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 .
Support for the amendments is within the instant application specification.
This second non-final rejection is being sent out to the Applicant since the provisional double patenting rejection over U.S. Patent Application No. 19659775 was inadvertently missed in the previous non-final rejection. The provisional double patenting rejection is addressed in this version of the office action.
Applicants’ amendment to the claims filed on 3/11/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-2, 5-6, 10, 13, 26, 29, 37, 42-43, 47-50, 58-59, 70, 74-75 are pending.
Claims 3-4, 7-9, 11-12, 14-25, 27-28, 30-36, 38-41, 44-46, 51-57, 60-69, 71-73, 76-118 are canceled.
Claim 70, 74-75 stand withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-2, 5-6, 10, 13, 26, 29, 37, 42-43, 47-50, 58-59 are pending and examined on the merits.
Applicant’s remarks filed on 3/11/2026 in response to the Non-Final Rejection mailed on 9/11/2025 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/11/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Rejections
The written description rejection of claims 1-2, 5-6, 10, 13, 26, 29, 37, 42-43, 47-50, 58-29 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ) is withdrawn in view of Applicant’s deletion of the recitation ‘functionally optimized’ from claim 1 of the instant application.
The scope of enablement rejection of claims 1-2, 5-6, 10, 13, 26, 29, 37, 42-43, 47-50, 58-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ) is withdrawn in view of Applicant’s deletion of the recitation ‘functionally optimized’ from claim 1 of the instant application.
The rejection of claims 1-2, 5-6, 10, 13, 26, 29, 37, 42-43, 47-50, 58-59 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ) is withdrawn in view of Applicant’s deletion of the recitation ‘functionally optimized’ from claim 1 of the instant application and amendment of claim 1 to recite ‘wherein at least one of the nitrogen fixing microbes in the consortium is a Klebsiella variicola deposited as ATCC PTA-126740 or a Kosakonia sacchari deposited as ATCC PTA-126743.’
Maintained 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1-2, 5-6, 10, 13, 26, 29, 37 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is maintained. The rejection has been modified in view of Applicant’s amendment of claim 1 to recite ‘wherein at least one of the nitrogen fixing microbes in the consortium is a Klebsiella variicola deposited as ATCC PTA-126740 or a Kosakonia sacchari deposited as ATCC PTA-126743.’ The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is a naturally occurring microorganism.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claim is drawn to a composition of matter, which is one of the four statutory categories.
Step 2, Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the claim is directed to a natural phenomenon (product of nature). Said natural phenomenon is a composition of unaltered microbes.
Claims 1-2, 5-6, 10, 13, 26, 29, 37 are directed towards a synthetic composition of microbes, comprising: a consortium of at least two nitrogen fixing microbes-that differ in functional attributes along at least one of the following dimensions: a) nutrient utilization; b) temporal occupation; c) oxygen adaptability; and d) spatial occupation, wherein at least one of the nitrogen fixing microbes in the consortium is a Klebsiella variicola deposited as ATCC PTA-126740 or a Kosakonia sacchari deposited as ATCC PTA-126743. In the broadest reasonable interpretation of the claim, said synthetic composition of microbes is genetically unmodified and naturally occurring as Applicant has not provided any guidance on the mechanism at which recited strains Klebsiella variicola deposited as ATCC PTA-126740 and Kosakonia sacchari deposited as ATCC PTA-126743 were synthesized. ‘ Furthermore, a synthetic composition of microbes’ is interpreted as a consortium of naturally occurring microbes that are cultured in the same environment. There is no indication in the specification that the claimed mixture of bacteria has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring bacteria. The recitation of said microbial species being ‘non-intergeneric remodeled bacterium’ (Instant Application Specification para 0137) does not provide enough information that would overcome the rejection as the term ‘remodeled’ is broad and could be naturally occurring. Applicant is reminded that the claims are read in-light of the specification. The claims must stand alone. Thus, the mixture does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception.
