The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The amendment filed on 6-22-2026 is acknowledged. Claims 1-4, 9 and 12-13 have been amended. Claims 10-11 and 22 have been canceled. Claims 1-9, 12-21 and 23 are pending. Claims 4-8 and 14-21 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-3, 9 and 12-13 are currently under examination. It should be noted that claim 21 has an improper status identifier which must be corrected in order for any response to this action to be considered fully responsive.
Claim Objections
The objection to claims 1-4, 9 and 12-13 for reciting claim language drawn to non-elected inventions is maintained for reasons of record. The amendment to said claims is insufficient to overcome the objection as the elected invention is limited to the B/00227 strain.
Claim Rejections Withdrawn
The rejection of claims 1-4 and 9-13 under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more is withdrawn in light of the amendment thereto.
The rejection of claim 9 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement (biological deposit) requirement is withdrawn.
The rejection of claim 1 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the phrase “…comprises at one 16S nucleotide sequence…” is withdrawn in light of the amendment thereto.
The rejection of claim 1 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the phrase “…comprises a nucleotide sequence according to SEQ ID No 1.” is withdrawn in light of the amendment thereto.
The rejection of claim 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the phrase “…in a similar manner to said deposited strains.” is withdrawn in light of the amendment thereto.
The rejection of claim 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the phrase “…comprising purified bacterial strains according to claim 1.” is withdrawn. Cancellation of said claim has rendered the rejection moot.
The rejection of claim 10 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for lacking proper antecedent basis for the limitation "purified bacterial strains" in line 2 is withdrawn. Cancellation of said claim has rendered the rejection moot.
The rejection of claim 11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the phrase “…comprising purified bacterial strains according to claim 1.” is withdrawn. Cancellation of said claim has rendered the rejection moot.
The rejection of claim 11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for lacking proper antecedent basis for the limitation "purified bacterial strains" in lines 2-3 is withdrawn. Cancellation of said claim has rendered the rejection moot.
The rejection of claim 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the phrase “…comprising purified bacterial strains according to claim 1.” is withdrawn in light of the amendment thereto
The rejection of claim 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for lacking proper antecedent basis for the limitation "purified bacterial strains" in line 2 is withdrawn in light of the amendment thereto.
The rejection of claim 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the phrase “…comprising bacterial strains according to claim 1.” is withdrawn in light of the amendment thereto.
The rejection of claim 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for lacking proper antecedent basis for the limitation "bacterial strains" in line 2 is withdrawn in light of the amendment thereto.
The rejection of claims 1-3 and 9-13 under 35 U.S.C. 102(a)(2) as being anticipated by Fuenzalida et al. (U.S. Patent Application Publication US 2022/0053770) is withdrawn in light of the amendment thereto.
Claim Rejections Maintained
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.
Written Description
The rejection of claim 1-4, 9 and 12-13 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 is maintained for reasons of record. 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 argues:
1. The instant application discloses 5 closely related Kitasatospora strains with strong antimicrobial activity. These strains all have in common a specific region in their 16S rDNA sequence-SEQ ID No. 1 (ACCGTGGAGACACGGT). SEQ ID No. 1 is not present in the 16S rDNA sequences of other related Kitasatospora strains. Consequently, the presence of SEQ ID No. 1 constitutes a common structure of strains having the antimicrobial activity as described in instant application.
2. In her declaration Dr. Romero discusses data in the instant application and provides additional data showing a structure-function relationship regarding SEQ ID No. 1 in Kitasatospora strains.
Applicant’s arguments have been fully considered and deemed non-persuasive.
With regard to Points 1 and 2, the instant claims are not limited to Kitasatospora strains as they encompass any and all bacteria a 16S polynucleotide with a sequence with at least 96% sequence identity to SEQ ID NO:2 and comprising a nucleotide sequence of SEQ ID NO:1 that convey resistance against any and all of the recited pathogens in any and all plants. Moreover, the specification is limited to the in vitro effect of the B/00227 strain on the growth of Fusarium graminearum (Example 1); the in vitro effect of the B/00227 strain on the growth of Ramularia collo-cygni strains, Sclerotinia sclerotiorum strains, Fusarium oxysporum strains, Fusarium pseudograminearum strains, Rhizoctonai solani strains, Botrytis cinerea strains, Colletotrichum graminicola strains, Microdochium nivale strains, Gaemannomyces gramis var, tritici strains, Tapesia yallundae, PDA, Phytophthora infestans PDA and Rhizobium rhizogenes (Example 2); the effect of B/00227 against Rhizoctonia and Pythium in Lactuca sativa plants (Example 3); and the effect of B/00227 against Fusarium graminearum strains on Triticum aestivum plants (Examples 4 and 5). The specification, with the exception of prophetic statements regarding the efficacy of the broad genera of bacteria with the claimed biological effects against a laundry list of “plant pathogens”, is silent with regard to any Kitasatospora--like strains (other than B/00225, B00226, B/00227, B/00228 and B/00231) having any type of efficacy against any plant pathogen. This limited disclosure cannot be extrapolated to the claimed genus of bacteria. Consequently, the skilled artisan cannot immediately envision or recognize at least a substantial number of members of the claimed genus of bacteria with the claimed genomic and biological characteristics.
