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 .
Election/Restrictions
Applicant's election with traverse of Group I, encompassing Claims 19-29 in the reply filed on 05/05/2026 is acknowledged. The traversal is on the ground(s) that Applicant asserts that “the groups of inventions do relate to a single general inventive concept under PCT Rule 13.1 because the claims of Groups II and III include the endophyte recited in the claims of Group I and would not be considered a search burden to examine”. This is not found persuasive, as Examiner made a prima facie case that lack of unity is not present, as the common technical feature does not make a contribution over the prior art, and the Applicant has not rebutted whether the invention represents a new contribution over the common technical feature.
The requirement is still deemed proper and is therefore made FINAL.
Priority
The instant application is a U.S. National Stage application under 35 U.S.C. §371 from International Patent Application No. PCT/IB2021/052670 filed March 31, 2021, which claims the benefit of priority from New Zealand Patent Application No. 771857 filed January 19, 2021. Acknowledgment is made of applicant' s claim for foreign priority under 35 U.S.C. 119 (a)-(d). As such, the effective filing date of Claims 19-31 is January 19, 2021.
Status of the Claims
Claims 19-31 are pending.
Claims 30-31 are withdrawn from consideration as being directed to a non-elected invention.
Claims 19-29 are examined herein.
Information Disclosure Statement
The Information Disclosure Statements filed on 10/20/2025 and 10/21/2025 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. Signed copies of the lists of references cited are included with this Office Action.
Drawings
The drawings are objected to for the following reasons:
37 CFR 1.84 (u)(1) states “View numbers must be preceded by the abbreviation "FIG."”
In the current case, the view number for Figures 1-7 are preceded by the word “Figure” instead
of the abbreviation “FIG.”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office
action to avoid abandonment of the application. Any amended replacement drawing sheet should
include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is
being amended. The figure or figure number of an amended drawing should not be labeled as
“amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the
replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate
changes made to the brief description of the several views of the drawings for consistency. Additional
replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing
sheet submitted after the filing date of an application must be labeled in the top margin as either
“Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by
the examiner, the applicant will be notified and informed of any required corrective action in the next
Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The deposit receipts on pgs. 44-47 should be separated from the instant specification.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on pgs. 40 and 41. 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.
The listing of references in the specification (pgs. 40-42) 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.
Pg. 28, lines 5-6 appear to be missing an in-text citation.
Appropriate correction is required.
Claim Objections
Claims 19-29 are objected to because of the following informalities:
Claim 19 should be amended to recite “…a host plant that is infected with an isolated strain of an Epichloë endophyte…”
Claim 20 recites the term “SSR” which is not a defined acronym. As Claim 20 is the first recitation of “SSR”, Applicant is advised to clearly define the full name of the abbreviation.
Claim 21, line 5 should be amended to recite “…has the number of
Claim 22, line 2 should be amended to recite “…the following 24
Claim 22, line 5 should be amended to recite “…has the number of
Claim 23 should be amended to recite “…is AR128 (NRRL 68010), , or a combination thereof”.
The term “in planta” in Claim 25 should be italicized.
Claim 27 should be amended to recite “…more than about 0.1 ppm ergovaline, , or both.”
Claim 28 should be amended to recite “…the isolated strain of the Epichloë endophyte of claim 19.”
Dependent claims are included in all objections.
Appropriate correction is required.