Step 2A, Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claims 1, 5-6, 10, 13, 26, 29, 37 include the additional element of differing in functional attributes along at least one of the following dimensions: a) nutrient utilization; b) temporal occupation; c) oxygen adaptability; and d) spatial occupation. Such a limitation is native to the bacterium. Therefore, it does not integrate the judicial exception into a practical application for the same reasons discussed above. Furthermore, additional elements of the synthetic composition comprising at least one of the nitrogen fixing microbes in the consortium is a Klebsiella variicola deposited as ATCC PTA-126740 or a Kosakonia sacchari deposited as ATCC PTA-126743 do not integrate the judicial exception into a practical application as Applicant has not provided any guidance within the claim language as to if and how said microbes are not naturally occurring.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No. The judicial exception is recited without additional limitations amounting to significantly more than the exception. All of the signified additional elements to the judicial exception are considered to be native to the bacteria on which the judicial exception is to be performed as noted in Step 2A, Prong 2, and, therefore, do not amount to significantly more than the judicial exception that is claimed because the claim does not include any additional features that could add significantly more to the exception.
In reference to claim 1 of Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), which recites ‘an inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific,’ the inoculant of claim 1 was held to be ineligible subject matter.
Discovery of the fact that certain strains of each species of these bacteria can be mixed without harmful effect to the properties of either is a discovery of their qualities of non-inhibition. It is no more than the discovery of some of the handiwork of nature and hence is not patentable. The aggregation of select strains of the several species into one product is an application of that newly-discovered natural principle. But however ingenious the discovery of that natural principle may have been, the application of it is hardly more than an advance in the packaging of the inoculants. Each of the species of root-nodule bacteria contained in the package infects the same group of leguminous plants which it always infected. No species acquires a different use. The combination of species produces no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility. Each species has the same effect it always had. The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee.
Recently, the Supreme Court looked back to this claim as an example of ineligible subject matter, stating that “the composition was not patent eligible because the patent holder did not alter the bacteria in any way.” Myriad, 133 S. Ct. at 2117.
In this regard, as the instant claims recite judicial exceptions that are not integrated into practical application, and no elements that amount to significantly more than the judicial exception as recited, the claims were found not to be drawn to eligible subject matter under 35 U.S.C. 101 as the combination of ‘synthetic composition of microbes’ produces no new bacteria and no changes in the claimed bacteria. Each species has the same effect it always had. The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee.
RESPONSE TO REMARKS: Applicant's arguments filed 3/11/2026 have been fully considered but they are not persuasive. Beginning on p. 11 of Applicants’ remarks, Applicants in summary contends that Klebsiella variicola deposited as ATCC PTA-126740 and Kosakonia sacchari deposited as ATCC PTA-126743 are genetically engineered, therefore they are not naturally occurring.
This argument is found to be not persuasive. Examiner acknowledges the instant application specification providing additional information of the genetic makeup of Klebsiella variicola deposited as ATCC PTA-126740 and Kosakonia sacchari deposited as ATCC PTA-126743. However, just depositing a microorganism does not overcome the 35 USC 101 rejection. Applicant has to show that the deposited strain is “markedly different” from its natural counterpart. Examiner had to reinstate the above rejection since applicant has deleted the language “functionally optimized for nitrogen fixation and targeted delivery to a host plant” in claim 1. Examiner had withdrawn the previous 35 USC 101 rejection when applicant amended claim 1 with the above language, which at least showed that with respect to N2 fixation, these deposited strains differed from the naturally occurring counterpart. Amending claim 1 by restating the deleted language may overcome this rejection. Applicant is reminded that while claims are read in light of the specification, claims must stand alone and the contents of the specification cannot be construed to be claim limitations. Independent claim 1 does not provide any guidance on the genetic makeup (genetic engineering) of said strains. It is suggested that Applicant amend the claim language.
New 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.
