperature, duration of temperature, light/dark cycles, etc.) of the control barley and sugar beet plant material are clearly defined.
Response to Arguments
Applicant’s Remarks on pgs. 6-7 in the reply filed on 06/01/2026 are acknowledged but do not overcome these new rejections for the reasons given in the 35 U.S.C. §112(b) rejections above.
Claim Rejections – 35 USC § 112
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.
---The following are new rejections from those set forth in the Office Action dated 02/13/2026 made in view of Applicant’s amendments to the claims. Applicants Remarks in the reply filed on 06/01/2026 are acknowledged but are deemed inapposite to the new rejections.---
Claims 1-3, 10-13, and 15-20 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.
Claims 1-3, 10-13, and 15-20 are broadly directed to a method for increasing meiotic recombination in barley or sugar beet plant material, wherein the method comprises the following steps:(a) providing a barley or sugar beet plant material able to undergo meiosis;(b) identifying a treatment window having a start point and an end point based on morphological and/or molecular characteristics specific for the barley or sugar beet plant material of interest by aligning pre-meiosis and/or meiosis stages to at least one morphological and/or molecular characteristic;(c) optionally synchronizing the barley or sugar beet plant material;(d) treating the barley or sugar beet plant material with a diurnal fixed temperature setting for a defined time span based on the start point and the end point of the treatment window identified in step (b); and(e) obtaining a barley or sugar beet plant material with increased meiotic recombination in comparison to a control barley or sugar beet plant material grown under ambient greenhouse or standard growth-cabinet conditions without the treatment with the diurnal fixed temperature setting, as well as plant materials obtained from the method above.
Applicant describes two examples of optimizing the temperature conditions for growing barley and sugar beet plants in a greenhouse setting, and two examples wherein Applicant has identified a “treatment window” for barley and sugar beet plants based on plant dissection and staging.
In the first example, Applicant describes a method conducted to identify the best “treatment window” for barley that began with the germination and 8-week vernalization of barley. During vernalization, Applicant describes monitoring the barley plants for the detectable first node, then identifying the three most mature plants, and removing and measuring their spikes, wherein all plants should be 0.5 cm or smaller. After that, Applicant describes moving the plants into a growth cabinet where the plants were exposed to different temperature settings in the range of 18-30° C, under a 16h day and 8h night regime (pg. 20, Example 1). The diurnal temperature setting was applied until the flag leaf was emerging or the spike was above three cm in length for the smallest plants (least advanced) which was again confirmed by feeling the spike inside the stem (pg. 21, Example 1). For harvest, fertility counts were performed, always per tray to assess variability of sterility between center and edge of trays. Measurements were taken for the parameters of ear length, grain sites and grain number and F2 seeds were sown and leaves were sampled and sent for genotyping (pg. 21, Example 1). After pinpointing the zones of the chromosomes where an increased recombination frequency was observed, Applicant describes the results of the diurnal temperature treatment (Note, the stage of meiosis or pre-meiosis was not taken into account for this experiment), showing that depending on the “treatment window” (sans stage of meiosis) and the temperature regimen chosen, a significant increase of crossovers could be observed in naturally low recombining regions on the long arm of, for example, chromosome 7H in Zone 2.1 ( Figure 4) showing a significant increase of recombination of even 86%. This data is based on a temperature setting of 28°C to 22°C for the diurnal treatment. Applicant describes that various settings worked well and recombination was increased by at least 50%, which was regarded to be highly significant, in case the heat treatment was not above 30°C. Applicant also describes that a delta of 4°C, S°C, 6°C or 7°C whilst pinpointing the exact start point and the end point in the tetrad step always yielded fairly fertile material, without disclosing the recombination frequency of this plant material or how this meiosis stage was aligned to a morphological or molecular characteristics specific to barley in the treated plant material. Applicant posits that their findings showed that a targeted treatment of plant material could positively affect the recombination frequency, in particular cold spots of recombination, whilst maintaining fertility of the plant material subjected to the protocols established (pg. 21, Example 2). Applicant has not provided any type of description regarding the structural features of the control barley plant material used in this experiment to make the determination that the treatment has a positive effect on recombination frequency of treated plant materials while maintaining some degree of fertility in the treated plant materials.
