Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group II, claims 10-18, in the reply filed on 12/03/2025 is acknowledged. The traversal is on the ground(s) that Applicant submits that there is no evidence of a serious search burden upon the office if all the claims are examined together in this application. This is not found persuasive because the method that employs with a plant/plant part and the method that employs with a Protostomia clade member have different design, modes of operation, function or effect, and the resultant products are different, as explained in the last office action. The specification provides no evidence that shows the two inventions are obvious variants. In addition, the search of the invention that involves with a plant will not necessarily reveal all arts relevant to the patentability of the invention that involves with a Protostomia clade. Inventions III and IV are patentably distinct from the invention of group II for the reasons discussed in the restriction/election action of 10/06/2025, and is maintained.
Upon further consideration, claim 22 (group V), drawn to a plant produced from the method of claim 10 (group II), is hereby rejoined with the elected invention of group II.
Claims 1-22 are pending.
Claims 1-9 and 19-21, are withdrawn from consideration as being directed to the non-elected invention.
Claims 10-18 and 22 are examined.
The requirement is still deemed proper and is therefore made FINAL.
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g). At paragraphs [0030] and [0031], Australian patent nos. 2014250680 and 2012283757, describe the preparation of catalysts which are understood to be essential to the claimed invention.
Improper Markush Grouping Rejection
Claims 10-18 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of a method that employs with a plant/plant part, and the method that employs with one or more members of a Protostomia clade, is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: a plant and Protostomia clade member are structurally and functional different organisms (Plantae vs Animalia), and are not functional equivalents.
To overcome this rejection, Applicant may amend the claims to delete “or a Protostomia clade” from the claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 10-18 and 22 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 10 is indefinite in the recitation of the phrase “ecological stem cell development” which is neither defined in the specification nor is known in the art. Further, the steps recited in the claim do not involve manipulation of stem cells, so the metes and bounds of the claim 10 is unclear. Also, source of the “ substrate” and “catalysts” is unclear and are not clearly defined in the specification. Claim 10 recites “catalysts comprise at least one of “source of” or a “ substrate”. Claim 11 recites “catalysts provides a substrate”. Claim 12 is confusing because the relationship between the “catalysts” and “substrate” is unclear. Dependent claims 11-18 and 22 are included in the rejection because they do not obviate the rejection.
At claims 12 and 13, it is unclear which organic material should be fermented
At claim 13, “a low temperature fermentation microorganisms” is not defined in the specification and is not known in the art.
At claims 10-13, the relationship between the “one or more prokaryotic organisms” and “low temperature fermentation microorganisms” is unclear. Also, it is unclear what activity of the low temperature fermentation microorganisms and what activity of the “one or more prokaryotic organisms” is stimulated.
At claim 16, “seedlings”, “algae”, and “cyanobacteria” are not plant parts.
At claim 17, the relationship between “plant or plant part” and “treated plant or treated plant part” is unclear.
At claim 18, the relationship between the “prokaryotic organisms” and “symbiotic microorganisms” associated with the plant or plant part is unclear.
At claim 22, the method of claim 10 does not produce a “naturally genetically strengthened plant and/or plant part”.
Clarification is required to more clearly define the metes and bounds of the claims.
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 10-18 and 22 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 are drawn to a method of ecological stem cell development that stimulates gene shuffling, the method comprising amending a growing site with one or more catalysts to obtain an amended growing site, wherein the one or more catalysts comprise at least one of a source of or a substrate produced by, and which stimulates activity of, one or more prokaryotic organisms; and contacting, at least one of a plant or plant part with a soil sample from the amended growing site, at least one of at least one of a plant or plant part, wherein an exchange of genetic material occurs between the one or more prokaryotic organisms and the at least one of the plant or the plant part; wherein a first of the one or more catalysts provides a substrate that stimulates activity of low temperature fermentation microorganisms; wherein the first of the one or more
catalysts comprises a humified soil prepared from continuous fermentation of an organic
material, wherein the continuous fermentation comprises a source of, and provides a
habitat for, sustained activity of the low temperature fermentation microorganisms; wherein a second of the one or more catalysts comprises a liquid fertilizer prepared from continuous fermentation of an organic material, wherein the continuous fermentation comprises a source of, and a habitat for, activity of low temperature fermentation microorganisms; wherein the one or more prokaryotic organisms comprise at least one of one or more species of Archaea or one or more species of bacteria comprising at least one of purple non-sulphur producing heterotrophic photosynthetic bacteria, Lactobacillus species, yeasts, Actinomycetes species, Nocardia species, a ray fungi, plankton or chemotrophic bacteria. The claims further encompass contacting the plant or plant part with a soil sample from the amended site, wherein an exchange of genetic material occurs between the one or more prokaryotic organisms and the plant or plant part; wherein the contacting comprises cultivating the at least one plant or plant part thereof in the soil sample from the amended growing site, and growing the plant or plant part thereof; said method wherein at least one of: the exchange of genetic material occurs at least one of directly between the one or more prokaryotic organisms and the at least one of the plant or the plant part, or indirectly via an exchange of genetic material between the one or more prokaryotic organisms and a symbiotic microorganism associated with the at least one of the plant or the plant part, or by incorporation of the one or more prokaryotic organism into a colony associated with the at least one of the plant or the plant part.
