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 .
Claim Interpretation
Applicant’s claims for example recite a plant growth regulator/composition comprising an extract of an ergothioneine-producing microorganism as an active ingredient. Comprising language is open-ended and excludes nothing from the instant claims thus comprising an extract reads on the microorganism itself and cultures of the cells, etc. of the microorganism as these cells and cultures of the cells would comprise any and all components of any extracts and as such read on the claimed plant growth regulator.
Applicant’s also claim in claim 11 that the composition is subject to an extraction treatment. However, again the claims use the comprising language which is open-ended as discussed above. Further, the claims are actually to the composition and not the method of making that composition/extraction method and it is known, “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). In the instant case, because nothing is actually excluded from the claimed composition the cultures of the specific microorganisms do read on the claimed compositions comprising extracts.
With respect to claim 13, based on the specification, etc. the examiner is interpreting this claim to actually read “at least one of hot water extraction…and autoclave extraction.”
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 1-3, 5-9, and 11-15 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring product without significantly more. The claim(s) recite(s) that they comprise a regulator/composition comprising an extract of an ergothioneine producing microorganism as an active ingredient which is a natural product/naturally occurring product and the composition claims as currently written do not require anything that is significantly more than the naturally occurring product because for instance the claimed Dirkmeia churashimaensis (also known as Pseudozyma churashimaensis) was naturally occurring and known to naturally produce ergothioneine as is taught/evidenced by Sato et al. (AMB Express, 2024, vol. 14, article 20). This judicial exception is not integrated into a practical application because the claims fail to incorporate the natural phenomenon/natural product without significantly more. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed compositions of the product of nature, extracts of naturally occurring microorganisms such as Dirkmeia churashimaensis, do not require anything else in the composition, the claimed compositions are nothing more than an attempt to generally link the product of nature to a particular technological environment (plant growth regulator) which is merely an intended use and does not structurally limit or change the natural product, extracts of Dirkmeia churashimaensis which is known to produce ergothioneine, in any way from the naturally occurring Dirkmeia churashimaensis which can be naturally disrupted/broken up to release its contents/extracts in nature (e.g. by physical damage/crushing, etc.).
Instant claims 1-3, 5-9, 11-15 recites and/or claim/include a microorganism extract wherein the extract comprises/contains an extract of an ergothioneine producing microorganism. Thus, the composition need not contain anything except the microorganism whole and broken up which occurs naturally via physical breaking/grinding, etc. or in culture which does not change the microorganism from that which occurs in nature. Thus it appear that this judicial exception is not integrated into a practical application because nothing else is required by applicant’s claims and as such the claims fail to integrate the judicial exception into a practical application. This is because merely a composition which need only comprise a product of nature and nothing else reads on that which is already found in nature.
Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012), the Supreme Court set forth a two-step framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts. The first step looks to determine whether claims are directed to a patent-ineligible concept. Mayo, 132 S. Ct. at 1297. If they are, the second step is to consider whether the additional elements recited in the claim “transform the nature of the claim” into a patent eligible application by reciting an “inventive concept” that is “sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself.” Id. at 1294.
Claim 1 of U.S. Patent No. 6,355,623 in the Mayo dispute is reproduced here for applicant’s convenience:
1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8.times.10.sup.8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8.times.10.sup.8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
In addition, the court in Arisosa Diagnostics, Inc v. Sequenom, Inc., No. 2014-1139, Fed. Cir. June 12, 2015 found ineligible claims drawn to a method of detecting paternally inherited cell free fetal DNA (cffDNA) in serum or blood. It is determined that the natural phenomenon in the claims is the cffDNA found in serum or blood.
The PTO guidance for determining subject matter eligibility under 35 U.S.C. 101 may be found in the Federal Register notice/ Subject Matter Eligibility update,” hereafter referred to as the “Guidance.” The Guidance supersedes the factor-based analysis of the “Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural Phenomena, and/Or Natural Products” from March of 2014.
The Guidance provides a test for determining subject matter eligibility under 35 U.S.C. 101 that comprises the following steps:
1) Is the claim to a process, machine, manufacture, or composition of matter? If the answer to this question is “no,” then the claim is not eligible subject matter under 35 U.S.C. 101. If the answer to this question is “yes,” then the analysis proceeds to the second step.
2) Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)? If the answer to this question is “no,” then the claim is eligible subject matter under 35 U.S.C. 101. If the answer to this question is “yes,” then the analysis proceeds to the third step.
3) Does the claim recite additional elements that amount to significantly more than the judicial exception? If the answer to this question is “no,” then the claim is not eligible subject matter under 35 U.S.C. 101. If the answer to this question is “yes,” then the claim is eligible subject matter under 35 U.S.C. 101. Applicant is also directed to Section III of the Guidance (“Sample Analyses”), in particular, Example 5, Mayo v. Prometheus (U.S. Patent No. 6,355,623).
In the instant case, the claims are drawn to one of the statutory categories, i.e., a composition of matter, so the analysis proceeds to the second step. With respect to the second step, the claims are deemed to be directed to a judicially recognized exception, i.e., a product of nature, because, claims 1-3, 5-9, 11-15 are drawn to a composition which need only comprise the natural product/naturally occurring product that is an extract of an ergothioneine producing microorganism of which the claimed species include/are naturally occurring microorganisms e.g. D. churashimaensis and as the claimed extract need only comprise/be broken up and whole D. churashimaensis or cultures of naturally occurring yeast cells, e.g. D. churashimaensis which are naturally occurring the claimed extracts do not require significantly more than the naturally occurring product as it is found in nature as nothing in culturing the microorganism would read or the claimed hot water extraction (as per the reasoning discussed below in the 103 rejections over Ryu) or grinding the microorganism significantly and/or materially changes the microorganism from the D. churashimaensis which is found in nature. This discovery does not, by itself, render the instant claims as patent eligible. Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 2117 (2013) (“Myriad”). As a result, the answer to the second question is deemed to be “yes,” and the analysis proceeds to the third step. As indicated above, the third step asks whether the claim recites elements or steps in addition to the claimed judicial exception that amount to significantly more than the judicial exception. As indicated above, the instant claims are drawn to a composition which need only contain extracts of an ergothioneine producing microorganisms and which do not distinguish the extract from merely just being the cells themselves or the cells in culture both of which contain all parts of the D. churashimaensis, e.g. whole cells, broken cells etc. which are known to naturally occur in the claimed D. churashimaensis as it is naturally found, thereby claiming a composition which comprises an extract of microorganisms is not significantly more than the judicial exception and as such the claims are still not patent eligible at this time as the claims use comprising language which open-ended and does not exclude the cells themselves in culture media or merely broken and whole cells of D. churashimaensis which occur together in nature from reading on the claimed extracts.
