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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/16/2026 has been entered.
Amendments and Claim Status
In the reply filed 01/16/2026, Applicant canceled claims 3, 12 and 14, amended claims 1, 4-5, 8, 11, 13, 20, 37 and 39, and added new claims 42-44.
Claims 1-2, 4-5, 8, 10-11, 13, 20, 23-25 and 37-44 are pending and under examination.
Claim Objections
Claim 4 is objected to because of the following informalities: Claim 4 is missing a comma after “the composition of claim 1”. Appropriate correction is required.
Claim 38 is objected to because of the following informalities: Claim 38 is missing the word “of” after “at least one” in line 2 of the claim. The phrase should read “at least one of …” Appropriate correction is required.
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.
Claims 1-2, 5, 8, 10, 23-25, 37 and 41-42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mizuguchi et al. (JP 2012246228 A, 12/13/2012) (Of Record) as evidenced by Doern (Clinical Infectious Diseases, 01/01/2000) (Of Record).
Regarding claims 1-2, 5 and 37, Mizuguchi et al. disclose a plate assay medium preparation comprising a basic medium comprising yeast extract, reading on a nitrogen source, gellan gum and magnesium chloride hexahydrate (Bottom of Page 13). Mizuguchi et al. further disclose growth supplements comprising ACES, reading on a buffer, Iron (III) diphosphate (iron (III) pyrophosphate, soluble), L-cysteine and 2-Oxoglutaric acid, reading on a microbial fermentable carbon source, which were mixed with the plate assay medium (Page 14, Sentences 1-6). The medium was for growing Legionella, and other strains (Page 14, Sentence 7).
Under the broadest reasonable interpretation, the composition disclosed by Mizuguchi et al. reads on a growth medium configured for the growth of Francisella, as evidenced by Doern. Doern discloses similarities between culturing Legionella species and Francisella tularensis. Legionella and F. tularensis are both slow-growing, fastidious bacteria that are logistically complex to culture (Page 166, Right Column, Paragraph 2). Legionella requires L-cysteine for growth with growth enhancement occurring with the addition of iron salts (Page 167, Left Column, Paragraph 3). Additionally, Legionella grows well on ACES-buffered charcoal yeast extract agar supplemented with L-cysteine, alpha-ketoglutarate and iron (BYCE) (Page 167, Left Column, Paragraph 4). Doern further discloses agar media supplemented with cysteine and glucose have been used to culture F. tularensis and more recently it has been discovered BCYE can adequately support the growth of F. tularensis (Page 168, Left Column, Paragraph 3). Therefore, the culture medium of Mizuguchi et al. would inherently be capable of supporting the growth of Francisella.
Thus, Mizuguchi et al. anticipate instant claims 1-2 insofar as they disclose a growth medium comprising L-cysteine, reading on an amino acid comprising sulfur, 2-Oxoglutaric acid, reading on a microbial fermentable carbon source, yeast extract, reading on a nitrogen source, iron (III) pyrophosphate, reading on a first salt comprising Ferric pyrophosphate. Additionally, the medium disclosed by Mizuguchi et al. is free of mammalian blood and products thereof, and the medium is for growing Legionella and other microorganisms, reading on configured to allow growth of a living microorganism comprising one or more Francisella species as evidenced by Doern. Mizuguchi et al. anticipate instant claim 5 insofar as disclosing the use of yeast extract and instant claim 37 insofar as disclosing the use of ACES, a buffer.
Regarding claim 8, as disclosed above, Mizuguchi et al. disclose the basic medium comprises magnesium chloride hexahydrate (Bottom of Page 13). Magnesium chloride hexahydrate is a salt. It appears any salt in the medium would satisfy the requirement of a salt being ‘a regulator of osmotic stress’ as the instant Specification notates ‘a salt to regulate osmotic water’ (Instant Specification, Paragraph [0047]). More specifically, the instant Specification states:
osmotic shock or osmotic stress is physiologic dysfunction caused by a sudden change in the solute concentration around a cell, which causes a rapid change in the movement of water across its cell membrane. Under conditions of high concentrations of either salts, substrates or any solute in the supernatant, water is drawn out of the cells through osmosis. This also inhibits the transport of substrates and cofactors into the cell thus “shocking” the cell. Alternatively, at low concentrations of solutes, water enters the cell in large amounts, causing it to swell and either burst or undergo apoptosis (Instant Specification, Paragraph [0161]).
