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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(a)-(d) and (f)
[EP20214768.2 filed on 12/16/2020] and 35 U.S.C. 365(c) [national stage of PCT/EP2021/086323 filed on 12/16/2021] is acknowledged. As such the effective filing date for Claims 1-3, 10-13, and 15-20 is 12/16/2020.
Status of the Claims
Amendments dated 11/18/2025 have been entered.
Claims 4-9 and 14 have been cancelled by Applicant.
Claims 1-3, 10-13, and 15-20 are pending.
Claims 1-3, 10-13, and 15-20 are examined herein.
The objections to the Drawings have been withdrawn in view of Applicant’s amendments to the drawings.
All previous claim objections and rejections of record are rendered moot in light of Applicant’s amendments to the claims.
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 08/19/2025 in view of Applicant’s amendments to the claims---
Claims 1-3, 10-13, and 15-20 remain 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.
Claims 1 and 12-13 recite the terms “control plant material” or “control barley or sugar beet plant material” which render the claims indefinite. Applicant defines “control plant material” in the instant specification as “usually grown under natural conditions” (pg. 5). However, based on the instant disclosure, it is unclear what the growth conditions would need to be for barley or sugar beet plants to be considered “grown in natural conditions” (i.e., do the control plants need to be grown in a field or can they be grown in a greenhouse and still be considered “natural conditions”?) or what the alternative growth conditions would need to be for a barley or sugar beet plants to not be grown under natural conditions. Even though Claim 13 adds a further limitation, wherein the control plant material has not been treated according to Claim 1, step (d), this recitation does not actually define what conditions the control plant material is actually grown in to make the standard of comparison necessary to make determinations such as “increased meiotic recombination” in the treated 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 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., are the plants grown in a green house or in field conditions, growth temperature, duration of temperature, light/dark cycles, etc.) of the control plant material are clearly defined.
Claims 12 and 13 recite the term “control barley or sugar beet plant material” which renders the claims indefinite. There is insufficient antecedent basis for the limitation in the claim. Claim 1, from which Claims 12 and 13 depend, recites in part (e) “control plant material” and does not explicitly recite “control barley or sugar beet plant material”. For examination purposes, the “control plant material” from Claim 1 and the “control barley or sugar beet plant material” from Claims 12 and 13 will be treated as the same claim term. However, this determination does not relive Applicant from their duty to amend the claims in any further correspondence.
Response to Arguments
Applicant’s Remarks on pgs. 7-8 in the reply filed on 11/18/2025 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 08/19/2025 in view of Applicant’s amendments to the claims---
Claims 1-3, 10-13, and 15-20 remain 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.
Claims 1-3, 10-13, and 15-20 are broadly directed to 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 plant material, 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 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). It should be noted that Applicant has not actually described how this determination of an ideal start and end point to the treatment was made for the step of “identifying”, without further disclosure regarding the “series of tests” performed to make this determination. Applicant has not provided any type of description regarding the structural features of the control plant material used in this “series of tests” to identify an ideal treatment start point and endpoint for either barley or wheat.
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 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 has not actually described how this determination of an ideal start and end point to the treatment was made for the step of “identifying”, without further disclosure regarding what is meant by the “very particulars of sugar beet” used to make this determination. Additionally, Applicant has not provided any type of description regarding the structural features of the control plant material used in this experiment to identify an ideal treatment start point and endpoint for sugar beet.
