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 .
Detailed Action
Claims 1-11 are pending and is now under consideration for examination.
Priority
Acknowledgment is made of applicants’ claim for foreign priority under 35 U.S.C. 119(a)-(d). This application filed on 09/19/2023 and claims the priority date of Korea application 10-2022-0128700 filed on 10/07/2022; however, no English translation of said foreign priority application has been provided. Therefore, the priority date for instant claims under consideration is deemed to be the filing date of the instant application filed on 09/19/2023.
Information disclosure statement
The information disclosure statements (IDS) submitted on 09/19/2023 and 05/15/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statements is considered and initialed by the examiner.
Claim Objections
Claim 4 is objected, due to the following informality: Claim 4 recites “scureose,” is a spelling/typographical error; should read as “sucrose”. Correction is required.
Claim Rejections: 35 USC § 112(a)
The following is a quotation 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.
Written-Description
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, as containing subject matter which was not disclosed in the specification in such a way as to reasonably convey to one of skilled in the relevant art that the invention(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-11 as interpreted are directed to a method for producing any metabolite (genera of metabolites) using any acetogen strain (genera of acetogens) comprising: a first fermentation step of fermenting an acetogen strain (genera of acetogens) in a medium comprising synthesis gas and sugar; a second fermentation step of further fermenting the cultured acetogen strain by supplying the synthesis gas in the same medium after all the sugars are consumed in the first fermentation step, wherein the medium further comprises an adsorption resin (genera of resins) of a metabolite (genera of metabolites), and the metabolite comprises a carbon number of C2 to C6.
The specification discloses and is limited to a single species in the claimed method, i.e., said method comprising Clostridium carboxidivorans P7 (ATCC BAA-624) and the production of specific metabolites hexanol and hexanoic acid utilizing commercially available aromatic porous resins TRILITE GSH-20 and GSP-25 (see Examples 1-3, pages 13-18 of specification), which is insufficient to put one of skill in the art in possession of the attributes and features of all species within the claimed genus.
A sufficient written description of a genus of may be achieved by a recitation of structural features common to members of genus, which features constitute a substantial portion of the genus. There is no recited structural feature of the genus in the specification for the claimed process, i.e., a method for producing any metabolite (genera of metabolites) using any acetogen strain (genera of acetogens) comprising: a first fermentation step of fermenting an acetogen strain (genera of acetogens) in a medium comprising synthesis gas and sugar; a second fermentation step of further fermenting the cultured acetogen strain by supplying the synthesis gas in the same medium after all the sugars are consumed in the first fermentation step, wherein the medium further comprises an adsorption resin (genera of resins) of a metabolite (genera of metabolites), and the metabolite comprises a carbon number of C2 to C6. Therefore, one skilled in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
In University of California v. Eli Lilly & Co., 43 USPQ2d 1938, the Court of Appeals for the Federal Circuit has held that “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials”. As indicated in MPEP § 2163, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that a representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The Federal Circuit in Lilly, Fiers, Rochester and many other cases has determined that the written description issue applies to situations where the definition of the subject matter of the claims fails to provide description commensurate with the genus. Case law directly supports this rejection. As the District Court in University of Rochester v. G.D. Searle & Co., Inc. (2003 WL 759719 W.D.N.Y., 2003. March 5, 2003) noted “In effect, then, the '850 patent claims a method that cannot be practiced until one discovers a compound that was not in the possession of, or known to, the inventors themselves. Putting the claimed method into practice awaited someone actually discovering a necessary component of the invention.”
This is similar to the current situation since the breadth of the current claims; a method for producing any metabolite (genera of metabolites) using any acetogen strain (genera of acetogens) comprising: a first fermentation step of fermenting an acetogen strain (genera of acetogens) in a medium comprising synthesis gas and sugar; a second fermentation step of further fermenting the cultured acetogen strain by supplying the synthesis gas in the same medium after all the sugars are consumed in the first fermentation step, wherein the medium further comprises an adsorption resin (genera of resins) of a metabolite (genera of metabolites), and the metabolite comprises a carbon number of C2 to C6, which the present inventors were not in the possession of, or which were not known to the inventors.
Hence, claims are reading on significant numbers of inoperative embodiments in the claimed process that would render claims non-enabled/lack of written-description, when the specification does not clearly identify the operative embodiments or evidence of possession and undue experimentation is involved in determining those that are operative.” Atlas Powder Co. v. E.I. duPont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984); In re Cook, 439 F.2d 730, 735, 169 USPQ 298, 302 (CCPA 1971); MPEP 2164.08(b).