Therefore, ‘a second salt is a regulator of an osmotic stress’ is interpreted to mean the salt is capable of regulating osmotic stress. Thus, the disclosure of magnesium chloride hexahydrate reads on a second salt for regulating osmotic stress as it appears any salt would be capable of regulating an osmotic stress if used in a particular manner and/or concentration. It is noted the claim does not state the specific manner or concentration in which the salt is used to regulate an osmotic stress.
Regarding claim 10, under the broadest reasonable interpretation, the composition disclosed by Mizuguchi et al. reads on allowing growth of a BSL-2 strain and BSL-3 strain of Francisella. It is noted the instant Specification states the claimed FIRE medium bridges the gap between BSL-2 and BSL-3 Francisella studies by growing Francisella strains faster than more common media (Specification, Paragraph [0014]). Therefore, as the medium disclosed by Mizuguchi et al. is deemed to allow growth of Francisella as discussed regarding claim 1, the medium would also be inherently capable of growing BSL-2 and BSL-3 Francisella strains.
Regarding claim 23, Mizuguchi et al. disclose the medium contained 0.250 g iron (III) pyrophosphate (Page 14, Sentence 4).
Regarding claim 24, Mizuguchi et al. disclose the pH of the medium was 6.90 (Page 14, Sentence 7).
Regarding claim 25, under the broadest reasonable interpretation, the composition disclosed by Mizuguchi et al. reads on a growth medium that does not require refrigeration for storage. This claim is very broad and any amount of time can be considered the medium being stored. Therefore, this is a functional limitation of the growth medium of claim 1 that does not, in every instance within the scope of the functional language, materially change the structure of the growth medium.
Nonetheless, Mizuguchi et al. disclose the culturing of the bacteria once exposed to the antibacterial agent, in the medium discussed above, was stored at 35°C (Page 17, Sentence 4). It is noted the Instant Specification indicates refrigeration means archiving or storing or cooling to lower and/or maintain its temperature below the ambient one, usually 10°C or lower (Specification, Paragraph [0171]). As such, the disclosure of Mizuguchi et al. reads on not requiring refrigeration for storage.
Regarding claim 41, as discussed above, Mizuguchi et al. disclose the composition comprises L-cysteine. L-cysteine reads on a ligand-based signaling cue that potentiates cell division of one or more Francisella species because, as discussed above, Doern et al. disclose mediums for growing Francisella include cysteine.
Regarding claim 42, Mizuguchi et al. disclose the medium contained 10.0g yeast extract, reading on a nitrogen source, and 1.0g 2-Oxoglutaric acid, reading on a microbial fermentable carbon source (Bottom of Page 13 – Top of Page 14).
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 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.
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.
Claims 1-2, 5, 8, 10, 13, 20, 23-25, 37, 39 and 41-44 are rejected under 35 U.S.C. 103 as being unpatentable over Mizuguchi et al. (JP 2012246228 A, 12/13/2012) (Of Record) as evidenced by Doern (Clinical Infectious Diseases, 01/01/2000) (Of Record).
The teachings of Mizuguchi et al. are discussed above.