The scope of the claimed method encompasses the use of undescribed genus of genetically diverse plant species and plant parts cultivated in a genus of materially diverse growing sites amended with undescribed genus of catalysts that stimulate the activity of a genus of prokaryotic organisms including those from Archaea, purple non-sulfur producing heterotrophic photosynthetic bacteria, lactobacillus species, yeasts, Actinomycetes, Nocardia, ray fungi, plankton or chemotrophic bacteria; wherein an exchange of undescribed genus of genetic materials occurs between the plants and the prokaryotic organisms. However, the specification fails to describe a single example of development of ecological stem cell that stimulates gene shuffling using the claimed method.
The University of Rochester v. G.D. Searle & Co., Inc.(, U.S. District Court, Western District of New York, Decision and Order No. 00-CV-6161L,) decided 05 March 2003, at page 8, bottom paragraph, that method claims are properly subjected to a written description requirement if the starting material which requires that method is itself inadequately described. The court specifically stated, "(T)he claimed method depends upon finding a compound that selectively inhibits PGHS-2 activity. Without such a compound, it is impossible to practice the claimed method of treatment. It means little to “invent” a method if one does not have possession of a substance that is essential to practicing that method. Without that substance, the claimed invention is more theoretical than real;……… and there is no meaningful possession of the method."
The specification at paragraph [0017] states that “a method of ecological stem cell development that stimulates gene shuffling” comprises the steps of : a) amending a growing site with one or more catalysts to obtain an amended growing site, wherein the one or more catalysts comprise a source of, and/or a substrate produced by and which stimulates the activity of, one or more prokaryotic organisms (already present in the soil); and b) contacting a plant and/or plant part with a soil sample from the amended growing site by cultivating the plant is said amended site, wherein an exchange of genetic material occurs between the one or more prokaryotic organisms and the plant and/or plant part. At paragraph [0010], “catalyst” is defined as “a substance that produces or generates a reaction regardless of whether it undergoes a change itself. The specification, however, does not identify the composition and structure of a single catalysts suitable for the claimed method. The identity of the prokaryotic organisms capable of shuffling the genetic structure of the plant is not described either. The specification is silent of the starting materials for the development of the stem cell, the use of a single catalysts suitable for the amendment (as defined at [0011]) of the growing sites (as defined at [0012-0013]) including soil and non-soil growing media; the nature of the prokaryotic-plant relationship and the identity of the genetic material to be exchanged by the plant/part and prokaryote are not described; and the identity of the resultant naturally genetically strengthened (as defined in the specification) plant or plant parts is unknown. The specification does not describe a single plant species or part thereof with “naturally genetically strengthened” produced by said claimed method. The specification also fails to describe which activity of the one or more prokaryotic organisms should be stimulated and which genetic material should be exchanged between which plant species and which prokaryotic organisms. There is no description of any catalysts or substrate or any particular plant-prokaryotic suitable for the claimed method of stem cell development that stimulates gene shuffling and/or genetically strengthened plant that can be obtained from the claimed method.
The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; The Applicant must convey with reasonable clarity to those skilled in the art that, as of the effective filing date, he or she was in possession of the invention.
The Federal Circuit court stated that a written description of an invention "requires a precise definition, such as by structure, formula [or} chemical name, of the claimed subject matter sufficient to distinguish it from other material". University of California v. Eli Lilly and Co., 43 USPQ2d 1398 (Fed. Cir. 1997). The court also stated "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of is not a description of that material". Id.
Since the specification fails to adequately describe the specific catalysts, prokaryotic organisms capable of shuffling the genetic structure of the plant, and the specific plants, the starting materials for the development of the stem cells, the method that employs said elements is similarly not described.
Therefore, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that Applicant was in possession of the invention as broadly claimed at the time of filing.
Claim Rejections - 35 USC § 112, Enablement
Claims 10-18 and 22 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.
