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 .
Claim Status
The claim amendments as filed on 2/6/2026 have been entered.
Claims 1-46, 52-53, 56-57, 59-65, 68-71, 73-78, 80, 82-85, 87-94, 96, 99-106, 108, 112-113, 116, 118-122, 126-136, 138, 140-143, 148-150, 152-154, 157-161, 163-165, 167-169, 171, 174-182, 184, 186-258 and 261-262 have been cancelled.
Claims 47-51, 54-55, 58, 66-67, 72, 79, 81, 86, 95, 97-98, 107, 109-111, 114-115, 117, 123-125, 137, 139, 144-147, 151, 155-156, 162, 166, 170, 172-173, 183, 185 and 259-260 are currently pending and are being examined in this application.
Priority
This application claims priority to US Provisional 63/331,119 (filed on 4/14/2022).
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. For example, see [0114]. 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.
Claim Objection
Claim 79, 166, 183 are objected to because of the following informalities:
Claim 79 recites “one or more one or more” in line 2 of the claim, which the second occurrence of “one or more” is redundant and should be deleted.
Claim 183 recites “one or more one or more” in line 2 of the claim, which the second occurrence of “one or more” is redundant and should be deleted.
Claim 166 recites “The method of any of claims 162”, which the phrase “any of” should be deleted, and the term “claims” should be in the singular form.
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 47-51, 54-55, 58, 66-67, 72, 79, 81, 86, 95, 97-98, 107, 109-111, 114-115, 117, 123-125, 137, 139, 144-147, 151, 155-156, 162, 166, 170, 172-173, 183, 185 and 259-260 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon/product without significantly more.
The claim(s) recite(s) naturally occurring bacteria strains. This judicial exception is not integrated into a practical application as discussed below. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception as discussed below. See MPEP 2106 for the streamlined analysis of subject matter eligibility evaluation.
In this case,
Step 1 Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claims are drawn to a process (a method) of applying a bacteria strain to a plant.
Step 2A Is the claim directed to a law of nature, a natural phenomenon (product of nature), or Abstract idea?
Step 2A Prong one (MPEP2106.04(c)): Does the claim recite a natural phenomenon (product of nature)? Yes, the instant claims are in essentially drawn to a method of “applying… bacterial strain to… plant”, which the selected bacteria strain or strain(s) were isolated from nature (such as ones isolated from “branches of willow and poplar trees), as stated in the instant specification (see Spec., pp3+; [0005]+). Claims 95 and 144 also recite additional natural ingredients such as “nutrient additive” and a “carrier”, which the nutrient additive can be any naturally occurring nutrient that are naturally associated with the various bacteria strains, and the “carrier” can be any substance including water. These isolated bacteria, nutrient and carrier are not “markedly different” from its naturally occurring counterparts since they are isolated from nature and not genetically engineered. In fact, they are the exact same bacteria strains as existing in nature without any functional and/or structural difference from the naturally existing ones.
Step 2A prong two (MPEP2106.04(d)): Does the claim recite additional elements that integrate the judicial exception into a practical application? No, in this case, there is no additional elements that integrate the judicial exception into a practical application. The claims only recites generic application to any plant. The claimed method of “enhancing nitrogen fixation in a host plant” is what occurs in nature since the bacteria strains were isolated from plants in the field (Spec., pp 3+, para 5). Since the answer to 2A Prong two is “NO”, the analysis continues to Step 2B.
Step 2B (MPEP2106.05): Does the claim recite additional elements that amount to significantly more than the judicial exception? No. In this case, there is no additional elements that renders the claim as whole that amounts to significantly more. The isolated bacteria strains from nature are not modified in any way, and their functionalities have not been changed/improved.
Therefore, the claims are not eligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 55, 114, 145 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.
Claims 55 and 114 recite “a nitrogenase like enzyme” which recitation is unclear. The phrase "nitrogenase like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "nitrogenase"), thereby rendering the scope of the claim(s) unascertainable. The instant specification does not provide a definition for “nitrogenase like”, i.e. does not specific what enzyme or protein would be encompassed by “nitrogenase like enzyme.” See MPEP § 2173.05(d).
