DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
1) A request for continued examination under 37 C.F.R 1.114, including the fee set forth in 37 C.F.R 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 C.F.R 1.114, and the fee set forth in 37 C.F.R 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 C.F.R 1.114. Applicants’ submission filed on 11/14/25 has been entered.
Applicants’ Amendment
2) Acknowledgment is made of Applicants’ amendment filed 11/14/25 in response to the final Office Action mailed 05/16/25. Said amendment is non-compliant under 37 C.F.R 1.121 in that claim 38, now including changes indicated via strikethrough, has incorrect status identifier. Appropriate correction is needed.
Status of Claims
3) New claims 62-64 have been added via the amendment filed 11/14/25.
Claims 35, 37, 38 and 45 have been amended via the amendment filed 11/14/25.
Claims 35-38, 45 and 47-64 are pending.
Claims 47-54 and 57-61 were previously withdrawn.
Claims 35-38, 45, 55, 56 and 62-64 are under examination.
Prior Citation of Title 35 Sections
4) The text of those sections of Title 35 U.S. code not included in this action can be found in a prior Office Action.
Prior Citation of References
5) The references cited or used as prior art in support of one or more rejections in the instant Office Action and not included on an attached form PTO-892 or form PTO-1449 have been previously cited and made of record.
Objection(s) Withdrawn
6) The objection to the specification set forth in paragraph 8 of the Office Action mailed 01/03/2025 and maintained in paragraph 5 of the Office Action mailed 05/16/25 is withdrawn in light of Applicants’ amendments to the specification.
Rejection(s) Withdrawn
7) The rejection of claim 37 set forth at paragraph 14(f) of the Office Action mailed 01/16/25 and maintained in paragraph 24 of the Office Action mailed 05/16/25 under 35 U.S.C § 112(b) or 35 U.S.C § 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in light of Applicants’ claim amendment.
8) The rejection of claims 35-38 and 45 set forth at paragraph 12 of the Office Action mailed 01/16/25 and maintained in paragraph 22 of the Office Action mailed 05/16/25 and the rejection of claims 55 and 56 set forth in paragraph 22 of the Office Action mailed 05/16/25 under 35 U.S.C § 101 as being directed to a judicial exception without significantly more is withdrawn in light of Applicants’ amendments to the base claims 35 and 45.
Applicants contend that claim 35 has been amended to clarify that the product is configured for the specific purpose of providing bioprotection and/or biofertilizer phenotypes to a plant that is free of the endophyte strain prior inoculation therewith. Applicants assert that when viewed as a whole including all of its limitations, the amended claim 35 recites a practical application of the claimed product, meaningfully limits the product to such practical application thereof, and when viewed as a whole amounts to significantly more than any identified judicial exception. Applicants state that claim 35 passes step 2A prong II and step 2B of the Office's SME test, and accordingly should be found to be directed to patent-eligible subject matter. Applicants state that claim 45 is similarly amended to recite that the plant is free of the specific endophyte prior to inoculation therewith and that the result of the inoculation results in improved bioprotection and/or biofertilizer phenotypes as compared to the plant prior to inoculation. Applicants submit that to the extent that "a plant" or "an endophyte" are considered "products of nature", the features of claim 45, when viewed as a whole, provide markedly different characteristics than any identified product of nature under Step 2A prong I of the Office's SME test; a practical application of any identified product of nature under Step 2A prong II; and amount to significantly more than any identified product of nature under Step 2B. Applicants state that claim 45 expressly recites a plant and a specific endophyte where the plant has two different states (e.g. prior to AND post inoculation) and associated properties in each state. Applicants assert that prior to inoculation the plant is free of the endophyte and exhibits certain biofertilizer and/or bioprotection phenotype and post inoculation, the plant is stably infected with the specified endophyte and exhibits improved biofertilizer and/or bioprotection phenotypes as compared to the plant in its "prior to" inoculation state. Applicants opine that these limitations/states/properties are expressly recited in claim 45, and when considered as a whole with the balance of limitations should be found to meet all prongs of, and all Steps 2A and 2B of the Office's SME test.
Applicants’ arguments have been carefully considered, but are not persuasive. Applicants are referred to the new rejection set forth below in this Office Action to address the claims as amended.
