The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The amendment filed on 8-18-2025 is acknowledged. Claim 24 has been amended.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 8-18-2025 is acknowledged. The traversal is on the ground(s) that once the claims of Group I are found allowable the restriction should be revisited and the claims of Groups II-IV be rejoined. Applicant’s arguments have been fully considered. As set forth in the Restriction requirement filed on 2-21-2025, when applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder given the proviso that the non-elected claims includes all the limitations of the allowable product/apparatus claims. With regard to the species elections set forth in said Restriction requirement, said elections are hereby withdrawn in light of the amendment of 8-18-2025.
The requirement is still deemed proper and is therefore made FINAL.
Claims 26-43 are pending. Claims 37-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 24-36 are currently under examination.
Information Disclosure Statement
The Information Disclosure Statements filed on 4-19-2022 and 9-22-2023 have been considered. Initialed copies are attached hereto.
It should be noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see pages 15, 20 and 30 for example). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
It should be noted that the cited occurrences of improper use are only exemplary and Applicant should review the entire specification to correct any other improper use of embedded hyperlink and/or other form of browser-executable code.
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 24-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant’s claims recite a Bifidobacterium animalis subsp. lactis HEM20-01 deposited under accession no. KCTC14143BP. Bifidobacterium animalis subsp. lactis HEM20-01 is a naturally occurring bacteria. Thus, the claims do recite a product of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, applicant’s specification states that the claimed Xanthomonas species were isolated from Lolium perenne plants (see page 12 or specification). Thus, the strains reads directly on a product of nature because, as admitted by applicant, the strain was isolated from a naturally occurring source. The selected bacterial strain would be the same as the identical bacterial strain found in nature because selection only occurs from what exists. Thus, the claims are drawn directly to a product of nature. Thus, the claimed Xanthomonas sp. and species “related to Xanthomonas translucens pathovars” cannot display markedly different characteristics in comparison with the naturally occurring counterpart because they are one and the same. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to Xanthomonas sp. GW, SI and SS as well as species “related to Xanthomonas translucens pathovars” with an intended use acting as a biofertilizer or bioprotectant. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the additional element is either an inherent characteristic of the recited bacterial or an intended use. However, neither said inherent characteristics or applicant’s intended use are considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
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.
Biological Deposit
Claims 34-36 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 (biological deposit) 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.
It is apparent that Xanthomonas species GW, SI and SS as deposited with the National Measurement Institute on 17 May 2019 with accession numbers V19/009902, V19/009905 and V19/009909, respectively are required in order to practice the invention. The deposit of biological organisms is considered by the Examiner to be necessary for the enablement of the current invention (see 37 CRF 1.808(a)). The examiner acknowledges the deposit of organisms with National Measurement Institute with the accession numbers V19/009902, V19/009905 and V19/009909 in partial compliance with this requirement. However, said deposits are not in full compliance with 37 CFR 1.803-1.809.
If the deposit is made under terms of the Budapest Treaty, then an affidavit or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit, or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the following criteria have been met:
1) during the pendency of the application, access to the deposit will be afforded to one determined by the Commissioner to be entitled thereto;
2) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent; and
3) the deposits will be maintained for a term of at least thirty (30) years from the date of the deposit or for the enforceable life of the patent or for a period of at least five (5) years after the most recent request for the furnishing of a sample of the deposited material, whichever is longest; and
4) a viability statement in accordance with the provisions of 37 CFR 1.807; and
5) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition, the identifying information set forth in 37 CRF 1.809(d) should be added to the specification. See 37 CFR 1.803 – 1.809 for additional explanation of these requirements.
