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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07-07-2026 has been entered.
Applicant’s amendment to the claims and arguments filed on 07-07-2026 has been entered. Claims 1, 7, 27, 28, 29 have been amended. Claims 2-3, 8, 13, 16, 23-24 have been canceled. Claim 30 has been added. Claims 1, 4-7, 9-12, 14-15, 17-22, 25-30 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-2, 4-7, and 9) in the reply filed on 05-15-2024 is acknowledged.
Claims 10-12, 14-15, 17-22 and 25-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05-15-2024.
Claims 1, 4-7, 9, 27-30 are under consideration.
Priority
This application is a 371 of PCT/IB2019/059664 filed on 11/11/2019 which claim priority from foreign application INDIA 201841042227 filed on 11/09/2018. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
New-Claim Rejections - 35 USC § 112- necessitated by amendments
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 1, 4-7, 9, 27-29 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.
The base claims 1, 27, 28, and 29 recite the phrase “configured to be inoculated with and support cultivation of one or more microorganisms selected from the group consisting of methanotrophs and methylotrophs” which is vague and renders the claims indefinite. The phrase “configured to be inoculated with and support cultivation of one or more microorganisms selected from the group consisting of methanotrophs and methylotrophs” defines the claimed growth media composition by an alleged capability or intended result rather than by clearly identified structural or compositional characteristics. The instant specification does not teach or define the claimed phrase “configured to be inoculated with and support cultivation of one or more microorganisms selected from the group consisting of methanotrophs and methylotrophs” in terms of a particular structural or compositional characteristic of the claimed composition. For example, the claims do not identify what characteristics, other than the expressly recited chemical components and properties, establish that the composition is “ configured to” support cultivation, nor does it specify a criterion or condition by which such capability is determined. The instant specification instead describes inoculation and cultivation as steps performed in method employing the growth media composition. In particular, the instant specification states that the method comprises culturing a microorganism in the growth media composition with the microorganism, followed by gaseous substrate and oxygen (See page 13, lines 15-27 of the instant specification).
Thus, it is unclear what composition falling within the recited compositional limitations would, and would not, satisfy the requirement of being “configured to be inoculated with and support cultivation of one or more microorganisms selected from the group consisting of methanotrophs and methylotrophs”. The metes and bounds of this functional limitation therefore cannot be determined with reasonable certainty from the claim language and the specification.
The base claim 27 recites the phrase “devoid of a yeast fermentation product” which is vague and renders the claims indefinite. For example, the instant specification does not define the term “a yeast fermentation product”, and there is no guidance/step provided for adding or removing or avoiding yeast fermentation products in the instant disclosure. Does the phrase “devoid of a yeast fermentation product” mean any and all possible yeast fermentation products are excluded from the claim, or does it refer to a single yeast fermentation product or subset of yeast fermentation products that are intended to be excluded from the claim? If the latter, which one(s) are referred to by the phrase? It is further unclear if the term “a yeast fermentation product” can include any incidental byproduct of any type of yeast fermentation. This latter interpretation may include a very large genus of things being excluded from the claim scope, even though the instant specification does not have teachings of excluding any and all fermentation products. This is also in contrast to the instant disclosure and claims, which recite components that might reasonably be considered as ‘fermentation products’. For example, the cited claims recite NH3 (Ammonia) as a potential nitrogen source (e.g., claim 1, lines 9-10; etc.). It is well-known in the art that ammonia (NH3) is frequently generated during fermentation by microorganisms such as yeast, particularly through the degradation of nitrogen-rich compounds. It is a common by product of protein fermentation, often produced by microorganisms such as fungi via deamination of amino acids or urea breakdown. Another example of a well-known fermentation product is methanol which can be generated during fermentation by yeast, particularly in fruit-based fermentations under anaerobic conditions. Thus, it is unclear what fermentation products are necessarily included or necessarily excluded from the scope of the claims as currently written.
Claims 4-7, 9 are included in the rejection because they directly or indirectly depend from base claim. Appropriate correction is required.
Maintained in modified form-Claim Rejections - 35 USC § 112- necessitated by amendments
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.
Claim 27 remains rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
In the instant case, the recitation of the phrase “devoid of a yeast fermentation product” in the base claim 27 is considered new matter. Applicant does not explicitly point to any particular portion of the disclosure for specific support for the claimed amendment. Upon further review of the original disclosure, the examiner could not find explicit or implicit support for the recited limitations. Thus, there is no apparent explicit or implicit support for the limitation of “devoid of a yeast fermentation product” as recited in the amended claims. For example, there are no teachings/guidance in the instant disclosure for the term “yeast fermentation product”. There is no guidance/step for adding or removing or avoiding fermentation product for preparation of medium composition in the instant disclosure. The specification of the claimed invention only teaches “increase the biomass concentration during fermentation and thereby causing increased fermentation products.” (page 1, lines 20-22). Thus, there is no guidance that there is no yeast fermentation product added, and there is no guidance regarding what that yeast fermentation product encompasses. Therefore, before the effective filing date of the claimed invention, a skilled artisan would not have recognized from the original disclosure that Applicant was in possession of embodiments of the claimed compositions that are “devoid of a yeast fermentation product”, as claimed. In case applicants have evidence to support otherwise, applicants are invited to indicate page and line number for the written support specifically for said limitations. MPEP 2163 .06 notes "If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph-written description requirement". In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981)". Claims 4-7, and 9 depend directly or indirectly from a rejected base claim. This is a new matter rejection.
Response to Arguments
Applicant's arguments filed 07-07-2026 have been fully considered but they are not persuasive.
Applicant argue that:
Claim 27 has now been amended to clarify that the "fermentation product" that is recited to be excluded from the growth media composition excludes "yeast fermentation product." When the claim is read in light of the specification and prosecution history, a person of ordinary skill in the art would readily understand with reasonable certainty that the claimed composition does not include any material obtained as a result of yeast fermentation, including harvested fermentation broth, microbial biomass, fermentation supernatant, residual growth by-products, biosurfactants or other microorganism-derived fermentation products. Hence, the amendment in the claim language renders moot the objection raised in this regard. (Remarks, page 14).