Rejection(s) under 35 U.S.C § 102 Maintained
9) The rejection of claims 35-38, 45, 55 and 56 set forth at paragraph 26 of the Office Action mailed 05/16/25 under 35 U.S.C § 102(a)(1) as being anticipated by KR 20170050251 A (English Translation, of record) is maintained.
New dependent claims 62-64 are now added to this rejection.
Applicants state that they reiterate and incorporate their prior-filed remarks regarding the KR '251 reference into the present response. Applicants allege that the Office has failed to establish a prima facie anticipation rejection against any claim of the application and state that the initial burden remains with the Office. Applicants state that the strain of the ‘251 reference appears to have been isolated from Brassica napus, whereas the strain of the present invention was isolated from perennial ryegrass and therefore the two strains are different. However, it should be noted that ‘isolated’ is a process limitation in a product claim. The patentability of a product does not depend on its method of preparation. If the product in the product-by-process claim is the same as or obvious over a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Applicants further contend that the ‘251 reference lists five sequences of Stenotrophomonas and acknowledge that one of which is the 16S sequence. Applicants state that upon review of Genbank, five additional Stenotrophomonas sequences can also be found. Applicants present a tree of 16S alignments from the type strain (e-p10), the isolate (B03) of the present invention, and the '251 reference isolate (LY490458), and submit that this data clearly demonstrates that based on 16S, there are 3 different strains of Stenotrophomonas rhizophila. Said tree as presented by Applicants is reproduced below, which is completely illegible:
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The illegible tree allegedly demonstrating that there are 3 different strains of Stenotrophomonas rhizophila based on 16S and the conclusory statements that are no more than attorney arguments (In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997)), the Office is unable to make a decision at this time on whether or not to withdraw the rejection of record. Applicants should consider presenting a fully legible response.
Rejection(s) under 35 U.S.C § 101
10) 35 U.S.C § 101 states:
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.
11) Claims 35-38, 45, 55, 56 and 62-64 are rejected under 35 U.S.C § 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Instant claim 35 is directed to the JB strain of Stenotrophomonas rhizophila. Claim 45 is directed to a plant or part thereof inoculated with one or more endophyte strains, wherein the endophyte strain is Stenotrophomonas rhizophila strain JB, wherein the plant into which the endophyte strain is inoculated is otherwise free of said endophyte prior to inoculation therewith as recited. Because the claimed strain and/or the plant or part thereof are composed of matter, at least one embodiment encompassed within the broadest reasonable interpretation (BRI) of the instant claims is directed to a statutory category, i.e., a composition of matter (Step 1: YES). The as-filed specification at lines 16-17 of page 11 documents that the JB strain of Stenotrophomonas rhizophila was isolated from perennial ryegrass (Lolium perenne) plants, i.e., from nature. Therefore, the claimed strain is a naturally occurring strain. There is no evidence that the claimed JB strain of Stenotrophomonas rhizophila is modified in any way and it is markedly different from what exists in nature. Supreme Court has made it clear in Myriad that eligibility requires the creation of something not naturally occurring, which is markedly different from what exists in nature. Unlike the Chakrabarty bacterium, which was new “with markedly different characteristics from any found in nature” 447 U.S., at 310, 100 S. Ct. 2204, 65 L. Ed. 2d 144, due to the multiple additional plasmids and resultant “capacity for degrading oil”, there is no indication that the instantly claimed strain is genetically manipulated or structurally modified in any marked or significant way such that the structural difference results in change of properties of the strain. Furthermore, having said strain in a naturally occurring uninfected or uninoculated part of a barley plant does not markedly change the strain or the plant part. The recitation “when used to provide .....” in claim 35 represents the intended use of the strain. Note that in Chakrabarty and Myriad, the marked difference inquiry was focused on the modified structural characteristics of the product, not how it was used or how it was made. The recitations of bioprotection and/or biofertilizer phenotype such as solubilization of phosphate and production of a bioprotectant compound represent the inherent qualities, properties or characteristics inseparable from said naturally occurring strain and therefore are a handiwork of nature. Note that “….. patents cannot issue for the discovery of phenomena of nature”. Le Roy v. Tatham, 14 How. 156, 175. The qualities of the bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none.” See Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. at 130, 1948. In Funk Brothers, the Court held that the composition was not patent eligible because the patent holder did not alter the bacteria in any way. In