Claim Rejections – 35 USC § 112
Indefiniteness
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 19-29 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
Claim 19 is rendered indefinite for the recitation of “ans017”, “ans030”, “ans033”, “ans054”, “egs002” and “egs027” which are ransom alphanumeric terms denoted by Applicant to name the simple sequence repeat marker loci that apparently characterize and distinguish endophyte strains (Specification, pgs. 22-23; Table 2 and Table 3). These terms have no art recognized meaning without reference to a sequence or specific database, which are non-patent references, because the names appear to be arbitrary, and the specific characteristics associated therewith could be modified. The instant specification only describes the terms by the primer sequences that previously had been shown to generally amplify Epichloë endophyte polymorphic DNA sequences from when the endophytes are in planta (Table 2) and by their allele size in specific Epichloë endophyte strains (Table 3), which does not constitute an actual definition for the terms. Furthermore, it is unclear if the instant alleles are a genus of alleles or a particular species meant to delineate the instant Epichloë strain from other isolated Epichloë strains. For example, there are ans033 alleles in the public domain that are the size of 181 bp [See Hume et al. (WO 2019/162816 A1)] or with the sizes ranging from 176-194 bp [See Simpson et al. (WO 2019/162863 A1)]. As such, it is unclear if Applicant’s instant claims intend to encompass all the alternative alleles or just the species listed in the claims that are alleles with distinct sequences that are currently not disclosed by Applicant. Since the definitions of “ans017”, “ans030”, “ans033”, “ans054”, “egs002” and “egs027” are essential to determining the metes and bounds of the claimed invention, the claim is rendered indefinite.
Claims 20-22 are indefinite because at the last line, “as shown in Table 3” fails to set forth the metes and bounds of the claimed invention. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
Claim 20 is rendered indefinite for the recitation of “ans014”, “ans015”, “ans016”, “ans019”, “ans024”, “ans025”, “ans031”, “ans032”, “ans035”, “ans036”, “ans044”, “ans047”, “ans049”, “ans056”, “egs004”, “egs010” and “egs027” which are ransom alphanumeric terms denoted by Applicant to name the simple sequence repeat marker loci that apparently characterize and distinguish endophyte strains (Specification, pgs. 22-23; Table 2 and Table 3). These terms have no art recognized meaning without reference to a sequence or specific database, which are non-patent references, because the names appear to be arbitrary, and the specific characteristics associated therewith could be modified. The instant specification only describes the terms by the primer sequences that previously had been shown to generally amplify Epichloë endophyte polymorphic DNA sequences from when the endophytes are in planta (Table 2) and by their allele size in specific Epichloë endophyte strains (Table 3), which does not constitute an actual definition for the terms. Furthermore, it is unclear if the instant alleles are a genus of alleles or a particular species meant to delineate the instant Epichloë strain from other isolated Epichloë strains. For example, there are egs027 alleles in the public domain that are egs027 allele with the size of 359 bp [See Hume et al. (WO 2019/162816 A1)] or with sizes ranging from 345-366 bp [See Simpson et al. (WO 2019/162863 A1)]. As such, it is unclear if Applicant’s instant claims intend to encompass all the alternative alleles or just the species listed in the claims that are alleles with distinct sequences that are currently not disclosed by Applicant. Since the definitions of “ans014”, “ans015”, “ans016”, “ans019”, “ans024”, “ans025”, “ans031”, “ans032”, “ans035”, “ans036”, “ans044”, “ans047”, “ans049”, “ans056”, “egs004”, “egs010” and “egs027” are essential to determining the metes and bounds of the claimed invention, the claim is rendered indefinite. Additionally, Claim 19, from which Claim 20 depends already requires an egs027 allele, so it is unclear how the “egs027” recited in Claim 20 would further limit Claim 19, if chosen as the “at least one additional SSR allele” in Claim 20. Would the second “egs027” allele be different from the first “egs027” allele recited in Claim 19?