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, published in the Official Gazette and also available at <http://www.uspto.gov>.
Claim Rejections: 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1-11 are rejected under 35 U.S.C. 103(a) as being unpatentable over Um et al., (US 10,975,448 B2 in IDS; publication date 07/25/2019) and further in view Tracy et al., (US 9,938,542 B2; publication date 09/01/2016), Raganati et al., (Separat. Purification. Technol., 2018, Vol. 191: 328-339) and Nielsen et al., (Bioresource Technol., 2010, Vol. 10: 2762-2769).
Regarding claims 1-4 and 9-10, the disclosure of Um et al., (US 10,975,448 B2 in IDS; publication date 07/25/2019) teaches a Clostridium sp. JS66 strain producing metabolites having 4 to 6 carbon atoms in a high yield (see Abstract; and entire document); said reference strain producing metabolites having 6 carbon atoms in a high yield (hexanoic acid) not only in sugar-based metabolism but also when a carbon source other than sugars is used as a substrate such as carbon monoxide (CO), carbon dioxide (CO2) and hydrogen (H2) (Figs. 1-4, 10, & 15-22; Summary of the Invention, col. 2, lines 50-67 to col. 3, lines 1-25); the substrate is a gas comprising a carbon source, the culture may be carried out at an initial total gas pressure of 3 bar or less, for example, 0.5 to 2 bar, for example, 1.5 bar, although not limited thereto (col. 7, lines 13-21); said method comprising culturing first in the presence of glucose; followed by washing and culturing in a second medium comprising a mixed gas of carbon monoxide, carbon dioxide, and hydrogen in the volume percentages of 30%, 30% and 40%, respectively, as the substrate under the total gas pressure of 1.5 bar (Examples 3-8; cols.10-14).
Similarly, regarding claims 1-4 and 9-10, the disclosure of Tracy et al., (US 9,938,542 B2; publication date 09/01/2016) also teach a fermentation method performed to make one or more bioproducts such as alcohols, organic acids/hexanoic acid of less than 7 carbons, acetone, 2,3-butanediol and mixtures thereof with a microorganism/Clostridium sp./acetogen; the reference mixotrophic fermentation method includes providing an isolated organism and providing a first feedstock and a second feedstock for use in a fermentation medium; the first feedstock includes a carbon source that is metabolized by the native form of the organism at a rate of less than 0.01 g/hr/g cell mass, and the second feedstock includes CO, CO2, H2, or mixtures thereof; the mixotrophic fermentation method also includes culturing the organism in the fermentation medium, whereby both feedstocks are metabolized and a fermentation broth is formed, the broth having at least one bioproduct/metabolite (see Abstract; Fig. 1-5; Summary of the invention, cols. 2-4; cols. 20-28; and entire document).
However, Um et al., and Tracy et al., are silent regarding wherein the medium further comprises an adsorption resin of a metabolite (as in claim 1); and adsorption resin comprises porous polymer particles, wherein the porous polymer particles satisfy at least one of the followings: a specific surface area of 700 to 1500 m2/g; a pore radius of 40 to 85 Å; a particle size range of 200 to 1500μm; and a pore volume of 0.8 to 1.8 ml/g; and wherein the porous polymer particles are porous aromatic-based polymer particles (as in claims 5-8).
Regarding claims 1 and 5-8, Raganati et al., (Separat. Purification. Technol., 2018, Vol. 191: 328-339) provide teaching, suggestion and motivation to include adsorption resin in the fermentation process/acetone-butanol-ethanol (ABE) fermentation for in situ adsorption and product/metabolite recovery and to reduce toxicity (see Abstract; and entire document); said reference discloses the use of various Amberlite adsorbents/polyaromatic resins with pore diameters 50-90 Angstrom and specific pore volume (mL/g) of 0.98, 1.14 and 0.5 (Table 2, page 329) and optimization for the use of resins for product/metabolite recovery (Fig. 1-8 & Table 3-5, pages 330-338).
Regarding claims 1 and 5-8, Nielsen et al., (Bioresource Technol., 2010, Vol. 10: 2762-2769) also teach predicting the adsorption of second generation biofuels by polymeric resins with applications for in situ product recovery (ISPR); said reference products/metabolites includes ethanol, propanol, butanol and the use of various Amberlite adsorbents/polyaromatic resins having specific surface area m2 g-1 of 300-1100 (Abstract; Table 1-2, pages 2763-2764; Conclusions and entire document).