As a result, it is the Examiner’s position that the instant claims inform a relevant audience about a naturally existing compound and compositions that need only comprise the naturally occurring D. churashimaensis cells broken and whole as they would exist in nature, etc. Thus, the claims do not amount to significantly more than the product of nature, and accordingly, the claimed invention is not directed to patent eligible subject matter under 35 U.S.C. 101.
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.
Claims 13-15 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 is indefinite because it recites wherein the extract is obtained by treating said microorganism by extraction treatment comprising at least hot water extraction…and autoclave extraction. It is unclear to the examiner how applicants are accomplishing all of the claimed modes of extraction on the claimed extract? Specifically, are all the claimed modes of extraction being done separately to the microorganism and then are they being combined into a mixed extract? Or are they being done stepwise in a specific order? Or are applicants for instance forming a successive extract by for instance first performing a grinding extraction then subjecting the grinding extract to a hot water extraction, and then subjecting the extract from the grinding and hot water extraction to a methanol extraction, etc.? Or did applicants actually intend the claim to read comprising at least hot water extraction…or autoclave extraction, or did applicants intend the claim to read …comprising at least one of… or autoclave extraction? Thus, the metes and bounds of what applicants are trying to accomplish with this claim are completely indefinite and because there are nearly an indefinite number of possible interpretations and orders of extraction methods which could be encompassed by the claim. Thus, until the claim language is made clear as to what extractions are being performed and/or combined and/or being done successively this claim is not being further examined with respect to prior art due to the multiple ambiguities.
Claims 13-15 are also indefinite because they recite “hot water”. The term “hot” in claims 13-15 is a relative term which renders the claim indefinite. The term “hot” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear to the examiner what range of temperatures is considered “hot” with respect to the claimed “hot water”. For purposes of applying art the examiner has interpreted this to mean temperatures of 40 °C or above.
Claim 18 is also rejected because it depends from and/or include the limitations of claim 15 and does not resolve the ambiguities of that claim.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 4-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Otsu et al. (JP2018130091A from IDS, espacenet machine translation/global dossier machine translation used).
Regarding claim 1, Otsu teaches a fertilizer/plant growth composition comprising a culture of a microorganism capable of synthesizing/producing ergothionein/ergothioneine, and wherein the fertilizer comprising the ergothioneine can be formed by subjecting the microorganism culture to extraction (see paragraph beginning: The fertilizer of the embodiment can be manufactured using the culture of the embodiment as a raw material…; paragraph beginning: The fertilizer of the embodiment includes a culture of a microorganism capable of biosynthesizing ergothionein…; paragraph beginning: The fertilizer of the embodiment may be a culture of the microorganism capable of biosynthesizing ergothionein itself or a diluent such as water or an additive such as nutrient may be added to the culture of the embodiment…)
Regarding claim 4, Otsu teaches treating a plant with the plant growth regulator comprising ergothioneine extract from microorganisms was applied as a hydroponic culture solution to plants and/or seeds (see Examples 1-4 cultivation of plants section; The fertilizer of the embodiment can be manufactured using the culture of the embodiment as a raw material…; paragraph beginning: The fertilizer of the embodiment includes a culture of a microorganism capable of biosynthesizing ergothionein…; paragraph beginning: The fertilizer of the embodiment may be a culture of the microorganism capable of biosynthesizing ergothionein itself or a diluent such as water or an additive such as nutrient may be added to the culture of the embodiment…).
Regarding claims 5-9, Otsu teaches wherein their fertilizer/plant growth regulating composition (which contains the culture of the microorganisms which produce ergothioneine, and teaches that the culture of the microorganisms can be the fertilizer) contains 50 mg/L or more of ergothioneine and this anticipates the amounts of erogothioneine applicant’s instantly disclose for use in their compositions and as such Otsu’s compositions are inherently compositions which are agents for increasing seed yield, increasing plant height, increasing flower number, increasing aboveground part weight, and increasing underground part weight as claimed as these are intended uses of the composition(s) which comprise the disclosed amount of ergothioneine in applicant’s specification and as the composition of Otsu contains this same amount of ergothioneine it will inherently function as these types of agents (See culture and fertilizer section, specifically paragraph beginning: The culture according to the embodiment contains 50 mg / L or more of ergothioneine,…; and the paragraph beginning: The fertilizer of the embodiment includes a culture of a microorganism capable of biosynthesis of ergothioneine. That is, the culture can be used as a fertilizer…; paragraph beginning: The fertilizer of the embodiment can be manufactured using the culture of the embodiment as a raw material…; paragraph beginning: The fertilizer of the embodiment includes a culture of a microorganism capable of biosynthesizing ergothionein…; paragraph beginning: The fertilizer of the embodiment may be a culture of the microorganism capable of biosynthesizing ergothionein itself or a diluent such as water or an additive such as nutrient may be added to the culture of the embodiment…).
Otsu teaches all limitations of the claims and thereby anticipates the claims.
Claims 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryu et al. (WO2018/004016 with US20200029574 used solely as an English translation for citation purposes) as evidenced by NCBI taxonomy browser for Dirkmeia churashimaensis (cited on 892) and Sato et al. (AMB Express, 2024, vol. 14, article 20).