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 21 recites the broad recitation "at least two additional SSR alleles", and the claim also recites " which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the “preferred” feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 22 is rendered indefinite for the recitation of “B10”, “B11”, “ans014”, “ans015”, “ans016”, “ans017”, “ans019”, “ans024”, “ans025”, “ans030”, “ans031”, “ans032”, “ans033”, “ans035”, “ans036”, “ans044”, “ans047”, “ans049”, “ans054”, “ans056”, “egs002”, “egs004”, “egs010” and “egs027” which are ransom alphanumeric terms denoted by Applicant to name the simple sequence repeat marker loci that apparently characterize and distinguish endophyte strains (Specification, pgs. 22-23; Table 2 and Table 3). These terms have no art recognized meaning without reference to a sequence or specific database, which are non-patent references, because the names appear to be arbitrary, and the specific characteristics associated therewith could be modified. The instant specification only describes the terms by the primer sequences that previously had been shown to generally amplify Epichloë endophyte polymorphic DNA sequences from when the endophytes are in planta (Table 2) and by their allele size in specific Epichloë endophyte strains (Table 3), which does not constitute an actual definition for the terms. Furthermore, it is unclear if the instant alleles are a genus of alleles or a particular species meant to delineate the instant Epichloë strain from other isolated Epichloë strains. For example, there are ans033 alleles in the public domain that are the size of 181 bp [See Hume et al. (WO 2019/162816 A1)] or with the sizes ranging from 176-194 bp [See Simpson et al. (WO 2019/162863 A1)]. As such, it is unclear if Applicant’s instant claims intend to encompass all the alternative alleles or just the species listed in the claims that are alleles with distinct sequences that are currently not disclosed by Applicant. Since the definitions of “B10”, “B11”, “ans014”, “ans015”, “ans016”, “ans017”, “ans019”, “ans024”, “ans025”, “ans030”, “ans031”, “ans032”, “ans033”, “ans035”, “ans036”, “ans044”, “ans047”, “ans049”, “ans054”, “ans056”, “egs002”, “egs004”, “egs010” and “egs027” are essential to determining the metes and bounds of the claimed invention, the claim is rendered indefinite.
Claim Rejections - 35 USC § 112
Enablement
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.
Claim 23 is 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 invention appears to employ novel endophytes. Since the endophytes are essential to the claimed invention it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the endophytes are not so obtainable or available, the requirements of 35 USC § 112 may be satisfied by a deposit of the endophytes. The specification does not disclose a repeatable process to obtain the specific endophytes and it is not apparent if the endophytes are readily available to the public. It is noted that Applicants have deposited the endophytes (pg. 43) but there is no indication in the specification as to public availability.
(a) If a deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention has been deposited and accepted, and will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
(b) If a deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make the same, or by a statement by an attorney of record over his or her signature and registration number showing that:
(i) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(ii) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent in accordance with 37 CFR § 1.808(a)(2);
(iii) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(iv) a test of the viability of the biological material at the time of deposit (see 37 CFR § 1.807); and,
(v) the deposit will be replaced if it should ever become inviable.
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 19-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (e.g., compositions of matter) (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1).
Claim 19-27 are drawn to an artificial combination comprising a host plant that is infected with an isolated Epichloë endophyte. As evidenced by the instant disclosure, the Epichloë endophytes used in the combination recited in Claims 19-27 are naturally occurring fungal endophytes (products of nature) that were isolated from Lolium perenne plants (products of nature) (pg. 20, Example 1) and then reintroduced into a host plant (product of nature). The instant specification defines the scope of host plants that the naturally occurring Epichloë endophytes (products of nature) can infect as “…a grass plant or part thereof, preferably a Lolium spp. plant, preferably L. perenne, L. boucheanum, or L. multillorum, or a cultivar thereof, preferably L. perenne cultivar Grasslands Samson, preferably L. boucheanum cultivar Platform or preferably L. multillorum cultivar Asset” (Specification, pg. 12, lines 7-10)— meaning that the naturally occurring Epichloë endophytes (products of nature) included in the scope of the invention can infect the very plant (L. perenne) that they were already naturally found in. Additionally, the instant specification defines the term “artificial combination” as encompassing “…any inoculation of a plant, particularly a plant, preferably a grass plant, preferably a Lolium spp. (ryegrasses) plant, preferably L. perenne, L. boucheanum, and/or L. multillorum, with AR128 or AR166 to form a plant/fungal symbiotic association that is not known from nature” (Specification, pg. 6, lines 22-25), which, while reciting that the artificial combination is not known in nature, also recites that the artificial combination of host plant and endophyte includes the combination of the very plant (L. perenne) that the endophyte was already naturally found in being infected with the naturally-occurring Epichloë endophytes (AR128 and AR166). As such, it appear that the term “artificial combination” does not impose a meaningful limitation on the scope of the claims such that all others are not precluded from using the product of nature; therefore, the claims encompass a naturally occurring Epichloë endophytes (products of nature) infecting the very plant (L. perenne) that they were already naturally found to infect in nature. Therefore, the host plant infected with the Epichloë endophyte recited in Claims 19-27 cannot be distinguished from host plants that naturally comprise the Epichloë endophyte. The same logic applies to the host plant, or part thereof, recited in Claim 28 and the artificially infected host plant, wherein the part thereof is a seed, that is recited in Claim 29.