The instant claims are drawn to bacterial strains with a 16S polynucleotide with a sequence with at least 96% sequence identity to SEQ ID NO:2 and comprising a nucleotide sequence of SEQ ID NO:1 wherein said bacterial strain confers a broad-spectrum pathogen control or resistance to a plant wherein the pathogen is selected from a Fusarium ssp., a Phytophthora spp., a Pythium spp., a Rhioctonia spp., a Puccinia spp., a Mycosphaerella spp., a Sclerotinia spp., a Botrvtis spp., a Rhizobium spp., a Colletotrichum spp., a Microdochium spp., a Gaeumannomyces spp., a Tapesia spp., a Ustilago spp., a Ramularia spp., and a Zvmosepetoria spp.. The rejected claims optionally encompass the B/00227 strain or mutants thereof (claim 9). Consequently, the rejected claims encompass the any and all bacteria a 16S polynucleotide with a sequence with at least 96% sequence identity to SEQ ID NO:2 and comprising a nucleotide sequence of SEQ ID NO:1 that convey resistance against any and all of the recited pathogens in any and all plants.
To fulfill the written description requirements set forth under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. To adequately describe the genus of bacterial strains, Applicant must adequately describe not only which bacteria have a 16S polynucleotide with a sequence with at least 96% sequence identity to SEQ ID NO:2 and comprising a nucleotide sequence of SEQ ID NO:1, but also which of those strains (if any) are capable of conveying broad-spectrum pathogen control or resistance to a given pathogen to a given plant. The specification is limited to the in vitro effect of the B/00227 strain on the growth of Fusarium graminearum (Example 1); the in vitro effect of the B/00227 strain on the growth of Ramularia collo-cygni strains, Sclerotinia sclerotiorum strains, Fusarium oxysporum strains, Fusarium pseudograminearum strains, Rhizoctonai solani strains, Botrytis cinerea strains, Colletotrichum graminicola strains, Microdochium nivale strains, Gaemannomyces gramis var, tritici strains, Tapesia yallundae, PDA, Phytophthora infestans PDA and Rhizobium rhizogenes (Example 2); the effect of B/00227 against Rhizoctonia and Pythium in Lactuca sativa plants (Example 3); and the effect of B/00227 against Fusarium graminearum strains on Triticum aestivum plants (Examples 4 and 5). The specification, with the exception of prophetic statements regarding the efficacy of the broad genera of bacteria with the claimed biological effects against a laundry list of “plant pathogens”, is silent with regard to any Kitasatospora--like strains (other than B/00225, B00226, B/00227, B/00228 and B/00231) having any type of efficacy against any plant pathogen. This limited disclosure cannot be extrapolated to the claimed genus of bacteria. Consequently, the skilled artisan cannot immediately envision or recognize at least a substantial number of members of the claimed genus of bacteria with the claimed genomic and biological characteristics.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed' ”. The courts have decided:
The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the “written description” inquiry, whatever is now claimed.
See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
MPEP 2163.02 further states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Additionally, MPEP 2163 states:
"A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)”
And:
For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
Therefore, because the art is unpredictable, in accordance with the MPEP and currently case law, the description of claimed bacteria with a 16S polynucleotide with a sequence with at least 96% sequence identity to SEQ ID NO:2 and comprising a nucleotide sequence of SEQ ID NO:1 wherein said bacterial strain confers a broad-spectrum pathogen control or resistance to a plant is lacking.
New Grounds of Rejection
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 1-4 and 9-13 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.
Claim 1 is rendered vague and indefinite by the use of the phrase “…conferring a broad-spectrum pathogen control or resistance…” and “wherein said pathogen is selected from Fusarium ssp., Phytophthora spp., Pythium spp., Rhioctonia spp., Puccinia spp., Mycosphaerella spp., Sclerotinia spp., Botrvtis spp., Rhizobium spp., Colletotrichum spp., Microdochium spp., Gaeumannomyces spp., Tapesia spp., Ustilago spp., Ramularia spp., or Zvmosepetoria spp.”. It is unclear how one confers “broad-spectrum pathogen control or resistance” against a single pathogen species. As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 9 is rendered vague and indefinite by the use of the phrase “The agricultural active …”. It is unclear what is meant to be engendered by said phrase.
Claim 9 recites the limitation "The agricultural active " in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "The formulation" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 September 1, 2026
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