Response to Arguments:
As explained above, upon further review of the original disclosure, the examiner could not find explicit or implicit support for the recited limitations of “devoid of a yeast fermentation product” as recited in the amended claims. For example, there are no teachings/guidance in the instant disclosure for the term “yeast fermentation product”. There is no guidance/step for adding or removing or avoiding fermentation product for preparation of medium composition in the instant disclosure. The specification of the claimed invention only teaches “increase the biomass concentration during fermentation and thereby causing increased fermentation products.” (page 1, lines 20-22). However, there is no guidance what fermentation products can be included or excluded. There are several fermentation products of different microorganisms that overlap with yeast fermentation products. For example, the cited claims recite NH3 (Ammonia) as a potential nitrogen source (e.g., claim 1, lines 9-10; etc.). It is well-known in the art that ammonia (NH3) is frequently generated during fermentation by microorganisms such as yeast, particularly through the degradation of nitrogen-rich compounds. It is a common by product of protein fermentation, often produced by microorganisms such as fungi via deamination of amino acids or urea breakdown. Another example of a well-known fermentation product is methanol which can be generated during fermentation by yeast, particularly in fruit-based fermentations under anaerobic conditions. Thus, there is no guidance that there is no yeast fermentation product added, and there is no guidance regarding what that yeast fermentation product encompasses. Therefore, before the effective filing date of the claimed invention, a skilled artisan would not have recognized from the original disclosure that Applicant was in possession of embodiments of the claimed compositions that are “devoid of a yeast fermentation product”, as claimed.
New-Claim Rejections - 35 USC § 102/103- necessitated by amendments
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 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.
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.
Claim 1, 5, 9 and 30 are rejected under 35 U.S.C. 102 (a)(2)/ 35 U.S.C. 103 as being anticipated/ unpatentable by Farmer et al (Pub. No .: US 2021/0400963 A1, Provisional application No. 62/738,504 , filed on Sep. 28, 2018 .)
Claim interpretation:
As described in the 35 U.S.C. 112(b) rejection, the phrase “configured to be inoculated with and support cultivation of one or more microorganisms selected from the group consisting of methanotrophs and methylotrophs” is unclear in term of what structural and compositional characteristics are intended for the claimed composition. Thus, the phrase “configured to be inoculated with and support cultivation of one or more microorganisms selected from the group consisting of methanotrophs and methylotrophs” is interpreted as intended use: A 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.
According to the specification of the claimed invention, the nitrogen containing source selected from a group comprising HNO3, NH3 and a combination thereof, phosphate containing source selected from a group comprising H3PO4, KH2PO4 and a combination thereof) and sulphate containing source H2SO4 KHSO4) and a combination thereof in the growth media composition enable the composition to be self-sterilized. Further, presence of HNO3, H2SO4/KHSO4 and H3PO4/ KH2PO4 in the growth media composition makes the media homogenous and brings the pH less than 3, preferably pH of about 2.5, wherein the contaminants cannot survive (see page 5, lines 23-31 of the specification of the claimed invention). Therefore, being self-sterilized is interpreted to have the presence of HNO3, H2SO4/KHSO4 and H3PO4/ KH2PO4 to make the media homogenous and brings the pH less than 3, wherein the contaminants cannot survive.
According to the specification of the claimed invention, the microelement is selected from a group comprising MgSO4.7H2O, CaCl2.2H2O and a combination thereof (page 2, lines 1-2). Thus, MgSO4.7H2O, CaCl2.2H2O are interpreted as microelement.
According to the specification of the claimed invention, the trace element is selected from a group comprising FeNa-EDTA, NaMoO4.2H2O, FeSO4.7H2O, ZnSO4.7H2O, H3BO3, CoCl2.6H2O, 5 Na2-EDTA Dihydrate, MnCl2.4H2O, NiCl2.6H2O, CuSO4.5H2O and a combination thereof. Thus, FeNa-EDTA, NaMoO4.2H2O, FeSO4.7H2O, ZnSO4.7H2O, H3BO3, CoCl2.6H2O, 5 Na2-EDTA Dihydrate, MnCl2.4H2O, NiCl2.6H2O, CuSO4.5H2O are interpreted as trace elements.
The specification of the claimed invention teaches “the growth media composition is a homogenous mixture” (Page 6, lines 7-8); however, the instant disclosure does not define what degree of being homogenous can be accepted as being “homogenous”. Since growth media composition can be mixed at a certain degree, media composition being in a mixture is interpreted broadly as “homogenous” at a certain degree.
Regarding to claim 1 and claim 30, Farmer et al teach nutrient medium for microbial growth, and typically, the nutrient medium includes a carbon source, a nitrogen source, salts and appropriate additional nutrients and microelements. The pH and oxygen levels are maintained at values suitable for a given microorganism ([0008], page 1) (For the preamble).
Farmer et al teach inorganic nutrients, including trace elements such as iron, zinc, copper, manganese, molybdenum and/or cobalt may also be included in the medium. Furthermore, sources of vitamins, essential amino acids, proteins and microelements can be included ([0074], page 6). One or more inorganic salts may also be included in the liquid growth medium. Inorganic salts can include, for example magnesium sulfate (MgSO4), calcium chloride (CaCl2), zinc sulfate (ZnSO4), manganese chloride (MnCl2), copper sulfate (CuSO4) etc. ([0073], page 6) (For the claimed: comprising microelement and trace element)
Farmer et al teach the liquid growth medium comprises a nitrogen source. The nitrogen source can be, for example, potassium nitrate, ammonium nitrate, etc. ([0072], page 6). Nitric acid (HNO3) can also be added ([0119], page 8) (For the claimed: nitrogen containing source selected from a group comprising HNO3 and NH3).
Farmer et al teach phosphate containing source: potassium dihydrogen phosphate, monopotassium phosphate, dipotassium hydrogen phosphate, disodium hydrogen phosphate ([0073], page 6). Phosphoric (H3PO4) and phosphorous acids or their salts may also be used ([0118], page 8) (For the claimed: phosphate containing source selected from a group comprising H3PO4 and KH2PO4 ).
Farmer et al teach sulphate containing source: magnesium sulfate, iron sulfate, manganese sulfate, zinc sulfate, copper sulfate, etc. ([0073], page 6). Sulfuric acid (H2SO4) can also be added ([0119], page 8) (For the claimed: sulphate containing source selected from a group comprising H2SO4 and KHSO4).
Farmer et al teach the pH of the culture should be suitable for the microorganism of interest. In some embodiments, the pH is about 2.0 to about 5.0 ([0086], page 6). In other embodiments, the medium may be pasteurized or, optionally, no heat at all added, where the use of pH and/or low water activity may be exploited to control unwanted microbial growth ([0080], page 6). In other embodiments, the cultivation system may be self-sterilizing, meaning the organism being cultivated is capable of preventing contamination from other organisms due to production of antimicrobial growth by-products (e.g., biosurfactants) ([0085], page 6) (For the claimed: wherein the growth media composition has pH of less than 3 and wherein the growth media composition is self-sterilized).