Ryu teaches that the claimed Dirkmeia churashimaensis (which is also known as Pseudozyma churashimaensis as evidenced by NCBI taxonomy browser (see entire page)) which they refer to as Pseudozyma churashimaensis is naturally occurring and when applied as a culture and/or a culture liquid thereof in effective amounts is/are known to increase plant yields, e.g. seed yields/plant growth because if the pepper yield is increased then inherently the seed yield is increased (abstract; Claims 4, 6, also:[0001]; [0008-0011]; [0025-0027]; [0028-0029]; Example 7). The examiner notes that the culture/culture liquid of Ryu reads on the claimed extract comprising ergothioneine (as evidenced by Sato, the Dirkmeia churashimaensis/ Pseudozyma churashimaensis contain/produce ergothioneine (See Table 1)) because nothing in the instant claims actually requires the extracts to be separated from the microorganism cells as the claims use comprising language which is open-ended does not exclude anything from the instant claims further there is no specific extract claimed and as such anything which contains any components of the Dirkmeia churashimaensis/ Pseudozyma churashimaensis and ergothioneine, e.g. the culture of Dirkmeia churashimaensis/ Pseudozyma churashimaensis anticipates the claimed extracts as currently claimed. Further, because Ryu teaches applying the same compositions comprising the same extracts then obviously the cultures of Ryu would be leading to the claimed higher plant growth effects than compositions containing the same amount of only ergothioneine as an active agent without the other extract components.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, and 4-10, specifically 2 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Otsu et al. (JP2018130091A from IDS, google patents machine translation used) as applied to claims 1, 4-9 above and further in view of Mottram (US5952267) and Barnhardt (https://barnhardt.net/journey-of-cotton-harvesting/, dated 01/31/2018).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Otsu teaches the composition and method of claims 1, and 4-9 as discussed above and incorporated herein.
Regarding claim 2, Otsu specifically exemplifies that the microorganisms that produce the ergothioneine used in their fertilizers, e.g. extracts comprising ergothioneine, include/are those of the genus mycobacterium as claimed (see paragraph beginning: The microorganism that can biosynthesize ergothioneine may be a microorganism that originally has the ability to biosynthesize ergothioneine…; see paragraph beginning: The fertilizer of the embodiment can be manufactured using the culture of the embodiment as a raw material…; paragraph beginning: The fertilizer of the embodiment includes a culture of a microorganism capable of biosynthesizing ergothionein…; paragraph beginning: The fertilizer of the embodiment may be a culture of the microorganism capable of biosynthesizing ergothionein/ergothioneine itself or a diluent such as water or an additive such as nutrient may be added to the culture of the embodiment…).
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
Regarding claim 10, Otsu does not specifically teach wherein the fertilizer treatment ends at least 27 days before harvesting the plant. However, this deficiency in Otsu is addressed by Mottram and Barnhardt.
Mottram teaches that 2-mercaptohistidine betaine which is another name for ergothioneine was known to be useful as an osmolyte regulator for plants and alleviates or combats the effects of stress in plants (See abstract; Col. 3, ln. 1-13; Col. 3, ln. 16; Col. 3, ln. 46-Col. 4, ln. 43; claims). Mottram further teaches wherein the betaines which can expressly be/include the claimed ergothioneine/2-mercaptohistidine betaine are applied before, during or after flowering and can be applied to the plants at any time from planting until harvesting but is typically applied early in the life of crops, and is typically applied to cotton plant at 77 or 98 days after planting (as evidenced by Barnhardt, cotton is typically fully mature and reading for harvesting approximately 160 days after being planted) and as such Mottram teaches wherein their application/treatment of the plant preferably ends at least 27 days before harvesting the plant as is instantly claimed (see entire document; claims; Col. 3, ln. 16; Col. 3, ln. 46-Col. 4, ln. 43; abstract; Col. 3, ln. 1-13; Col. 3, ln. 16; claims; Barnhardt: see with cotton harvesting, timing is everything section).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to form the claimed plant growth regulator comprising the claimed components when looking to Otsu because as discussed above Otsu expressly teaches applicants composition of claim 1. Regarding the microorganisms from which the extract is taken/produced which are not required to be part of the claimed plant growth regulator Otsu teaches wherein these microorganisms can include the claimed mycobacterium.
Regarding the specific species of microorganisms claimed in claim 3, applicant’s claims actually only require an microorganism extract comprising ergothioneine, e.g. the claim only requires ergothioneine, and the source of that ergothioneine does not actually matter in light of applicants claim 1 which only requires the extract to contain ergothioneine and as such the extract can be only ergothioneine and the source of that ergothioneine does not further limit the claimed composition in any way as ergothioneine is a compound with a specific structure and ergothioneine is the same structural compound independent of the source from which it is isolated/extracted. Thus, specific microorganism from which it is extracted does not further limit the composition of claim 1 and as such is not being afforded patentable weight. Thus, the ergothioneine of Otsu which is extracted from microorganism reads on applicant’s claim 3 as it is currently written.
Regarding new claim 10, it would have been obvious to one of ordinary skill in the art at the time of the instant filing to have ended treatment of the plant with the plant growth regulator at least 27 days before harvesting the plant. One of ordinary skill in the art would want to end treatment then because while it is known to apply the plant growth compositions comprising ergothioneine to the plants at any time from planting until harvesting typical application timings are at 77 or 98 days after planting for cotton plants (as evidenced by Barnhardt cotton, cotton is typically fully mature and reading for harvesting approximately 160 days after being planted). Thus, based on the timings of other crops it would be obvious to finish application of the claimed plant growth compositions at least 27 days before harvest based upon the known application timings for applying ergothioneine which is contained in the claimed plant growth regulator compositions which are rendered obvious by the combined references as discussed above.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 6-9, and 11-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryu et al. (WO2018/004016 with US20200029574 used solely as an English translation for citation purposes) as evidenced by NCBI taxonomy browser for Dirkmeia churashimaensis (cited on 892) and Sato et al. (AMB Express, 2024, vol. 14, article 20) as applied to claims 1-5 above and further in view of Otsu et al. (JP2018130091A from IDS, google patents machine translation used, cited previously).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Ryu as evidenced by NCBI and Sato teaches the composition/plant growth regulator of claims 1-5 as discussed above and incorporated herein.