In the second example, Applicant describes a method identify the best treatment window in barley to minimize off-target effects such as reduced fertility (or total sterility) to improve and to standardize the methods for enhancing recombination frequency. However, the barley plant material in this experiment did not go through any sort of diurnal heat treatment, merely dissection and aligning morphological characteristics (leaf number, height, leaf collar, ear base, spike size, and anther size) to a meiotic stage of the plant cell cycle (pg. 22, Example 3). Applicant states that it was confirmed that the ideal treatment start for both wheat and barley would be before meiosis, which was found to correspond to an 0.3 cm to 0.5 cm spike in barley, which has been shown to give the best correlation between meiotic stage and morphological parameter besides anther size and the ideal end date would be at the end of meiosis II (e.g. matching to the tetrad stage) which correlated to an ear size of over 2 to 3 cm, as this was found to improve fertility (pg. 22, Example 3).
In the third example, Applicant describes a method conducted to identify the best “treatment window” for sugar beet, wherein the treatment window was identified lasting three weeks starting from the first identification of flower development. With the treatment regimens, Applicant describes starting with lower temperatures starting from 18°C for the night treatment in the diurnal treatment scheme. Applicant states that “temperatures of 20°C or higher seemed to be more promising”, without describing how that determination was made. Applicant discloses that the day temperature was chosen to be higher than the night temperature (4°C to 10°C higher) . Applicant states that a “delta of around 4°C to 8°C seems to be most promising”, without describing how that determination was made. Applicant verified that drastic heat and/or cold shock treatments as described by the literature (above 30°C, above 34°C or even above 36°C and below S°C for the cold shock, respectively) were not suitable in the case where fertile plant material is desired in the end (pg. 23, Example 4). After further cultivation Applicant discloses that plant material was obtained and sent for genotyping. Applicant has not provided any type of description regarding the structural features of the control sugar beet plant material used in this experiment, nor any results that actually measured meiotic recombination and fertility rate of the sugar beet plants used in the experiment.
In the fourth example, Applicant describes dissecting sugar beet inflorescences to determine that inflorescence development is asynchronous and that every stage from pre-meiosis to mature pollen can be found (pg. 24, Example 5). Applicant describes that treatment for the sugar beet plant material should start at the onset of the transition from vegetative to reproductive growth, around the time when an early inflorescence structure can be identified. Sugar beet flowers around 3 to 4 weeks and therefore the treatment window was chosen to be the same as the flowering window based on the “very particulars of sugar beet”(pg. 24, Example 5). It should be noted that the sugar beet plant material in this experiment did not go through any sort of diurnal heat treatment, merely dissection and aligning one morphological characteristic (inflorescence development) to a meiotic stage of the plant cell cycle.
Applicant fails to describe the vast genus of control barley and sugar beet plant material able to be used as a point of comparison in the methods of the invention, wherein the vast genus of control barley and sugar beet plant material is required to be grown and maintained in currently undescribed “ambient greenhouse” or “standard growth-cabinet” conditions that are “control conditions” in relation to the plant material being treated with diurnal temperatures which have some degree of linkage to improving the meiotic recombination of said plant material, without completely eliminating plant fertility. As stated in the 35 U.S.C. 112(b) rejection above, Applicant does not describe what these control growth conditions would be and how they would differ from the “treatment” growth conditions, as neither the claims nor the instant specification teach the control plant material growth conditions—in a growth-cabinet or greenhouse. Applicant does not describe the growth temperature, duration of temperature, light/dark cycles associated with plants grown in under ambient greenhouse conditions (Specification pg. 23, lines 8-10) and Applicant does not describethe growth temperature, duration of temperature, light/dark cycles associated with plants grown in a standard growth cabinet (Specification, pg. 20, lines 18-22).
The state of the art, in regard to growing barley in a greenhouse under ambient (not controlled by human intervention) conditions, discloses that barley growth conditions in a greenhouse setting within a 24-hour time period would encompass temperatures ranging from 15-25° C (See Konate et al. (2020); pg. 3, paragraph bridging left and right columns; pg. 6, Figure 2). As such, it is unclear how the control barley plant material used in the instant invention can be grown under art-recognized ambient greenhouse conditions without being grown at a temperature that is included in the range of temperatures that would be part of the instant inventions “treatment” growth conditions. Due to the inadequate description in the instant specification and the state of the art, it is unclear what the growth conditions would need to be for a control barley plant material to be grown under ambient greenhouse conditions without the ambient greenhouse conditions also encompassing the “treatment” conditions.