Claims 1-2, 5-6, 10, 13, 26, 29, 37, 42-43, 47-50, 58-59 are newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46, 51, 69-71, 131 of U.S. Patent Application No. 17922712 which are commonly owned and have common inventors and filed after the instant application. The new rejection is necessitated by Applicant’s amendment of claim 1 to recite ‘nitrogen fixing microbes.’ Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn to a synthetic composition of microbes, comprising: a consortium of at least two nitrogen fixing microbes-that differ in functional attributes, wherein at least one of the nitrogen fixing microbes in the consortium is a Klebsiella variicola deposited as ATCC PTA-126740 or a Kosakonia sacchari deposited as ATCC PTA-126743 of which claims 46, 53-54, 69-71, 131 of U.S. Patent Application No. 17922712 are also drawn.
The instant application claims 1-2, 5-6, 10, 13, 26, 29, 37, 42, 47-50, 58-59 are not patentably distinct from claims 46, 51, 53, 69-71, 131, of ‘712 because claims 46, 53, 69-71, 69-71, 131, of ‘712 recites a composition comprising genetically engineered Klebsiella variicola deposited as ATCC PTA-126740 or a Kosakonia sacchari deposited as ATCC PTA-126743 comprising a genetical alteration in the nifL and glnD genes for increased nitrogen fixation, which is not patentably distinct from the instant application claims 1-2, 5-6, 10, 13, 26, 29, 37, 42-43, 47-50, 58-59.
Although this is a provisional nonstatutory rejection, it is noted that a notice of allowance has been issued for U.S. Patent Application No. 17922712 on 2/27/2026. However, at the time of filing the instant office action, it has not been issued a patent number.
Claims 1-2, 5-6, 10, 13, 26, 29, 37, 42-43, 47-50, 58-59 are newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46-73, 131-173 of U.S. Patent Application No. 19659775 which are commonly owned and have common inventors and filed after the instant application. The new rejection is necessitated by Applicant’s filing of US Patent Application Number 19/659,775, dated 4/27/2026. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are drawn to a synthetic composition of microbes, comprising: a consortium of at least two nitrogen fixing microbes-that differ in functional attributes, wherein at least one of the nitrogen fixing microbes in the consortium is a Klebsiella variicola deposited as ATCC PTA-126740 or a Kosakonia sacchari deposited as ATCC PTA-126743 of which claims 46-73, 131-173 of U.S. Patent Application No. 19659775 are also drawn.
The instant application claims 1-2, 5-6, 10, 13, 26, 29, 37, 42, 47-50, 58-59 are not patentably distinct from claims 46-73, 131-173, of ‘775 because claims 46-73, 131-173 of ‘775 recites a composition comprising genetically engineered Klebsiella variicola deposited as ATCC PTA-126740 or a Kosakonia sacchari deposited as ATCC PTA-126743 comprising a genetical alteration in the nifL and glnD genes for increased nitrogen fixation, which is not patentably distinct from the instant application claims 1-2, 5-6, 10, 13, 26, 29, 37, 42-43, 47-50, 58-59.
Although this is a provisional nonstatutory rejection, it is noted that a notice of allowance has been issued for U.S. Patent Application No. 19659775 on 4/27/2026. However, at the time of filing the instant office action, it has not been issued a patent number.
Conclusion
Claims 1-2, 5-6, 10, 13, 26, 29, 37, 42-43, 47-50, 58-59 are pending and examined on the merits.
Claims 3-4, 7-9, 11-12, 14-25, 27-28, 30-36, 38-41, 44-46, 51-57, 60-69, 71-73, 76-118 are canceled.
Claim 70, 74-75 stand withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-2, 5-6, 10, 13, 26, 29, 37, 42-43, 47-50, 58-59 are rejected.
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA NICOLE JONES-FOSTER/ Examiner, Art Unit 1656
/MANJUNATH N RAO/ Supervisory Patent Examiner, Art Unit 1656
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