Regarding claims 13, 20 and 39, Mizuguchi et al. disclose the antibacterial agent of the present invention has a high specificity for Legionella bacteria and low killing ability or growth inhibition ability against other bacteria, selective killing or growth inhibition of Legionella bacteria can be performed (Page 8, Paragraph 2). The Legionella and other bacteria were plated on the agar and the effects of different antibacterial agents were tested (Page 14, Last 2 Paragraphs/Sentences). Therefore, as the antibacterial agent of Mizuguchi et al. selects for Legionella, the composition reads on being configured to convert into a selective growth medium. The antibacterial agent further comprises an antibacterial substance (Claim 7 of Mizuguchi et al.). Mizuguchi et al. further disclose antibacterial substances means any antibacterial substance other than the antibacterial agent of the present invention, such antibacterial substances include multiple different types of antibiotics, some of which are glycopeptides like vancomycin and lipopeptides like polymyxin and bacitracin (Page 6, Paragraph 2). Polymyxin is a cyclic peptide antibiotic.
Mizuguchi et al. do not explicitly state their medium comprises an antibiotic or that the antibiotic is polymyxin or vancomycin.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized any of the antibacterial substances, which includes the antibiotics vancomycin and polymyxin, in the medium because Mizuguchi et al. specifically state they are antibacterial substances usable in their invention. Thus, it would have been obvious to utilize vancomycin and/or polymyxin in the medium of Mizuguchi et al. motivated by the desire to determine the effects of said antibiotics on the bacteria being grown.
Regarding claim 43, as discussed above, Mizuguchi et al. disclose the medium contained 10.0g yeast extract, reading on a nitrogen source, and 1.0g 2-Oxoglutaric acid, reading on a microbial fermentable carbon source (Bottom of Page 13 – Top of Page 14).
Mizuguchi et al. do not disclose the amount of the nitrogen source present in the growth medium is about 5 times higher than the amount of the microbial fermentable carbon source.
“Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges through routine experimentation.” See MPEP 2144.05(II)(A). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine all operable and optimal amounts of nitrogen and carbon because nitrogen and carbon are recognized result-effective variables present in growth mediums. Therefore, the amount of nitrogen and carbon would have been routinely and predictably optimized when creating a growth medium. Although the prior art does not teach the amount of nitrogen or carbon claimed, since the claimed components are known components of growth mediums, it would have been conventional and within the skill level of an ordinary artisan to identify and modify the amounts of nitrogen and carbon motivated by the desire to create a growth medium with adequate nitrogen and carbon for the microorganism being grown.
Regarding claim 44, Mizuguchi et al. disclose the medium contains 0.40g L-cysteine, reading on an amino acid comprising sulfur (Top of Page 14).
Mizuguchi et al. do not disclose the amino acid comprising sulfur is in a range of about 0.1% (w/v) to about 0.5% (w/v) of the growth medium.
“Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges through routine experimentation.” See MPEP 2144.05(II)(A). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine all operable and optimal amounts of cysteine because cysteine is an art recognized result-effective variable when growing specific microorganisms, such as Francisella and Legionella. Therefore, the amount of cysteine would have been routinely and predictably optimized when creating a growth medium specific to the desired microorganism, such as Francisella or Legionella. Although the prior art does not teach the amount of cysteine claimed, since the claimed component is a known component of specific growth mediums, it would have been conventional and within the skill level of an ordinary artisan to identify and modify the amount of cysteine motivated by the desire to create a growth medium with adequate cysteine for the microorganism being grown.
Claims 1-2, 4-5, 8, 10, 13, 20, 23-25, 37, 39 and 41-44 are rejected under 35 U.S.C. 103 as being unpatentable over Mizuguchi et al. (JP 2012246228 A, 12/13/2012) (Of Record) as evidenced by Doern (Clinical Infectious Diseases, 01/01/2000) and further in view of Katou et al. (JP H08196288 A, 08/06/1996).
The teachings of Mizuguchi et al. are discussed above.
Regarding claim 4, Mizuguchi et al. does not disclose wherein the carbon source comprises lactose, sucrose or dextrose.
