Prosecution Insights
Last updated: April 19, 2026
Application No. 18/897,262

Methods And Systems For Producing A Protein Of Interest In A Plant

Final Rejection §103§112
Filed
Sep 26, 2024
Examiner
WILLIAMS, KEITH RICHARD
Art Unit
1663
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Immunitybio Inc.
OA Round
4 (Final)
30%
Grant Probability
At Risk
5-6
OA Rounds
2y 4m
To Grant
0%
With Interview

Examiner Intelligence

Grants only 30% of cases
30%
Career Allow Rate
3 granted / 10 resolved
-30.0% vs TC avg
Minimal -30% lift
Without
With
+-30.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 4m
Avg Prosecution
26 currently pending
Career history
36
Total Applications
across all art units

Statute-Specific Performance

§101
20.3%
-19.7% vs TC avg
§103
31.2%
-8.8% vs TC avg
§102
13.9%
-26.1% vs TC avg
§112
32.1%
-7.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 10 resolved cases

Office Action

§103 §112
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 In response to previous restriction requirement, applicant has chosen to elect Group III for examination, consisting of claims 1 & 8-11, without traverse. Claim Status Claims 1, 11 & 22-24 are under examination on the merits. Claims 8-10 & 21 are cancelled. Claims 2-7 & 12-20 are withdrawn from examination. Priority Claims 1, 11 & 22-24 receive the U.S. effective filing date of 06-09-2021 Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1, 11 & 22-24 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. The amended claim recites a limitation of the oolitic aragonite additive when incorporated into the medium environment. This describes the moisture content after incorporation into a complete growing medium. Applicant refers to p.19, par.66 for support to this amendment, wherein the last line of the paragraph mentions moisture content. However, the specification does not describe moisture content of the complete medium, or of the aragonite fraction after mixing with other ingredients. The specification only describes the moisture content of the oolitic aragonite prior to incorporation with other media components. Because the claims are limiting to a feature not described in the specification, claim 1 and dependent claims 11 & 22-24 are rejected for introducing new matter. Response to Arguments Applicant urges that addition of the amended limitation of moisture content <10% after the incorporation of aragonite adds an additional feature making claim 1, and thus all dependents, non-obvious. This is not found persuasive because the specification only describes the moisture content of oolitic aragonite before it is added to the growing medium. The claim recites a moisture content of <10% when incorporated. This is not described in the specification, nor is it clear how one would arrive at the specific moisture content of a singular component of a multi-component soil medium when in use. Absent specific teachings to the contrary, a growing medium’s moisture will reasonably be considered to fluctuate throughout the course of crop production, with total media saturation or near saturation occurring when plants are being watered or during rain, and moisture levels reaching low points or complete dryness (i.e. <10%) between watering or during drought. Within such range of commonly encountered moisture changes, it is not clear how the physical adsorption properties of aragonite would change relative to the total moisture reading of the soil, when aragonite comprises a component of it. Because this new matter is not described in the specification, Applicant’s arguments are unconvincing. 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. Claims 1, 11 & 22-24 are rejected as being unpatentable over Genty [US 10803312 B2; Published 06-06-2019], Scott [Aust. J. Agric. Res., 1992, 43, 1175-85; Published 11-29-1992], Kajiyama [US 3988141; Published 01-23-1975], Marcotte [Cage Mill Operation, Application and Aglime. Rock Products News, ‘rockproducts.com/2020/03/13/cage-mill-operation-application-and-aglime/’; Published 03-13-2020], and Evans [Greenhouse Management Online. University of Arkansas Extension, https: //greenhouse.hosted.uark.edu/, verified 23 Feb 2026; Published 2008]. Due to Applicant’s amendment of the claims, the rejection is modified from that set forth in the Office Action dated 24 Nov 2025. Applicant’s arguments filed 19 Jan 2026 have been fully considered but they are not persuasive. Claims are drawn to a system comprising the following components/limitations: (a) growing medium containing ball milled oolitic aragonite comprising particles of 3-10μm and of wherein the aragonite contains <10% moisture (amended), (b) a plant producing a protein of interest, (c) incubation equipment including lighting, (d) at least one sensor to determine at least one parameter of the plant, (e) a memory, (f) a processor, (g) controlling of duration, intensity and wavelength of light, (h) a CaCO3 soil additive >10% by weight, (i) control of water, food or chemicals in addition to controlling light, (j) inclusion of calcium-magnesium carbonate (CaCO3 + MgCO3), and (k) inclusion of at least one of gypsum, borax, weathered lignite, phosphate, paramagnetic basalt powder, glacial gravel dust, potassium, fulvic acid powder, or humic acid powder. Genty teaches a system having components (b-g) as claimed in the instant application (i.e. limitations of claims 1 & 22). Claim 1 of Genty [column 18, line 35] provides description of producing 'one or more' plants of interest in an indoor farm. Any plant of interest being grown will produce desirable proteins [i.e. claim 1] that comprise the harvested parts of crop plants. Growing plants in a growth chamber or greenhouse will obviously produce various proteins of the cells and tissues harvested. The definition of 'incubator' is commonly understood to be an apparatus or controlled environment for the care and rearing of living things. Applicant provides no alternate definition to suggest different than the common meaning. Therefore, an ‘incubator’ includes a greenhouse or any artificially controlled plant growing environment. As such, Genty teaches components (b-g) of the claimed system. Genty teaches that beyond measurement of generic plant growth (i.e. protein in the form of tissue production), their system operates via “determining…a phytochemical efficiency” of plants in their claim 2. Protein production rate, protein compositional ratio, and/or concentration of proteins is included by such claim (i.e. characterization of protein production is a phytochemical efficiency). Genty also teaches components of an indoor growing system that sense the plants by using imaging sensors [col.18, 1.49] and analyze the image data [col.18, 1.56]. They teach using this data to control parameters of the growing environment via a data warehouse (memory component) which communicates with a computational decision making-model to provide a data processing function [col.18, lines 54 & 37]. Further, Genty claims information is processed and analyzed by the system to control the light fixtures in the growing environment [col.18, 1.63-67]. Genty’s system modifyies light intensity, the spectral output (wavelength), and photoperiod (duration of light cycle) to optimize plant growth. [Abstract]. Genty thus clearly teaches components (b-g) of Applicant’s claim 1. While they focus on, and claim, lighting parameters it is important to note their disclosure indicates the system can be used to control any crop production input, including water and nutrient applications [col.3, l.45-54]. Regarding claim 22; its distinction is that it is directed to control of plant growing inputs in addition to control of light, via a controller distributing water or chemicals. Genty teaches this. While the focus of their disclosure is the control of light conditions, their automated growing system is described as being able to control any input relevant to or influencing the growth of plants. This is highlighted in their ‘Detailed Description’, wherein they list a variety of input factors to be controlled or regulated based on sensor data [col.4, l.45-54]. This is component (i) of Applicant’s claimed system. Thus, Genty teaches all ‘non-media’ limitations of the incubator and plant/plant protein production components (b-g & i) of Applicant's system. Genty does not teach growing media to be used in such a system, comprising aragonite or other components and their proportions. However, Scott, Kajiyama, Marcotte and Evans teach all compositional aspects of the growing media claimed by Applicant. Scott teaches finer sizings of agricultural lime are more desirable (i.e. valuable) due to the functional characteristics of smaller particles. They teach that there is essentially no lower sizing limit to this size-to-value relationship (i.e. no particle size is ‘too small’) [p.1184, par.5]. They teach finer grades of ag lime additives have greater functional benefit to soil, and describe testing effectiveness of ground/milled CaCO3 down to a sizing of 0.005mm, which is the equivalent of 5 μm. This directly teaches use of, and benefit contributed by, CaCO3 soil additives in the range of 3-10μm being claimed by Applicant in claim 1 (a). This teaches the size limitation of system component (a) above. Kajiyama teaches the use of ‘finely divided’ marine oolitic aragonite as a form of CaCO3 useful to horticulture, teaches specifics of such aragonite soil additive compositions. They teach using aragonite in soil mixes can increase yield by 40% and additionally teach that it can be applied in any amount without detrimental effect [Abstract]. They describe the use of aragonite with plants cultivated in pots [col.2, 1.55-67] then specifically claim this use as a soil additive in claim 1 of their patent [col.7, 1.4]. Kajiyama further teaches the various compositional characteristics of aragonite, and