Applicant fails to describe the vast genus of control plant material able to be used as a point of comparison in the methods of the invention, wherein the vast genus of control plant material is required to be grown and maintained in currently undescribed conditions that are “control conditions” in relation to the plant material being used in an undefined treatment with diurnal temperatures which has some degree of linkage to improving the meiotic recombination of said plant material, without completely eliminating plant fertility. Even when examining the two exemplified species of plant material described by the Applicant, Applicant fails to provide any description of the control plant material (or conditions it was grown in) used in the barley or sugar beet working examples. As stated in the 35 U.S.C.§ 112(b) rejection above, Applicant defines “control plant material” in the instant specification as “usually grown under natural conditions” (pg. 5). However, the Applicant does not describe what the growth conditions would need to be for barley or sugar beet plants to be considered “grown in natural conditions” or what the alternative growth conditions would need to be for a barley or sugar beet plants to not be grown under natural conditions. Even though Claim 13 adds a further limitation, wherein the control plant material has not been treated according to Claim 1, step (d), Applicant does not actually define what conditions the control plant material is actually grown in to make the standard of comparison necessary to make determinations such as “increased meiotic recombination” in the treated plant material.
When looking at the narrowest embodiment of the working examples, Applicant does not describe how the determination of an ideal start and end point to the treatment was made for the step of “identifying” with barley and sugar beet. In the case of sugar beet, from the working examples, Applicant does not even provide evidence that exposing sugar beet plant material to optimized diurnal temperature settings the prescribed treatment window would actually result in some degree of improved recombination frequency or improved fertility rate in the treated plant material. Applicant also does not define the morphological and/or molecular characteristics specific to sugar beet plant material for determining when the tetrad stage of meiosis has begun in sugar beet (claimed treatment end point), thus Applicant does not adequately describe the structure features of the treatment end point for sugar beet plant material undergoing the claimed treatment method in such a way that one of ordinary skill in the art would be capable of identifying the morphological and/or molecular characteristics considered to be the indicators of the treatment endpoint for sugar beet plant material from the morphological and/or molecular characteristics what would not be the indicators of the treatment endpoint for sugar beet plant material.
Applicant fails to describe the structural features of the claimed barley and sugar beet plant material such that one of ordinary skill in the art would be able to distinguish the start and end point of treatment windows that would or would not lead to obtaining treated barley or sugar beet plant material with increased meiotic recombination or improved recombination frequency.
Applicant fails to describe the structural features of the claimed sugar beet plant material such that one of ordinary skill in the art would be able to distinguish treatment windows and morphological or molecular characteristics aligned to stages of plant development that would or would not lead to obtaining treated sugar beet plant material with increased meiotic recombination or improved recombination frequency.
Applicant fails to describe the structural features of the control plant material in the methods of the invention such that one of ordinary skill in the art would be able to distinguish control plant material that could not be used as a point of comparison in the methods of the invention.
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. 7-8 in the reply filed on 11/18/2025 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 Lloyd et al. (Genetics 208.4 (2018): 1409-1420; IDS Document) which teaches growing A. thaliana Col-0 plants under long-day growth conditions (16 hour day at 19–21°C/8 hour night at 15°C) until the primary inflorescence began to emerge from the rosette. Plants were then transferred to a range of small, constant temperature, long-day growth chambers at the experimental temperatures (5–30°C). For cytology, Lloyd et al. teaches that plants were grown to the same developmental age and height after flowering, and then transferred to growth chambers at 8, 18, or 28°C for 1 week before material was collected to make slides. As the duration of meiosis has previously been demonstrated to last 33 hours at 18.5°C, 1 week was chosen to be long enough to complete meiosis at each temperature without causing a significant impact on the developmental trajectory of the plants. However, the disclosure of Lloyd et al. does not teach or suggest treating the Col-0 plants with two fixed diurnal temperature for the whole of meiosis, much less targeting the Col-0 plants with the two diurnal temperatures from the point of pre-meiosis, wherein the treatment is targeted to begin upon the detection of an early inflorescence or the onset of reproductive growth, until the tetrad stage of meiosis. In fact, Lloyd et al. teaches ending the two diurnal temperature treatment as soon as the inflorescence began to emerge from the rosette. The disclosure of Lloyd et al. also doesn’t teach or suggest that the methods of their invention could be extrapolated to any other dicot plants, much less sugar beet.
Conclusion
No claims are allowed.
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.
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