Farmer et al teach the use of reactor comprises a mixing apparatus for continuous agitation and mixing of the culture ([0150], page 10). Thus, the liquid growth medium composition is inherently well mixed and homogenous. Additionally, Farmer et al teach “These nitrogen sources may be used independently or in a combination of two or more” ([0072], page 6) and “These inorganic salts may be used independently or in a combination of two or more” ([0072], page 6). Since Farmer et al teach combining and mixing different medium composition which is well-known technique in the art, a person of ordinary skill in the art would be able to combine and mix different medium composition to have a growth media composition with certain degree of being homogenous. Moreover, Farmer et al teach “the composition can be mixed in with standard feed components and formulated into uniform, homogenized pellets. The supplemented feed pellet can comprise consistent concentrations of the microbe-based composition per pellet.” ([0163], page 11). Thus, uniform, homogenized pellets with consistent concentrations of the microbe-based composition are also liquid composition with certain degree of being homogenous (uniform, homogenized). (For the claimed: wherein the growth media composition is homogenous).
Farmer et al teach “The medium can include nutrient sources, for example, a protein source, a carbon source, a lipid source, a nitrogen source, and/or a source of other nutrients, such as micronutrients. Each of these nutrient sources can be provided in an individual package that can be added to the reactor at appropriate times during the fermentation process. Each of the packages can include several sub-packages that can be added at specific points (e.g., when yeast, pH, and/or nutrient levels go above or below a specific concentration) or times (e.g., after 10 hours, 20 hours, 30 hours, 40 hours, etc.) during the fermentation process” ([0148], page 10, Example 1). Thus, Farmer et al teach embodiments where a nutrient source such as a carbon source can be absent at specific points or times and can be added to the reactor at appropriate times during the fermentation process. (For the claimed: devoid of a carbon source)
In view of foregoing, it is apparent that the prior art taught medium composition as same as the claimed composition. Thus, it is expected that the medium composition as taught by Farmer et al can support cultivation of methanotrophs and/or methylotrophs. It is noted that, for composition of matter claims, if the composition is physically the same, it must have the same properties. When the structure taught by the reference is identical or substantially identical to that of the claims, the claimed properties or functions are presumed to be inherent. Similarly, for product-by-process claims, determination of patentability is based on the product itself. “The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” see MPEP 2112.01(I), 2113(I), see MPEP 2112.01 and 2112.02.
Regarding to claim 5, Farmer et al teach the liquid growth medium comprises a nitrogen source. The nitrogen source can be, for example, potassium nitrate ([0072], page 6). Farmer et al teach phosphate containing source: potassium dihydrogen phosphate, monopotassium phosphate, dipotassium hydrogen phosphate, disodium hydrogen phosphate ([0073], page 6). Farmer et al teach sulphate containing source: magnesium sulfate, iron sulfate, manganese sulfate, zinc sulfate, copper sulfate, etc. ([0073], page 6).
Regarding to claim 9, Farmer et al teach the cultivation method utilizes submerged fermentation in a liquid growth medium. The culture medium can be formulated for enhanced biosurfactant production ([0070], page 5). Farmer et al teach inorganic nutrients, including trace elements such as iron, zinc, copper, manganese, molybdenum and/or cobalt may also be included in the medium. Furthermore, sources of vitamins, essential amino acids, proteins and microelements can be included ([0074], page 6). Farmer et al teach the liquid growth medium comprises a nitrogen source. The nitrogen source can be, for example, potassium nitrate, ammonium nitrate, etc. ([0072], page 6). Nitric acid (HNO3) can also be added ([0119], page 8). Farmer et al teach phosphate containing source: potassium dihydrogen phosphate, monopotassium phosphate, dipotassium hydrogen phosphate, disodium hydrogen phosphate ([0073], page 6). Phosphoric (H3PO4) and phosphorous acids or their salts may also be used ([0118], page 8). Farmer et al teach sulphate containing source: magnesium sulfate, iron sulfate, manganese sulfate, zinc sulfate, copper sulfate, etc. ([0073], page 6). Sulfuric acid (H2SO4) can also be added ([0119], page 8).
Thus, it is concluded that:
Claims 1, 5, 9 and 30 are being anticipated by Farmer et al under 35 U.S.C. 102 (a)(2).
In an event that the claimed subject matter is not considered to be anticipated by Farmer et al, claim 1, 5, 9 and 30 are nevertheless unpatentable under 35 U.S.C. 103 because Farmer et al teach the same or substantially the same growth media composition having the claimed microelements, trace elements, nitrogen-containing source, phosphate containing source, and sulphate-containing source, as well as the claimed properties of being homogeneous, pH< 3 and self-sterilized, and teach the use of growth media for cultivation of microorganism as described above. Accordingly, any differences between the claimed subject matter and the growth media composition taught by Farmer et al would have been within the level of a person having ordinary skill in the art before effective filing date of the claimed invention. One of ordinary skill in the art would have been motivated to combine teachings of Farmer et al to arrive at the claimed invention because Farmer et al teach “the system is provided with a culture medium. The medium can include nutrient sources, for example, a protein source, a carbon source, a lipid source, a nitrogen source, and/or a source of other nutrients, such as micronutrients. Each of these nutrient sources can be provided in an individual package that can be added to the reactor at appropriate times during the fermentation process. Each of the packages can include several sub-packages that can be added at specific points (e.g, when yeast, pH, and/or nutrient levels go above or below a specific concentration) or times (e.g., after 10 hours, 20 hours, 30 hours, 40 hours, etc.) during the fermentation process” ([0148], page 10, Example 1).
Maintained in modified form-Claim Rejections - 35 USC § 103- necessitated by amendments
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 4, 6-7, 27, 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Farmer et al (Pub. No .: US 2021/0400963 A1, Provisional application No. 62/738,504 , filed on Sep. 28, 2018 .) in view of Lessard et al (Pub. No.: US 2005/0227356A1, Pub. Date: Oct. 13, 2005) as evidenced by Miyaji (Methods in Enzymology, Volume 495, 2011, Pages 211-225, Chapter 14, ISSN 0076-6879, DOI: 10.1016/B978-0-12-386905-0.00014-0) and as evidenced by Sikora et al (J. Microbiol. Biotechnol. (2011), 21(3), 305–316, doi: 10.4014/jmb.1006.06022)
The teachings of Farmer et al above are incorporated herein in their entirety.
Farmer et al teach one or more inorganic salts may also be included in the liquid growth medium. Inorganic salts can include ([0073], page 6). Farmer et al teach chelating agents (e.g., EDTA, citric acid, sodium citrate), fracking sand and beads, emulsifiers, surfactants, and other materials known in the art ([0194], Page 13). Nitric acid (HNO3) and Sulfuric acid (H2SO4) can also be added ([0119], page 8), Phosphoric (H3PO4) and phosphorous acids or their salts may also be used ([0118], page 8)
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Farmer et al do not teach NaMoO4.2H2O, H3BO3, CoCl2.6H2O, NiCl2.6H2O and concentrations of the recited one or more micro elements or trace elements. Lessard et al cure the deficiency.