Written Description
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 24-36 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 rejected claims are drawn to endophyte strains isolated from a plant of the Poaceae family, wherein said endophyte is Xanthomonas sp. selected from the group of. Xanthomonas species GW, SI and SS as deposited with the National Measurement Institute on 17 May 2019 with accession numbers V19/009902, V19/009905 and V19/009909, respectively or a species closely related to Xanthomonas translucens pathovars wherein said endophyte strain has efficacy as a biofertilizer for any and all plants and/or as a bioprotectant for any and all plants against any and all pathogens. The claims optionally require:
the bioprotection and/or biofertilizer phenotype includes production of an unnamed bioprotectant compound in the plant into which the endophyte is inoculated (claim 25);
the bioprotectant compound is selected from the group consisting of siderophore xanthoferrin, and/or xanthomonadin, or a derivative, isomer and/or salt thereof (claim 26);
the bioprotection and/or biofertilizer phenotype is selected from the group consisting of production of organic acids, solubilization of phosphate and nitrogen fixation in the plant into which the endophyte is inoculated (claim 27);
the microorganism comprises bacterial strains that are unable to synthesize the pro-metastatic quorum sensing peptide and are able to reduce or inhibit the production of the pro-metastatic quorum-sensing peptide by gut microbiota (claim 17);
the plant from which the endophyte is isolated is a pasture grass. (claim 28), the pasture grass is from the genus Lolium or Festuca (claim 29) or the pasture grass is from the species Lolium perenne or Festuca arundinaceum (claim 30);
the plant into which the endophyte is inoculated includes an endophyte-free host plant or part thereof stably infected with said endophyte (claim 31);
the plant into which the endophyte is inoculated is an agricultural plant species selected from one or more of forage grass, turf grass, bioenergy grass, grain crop and industrial crop (claim 32);
the plant into which the endophyte is inoculated is a forage, turf or bioenergy grass selected from the group consisting of those belonging to the genera Lolium and Festuca, including L. perenne (perennial ryegrass), L. arundinaceum (tall fescue) and L. multiflorum (Italian ryegrass), and those belonging to the Brachiaria-Urochloa species complex (panic grasses), including: Brachiaria brizantha, Brachiaria decumbens, Brachiaria humidicola, Brachiaria stolonfera, Brachiaria ruziziensis, B. dictyoneura, Urochloa brizantha, Urochloa decumbens, Urochloa humidicola, Urochloa mosambicensis as well as interspecific and intraspecific hybrids of Brachiaria-Urochloa species complex such as interspecific hybrids between Brachiaria ruziziensis x Brachiaria brizantha, Brachiaria ruziziensis x Brachiaria decumbens, [Brachiaria ruziziensis x Brachiaria decumbens] x Brachiaria brizantha, [Brachiaria ruziziensis x Brachiaria brizantha] x Brachiaria decumbens (claim 34);
the plant into which the endophyte is inoculated is a grain crop or industrial crop grass selected from the group consisting of those belonging to the genus Triticum, including T aestivum (wheat), those belonging to the genus Hordeum, including H. vulgare (barley), those belonging to the genus Avena, including A. sativa (oats), those belonging to the genus Zea, including Z. mays (maize or corn), those belonging to the genus Oryza, including O. sativa (rice), those belonging to the genus Saccharum including S. officinarum (sugarcane), those belonging to the genus Sorghum including S. bicolor (sorghum), those belonging to the genus Panicum, including P. virgatum (switchgrass), those belonging to the genera Miscanthus, Paspalum, Pennisetum, Poa, Eragrostis and Agrostis (claim 35);
the plant into which the endophyte is inoculated is a grain crop or industrial crop selected from the group consisting of wheat, barley, oats, chickpeas, triticale, fava beans, lupins, field peas, canola, cereal rye, vetch, lentils, millet/panicum, safflower, linseed, sorghum, sunflower, maize, canola, mungbeans, soybeans, and cotton. (claim 36).
