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 .
Claims 1-15, and 125-136 as amended on 31 August 2020 were examined and rejected in a non-final Office action posted on 24 August 2023. Applicant responded on 21 December 2023. A final rejection was posted on 9 April 2024. Applicant responded on 9 August 2024 with an RCE amending and cancelling claims. Claims 125-133 were examined and rejected in an Office action posted 2 December 2024. Applicant responded on 2 May 2025 amending and cancelling two claims. Claims 125-126 and 129-133 were examined and rejected in an Office action posted 12 August 2025.
Applicant responded on 12 January 2026 with an RCE
125-126 and 129-133 are examined herein.
amending and cancelling 1claims.
Examiner's Notes & Claim Interpretation
Citations to Applicant's specification, if any, are abbreviated herein "Spec."
Claim 125 uses the limitation “surrogate assay” in the third line of part (e).
Merriam-Webster defines the noun "surrogate" "1 a : one appointed to act in place of another" and "3: one that serves as a substitute" (accessed 26 November 2024)(see Office action 2 Dec. 2024, p. 5). Thus in his context, "surrogate" is synonymous with "model." Claim 125 is drawn to an experiment with a with a control using yeast as a model organism for a plant.
The last lines of claim 125 read
wherein the growth response of the yeast cell is a surrogate assay for determining the impact on plant health of expression of the gene of interest, wherein the growth response of the yeast cell is determined by colony size or optical density, and wherein the growth response of the yeast cell is used as a high-throughput surrogate assay for determining impact on plant health.
Claim 125 is a method claim. Nothing in the lines above represents an actual step. They certainly ‘breathe life’ into the claim and provide context. The “health” of a plant is not given any particular meaning and can be reasonably interpreted as, e.g., a lack of drought resistance or stress tolerance compared to a plant exhibiting drought resistance or stress tolerance.
In fact, “high-throughput” is somewhat at odds with the claim only requiring two yeast cells.
Withdrawal of Objections and Rejections
The rejection of claims 125-126 and 128-136 under 35 U.S.C. 112(a)’s written description requirement is withdrawn in view of Applicant’s amendments to the claims.
35 USC § 112(b)-Based Claim Rejections
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.
Claim 129 is 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.
Claim 129 is rejected because it is impossible to “operably link” a promoter to the “no gene” embodiment.
35 USC § 112(d)-Based Claim Rejections -
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 133 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 133 requires hyperspectral imaging, but claim 131 requires visual inspection. So claim 133 falls outside the scope of its base claim.
35 USC § 102 Based Claim Rejections
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 125, 126, and 129-132 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (2010) J Plant Physiol 167:1172-78as evidenced by the teachings of the ATCC for a map and sequence of p416GPD vector cited by Song et al. GenBank (2005) DQ269148.1 (map from ATCC (2026) accessed 8 October 2026).
Claim 125 compares two yeast cells, one expressing a "gene of interest" and the other not expressing the "gene of interest."
A Markush group of alternatives for the “gene of interest” includes genes that, for example, would provide drought resistance. For the ‘second’ gene are several genes for marker proteins such as the CAT gene or a housekeeping gene or no gene at all.
The claim then requires comparing growth.
The final part of the claim calls this a “surrogate” assay AND requires that this “is used as a high-throughput surrogate assay for determining impact on plant health.”
Song et al. discloses that (at p. 1172, btm.)
In this study, the functional characters of three organellar and two cytosolic AtHsp90 proteins were analyzed in the model organism yeast S. cerevisiae.
At the beginning of the abstract, Song et al. discloses
The genome of Arabidopsis thaliana contains seven Hsp90 family genes. Three organellar and two cytosolic AtHsp90 isoforms were characterized by functionally expressing them in a temperature-sensitive Hsp90 mutant and a conditional Hsp90-null mutant of Saccharomyces cerevisiae.
On page 1173, , 2nd para. of “Plasmid constructions, the authors describe their controls.
Yeast cells with p416GPD and pScHsp82 acted as negative and positive controls.
At the end of the article, the authors state
This preliminary study provides important information about the function of AtHsp90 family members against abiotic stress.
Thus, Song et al. satisfies the claim’s requirement for at least two yeast cells, one of which is a control. The heat shock genes satisfy the requirement of claim 125 for a gene of interest involved in stress tolerance. Figure 1 visually shows colony size as an experimental result.
Given the number of colonies, this discloses a high-throughput screen more than the claim itself which only requires two cells.
Since Song et al. teaches expressing heat shock genes from Arabidopsis in yeast, this is a surrogate assay.
A recent map of the p416GPD vector cited by Song et al. under “Plasmid constructions” is provide for convenience. (map from ATCC accessed 8 October 2026).
Therefore Song et al. anticipates claims 125 and 126.
Claim 129 requires that the gene of interest by operably linked to a promoter so it is expressed. Since Song et al. expresses the gene it is evident that indeed, the gene of interest was operably linked to a promoter. Therefore Song et al. anticipates claims 129 and 130.
Song et al.’s Figure 1 allows for visual observation of colony size and thus anticipates claim 131 and 132.
35 USC § 103-based Claim Rejections
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 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:
§ 103. Conditions for patentability; non-obvious subject matter
A patent for a claimed invention may not be obtained, . . . . 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 125, 126, 129, 130, 131, and 132 are rejected under 35 U.S.C. 103 as being unpatentable over Rine (2014)/(2017) Mol Biol Cell 25(5):549-73 (published online 2017) in view of
Huang et al., U.S. Patent Publication 2008/0153102 A1;
Chaerle et al. (2001) Biochim Biophys Acta 1519:153-66; and
Callahan et al. Calahan (2011) Genet 189:507-19.
