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 .
The amendment filed 03/27/2026 has been entered. Claims 1 and 3 have been amended. Claims 1-23 are pending. Claims 13-23 are withdrawn. Claims 1-12 are under examination.
Claim Rejections Withdrawn
The rejection of claim 3 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 1-4, 7 and 10-12 under 35 U.S.C. 102(a)(1) as being anticipated by Alper et al. The ISME Journal (2020) 14:2703-2714 cited in IDS is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 1, 3, 8-9 and 11 under 35 U.S.C. 103 as being unpatentable over Alper et al. The ISME Journal (2020) 14:2703-2714 cited in IDS in view of Hairston et al. US 5215747 6/1/1993 and Choi et al. Biochemical and Biophysical Research Communications, Volume 365, Issue 1, 2008, Pages 89-95 is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 1, 5 and 6 under 35 U.S.C. 103 as being unpatentable over Alper et al. The ISME Journal (2020) 14:2703-2714 cited in IDS in view of Rostami et al. Pesticide Biochemistry and Physiology 140 (2017)17-23, 2017 is withdrawn in view of the amendment to the claims.
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.
The rejection of claims 1-12 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.
The claims are drawn to a genus of Paenibacillus spores which form colonies when plated on a medium suitable for colony formation, and wherein of all such colonies formed within 72h for aerobic cultures after plating at least 40% are formed within 48h, and/or at least 40% of spores are obtainable or obtained from a fermentation harvested during a first spore formation phase and/or the mean content of dipicolinic acid per spore is at most 80% of the mean content of dipicolinic acid of spores fermented in a suitable medium until plateau phase.
The genus of Paenibacillus spores comprises different species and strains of Paenibacillus. Examples of Paenibacillus species P. agarexedens, P. agaridevorans P. alginolyticus P. alkaliterrae P. alvei P. amylolyticus P. anaericanus P. antarcticus P. apiaries P. assamensis P. azoreducens P. azotofixans P. barcinonensis P. borealis P. brasilensis P. brassicae P. campinasensis P. chinjuensis P. chitinolyticus P. chondroitinus P. cineris P. cookie P. curdlanolyticus P. daejeonensisP. Dendritiformis P. durum P. ehimensis P. elgii P. favisporus P. glucanolyticus P. glycanilyticus P. gordonae P. graminis P. granivorans P. hodogayensis P. illinoisensis P. jamilae P. kobensis P. koleovorans P. koreensis P. kribbensis P. lactis P. larvae P. lautus P. lentimorbus P. macerans P. macquariensis P. massiliensis P. mendelii P. motobuensis P. naphthalenovorans P. nematophilus P. odorifer P. pabuli P. peoriae P. phoenicis P. phyllosphaerae P. polymyxa
P. popilliae P. pulvifaciens P. rhizosphaerae P. sanguinis P. stellifer P. terrae P. thiaminolyticus P. timonensis P. tundrae P. turicensis P. tylopili P. Validus P. vortex P. vulneris P. wynnii and P. xylanilyticus. Further, Paenibacillus species are listed on page 16-17 of the instant specification.
The genus also comprises different strains of each species.
Members of the genus also have the function of preventing, limiting or reducing phytopathogenic fungal or bacterial disease and/or improve or promote health of a plant and/or increase or promote yield of plants when applied to such a plant, part or propagation material thereof or to the substrate where the plants grow.
The specification only reduces one member of the genus having the above characteristics i.e. Paenibacillus strain 32. See p. 7 lines 24-54 and p. 8 lines 1-24.
The disclosure of one member of the genus is insufficient to deem possession of the whole genus.
The specification does not disclose complete structure, partial structure, physical or chemical properties of a representative number of species of the genus of Paenibacillus with the above characteristics.
Adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See Noelle v Lederman. 355 F. 3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) and In re Alonso (Fed. Cir. 2008-1079).
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus."). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004).
Even though one of ordinary skill in the art could screen for additional members of the genus of Paenibacillus that have the recited characteristics and function(s) , possession of a claimed genus is not shown by how obtain members of the genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69USPQ2d at 1895. The written description provision of 35 U.S.C. § 112 are severable from its enablement provision Vas-Cath, Inc. v. Mahurkar, 1115.
For these reasons, Applicants were as of the effective filing date only in possession of the Paenibacillus strain 32 having the characteristics set forth in claims 1a-1c and other functions recited in the claims such as for pest control and preventing, limiting a phytopathogenic fungal or bacterial disease etc..
Response to Applicants Statement
Applicant state that claim 1 has been amended to recite a prokaryotic microorganism of genus Paenibacillus and that the Office acknowledged that this genus is reduced to practice in the present specification.
Applicants statement has been carefully considered but is not found persuasive. As set forth in the rejection previously and set forth above Applicants were as of the effective filing date only in possession of the Paenibacillus strain 32.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-4 and 6-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Curtis et al. US2019/0144874 5/16/2019.