Regarding claim 145, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 47-51, 54-55, 58, 66-67, 72, 79, 81, 86, 95, 97-98, 107, 109-111, 114-115, 117, 123-125, 137, 139, 144-147, 151, 155-156, 162, 166, 170, 172-173, 183, 185 and 259-260 are rejected under 35 U.S.C 112, first paragraph, as containing subject matter which is 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 biological materials, specifically the various endophyte strains, NRRL B-68081, NRRL B-68078, NRRL B-68080, and NRRL B-68079. Because the biological materials are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. It is not apparent if the biological material or source materials are both known and readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
If a deposit is made under the terms of the Budapest Treaty, then an 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 will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
a). during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
b.) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
c.) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last requestor for the enforceable life of the patent, whichever is longer.
d.) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. § 1.807); and
e.) the deposit will be replaced if it should ever become inviable.
Applicant’s attention is directed to MPEP §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that “the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination.” The specification should be amended to include this information, however, applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
‘989 Application
Claims 47-51, 54-55, 58, 66-67, 72, 79, 81, 86, 95, 97-98, 107, 109-111, 114-115, 117, 123-125, 137, 139, 144-147, 151, 155-156, 162, 166, 170, 172-173, 183, 185 and 259-260 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 251-295 of copending Application No. 18/223989 (reference application; hereinafter referred to as ‘989 application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘989 application claims method of treating plants using various endophyte strains.
For example, the ‘989 application claims the followings:
251. (Previously Presented) A method of producing an inoculant for treating and improving the health of a heterologous host plant, comprising co-fermenting at least two of the following endophyte strains Pseudomonas siliginis, Curtobacterium salicaceae, Rhizobium populi, and WW5 Sphingobium sp.
260. (Previously Presented) The method of claim 251, further comprising adding a pre-biotic composition to said inoculant composition that is operable to enhance colonization of the heterologous host plant by the at least two endophyte bacterial strains, wherein said pre-biotic composition comprises at least one of a microbial nutrient package, a plant biostimulant, an osmoprotectant, a buffer, a seed lubricant, an antioxidant, a mineral nutrient, a carbohydrate, and a mucilage gel.
277. (Previously Presented) A method of producing a coated seed, comprising a. fermenting at least one of the following endophyte strains Pseudomonas siliginis,Curtobacterium salicaceae, Rhizobium populi, and WW5 Sphingobium sp.; and b. applying an inoculant comprising said at least one endophyte strains to a seed of a heterologous host plant.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
‘874 Application
Claims 47-51, 54-55, 58, 66-67, 72, 79, 81, 86, 95, 97-98, 107, 109-111, 114-115, 117, 123-125, 137, 139, 144-147, 151, 155-156, 162, 166, 170, 172-173, 183, 185 and 259-260 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 251-295 of copending Application No. 19/374874 (reference application; hereinafter referred to as ‘874 application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘874 application claims method of treating plants using various endophyte strains.
For example, the ‘874 application claims the followings:
1. A plant inoculant composition for treating a host plant comprising at least one heterologous endophyte bacterial strain,, wherein said at least one heterologous endophyte bacterial strain is selected from the group consisting of HT1-4, HT1-7, HT1-8, HT1-9, HT1-10, SD1, SD2, R10, 11R-B1, 11R-B2, 11R-BB, 11R-BC, AWS1, WP5, WP4-10-4, WP4-4-2, WP4-5-3, WP4-3-3, WP4-4-6, WP4-3-1, TP SK3, TP SK5, TP SN7, PM PF3, PM SK6, PS SN1, M2, M3, M5, WP8 and WPL8-1.
2. The composition of Claim 1, comprising a plurality of heterologous endophyte bacterial strains, each independently selected from the group consisting of: HT1-2, HT1-4, HT1-7, HT1-8, HT1-9, HT1-10, SD1, SD2, R10, 11R-B1, 11R-B2, 11R-BB, 11R-BC, AWS1, WP5, WP4-10-4, WP4-4-2, WP4-5-3, WP4-3-3, WP4-4-6, WP4-3-1, WW5, WW6, WW7, PTD1, TP SK3, TP SK5, TP SN7, PM PF3, PM SK6, PS SN1, M2, M3, M5, WP1, WP8 and WPL8-1.
17. A method of enhancing nutrient uptake in a host plant, said method comprising applying to the foliage or seed of said host plant, or to the locus of said plant, or to the locus of said seed is to be sown, a composition as defined in Claim 1.
18. A method of increasing biomass in a host plant, said method comprising applying to the foliage or seed of said host plant, or to the locus of said plant, or to the locus of said seed is to be sown, a composition as defined in Claim 1.
19. A plant treated with a composition as defined in Claim 1, wherein at least one heterologous endophyte bacterial strain from said composition is incorporated into tissue of said plant.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion and Correspondence
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUE LIU whose telephone number is (571)272-5539. The examiner can normally be reached M-F 9-5.
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/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