As such, disclosure of strategy and methods for to include adsorption resin in the fermentation process/acetone-butanol-ethanol (ABE) fermentation for in situ adsorption and product/metabolite recovery and to reduce toxicity; said polyaromatic resins with pore diameters 50-90 Angstrom and specific pore volume (mL/g) of 0.98, 1.14 and 0.5; and having specific surface area m2 g-1 of 300-1100 (as in claims 1 and 5-8), such as that of references of Raganati et al., and Nielsen et al., teaching the advantages of said modifications i.e., incorporating polymeric resins in the claimed process, clearly suggests to a skilled artisan to modify the teachings of Um et al., and Tracy et al., and incorporate the structural and functional elements of Raganati et al., and Nielsen et al., in the claimed method for producing a metabolite using a acetogen strain comprising: a first fermentation step of fermenting an acetogen strain (genera of acetogens) in a medium comprising synthesis gas and sugar; a second fermentation step of further fermenting the cultured acetogen strain by supplying the synthesis gas in the same medium after all the sugars are consumed in the first fermentation step, wherein the medium further comprises an adsorption resin including the structural and functional elements of the instant invention are well known in the art (for details see the rejection above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claimed method of industrial significance and incorporate the modification to the claimed process, as suggested Raganati et al., and Nielsen et al., and to modify the teachings of Um et al., and Tracy et al. A person of ordinary skill in the art is motivated to make such change, because to include adsorption resin in the fermentation process for in situ adsorption and product/metabolite recovery and a skilled artisan would realize such a modification would be useful to increase the product recovery and reduce the toxicity of metabolites for the fermenting acetogens. One of ordinary skill in the art has a reasonable expectation of success at adding the step i.e., to include adsorption resin in the fermentation process for in situ adsorption and product/metabolite recovery as suggested in the teachings Raganati et al., and Nielsen et al., and are well known in the art. Therefore, the inventions as a whole lack an inventive step over the prior art. The expectation of success is high, because the combined teachings of Um et al., Tracy et al., Raganati et al., and Nielsen et al., also provide the structural and functional elements of the instant invention (Teaching, Suggestion and Motivation).
Regarding specific choice of adsorption resin are also provided/suggested in the combination of references, and examiner also takes the position the following position; optimization of known variables, and the examiner finds support in: MPEP 2144.05 [R-5]: A. Optimization Within Prior Art Conditions or Through Routine Experimentation Generally, differences in choice of resins, pore size etc., will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation". As to optimization results, a patent will not be granted based upon the optimization of result effective variables when the optimization is obtained through routine experimentation unless there is a showing of unexpected results which properly rebuts the prima facie case of obviousness. See In re Boesch, 617 F.2d 272,276,205 USPQ 215,219 (CCPA 1980). See also In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (Fed. Cir. 1990), and In re Aller, 220 F2d 454,456,105 USPQ 233,235 (CCPA 1955). Furthermore, "it is prima facie obvious to combine two compositions or two methods each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition or third method to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Given this extensive teaching in prior art (Um et al., Tracy et al., Raganati et al., and Nielsen et al.,) i.e., a method for producing any metabolite (genera of metabolites) using any acetogen strain (genera of acetogens) comprising: a first fermentation step of fermenting an acetogen strain (genera of acetogens) in a medium comprising synthesis gas and sugar; a second fermentation step of further fermenting the cultured acetogen strain by supplying the synthesis gas in the same medium after all the sugars are consumed in the first fermentation step, wherein the medium further comprises an adsorption resin (genera of resins) of a metabolite (genera of metabolites), and the metabolite comprises a carbon number of C2 to C6, as taught by the instant invention and as claimed in claims 1-11 is not of innovation but of ordinary skill in the art and the expectation of success is extremely high i.e., “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at, 82 USPQ2d at 1397”.
Hence, claims 1-11 are rejected under 35 U.S.C. 103(a) as being unpatentable over Um et al., (US 10,975,448 B2 in IDS; publication date 07/25/2019) and further in view Tracy et al., (US 9,938,542 B2; publication date 09/01/2016), Raganati et al., (Separat. Purification. Technol., 2018, Vol. 191: 328-339) and Nielsen et al., (Bioresource Technol., 2010, Vol. 10: 2762-2769).
Allowable Subject Matter/Conclusion
None of the claims are allowable.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652