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 9, 10, 12, 24 and 25 are presented for examination.
The amendments and remarks filed on 02/20/2026 have been received and entered.
Continued Prosecution Application
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/20/2026 has been entered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 9, 10, 12, 24 and 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
First, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101 defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. The latter three categories define "things" or "products" while the first category defines "actions" (i.e., inventions that consist of a series of steps or acts to be performed). See 35 U.S.C. 100(b) ("The term ‘process’ means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material."). See MPEP § 2106.03 for detailed information on the four categories.
Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called "judicially recognized exceptions" or simply "exceptions") are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). See MPEP § 2106.04 for detailed information on the judicial exceptions.
Claims are drawn to A plurality of crop plants having improved yield consistency, in
an agricultural locus relative to a control set of crop plants, comprising:
a plurality of crop plants in association with a plurality of remodeled nitrogen fixing
bacteria, wherein the plurality of remodeled nitrogen fixing bacteria colonize the rhizosphere of
the plurality of crop plants and supply the plurality of crop plants with at least 1% of their in planta
fixed N,
wherein each bacterium of the plurality of remodeled nitrogen fixing bacteria comprises at
least one genetic variation introduced into at least one gene, or non-coding polynucleotide, of the
nitrogen fixation or assimilation genetic regulatory network, and wherein the standard deviation
of mean yield measured across the agricultural locus, in bushels per acre, is lower for the plurality of crop plants in association with the plurality of remodeled nitrogen fixing bacteria, as compared
to a control plurality of crop plants, when the control plurality of crop plants is provided to the
agricultural locus, wherein the agricultural locus comprises soil that is agriculturally challenging
due to one or more of: high sand content, high water content, unfavorable pH, poor drainage or
underperformance relative to a control soil, as measured by mean yield of a crop in the underperforming soil compared to mean yield of a crop in a control soil.
Analysis of the flowchart:
Step 1, is the claim to a process, machine, manufacture or composition of matter? Yes. The claim is drawn to a composition of matter.
Step 2A. Prong one: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
Yes, Claims 9, 10, 12, 24 and 25 are drawn to plurality of crop plants in association with nitrogen fixing bacteria.
Step 2A. Prong two: Does the claims recite additional elements that amount to significantly more than the judicial exception?
No. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, as there is no indication that the claimed product to have any characteristics that are different from the naturally occurring component of an natural compound.
For the reasons described above, the claimed compositions are not markedly different from their closest naturally occurring counterparts and thus are product of nature judicial exceptions. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements beyond the claimed products themselves. Also, this is a product claim and since there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more thana judicial exception and are thus deemed patent ineligible subject matter.
Claim Rejections - 35 USC § 112
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 12 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 12 is rejected as being indefinite for the recitation of the term for N fixation activity
"fixed N of at least about 2.75 x 10-12 mmol N per CFU per hour". The claims are
indefinite because this unit of measure is not defined, its methodology of measuring and
calculating are not defined, and it is unclear how the metes and bounds of the claims are to be determined.
Firstly, it should be noted that Applicant appears to be the only user of this term "fixed N
of at least about 2.75 X 10-12 mmol N per FUC per hour" while no other art, patent publications or non-patent publications have employed this concept, or the equivalent, e.g., N
per CFU per hour. Therefore, a skilled artisan has to rely solely on Applicant's disclosure to
ascertain not only the meaning of this term but more importantly, how to determine/measure it.
The Specification in multiple instances has stated, the precise value of mmol N produced per microbe per hour (mmol N/Microbe hr)". However, the Specification has not described or defined, explicitly or via incorporation of reference, how this unit is determined or measured, and the methodology in the measuring and calculation.
Therefore, it is impossible for a skilled artisan, looking at any engineered bacterium, to ascertain
whether it is encompassed within the scope of the instant claims.
Therefore, the claims are rejected.
Applicant is reminded to considered new matter issue when attempting to add the
methodology for determining the N fixation units.
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.
Claim9, 10, 12, 24 and 25 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 claims A plurality of crop plants having improved yield consistency, in an agricultural locus relative to a control set of crop plants, comprising:
a plurality of crop plants in association with a plurality of remodeled nitrogen fixing
bacteria, wherein the plurality of remodeled nitrogen fixing bacteria colonize the rhizosphere of
the plurality of crop plants and supply the plurality of crop plants with at least 1% of their in planta
fixed N,
wherein each bacterium of the plurality of remodeled nitrogen fixing bacteria comprises at
least one genetic variation introduced into at least one gene, or non-coding polynucleotide, of the
nitrogen fixation or assimilation genetic regulatory network, and wherein the standard deviation
of mean yield measured across the agricultural locus, in bushels per acre, is lower for the plurality of crop plants in association with the plurality of remodeled nitrogen fixing bacteria, as compared
to a control plurality of crop plants, when the control plurality of crop plants is provided to the
agricultural locus, wherein the agricultural locus comprises soil that is agriculturally challenging
due to one or more of: high sand content, high water content, unfavorable pH, poor drainage or
underperformance relative to a control soil, as measured by mean yield of a crop in the
underperforming soil compared to mean yield of a crop in a control soil.