Regarding claims 11-12 and 16-18, Ryu teaches that the claimed Dirkmeia churashimaensis (which is also known as Pseudozyma churashimaensis as evidenced by NCBI taxonomy browser (see entire page)) which they refer to as Pseudozyma churashimaensis is naturally occurring and when applied as a culture and/or a culture liquid thereof in effective amounts is/are known to increase plant yields, e.g. seed yields, which read on the claimed promoting plant growth because if the pepper yield is increased then inherently the seed yield (a mode of plant growth) is increased (abstract; Claims 4, 6, also:[0001]; [0008-0011]; [0025-0027]; [0028-0029]; Example 7). The examiner notes that the culture/culture liquid of Ryu reads on the claimed extract comprising ergothioneine (as evidenced by Sato, the Dirkmeia churashimaensis/ Pseudozyma churashimaensis contain/produce ergothioneine (See Table 1)) because nothing in the instant claims actually requires the extracts to be separated from the microorganism cells as the claims use comprising language which is open-ended does not exclude anything from the instant claims further there is no specific extract claimed and as such anything which contains any components of the Dirkmeia churashimaensis/ Pseudozyma churashimaensis and ergothioneine, e.g. the culture of Dirkmeia churashimaensis/ Pseudozyma churashimaensis anticipates the claimed extracts as currently claimed. Further, because Ryu teaches applying the same compositions comprising the same extracts then obviously the cultures of Ryu would be leading to the claimed higher plant growth effects than compositions containing the same amount of only ergothioneine as an active agent without the other extract components.
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
Regarding claims 6-9, Ryu and the combined evidentiary references do not teach wherein the composition is an agent for increasing plant height, flower number, etc. as claimed. However, these are intended uses of the composition and it would be obvious to one of ordinary skill in the art to optimize the amounts of active agents in the composition to allow for increased plant height, flower number, etc. since Ryu already expressly teaches that applying the claimed cultures of Pseudozyma churashimaensis/Dirkmeia churashimaensis which reads on the claimed extracts thereof leads to increased seed yields because it leads to increased crop yields of peppers which contain the seeds as discussed above. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 11-18, Ryu does not specifically teach wherein the plant growth regulator contains ergothioneine in an amount of 0.1 ppm or greater or wherein the abstract is obtained by subjecting said microorganism or crushed products…to an extraction treatment that extract active ingredients…that are present within said cells…as claimed. However, as discussed above the claims use comprising language and because the claims do not exclude microbial cells and exclude nothing from the claimed composition the mode of making the extract is not particularly limiting to the scope of the plant growth regulator because by having the microbial cells in culture present then all possible extracts of the ergothioneine producing microorganisms, specifically Pseudozyma churashimaensis/Dirkmeia churashimaensis are present in the culture of Pseudozyma churashimaensis/Dirkmeia churashimaensis because it contains all components which are present in the cells/produced by the cells. Ryu also does not teach the claimed modes of extraction. Further, Ryu teaches that any culturing methods are useful for culturing their Pseudozyma churashimaensis/Dirkmeia churashimaensis. However, these deficiencies in Ryu are addressed by Otsu.
Otsu teaches a fertilizer/plant growth composition comprising a culture of a microorganism capable of synthesizing/producing ergothionein/ergothioneine, and wherein the fertilizer comprising the ergothioneine can be formed by subjecting the microorganism to culturing conditions at 40 °C, which reads on the claimed hot water extraction as the culture being heated to this temperature in media which would necessarily contain water and the claimed hot water extraction does not exclude other components from the extract/extraction mixture/composition and applicant’s specification exemplifies that they prefer temperatures of at least 40 °C (see paragraph beginning: The culture can be performed, for example, under aerobic conditions. (through end of the long paragraph); see paragraph beginning: The fertilizer of the embodiment can be manufactured using the culture of the embodiment as a raw material…; paragraph beginning: The fertilizer of the embodiment includes a culture of a microorganism capable of biosynthesizing ergothionein…; paragraph beginning: The fertilizer of the embodiment may be a culture of the microorganism capable of biosynthesizing ergothionein itself or a diluent such as water or an additive such as nutrient may be added to the culture of the embodiment…).
Otsu teaches treating a plant with the plant growth regulator comprising ergothioneine extract from microorganisms was applied as a hydroponic culture solution to plants and/or seeds (see Examples 1-4 cultivation of plants section; The fertilizer of the embodiment can be manufactured using the culture of the embodiment as a raw material…; paragraph beginning: The fertilizer of the embodiment includes a culture of a microorganism capable of biosynthesizing ergothionein…; paragraph beginning: The fertilizer of the embodiment may be a culture of the microorganism capable of biosynthesizing ergothionein itself or a diluent such as water or an additive such as nutrient may be added to the culture of the embodiment…).
