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 without traverse of Group I, claims 36-53 in the reply filed on 18 September 2025 is acknowledged.
Claims 54-56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 18 September 2025.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The listing of references page 26 of 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 use of Trade Names or Trademarks have been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. See for example, but not limited to, page 14 of the Specification.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on pages 14, 23 and 26. 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 disclosure is objected to because of the following informalities: The Specification contains two “Table 1” on pages 14 and 25. Applicant should amend the table designation on page 25.
Appropriate correction is required.
Claim Objections
Claims 37-51 and 53 are objected to because of the following informalities:
At claims 37-51, “An endophyte” should read -- The endophyte -- because they depend from a previous claim.
At claim 44, line 3, “Fungus” should not be capitalized.
Claim 51 should not recite a deposit date because the deposit(s) may need to be replaced during the life of a patent and would have a different date.
At claim 53, line 2, “an endophyte” should read -- the endophyte --.
Appropriate correction is required.
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 36-53 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature and process without significantly more. The claim(s) recite(s) a substantially purified or isolated Pseudomonas sp. (claims 36-52) and a method of inoculating a plant with said endophyte (claim 53). This judicial exception is not integrated into a practical application because Applicant teaches that the exemplified endophytes denoted EB-010, EB-013, EB-017 and EB-117 were isolated from four different cannabis plant on page 12 of the Specification. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are directed to endophytes that occur in nature. Instant claims 37-52 are directed to inherent properties of the claimed endophytes and the combination(s) (endophyte and plant host) also occur in nature. The method of claim 53 is directed to a natural phenomenon without significantly more.
The Supreme Court’s cited rationale for considering even "just discovered" judicial exceptions as exceptions stems from the concern that "without this exception, there would be considerable danger that the grant of patents would ‘tie up’ the use of such tools and thereby ‘inhibit future innovation premised upon them.’" Myriad, 569 U.S. at 589, 106 USPQ2d at 1978-79 (quoting Mayo, 566 U.S. at 86, 101 USPQ2d at 1971).
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 36-50, 52 and 53 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.
Applicant claims a substantially purified or isolated Pseudomonas sp. endophyte of a plant of the Cannabaceae family capable of conferring a bioprotection phenotype to the plant or part thereof or capable of conferring a bioprotection phenotype to a plant or part thereof to which it is inoculated.
Applicant describe four Pseudomonas sp. isolates from a Cannabis sativa plant (page 12, lines 34-35 of the Specification) denoted EB-010, EB-013, EB-017 and EB-117. Applicant further describes a general method of isolating bacteria from root tissue on page 12, lines 18-32 of the Specification.
Applicant does not describe the broad genus of Pseudomonas sp. endophytes of a plant of the Cannabaceae family capable of conferring a bioprotection phenotype to the plant or part thereof or capable of conferring a bioprotection phenotype to a plant or part thereof to which it is inoculated other than by a method of isolation. The metabolic limitations at claims 40-43 do not adequately describe the very broad genus because it is unclear if the metabolic traits confer the bioprotection phenotype.
Hence, it is unclear Applicant was in possession of the invention as broadly claimed.
See University of Rochester v. G.D. Searle & Co., 68 USPQ2d 1424, 1433 (DC WNY 2003) which teaches knowing the "starting point" is not enough; that is little more than a research plan. The court held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112.
Claim 51 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 endophytes and it is not apparent if the endophytes are readily available to the public. It is noted that applicants have deposited the endophytes 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.
The Specification does not comply with 37 CFR 1.809(d) as follows:
(d) For each deposit made pursuant to these regulations, the specification shall contain:
(1) The accession number for the deposit;
(2) The date of the deposit;
(3) A description of the deposited biological material sufficient to specifically identify it and to permit examination; and
(4) The name and address of the depository.
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 40, 44, 45 and 53 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.
At claim 40, lines 3, 4, 6 and 7 the limitation “at least about” renders the claim indefinite because is directed to both a defined range and an undefined range at the same time.