The claims are broad in scope to encompass a wide range of bacterium, including gram
negative, positive, and photosynthetic bacteria, for example (at least for claim 9 and its
dependent claims 10, 12 and 25). Even the narrower claims 24, encompass
numerous gene or non-coding polynucleotide.
In addition, each of the bacterial genera, species, isolates, and strains, comprise a
complex network of genetic factors that are directly or indirectly involved in nitrogen fixation, or
the regulatory mechanism of nitrogen fixation, plant colonization, and the regulation of plant
colonization.
Furthermore, the claims are broad in scopes regarding the diverse range of genetic
modifications, that encompass any heterologous genetic elements as long as the elements are
from the same genus of bacteria; or any type of genetic modifications including insertions,
deletions, substitutions, rearrangements, etc., and any combinations thereof; and any type of gene
or genome editing at any locus of the bacterial genome; and any combinations of genetic
transformation (with intergeneric elements), mutagenesis, genome editing, and/or directed
evolution.
In contrast to the broad scope of the claims, applicant has only described eleven strains
of bacteria (at least two wild-type strains and at least seven genetically altered strains) by their
deposit numbers and species (three different species in total); and the strains as having nitrogen
production activity and peak colonization capacities as set forth in FIGS. 8, 24, 25, and Tables 28
and 29, etc. Applicant has asserted a description of "more than a dozen representative members
of the described genus." Applicant has further described results showing nitrogen production
activity and peak colonization activities in with respect to various strains in corn fields and in the
laboratory/greenhouse. Specifically, Applicant shows the results from 13 strains that satisfy the
requirements of the claims in the field. Those 13 strains are comprised of four bacterial species -
Kosakoinia sacchari, Kosakoinia pseudosacchari, Rahnella aquaiilis and Klebsiella variicola -
and those strains comprise mutations in three genes - nifL, glnE and amtB. (Tale 25, e.g.).
However, Applicant has not described the structural features essential to the claims - the
genetic modification of the broad range of bacteria or combination of
bacteria species having the specific functional activity of fixing N of "at least about 2.75 x 10-12 mmol N per CFU per hour”.
Applicant has not described the structures that are required for the functions of colonizing
plant roots at the required levels, producing nitrogen at the required levels and excreting nitrogen
such that it is utilized by/incorporated into plants at the required levels. Taking just the nitrogen
fixation requirement as an example, Mus et al. (Appl. Environ. Microbial. 82.13 (2016): 3698-
3710) teaches that within the Nif operon there are genes that are likely involved in nitrogen
fixation but have unknown functions. As such even within the Nif genes, structures required for
function are unknown. (p. 3704 left col. 1 4 - right col. 1 1). Mus et al. further teaches that other
genes are found in both diazotrophs and non-nitrogen fixing bacteria (such as the fixABCX
genes) that appear to have function in nitrogen fixation but also have unknown functions. (p.
3704 left col. 1 4 - right col. T 1). As such, a skilled artisan would not be able to reasonably
predict which bacteria that can perform the recited functions from other bacteria that would not,
based upon their structural composition.
Thus, these results demonstrated, despite the alleged understanding and modeling
Applicant has based on to design an "all encompassing" method to identify any and all "non-
intergeneric remodeled bacteria" having the functional activity of fixing N of "at least about
2.75 x 10⁻12 mmol N per bacterial cell per hour"
Furthermore, regarding the aspect of root colonization, Applicant, or the state of the art,
at the time of filing of the instant application has not provided an adequate
understanding of the essential features governing a bacterium's ability to colonize the root tissue
of the diverse range of host plant in any environmental conditions.
Buddrus-Schiemann et al. (Microb Ecol (2010) 60:381-393) teaches that the colonization
capacity of Pseudomonas, plant growth promoting bacteria (PGPBs) that colonize the rhizosphere of plant roots, is greatly affected by soil type conditions (p. 386 right col. 1 2), and
the presence of other microbes in the rhizosphere and time (p. 387 left col. 1 1 - p. 398 left col. 1
1, Table 2, Figure 3). Okubo et al. (Microbes Environ. Vol. 29, No. 2, 184-190, 2014) teaches
that temperature, carbon-dioxide levels and plant growth stages greatly affect the colonization
capacities of rhizosphere-colonizing bacteria, (p. 185 right col. 1 5 - p. 189 left col.