Regarding to claims 4 and 29, Lessard et al teach defined medium with NaMoO4.2H2O, H3BO3, CoCl2.6H2O, NiCl2.6H2O ([0194], page 21, see below). For example:
Lessard et al teach 1g MgSO4.7H2O per liter ([0194], page 21). Therefore, MgSO4.7H2O is in an amount of 0.1% (w/v).
Lessard et al teach 1 ml A9 per liter trace elements solution containing
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0.5g FeSO4.7H2O per liter = 0.0005g/ 1000ml =0.00005% (w/v).
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Therefore, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the rejected claims to combine the teachings of prior art to modify the growth media composition of Farmer et al by using NaMoO4.2H2O, H3BO3, CoCl2.6H2O, NiCl2.6H2O as taught by Lessard et al as instantly claimed, with a reasonable expectation of success. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to do so because Lessard et al teach that secretion of desired proteins into the growth media has the advantages of simplified and less costly purification procedures ([0132], page 13), and continuous or semi-continuous culture allows for the modulation of one factor or any number of factors that affect cell growth or end product concentration ([0137], page 14). One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Lessard et al were successful in producing metabolite product from bacterial culture with working examples, data and instructions.
Regarding to claim 6, the dilution of inorganic salts and solutions is considered as a routine experimentation process. One skilled in the art would be able to prepare, dilute and mix with other components from stock solution for making working solution with optimization of appropriate concentration for making the media. For example, Farmer et al teach “the medium can include nutrient sources, for example, a protein source, a carbon source, a lipid source, a nitrogen source, and/or a source of other nutrients, such as micronutrients. Each of these nutrient sources can be provided in an individual package that can be added to the reactor at appropriate times during the fermentation process. Each of the packages can include several sub-packages that can be added at specific points (e.g, when yeast, pH, and/or nutrient levels go above or below a specific concentration) or times (e.g., after 10 hours, 20 hours, 30 hours, 40 hours, etc.) during the fermentation process ([0148], page 8). Farmer et al teach that the characteristics and formulation, e.g., nutrients, carriers, additives, and/or yeast cell concentration, of the yeast fermentation product can be optimized depending upon the desired application ([0109], page 8).
Also, Lessard et al teach “Continuous or semi-continuous culture allows for the modulation of one factor or any number of factors that affect cell growth or end product concentration. ….. Methods of modulating nutrients and growth factors for continuous culture processes as well as techniques for maximizing the rate of product formation are well known in the art of industrial microbiology and a variety of methods are detailed by Brock, Supra”. For example, Lessard et al teach medium composition in [0194], page 21 (see above):
Thus, according to prior art, it is indicating that the nutrients concentrations/medium formulations were recognized in the prior art to be a result-effective variable. A person of ordinary skill in the art would have been motivated to perform the titration or dilution or concentration preparation a plurality of times out of the course of routine optimization, in order to improve application of media composition and increase biomass of microorganism.
Regarding to claim 7, as described above, Farmer et al teach “the pH of the culture should be suitable for the microorganism of interest. In some embodiments, the pH is about 2.0 to about 5.0” ([0086], page 6). Farmer et al teach that “in one embodiment, prior to inoculation , the components of the liquid culture medium can be no heat at all added, where the use of pH and/or low water activity may be exploited to control unwanted microbial growth” ([0080], page 6). Farmer et al teach the use of the reactor comprising a mixing apparatus for continuous agitation and mixing of the culture ([0150], page 10) (For the claimed: wherein the growth media composition is having pH of about 2.5; and the growth media composition is homogenous.)
In addition, Farmer et al teach the medium can include nutrient sources, for example, a protein source, a carbon source, a lipid source, a nitrogen source, and/or a source of other nutrients, such as micronutrients. Each of these nutrient sources can be provided in an individual package that can be added to the reactor at appropriate times during the fermentation process. Each of the packages can include several sub-packages that can be added at specific points during the fermentation process ([0148], page 10). Also, purity can be measured by any appropriate standard method, for example, by column chromatography, thin layer chromatography, or high-performance liquid chromatography (HPLC) analysis ([0041], page 3). Thus, measurement of w/w ratio of element such as elemental nitrogen to phosphate or elemental nitrogen to sulphate is considered as a routine experimentation process as evidenced by Miyaji who teach the use of atomic absorption spectroscopy (AAS) or inductive-coupled plasma atomic emission spectroscopy (ICP-AES) that can be used to accurately determine the amount of mineral salt in a solution (Page 214, 2nd para.). Also, as evidenced by Sikora et al who teach assay using the ferrozine colorimetric method and the absorbance at 562 nm with a calibration curve to determine Fe (II) in FeSO4 solution samples (Page 307, left column, 3rd para.). Therefore, the amount level of inorganic matter such as elemental nitrogen, phosphate, sulphate can be determined by routine experimentation and the ratio between these groups can be optimized to prepare optimal bacterial media for each bacterial strain (For the claimed: wherein ratio of elemental nitrogen to phosphate (w/w) is ranging from about 1:2 to 10: 1; ratio of elemental nitrogen to sulphate (w/w) is ranging from about 1: 1 to 10: 1).
Regarding claim 27, Farmer et al teach:
Farmer et al teach “In one embodiment, prior to inoculation of the system, the fermentation medium, air, and equipment can be sterilized or disinfected.” ([0079], page 6). Since the medium was generated prior to inoculation of the system, there was no cell in the medium; therefore, there is no fermentation product generate by the cell. Further, Farmer et al teach “In one embodiment, the liquid growth medium comprises a nitrogen source. The nitrogen source can be, for example, yeast extract, potassium nitrate, ammonium nitrate, ammonium sulfate, ammonium phosphate, ammonia, urea, and/or ammonium chloride. These nitrogen sources may be used independently or in a combination of two or more” ([0072], page 6). Thus, yeast fermentation product can be optionally included or excluded in the medium (For the claimed: devoid of a yeast fermentation product).
“The medium can include nutrient sources, for example, a protein source, a carbon source, a lipid source, a nitrogen source, and/or a source of other nutrients, such as micronutrients. Each of these nutrient sources can be provided in an individual package that can be added to the reactor at appropriate times during the fermentation process. Each of the packages can include several sub-packages that can be added at specific points (e.g, when yeast, pH, and/or nutrient levels go above or below a specific concentration) or times (e.g., after 10 hours, 20 hours, 30 hours, 40 hours, etc.) during the fermentation process” ([0148], page 10, Example 1). Thus, Farmer et al teach embodiments where a nutrient source such as a carbon source can be absent at specific points or times and can be added to the reactor at appropriate times during the fermentation process. (For the claimed: devoid of a carbon source)
Regarding claims 27, 28, 29 , as mentioned above in the claim interpretation, the phrase “configured to be inoculated with and support cultivation of one or more microorganisms selected from the group consisting of methanotrophs and methylotrophs” is interpreted as intended use: A 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. For example, see the above rejection of this claim under 35 U.S.C. 112(b) regarding this same limitation.