its admixture to soils, which address limitations of claims 11 & 23. Kajiyama teaches proportions of aragonite to up to 10% magnesium hydroxide by weight [col.8, 1.10-14]. By definition an additive of two parts, of which one (magnesium hydroxide) can be up to 10% inherently limits the second part (calcium component) to 90-99%. Claim 11 of the instant application specifies the calcium component of the additive is at least 10%. This teaches the compositional limitation of component of (h) of the claimed system. Thus, the claimed proportion of the calcium component being >10% is within the range of values taught by Kajiyama. Newly added claim 23 recites use of calcium carbonate sources including calcium-magnesium carbonate (CaCO3+MgCO3), which is also provided for by Kajiyama’s disclosure, as they teach dolomitic lime and magnesia-lime (i.e. CaCO3+MgCO3) as alternate forms of magnesium replenishing agents that can be used in soil mixes with aragonite [col.1, l.20-23; col.5, l.39-52]. This teaches the compositional limitation of component (a), and component (j) of the claimed system. Marcotte teaches the process of grinding, or milling, using ball mills to achieve the ultra-fine small sizes indicated by Scott. They describe that agricultural lime is reduced in size via crushing mills and that for ultra-fine lime, ball mills are used [par.15-16]. This teaches the limitation directed to the method of producing the aragonite additive of component (a) above. Evans teaches the inclusion of phosphates with calcium soil amendments, as in newly added claim 24 [See Evans ‘Substrates’, Section 4: Common Substrate Amendments, ‘Superphosphates’]. This teaches the component of (k) above. Additionally, Evans teaches that when designing and mixing growing media, components are mixed dry to avoid clumping and (i.e. <10% moisture) to achieve uniform particle distribution, and that water is then added to achieve proper growing moisture, after mixing components but prior to placement in containers or use [‘Substrates’, Section 7:Mixing and Handling of Growing Media, par.3-5]. This teaches the <10% moisture component of (a) above. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to have combined the system taught by Genty, with improved soil media using fine lime additives described by Scott, preferably from the highly beneficial and renewable oolitic aragonite taught by Kajiyama. Marcotte further directs one to ball mills as a preferred method of generating ultra-fine lime particles. Evans points to other beneficial soil additives, including phosphate(s). Combining these known components, one would arrive at the instantly claimed method and/or system. One trained in researching horticultural production systems would have clear precedent for all components of Applicant’s system as reported in the prior art. Applicant merely claims a more detailed characterization (i.e. more specific sizing measurements) of an extant product established in the public domain (i.e. ‘sea calcium’), combined with routine processing using ball mills and growing systems. Simply because such small particles (i.e. 3-10μm), are not routinely characterized in commercially graded, ball-milled lime, or are not characterized when oolitic aragonite ‘sea calcium’ is used as the CaCO3 source, does not mean particles 3-10μm are not present, absent any evidence to the contrary. Merely looking at an existing product with a ‘bigger microscope’ and describing what one sees does not amount to invention. The shortcoming of Genty's disclosure in not describing the growing medium to be used is merely because their research appears to be focused on the environmental control systems, in which any known growing medium might be used. Prior art describes the relevant components of such media, including the clear benefits of fine lime additives indicated by Scott, along with the purported benefits of oolitic aragonite-based CaCO3 made by Kajiyama, which would make it obvious to combine these components for a predictable outcome of an improved plant growing system. Additionally, Marcotte directly indicates ball mills can be used to achieve such ultra-fine fractions of agricultural lime. It would be obvious to seek out any commercial, and renewable source of increasingly refined forms of such calcium, including finely ground sizes of oolitic aragonite. When presented optional methods of milling/grinding aragonite it would be obvious to use the lowest-energy, or cost, means of grinding, milling, or otherwise processing to ultra-fine sizing, including use of a ball mill. It would also be obvious to include magnesium sources such as magnesia-lime, as taught by Kajiyama, and supplemental, known growth-enhancing amendments or additives such as phosphorus, taught by Evans. Such work is routine in the formulation and optimization of growing media. One would be motivated to combine these disclosures in order to generate a production