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 statements (IDS) submitted on 10/18/23 and 01/20/26 were filed and entered. The submissions are in compliance with the provisions of 37 CFR 1.97 and have been considered by the Examiner.
Election/Restrictions
3. Applicant’s election without traverse of Group I, in the reply filed on 01/20/26, is acknowledged.
Claim Status
4. The amendment, filed 01/20/26, has been entered.
5. Claims 1-5, 7-12, 14-19, 21-22, 24, 26-32, 35-36, 38-41, 44, and 62-63 are pending. Claims 6, 13, 20, 23, 25, 33-34, 37, 42-43, and 45-61 are cancelled. Claims 24, 26-32, 35-36, 38-41, 44, and 62-63 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/20/26. Claims 1-5, 7-12, 14-19, and 21-22 are under examination.
Claim Rejections - 35 USC § 101
6. Claims 1-5, 7-12, 14-19, and 21-22 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.
The claims recite a bacterial strain deposited as NRRL No. B-67089 (see claim 1); which has been identified as bacterial strain AIP61892 as described in WO 2017/040273 (i.e. see “Hammer” below; and instant specification, page 2, lines 34-36) which appears to be a naturally occurring strain of as a Bacillus subtilus (e.g. see WO2017/040273; page 2, section II) and/or a bacterial strain AIP1620 (i.e. see claims 7, 14, and 21) that appears to be a naturally occurring strain of Pseudomonas fluorescens deposited and assigned NRRL No. B-50897 (e.g. see “Jones” US2015/0218568 at [0019-0021, 0033-34, 0059-60] and Example 1). Thus, the claims are directed to a statutory category and Step 1 of the Subject Matter eligibility analysis is yes.
The judicial exception(s) is/are not integrated into a practical application because the naturally occurring bacteria do not appear to be markedly different from their naturally occurring counterparts, in the natural state, since each does not appear to have been modified in any way. Therefore, the product claims are directed to a judicial exception (i.e. nature-based products; Step 2A prong 1 is yes) that is not integrated into a practical application (i.e. 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, 3, 8, 10, 15, 16, 17, and 22 (i.e. merely concentrating a JE does not add an additional element). For the claim 9, the addition element of a seed is another judicial exception (i.e. seeds are products of nature). Similarly for claims 7, 14, and 21 the additional element of another bacterium merely adds an additional JE. For claim 2, the additional element encompasses water (i.e. a liquid formulation). For claims 4, 5, 11, 12, 18, and 19, the additional element(s) of a fungicide or bactericide, is/are not sufficient to amount to significantly more than the judicial exception because there is no indication that any of these additional element(s) changes any structural or functional features of the judicial exception per se as evidenced by, for example, Hammer (WO 2017/040273; see above) which teaches the bacterial strains are compatible with (i.e. able to survive and reproduce in the presence of) biocides including fungicides, herbicides, insecticides and the like (e.g. see page 6, lines 10-20). Therefore, all the components in the composition function as they would individually, and 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.
Thus, taken alone, the additional elements do not amount to significantly more than the above identified judicial exceptions (i.e. one or more naturally occurring bacteria). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually because the additional element(s) are recited at a high level of generality and are well-understood, routine, conventional activities engaged in by the scientific community; see Hammer (WO 2017/040273) and Jones (US2015/0218568). Consequently, the additional element(s) are not sufficient to make the judicial exception eligible for patent protection (i.e. Step 2B is no).
Therefore, based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are held to claim a law of nature and natural products, and are consequently rejected as ineligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 1-5, 7 and 8, 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.
The term “stable” in claim 1 is a relative term which renders the claim indefinite. The term “stable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In other words, what degree of stability is required to be included or excluded from the claim scope?
Other dependent claims do not clarify the issue identified above, therefore clarification is required to remove scope ambiguity.
Claim Rejections - 35 USC § 112
9. 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.
10. Claims 1-5, 7-12, 14-19, and 21-22 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 appears to employ novel biological materials (if however, that is not the case, clarification is required; see references to prior art), specifically a bacterial strain deposited as NRRL No. B-67089 (see claim 1) deposited on August 6, 2015 and assigned NRRL No. B-67089 and/or a bacterial strain AIP1620 deposited on January 31, 2014 and assigned NRRL No. B-50897 (see claims 7, 14, and 21). 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(s) is/are 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 2-3 of the specification that the biological materials were deposited according to the Treaty of Budapest, a statement that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent is additionally required. It is also noted, that Applicant states the strains are known in the prior art (i.e. what appears to be their own prior work), however, the references to which they pertain to, did not appear to be found in a patent and thus, the statement identified above, would still be required.