the instant case, a part of a plant inoculated as recited in claim 45 does not or is not required to exhibit improved bioprotection and/or biofertilizer phenotypes. Having the natural strain into a part of a naturally occurring uninoculated plant does not add significantly more to the natural product such that it is practically applied. Thus, the strain itself as claimed claims 35-38 and a part of a naturally occurring plant as claimed in claims 45, 55, 56 and 62-64 are a ‘product of nature’ exception, and the claims are directed to a judicial exception(s) (Step 2A Prong One: YES). Judicial exceptions include all natural products including those derived from natural sources or patients such as naturally occurring microorganisms, proteins, peptides, glycoproteins, glycopeptides, carbohydrates, and other substances found in or derived therefrom, or from nature. Next, the claims as a whole are analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claims
amount to significantly more than the exceptions. Having the strain with a part of a naturally occurring plant does not amount to significantly more. There is nothing that provides significantly more or that integrates the claimed naturally occurring strain and naturally occurring plant part, i.e., the judicial exceptions, into a practical application (Step 2A Prong Two: NO). The process limitation ““when used to provide .....” does not apply or use the exception(s) in any meaningful way and does not integrate the law of nature into a practical application. This limitation merely indicates a field of use in which to apply the judicial exceptions and therefore fail to provide meaningful limits on the claims. Such limitations merely limit the use of the judicial exceptions to a particular technological environment, or merely instruct to implement or use the strain in a method. The claims as a whole do not amount to significantly more than a ‘product of nature’ (Step 2B: NO). Therefore, the claims are not directed to a patent eligible subject matter.
The rationale for this determination is formed in view of the 2019 PEG, the 2015 Update of the 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 4618) (hereafter Interim Eligibility Guidance) dated 16 December 2014, the Life Sciences Examples issued in May 2016, and in view of Myriad v Ambry, CAFC 2014-1361, -1366, 17 December 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U. S. (June13, 2013).
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ) Second Paragraph
12) 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.
13) Claims 35-38, 45, 55, 56 and 62-64 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 inventor or a joint inventor, or for the pre-AIA the Applicants regard as the invention.
(a) Claim 35, as amended, is incomplete and confusing in the phrase: “when used to provide bioprotection ......... with the endophyte strain, ...... wherein the endophyte strain is ..... V19/009906”. The limitation “when used ..., wherein” renders the amended claim indefinite and incomplete.
(b) Claims 36 and 38 are indefinite in having improper antecedence in the limitation “the bioprotection and/or biofertilizer phenotype”. Claims 36 and 38 depend from the amended claim 35, which recites the plural “bioprotection and/or biofertilizer phenotypes”.
(c) Claim 45, as amended, is ambiguous, indefinite and internally inconsistent in the limitations “one or more endophyte strains”, the two recitations of “the endophyte strain is” (see lines 2 and 4), “said endophyte” (see line 4), and the two recitations of “said endophyte strain” (see lines 6 and 8). It is unclear whether the claimed plant or part thereof is inoculated with more than one generic endophyte strains and the JB strain of Stenotrophomonas rhizophila. One of ordinary skill cannot recognize or identity in an unambiguous way that which is being claimed and therefore cannot understand the scope of the claim. The metes and bounds of the claim are indeterminate.
(d) Claim 45, as amended, is indefinite for lacking sufficient antecedence in the limitation “inoculation therewith” (see line 5) and “inoculation with” (see line 8). For proper antecedence, it is suggested that Applicants replace said limitations with --the inoculation therewith-- and --the inoculation with-- respectively.
(e) Claims 36-38, which depend directly or indirectly from claim 35, and claims 55, 56 and new claims 62-64, which depend directly or indirectly from claim 45, are also rejected as being indefinite due to the indefiniteness identified in the base claim(s).
Claim(s) Interpretation
14) The claim limitation “when used to provide .....” in claim 35 represents the intended use of the claimed endophyte strain. The claimed Stenotrophomonas rhizophila strain JB is one that is not required to comprise SEQ ID NO: 1 as the 16S Amplicon sequence. The claim limitation ‘isolated’ in claim 35 represents a process limitation in a product claim.
The patentability of a product does not depend on its method of preparation. If the product in the product-by-process claim is the same as or obvious over a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Rejection(s) under 35 U.S.C § 102
15) 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
16) Claims 35-38, 45 and 62-64 are rejected under 35 U.S.C § 102(a)(1) and 35 U.S.C § 102(a)(2) as being anticipated by Dashti et al. (US 2014/0341856 A1, of record).