Consequently, the instant claims encompass a myriad bacterial organisms with varying genotypes/phenotypes and differing biological characteristics. People of skill in the art require evidence that a benefit can be derived by the application of a given substance(s). The specification, as filed, is limited to the effects of Xanthomonas sp. strain GW on barley. Specifically the specification demonstrates that said strain is a bioprotectant against the phytopathogen Bipolaris sorokiniana (Example 7); aid in the ability of barley to grow in nitrogen limiting conditions through nitrogen fixation (Example 9); and aid in the ability of barley to grow in conditions with insoluble phosphate through phosphate solubilization (Example 10). Moreover, while the specification shows the effects of Xanthomonas sp. strain GW on barley, it is silent with regard to the doses, mode of administration and dosing regimen needed for Xanthomonas sp. strain GW on any other plant (or the use of any other Xanthomonas sp. or species closely related to Xanthomonas translucens pathovars on any plant). Applicant describes the use of the aforementioned microorganisms in a generalized and prophetic sense but fails to demonstrate the biological of any microorganism (other than Xanthomonas sp. strain GW on barley) with the claimed phenotype. Additionally, the specification is silent with regard to the means by which one would identify a species closely related to Xanthomonas translucens pathovars or which (if any) of those strains would exhibit the claimed phenotype. While the skill in the art of microbiology is high, to date, prediction of a given biological function in a given system is quite unpredictable. Given the lack of success in the art, the lack of working examples and the unpredictability of the identifying bacterial strains with a given phenotype or biological characteristics within a given system, none of the claimed “Xanthomonas sp. (or than the GW strain) or any “species closely related to Xanthomonas translucens pathovars therapeutic compositions” meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. The specification provides insufficient written description to support the genus encompassed by the claim.
To fulfill the written description requirements set forth under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. To adequately describe the genus of endophytes, Applicant must not only adequately describe: which bacterial strains constitute “a species closely related to Xanthomonas translucens pathovars”; which bacterial have the claimed biological characteristics in a given system; and the bioprotectant compound that must be produced by a given strain to provide protection against a given pathogen in a given system (e.g. plant). Moreover, Applicant must describe the means and concentrations by which said strains need to be administered in order to have efficacy in achieving a given biological outcome. The specification, however, does not disclose distinguishing and identifying features of a representative number of members of the genus of bacterial strains to which the claims are drawn, such as a correlation between the genotype/phenotype of a given microorganism and its recited function (i.e. have efficacy as a bioprotectant or biofertilizer), so that the skilled artisan could immediately envision, or recognize at least a substantial number of members of the claimed genus of bacterial strains and therefore, the specification fails to adequately describe at least a substantial number of members of the genus of therapeutics to which the claims refer.
To fulfill the written description requirements set forth under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. To adequately describe the genus of therapeutics, Applicant must adequately describe a structure/function correlation (i.e. demonstration of which of bacterial strains with the claimed genotypical/phenotypical characteristics, if any, has efficacy as a biofertilizer and/or bioprotectant in a given system).
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed' ”. The courts have decided:
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 filing date sought, he or she was in possession of the invention. The invention is, for purposes of the “written description” inquiry, whatever is now claimed.
See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
MPEP 2163.02 further states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Additionally, MPEP 2163 states:
"A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)”
And:
For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
Therefore, because the art is unpredictable, in accordance with the MPEP and currently case law, the description of claimed bacterial strains is not deemed representative of the genus of endophytes which are bioprotectants and/or biofertilizers to which the claims refer.
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 24-36 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 1 is rendered vague and indefinite by the use of the term “a species closely related to Xanthomonas translucens pathovars”. It is unclear what constitutes “closely related” or by what means said relatedness is determined. Consequently, it is impossible to determine the metes and bounds of the claimed invention.
Claim 25 recites the limitation "the bioprotectant compound" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 is rendered vague and indefinite by the use of the phrase “…the bioprotectant compound…”. It is unclear what specific bioprotectant compound said phrase is referring to given that the independent claim no limitation regarding such a compound. As written, it is impossible to determine the metes and bounds of the claimed invention.
Conclusion
No claim is allowed.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 November 15, 2025