Claim Rejections - 35 USC § 102
11. 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.
12. 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.
13. Claims 1-5, 9-12, and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hammer et al. 2017 (WO 2017/040273).
Hammer teaches liquid and solid compositions for preventing plant diseases comprising a bacterial strain identified as AIP61892 and deposited as NRRL No. B-67089 (e.g. see abstract, Figure 2, page 3, lines 17-20; and page 5, lines 30-32; meeting limitations found in instant claims 1-2, 9, and 16). Hammer teaches coated seeds (e.g. page 16, lines 13-23; meeting limitations found in claim 9). Hammer teaches compositions comprising a second biocontrol agent (e.g. see page 2, line 28 to page 4, line 2; meeting limitations found in instant claims 4, 11, and 18). Hammer teaches the bacterial strains are compatible with biocides including fungicides, herbicides, insecticides and the like (e.g. see page 6, lines 10-20; also meeting limitations found in instant claims 4, 11, and 18). Hammer teaches biocides encompass, for example, prothioconazole (e.g. see page 46, line 34; meeting limitations found in instant claims 5, 12, and 19). Hammer teaches bacterial concentrations of 108 or greater CFU/ml (e.g. see pages 4-5, bridging paragraph; meeting limitations found in claims 3, 10, and 17).
Therefore, Hammer anticipates the invention as claimed.
Claim Rejections - 35 USC § 103
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 1-5, 7-12, 14-19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Hammer et al. 2017 (WO 2017/040273) in view of Jones et al. 2015 (US 2015/0218568).
The teachings of Hammer are set forth above, meeting limitations found in instant claims 1-5, 9-12, and 16-19, along with dependent claims 8, 15, and 22.
Therefore the difference between the prior art and the invention is the inclusion of a particular second bacterial strain, for example, AIP1620 (identified as NRRL No. B-50897) in dependent claims 7, 14 and 21.
However, Jones teaches similar compositions for protecting plants comprising a mix the bacterial strains including Bacillus and Pseudomonas, including Pseudomonas fluorescens in general, and strain NRRL No. B-50897, in particular (aka AIP1620; e.g. see [0019-0021, 0033-34, 0059-60] and Example 1). Jones teaches the importance of protecting plants, including economically important crops, from plant pathogens and diseases and that the use of chemical pesticides imposes a level of risk including endangering health and environment (e.g. [0003-5]).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to combine composition for protecting plants against diseases comprising NRRL No. B-67089, as taught by Hammer, with compositions for protecting plants against diseases comprising NRRL No. B-50897 (aka AIP1620), as taught by Jones, thereby arriving at the claimed invention, because both compositions were taught for the same purpose of protecting plants from disease-causing pathogens, as set forth above. Therefore, each and every element is taught in the prior art and the combination has a beneficial result; however, the combination amounts to no more than a predictable use of prior art elements according to their established functions.
The person of ordinary skill in the art would have been motivated to make the modification because MPEP 2144.06 states that combining equivalents known for the same purpose is obvious. For example: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). Further, Jones taught the importance of protecting crops and the advantages of biological agents over chemical ones, including the chemical ones were disadvantageous for causing risk to health and the environment. The person of ordinary skill in the art would have had a reasonable expectation of success because Hammer had already taught compositions comprising NRRL No. B-67089 were effective against plant pathogens and Jones had already taught compositions comprising NRRL No. B-50897 were effective against plant pathogens. Therefore, the combination of the two compositions leads to expected results because each element performs the same function as it does individually (i.e. protects the plants from disease-causing pathogens).
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e. compositions comprising NRRL No. B-67089 for protecting plants and compositions comprising NRRL No. B-50897 for protecting plants) were known in the art. In addition, combining these elements yields a composition wherein each element merely performs the same function as it does separately; thus the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, it would have been obvious to a person of ordinary skill in the art to combine these prior art elements according to a known method to yield predictable results.
The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
18. No claims are allowed.
19. 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, Dan Kolker can be reached on (571)-272-3181. 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
February 10, 2026