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
Amended claims 1-20 and 30-32 (dated 08/21/2024) are pending and is now under consideration for examination.
Priority
Applicants’ claim for the benefit of priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a 371 of PCT/US2023/062956 filed on 02/21/2023, which claims benefit of Provisional application: 63/313,129 filed on 02/23/2022.
Information disclosure statement
The information disclosure statement (IDS) submitted on 08/21/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statement is considered and initialed by the examiner.
Objections to Abstract/Specification
The Abstract of the disclosure is objected to because, Abstract should be on a separate sheet of paper. The abstract of the disclosure is objected to because the abstract is presented as part of the first page of a WO publication. The abstract should be presented as a single sheet apart from all other bibliographic material including the information included on the first page of a WO publication. If EFS is used to submit a replacement abstract, the appropriate abstract (ABST) document code should be used for the one-page document. Correction is required. See MPEP § 608.01 (b).
Claims Objections
I. Recitation of “and/or” in claim 1 and claims 2-20 and 30-32 depending therefrom makes the claim indefinite, as it is not clear what limitations must be present.
II. Claim 1 and claims 2-20 and 30-32 depending therefrom is objected to, due to the following informality: Claim 1 recites subject-matter in parentheses; i.e., “(e.g., corn)”; and claim 30 recites subject-matter in parentheses; i.e., (e.g., ethanol yield) and it is not clear whether the subject-matter recited in parentheses is a limitation of claims 1 and 30 or merely exemplary?; examiner urges the applicants’ to make a direct reference and not recite the limitation in parentheses. Appropriate correction is required.
Claim Rejections: 35 USC § 112(b)
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.
I. Claim 1 and claims 2-20 and 30-32 depending therefrom is 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 pre-AIA the applicant regards as the invention; recitation of “and/or” in claims 1 and 18 makes the claims indefinite, as it is not clear what limitations must be present. The metes and bounds of claims 1-20 and 30-32 are not clear and thus, it would not be possible to one of ordinary skill in the art to define the metes and bounds of the desired patent protection. Claim 1 is not clear and concise, and contains a multitude of "and/or" options, such that hundreds of different processes are encompassed within a single claim. This way of claiming renders the claim lengthy and it is difficult to understand for the reader what are the essential (non-optional) features of the claimed process and the desired patent protection. Further, most of the options are repeated in the dependent claims. Hence, it is superfluous to present all possible options within the main independent claim. The description and claims mention a multitude of alternatives of how the process may be carried out, but it is not evident which options are preferred and wherein all possibilities are indicated, but wherein it still has to be determined which of these options will reveal to be functioning or to be advantageous in comparison to known processes. It is noted that the application may not be amended in such a way that the application is restricted to a particular combination or selection of features that was not evident from the original disclosure. Such combination/selection would introduce subject-matter which extends beyond the content of the application as filed, particularly if there is no particular teaching of the disclosure, as a whole, towards the preference for such a particular selected embodiment out of the multitude of embodiments presented as equal alternatives.
II. Claim 1 and claims 2-20 and 30-32 depending therefrom 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 applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
In the present instance, claim 1 recites the broad recitation “… starch containing material…”, and the claim also recites “… purification of the oil (e.g., corn)…” which is the narrower statement of range/limitation (range within range); and claim 30 recites the broad recitation “…fermentation product yield” and the claim also recites “… fermentation product yield (e.g., ethanol yield)…” which is the narrower statement of range/limitation (range within range). It is not clear what the applicants’ intend to encompass in the rejected claims and the metes and bounds of the claims are unclear and as being indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. Correction and clarification is required.
III. Claim 7 is 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.
Regarding claim 7, recites “process of claim 6, wherein the yield enhancing composition is added to the thin stillage that is fed to the mashing step in 1a),…”, and claim 7 depends from claims 6, 5 and 1 and lacks antecedent basis, as claims 1 and 5-6 do not recite “mashing step in the claim”, and claim 1a) is limited to the recitation of “forming slurry” and claim 1 a) is not directed to “mashing step”. Therefore, it is not clear to the examiner what the applicants’ are referring to in claim 7 and there is insufficient antecedent basis for this limitation in claim 7. Clarification and correction is required.