Dashti et al. disclosed an isolated, plant growth promoting Stenotrophomonas rhizophila (i.e., endophyte strain) identified by the DSMZ, Brauschweig, Germany and a biological treatment of controlling tomato plant viruses and strengthening the protection of crop plants including the tomato plants via inoculation of an uninfected plant with the plant growth-promoting Stenotrophomonas rhizophila. The post-inoculation protection efficacy against the infection was highest for the plants treated with the plant growth-promoting Stenotrophomonas rhizophila compared to the untreated or uninoculated plants. The mechanism by which the protection (i.e., bioprotection phenotype) of the plant is enhanced included solubilization of mineral phosphates. See abstract; claims 2, 3 and 1; and sections [0023] to [0026], [0029] and [0033]; and the last sentence of section [0006]. The prior art strain of Stenotrophomonas rhizophila reads on the instantly claimed JB strain of Stenotrophomonas rhizophila. The phenotype of production of the recited bioprotectant compound such as spermidine or an isomer or salt thereof in the plant and the solubilization of phosphate are intrinsic to and inseparable from the prior art strain. Absent evidence of specific structural features that distinguish the claimed JB strain of Stenotrophomonas rhizophila from that of the prior art, there is sufficient overlap to reasonably conclude that the prior art strain of Stenotrophomonas rhizophila is Applicants’ JB strain of Stenotrophomonas rhizophila merely having the accession number V19/009906. Since the Office does not have the facilities for examining and comparing these strains of Stenotrophomonas rhizophila, the burden is on the Applicants to show a novel or an unobvious difference between the instantly claimed product and the prior art product. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzerald et al., 05 USPQ 594.
Claims 35-38, 45 and 62-64 are anticipated by Dashti et al.
17) Claims 35-38, 45, 55, 56 and 62-64 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by WO 2017/019633 (‘633).
WO ‘633 disclosed multiple endophyte strains of isolated and biologically pure Stenotrophomonas rhizophila having the mineral phosphate solubilization activity. Agricultural bioinoculants comprising the same are taught. Said strains protected plants including food crops such as barley against pathogens. Said strains provide a wide range of agricultural applications including improvements in growth of plants and plant parts, improved resistance to disease, and improvements in other desired plant phenotypic characteristics, i.e., bioprotection and/or biofertilizer phenotypes. Said endophyte strains inhabiting plants, plant rhizosphere, and plant roots and preventing pathogenic organisms from colonizing them are taught. Plants and seeds applied with said bioinoculants are taught. Said Stenotrophomonas rhizophila are the deposited strains available to the public. A single such strain from Table 3 is utilized to promote one or more desirable plant properties. See sections [0003], [0219], [0299], [0300], [0037], [0319], [0334], [0097], [0013], [0036] and [0164]; 3rd full sentence of sections [0015] and [0022]; parts of Table 3 on pages 33-34; and footnote to Table 3. The prior art strains of Stenotrophomonas rhizophila read on the instantly claimed JB strain of Stenotrophomonas rhizophila, which merely has the accession number V19/009906. The phenotype of production of the recited bioprotectant compound or a salt or isoform thereof are intrinsic to and inseparable from the prior art strain. Absent evidence of specific structural features that distinguish the claimed JB strain of Stenotrophomonas rhizophila from that of the prior art, there is sufficient overlap to reasonably conclude that the prior art strain of Stenotrophomonas rhizophila having the anti-pathogen bioprotection phenotype is the Applicants’ JB strain of Stenotrophomonas rhizophila. Since the Office does not have the facilities for examining and comparing these strains of Stenotrophomonas rhizophila, the burden is on the Applicants to show a novel or an unobvious difference between the instantly claimed product and the prior art product. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzerald et al., 05 USPQ 594.
Claims 35-38 45, 55, 56 and 62-64 are anticipated by WO ‘633.
Conclusion
18) No claims are allowed. The JB strain of Stenotrophomonas rhizophila that is isolated and purified and comprising the 16S Amplicon sequence of SEQ ID NO: 1 is free of prior art currently of record.
In line 2 of claims 36, 38, 62 and 64, for proper antecedence, it is suggested that Applicants replace the limitation ‘biofertilizer phenotype’ with the limitation --the biofertilizer phenotype--.
Correspondence
19) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Supervisor of AU 1645, Daniel E. Kolker, can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
20) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
February, 2026
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