The teachings of these art show that the factors that combine to regulate a bacterium's
nitrogen fixing capabilities and colonization ability, in a complex manner that has not been
adequately described at the time of filing of the instant application, in order for Applicant to
broadly claim all future discoveries. See Vas-Cath Inc. V. Mahurkar 1991 (CA FC) 19 USPQ2d 1111, 1115, which teaches that the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent; and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by
pretending that his invention is more than what it really is, or different from its ostensible
objects, that the patentee is required to distinguish his invention in his specification. In this case,
there is no way that a practitioner would be able to determine if a method using any particular
strain of bacteria is infringing the instant claims, and therefore, the public has not been put on
notice with a sufficient description of the claimed invention.
The limited number of species described by Applicant are insufficient to describe the
recited genus by virtue of example.
Hence, Applicant has not, in fact, described the claimed methods within the full scope of
the claims, and the specification fails to provide an adequate written description of the claimed
invention.
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 9, 10, 12, 24 and 25 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In In re Wands (8 USPQ2d 1400 (CAFC 1988)), the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation". These factors include: (a) the quantity of experimentation; (b) the amount of guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the predictability of the prior art; (g) the breadth of the claims; and (h) the relative skill in the art.
The factors are analyzed in turn for the instant case as follows:
In the instant case, in order to practice of making the claimed genus of "non-intergeneric
remodeled bacteria" to have the functional activity of fixing N of "at least about 2.75 x10-12 mmol N
per bacterial cell per hour" it would require an unpredictable amount of undue experimentation for the following reasons:
The claims are extremely broad in scope as discussed above. To reiterate, the claims are
broad in encompassing a wide range of bacterium, including gram negative, positive, and
photosynthetic bacteria, for example (at least for claim 9 and its dependent claims 10, 12 and 25).
In addition, each of the bacterial genera, species, isolates, and strains, comprise a complex network of genetic factors that are directly or indirectly involved in nitrogen fixation, or the regulatory mechanism
of nitrogen fixation, plant colonization, and the regulation of plant colonization.
Furthermore, the claims are broad in scopes regarding the diverse range of genetic modifications
and any combinations of genetic transformation (with intergeneric elements), mutagenesis,
genome editing, and/or directed evolution.
However, in contrast to the extremely broad scope, Applicant has only described a
limited set of bacteria, limited type of modification in a very limited number of genes.
As discussed above, Applicant has not provided teachings sufficient to enable one of
ordinary skill in the art to practice the claimed invention using bacteria across the scope of the
claims.
The genus of modified bacteria required for the invention is vast, encompassing any
Bacteria that can perform the recited functions, including bacteria that are normally not capable of performing the recited functions but have been genetically modified to do so by inserting genes encoding polypeptides that enable colonization at the required levels, nitrogen production at the required levels and excretion such that plants will absorb and incorporate the excreted nitrogen products at the required levels.
Taking just the nitrogen fixation requirement as an example, Mus et al. (Appl. Environ.
Microbiol. 82.13 (2016): 3698-3710) teaches that within the Nif operon there are genes that are
likely involved in nitrogen fixation but have unknown functions. As such even within the Nif
genes, structures required for function are unknown. (p. 3704 left col. 1 4 - right col. 11). Mus
et al. further teaches that other genes are found in both diazotrophs and non-nitrogen fixing
bacteria (such as the fixABCX genes) that appear to have function in nitrogen fixation but also
have unknown functions. (p. 3704 left col. 1 4 - right col. 11). As such, a skilled artisan would
not be able to reasonably predict which bacteria that can perform the recited functions from other
bacteria that would not, based upon their structural composition.
Thus, these results demonstrated, despite the alleged understanding and modeling
Applicant has based on to design an "all encompassing" method to identify any and all "non-
intergeneric remodeled bacteria" having the functional activity of fixing N of "at least about
2.75 x10-12 mmol N per bacterial cell per hour" the unpredictability remains.
The state of the art, in view of the disclosure from the applicant, demonstrate that it would have been highly unpredictable to engineer genus of nitrogen fixing bacteria within the confines of genes directly involved in nitrogen fixation (i.e., the nif operon), even given the relatively rich
scientific knowledge of the many decades of studying biological N fixation (BNF), which still
remains a sort of holy grail. Given the broad range of bacteria encompassed in the claim, the
diverse range of genetic modification of myriads of genes directly responsible or indirectly-but
not less critically-regulating the N fixation activity, in conjunction with the even more complex
interaction between microorganism and the host plant required for root colonization, the level of
unpredictability is even higher.
