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 .
DETAILED ACTION
Claims 1-16 are pending and under examination.
Priority and Domestic Benefit
Applicant’s claim for priority to the filing date of EP19156407.9 filed 11 February 2019 and PCT/EP2020/053235 filed 10 February 2020 is acknowledged.
Applicant’s domestic benefit to Application no. 17/429,905 is also acknowledged.
The effective filing date is 11 February 2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12 September 2025 is being considered by the examiner. It is noted that the cited reference JP2008508471A is drawn to a steam turbine and method of operating thereof, which is considered to not be relevant to the instant invention.
Claim Objections
Claims 5, 9-10, 14, and 16 are objected to because of the following informalities:
Claims 5 and 9-10 need to delete the hyphens separating the “wt.” and “%”.
Claim 14 should replace the limitation “the Bacillus strain as deposited under DSM 33014” with “the Bacillus amyloliquefaciens strain DSM 33014” in order to maintain consistency when referring to the Bacillus amyloliquefaciens DSM 33014 strain.
Claim 16 should italicize the gene names yqfD, gyrB, rpoB, and groEL to be consistent with standard genomic notation format.
Claim 16 recites atypical language to refer to different sequences that are found in Bacillus amyloliquefaciens DSM 33014. It is suggested to replace the word “exhibits” to the word “comprises”.
Appropriate correction is required.
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.
Claims 14-16 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was 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.
It is apparent that biological material Bacillus amyloliquefaciens DSM 33014 is required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the biological material Bacillus amyloliquefaciens DSM 33014.
The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the Bacillus amyloliquefaciens DSM 33014 that is considered necessary to make and use the invention is both known and readily available to the public.
It is noted that Applicants have deposited Bacillus amyloliquefaciens DSM 33014 at the DSMZ under the terms of the Budapest Treaty (Specification pg. 3 lns. 11-17), but there is no indication in the specification as to public availability.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that all restrictions imposed by the depositor on the availability to the public on the deposited material will be irrevocably removed upon granting of the patent, would satisfy the deposit requirement made herein.
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 2 and 4-16 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 2 recites that the composition of claim 1 contains a bacillaene producing microorganism, however claim 1 recites a composition containing bacillaene or a derivative thereof. It is not clear if the composition is now limited to contain only bacillaene made from the bacillaene producing microorganism, or if the claim limits the composition to further comprise a bacillaene producing microorganism, in addition to bacillaene or a derivative thereof.
Claim 2 further recites the bacillaene producing microorganism belongs to a genus selected from the group consisting of Bacillus, Paenibacillus, and mixtures thereof. It is unclear how the bacillaene producing microorganism can belong to a mixture of the two different genera Bacillus and Paenibacillus. One microorganism cannot belong to a genus of mixtures of two different genera.
Claim 4 recites that the composition of claim 1 comprises at least one feed or food ingredient, however claim 1 recites a composition containing bacillaene or a derivative thereof. It is not clear if the composition is now limited to comprise only at least one feed or food ingredients recited in claim 4, or if claim 4 limits the composition to further comprise at least one feed or food ingredients recited in claim 4.
Claim 4 recites the composition of claim 1 comprises at least one feed or food ingredient. It is unclear if claim 4 limits the composition to be in the form of a feed or food composition due to its incorporation of a feed or food ingredient, or if the scope of the composition is still broad enough to encompass non-feed or food compositions.
Claim 4 recites that the feed or food ingredient may be a milk replacer, but neither the claims nor the specification provide any description as to what constitutes a milk replacer; thus, it is unclear what the scope of the “milk replacer” is in the context of the present invention. The same issue with the ingredient “acid-based products” is found.
Claim 7 recites the limitation "the spores of the bacillaene producing microorganism" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites a mutant of the Bacillus strain as deposited under DSM 33014, with a sequence identity of at least 98% to the genome sequence of the Bacillus strain as deposited under DSM 33014 without any sequence identifier, i.e. SEQ ID NO. It is unclear what is the genome sequence of Bacillus amyloliquefaciens DSM 33014 that is to be compared to the mutant. Therefore, it is unclear what particular sequence is to be compared. The specification does not provide any full genome sequence of Bacillus amyloliquefaciens DSM 33014, nor does it provide any further guidance to assist one of ordinary skill in the art in determining the meaning of the limitation.
Claims 5-16 depend on claim 2, claim 12 depends on claim 7, and claims 15-16 depend on claim 14, so those claims are rejected for the same reasons.
