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 .
Status of the Claims
Claims 2-5, 7-8, 10-16, 19-20, 22-23, 25-31, 33, 35, 37-39, 41-43, 45-62, 64-79, 85-86, 88, and 90 are cancelled. Claims 1, 6, 9, 17, 32, 34, 36, 40, 44 and 63 are pending (claim set as filed on 11/28/2023). Claims 18, 21, 24, 80-84, 87 and 89 are withdrawn after restriction/election requirement.
Election/Restrictions
Claims 18, 21, 24, 80-84, 87 and 89 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected composition or method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/20/2026.
Applicant’s election without traverse of claims 1 and 6 in the reply filed on 1/20/2026 is acknowledged.
The election of species requirement for claims 1 and 6, as set forth in the Office Action mailed on 11/19/2025, has been reconsidered and is hereby withdrawn.
In view of the above noted withdrawal of the election of species requirement, applicant is
advised that if any of the claim represented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claims may be subject to
provisional statutory and/or non-statutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer
applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP §
804.01.
Priority
This application filed on 9/29/2023 claims benefit to a provisional application no. 63/428,708 filed on 11/29/2022. The claim to benefit is acknowledged and therefore, the effective filing date of the application is 11/29/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/28/2023 and 1/20/2026 are considered, initialed, and attached hereto. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
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 32, 36, and 44 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.
Claims 32 and 44 use the term “at least about” which is a relative term which renders the claim indefinite. The term “at least about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree. The claims recite “at least“ which limit the claims to the specified numerical value, but also recite “about” which includes the lower range of this value as well. The scope of the numerical range of the inventions is then unclear as to when one would infringe on them..
Claim 36 uses the term “at less than about” which is a relative term which renders the claim indefinite. The term “at less than about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree. The claim recites “at less than” which limits the claim to the specific numerical value, but also recites “about” which includes the lower range of this value as well. The scope of the numerical range of the invention is then unclear as to when one would infringe on it.
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, 6, 9, 17, 32, 34, 36, 40, 44, and 63 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
With regards to Step 1, the bacteria and the excipients of claims 1, 6, 9, 17, 32, 34, 36, 40, 44, 63 are a composition of matter.
With Regards to Step 2A, prong one, claims 1, 6, 9, and 17 are directed toward a composition comprising a bacteria species Escherichia coli and broadest embodiment of the stabilizing excipients. Claims 32, 34, 36, 40, 44, and 63 are directed toward additional elements of the composition such as number of colony forming units (CFU), its viability upon tableting, and its stability under different conditions such as temperature, humidity, ionizing radiation, exposure to organic solvents. The claimed Escherichia coli bacteria and the stabilizing excipients are considered to be judicial exceptions as they are natural products with no markedly different structure or function than what would be found in nature. The additional claimed elements are considered to be judicial exceptions are they are dependent on the original composition and do not make any modifications to the bacteria and stabilizing excipients to make them more than what they would be naturally. These elements do no interact with each other to form a materially different structure, but are merely combined in the composition. It should be noted that the mere isolation of abacterial organism and stabilizing excipients from the natural environment is not patent eligible.
With regards to Step 2A, prong two, claims 1, 6, 9, 17, 32, 34, 36, 40, 44, 63 do not recite any elements in addition to the bacteria and excipients (all Judicial exceptions) to integrate into the instant application. Claims 32, 34, 36, 40, 44, and 63 recite CFU and conditions for stability and viability which does not change the judicial exceptions themselves or practically integrate them. The intended use of the application to study growth of the Escherichia coli with its excipients does not in any way change the natural structure or inherent functionality of the Escherichia coli bacterial strain and the excipients. As such, there is no additional elements integrated that apply or use the judicial exception in some other meaningful way.
With regards to Step 2B, claims 1, 6, 9, 17, 32, 34, 36, 40, 44, 63 do not recite any elements other than the judicial exceptions of the bacterial species Escherichia coli and the broadest embodiment of the stabilizing excipients. As such, claims 1, 6, 9, 17, 32, 34, 36, 40, 44, 63 do not recite additional elements that alone or together amount to significantly more than the judicial exception itself and therefore are not patent eligible.
For the following reasons, claims 1, 6, 9, 17, 32, 34, 36, 40, 44, 63 are not deemed to encompass patent eligible subject matter under 35 USC § 101. Claims 6, 9, 17, 32, 34, 36, 40, 44, and 63 are rejected for being dependent on claim 1.