The disclosure of Curtis et al describes methods, compositions and genetic constructs that provide a platform for delivering recombinant enzymes and other molecules of interest (e.g., peptide, protein) to an environment (e.g., plant, field) using spore-forming members of the Paenibacillus genus. The disclosure also provides methods of identifying spore surface-targeting sequences in Paenibacillus and other bacterial genera. See paragraph 8.
Claim 1-2 and 6: Curtis et al disclose a spore composition comprising purified spores of Paenibacillus cells that express a fusion protein comprising a payload protein that confers or modifies a plant trait or attribute e.g. an enzyme involved in the production or activation of a plant growth stimulating compound; an enzyme that degrades or modifies a bacterial, fungal, or plant nutrient source; a microbicidal or microbiostatic compound; or an enzyme, protein, or peptide that protects a plant from a pathogen or a pest and (ii) an N-terminal targeting sequence that localizes the fusion protein to the spore surface of the Paenibacillus cells. See paragraph 8-9, 97-146.
Claim interpretation regarding the limitation of claim 1a: the Paenibacillus spores of the spore composition of Curtis et al are spores of a prokaryotic microorganism and absent evidence to the contrary said spores should form colonies when plated on a medium suitable for colony formation, and wherein of all such colonies formed within 72h for aerobic cultures after plating at least 40% are formed within 48 hr.
Claim interpretation regarding the limitation of claim 1b: the limitation is drawn to the process of obtaining the spores from fermentation harvested during a first spore formation phase. At least 40% of spores of the composition of Curtis et al is obtainable from fermentation harvested during a first spore formation absent other evidence to the contrary.
Claim interpretation regarding the limitation of claim 1c: the spore composition of Curtis et al is the same as claimed and thus the mean content of dipicolinic acid per spore is at most 80% of the mean content of dipicolinic acid of spores fermented in a suitable medium until plateau phase, absent other evidence to the contrary.
"Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
"When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. Since the Office does not have the facilities for comparing the spores of the claimed spore composition comprising purified spores of a prokaryotic microorganism with that of the spores of a spore composition comprising purified spores of a prokaryotic microorganism of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430(CCPA 1977) and In re Fitzgerald et al., 619 F.2d 67, 205 USPQ 594 (CCPA 1980).
Claim 3-4: the composition further comprises a pest control agent such as a fungicide or insecticide and wherein the composition improves or promotes health of a plant form fungi insects. See paragraph 148. Curtis et al disclose formulations are prepared in a known manner, by mixing composition with customary adjuvants, such as, for example, customary extenders and also solvents or diluents, colorants, wetters, dispersants, emulsifiers, antifoams, preservatives, secondary thickeners, stickers, gibberellins, and also water. See paragraph 179.
Claim 7: Curtis et al disclose a plant protection product comprising a plant cultivation substrate coated with the composition i.e. a seed coated with the composition. See paragraph 151.
Claim 8: Curtis et al disclose a plant or plant part or plant propagation material comprising on its surface the composition i.e. seed, plant, fruit, foliage. See paragraphs 151-152.
Claim 9: Curtis et al disclose a plantation (agriculture, greenhouse, forestry, horticulture) comprising plants, plant parts, or plant propagation material treated on its surface or infused with the composition. See paragraphs 175-176, 179.
Claim 10, 11 and claim 12: the composition of Curtis et al is considered a cleaning product since it comprises antifungal properties. In addition, the phrases “cleaning product”, “building product” and “cosmetic product” do not necessarily convey a structure in the claim and moreover, no other component of a cleaning or building or cosmetic is listed along with the composition.
Claim 11: Curtis et al disclose a food, feed e.g. wheat, barley, rye, oats maize, soybeans, cotton, canola, oilseed rape and rice comprising the composition. See paragraph 175.
Response to Applicants Argument
Applicants argue that the present claims recite a spore composition of genus Paenibacillus, wherein the mean content of dipicolinic acid per spore is at most 80% of the mean content of dipicolinic acid of spores fermented in a suitable medium until plateau phase. Applicants state Curtis teaches a nucleic acid molecule comprising a polypeptide to Paenibacillus and Curtis is silent in the use of dipicolinic acid which is a main component of the present application.
Applicants argument has been carefully considered.
This is because the Paenibacillus spores of Curtis et al absent other evidence to the contrary should form colonies when plated on a medium suitable for colony formation, and wherein of all such colonies formed within 72h for aerobic cultures after plating at least 40% are formed within 48 hr.
Regarding claim 1b the limitation is drawn to the process of obtaining the spores from fermentation harvested during a first spore formation phase. The claims are drawn to a composition.
At least 40% of spores of the composition of Curtis et al would be obtainable from fermentation harvested during a first spore formation absent other evidence to the contrary.