MPEP 2106.04(c) states that if a claim includes a nature-based product that does not exhibit
markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim recites a "product of nature" exception, and requires further analysis in Step 2A Prong Two to determine whether the claim as a whole integrates the exception into a practical application (Step 2A, Prong One: YES).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed invention is directed to naturally-occurring process(es), nucleotides, cells, and organisms. The claimed combination of host plant and Epichloë endophyte have inherent properties that are recited in the claims, such as the presence of certain alleles that would be inherent to the isolated Epichloë endophyte as it is found in nature (See Example 2 in the instant specification), as well as the production of alkaloids that are an inherent feature of the Epichloë endophyte as it is found in nature (See Example 1, pg. 20, lines 12-19). The instant combination of host plant and Epichloë endophyte does not require any transformation event or an additional element to show a practical application or integration of the natural principle. Therefore, Claims 19-29 are directed to a natural product with no additional elements to demonstrate that the claims as a whole integrate the exception into a practical application (Step 2A, Prong 2: NO).
A claim that focuses on use of a product of nature must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the product of nature itself. Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S.Ct. 1289,101 USPQ2d 1961 (2012), at 1966. To show integration, the additional elements must relate to the product of nature in a significant way to impose a meaningful limit on the claim scope. Although the instant claim recites the term “isolated” Epichloë endophyte, this step is not a substantial integration of the product of nature sufficient to confer patent eligibility. As described in the instant specification (Example 5), the “isolated” Epichloë endophyte is merely taken from is natural host, sub-cultured for identification, wherein the instant claims direct the “isolated” endophyte to be re-infected into a host plant—the scope of which includes the Epichloë endophyte’s natural host plant. As such, the process of isolating the Epichloë endophyte does not change the structural, functional ,physiological, or morphological characteristics of the Epichloë endophyte in such a way that it changed so as to not be the same naturally-occurring Epichloë endophyte (AR128 and AR166). As such, the “isolated” Epichloë endophyte recited in Claim 19 cannot be distinguished from naturally-occurring Epichloë endophyte. Claims 19-29 do not contain additional elements to demonstrate the claims as a whole integrate the exception into a practical application, the claims simultaneously do not recite significantly more than the exception itself. Since there is no meaningful limitation in Claims 19-29 that transform the exception into a patent-eligible application, such that the claims do not amount to significantly more than the exception itself, Claims 19-29 are not patent-eligible (Step 2B: NO).
Claim Rejections - 35 USC § 112
Scope of Enablement
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 19-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an artificial combination comprising a , wherein the isolated strain of Epichloë comprises B10, B11, ans014, ans015, ans016, ans017, ans019, ans024, ans025, ans030, ans031, ans032, ans033, ans035, ans036, ans044, ans047, ans049, ans054, ans056, egs002, egs004, egs010 and egs027, does not reasonably provide enablement for any host plant from any diverse source in the art or an isolated Epichloë strain that only comprises a subset of the alleles recited in Table 3. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: (1) the quantity of experimentation necessary; (2) the amount of direction or guidance presented; (3) the presence or absence of working examples of the invention; (4) the nature of the invention; (5) the state of the prior art; (6) the relative skill of those in the art; (7) the predictability or unpredictability of the art; (8) the breadth of the claim. In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988).