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)(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, 17, 34, and 40 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Danino (Pre-Grant Publication No. US 2021/0308195 A1– date of patent 10/7/2021) and as evidenced by Vermont Agency of Agriculture (Vermont Agency of Agriculture, “Eye on E. coli: Understanding pathogens of concern for fruit and vegetable farms”, 2022 Jan 12, https://agriculture.vermont.gov/produce-program/eye-e-coli-understanding-pathogens-concern-fruit-and-vegetable-farms, accessed 2026 Mar 27, pgs. 1-3).
Danino’s general disclosure relates to a programmable bacteria to deliver therapeutic agents (see abstract).
Regarding claim 1, Danino teaches a composition comprising Escherichia coli bacteria species (see pg. 33, claim 2) and a stabilizing excipient comprising glucose, lactose, and sucrose (see pg. 33, claim 10 and [0164]).
Regarding claim 17, Danino teaches that the E. coli used is the Nissle 1917 strain (see pg. 33, claim 3).
Regarding claims 34, Danino teaches the bacterial composition (see pg. 33, claims 2 and 30 and [0164]). It is inherent that the E. coli bacteria comprising the composition is stable at about 23[Symbol font/0xB0]C, 37[Symbol font/0xB0]C, and 50[Symbol font/0xB0]C for at least 30 days, as evidenced by Vermont Agency of Agriculture (see Vermont Agency of Agriculture pg. 3, ¶ 4). Vermont Agency of Agriculture discloses that E. coli can be stable for months at a range of 45-121[Symbol font/0xB0]F (or 7.2-49.4[Symbol font/0xB0]C), of which about 23[Symbol font/0xB0]C, 37[Symbol font/0xB0]C, and 50[Symbol font/0xB0]C fall into this range.
Regarding claim 40, Danino teaches that the composition is stable when exposed to organic solvents such as ethanol, which is added as an excipient (see pg. 33, claim 10 and [0164]).
Claim Rejections - 35 USC § 103
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 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.
Claims 1, 6, 32, 34, 40, 44, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Lobacki (Pre-Grant Publication No. US 2022/0088090 A1 – date of patent 6/7/2022) as evidenced by Vermont Agency of Agriculture (Vermont Agency of Agriculture, “Eye on E. coli: Understanding pathogens of concern for fruit and vegetable farms”, 2022 Jan 12, https://agriculture.vermont.gov/produce-program/eye-e-coli-understanding-pathogens-concern-fruit-and-vegetable-farms, accessed 2026 Mar 27, pgs. 1-3).
Lobacki’s general disclosure relates to a microbial composition to administer anti-cancer therapy (see abstract).
Regarding claim 1, Lobacki teaches a composition comprising a bacterial species (see col. 85, claim 1) where Escherichia coli is considered an embodiment of the bacteria (see col. 37, line 58), and stabilizing excipients comprising glucose, fructose, sucrose, and a combination thereof (see col. 85, claim 7). Lobacki suggests the combination of the E.coli bacteria and the stabilizing excipients, but one would not immediately envisage the combination as claimed.
However, it would be obvious to one of ordinary skill in the art to combine the E. coli bacteria and stabilizing excipients together in the composition taught by Lobacki. Motivation to do so would be because Lobacki teaches an E.coli bacteria in a composition and excipients of glucose, fructose, sucrose, and a combination thereof in a composition. Hence, the ordinary artisan would find it obvious to combine both the bacteria and excipients from Lobacki’s suggestion into one composition as Lobacki teaches that the excipients are prebiotics that nutritionally supplement the bacteria in the microbial composition (see col. 53, lines 39-54).
Regarding claim 6, Lobacki teaches a second stabilizing excipient of caffeine (see col. 71, lines 32-34). Lobacki discloses caffeine as a component of the polymer coating of the encapsulated microbial composition As applicant recites “or” when listing the species that the second excipient is selected from, caffeine was chosen following the withdrawal of the election of species requirement for claim 6.
Regarding claim 32, Lobacki teaches the bacterial composition exhibits between at least 1 x 106 to 1 x 1010 CFU (see col. 26, lines 59-62).
Regarding claims 34, Lobacki teaches the bacterial composition (see Lobacki col. 85, claims 1 and 7). It is inherent that the E. coli bacteria comprising the composition is stable at about 23[Symbol font/0xB0]C, 37[Symbol font/0xB0]C, and 50[Symbol font/0xB0]C for at least 30 days, as evidenced by Vermont Agency of Agriculture (see Vermont Agency of Agriculture pg. 3, ¶ 4). Vermont Agency of Agriculture discloses that E. coli can be stable for months at a range of 45-121[Symbol font/0xB0]F (or 7.2-49.4[Symbol font/0xB0]C), of which about 23[Symbol font/0xB0]C, 37[Symbol font/0xB0]C, and 50[Symbol font/0xB0]C fall into this range.