IV. Claim 18 is 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 pre-AIA the applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
In the present instance, claim 18 recite the broad recitation and also recites “optionally”, which is the narrower statement of the range/limitation (range within range). It is not clear what the applicants’ intend to encompass in the rejected claim and the metes and bounds of the claim is unclear and as being indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. Correction and clarification is required.
Claim rejections: 35 U.S.C. 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 18 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 18 depends from 1; claim 18 recites “The process of claim 1, wherein a biomass other than the starch-containing material is optionally pretreated and incubated with the yield enhancing composition before being fed to liquefying step b), saccharifying step c), and/or fermenting step d);” and depends from claim 1 and does not further limit independent claim 1, as claim 1 is limited to “starch containing material” and claim 1 does not recite any other material and is limited to starch-containing material. Dependent claim 18 broadens the scope of independent claim 1 (also see 35 U.S.C. 112(b) rejections above for claims interpretation).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Clarification and correction required.
Claim Rejections: 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(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 1-20 and 30-32 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 1-20 and 30-32 as interpreted are directed to a process for production of any fermentation product (genus of products) and any biogas (genus of biogas), said process comprising a genera of enzymes and a genus microorganisms/strains including microorganisms of undefined and unlimited phenotype/genotype or strains including naturally-occurring and genetically modified microorganisms (also see claims objections, 35 U.S.C. 112(b) and 35 U.S.C. 112(d) rejections above for claim interpretation).
The specification discloses and is limited to a prophetic process for producing methane, wherein said process comprising specific yield enhancing compositions 1-17 comprising specific enzymes … (see Examples 1-12, pages 86-91 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.
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 comprises to a process for production of any fermentation product (genus of products), said process comprising a genera of enzymes and a genus microorganisms/strains including microorganisms of undefined and unlimited phenotype/genotype or strains including naturally-occurring and genetically modified microorganisms (also see claims objections, 35 U.S.C. 112(b) and 35 U.S.C. 112(d) rejections above for claim interpretation) and in the claimed process 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 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.
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.
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 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.
Claims 1-20 and 30-32 are rejected under 35 U.S.C. 103(a) as being unpatentable over Rosenberger et al., (US 2014/0065685 A1, in IDS) and in view of Palve et al., (Sustainable Bioconversion of Waste to Value Added Products, Advances in Science, Technology & Innovation, 2021, pages 1-22), Bleyer et al., (US 2015/0191750 A1, in IDS), Veit et al., (US 2010/0317091 A1, in IDS), Bonk et al., (US 2022/0033860 A1, in IDS) and Bijl et al., (US 2014/0134697 A1).
Claims 1-20 and 30-32 of the instant application as interpreted are directed to a process for the production of any fermentation product (genus of products) and any biogas (genus of biogas), said process comprising a genera of enzymes and a genus microorganisms/strains including microorganisms of undefined and unlimited phenotype/genotype or strains including naturally-occurring and genetically modified microorganisms; examiner reiterates claim 1 is not clear and concise, and contains a multitude of "and/or" options, such that hundreds of different processes are encompassed within a single claim. This way of claiming renders the claim lengthy and it is difficult to understand for the reader what are the essential (non-optional) features of the claimed process and the desired patent protection; further, most of the options are repeated in the dependent claims (also see claims objections, 35 U.S.C. 112(b) and 35 U.S.C. 112(d) rejections above for claim interpretation).
Regarding claims 1-20 and 30-32, Rosenberger et al., (US 2014/0065685 A1, in IDS; see Abstract; Claims; Figures; and entire document) discloses a combined process comprising bioethanol production from a feedstock such as corn, with mashing using the outflow of biogas fermentation, combined with biogas production from whole stillage or from thin stillage “A system and process for producing ethanol and biogas. An incoming feedstock and water is directed to a preparation unit that frees sugar from the feedstock. The feedstock is directed to a fermenter that ferments the sugar to produce a beer that includes ethanol and feedstock. The beer is directed to a distillation unit which separates the ethanol from the feedstock and produces ethanol and whole stillage. The stillage derived is direct to an anaerobic membrane bioreactor unit. The stillage is subjected to anaerobic digestion in the anaerobic digester and this produces mixed liquor that includes suspended solids. Mixed liquor including the suspended solids is directed to the membrane separation unit which filters the suspended solids and produces a concentrated reject (retentate) stream and a backset permeate stream. The backset permeate stream is then mixed with the incoming feedstock” (Abstract). It is implicit that the outflow of the biogas fermentation already contains microorganisms and enzymes. Further, Rosenberger et al., indicates (see ¶ [0012], [0014-0027]): "Generally, the feedstock and water is heated and this can be achieved by adding steam to the feedstock-water mixture. The presence of the feedstock plus water with the addition of enzymes causes the starch found in the plant material to be converted to sugar. Thus, the substrate preparation unit 102 produces feedstock in the form of a mash where the starch associated with the feedstock has been converted to sugar." (see ¶ [0012]). Hence, it is evident that the process should comprise steps of liquefaction at high temperature (by addition of steam) and saccharification to produce fermentable sugars. Further, the addition of enzymes to the corn mash is described to be done along with the addition of outflow of biogas fermentation. Hence, it is immediately evident that the addition of enzymes to the corn mash can be done directly, or can be done by first mixing these enzymes into the flow of the outflow from the biogas process before entering the mashing reactor.