At claim 40, lines 2 and 5, the limitation “is capable of” is indefinite. It is unclear what is required to render the “endophyte” “capable of” the recited result. Hence, the metes and bounds of the claim is unclear.
At claim 4, line 8, “one or more of the” renders the claim indefinite because the following list includes single function species like betalactone and multiple function genera like T1PKS. Hence, the metes and bounds of the claim are unclear.
At claim 40, line 10, “(e.g. entolysin)” renders the claim indefinite because the claim recites a broad limitation “T1PKS” followed by a narrow limitation. Hence, the metes and bounds of the claim are unclear.
Claim 44 is infinite. Claim 44 appears to be further limiting a plant which claim 36 is directed to an endophyte. At line 2, “which is or may be infected” does not define the metes and bounds of the endophyte of claim 36. Claim 45 is also indefinite because it depends from claim 44 and does not obviate the indefiniteness of claim 44.
At claim 53, line 2, “the plant or part thereof” lacks proper antecedent basis in the claim. Hence, the metes and bounds of the claim are unclear.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 36-48, 52 and 53 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scott et al (2018, Can. J. Microbiol. 64: 664-680).
Scott et al disclose (Table 4) four Pseudomonas strains (BTC6-3, BTC8-1, BTG8-5, and BT 14-4) which are endophytes of Cannabis sativa isolated from plant leaves, petioles, and seeds (Abstract). Scott et al disclose the four strains were assayed for antifungal activity (i.e., an in vitro bioprotection assay) against a panel of seven fungi, including the Cannabis sativa pathogens Botrytis cinerea, Sclerotinia sclerotiorum, and Rhizoctonia solani (Results subheading "Antifungal activity"; Table 4). Scott et al disclose that Botrytis cinerea radial growth was reduced compared to untreated controls by 18.6% by Pseudomonas strain BTC8-1 and by 22% by Pseudomonas strain BTG8-5 (Table 4). Scott et al disclose that all four strains produced siderophores (Table 3), and so may be taken to possess the corresponding gene clusters. Hence, Scott et al had previously disclose the claimed invention.
Scott et al are silent about the presence of recited metabolite biosynthesis traits recited in instant claims 41-43. The Office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same, material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the Applicant to provide that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Claim(s) 36-49, 52 and 53 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Afzal et al (2015 Pak. J. Bot. 47(5): 1999-2008).
Afzal et al disclose in Table 3 four Pseudomonas strains (Pseudomonas geniculata MOSEL-tne1, Pseudomonas koreensis MOSEL-tnc2, Pseudomonas plecoglossicida MOSEL-p18, Pseudomonas taiwanensis MOSEL-t14) which are isolated endophytes of Cannabis sativa (Abstract). Afzal et al disclose that Pseudomonas geniculata MOSEL-tnel, Pseudomonas koreensis MOSELtnc2, and Pseudomonas plecoglossicida MOSEL-p18 were selectively isolated from the Cannabis sativa rhizosphere, while Pseudomonas taiwanensis MOSEL-t14 was isolated directly from Cannabis sativa roots (Materials and Methods subheading "Isolation of endophytic bacteria"; Table 3). Afzal et al disclose that Pseudomonas koreensis MOSEL-tnc2 exhibited strong inhibition of Aspergillus niger growth, while Pseudomonas taiwanensis MOSEL-t14 somewhat inhibited the growth of Fusarium oxysporum in an antifungal assay, i.e. an in vitro bioprotection assay (Tables 3; Methods and Materials subheading "Antifungal activity"). Afzal et al disclose that all four strains produced siderophores (Table 3), and so may be taken to possess the corresponding gene clusters. Hence, Afzal et al had previously disclosed the claimed invention.
Afzalet al are silent about the presence of recited metabolite biosynthesis traits recited in instant claims 41-43. The Office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same, material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the Applicant to provide that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Conclusion
No claims are allowed.
Claims 50 and 51 appear to be free of the prior art which does not teach isolating a Pseudomonas corrugate species as an endophyte of a plant of the Cannabaceae family or the specifically recited strains.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/David H Kruse/
Primary Examiner, Art Unit 1663