In contrast to the extremely broad scope of the claims and the high level of
unpredictability, Applicant has only offered a very limited set of working example that serve to
address a very narrow range of the claim scope. However, as discussed above, even regarding
the nifL gene and promoter in K. variicola (the species used in Applicant's working example),
the level of unpredictability is high.
Given limited guidance supplied by Applicant, the breadth of the claims and the nature of
the invention, as well as the unpredictability in the art, it would have required one skilled in the
art undue trial and error experimentation to practice the claimed invention through the full scope of its claims.
Claim Rejections - 35 USC § 102/103
(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.
Claim(s) 9-12, 24 and 25 is/are rejected under 35 U.S.C. 102(b) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Temme et al. (WO 2017011602).
Temme et al. teach methods of increasing nitrogen fixation in a non-leguminous plant. The methods can comprise exposing the plant to a plurality of bacteria. Each member of the plurality comprises one or more genetic variations introduced into one or more genes or non- coding polynucleotides of the bacteria's nitrogen fixation or assimilation genetic regulatory network, such that the bacteria are capable of fixing atmospheric nitrogen in the presence of exogenous nitrogen. The bacteria are not intergeneric microorganisms. Additionally, the bacteria, in plant, produces 1% or more of the fixed nitrogen in the plant. See the abstract and claim 1. Temme et al. teach the plant is an agricultural crop plant. In further embodiments, the agricultural crop plant is selected from sorghum, canola, tomato, strawberry, barley, rice, maize, and wheat. In further embodiments, the plant is a genetically modified organism. In further embodiments, the plant is not a genetically modified organism. In some embodiments, the plant has been genetically engineered or bred for efficient nitrogen use. See Para [0064] and claim 23. Temme et al. teach microbes in and around food crops can influence the traits of those crops. Plant traits that may be influenced by microbes include: yield (e.g., grain production, biomass generation, fruit development, flower set); nutrition (e.g., nitrogen, phosphorus, potassium, iron, micronutrient acquisition); abiotic stress management (e.g., drought tolerance, salt tolerance, heat tolerance); and biotic stress management(e.g., pest, weeds, insects, fungi, and bacteria). Strategies for altering crop traits include: increasing key metabolite concentrations; changing temporal dynamics of microbe influence on key metabolites; linking microbial metabolite production/degradation to new environmental cues; reducing negative metabolites; and improving the balance of metabolites or underlying proteins. See Para [0064]. Temme et al. teach the plant is grown in soil from a field which has been administered at least 50 lbs. of nitrogen-containing fertilizer per acre, and wherein the nitrogen- containing fertilizer comprises at least 5% nitrogen by weight. See claim 9. The use of at least one gene, a non-coding nucleotide of the bacterium's nitrogen fixation or assimilation genetic regulatory network are selected from the group consisting of: nifA, nifL, ntrB, ntrC, polynucleotide encoding glutamine synthetase, glnA, glnB, glnK, drat, amtB, polynucleotide encoding glutaminase glnD, glnE, nifJ, nifH, nifD, nifK, nifY, nifE, nifN, nifU, nifS, nifV, nifW, nifZ, nifM, nifF, nifB, and nifQ as claimed in claim 24 is taught in claims 16, 41 and 61. The non-intergeneric bacteria as claimed in claims 25 is taught in claims 27 and 55. The increase in yield is taught in Paras [0063], [0064], [0087] and [00117].
Claim Rejections - 35 USC§ 102/103
Claim(s) 9-13, 24 and 25 is/are rejected under 35 U.S.C. 102(b) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kumar et al. (WO9305154).
Kumar et al. teach a method of providing plants with a source of fixed nitrogen which comprises Introducing a mutant nitrogen fixing bacterium into nitrogen fixing association with plant tissue. See claim 12. Kumar teaches that the mutant bacteria are introduced to the soil before or after planting. See claim 13. Kumar also teaches the mutant bacteria is introduced to the plant and seeds before or after planting. See claims 14 and 15. It would have been obvious to a person skilled in the art to determine the percentage of nitrogen received by the plants, the amount of fixed nitrogen and the genetic variation introduce into a gene considering
that applicant is claiming a plurality of plants in combination with a nitrogen fixing microbes with no other limitations. The nitrogen fixing bacterium of claim 24 is taught in the abstract. The determination of bushels per acre and comparing the yield with controlled plants is considered to be within the skill of artisan in the absence of evidence to the contrary. Kumar makes clear that the crop plants having the claimed nitrogen fixing bacteria as old and well known. The improved yield consistency is the inherent property of the same crop plant being in association with the same nitrogen fixing bacterium of Kumar, considering that the claims are drawn to a product and not a method of use.