Claim 19-29 are broadly directed to an artificial combination comprising a host plant that infected with an isolated strain of Epichloë endophyte, a host plant or part thereof that is artificially infected with the isolated strain of the Epichloë endophyte of claim 19, and the artificially infected host plant of claim 28 wherein the part thereof is a seed. The genus of host plants (to be infected with the Epichloë endophyte) included in the scope of the claims appear to be any plant from any diverse source in the art.
Applicant teaches that Epichloë endophytes used in the working examples of the specification were isolated strains (AR128 and AR166) from Lolium perenne accessions (56085 and 61701), wherein the collected plants were assessed for the presence of Epichloë endophyte using the immuno-detection method. Applicant teaches that the in vitro characteristics of fungal strains, when grown on PDA, were consistent with published descriptions of Epichloë festucaevar. lolii, syn. Neotyphodium lolii (pg. 26, lines 20-21). Seeds from each Epichloë endophyte-infected plant were harvested and sent to New Zealand for further examination (pg. 20; Table 10). After identifying AR128 and AR166 as epoxyjanthitrem-producing strains of Epichloë (pg. 20, lines 18-19) and identifying their SSR allele profile and allele size (pgs. 20-24, Table 2 and 3), seeds of Lolium perenne cultivar Samson, Lolium boucheanum cultivar Platform, and Lolium multinorum cultivar Asset were artificially inoculated with Epichloë strains AR128 and AR166 (pg. 26-27, Example 6) for downstream alkaloid expression assays (pgs. 27-29, Example 7, Tables 5 and 6), animal toxicology assays (after consumption of artificially infected Lolium plants) (pgs. 30-33, Example 8, Table 7), and insect pest resistance assays (pgs. 33-39, Example 9). The only plants used as host plants for Epichloë endophyte infection in the working examples of the instant invention are Lolium plants.
Applicant does not teach the artificial infection of any Epichloë endophytes in plants outside of the genus Lolium, much less artificial infection of Epichloë endophyte strains AR128 and AR166 in plants outside of the genus Lolium in any working or prophetic examples of the instant specification.
The state of the prior art, regarding the range of host plants that Epichloë endophytes can successfully infect, teaches that while Epichloë endophytes are naturally found in a wide range of temperate grasses, the Epichloë fungus has co-evolved with it host grass over millennia to the point where the genome of Epichloë has genes for improved host compatibility (Caradus and Johnson; Journal of Fungi 6.4 (2020): 322; Abstract, pg. 6, Sections 2.4 and 2.5). Caradus and Johnson et al. teach that moving Epichloë strains across grass taxa has been difficult and largely unsuccessful, suggesting that Epichloë species and even some strains have developed through co-speciation and are essentially host species specific (pg. 6, Section 2.5). The disclosure of Caradus and Johnson et al. does not teach any functional or structural information about Epichloë fungus that provides guidance to one of ordinary skill in the art to achieve the successful infection of Epichloë fungus in any plant species known in the art.
Based on the teachings of the instant specification and the prior art, it would appear that it would require one of ordinary skill in the art undue trial and error experimentation to successfully infect any grass species from any diverse source in the art (other than Lolium plants) with the instantly claimed Epichloë endophyte, much less successfully infect any species of plant from any diverse source in the art with the instantly claimed Epichloë endophyte, due to the host specificity of any given Epichloë endophyte strain. At the most basal level, this would require a study on all plant species to determine if the instantly claimed Epichloë endophyte could systemically or locally infect the plant in such a way that the plant retains the endophyte in a seed it produces, not including the undue experimentation required for designing artificial infection protocols so the instantly claimed Epichloë endophyte could be successfully introduced to any plant species known in the art.
Accordingly, Applicant has not demonstrated that all the members of the broad genus of host plants from any diverse source in the art would be able to be successfully infected with the instantly claimed Epichloë endophyte (i.e., performing as a viable host for the claimed endophyte), and without a function the claimed genus does not have an obvious use. Applicant has not provided teachings to enable the use across the entire spectrum of host plants from any diverse source known in the art and the examples actually provided by Applicant do not provide adequate teachings to enable the scope of the invention without undue experimentation.