Response to Arguments
Applicant's arguments filed 07-07-2026 have been fully considered but they are not persuasive.
1. Applicant argue that:
“As explained in the December 2025 declaration, paragraphs [0117], [0118] and [0119] of Farmer describe the addition of ingredients to a fermentation product obtained after harvesting from the fermentation process. Such post-harvest ingredients are not components of Farmer's growth medium and cannot be equated with the claimed growth media composition. Farmer's post-harvest additives cannot be imported into Farmer's growth medium in order to meet the standard for anticipation, nor can they be combined with separate growth medium salt lists to reconstruct Applicant's claimed composition. A composition added to a harvested fermentation product is not transformed into a growth medium merely because some ingredients overlap ” (remark, page 17).
Response to Arguments:
First, as described above in Farmer et al teach one or more inorganic salts may also be included in the liquid growth medium. Inorganic salts can include, for example, Inorganic salts can include, for example, potassium dihydrogen phosphate (KH2PO4), monopotassium phosphate, dipotassium hydrogen phosphate, disodium hydrogen phosphate, potassium chloride, magnesium sulfate, magnesium chloride, iron sulfate, iron chloride, manganese sulfate, manganese chloride, zinc sulfate, lead chloride, copper sulfate, calcium chloride, calcium carbonate, calcium nitrate, magnesium sulfate, sodium phosphate, sodium chloride, and/or sodium carbonate. These inorganic salts may be used independently or in a combination of two or more ([0073], page 6). Farmer et al teach “In other embodiments, the medium may be pasteurized or, optionally, no heat at all added, where the use of pH and/or low water activity may be exploited to control unwanted microbial growth” ([0080], page 6). In a further embodiment, pH adjusting agents include potassium hydroxide, ammonium hydroxide, potassium carbonate or bicarbonate, hydrochloric acid, nitric acid, sulfuric acid or a mixture ([0119], page 8). It is noted that the chemicals required by the claims such as HNO3, NaNO3, NH3, H3PO4, H2SO4, KHSO4, KH2PO4 are present in the liquid media in form of ions: NO3-, SO42-, PO43-, K+, H+ that are all encompassed by the Farmer et al’s teaching [0073]: these salts can be in a combination of two or more in the medium, all of the ions for H3PO4 and KH2PO4, (H+, K+, PO43-) are all present the liquid growth medium which satisfy the requirement of the claims.
Second, it appears applicant argue the intended use of the medium carrying the fermentation product: applicant argue that the medium carrying the fermentation product in [0117], [0118] and [0119] not components of Farmer's growth medium because they are added after the harvest. It is noted that applicant haven’t provided any evidence that the medium carrying the fermentation product in [0117], [0118] and [0119] can’t support microorganism growth. Applicant haven’t provided any evidence that the medium carrying the fermentation product are without cells growth. Applicant’s arguments regarding intended use of “growth medium” is nevertheless not persuasive because a 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.
2. Applicant argue that:
Farmer does not inherently disclose a pH <3 self-sterilized growth media composition Applicants respectfully submit that Farmer's pH disclosure is not the same as the claimed pH/self-sterilization feature. The December 2025 Declaration explains that paragraph [0080] of Farmer refers to exploiting pH and/or low water activity for controlling unwanted microbial growth, whereas paragraph [0087] indicates that such pH is above 3, not below 3. The Declaration further explains that paragraph [0086] of Farmer relates to pH suitable for culturing microorganisms of interest, which in the case of Farmer, is yeast for producing sophorolipids (SLP). While said paragraph [0086] generically discloses that pH can be 2 to 5, this is a general non-specific embodiment without hinting at the organism to be cultured, for which this pH should be employed (Remarks page 18-19)
Response to Arguments:
Farmer et al explicitly teach a pH <3 self-sterilized growth media composition: Farmer et al teach “the pH of the culture should be suitable for the microorganism of interest. In some embodiments, the pH is about 2.0 to about 5.0” ([0086], page 6), and “In other embodiments, the medium may be pasteurized or, optionally, no heat at all added, where the use of pH and/or low water activity may be exploited to control unwanted microbial growth” ([0080], page 6), and “In other embodiments, the cultivation system may be self-sterilizing, meaning the organism being cultivated is capable of preventing contamination from other organisms due to production of antimicrobial growth by-products (e.g., biosurfactants)” ([0085], page 6).
3. Applicant argue that:
Farmer does not disclose the claimed homogeneous media composition: Applicants respectfully disagree that Farmer's reactor agitation or homogenized feed pellets disclose, teach, or inherently produce the claimed homogeneous growth media composition. The Examiner's reliance on mixing, agitation, or homogenization in Farmer is insufficient. Farmer's homogenized pellets are also not the claimed liquid growth media composition; they are feed formulations containing microbe-based compositions. A disclosure that a reactor may be mixed or that a product formulation may be homogenized is not a disclosure that the claimed growth media composition itself is homogeneous (Remarks page 19-20)
Response to Arguments:
It is noted that the instant specification teach “stirred for about 10minutes to obtain a homogenous solution (see page 8, line 1).
Farmer et al explicitly teach the use of reactor comprises a mixing apparatus for continuous agitation and mixing of the culture ([0150], page 10). Thus, the liquid growth medium composition is inherently well mixed and homogenous. Additionally, Farmer et al teach “These nitrogen sources may be used independently or in a combination of two or more” ([0072], page 6) and “These inorganic salts may be used independently or in a combination of two or more” ([0072], page 6). Since Farmer et al teach combining and mixing different medium composition which is well-known technique in the art, a person of ordinary skill in the art would be able to combine and mix different medium composition to have a growth media composition with certain degree of being homogenous. Moreover, Farmer et al teach “the composition can be mixed in with standard feed components and formulated into uniform, homogenized pellets. The supplemented feed pellet can comprise consistent concentrations of the microbe-based composition per pellet.” ([0163], page 11). Thus, uniform, homogenized pellets with consistent concentrations of the microbe-based composition are also liquid composition with certain degree of being homogenous (uniform, homogenized). (For the claimed: wherein the growth media composition is homogenous).
4. Applicant argue that:
Farmer's growth medium mandates presence of carbon source and is materially different from the claimed methanotroph/methylotroph media system
The December 2025 Declaration explains that paragraph [0071] of Farmer emphasizes that Farmer's liquid growth medium comprises a carbon source, which is vital for growth of yeast/fungi. By contrast, Applicant's claimed growth media composition per se does not include a carbon source; this distinction is reflected explicitly in pending claims 1 and 27 and implicitly in pending claims 28-30. The present specification further makes it clear that Cl substrate is supplied separately to the reactor, for example by sparging methane or methanol.
