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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 16, 17 and 20-26 and the species “siderophore”, in the reply filed on 7/13/26 is acknowledged.
Claims 1-3, 5-7 and 11-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/13/26.
Claim Status:
Claims 4, 8-10, 14, 15, 18 and 19 are cancelled.
Claims 1-3, 5-7, 11-13, 16, 17 and 20-25 are pending.
Claims 1-3, 5-7 and 11-13 are withdrawn.
Claims 16, 17 and 20-25 are presented for examination on the merits as they read upon the elected subject matter.
Priority
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Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 10/14/24 and 02/21/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 16, 17 and 20-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) a composition comprising an iron capturing agent non-pathogenic Bacillus species bacterium and/or an iron capturing growth by-product thereof. This judicial exception is not integrated into a practical application because of the following rational. The claims are directed to a composition of matter and is a nature-based product limitation. The preamble here does not positively add limitations to the claimed composition, or further modify limitations recited in the body of the claim, and thus does not limit the claim. Instead, it indicates an intended use for the claimed composition, i.e., the composition is intended for use treating and/or preventing iron deficiency and/or iron chlorosis. The broadest scope of the claims includes a natural product singly or in combination. Bacillus is a naturally occurring bacterial species and siderophores are produced by bacteria including non-pathogenic Bacillus species1. Thus, each component is a naturally occurring component and the combination of components is found in nature.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional components are all natural products and there is no indication that mixing these components changes the structure of the Bacillus, even in spore or biofilm form, or siderophore. The Bacillus species claimed are not altered in any way by Applicant. Because the claimed mixture here does not have a different effect than its natural counterparts, it does not have markedly different characteristics, and therefore is a “product of nature” exception and patent ineligible.
Claim Rejections - 35 USC § 102
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) 16 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zorner et al. (WO2021257499).
Regarding claims 16 and 20, Zorner et al. disclose a plant health promoting composition comprising one or more microorganisms and/or growth by-products thereof (Claim 1) where the microorganisms are Bacillus amyloliquefaciens NRRL B-67928 and Bacillus subtilis NRRL B-68031 (Claim 4), which inherently are iron-capturing agents as claimed, and mixed in water (Claim 7).
Claim(s) 16, 22, 24 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dagher et al. (US11089785; of record).
Regarding claims 16, 22 and 25, Dagher et al. disclose compositions comprising a Bacillus species and a siderophore such as bacillibactin and nutrients (Claims 1-9).
Regarding claim 24, Dagher et al. disclose a composition with metabolites (microbial growth by-product) (Claims 1-2) that include bacillaene, difficidin, macrolactin, kalimantacin/batumin, plantathiazolicin/plantazolicin, and bacteriocin, or any combination thereof (Claim 8), which are natural antibiotics. Additionally, at least bacillaene, batumin and kalimantacin are polyketides and bacteriocin and plantazolicin are peptides. Furthermore, the other species claimed would be naturally synthesized by the microbes as a growth-by-product since they are by-products of microbial growth.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 16, 17 and 20-25 are rejected under 35 U.S.C. 103 as being unpatentable over Zorner et al. (WO2021257499), as applied to claims 16 and 20 above, and Dagher et al. (US11089785; of record).
Applicant claims, for example:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of an agricultural research scientist, as is the case here, then one can assume comfortably that such an educated artisan will understand how specific soil bacteria drive nutrient cycling, nitrogen fixation, mineral support, suppress plant diseases, and promote crop growth, using this knowledge to improve farming methods and soil health for the benefits of the plants as well as draw conventional ideas from agricultural soil composition improving art— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
It is well settled that “a disclosure that anticipates under § 102 also renders the claim invalid under §103, for anticipation is the epitome of obviousness. See MPEP 1207.03(a)(II) states: “"lack of novelty is the epitome of obviousness." May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))”. Accordingly, the claims rejected under §102 above are also invalid under §103.
The references of Zorner et al. and Dagher et al. are discussed in detail above and those discussions are incorporated by reference.
Regarding claim 17, Zorner et a. teach a pH of about 3.5 to 7.0 and about 4.0 to 6.5 (Page 24, lines 14-16), thus within the claimed range of a pH of 6.8 or less.
Regarding claim 21, Zorner et al. teach the microbes may be planktonic or in a biofilm form (Page 12, lines 28-30) or can be in an active or inactive form such as spores (Page 23, lines 20-23).
Regarding claims 23-25, Zorner et al. teach that the composition can
include nutrients and/or micronutrients for enhancing plant and/or microbe growth, such as magnesium, phosphate, nitrogen, potassium, selenium, calcium, sulfur, iron, copper, and zinc; and/or one or more prebiotics, such as kelp extract, fulvic acid, chitin,
humate and/or humic acid. (Page 17, lines 25-29). Zorner et al. also teach manganese (Page 21, lines 1-2 and 7-10) as well as essential amino acids useful for the biosynthesis of proteins (Page 21, lines 3-6). Zorner et al. teach that the composition can comprise a biosurfactant composition (Page 6, lines 8-9). Zorner et al. teach: “A "metabolite" refers to any substance produced by metabolism (e.g. , a growth by-product) or a substance necessary for taking part in a particular metabolic process. Examples of metabolites include, but are not limited to, biosurfactants, biopolymers, enzymes, acids, polyketides, solvents, alcohols, proteins, vitamins, minerals, microelements, and amino acids.” (Page 10, lines 3-6). Polyketides would include siderophores.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
1. The difference between the instant application and Zorner et al. is that Zorner et al. do not expressly teach adding a siderophore to the composition. This deficiency in Zorner et al. is cured by the teachings of Dagher et al. Zorner et al. also does not teach adding L-alanine or L-Leucine.
1. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a siderophore to the composition of Zorner et al., as suggested by Dagher et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Zorner et al. suggest adding polyketides and the artisan in this art recognizes polyketides as siderophores as taught by Dagher et al. Thus, it would be obvious to add any of the siderophore species taught by Dagher et al. to the composition of Zorner et al. with a reasonable expectation of success. With regard to the amino acids L-alanine and L-leucine, it is merely judicious selection of known amino acids by the ordinary artisan to add to the composition with a reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
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.
Claim 16, 17 and 20-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 13 and 16-21 of copending Application No. 18843515. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending is also directed to compositions of iron-capturing non-pathogenic Bacillus species and/or an iron capturing growth product, which is a siderophore, (Claims 12, 16 and 18), having a pH of 6.8 or less (Claim 13), in the form of a spore or biofilm (Claim 17), L-alanine, L-leucine or manganese (Claim 19), microbial growth by-products (Claim 20) and a nutrient or prebiotic (Claim 21). Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 16, 17 and 20-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15, 16 and 19-24 of copending Application No. 18843550. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending is also directed to compositions of iron-capturing non-pathogenic Bacillus species and/or an iron capturing growth product, which is a siderophore, (Claims 15, 19 and 21), having a pH of 6.8 or less (Claim 16), in the form of a spore or biofilm (Claim 20), L-alanine, L-leucine or manganese (Claim 22), microbial growth by-products (Claim 23) and a nutrient or prebiotic (Claim 24). Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 16, 17 and 20-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19, 23, 24, 26, 27, 30 and 32 of copending Application No. 18843824. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending is also directed to compositions of iron-capturing non-pathogenic Bacillus species and/or an iron capturing growth product, which is a siderophore, (Claims 19 and 24), in the form of a spore or biofilm (Claim 23), L-alanine, L-leucine or manganese (Claim 26), microbial growth by-products (Claim 23) and a nutrient or prebiotic (Claims 27, 30 and 32).
The copending does not expressly teach the pH of the composition. However, since the composition is for reducing enteric methane in a livestock’s digestive system and administration to livestock, the artisan can readily envision a liquid dosage form with a mildly acidic to neutral pH which would include a pH of 6.8 or less.
Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 16, 20, 22 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 10 and 11 of U.S. Patent No. 12577179 (same assignee). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented method employs a composition comprising an irrigation additive biosurfactant and one or more beneficial microorganisms (Claims 1 and 3-4) where the beneficial microorganism can be Bacillus species (Claim 10) such as Bacillus amyloliquefaciens NRRL B-67928 (Claim 11). It is the Examiner’s position that the microorganisms claimed naturally produce siderophores and any number of the microbial growth by-products of instant claim 24.
Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter.
Claims 16, 20, 22 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 4-6 of U.S. Patent No. 12529000 (same assignee). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent teaches a microbe-based soil treatment composition for use in the method that comprises Bacillus amyloliquefaciens NRRL B-67928 and/or microbial growth by-products (Claims 1 and 2) where the by-products include biosurfactants (Claims 4-6). It is the Examiner’s position that the microorganisms claimed naturally produce siderophores and any number of the microbial growth by-products of instant claim 24.
Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter.
Claims 16, 20, 22, 24 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, and 11 of U.S. Patent No. 12063935 (same assignee). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent employs a composition comprising one or more beneficial microorganisms including Bacillus amyloliquefaciens and Bacillus subtilis in the method (Claim 1) and is applied alongside a source of nutrients (Claim 5) and prebiotics (Claim 6) where the Bacillus is B-67928 (Claim 11). Thus, it is obvious to combine the beneficial bacteria with nutrients and prebiotics. It is the Examiner’s position that the microorganisms claimed naturally produce siderophores and any number of the microbial growth by-products of instant claim 24.
Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
1 See: Koppisch et al. (Biometals 2008;21:581-589) teaching: “numerous innocuous soil residing
isolates of B. cereus and B. thuringiensis strains located in every phylogenetic branch are also
fully capable of producing petrobactin.” (Page 586, left column 1st paragraph; and the Abstract). Also note Krober et al. (Fronters in Microbiology 2014(5):pages 1-16) teaching: “Genome analyses of B. amy- loliquefaciens revealed that the organism harbors eight different gene clusters comprising genes associated with the production of secondary metabolites providing it with its biocontrol properties (Chen et al.,2007). These secondary metabolites can be classified into three different categories: the polyketides macrolactin (mln), bacillaene (bae), and difficidin (dfn) featuring antibacterial properties(Chen et al.,2006), the cyclic lipopeptides surfactin (srf ), fengycin (fen), and bacillomycin (bmy) providing mainly antifungal properties (Koumoutsi et al.,2004) and the third category including the iron-siderophore bacillibactin(bac)” (Page 2, left column 2nd paragraph).
Prosecution Insights