However, Katou et al. disclose culturing a microorganism, Francisella (Abstract). Katou et al. further disclose the bacterial culture must contain an appropriate amount of a carbon source, nitrogen source, inorganic substance and necessary growth and production promoting substances, wherein the carbon source can be one or more of the following including glucose, starch, dextrin, mannose, fructose, sucrose and lactose (Paragraph [0013]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used lactose or sucrose as the carbon source in the composition of Mizuguchi et al. since the composition does not require a specific carbon source and lactose and sucrose are both known and effective carbon sources for culturing microorganisms as taught by Katou et al.
Claims 1-2, 5, 8, 10-11, 13, 20, 23-25, 37, 39 and 41-44 are rejected under 35 U.S.C. 103 as being unpatentable over Mizuguchi et al. (JP 2012246228 A, 12/13/2012) (Of Record) as evidenced by Doern (Clinical Infectious Diseases, 01/01/2000) and further in view of Mager et al. (Nature, 1954).
The teachings of Mizuguchi et al. are discussed above.
Regarding claim 11, Mizuguchi et al. do not disclose the composition further comprising thiamine.
However, Mager et al. disclose the cultivation of Pasteurella tularensis in a chemically defined medium (Title). Pasteurella tularensis was later renamed Francisella tularensis.
Mager et al. further disclose a chemically defined medium for the cultivation of P. tularensis composed of glucose, cysteine, sodium chloride, salt A and B and thiamine, of which enabled positive growth of all strains of P. tularensis cultured (Page 747, Paragraph 2). Additionally, Mager et al. found compounds that are strong buffers with a pK value of about 8-9 were effective for supporting the growth of P. tularensis (Page 747, Paragraph 6).
Exemplary rationales that may support a conclusion of obviousness include combining prior art elements according to known method to yield predictable results. See MPEP 2143(I)(A). Mizuguchi et al. disclose a composition for culturing Legionella, a fastidious bacteria. Doern discloses Legionella species and F. tularensis can grow on similar media and therefore the claimed Francisella would be inherently capable of growing on the claimed medium. Mager et al. disclose a composition for culturing P. tularensis containing thiamine. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize thiamine in the composition of Mizuguchi et al. motivated by the desire to further tailor the composition for the growth of F. tularensis as thiamine being included in a chemically defined media promoted the growth of multiple strains of P. tularensis as taught by Mager et al.
Claims 1-2, 5, 8, 10, 13, 20, 23-25, 37-39 and 41-44 is rejected under 35 U.S.C. 103 as being unpatentable over Mizuguchi et al. (JP 2012246228 A, 12/13/2012) (Of Record) as evidenced by Doern (Clinical Infectious Diseases, 01/01/2000) (Of Record), and further in view of Mitchell et al. (KR 20160131209 A, 11/16/2016) (Of Record).
The teachings of Mizuguchi et al. are discussed above.
Regarding claim 38, as discussed above, Mizuguchi et al. disclose the ACES buffer. Mizuguchi et al. additionally disclose a phosphate buffer (Page 17, Sentence 4).
Mizuguchi et al. do not disclose wherein the buffer comprises at least one of HEPES, PIPES, MOPS, a dibasic phosphate solution and a monophasic phosphate solution.
However, HEPES was known to buffer bacterial cell cultures as taught by Mitchell et al. Mitchell et al. disclose:
The predatory bacterium Delorovibrio bacterium borus was always cultured and maintained in HEPES buffer added with Ca and Mg salts at concentrations of 4 mM and 2 mM, respectively. This buffer was used as a control in all experiments. In order to obtain bacteria-free predatory culture, the cultured medium was cultured for 24 hours in medium containing MG1655 fed E. coli, and the culture was filtered with a 0.22-μm filter three times to remove all E. coli and predatory bacteria (Page 5, Paragraph 2).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used HEPES as the buffer in the composition of Mizuguchi et al. as it is a known and effective buffer for growing bacteria as taught by Mizuguchi et al. who utilize HEPES buffer for growing bacteria.