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 8 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 8 recites the bacillaene producing microorganism belongs to a genus selected from the group consisting of Bacillus and Paenibacillus; however, parent claim 2 already limits the bacillaene producing microorganism to belong to a genus selected from the group consisting of Bacillus, Paenibacillus, and mixtures thereof. Therefore, claim 8 does not further limit the subject matter of parent claim 2.
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.
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 1-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a product of nature without significantly more.
Claims 1-16 are drawn to the statutory category of a composition of matter (Step 1: Yes).
Claim 1 recites a composition comprising bacillaene or a derivative thereof. Bacillaene is a naturally occurring secondary metabolite discovered and isolated from fermentation broths of Bacillus subtilis (Specification pg. 1 lns. 32-34). Neither the claims nor the specification provide any limiting definition for “derivatives thereof” such that it excludes any non-natural derivative forms of bacillaene.
Claims 2 and 8 recite the composition contains a bacillaene producing microorganism that belongs to the genus of Bacillus or Paenibacillus. According to the instant disclosure, Bacillus amyloliquefaciens DSM 33014 is a bacillaene producing microorganism belonging to the genus Bacillus. Bacillus amyloliquefaciens DSM 33014 is a naturally occurring microorganism that was identified by screening naturally occurring isolates (Specification pg. 3 lns. 11-12).
Claim 3 recites that the composition is a feed, food, therapeutic, or plant treating composition. This claim does not recite any additional compositional ingredients, and does not limit the structure of the claimed composition. It merely limits the form that the composition may take.
Claim 4 recites that the composition comprises at least one ingredient selected from the group consisting of proteins, carbohydrates, fats, probiotics, prebiotics, enzymes, vitamins, immune modulators, milk replacers, minerals, amino acids, coccidiostats, acid-based products and medicines.
Proteins, carbohydrates, fats, enzymes, vitamins, minerals, and amino acids are all naturally occurring compounds produced by or found in living microorganisms.
A probiotic is a microorganism that has a beneficial effect on a host microorganism. A bacillaene producing microorganism such as Bacillus amyloliquefaciens FZB42 has a beneficial, probiotic effect on host plants as evidenced by Abstract of Chowdhury et al. (Biocontrol mechanism by root-associated Bacillus amyloliquefaciens FZB42 – a review. (2015) Front. Microbiol. 6:780. doi: 10.3389/fmicb.2015.00780). It is noted that Bacillus amyloliquefaciens FZB42 is a naturally occurring microorganism, thus is a naturally occurring probiotic, as evidenced by the Results para. 1 of Idriss et al. (Extracellular phytase activity of Bacillus amyloliquefaciens FZB45 contributes to its plant-growth-promoting effect, Microbiology, Vol 148, Iss. 7, 2002).
Prebiotics are complex plant fibers that act as food for probiotic organisms, and they exist naturally in dietary food products like asparagus, sugar beet, garlic, chicory, onion, artichoke, wheat, honey, banana, barley, tomato, rye, soybean, milk, peas, beans, seaweeds, and algae as evidenced by pg. 4 sec 4 of Davani-Davari et al. (Prebiotics: Definition, Types, Sources, Mechanisms, and Clinical Applications. Foods. 2019; 8(3):92. https://doi.org/10.3390/foods8030092).
Immune modulators include naturally occurring immunomodulators produced by many natural medicinal herbs as evidenced by Table 1 of Alanazi et al. (Medicinal Herbs: Promising Immunomodulators for the Treatment of Infectious Diseases. Molecules. 2023; 28(24):8045. https://doi.org/10.3390/molecules28248045).
As the scope of “milk replacers” is uncertain, claim 4 is interpreted to include dairy milk substitutes, such as soy milk, oat milk, and almond milk, which are naturally occurring extracts of soy, oat, and almond, respectively.
The dried leaves of naturally occurring Artemisia annua function as a natural coccidiostat as evidenced by Title and Abstract of Almeida et al. (Use of Artemisia annua as a natural coccidiostat in free-range broilers and its effects on infection dynamics and performance, Veterinary Parasitology, Volume 186, Issues 3–4, 2012, Pages 178-187, https://doi.org/10.1016/j.vetpar.2011.11.058).
As the scope of “acid-based products” is uncertain, the term “acid-based products” in claim 4 is interpreted to include any acids, which include amino acids, and fatty acids produced by naturally occurring microorganisms.
Medicines are preparations used for the treatment or prevention of disease. As discussed above, the dried leaves of naturally occurring Artemisia annua serve as a natural coccidiostat, which is a medicine used to treat the parasitic disease coccidiosis.