Regarding claims 1-20 and 30-32, the following references teach the strategies for bioconversion of biowastes (methods for bioconversion and compositions of biowastes) for energy production and fermentation products of interest including structural and functional elements of the instant invention. Applicants’ are directed to the following references:
Palve et al., (Sustainable Bioconversion of Waste to Value Added Products, Advances in Science, Technology & Innovation, 2021, pages 1-22) provide teaching, suggestion, motivation and strategies for bioconversion of biowastes (methods for bioconversion and compositions of biowastes) for energy production and fermentation products of interest; said biowastes includes industrial and agricultural biowastes for producing nutrient-rich/complete feed stock and creation of chemicals, byproducts and biofuels, biogas such as methane and hydrogen (see Abstract; Figs. 1-2, 4-7 & 9-12; Table 1; and entire document); Palve et al., teach waste mass obtained from different sources (Fig, 1, page 2); schematic set-up of the process for utilizing waste/biomass for the production biogas and fermentation product (Fig. 2, page 3); Methods and sources of wastes/biomass for bioconversion (pages 4-8; Table 7 & Fig. 5, page 7); Enzymatic bioconversion process comprising a mixture/cocktail of many enzymes (pages 8-9). Palve et al., conclude “Herein, we systematically discussed the foremost approaches that have been employed for the bioconversion of various biowaste management applications aiming to produce value-added chemicals, byproducts, and biofuels (e.g., bioethanol, biodiesel, hydrogen, and methane). The well-developed microbial, enzymatic, fermentative, and composting bioconversion systems could offer effective ways to produce well-defined chemicals and energy products with the least amount of pollutants and byproducts” (¶ 4 Conclusion, page 14).
Bleyer et al., (US 2015/0191750 A1, in IDS), discloses ethanol production with treatment of stillage for recovery of oil and production of methane from de-oiled stickwater (Abstract; Claims; Figures 1-11; Examples; and entire document). Corn mashing is done with aqueous fractions (stickwater-backset or biogas outflow), see especially Figures 5, 6, 10 and 11. Example 10, in ¶ [0213] demonstrates biogas production from stickwater fraction of thin stillage (stillage from which oil and protein is separated; said invention provides for oil, a protein-containing solids fraction, ¶ [0036]) with the addition of a microorganism mixture from a functioning digester. In Bleyer et al., the liquefaction and saccharification taking place before fermentation into ethanol and in (¶ [0070-0071]), Bleyer et al., indicates that "grain is milled, slurried, and cooked with enzymes to obtain a sugar-rich mash” and these steps are well known in the art; from there it is obvious that the process can be carried out either as a conventional dry grind process, including liquefaction at high temperature, followed by saccharification, or as a granular starch hydrolysis process; Summary of the process and sequential steps (¶ [0129-0136]). Hence, in the view of the general knowledge of the practitioner, it was immediately obvious that the process of Bleyer et al., would normally comprise liquefaction and saccharification as indicated in steps b) and c) of present claim 1.
Veit et al., (US 2010/0317091 A1, in IDS), discloses an integrated process comprising bioethanol production from plant materials such as corn, with mashing using thin stillage and/or the outflow of biogas fermentation, combined with biogas production from thin stillage (Abstract; ¶ [0005-0009]; Claims; Figures). In ¶ [0020], Veit et al., indicates: "In the pretreatment, the corn mash is heated and combined with enzymes to break down the starches into sugars"; again, in the view of the general knowledge of the practitioner, it was immediately obvious that this process would normally comprise liquefaction and saccharification by the use of enzymes as indicated in steps b) and c) of present claim 1.