Applicant's arguments filed 12 January 2026 as they apply have been fully considered but they are not persuasive. Applicant is claiming using yeast as a model organism.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:a. Determining the scope and contents of the prior art.b. Ascertaining the differences between the prior art and the claims at issue.c. Resolving the level of ordinary skill in the pertinent art.d. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 125 compares two yeast cells, one expressing a "gene of interest" and the other not expressing the "gene of interest."
A Markush group of alternatives for the “gene of interest” includes genes that, for example, would provide drought resistance. For the ‘second’ gene are several genes for marker proteins such as the CAT gene or a housekeeping gene or no gene at all.
The claim then requires comparing growth.
The final part of the claim calls this a “surrogate” assay AND requires that this “is used as a high-throughput surrogate assay for determining impact on plant health.”
Applicant is claiming a yeast cell as a model organism relative to model plants.
Using yeast as a model organism for plants is obvious
Rine titled his 2014 review article “A future of the model organism model.”
In the first full paragraph of page 552, Rine teaches “Surrogate genetics—the testing of a gene from one organism in the context of a model organism.”
The second column of page 551 is largely devoted to improving yield in plants, “yield stability” in plants The second paragraph focuses on yeast genes that improve drought resistance in plants.
Drought resistance is recited in the sixth line of claim 125. Nitrogen use is also recited in the same line.
The additional limitations found in claim 125 are also obvious
With the “first” and “second” yeast cells, that is just an experimental yeast and a control yeast. Huang et al. teaches controls in paragraph 0036 and ”a high throughput system for screening nitrogen usage” in paragraph 0056.
Chaerle et al.(2001), another review article teaches “imaging techniques to monitor plant health” (the title).
Rine cites to Callahan et al. which teaches yeast growth to monitor “desiccation tolerance” i.e. drought resistance. See, in particular the “Results” section beginning on page 510.
Further, claim 125 ends with “wherein the growth response of the yeast cell is used as a high-throughput surrogate assay for determining impact on plant health.” This does not reflect an active step in the method. Further, the claim explicitly requires only TWO yeast cells.
It would have been prima facie obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention as per the teachings of Rine’s review article to use yeast as a model organism for a plant.
Given the level of skill in the art as of the effective filing date of the claimed invention one of ordinary skill in the art would have had a reasonable expectation of success. Rime’s review article was submitted in 2013 and accepted in 2014.
Therefore claim 125 is obvious.
Using S. cerevisiae is obvious as seen in Rine – the second column of page 550 and throughout the cited references. Thus claim 126 is obvious.
Claim 129 recites features of an expression cassette, e.g. Huang et al. paragraph 0074, and thus claims 129 and 130 are obvious.
Using one’s eyes to observe the growth is obvious and thus claims 131 and 132 are obvious.
Applicant’s Argument & Response
On page 7 or the response, Applicant discusses Huang et al. and alleged deficiencies in the analysis.
Applicant’s analysis is not persuasive. Applicant is trying to claim the use of yeast as a model organism. The claims are not tied to any specific aspect of plant health, Applicant is claiming a genus. That is not novel in view of the prior art.
Further, Huang et al. is no longer the primary reference.
A combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. When a work is available in one field, design incentives and other market forces can prompt variations of it, either in the same field or in another. If a person of ordinary skill in the art can implement a predictable variation, and would see the benefit of doing so, § 103 likely bars its patentability. (citing to United States v. Adams, 383 U.S. 39, 50-52, 86 S. Ct. 708, 174 Ct. Cl. 1293 (1966).)
KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 405, 127 S. Ct. 1727, 1734, 82 U.S.P.Q.2D 1385, 1389 (2007).
Claim 133 is rejected under 35 U.S.C. 103 as being unpatentable over
Rine (2014)/(2017) Mol Biol Cell 25(5):549-73 (published online 2017) in view of
Huang et al., U.S. Patent Publication 2008/0153102 A1;
Chaerle et al. (2001) Biochim Biophys Acta 1519:153-66; and
Callahan et al. Calahan (2011) Genet 189:507-19; ;and in further view of
Lee (2015). "Plant Health Detection and Monitoring" in: Park & Lu (eds) Hyperspectral Imaging Technology in Food and Agriculture;. Food Engineering Series; Springer, (NY).
Applicant's arguments filed 12 January 2026 as they apply have been fully considered but they are not persuasive.
As seen above, the base claim of claim 133 is rejected under35 USC 103.
The first four references do not teach hyperspectral imaging. However, in view of the teachings of Lee (2015) (p. 276) it would have been prima facie obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to combine Lee's teachings with the first two references to use hyperspectral imaging to determine plant health. Given the level of skill in the art as of the effective filing date of the claimed invention one of ordinary skill in the art would have had a reasonable expectation of success. Also note the association of the colors on page 276. Therefore claim 133 is obvious.
Applicant addresses this rejection separately at the end of page 10 but relies on the argument against the base claim.
Other Prior Art
The following prior art, not cited above, is cited below. Gangadhar et al. also discloses many of the limitations of, for example, claim 125. For example, ““yeast cells over-expressing heterologous potato cDNA sequences to tolerate heat stress” in the abstract. Gangadhar et al. (2014) Mol Genet Genom 289:185–201.
Conclusion
No claim is allowed.
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/RUSSELL T BOGGS/Examiner, Art Unit 1663
