DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on 09/28/23 was filed and entered. The submission is in compliance with the provisions of 37 CFR 1.97 and has been considered by the Examiner.
Claim Status
3. The preliminary amendment, filed 09/28/23, has been entered. Claims 1-17 are pending and under examination. Claims 3, 4, 6-15, and 17 are amended.
Claim Objections
4. Claims 4 and 9 are each objected to because of the following informalities: unconventional word order. Both claims read “…leafy vegetables greens” where “leafy green vegetables” is proper (also see page 1, line 6 of instant specification). Appropriate correction is required.
Duplicate Claim Warning(s)
5. Applicant is advised that should claim 1 be found allowable, claim 16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 101
6. 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.
7. Claims 1-7 and 16-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nature-based product (e.g. naturally occurring bacteria) without significantly more.
Instant claims recite bacterial strains isolated from edible leaves chosen from the group consisting of Pseudomonas punonensis having accession number LMG P-32204, Bacillus coagulans having accession number LMG P-32205, Bacillus coagulans having accession number LMG P-32206, and Pseudomonas cedrina having accession number LMG P-32207 (emphasis added) which are naturally occurring bacteria (i.e. each was isolated from leaves) and thus constitute nature-based products. Therefore, although the product claims are directed to a statutory category (i.e. Step 1 of the Subject Matter Eligibility analysis is yes), they are also directed to a judicial exception (i.e. nature-based products); thus, Step 2A, prong 1 is also yes.
This judicial exception is not integrated into a practical application because the naturally occurring bacterial strains do not appear to be markedly different from their naturally-occurring counterparts, in the natural state, since none of them were modified in any way. Therefore, Step 2A, prong 2 is no.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements in claims 1, 2, 3, 4, 5, 6, 7, 16 or 17 because these claims merely add intended uses of the claimed product and/or the “composition” per se does not require any additional particular components. With regards to the combination of naturally occurring bacteria in claim 7, a mere mixture or aggregation of products, natural or not, does not structurally and/or functionally change the nature-based product from what exists in the environment and that in order to be eligible, every embodiment within the broadest reasonable interpretation of the claim must be eligible; also see Funk Brothers Seed Co. v. Kalo Inoculant Co. 333 U.S 127 (1948). Consequently, Step 2B is no.
Accordingly, based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are held to claim a law of nature (i.e. nature-based products), and are rejected as ineligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
8. 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.
9. Claims 3, 8-9 and 15 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 3 is indefinite because neither Escherichia or Enterobacteriaceae are “species” per se as Escherichia is a genus and Enterobacteriaceae is a family; thus it is unclear what Applicant is trying to encompass. In the interest of completeness, it is also noted that, by convention, Escherichia but not Enterobacteriaceae should be in italics. In the interest of compact prosecution, the claim has been interpreted to encompass any and/or all species of either the Escherichia genus or Enterobacteriaceae family; nevertheless, clarification is required to remove scope ambiguity.
Claim 8 is indefinite because the body of the claim does not meet the goal of the preamble and thus it is unclear how to meet the goal of the preamble. For example, the only positively recited step, i.e. “…utilizing at least one bacterial strain according to claim 1” does not lead to either (a) preventing establishment and growth of human pathogens on seeds and vegetables or (b) as bio-fertilizer as required by the preamble and thus does not delimit how this utilization is actually practiced; see MPEP 2173.05(q). Further, as written, the claim encompasses an embodiment as “A method of bio-fertilizer” which simply does not make sense. Accordingly, clarification is required to ascertain the metes and bounds of this claim. Dependent claims 10-14 (but not 9 or 15) add at least one positively recited step(s) regarding how to utilized the claimed bacteria and thus have been left out of the rejection. For the purpose of compact prosecution, any utilization of one or more of the strains will be interpreted to meet the limitation of claim 8; nevertheless, clarification is required to ascertain its metes and bounds.
Regarding claim 15, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention; See MPEP § 2173.05(d). Further, claim 15 does not make sense because it is unclear what or how the limitation of “…increasing the bacterial diversity on vegetables such as leafy vegetables as obtained after sowing” is executed. Thus, clarification is required.
Therefore, clarification is required to remove ambiguity of scope in these claims.
Claim Rejections - 35 USC § 112
10. 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.
11. Claims 1-17 are rejected under 35 U.S.C. 112(a) 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. This is a biological deposit rejection.
The invention(s) appear(s) to employ novel biological materials, specifically newly isolated strains of Pseudomonas punonensis, Bacillus coagulans and Pseudomonas cedrina. Since the biological materials are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that “…the specific biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent”, would satisfy the deposit requirement made herein.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant's attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that "the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination." The specification should be amended to include this information; however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
Although Applicants have noted on pages 3 and 10 of the specification (and in claim 1) that the newly isolated strain of Pseudomonas punonensis has an accession number LMG P-32204; and Bacillus coagulans has an accession number LMG P-32205; and Bacillus coagulans has an accession number LMG P-32206; and Pseudomonas cedrina has an accession number LMG P-32207; a statement regarding deposition under Treaty of Budapest and a statement that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent; or a statement including (a)-(e) above, is required to satisfy the conditions set forth in 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 102/103
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. Claims 1-6, 8 and 16-17 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as being unpatentable over Faber et al. 2021 (US 2021/0085729; of record).