Claims 1-2, 5, 8, 10, 13, 20, 23-25, 37, 39 and 40-44 are rejected under 35 U.S.C. 103 as being unpatentable over Mizuguchi et al. (JP 2012246228 A, 12/13/2012) (Of Record) as evidenced by Doern (Clinical Infectious Diseases, 01/01/2000) (Of Record) and further in view of Chalker et al. (WO 2020039213 A1, 02/27/2020) (Of Record).
The teachings of Mizuguchi et al. are discussed above.
Regarding claim 40, Mizuguchi et al. do not disclose wherein the second salt comprises sodium chloride.
However, Chalker et al. disclose a charcoal-free solid agar medium for culturing Legionella (Abstract). The medium for culturing Legionella consisting of horse serum at 100 g/L, yeast extract at 10 g/L, ACES buffer at ~3.6 g/L, ferric pyrophosphate at 0.25 g/L, alpha-ketoglutarate at 1 g/L, L-cysteine 40 g/L and agar 10 g/L (Table 1). In a preferable embodiment, the charcoal-free solid agar medium comprises a concentration of a sodium-containing salt (Page 15, Paragraph 7). Further, in a preferable embodiment, a sodium-containing salt is sodium chloride (Page 18, Paragraph 10).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used sodium chloride as the buffer in the composition of Mizuguchi et al. as it is a known and effective salt used in media for growing Legionella as taught by Chalker et al. who utilize sodium chloride as the salt in their media for growing Legionella.
Response to Arguments
Applicant's arguments filed 01/16/2026 with the Request for Continued Examination have been fully considered but they are not persuasive.
Applicant states on Page 6 the claimed property possessed by the claimed medium is not present in the prior art medium of Mizuguchi et al. as alleged by the Examiner as shown in the Rule 132 Declaration by Inventor Dr. Monique Louise van Hoek.
Regarding the Declaration under 37 C.F.R. 1.132, it is the Examiner’s position that the Declaration does not show the medium disclosed by Mizuguchi et al. does not allow the growth of one or more Francisella species. It is the Examiner’s position that the Declaration shows the medium disclosed by Mizuguchi et al. does grow at least one Francisella species. The color copy of Figure 2 presented to the Examiner as part of the interview agenda that took place on 01/15/2026 is pasted below for reference because it is hard to differentiate between the different strains in the black and white version of Figure 2.
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According to Figure 2, the brown line showing the growth of FTN U112 on Mizuguchi media indicates FTN U112, a species of Francisella, does in fact grow on Mizuguchi media. While Francisella may not grow as well, meaning as rapidly, on Mizuguchi media as it does on FIRE media, some growth is still growth and reads on instant claim 1 which simply requires the growth medium to allow growth of one or more Francisella species. Thus, Mizuguchi et al. still anticipate the instant claims as set forth above.
Applicant further argued α-ketoglutarate is a non-fermentable carbon source on Page 7.
The Examiner respectfully disagrees. Arguments presented by the Applicant cannot take the place of factually supported objective evidence. See MPEP § 2145. It is the Examiner’s position that α-ketoglutarate, also known as 2-oxoglutaric acid (the carbon source disclosed by Mizuguchi et al.), is a microbial fermentable carbon source as evidenced by Zhang et al. Zhang et al. disclose Saccharomyces cerevisiae, reading on a microbe, can grow using α-ketoglutarate as the sole carbon source (Page 3, Paragraph 4).
The remainder of Applicant’s arguments restate that Mizuguchi et al. do not disclose all of the limitations of instant claim 1 and the secondary references do not fill in the gaps of the primary reference.
The Examiner respectfully disagrees. It is the Examiner’s position that Mizuguchi et al. do teach all of the limitations of instant claim 1 and all utilized secondary references teach the limitations they are cited to address.
Conclusion
Claims 1-2, 4-5, 8, 10-11, 13, 20, 23-25 and 37-44 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY T WHITE whose telephone number is (571)272-0683. The examiner can normally be reached Monday - Friday 8:30 - 5:00 EST.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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