Claims 5-7 and 9-12 recite intended capabilities of the bacillaene producing microorganism, but do not recite any additional compositional elements that would differentiate the claim composition from its closest natural counterpart.
Claim 13 recites the bacillaene producing microorganism is selected from the group consisting of B. subtilis, B. amyloliquefaciens, B. methylotrophicus, B. atropheus, P. polymyxa, and P. durus, all of which are microorganisms that exist in and are isolated from nature.
Claim 14 recites the bacillaene producing microorganism is selected from the group consisting of Bacillus amyloliquefaciens strain DSM 33014, and a mutant of the Bacillus strain as deposited under DSM 33014, with a sequence identity of at least 98 % to the genome sequence of the Bacillus strain as deposited under DSM 33014. As discussed above, Bacillus amyloliquefaciens DSM 33014 is a bacillaene producing microorganism that is a naturally occurring microorganism that was identified by screening naturally occurring isolates (Specification pg. 3 lns. 11-12).
Claim 15 recites intended capabilities of the mutant Bacillus bacillaene producing microorganism of claim 14, but does not recite any additional compositional elements that would differentiate the claim composition from its closest natural counterpart.
Claim 16 recites certain identifiable properties of Bacillus amyloliquefaciens DSM 33014, but does not recite any additional compositional elements that would differentiate the claim composition from its closest natural counterpart.
Therefore, the instant invention recites a judicial exception of a product of nature (Step 2A Prong One: Yes).
This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are directed to a composition, and do not recite any method steps, applications, or therapeutic interventions that would integrate the composition into a practical purpose.
Therefore, the instant invention is directed to the judicial exception of a product of nature and does not include any additional elements that amount to significantly more than the recited judicial exception of a product of nature, and so the instant invention is not patent eligible subject matter under 35 USC §101 (Step 2A Prong Two and Step 2B: No).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chowdhury et al. (Biocontrol mechanism by root-associated Bacillus amyloliquefaciens FZB42 – a review. (2015) Front. Microbiol. 6:780. doi: 10.3389/fmicb.2015.00780).
Regarding claims 1-3, 8, and 13, Chowdhury teaches that the microorganism Bacillus amyloliquefaciens subsp. plantarum FZB42 is capable of producing bacillaene (Table 1, pg. 5 left col. para. 2). Chowdhury also teaches that Bacillus amyloliquefaciens subsp. plantarum FZB42 is used as a biofertilizer and biocontrol agent in agriculture, including plants (Abstract). Therefore, Chowdhury teaches a plant treating composition comprising bacillaene produced by a bacillaene producing microorganism Bacillus amyloliquefaciens subsp. plantarum FZB42 and the Bacillus amyloliquefaciens subsp. plantarum FZB42 strain itself.
Regarding claim 4, Chowdhury teaches that the bacillaene producing microorganism Bacillus amyloliquefaciens subsp. plantarum FZB42 produces many compounds including proteins, carbohydrates, fats, enzymes, amino acids, acid-based products, and medicines such as antibiotics (Table 1, Figs. 2-4, pgs. 3-5).
Regarding claims 5-7 and 9-12, these claims recite functional characteristics of the bacillaene producing microorganism, which is taught by Chowdhury, but do not recite any additional compositional elements that would differentiate the claim composition from its closest natural counterpart.
Regarding claims 14 and 16, Chowdhury’s Bacillus amyloliquefaciens subsp. plantarum FZB42 comprises a 16s rDNA sequence that is 100% identical to the 16s rDNA sequence of SEQ ID NO: 1, a yqfD sequence that is 98.5% identical to the yqfD sequence of SEQ ID NO: 2, a gyrB sequence that is 98.6% identical to the gyrB sequence of SEQ ID NO: 3, a rpoB sequence that is 99.5% identical to the rpoB sequence of SEQ ID NO: 4, and a groEL sequence that is 98.8% identical to the groEL sequence of SEQ ID NO: 5 (See below alignments). Therefore, Chowdhury’s Bacillus amyloliquefaciens subsp. plantarum FZB42 is a mutant of Bacillus amyliliquefaciens of at least 98% sequence identity to the genome sequence of DSM 33014.
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Regarding claim 15, the claim recites inherent characteristics of the mutant Bacillus bacillaene producing microorganism of claim 14, but does not recite any additional compositional elements; thus, if a composition in the prior art teaches all of the structural limitations of the claimed composition, instant claim 15 will be considered to be anticipated.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER M DURYEE whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/Alexander M Duryee/Examiner, Art Unit 1657 /LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
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