While paragraph [0071] is merely "one embodiment" of Farmer, when read in the context of the whole document, it is clear that the carbon source is mandatory for liquid growth media of Farmer, as the whole document focuses on production of SLP through yeast, which cannot take place without presence of carbon source as such in the yeast growth media. This position is further crystallized when read with paragraphs [0019] and [0020], where again importance of production of SLP by yeast and presence of carbon source in the growth media composition is emphasized (Remarks page 20-21).
Response to Arguments:
As applicant admitted [0071] of Farmer et al teach embodiment where liquid growth medium is devoid of a carbon source.
Additionally, Farmer et al teach “The medium can include nutrient sources, for example, a protein source, a carbon source, a lipid source, a nitrogen source, and/or a source of other nutrients, such as micronutrients. Each of these nutrient sources can be provided in an individual package that can be added to the reactor at appropriate times during the fermentation process. Each of the packages can include several sub-packages that can be added at specific points (e.g, when yeast, pH, and/or nutrient levels go above or below a specific concentration) or times (e.g., after 10 hours, 20 hours, 30 hours, 40 hours, etc.) during the fermentation process” ([0148], page 10, Example 1). Thus, Farmer et al teach embodiments where a nutrient source such as a carbon source can be absent at specific points or times and can be added to the reactor at appropriate times during the fermentation process. (For the claimed: devoid of a carbon source)
5. Applicant argue that:
Applicants further traverse the Examiner's position that the mere presence of ions, such as NH4+, NO3-, H+, Na+, K+, PO43-, and SO42-, in solution satisfies the claimed recitation of HNO3, NaNO3, NH3, H2SO4, KHSO4, H3PO4, and KH2PO4. The Final Rejection relies on Farmer's inorganic salt list and concludes that all ions corresponding to the claimed compounds are present together in solution. This approach improperly converts generic nutrient salts into the specific selected acid/nutrient sources of the claimed composition.
“The availability of nutrient ions to microorganisms is strongly influenced by the chemical source from which they are supplied. Soluble salts, such as calcium chloride (CaCl2), phosphoric acid (H3PO4), ferrous sulfate (FeSO4), zinc sulfate (ZnSO4), and magnesium sulfate (MgSO4), dissociate readily in aqueous systems and predominantly exist as dissolved ionic species, thereby increasing their immediate bioavailability. In solution, calcium exists primarily as (Ca2+), phosphorus mainly as orthophosphate species, such as (H2PO4-) and (HPO42-) iron as (Fe2+) (with potential oxidation to (Fe3+) under aerobic conditions), zinc as (Zn2+), and magnesium as (Mg2+). These soluble forms are generally more accessible for microbial uptake and metabolic processes.” (Remarks page 21-22)
Response to Arguments:
The claims require a growth media composition comprising HNO3, NaNO3, NH3, H2SO4, KHSO4, H3PO4, and KH2PO4. Applicants haven’t provided evidence for these solutions cannot exist as NH4+, NO3-, H+, Na+, K+, PO43-, and SO42-, in solution. Applicants haven’t provided evidence for what form HNO3, NaNO3, NH3, H2SO4, KHSO4, H3PO4, and KH2PO4 would exist in solutions. The chemicals required by the claims such as HNO3, NaNO3, NH3, H3PO4, H2SO4, KHSO4, KH2PO4 are present in the liquid media in form of ions: NO3-, SO42-, PO43-, K+, H+ that are all encompassed by the Farmer et al’s teaching such as in [0073]: these salts can be in a combination of two or more in the medium, all of the ions for H3PO4 and KH2PO4, (H+, K+, PO43-) are all present the liquid growth medium which satisfy the requirement of the claims.
It appears applicant also admitted that soluble salts would exist in solutions as ions in solution (see Remarks page 21-22) : “Soluble salts, such as calcium chloride (CaCl2), phosphoric acid (H3PO4), ferrous sulfate (FeSO4), zinc sulfate (ZnSO4), and magnesium sulfate (MgSO4), dissociate readily in aqueous systems and predominantly exist as dissolved ionic species, thereby increasing their immediate bioavailability”
6. Applicant argue that:
“Response to Examiner's Position Regarding the Claimed Growth Medium Composition: The rejection improperly treats Farmer's disclosure of various nutrient sources as a teaching of the presently claimed medium. Farmer merely identifies broad classes of nutrients that may be used in fermentation media and provides extensive lists of alternative nitrogen, phosphate and sulphur sources. Such a disclosure does not constitute a teaching or suggestion of the specific combination now claimed. In fact, Farmer does not provide any concentration for salts and other media components, to enable a person skilled in the art to arrive at a workable media composition, without extensive experimentation”
“Response to examiner's position that farmer's medium would inherently possess the claimed characteristics …..Farmer presents a broad genus of media formulations suitable for a variety of microorganisms and fermentation processes. Countless embodiments encompassed by Farmer would not result in the claimed acidic and self-sterilizing composition. Consequently, Farmer does not inherently disclose the claimed properties”
“Response to Examiner's Position Regarding Homogeneity …. the Examiner has not identified a reason why a person of ordinary skill would have modified Farmer's fermentation-product system to arrive at Applicant's claimed growth media composition, much less with a reasonable expectation of achieving homogeneity, pH less than 3, self-sterilization and absence of fermentation products. Nonetheless, homogeneity alone is also not the invention. The invention achieves:
• homogeneity,
• self-sterilization,
• AND sustained high biomass.”
(Remarks page 23-25)
Response to Arguments:
It is noted that the base claims recites nutrient sources without any concentrations. Additionally, Farmer et al teach optimization for nutrient sources: “The characteristics and formulation, e.g., nutrients, carriers, additives, and/or yeast cell concentration, of the yeast fermentation product can be optimized depending upon the desired application” ([0109], page 8) and “The medium can include nutrient sources, for example, a protein source, a carbon source, a lipid source, a nitrogen source, and/or a source of other nutrients, such as micronutrients. Each of these nutrient sources can be provided in an individual package that can be added to the reactor at appropriate times during the fermentation process. Each of the packages can include several sub-packages that can be added at specific points (e.g, when yeast, pH, and/or nutrient levels go above or below a specific concentration) or times (e.g., after 10 hours, 20 hours, 30 hours, 40 hours, etc.) during the fermentation process” ([0148], page 10, example 1).
Farmer et al teach in [0073] page 6 “in one embodiment, one or more inorganic salts may also be included in the liquid growth medium. Inorganic salts can include, for example, potassium dihydrogen phosphate, monopotassium phosphate….. These inorganic salts may be used independently or in a combination of two or more”. Thus, Farmer et al teach all of the ions recited in the claims together: NH4+, NO3-, H+, Na+, K+, PO43-, SO42--, which satisfy the claims because it clearly that the chemicals recited in the claims HNO3, NaNO3, NH3, H2SO4, KHSO4, H3PO4 and KH2PO4 would have to exist in solution as NH4+, NO3-, H+, Na+, K+, PO43-, SO42-. Thus, Farmer et al teach embodiments that all those chemicals in [0073] can exist in solutions together which are inherently in form of NH4+, NO3-, H+, Na+, K+, PO43-, SO42-.