The instant claims are drawn to a method of ecological stem cell development that stimulates gene shuffling” comprises the steps of : a) amending a growing site with one or more catalysts to obtain an amended growing site, wherein the one or more catalysts comprise a source of, and/or a substrate produced by and which stimulates the activity of, one or more prokaryotic organisms; and b) contacting a plant and/or plant part with a soil sample from the amended growing site by cultivating the plant is said amended site, wherein an exchange of genetic material occurs between the one or more prokaryotic organisms and the plant and/or plant part .
Factors to be considered in determining whether undue experimentation is required include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The scope of the claimed method encompasses the use of undescribed genus of genetically diverse plant species and plant parts cultivated in a genus of materially diverse growing sites amended with undescribed genus of catalysts that stimulate the activity of a genus of prokaryotic organisms including those from Archaea, purple non-sulfur producing heterotrophic photosynthetic bacteria, lactobacillus species, yeasts, Actinomycetes, Nocardia, ray fungi, plankton or chemotrophic bacteria; wherein an exchange of undescribed genus of genetic materials occurs between the plants and the prokaryotic organisms. However, the specification fails to provide guidance for a single example of development of ecological stem cell that stimulates gene shuffling using the claimed method. The specification provides insufficient guidance with respect to the starting materials for the stem cell development, specific catalysts, substrates, prokaryotic organisms, plant species , the specific genetic material to exchange between the prokaryotic organisms and plant species, the specific combinations of prokaryotic-plant interaction, and obtention of “naturally genetically strengthened plant” which are not defined in the specification. No identifying characteristics have been provided for any of the products required for the claimed method. There are no working examples. The state of the art shows that limited reports/studies are available on ecological stem cell development in relation to horizontal gene transfer (HGT) between plants and soil microorganism in natural or non-natural habitat. The key limitations disclosed in the art include: a rapid degradation of the extracellular DNA in soil; low rates of stable integration into the plant genome; and the physical separation of plant germline cells. Vogan and Higgs (Biol Direct (2011) 6:1) refers the HGT as a “risky evolutionary strategy” because of the possibility of acquiring useless or harmful genes. Vogan and Higgs list several disadvantages including : 1) a gene acquired by HGT may be non-coding, non-functional or a duplicate of a gene already in the cell, or a gene that only functions in the presence of other genes contained in the recipient cell. 2) the possibility of inserting the horizontally acquired gene randomly into the genome and disrupting existing gene function. And 3) one of ordinary skill in the art would not expect that any prokaryotic organism could exchange genetic material with any plant species or a plant part thereof. The instant specification fails to provide any guidance regarding how to overcome these limitations in HGT processes between the genus of prokaryotic organisms and the genus of plant species as required by the instant claims.
Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 clearly states: “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimidations of general ideas that may or may not workable. See also, Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that “a patent is not a hunting license. It is a reward for the search, but compensation for its successful conclusion”). Tossing out the mere germ of an idea does not constitute enabling disclosure. While Applicant is not required to provide working examples or carried out every aspect of the claimed invention, the 35 USC 112 (a) requires that “reasonable detain must be provided in order to enable members of the public to understand and carried out the invention. This requirement has not been met.
Therefore, for all the reasons discussed above a person of ordinary skill in the art must rely on undue trial and error experimentation to make and use the claimed invention no reasonable expectation of success. Consequently, the claimed invention is not enabled.
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.
Claims 10-18 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Von Maltzahn et al (US 9, 113, 636 B2) in view of each of Tiwari et al (Plants (2020), 9:305; Applicant’s IDS), Van Elsas et al (New Phytologist (2003)157:525-537) and Bellamy et al (US 11, 623, 257 B2).
The claims are drawn to a method of ecological stem cell development that stimulates gene shuffling, the method comprising amending a growing site with one or more catalysts to obtain an amended growing site, wherein the one or more catalysts comprise at least one of a source of or a substrate produced by, and which stimulates activity of, one or more prokaryotic organisms; and contacting, at least one of a plant or plant part with a soil sample from the amended growing site, at least one of at least one of a plant or plant part, wherein an exchange of genetic material occurs between the one or more prokaryotic organisms and the at least one of the plant or the plant part; wherein a first of the one or more catalysts provides a substrate that stimulates activity of low temperature fermentation microorganisms; wherein the first of the one or more
catalysts comprises a humified soil prepared from continuous fermentation of an organic
material, wherein the continuous fermentation comprises a source of, and provides a
habitat for, sustained activity of the low temperature fermentation microorganisms; wherein a second of the one or more catalysts comprises a liquid fertilizer prepared from continuous fermentation of an organic material, wherein the continuous fermentation comprises a source of, and a habitat for, activity of low temperature fermentation microorganisms; wherein the one or more prokaryotic organisms comprise at least one of one or more species of Archaea or one or more species of bacteria comprising at least one of purple non-sulphur producing heterotrophic photosynthetic bacteria, Lactobacillus species, yeasts, Actinomycetes species, Nocardia species, a ray fungi, plankton or chemotrophic bacteria. The claims further encompass contacting the plant or plant part with a soil sample from the amended site, wherein an exchange of genetic material occurs between the one or more prokaryotic organisms and the plant or plant part; wherein the contacting comprises cultivating the at least one plant or plant part thereof in the soil sample from the amended growing site, and growing the plant or plant part thereof; said method wherein at least one of: the exchange of genetic material occurs at least one of directly between the one or more prokaryotic organisms and the at least one of the plant or the plant part, or indirectly via an exchange of genetic material between the one or more prokaryotic organisms and a symbiotic microorganism associated with the at least one of the plant or the plant part, or by incorporation of the one or more prokaryotic organism into a colony associated with the at least one of the plant or the plant part.