In the absence of guidance from wither the instant specification or the prior art, and the unpredictability of any given Epichloë endophyte being able to infect any plant known in the art (as discussed in the prior art above), it would require undue trial and error experimentation for a skilled artisan to use the broadly claimed genus of host plants from any diverse source as a viable host for the claimed Epichloë endophyte, with no reasonable expectation of success. For this reason, the specification does not teach a person with ordinary skill in the art how to use the subject matter within the full scope of the claims.
Additionally, Claim 19 is directed to an isolated strain of an Epichloë endophyte from any diverse source known in the art that is defined as necessarily comprising six alleles (ans017 allele size of 306 10.8 base pairs (bp), an ans030 allele size of 308 10.8 bp, an ans033 allele size of 171 10.8 bp, an ans054 allele size of 297 10.8 bp, an egs002 allele size of 297 10.8 bp and an egs027 allele size of 344 0.8 bp) of a particular size which are presumably meant to delineate the instant isolated Epichloë strain from other isolated Epichloë strains known in the art (See 35 U.S.C. §112(b) rejections above).
Applicant teaches two distinct Epichloë endophytes used in the working examples of the specification that were isolated strains (AR128 and AR166) from Lolium perenne accessions (56085 and 61701), wherein the collected plants were assessed for the presence of Epichloë endophyte using the immuno-detection method. Applicant teaches that the in vitro characteristics of fungal strains, when grown on PDA, were consistent with published descriptions of Epichloë festucaevar. lolii, syn. Neotyphodium lolii (pg. 26, lines 20-21). Seeds from each Epichloë endophyte-infected plant were harvested and sent to New Zealand for further examination (pg. 20; Table 10). After identifying AR128 and AR166 as epoxyjanthitrem-producing strains of Epichloë (pg. 20, lines 18-19), Applicant identified their SSR allele profile and allele size (pgs. 20-24, Table 2 and 3) using 24 primer sequences taught in Table 2, and analyzing the PCR products.
Applicant has not provided working or prophetic examples in the instant specification wherein isolated Epichloë strains were differentiated from each other or other Epichloë endophytes known in the art and public domain, only using a subset of the alleles (such as those listed in Claims 19 and 20). Rather, the instant specification requires that the isolated Epichloë endophytes be identified and differentiated using the twenty-four primer sequences listed in Table 2, to amplify the twenty-four polymorphic DNA sequences (SSR alleles) recited in Claim 22.
The state of the prior art, regarding the identification of unique Epichloë endophyte strains using primer sequences that amplify SSR alleles, teaches isolated Epichloë endophytes that are identified and differentiated from other Epichloë strains known in the art, using twenty-two primer sequences [See Hume et al. (WO 2019/162816 A1, published 08/29/2019), Table 2; See Simpson et al. (WO 2019/162863 A1, published 08/29/2019), Table 2).
Based on the teachings of the instant specification and the prior art, it would appear that it would require one of ordinary skill in the art undue trial and error experimentation to successfully identify unique Epichloë strains from any diverse source in the art using only a subset of the alleles recited in Table 3 of the instant specification, much less successfully identify unique Epichloë strains from any diverse source in the art using only 6 of the alleles recited in Table 3 of the instant specification, with the expectation that the endophyte will infect a host plant of any species known in the art for some utility. At the most basal level, this would require a study on all plant species known in the art that comprise Epichloë endophytes, to first isolate the endophytes, then determine if the instantly claimed subset of SSR alleles recited in Claim 19 could actually differentiate and identify novel Epichloë endophytes at the strain level from other Epichloë endophytes known in the art and public domain, and then determine if the strains would have the same characteristics, function, or utility in a host plant as Epichloë endophytes comprising all 24 alleles recited in Table 3 and Claim 22 .