As described above, Farmer et al teach all the structural limitations for a medium being homogenous, pH less than 3, self-sterilization and absence of a carbon source required by the claims:
The specification of the claimed invention teaches “the growth media composition is a homogenous mixture” (Page 6, lines 7-8); however, the instant disclosure does not define what degree of being homogenous can be accepted as being “homogenous”. Since growth media composition can be mixed, media composition being in a mixture is interpreted broadly as “homogenous” at a certain degree. Farmer et al teach the use of reactor comprises a mixing apparatus for continuous agitation and mixing of the culture ([0150], page 10). Farmer et al teach the use of reactor comprises a mixing apparatus for continuous agitation and mixing of the culture ([0150], page 10). Thus, the liquid growth medium composition in the reactor is inherently well mixed and homogenous at a certain degree.. Additionally, Farmer et al teach “These nitrogen sources may be used independently or in a combination of two or more” ([0072], page 6) and “These inorganic salts may be used independently or in a combination of two or more” ([0072], page 6). Since Farmer et al teach combining and mixing different medium composition which is well-known technique in the art, a person of ordinary skill in the art would be able to combine and mix different medium composition to have a growth media composition with certain degree of being homogenous. Moreover, Farmer et al teach “the composition can be mixed in with standard feed components and formulated into uniform, homogenized pellets. The supplemented feed pellet can comprise consistent concentrations of the microbe-based composition per pellet.” ([0163], page 11). Thus, uniform, homogenized pellets with consistent concentrations of the microbe-based composition are also liquid composition with certain degree of being homogenous (uniform, homogenized).
Farmer et al teach the pH of the culture should be suitable for the microorganism of interest. In some embodiments, the pH is about 2.0 to about 5.0 ([0086], page 6). In other embodiments, the medium may be pasteurized or, optionally, no heat at all added, where the use of pH and/or low water activity may be exploited to control unwanted microbial growth ([0080], page 6). In other embodiments, the cultivation system may be self-sterilizing, meaning the organism being cultivated is capable of preventing contamination from other organisms due to production of antimicrobial growth by-products (e.g., biosurfactants) ([0085], page 6).
Farmer et al teach “The medium can include nutrient sources, for example, a protein source, a carbon source, a lipid source, a nitrogen source, and/or a source of other nutrients, such as micronutrients. Each of these nutrient sources can be provided in an individual package that can be added to the reactor at appropriate times during the fermentation process. Each of the packages can include several sub-packages that can be added at specific points (e.g., when yeast, pH, and/or nutrient levels go above or below a specific concentration) or times (e.g., after 10 hours, 20 hours, 30 hours, 40 hours, etc.) during the fermentation process” ([0148], page 10, Example 1). Thus, Farmer et al teach embodiments where a nutrient source such as a carbon source can be absent at specific points or times and can be added to the reactor at appropriate times during the fermentation process.
Thus, it is expected that the liquid growth medium of Farmer et al would have the same characteristics as the claimed growth media composition (i.e. being homogenous, pH less than 3, self-sterilization and absence of a carbon source). As per MPEP 2112 (II), inherent feature need not be recognized at the relevant time: There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention."); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed. Cir. 1999).
7. Applicant argue that:
“The proposed combination with Lessard requires hindsight reconstruction Applicants respectfully submit that the§ 103 rejection over Farmer in view of Lessard is based on hindsight reconstruction. The Examiner's rejection relies on selecting ingredients from Farmer's post-harvest product-additive disclosures, combining them with separate growth-medium disclosures, and further combining them with additional trace elements from other references. Such reconstruction is improper because the cited portions of Farmer are directed to different compositions used at different stages for different purposes.”
“The prior art provides no reasonable expectation of success Even if isolated ingredients in the claims were known individually, the rejection does not establish that a skilled artisan would have reasonably expected the specific claimed combination to provide a homogeneous, pH <3, self-sterilized growth media composition devoid of yeast fermentation product and carbon source, and suitable for
methanotroph/methylotroph growth.”
(Remarks Page 26-27)
Response to Arguments:
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, Farmer et al teach all the structural limitations for a medium being homogenous, pH less than 3, self-sterilization and absence of a carbon source required by the claims, as described above. Also, independent claims are also directed to a growth media composition with an intended use of “configured to be inoculated with and support cultivation of one or more microorganisms selected from the group consisting of methanotrophs and methylotrophs”. A 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.
In view of foregoing, in absence of evidence of any unexpected results, it would have been prima facie obvious for one of ordinary skill in the art seeking to produce a culture medium would use teachings of Farmer et al and Lessard et al to arrive at the invention. Given that different medium factors recited in the claims were commercially available and were routinely used in different combination for culturing microorganism cells for generation of biomass before effective filing date of the claimed invention, it would have been prima facie obvious for one of ordinary skill in the art to combine different agents/factors each of which is taught by the prior art references as described above to be useful for the same purpose in order to produce a new culture medium that is to be used for the very same purpose. In the instant case, the idea of combining them flows logically and has been taught in the prior art references. Further, patentable distinction is not evident between the claimed cultures medium for generating biomass and those taught by the cited references before the effective filing date. One of ordinary skill in the art would have had reasonable expectation of success in doing so because Farmer et al and Lessard et al were both successful in producing biomass in an in vitro microorganism cells culture using the described medium and methods.
8. Applicant argue that:
“Response to Examiner's Position Regarding Routine Optimization ….. Here, Farmer does not recognize the claimed combination ofHNQ3/NaNO3/NH3, H3PQ4/KH2PO4 and H2SO4/KHSQ4 as a result-effective media architecture for simultaneously achieving homogeneity, pH less than 3, self-sterilization, absence of carbon source and methanotroph/methylotroph growth. Farmer also does not teach that pH less than 3 is used to make a growth media composition self-sterilized. As mentioned above and as the December 2025 Declaration expressly explains, Farmer's contamination-control pH disclosure does not teach pH less than 3 for sterilizing the media composition……
The present invention therefore represents a purposeful selection of nutrient sources that simultaneously perform multiple functions. Specifically, the selected acidic components:
• provide essential nutrients;
• establish an acidic environment below pH 3;
• maintain media homogeneity;
• suppress microbial contamination;
• eliminate or reduce sterilization requirements; and
• facilitate industrial-scale methanotroph/methylotroph cultivation.