Von Maltzahn et al teach a method of increasing resilience of an agricultural plant against biotic and abiotic stresses, the method comprising amending a growth medium such as a soil or hydroponic liquid medium with a microbial formulation comprising a population of purified beneficial bacterial (endophyte) and other microorganisms that exhibits production of an auxin, an antimicrobial compound, siderophore, and/or a chitinase; and planting seed in said amended growth medium to produce a plant; wherein said microbial formulation provides benefits to a plant grown from said seed (column 6); said microbial formulation further comprising diverse bacterial isolates including Lactobacillus, Nocardia, and fungi. At column 83, lines 40-60, Von Maltzahn et al teach that the plant-microbial symbiotic association results in improved agronomic traits such as increased resistance to biotic and abiotic stresses and improved biological and physiological change to the plant. Von Maltzahn et al also teach modified plants with improved growth characteristics (Examples 5 and 6).
Von Maltzahn et al do not explicitly teach the one or more catalysts of the claims, or the exchange of a genetic material between a bacterial endophyte and plant.
Tiwari et al teach the beneficial relationship between endophytes and host plants including genetic exchange which has beneficial consequences for both plant development and microbial activities. Tiwari et al cite several studies regarding exchange of genetic materials between endophyte and associated plant species. One example is Van Elsas et al (New Phytologist (2003)157:525-537) who teach hot spots conductive for horizontal gene transfer (HGT) activity among plant- and soil associated bacteria. Van Elsas et al state “these hot spots can be characterized by their capacity to enhance bacterial metabolic activity, resulting in enhanced rates of genetic exchange (and mutational change) processes, which leads to enhanced adaptability of hot-spot-associated bacteria. Fig. 1 shows presence of manure and decomposed organic material in the rhizosphere, stimulating bacterial activities resulting in enhanced rate of genetic exchange as well as enhanced microbial activity. The manure and decomposed organic material are both considered “catalysts”.
Bellamy et al teach a method of improving nutrient quality and moisture holding capacity of soils by amending the soils with catalysts comprising a biofertilizer (a catalyst), a humus, humified soil (catalyst) prepared from a continuous fermentation of organic materials, an incubated culture, a collected substrate for energy generation. At column 5, lines 26 states “the catalysts may comprise a source of and/or a substrate produced by and which stimulates the activity of the one or more prokaryotic organisms. For instance, the prokaryotic organisms one or more species of Archaea, one or more species of bacteria…..purple non-sulfur producing heterotrophic photosynthetic bacteria, Lactobacillus species, yeasts, Actinomycetes species, Nocardia species, a ray fungi, plankton, chemotrophic bacteria…” . See instant claims 11-16.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of amending soils with microbial endophytes and planting seed/plant in said amended soils for enhanced plant growth and development as taught by Von Maltzahn et al, and to modify that method by incorporating a step of adding one or more of the catalysts taught by Bellamy et al, stimulating bacterial activities in the rhizosphere resulting in enhanced rate of genetic exchange between the plant and endophyte as well as enhanced microbial activity and improved plant traits with a reasonable expectation of success as taught by each of Tiwari et al and Van Elsas et al. One would have been motivated to do so, given the current nutrient depletion and moisture depletion in arable soils negatively affect soil quality and reduces crop yield and crop quality, and given that other available techniques, such as plant genetic engineering and plant breeding, for improving quality and production of agricultural plants have several health and timing/cost drawbacks as discussed by each of Von Maltzahn et al, Tiwari et al and Van Elsas et al. The rationale to support a conclusion that the claimed invention would have been obvious is that all elements recited in the claims were known in the prior art, and one of ordinary skill could have combined the elements with no change in their respective functions. Thus, the combination yielded predictable results as would have been expected by a skilled artisan.
Therefore, for all the reasons discussed above the claimed invention is a prima facie obvious.
Conclusion
No claim is allowed.
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/ Primary Examiner, Art Unit 1662
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