Otsu teaches wherein their fertilizer/plant growth regulating composition (which contains the culture of the microorganisms which produce ergothioneine, and teaches that the culture of the microorganisms can be the fertilizer) contains 50 mg/L or more of ergothioneine and this reads on the claimed amounts of erogothioneine applicant’s instantly disclose (0.1 ppm or greater) for use in their fertilizer compositions and as such Otsu’s compositions are inherently compositions which are agents for increasing seed yield, increasing plant height, increasing flower number, increasing aboveground part weight, and increasing underground part weight as claimed as these are intended uses of the composition(s) which comprise the disclosed amount of ergothioneine in applicant’s specification and as the composition of Otsu contains this same amount of ergothioneine it will inherently function as these types of agents (See culture and fertilizer section, specifically paragraph beginning: The culture according to the embodiment contains 50 mg / L or more of ergothioneine,…; and the paragraph beginning: The fertilizer of the embodiment includes a culture of a microorganism capable of biosynthesis of ergothioneine. That is, the culture can be used as a fertilizer…; paragraph beginning: The fertilizer of the embodiment can be manufactured using the culture of the embodiment as a raw material…; paragraph beginning: The fertilizer of the embodiment includes a culture of a microorganism capable of biosynthesizing ergothionein…; paragraph beginning: The fertilizer of the embodiment may be a culture of the microorganism capable of biosynthesizing ergothionein itself or a diluent such as water or an additive such as nutrient may be added to the culture of the embodiment…).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art to form the claimed plant growth composition comprising the claimed extracts because it was already known in the art to culture ergothioneine producing microorganisms at 40 °C and because this culturing will contain water it reads on the claimed hot water extraction, especially since the instant claims do not actually exclude the cell culture and/or the cells themselves from the composition as the claims are currently written.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 10 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryu et al. (WO2018/004016 with US20200029574 used solely as an English translation for citation purposes) as evidenced by NCBI taxonomy browser for Dirkmeia churashimaensis (cited on 892) and Sato et al. (AMB Express, 2024, vol. 14, article 20) as applied to claims 1-5 above and further in view of Otsu et al. (JP2018130091A from IDS, google patents machine translation used) as applied to claims 6-9, 11-18 above, which is further in view of Mottram (US5952267) and Barnhardt (https://barnhardt.net/journey-of-cotton-harvesting/, dated 01/31/2018).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Ryu as evidenced by NCBI and Sato teaches the composition/plant growth regulator of claims 1-5 as discussed above and incorporated herein, and Ryu and the other combined references together teach the composition/plant growth regulator of claims 6-9, 11-18 as discussed above and incorporated herein.
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
Regarding claim 10, Ryu as evidenced by NCBI and Sato, and/or Ryu and the combined references together do not specifically teach wherein the fertilizer treatment ends at least 27 days before harvesting the plant. However, this deficiency in the above cited references is addressed by Mottram and Barnhardt.
Mottram teaches that 2-mercaptohistidine betaine which is another name for ergothioneine was known to be useful as an osmolyte regulator for plants and alleviates or combats the effects of stress in plants (See abstract; Col. 3, ln. 1-13; Col. 3, ln. 16; Col. 3, ln. 46-Col. 4, ln. 43; claims). Mottram further teaches wherein the betaines which can expressly be/include the claimed ergothioneine/2-mercaptohistidine betaine are applied before, during or after flowering and can be applied to the plants at any time from planting until harvesting but is typically applied early in the life of crops, and is typically applied to cotton plant at 77 or 98 days after planting (as evidenced by Barnhardt cotton, cotton is typically fully mature and reading for harvesting approximately 160 days after being planted) and as such Mottram teaches wherein their application/treatment of the plant preferably ends at least 27 days before harvesting the plant as is instantly claimed (see entire document; claims; Col. 3, ln. 16; Col. 3, ln. 46-Col. 4, ln. 43; abstract; Col. 3, ln. 1-13; Col. 3, ln. 16; claims; Barnhardt: see with cotton harvesting, timing is everything section).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
Regarding new claim 10, it would have been obvious to one of ordinary skill in the art at the time of the instant filing to have ended treatment of the plant with the plant growth regulator at least 27 days before harvesting the plant. One of ordinary skill in the art would want to end treatment then because while it is known to apply the plant growth compositions comprising ergothioneine to the plants at any time from planting until harvesting typical application timings are at 77 or 98 days after planting for cotton plants (as evidenced by Barnhardt cotton, cotton is typically fully mature and reading for harvesting approximately 160 days after being planted). Thus, based on the timings of other crops it would be obvious to finish application of the claimed plant growth compositions at least 27 days before harvest based upon the known application timings for applying ergothioneine which is contained in the claimed plant growth regulator compositions which are rendered obvious by the combined references as discussed above.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on non-statutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 15-25 of copending Application No. 17597402 (reference application) in view of Ryu et al. (WO2018/004016 with US20200029574 used solely as an English translation for citation purposes), Otsu et al. (JP2018130091A from IDS, google patents machine translation used), Mottram (US5952267) and Barnhardt (https://barnhardt.net/journey-of-cotton-harvesting/, dated 01/31/2018), and as evidenced by NCBI taxonomy browser for Dirkmeia churashimaensis (cited on 892) and Sato et al. (AMB Express, 2024, vol. 14, article 20).
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘402 teaches using compositions comprising ergothioneine, specifically the naturally occurring L-(+)-ergothioneine to promote plant growth, increase seed yield, increase number of flowers, which are the same intended uses of the instantly claimed composition. ‘402 does not teach wherein their ergothioneine/L-ergothioneine is from microorganisms/extracted from microorganisms or wherein the composition is used for the other claimed intended uses of increasing plant height, increasing above ground part weight, and increasing underground part weight. However, the claims of ‘402 use comprising which is open-ended and excludes nothing else including the instantly claimed extract comprising ergothioneine/L-(+)-ergothioneine from a microorganism. However, these deficiencies in ‘402 are addressed by the combined references cited above. Further, as discussed above the instant claims also exclude nothing due to their use of comprising language and as such the ergothioneine of ‘402 is not excluded.
Ryu teaches that the claimed Dirkmeia churashimaensis (which is also known as Pseudozyma churashimaensis as evidenced by NCBI taxonomy browser (see entire page)) which they refer to as Pseudozyma churashimaensis is naturally occurring and when applied as a culture and/or a culture liquid thereof in effective amounts is/are known to increase plant yields, e.g. seed yields/plant growth because if the pepper yield is increased then inherently the seed yield is increased (abstract; Claims 4, 6, also:[0001]; [0008-0011]; [0025-0027]; [0028-0029]; Example 7). The examiner notes that the culture/culture liquid of Ryu reads on the claimed extract comprising ergothioneine (as evidenced by Sato, the Dirkmeia churashimaensis/ Pseudozyma churashimaensis contain/produce ergothioneine (See Table 1)) because nothing in the instant claims actually requires the extracts to be separated from the microorganism cells as the claims use comprising language which is open-ended does not exclude anything from the instant claims further there is no specific extract claimed and as such anything which contains any components of the Dirkmeia churashimaensis/ Pseudozyma churashimaensis and ergothioneine, e.g. the culture of Dirkmeia churashimaensis/ Pseudozyma churashimaensis anticipates the claimed extracts as currently claimed. Further, because Ryu teaches applying the same compositions comprising the same extracts then obviously the cultures of Ryu would be leading to the claimed higher plant growth effects than compositions containing the same amount of only ergothioneine as an active agent without the other extract components.