Claim Rejections - 35 USC § 102/103
Claim(s) 9, 10, 12, 24 and 25 is/are rejected under 35 U.S.C. 102(b) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Das (US 20150128670).
Das teaches a crop plant inoculants and biofertilizer composition comprising the recombinant microorganism capable of continuous biological nitrogen fixation in presence of fixed nitrogen and oxygen thereby increasing the yield of the crop plants and reducing the degradation of soil. See Para [0023]. Das teaches that The yield of the crop in the absence of chemical fertilizer and the presence of the recombinant microorganism HKD15 was found to be higher than the yield of the crop in the presence of Azotobacter chroococcum CBD15, as shown in Table 2. The recombinant Azotobacter chroococcum HKD15 was found to be an efficacious crop inoculant and a biofertilizer. See Para [0106]. It would have been obvious to a persons killed in the art to determine the percentage of nitrogen received by the plants, the amount of fixed nitrogen and the genetic variation introduce into a gene considering that applicant is claiming a plurality of crop plants in combination with a nitrogen fixing microbes with no other limitations. The increase in yield of the crop plants is taught in Para [0023]. The genes as claimed in claim 24 are taught in Para [0046], [0047], [0065] and claims. The determination of bushels per acre and comparing the yield with controlled plants is considered to be within the skill of artisan in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments and remarks have been noted. Applicant in his remarks argues that “The claimed lowered standard deviation across the locus comprising agriculturally challenging soil for the plurality of crop plants in association with the remodeled nitrogen fixing bacteria is evidence of improved yield consistency for said plurality of crop plants. In this way, the instant specification uncovers that the claimed remodeled nitrogen fixing bacteria provide improved yield consistency to the plurality of crop plants whose rhizospheres they colonize in agriculturally challenging environments (emphasis added). In
contrast, while Temme and Das disclose the effects that recombinant nitrogen fixing bacteria can
have on "yield" of crop plants to which they are introduced, neither reference makes mention of
"yield consistency" OR the use of said remodeled nitrogen fixing bacteria on crop plants in agriculturally challenging loci as recited in claim 9 as amended (emphasis added). Yield consistency differs from yield in that yield consistency affords the improved feature of a consistent yield across cultivated acreage, irrespective of weather, environment, or soil conditions, thereby allowing farmers an increased degree of predictability for achieving a desired yield across each planted acre. Additionally, Kumar makes no mention of yield or yield consistency or the use of the claimed remodeled nitrogen fixing bacteria in agriculturally challenging loci”. It is the examiner's position that that applicant is claiming a plurality of crop plants in combination with a nitrogen fixing microbes with no other limitations. Therefore, since the relied upon references teach the crop plants in combination with the same nitrogen fixing bacteria as claimed herein, the increase in yield consistency is going to be the inherent property of such combination. There is no evidence of record that the crop plants of the relied upon references in combination with the claimed nitrogen fixing bacteria is not capable of improving yield consistency. Applicant's attention is drawn to In re Spada, 911 F. 2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990), wherein he court stated "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In the instant case the prior art teaches the same crop plants in association of the same nitrogen fixing bacterium as claimed in the instant application. Therefore, improving yield consistency is an inherent property of the prior art plant crops. The unexpected results are also the inherent property of the prior art crop plants in association with the claimed nitrogen fixing bacteria. Although, Kumar does not teach the improvement of crop yield, but the claims are not directed to "a method of improving yield consistency". The claims are
drawn to plurality of crop plants in combination of nitrogen fixing bacterium, which is taught by Kumar. To plant the prior art’s product in an agriculturally challenging loci, does not create a patentably distinct product. Applicant has discovered a property of the claimed composition, which inherently exists in crop plants of the relied upon references. Applicant in his response refers to example 12 of specification to show results of Applicant's experiments across 47 different soil types in variable weather conditions across 13 states in the U.S., which revealed that the claimed microbes in association with a plurality of crop plants (i.e., corn plants) thrived in all of the evaluated soil types and weather conditions. Applicant also refers to table 35 to show corn yield of remodeled bacteria-treated plants exposed to challenging soil as compared to the level of corn yield by plants exposed to conventional soil. It is the examiner’s position that such advantages are the inherent property of the prior art product. The method of using a product in different soil and obtaining a higher yield does not create a patentably distinct product. The yield consistency is also the inherent property of the prior art product, considering that applicant is claiming the same product as prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617