Accordingly, Applicant has not shown that Epichloë endophytes comprising only an ans017 allele size of 306 10.8 base pairs (bp), an ans030 allele size of 308 10.8 bp, an ans033 allele size of 171 10.8 bp, an ans054 allele size of 297 10.8 bp, an egs002 allele size of 297 10.8 bp and an egs027 allele size of 344 0.8 bp (a subset of SSR sequences) would have would have the same characteristics, traits, or utility in a host plant as the strains identified as comprising all twenty-four SSR alleles recited in Table 3 (i.e., AR128 and AR116). Applicant has not provided teachings to enable the use across the entire spectrum of Epichloë endophytes from any diverse source known in the art that comprises an ans017, ans030, ans033, ans054, egs002, and egs027 allele (a subset of the alleles recited in Table 3) and the examples actually provided by Applicant do not provide adequate teachings to enable the scope of the invention without undue experimentation.
In the absence of guidance from wither the instant specification or the prior art, and the unpredictability of any given Epichloë endophyte with an ans017, ans030, ans033, ans054, egs002, and egs027 allele have the same characteristics, traits, or utility in a host plant as the strains identified as comprising all twenty-four SSR alleles recited in Table 3 (i.e., AR128 and AR116), it would require undue trial and error experimentation for a skilled artisan to use the broadly claimed genus of Epichloë endophytes from any diverse source comprising an ans017, ans030, ans033, ans054, egs002, and egs027 allele (a subset of the alleles recited in Table 3), with no reasonable expectation of success. For this reason, the specification does not teach a person with ordinary skill in the art how to use the subject matter within the full scope of the claims.
Closest Prior Art
Claims 19-29 appear to be provisionally free of the prior art, given the failure of the prior art to teach or suggest a Epichloë strain having all of the undefined alleles (See 35 U.S.C. §112(b) rejection above] recited in Claim 19. Because the alleles are only described by the primers that amplify their DNA sequences in an isolated Epichloë strain, and by the length of the identified alleles, it is unclear if Applicant intends for the instant claims to encompass any isolated Epichloë strain in the art that happens to have “hits” for the six DNA sequences that are identified and amplified with the primers associated with ans017, ans030, ans033, ans054, egs002, and egs027 (See Table 2 for primer sequences) regardless of their size, distinct sequence, or designation. Thus, this statement will remain provisional until the necessary information requested under the 35 U.S.C. §112(b) rejections above are received, corrections are made to the claims/description, and a complete search of the prior art can be completed. The closest prior art in regard to Claims 19-29 can be found in several different patent publications:
Hume et al. (WO 2019/162816 A1, published 08/29/2019) which teaches Epichloë endophyte strains AR3002, AR 3005, AR3007, and AR3042 comprising an ans033 alleles with the size of 181 bp and an egs027 allele with the size of 359 bp (Table 2). However, Hume et al. does not teach or reasonably suggest an Epichloë endophyte strain comprising all of the alleles listed in instant Claim 19.
Simpson et al. (WO 2019/162863 A1, published 08/29/2019) which teaches Epichloë endophyte strains AR3002, AR3013, AR3060, AR3067, AR3070, and AR3108, all of which comprising ans033 alleles with the sizes ranging from 176-194 bp and egs027 alleles with sizes ranging from 345-366 bp (Table 3). However, Simpson et al. does not teach or reasonably suggest an Epichloë endophyte strain comprising all of the alleles listed in instant Claim 19.
Cox et al. (AU 2018/253526 A1, published 05/16/2019) which teaches an Epichloë endophyte strain comprising an ans54 allele that is approximately 275.4 bp in size (Claim 15) and an ans033 allele that is approximately 134.4 bp in size (Claim 16). However, Cox et al. does not teach or reasonably suggest an Epichloë endophyte strain comprising all of the alleles listed in instant Claim 19.
Pennell et al. (WO 2008/133533 A1, published 11/06/2008) which teaches Epichloë endophyte strains AR4, AR5, AR8 and AR94 from Lolium cultivars and strains AR601, AR602, AR603, and AR604 from Festuca cultivars, all of which comprises an ans017 allele (Table 12). However, Pennell et al. does not teach or reasonably suggest an Epichloë endophyte strain comprising all of the alleles listed in instant Claim 19.
Conclusion
No claims are allowed.
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/KELSEY L MCWILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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