‘402, Ryu, and the combined evidentiary references do not teach wherein the composition is an agent for increasing plant height, flower number, etc. as claimed. However, these are intended uses of the composition and it would be obvious to one of ordinary skill in the art to optimize the amounts of active agents in the composition to allow for increased plant height, flower number, etc. since Ryu already expressly teaches that applying the claimed cultures of Pseudozyma churashimaensis/Dirkmeia churashimaensis which reads on the claimed extracts thereof leads to increased seed yields because it leads to increased crop yields of peppers which contain the seeds as discussed above. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Otsu teaches a fertilizer/plant growth composition comprising a culture of a microorganism capable of synthesizing/producing ergothionein/ergothioneine, and wherein the fertilizer comprising the ergothioneine can be formed by subjecting the microorganism to culturing conditions at 40 °C, which reads on the claimed hot water extraction as the culture being heated to this temperature in media which would necessarily contain water and the claimed hot water extraction does not exclude other components from the extract/extraction mixture/composition and applicant’s specification exemplifies that they prefer temperatures of at least 40 °C (see paragraph beginning: The culture can be performed, for example, under aerobic conditions. (through end of the long paragraph); see paragraph beginning: The fertilizer of the embodiment can be manufactured using the culture of the embodiment as a raw material…; paragraph beginning: The fertilizer of the embodiment includes a culture of a microorganism capable of biosynthesizing ergothionein…; paragraph beginning: The fertilizer of the embodiment may be a culture of the microorganism capable of biosynthesizing ergothionein itself or a diluent such as water or an additive such as nutrient may be added to the culture of the embodiment…).
Otsu teaches treating a plant with the plant growth regulator comprising ergothioneine extract from microorganisms was applied as a hydroponic culture solution to plants and/or seeds (see Examples 1-4 cultivation of plants section; The fertilizer of the embodiment can be manufactured using the culture of the embodiment as a raw material…; paragraph beginning: The fertilizer of the embodiment includes a culture of a microorganism capable of biosynthesizing ergothionein…; paragraph beginning: The fertilizer of the embodiment may be a culture of the microorganism capable of biosynthesizing ergothionein itself or a diluent such as water or an additive such as nutrient may be added to the culture of the embodiment…).
Otsu teaches wherein their fertilizer/plant growth regulating composition (which contains the culture of the microorganisms which produce ergothioneine, and teaches that the culture of the microorganisms can be the fertilizer) contains 50 mg/L or more of ergothioneine and this reads on the claimed amounts of erogothioneine applicant’s instantly disclose (0.1 ppm or greater) for use in their fertilizer compositions and as such Otsu’s compositions are inherently compositions which are agents for increasing seed yield, increasing plant height, increasing flower number, increasing aboveground part weight, and increasing underground part weight as claimed as these are intended uses of the composition(s) which comprise the disclosed amount of ergothioneine in applicant’s specification and as the composition of Otsu contains this same amount of ergothioneine it will inherently function as these types of agents (See culture and fertilizer section, specifically paragraph beginning: The culture according to the embodiment contains 50 mg / L or more of ergothioneine,…; and the paragraph beginning: The fertilizer of the embodiment includes a culture of a microorganism capable of biosynthesis of ergothioneine. That is, the culture can be used as a fertilizer…; paragraph beginning: The fertilizer of the embodiment can be manufactured using the culture of the embodiment as a raw material…; paragraph beginning: The fertilizer of the embodiment includes a culture of a microorganism capable of biosynthesizing ergothionein…; paragraph beginning: The fertilizer of the embodiment may be a culture of the microorganism capable of biosynthesizing ergothionein itself or a diluent such as water or an additive such as nutrient may be added to the culture of the embodiment…).
Mottram teaches that 2-mercaptohistidine betaine which is another name for ergothioneine was known to be useful as an osmolyte regulator for plants and alleviates or combats the effects of stress in plants (See abstract; Col. 3, ln. 1-13; Col. 3, ln. 16; Col. 3, ln. 46-Col. 4, ln. 43; claims). Mottram further teaches wherein the betaines which can expressly be/include the claimed ergothioneine/2-mercaptohistidine betaine are applied before, during or after flowering and can be applied to the plants at any time from planting until harvesting but is typically applied early in the life of crops, and is typically applied to cotton plant at 77 or 98 days after planting (as evidenced by Barnhardt cotton, cotton is typically fully mature and reading for harvesting approximately 160 days after being planted) and as such Mottram teaches wherein their application/treatment of the plant preferably ends at least 27 days before harvesting the plant as is instantly claimed (see entire document; claims; Col. 3, ln. 16; Col. 3, ln. 46-Col. 4, ln. 43; abstract; Col. 3, ln. 1-13; Col. 3, ln. 16; claims; Barnhardt: see with cotton harvesting, timing is everything section).
It would have been obvious to one of ordinary skill in the art to form the claimed composition and methods when looking to the combination of references cited above because each component was known in the art to be effective at improving plant growth on its own and as such it would be obvious to combine the components in order to form the most effective composition and methods for improving plant growth.
It also would be obvious to one of ordinary skill in the art to optimize the amounts of ergothioneine and effective amounts of the Pseudozyma churashimaensis/Dirkmeia churashimaensis culture in order to form the most effective compositions for improving plant growth because it is known, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Thus, one of ordinary skill in the art would conclude that the claimed invention is obvious when taken in view of ‘402 and the combined references as discussed and cited above.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of US Patent No. 11732236 (‘236) in view of Ryu et al. (WO2018/004016 with US20200029574 used solely as an English translation for citation purposes), Otsu et al. (JP2018130091A from IDS, google patents machine translation used), Mottram (US5952267) and Barnhardt (https://barnhardt.net/journey-of-cotton-harvesting/, dated 01/31/2018), and as evidenced by NCBI taxonomy browser for Dirkmeia churashimaensis (cited on 892) and Sato et al. (AMB Express, 2024, vol. 14, article 20).