…………….. ”
(Remarks Page 27-29)
Response to Arguments:
Farmer et al teach optimization for nutrient sources: “The characteristics and formulation, e.g., nutrients, carriers, additives, and/or yeast cell concentration, of the yeast fermentation product can be optimized depending upon the desired application” ([0109], page 8) and “The medium can include nutrient sources, for example, a protein source, a carbon source, a lipid source, a nitrogen source, and/or a source of other nutrients, such as micronutrients. Each of these nutrient sources can be provided in an individual package that can be added to the reactor at appropriate times during the fermentation process. Each of the packages can include several sub-packages that can be added at specific points (e.g, when yeast, pH, and/or nutrient levels go above or below a specific concentration) or times (e.g., after 10 hours, 20 hours, 30 hours, 40 hours, etc.) during the fermentation process” ([0148], page 10, example 1).
Also, Farmer et al teach purity can be measured by any appropriate standard method, for example, by column chromatography, thin layer chromatography, or high-performance liquid chromatography (HPLC) analysis ([0041], page 3). Thus, measurement of w/w ratio of element such as elemental nitrogen to phosphate or elemental nitrogen to sulphate is considered as a routine experimentation process as evidenced by Miyaji who teach the use of atomic absorption spectroscopy (AAS) or inductive-coupled plasma atomic emission spectroscopy (ICP-AES) that can be used to accurately determine the amount of mineral salt in a solution (Page 214, 2nd para.). Also, as evidenced by Sikora et al who teach assay using the ferrozine colorimetric method and the absorbance at 562 nm with a calibration curve to determine Fe (II) in FeSO4 solution samples (Page 307, left column, 3rd para.). Therefore, the amount level of inorganic matter such as elemental nitrogen, phosphate, sulphate can be determined by routine experimentation and the ratio between these groups can be optimized to prepare optimal bacterial media for each bacterial strain (For the claimed: wherein ratio of elemental nitrogen to phosphate (w/w) is ranging from about 1:2 to 10: 1; ratio of elemental nitrogen to sulphate (w/w) is ranging from about 1: 1 to 10: 1).
Also, Farmer et al teach all the structural limitations for a medium being homogenous, pH less than 3, self-sterilization and absence of a carbon source required by the claims, as described above.
8. Applicant argue that:
“Applicants' Declaration evidence establishes unexpected results and technical advantages….. Applicants' previously submitted Rule 132 declaration (April 2025) evidence demonstrates that the claimed growth media composition produces results that would not have been expected from Farmer or the cited secondary references. As previously submitted and discussed, comparative Declaration evidence establishes that merely lowering pH below 3 is insufficient, by itself, to achieve the claimed technical effect. Conventional media adjusted to acidic pH does not achieve the same combination of homogeneity, self-sterilization and sustained biomass growth. Similarly, homogeneity alone is not sufficient. Rather, the claimed technical effect arises from the specific combination of acidic nitrogen, phosphate and sulphate sources together with the claimed microelements and trace elements.
The evidence thus shows that the claimed composition is not an arbitrary selection of known nutrients or acids, but a synergistic media architecture in which the claimed components cooperate to provide:
(i) pH less than 3; (ii) homogeneity;
(iii) self-sterilization without external thermal sterilization;
(iv) absence of carbon source and yeast fermentation-derived ingredients; (v) compatibility with methanotroph/methylotroph growth using Cl substrates; and (vi) improved fermentation performance and process economics.
As submitted previously, the April 2025 Declaration compares the following:
• conventional NMS medium;
• NMS medium adjusted below pH 3;
• 10x NMS medium;
• 10x NMS medium adjusted below pH 3;
• claimed growth media composition.
…….”
(Remarks Page 29-32)
Response to Arguments:
As per MPEP 716.02 Allegations of Unexpected Results: Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Farmer et al teach all the structural limitations for a medium being homogenous, pH less than 3, self-sterilization and absence of a carbon source required by the claims. Thus, it is expected that the liquid growth medium of Farmer et al would have the same characteristics as the claimed growth media composition:
As an initial matter, it is noted that the instant specification of the claimed invention teaches “the growth media composition is a homogenous mixture” (Page 6, lines 7-8); however, the instant disclosure does not define what degree of being homogenous can be accepted as being “homogenous”. Since growth media composition can be mixed, media composition being in a mixture is interpreted broadly as “homogenous” at a certain degree. Farmer et al teach the use of reactor comprises a mixing apparatus for continuous agitation and mixing of the culture ([0150], page 10). Farmer et al teach the use of reactor comprises a mixing apparatus for continuous agitation and mixing of the culture ([0150], page 10). Thus, the liquid growth medium composition in the reactor is inherently well mixed and homogenous at a certain degree.. Additionally, Farmer et al teach “These nitrogen sources may be used independently or in a combination of two or more” ([0072], page 6) and “These inorganic salts may be used independently or in a combination of two or more” ([0072], page 6). Since Farmer et al teach combining and mixing different medium composition which is well-known technique in the art, a person of ordinary skill in the art would be able to combine and mix different medium composition to have a growth media composition with certain degree of being homogenous. Moreover, Farmer et al teach “the composition can be mixed in with standard feed components and formulated into uniform, homogenized pellets. The supplemented feed pellet can comprise consistent concentrations of the microbe-based composition per pellet.” ([0163], page 11). Thus, uniform, homogenized pellets with consistent concentrations of the microbe-based composition are also liquid composition with certain degree of being homogenous (uniform, homogenized)
Farmer et al teach the pH of the culture should be suitable for the microorganism of interest. In some embodiments, the pH is about 2.0 to about 5.0 ([0086], page 6). In other embodiments, the medium may be pasteurized or, optionally, no heat at all added, where the use of pH and/or low water activity may be exploited to control unwanted microbial growth ([0080], page 6). In other embodiments, the cultivation system may be self-sterilizing, meaning the organism being cultivated is capable of preventing contamination from other organisms due to production of antimicrobial growth by-products (e.g., biosurfactants) ([0085], page 6).
Farmer et al teach “The medium can include nutrient sources, for example, a protein source, a carbon source, a lipid source, a nitrogen source, and/or a source of other nutrients, such as micronutrients. Each of these nutrient sources can be provided in an individual package that can be added to the reactor at appropriate times during the fermentation process. Each of the packages can include several sub-packages that can be added at specific points (e.g., when yeast, pH, and/or nutrient levels go above or below a specific concentration) or times (e.g., after 10 hours, 20 hours, 30 hours, 40 hours, etc.) during the fermentation process” ([0148], page 10, Example 1). Thus, Farmer et al teach embodiments where a nutrient source such as a carbon source can be absent at specific points or times and can be added to the reactor at appropriate times during the fermentation process.
Thus, it is expected that the liquid growth medium of Farmer et al would have the same characteristics as the claimed growth media composition (i.e. being homogenous, pH less than 3, self-sterilization and absence of a carbon source etc).
Conclusion
No claim is allowed.
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/KHOA NHAT TRAN/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632