Faber teaches compositions comprising Bacillus coagulans used (i.e. utilizing at least one strain) for inhibiting growth of human pathogens, including Gram-positive and Gram-negative species, including Escherichia coli (e.g. [0013, 0047-0050, 0102]; meeting limitations found in instant claims 1, 3, 5, 8, 16, and 17).
With regards to “…isolated from edible leaves” in claim 1; it is noted that the method by which the strains were obtained is immaterial to their patentability because patentability of a product does not depend on its method of production (see In re Thorpe, 227 USPQ 964, 966 Fed. Cir. 1985; and MPEP 2113).
With regards to “…for preventing establishment and growth of human pathogens on seeds and vegetables” in claims 1 and 5; “…for preventing establishment and growth of human and plant pathogens on seeds and vegetables” in claims 2 and 6; “…for preventing spread of the human pathogens Escherichia and Enterobacteriaceae species on seeds and vegetables” in claim 3; “…wherein said vegetables are leafy vegetables greens” in claim 4 (all emphases added); none of these limitations add an additional component to the product claims and thus each has been interpreted as an intended use of the claimed product (see underlined verb phrases). It is noted that recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation (see MPEP 2144.07).
While Faber does not specifically teach the Bacillus coagulans is Bacillus coagulans having accession number LMG P-32205 or LMG P-32206; the bacteria is deemed to be the same, or at least substantially the same, as those claimed as evidenced by, for example, the same Latin name and the same use (i.e. protect against infections), and Bacillus coagulans cannot be separated from its properties. Therefore, Faber anticipates the invention.
Alternatively, it would have been prima facie obvious to substitute one Bacillus coagulans bacterial strain for another for the same purpose as desired.
Therefore, Faber teaches, or at least renders obvious, the composition as claimed because (1) Bacillus coagulans cannot be separated from its properties, and/or (2) the prior art teaches a product and method that only differs from the claimed invention by the substitution of a single component (i.e. substitution of the Bacillus coagulans strain’s identifying accession number) and KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill.
Therefore, the claimed invention is at least prima facie obvious, if not anticipatory, in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claim Rejections - 35 USC § 102/103
18. Claims 1-6 and 8-17 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as being unpatentable over Kritzman 2017 (US 2017/0135351; of record).
Kritzman teaches methods for using compositions comprising antagonistic bacteria to prevent the spread of bacterial diseases on plants, including cabbage (i.e. a leafy green vegetable) comprising the utilization of Pseudomonas cedrina alone or in combination with other antagonistic bacteria (e.g. see abstract; [0010-0014, 0109-0110]; and Figure 4; meeting limitations found in instant claims 1, 4, 5, 8, 9, 15, and 16). Kritzman teaches application via spraying or irrigating (e.g. [0037, 0045-55]; meeting limitations found in instant claims 10, 11, and 13). Kritzman teaches the composition are applied inside a package (e.g. [0013, 0062]; meeting limitations found in instant claim 12). Kritzman teaches concentrations encompassing 104 CFU/ml (e.g. see 0.5 x 104; [0108]; meeting limitations found in instant claim 14 with sufficient specificity; MPEP 2131.03 and/or 2144.05).
With regards to “…isolated from edible leaves” in claim 1; it is noted that the method by which the strains were obtained is immaterial to their patentability because patentability of a product does not depend on its method of production (see In re Thorpe, 227 USPQ 964, 966 Fed. Cir. 1985; and MPEP 2113).
With regards to “…for preventing establishment and growth of human pathogens on seeds and vegetables” in claims 1 and 5; “…for preventing establishment and growth of human and plant pathogens on seeds and vegetables” in claims 2 and 6; “…for preventing spread of the human pathogens Escherichia and Enterobacteriaceae species on seeds and vegetables” in claim 3; and “…for use in protection against infection in humans” in claim 17; (all emphases added); none of these limitations add an additional component to the product claims and thus each has been interpreted as an intended use of the claimed product (see underlined verb phrases). It is noted that recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation (see MPEP 2144.07).
While Kritzman does not specifically teach the Pseudomonas cedrina is Pseudomonas cedrina having accession number LMG P-32207; the bacteria is deemed to be the same, or at least substantially the same, as those claimed as evidenced by, for example, the same Latin name and the same use (i.e. protect against pathogens and diseases), and Pseudomonas cedrina cannot be separated from its properties. Therefore, Kritzman anticipates the invention.
Alternatively, it would have been prima facie obvious to substitute one Pseudomonas cedrina bacterial strain for another for the same purpose as desired.
Therefore, Kritzman teaches, or at least renders obvious, the composition as claimed because (1) Pseudomonas cedrina cannot be separated from its properties, and/or (2) the prior art teaches a product and method that only differs from the claimed invention by the substitution of a single component (i.e. substitution of the Pseudomonas cedrina strain’s identifying accession number) and KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill.
Therefore, the claimed invention is at least prima facie obvious, if not anticipatory, in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
19. No claims are allowed at this time.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http: //www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached on (571)-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY MAILLE LYONS/ Examiner, Art Unit 1645
November 21, 2025