‘236 claims/teaches a culture containing ergothioneine that is obtained from the specifically claimed microorganisms and this culture reads on the claimed extracts from the claimed microorganisms of claims 1-3 and partially reads on claims 11-12. ‘236 does not teach the claimed methods of promoting plant growth specifically the claimed types of plant growth, and does not teach wherein ergothioneine is present in the at least 0.1 ppm or greater or the claimed modes of extraction in the product by process limitations. However, these deficiencies are addressed by the secondary references cited above.
Ryu teaches that the claimed Dirkmeia churashimaensis (which is also known as Pseudozyma churashimaensis as evidenced by NCBI taxonomy browser (see entire page)) which they refer to as Pseudozyma churashimaensis is naturally occurring and when applied as a culture and/or a culture liquid thereof in effective amounts is/are known to increase plant yields, e.g. seed yields/plant growth because if the pepper yield is increased then inherently the seed yield is increased (abstract; Claims 4, 6, also:[0001]; [0008-0011]; [0025-0027]; [0028-0029]; Example 7). The examiner notes that the culture/culture liquid of Ryu reads on the claimed extract comprising ergothioneine (as evidenced by Sato, the Dirkmeia churashimaensis/ Pseudozyma churashimaensis contain/produce ergothioneine (See Table 1)) because nothing in the instant claims actually requires the extracts to be separated from the microorganism cells as the claims use comprising language which is open-ended does not exclude anything from the instant claims further there is no specific extract claimed and as such anything which contains any components of the Dirkmeia churashimaensis/ Pseudozyma churashimaensis and ergothioneine, e.g. the culture of Dirkmeia churashimaensis/ Pseudozyma churashimaensis anticipates the claimed extracts as currently claimed. Further, because Ryu teaches applying the same compositions comprising the same extracts then obviously the cultures of Ryu would be leading to the claimed higher plant growth effects than compositions containing the same amount of only ergothioneine as an active agent without the other extract components.
‘236, Ryu, and the combined evidentiary references do not teach wherein the composition is an agent for increasing plant height, flower number, etc. as claimed. However, these are intended uses of the composition and it would be obvious to one of ordinary skill in the art to optimize the amounts of active agents in the composition to allow for increased plant height, flower number, etc. since Ryu already expressly teaches that applying the claimed cultures of Pseudozyma churashimaensis/Dirkmeia churashimaensis which reads on the claimed extracts thereof leads to increased seed yields because it leads to increased crop yields of peppers which contain the seeds as discussed above. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Otsu teaches a fertilizer/plant growth composition comprising a culture of a microorganism capable of synthesizing/producing ergothionein/ergothioneine, and wherein the fertilizer comprising the ergothioneine can be formed by subjecting the microorganism to culturing conditions at 40 °C, which reads on the claimed hot water extraction as the culture being heated to this temperature in media which would necessarily contain water and the claimed hot water extraction does not exclude other components from the extract/extraction mixture/composition and applicant’s specification exemplifies that they prefer temperatures of at least 40 °C (see paragraph beginning: The culture can be performed, for example, under aerobic conditions. (through end of the long paragraph); see paragraph beginning: The fertilizer of the embodiment can be manufactured using the culture of the embodiment as a raw material…; paragraph beginning: The fertilizer of the embodiment includes a culture of a microorganism capable of biosynthesizing ergothionein…; paragraph beginning: The fertilizer of the embodiment may be a culture of the microorganism capable of biosynthesizing ergothionein itself or a diluent such as water or an additive such as nutrient may be added to the culture of the embodiment…).
Otsu teaches treating a plant with the plant growth regulator comprising ergothioneine extract from microorganisms was applied as a hydroponic culture solution to plants and/or seeds (see Examples 1-4 cultivation of plants section; The fertilizer of the embodiment can be manufactured using the culture of the embodiment as a raw material…; paragraph beginning: The fertilizer of the embodiment includes a culture of a microorganism capable of biosynthesizing ergothionein…; paragraph beginning: The fertilizer of the embodiment may be a culture of the microorganism capable of biosynthesizing ergothionein itself or a diluent such as water or an additive such as nutrient may be added to the culture of the embodiment…).
Otsu teaches wherein their fertilizer/plant growth regulating composition (which contains the culture of the microorganisms which produce ergothioneine, and teaches that the culture of the microorganisms can be the fertilizer) contains 50 mg/L or more of ergothioneine and this reads on the claimed amounts of erogothioneine applicant’s instantly disclose (0.1 ppm or greater) for use in their fertilizer compositions and as such Otsu’s compositions are inherently compositions which are agents for increasing seed yield, increasing plant height, increasing flower number, increasing aboveground part weight, and increasing underground part weight as claimed as these are intended uses of the composition(s) which comprise the disclosed amount of ergothioneine in applicant’s specification and as the composition of Otsu contains this same amount of ergothioneine it will inherently function as these types of agents (See culture and fertilizer section, specifically paragraph beginning: The culture according to the embodiment contains 50 mg / L or more of ergothioneine,…; and the paragraph beginning: The fertilizer of the embodiment includes a culture of a microorganism capable of biosynthesis of ergothioneine. That is, the culture can be used as a fertilizer…; paragraph beginning: The fertilizer of the embodiment can be manufactured using the culture of the embodiment as a raw material…; paragraph beginning: The fertilizer of the embodiment includes a culture of a microorganism capable of biosynthesizing ergothionein…; paragraph beginning: The fertilizer of the embodiment may be a culture of the microorganism capable of biosynthesizing ergothionein itself or a diluent such as water or an additive such as nutrient may be added to the culture of the embodiment…).