The state of the art, in regard to growing barley under standard growth cabinet conditions, teaches that “standard” grown cabinet conditions can vary from experiment to experiment. For example, Kong et al. (2025) teaches growing barley sprouts at a constant temperature of 22° C in a growth chamber with 85% humidity (pg. 2, right column, last paragraph). However, Hemming et al. (2012) teaches growing barley in a growth chamber under constant temperatures of 5°C or 25°C plus or minus 0.2°C and either a short-day treatment of 8-h light/16-h dark or a long-day treatment of 16-h light/8-h dark (paragraph bridging pgs. 1448-1449, left column, pg. 1449). Based on the state of the art, and without further disclosure from Applicant, it is unclear what “standard growth cabinet conditions” would be, as the conditions appear to vary in the state of the art, and even seem to overlap with the “treatment” conditions of the instant invention. Additionally, it is unclear based on the inadequate disclosure of the instant specification and the state of the art, what the growth conditions are for a barley plant being grown under standard growth-cabinet conditions.
Even though Claim 13 adds a further limitation, wherein the control barley or sugar beet plant material has not been treated according to Claim 1, step (d), this recitation does not actually define what conditions the control barley or sugar beet plant material is actually grown in to make the standard of comparison necessary to make determinations such as “increased meiotic recombination” in the treated barley or sugar beet plant material.
Applicant fails to describe the structural features of the control barley and sugar beet plant material in the methods of the invention such that one of ordinary skill in the art would be able to distinguish control barley and sugar beet plant material that could not be used as a point of comparison in the methods of the invention, from control barley and sugar beet plant material that could not be used as a point of comparison in the methods of the invention. Applicant fails to adequately describe the growth conditions of control barley and sugar beet plant material in a greenhouse or growth-cabinet in such a way so one of ordinary skill in the art would be able to differentiate control barley or sugar beet plant growth conditions from the growth conditions of the instantly claimed treatment conditions.
One of ordinary skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the broadly claimed genera in view of the disclosed species. Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the compositions used in the claimed methods and plant material, Applicant does not appear to have been in possession of the claimed genera at the time this application was filed.
Response to Arguments
Applicant’s Remarks on pgs. 6-7 in the reply filed on 06/01/2026 are acknowledged but do not overcome these new rejections for the reasons given in the 35 U.S.C. §112(a) rejections above.
Closest Prior Art
Claims 1-3, 10-13, and 15-20 appear to be free of the prior art. The closest prior art in regards to Claims 1-3, 10-13, and 15-20 can be found in Salgado et al. (Diss. University of Dundee, January 2019; IDS Document) which teaches a method for studying transcription during meiosis and meiosis under heat stress in barley plants (pg. 288, Introductions/Objectives), wherein barley seeds are grown in modular trays (pg. 291, Section 7.3.1) and the plants were grown in a growth cabinet with an air temperature of 18/16˚C during the light/dark period (pg. 292, first paragraph), until one tray of plants from each batch was moved to another cabinet for the heat stress conditions, 26 days after germinating; when the plants had a Zadoks growth stage of 13, with around three and a half unfolded leaves, and 13.5 cm height to the auricle, with a spike size of around 1.8 mm. The heat shock therefore started early enough to cover the development of all the plants from pre-meiosis to the end of meiosis (tetrads or microspores). The growth cabinet in heat shock conditions had also 16 hours photoperiod, but a 30˚C day and 25 ˚C night temperature regime (pg. 292, Section 7.3.3). Heat treated plant tissue was collected for downstream RNA extraction and analysis (pg. 294, first full paragraph), and staging data was noted for each of the dissected plants following these morphological features: number of unfolded leaves, height to the last auricle, number of nodes, spike size, anther size in the middle of the spike, and meiotic stage of the anther when possible (pg. 292, Section 7.3.5.).
However, the disclosure of Salgado fails to teach or suggest the primary purpose of the instant claims wherein plants that undergo a diurnal heat shock treatment that starts at the pre-meiosis or early meiosis stage identified by one or more of leaf number, leaf height, leaf collar length, ear base length, development of one or more spike(s), and ends at the tetrad stage identified by length of an ear, emergence of a flag leaf, a spike having a longitudinal axis longer than 2.7 cm, and/or an anther having a longitudinal axis no longer than 3 cm, have increased meiotic recombination relative to plants that have not undergone the short-term heat shock treatment.
Conclusion
No claims are allowed.
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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/KELSEY L MCWILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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