system with the highest possible potential yield based on known positive effects of oolitic aragonite as a finely milled form of calcium coupled to previously described, automated growing systems. Additionally, the organic and renewable nature of precipitated aragonite provides yet further motivation to utilize ‘oolitic’ marine sand as a source of this agricultural lime, and to combine it with with other known additives, such as magnesia-lime and/or phosphorous, to improve crop yield. All limitations of claims 1, 11 & 22-24 were clearly known in the art at the time of filing, and it would be routine for one to combine components of known beneficial soil amendments with existing automated growing systems in order to produce a high-value crop. This would include those plants engineered to produce highly valuable endogenous or exogenous proteins. Because of this, claims 1, 11 & 22-24 are rejected. Response to Arguments The previous non-final Office mailed 24 Nov 2025 action did not include withdrawn claim 18 in the obviousness rejection. Claims included in previous 103 rejection were 1, 11 & 22. For the purposes of compact prosecution, Applicants arguments are being considered as directed to the rejected claim 22, which also depends from claim 1 similar to claim 18, and to which no substantially different argument, other than dependency from 1, are being presented by Applicant. Applicant urges that previous 103 rejection of claims 1, 11 & 18 are improper because the amended language of claim 1 now includes a limitation drawn to moisture content, thus overcoming the previous rejection. This is not found persuasive because the specification only describes the moisture content of oolitic aragonite before it is added to the growing medium. The claim recites a moisture content of <10% when incorporated. This is not described in the specification, nor is it clear how one would arrive at the specific moisture content of a singular component of a multi-component soil medium when in use. Absent specific teachings to the contrary, a growing medium’s moisture will reasonably be considered to fluctuate throughout the course of crop production, with total media saturation or near saturation occurring when plants are being watered or during rain, and moisture levels reaching low points or complete dryness (i.e. <10%) between watering or during drought. Within such range of commonly encountered moisture changes, it is not clear how the physical adsorption properties of aragonite would change relative to the total moisture reading of the soil, when aragonite comprises a component of it. If the recited moisture content is intended to reflect aragonite as a singular, pre-mix component, such components are commonly mixed dry to avoid clumping and achieve uniform particle distribution [See Evans, above]. This reasonably includes any potential media component being used at <10% moisture (i.e. dry), making the newly added limitation both routine and obvious. Further, Applicant is silent as to argument of the specific reasons cited for previous obviousness rejection of claims 1, 11 & 22. Applicant urges that new claims 23 & 24 are non-obvious because they introduce the limitations of a calcium-magnesium carbonate, and, addition of at least one additional additive such as phosphorous, respectively. This is not found persuasive because the prior art of Kajiyama teaches the use of magnesium sources, including magnesia-lime and dolomitic lime, thus directly teaching the limitation of claim 23 [Kajiyama, col.1, l.20-23]. Further, prior art of Evans, referenced in the final rejection previously mailed 11 July 2025, which teaches mixture of horticultural soils includes both lime sources and additional supplements such as phosphorous [Evans, ‘Substrates’, Section 4], teaching the limitation of claim 24. 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. 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. Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEITH R WILLIAMS whose telephone number is (571)272-3911. The examiner can normally be reached Mon - Fri, 9:30 - 5:30 EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KEITH R. WILLIAMS/Examiner, Art Unit 1663 /Anne Kubelik/Primary Examiner, Art Unit 1663
Read full office action

Prosecution Timeline

Sep 26, 2024
Application Filed
Mar 04, 2025
Non-Final Rejection — §103, §112
Jun 12, 2025
Response Filed
Jul 10, 2025
Final Rejection — §103, §112
Sep 02, 2025
Response after Non-Final Action
Oct 14, 2025
Request for Continued Examination
Oct 16, 2025
Response after Non-Final Action
Nov 19, 2025
Non-Final Rejection — §103, §112
Jan 19, 2026
Response Filed
Mar 05, 2026
Final Rejection — §103, §112 (current)

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Prosecution Projections

5-6
Expected OA Rounds
30%
Grant Probability
0%
With Interview (-30.0%)
2y 4m
Median Time to Grant
High
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