Mottram teaches that 2-mercaptohistidine betaine which is another name for ergothioneine was known to be useful as an osmolyte regulator for plants and alleviates or combats the effects of stress in plants (See abstract; Col. 3, ln. 1-13; Col. 3, ln. 16; Col. 3, ln. 46-Col. 4, ln. 43; claims). Mottram further teaches wherein the betaines which can expressly be/include the claimed ergothioneine/2-mercaptohistidine betaine are applied before, during or after flowering and can be applied to the plants at any time from planting until harvesting but is typically applied early in the life of crops, and is typically applied to cotton plant at 77 or 98 days after planting (as evidenced by Barnhardt cotton, cotton is typically fully mature and reading for harvesting approximately 160 days after being planted) and as such Mottram teaches wherein their application/treatment of the plant preferably ends at least 27 days before harvesting the plant as is instantly claimed (see entire document; claims; Col. 3, ln. 16; Col. 3, ln. 46-Col. 4, ln. 43; abstract; Col. 3, ln. 1-13; Col. 3, ln. 16; claims; Barnhardt: see with cotton harvesting, timing is everything section).
It would be obvious to form the claimed compositions for the claimed modes of plant growth and having the claimed amounts of ergothioneine because it would be obvious to one of ordinary skill in the art to optimize the amounts of ergothioneine and effective amounts of the Pseudozyma churashimaensis/Dirkmeia churashimaensis culture in order to form the most effective compositions for improving plant growth because it is known, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
It also would have been obvious to one of ordinary skill in the art to form the claimed composition and methods when looking to the combination of references cited above because each component was known in the art to be effective at improving plant growth on its own and as such it would be obvious to combine the components in order to form the most effective composition and methods for improving plant growth.
Thus, one of ordinary skill in the art would conclude that the claimed invention is obvious when taken in view of ‘236 and the combined references as discussed and cited above.
Response to Arguments/Remarks
Applicant’s amendments to the claims have overcome the previous objections and have prompted the new grounds of rejection under 101, 112, 102, 103 and double patenting presented herein. Applicant’s arguments insofar as they pertain to the new grounds of rejection are addressed herein.
Applicants argue that the 101 should be overcome because throughout the reference their composition relates to extracts of the microorganisms which contain ergothioneine and other components which work together to form a highly effective plant growth regulator. The examiner respectfully points out that whether or not applicants have found a highly effective plant growth regulator does not mean the claims are patentable as they are currently written. Specifically as noted above, the claims use comprising language which is open-ended and as such the claimed compositions which comprise extracts actually still read on the cells and/or cell culture of naturally occurring microorganisms, e.g. Pseudozyma churashimaensis/Dirkmeia churashimaensis which are not materially different from the naturally occurring microorganisms and as such are still not patentable subject matter under 101 for the reasons discussed above at this time. That is to say the claims as currently written can actually contain only the cells of naturally occurring Pseudozyma churashimaensis/Dirkmeia churashimaensis, because the cells themselves would contain any extract of the cells which is what is claimed and the comprising language of the claims does not exclude the cells themselves and/or cultures of the naturally occurring cells, e.g. as grinding extracts as claimed would be mixtures of whole and broken cells which is how the cells would be naturally found/as they naturally occur and for these reasons the 101 rejection has been modified and changed to address the amended claim scope which is completely different from the previous claim scope.
Applicants argue that culture product of Otsu only contains products secreted from the microorganisms to the culture medium and does not contain components which are not secreted by the microorganisms and that this contrary to their extracts which contain other cellular components from the cells. The examiner respectfully disagrees because nothing in claim 1 as it is currently amended actually requires the extracts to contain cellular components which are not secreted. Claim 1 as currently written states that the extract contains ergothioneine, and the extract is obtained from culture products including culture precipitates or cultured microbial cells and nothing in this statement requires the extract to contain components beyond those which are secreted by the cells. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that their extracts contain cellular components and not just secreted components) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus, respectfully the examiner disagrees that the 102 rejection over Otsu was overcome by applicant’s amendments at this time especially in light of the claims using comprising language and as such the claims as they are currently written still read on the cells and cell culture that can be applied in Otsu to improve plant growth as is discussed above.
Applicants then argue that they get a higher result than the use of ergothioneine alone. This is not surprising as any organic matter from the cells themselves which as taught by Otsu can be used in their compositions and methods would be expected to provide an increase in plant growth because the organic matter functions as additional nutrients to the plants in addition to the ergothioneine. Additionally, applicants claims are actually much broader than the extracts that applicants are arguing due to the use of the comprising language. Regarding applicants table 3, applicants do not appear to have demonstrated that their results are actually unexpectedly synergistic as asserted, nor have they clearly demonstrated that their extracts provide greater than the expected additive result with any statistical significance, and nor are the claims commensurate in scope with these argued unexpected results. Further, it is not clear that these results would also not already be accomplished when applying the cells of Pseudozyma churashimaensis/Dirkmeia churashimaensis as is done in Ryu to improve plant growth which would be applying ergothioneine which is naturally produced by these cells and any and all cellular contents of the cells as is cited in the new 102 and 103 rejections above. Applicants then argue the new claims over Otsu. But the new claims have not even been rejected or searched until this office action. These preemptive arguments are not persuasive for the reasons discussed above which are incorporated herein at this time. Further applicants argue that Otsu does not teach stopping treatment as early as is now claimed. Firstly, this limitation is not required by all of applicants claims and secondly it would be obvious to optimize when the treatment with the claimed composition is stopped when taken in view of the new references Mottram and Barnhardt. Thus, the examiner disagrees that Otsu teaches away from this limitation when taken in view of new secondary references now cited herein. Applicants then argue that they can stop treatment much earlier. Again these are limitations which are not required by applicant’s claims. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., stopping treatment at 75, 73, 81, and 79 days before harvesting) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicants then argue that the double patenting rejection of record is not appropriate because the applications focus on completely different technical features. The examiner respectfully disagrees for the reasons discussed above which are incorporated herein at this time, especially since the instant claims and the prior art claims use comprising language which is open-ended and for instance nothing in ‘402 excludes the cells and extracts taught by the prior art which read on the claimed composition from being present and it is known to combine plant growth active agents together in a composition in order to form new compositions and methods for improving plant growth.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 Erin E Hirt whose telephone number is (571)270-1077. The examiner can normally be reached 10:30-7:30 ET M-F.
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, Sue X 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.
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.
/ERIN E HIRT/Primary Examiner, Art Unit 1616