Regarding claim 1c: the spore of Curtis et al is the same as claimed and thus the mean content of dipicolinic acid per spore is at most 80% of the mean content of dipicolinic acid of spores fermented in a suitable medium until plateau phase, absent other evidence to the contrary.
"Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The rejection of claim(s) 1 and 5 under 35 U.S.C. 103 as being unpatentable over
Curtis et al. US2019/0144874 5/16/2019 is maintained.
The disclosure of Curtis et al describes methods, compositions and genetic constructs for delivering recombinant enzymes and other molecules of interest (e.g., peptide, protein) to an environment (e.g., plant, field) using spore-forming members of the Paenibacillus genus and the disclosure of Curtis et al also provides methods of identifying spore surface-targeting sequences in Paenibacillus and other bacterial genera.
Claim 1: Curtis et al disclose a spore composition comprising purified spores of Paenibacillus cells that express a fusion protein comprising a payload protein that confers or modifies a plant trait or attribute e.g. an enzyme involved in the production or activation of a plant growth stimulating compound; an enzyme that degrades or modifies a bacterial, fungal, or plant nutrient source; a microbicidal or microbiostatic compound; or an enzyme, protein, or peptide that protects a plant from a pathogen or a pest and (ii) an N-terminal targeting sequence that localizes the fusion protein to the spore surface of the Paenibacillus cells. See paragraph 8-9, 97-146.
Claim interpretation regarding the limitation of claim 1a: the Paenibacillus spores of the spore composition of Curtis et al are spores of a prokaryotic microorganism and absent evidence to the contrary said spores should form colonies when plated on a medium suitable for colony formation, and wherein of all such colonies formed within 72h for aerobic cultures after plating at least 40% are formed within 48 hr.
Claim interpretation regarding the limitation of claim 1b: the limitation is drawn to the process of obtaining the spores from fermentation harvested during a first spore formation phase. At least 40% of spores of the composition of Curtis et al is obtainable from fermentation harvested during a first spore formation absent other evidence to the contrary.
Claim interpretation regarding the limitation of claim 1c: the spore composition of Curtis et al is the same as claimed and thus the mean content of dipicolinic acid per spore is at most 80% of the mean content of dipicolinic acid of spores fermented in a suitable medium until plateau phase, absent other evidence to the contrary.
"Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
"When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. Since the Office does not have the facilities for comparing the spores of the claimed spore composition comprising purified spores of a prokaryotic microorganism with that of the spores of a spore composition comprising purified spores of a prokaryotic microorganism of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430(CCPA 1977) and In re Fitzgerald et al., 619 F.2d 67, 205 USPQ 594 (CCPA 1980).
Regarding claim 5: Curtis et al disclose for end use application such as foliar spray, soil treatment and/or seen treatment dressing, the end-use formulation contains at least 1×10^4, at least 1×10^5, at least 1×10^6, 1×10^7, at least 1 x 10^8, at least 1×10^9, at least 1×10^10 colony forming units per gram. See paragraph 167.
Thus, it would not have been inventive to a person of ordinary skill in the art as of the effective filing date to have at least 104 cfu/ml of spores in a composition in order to arrive at least 1×10^4, at least 1×10^5, at least 1×10^6, 1×10^7, at least 1 x 10^8, at least 1×10^9, at least 1×10^10 colony forming units per gram in a foliar spray, soil treatment and/or seen treatment dressing.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP 2144.05.
The rejection of claim(s) 1 and 3 under 35 U.S.C. 103 as being unpatentable over
Curtis et al. US2019/0144874 5/16/2019 in view of Choi et al. Biochemical and Biophysical Research Communications, Volume 365, Issue 1, 2008, Pages 89-95 is maintained.
Curtis et al is set forth above but does not disclose the composition comprises fusaricidin.
Choi et al disclose that fusaricidin is peptide antibiotic antifungal agent including against Leptosphaeria maculans which causes black root rot of canola. See p. 89.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have added fungicide for example, fusaricidin to the composition of Curtis et al, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that Curtis et al discloses that the composition further comprises a fungicide and Choi et al disclose such a fungicide fusaricidin which has antifungal activity against Leptosphaeria maculans which causes black root rot of canola.
Response to Applicants Argument
Applicants argues that the claims are patentable over Curtis for at least for the reasons addressed above. Applicants argument regarding Curtis has been considered and is not found persuasive for the same reasons set forth above.
New Claim Rejections Based on Amendment
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites that the microorganism is selected from the group consisting of the taxonomic rank of phylum Firmicutes, class Bacilli, Clostridia and Negativicutes. However, claim 1 states that the prokaryotic microorganism is of genus Paenibacillus. Genus Paenibacillus is not part of a taxonomic rank of phylum Firmicutes, class Bacilli, Clostridia and Negativicutes. Therefore, claim 2 is improper dependent form for failing to further limit the subject matter of claim 1 upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Status of Claims
Claims 1-12 are rejected. Claims 13-27 are withdrawn.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
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