Regarding claim 40, Lobacki teaches that the composition is stable when exposed to organic solvents such as ethanol and chloroform during lyophilization (see col. 29, lines 36-39).
Regarding claim 44, Lobacki teaches that the composition retains between 5-15% viability (see col. 33, lines 40-43) and that the composition is embodied as a tablet (see col. 74, lines 7-8). Lobacki discloses that upon exposure to the organic solvent, the bacteria can lose up to 85-95% viability; it would be reasonable to interpret that the remaining viability is 5-15%.
Regarding claim 63, Lobacki teaches that the composition is stable when exposed to ionizing radiation as the microbes are prepared under irradiating conditions (see col. 40, lines 7-10).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lobacki (Pre-Grant Publication No. US 2022/0088090 A1 – date of patent 6/7/2022) in view of von Maltzahn (US Patent No.US 2018/0147222 A1– date of patent 6/11/2019).
Lobacki’s general disclosure and teachings have been set forth above.
Regarding claim 9, Lobacki teaches the stabilizing excipient of caffeine (see col. 71, lines 32-34).
Lobacki does not teach a stabilizing excipient of melibiose.
Von Maltzahn’s general disclosure relates to glycan therapeutics to modulate bacterial growth (see abstract).
Regarding claim 9, von Maltzahn teaches melibiose as a component of the composition (see col. 24, line 35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to add melibiose as taught in von Maltzahn to the bacterial composition taught in Lobacki. Motivation to do so would be because von Maltzahn teaches that glycans such as melibiose can prevent the growth of harmful microbes (see von Maltzahn col. 21, lines 26-31). Lobacki discloses a need for healthy donated fecal samples that are free from pathogenic microbes (see Lobacki col. 33, lines 46-47 and col. 34, lines 1-4) for use in the bacterial composition. The addition of melibiose to Lobacki’s composition would be considered advantageous as it could inhibit the growth of pathogenic microbes.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Lobacki (Pre-Grant Publication No. US 2022/0088090 A1 – date of patent 6/7/2022) in view of Kanthasamy (Pre-Grant Publication No. US 2019/0262298 A1– date of patent 8/29/2019).
Lobacki’s general disclosure and teachings have been set forth above.
Kanthasamy’s general disclosure relates to an engineered probiotic to produce therapeutics (see [0002]).
Regarding claim 17, Kanthasamy teaches the E. coli strain Nissle 1917 (see col. 25, claim 32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to use the claimed strain in Lobacki’s composition. The ordinary artisan would have been motivated to do so because Nissle 1917 is known as a non-pathogenic probiotic strain of E. coli (see Kanthasamy [0049]). Since Lobacki is directed towards an ingestible microbial composition, substituting the E. coli strain to Nissle 1917 would be advantageous as it would be safe for subject consumption and the state of the art indicates its routine use.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Lobacki (Pre-Grant Publication No. US 2022/0088090 A1 – date of patent 6/7/2022) in view of FDA (Food and Drug Administration, “Guideline for the Determination of Residual Moisture in Dried Biological Products”, 1990 Jan, pgs. 1-2).
The disclosure and teachings of Lobacki have been set forth.Regarding claim 36, Lobacki teaches that the composition is stable at low moisture after lyophilization (see col. 29, lines 36-39), but does not necessarily teach that the humidity was at less than about 5%. Lobacki also discloses that the bacterial composition remains stable for at least one month (see col. 25, lines 8-11).
FDA’s general disclosure relates to guidelines for lyophilization of biologicals (see introduction)
Regarding claim 36, FDA teaches a humidity of at less than about 5% (see pg. 2, ¶ 3). FDA discloses that biologicals after lyophilization usually have a moisture content between 1-5%.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to optimize the humidity percentage of the lyophilized composition as taught in Lobacki to at less than about 5% as taught in FDA. The ordinary artisan would have been motivated to so because FDA teaches that 1-5% is a common moisture content range for biologicals undergoing the lyophilization process (see FDA pg. 2, ¶ 3). Therefore, it would be reasonable to optimize the humidity content of the bacterial composition to be at 5% or less as this would offer a reasonable expectation of success for providing a stable composition.
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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/E.R.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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