Bonk et al., (US 2022/0033860 A1, in IDS) discloses a combined process comprising bioethanol production from corn meal with mashing using stillage and using the outflow of biogas fermentation, combined with biogas production from whole stillage (Abstract; Claims; Figures; Examples; and entire document). Bonk et al., indicates that the outflow of biogas fermentation contains cellulases and/or cellulase-producing microorganisms which are suitably added in the mashing step along with whole stillage (with whole stillage comprising cellulose), see especially claim 16 and ¶ [0046]. Bonk et al., also indicated that enzymes for digesting starch are added in the mashing step (see ¶ [0070]). While in Bonk et al., the cooking is indicated to be carried out at temperatures below the gelatinization temperature of starch, it was obvious to the skilled person that the saccharification may alternatively also be carried out by the conventional method, i.e. including liquefaction at high temperature, followed by saccharification at a lower temperature.
Bijl et al., (US 2014/0134697 A1) provides a process for the digestion of organic material into biogas which comprises: treating the organic material with one or more enzymes; separating the liquid fraction from the solid fraction of the enzyme-treated organic material; and digesting the liquid fraction to form biogas; wherein said organic material includes pig manure and anaerobic digestion utilizing microorganisms (Abstract; Figures; ¶ [00046-0047]; Examples 1-6; Claims; and entire document).
Hence, dependent claims 2-30 do not appear to contain any features which, in combination with the features of any claim to which they refer, meet the requirements of with respect of novelty and/or inventive step; the features of these claims are either already disclosed in any of, or they are implicit, or they are immediately obvious in the cited references above (for details see the rejection above).
Regarding specific choice of steps, arrangement of steps, choice of biomass, choice of enzymes 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 steps, arrangement of steps, choice of biomass, choice of enzymes will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating 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 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.
As such, disclosure of strategy and methods including structural and functional elements for the production of fermentation product and biogas in the claimed process, such as that of suggestions in references of Palve et al., Bleyer et al., Veit et al., Bonk et al., and Bijl et al., teaching the advantages of said modifications, and clearly suggests to a skilled artisan to modify the teachings of Rosenberger et al., and a skilled artisan would be motivated to incorporate the structural and functional elements including steps for the production of fermentation product and biogas of the cited secondary references in the claimed process, and the combined references also provide the advantages of modifying the primary teachings of Rosenberger et al., by incorporating the structural and functional elements of secondary references as claimed in the instant invention and 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 process, as suggested Palve et al., Bleyer et al., Veit et al., Bonk et al., and Bijl et al. A person of ordinary skill in the art is motivated to make such change depending on the experimental need i.e., for the production of any fermentation product (genus of products) and any biogas (genus of biogas), said process comprising a genera of enzymes and a genus microorganisms/strains including microorganisms of undefined and unlimited phenotype/genotype or strains including naturally-occurring and genetically modified microorganisms; examiner reiterates claim 1 is not clear and concise, and contains a multitude of "and/or" options, such that hundreds of different processes are encompassed within a single claim. This way of claiming renders the claim lengthy and it is difficult to understand for the reader what are the essential (non-optional) features of the claimed process and the desired patent protection; further, most of the options are repeated in the dependent claims (also see claims objections, 35 U.S.C. 112(b) and 35 U.S.C. 112(d) rejections above for claim interpretation), because a skilled artisan would realize such a modification would be useful to efficiently produce fermentation product and biogas of interest in the claimed process. One of ordinary skill in the art has a reasonable expectation of success at combining the steps in the claimed process, as suggested in the teachings of Rosenberger et al., Palve et al., Bleyer et al., Veit et al., Bonk et al., and Bijl et al., and are well known in the art. Therefore, the invention as a whole lack an inventive step over the prior art. The expectation of success is high, because the combined teachings of Rosenberger et al., Palve et al., Bleyer et al., Veit et al., Bonk et al., and Bijl et al., also provide the structural and functional elements of the instant invention (Teaching, Suggestion and Motivation).
Given this extensive teaching in prior art (Rosenberger et al., Palve et al., Bleyer et al., Veit et al., Bonk et al., and Bijl et al.,) the claimed process for the production of fermentation product and biogas, as taught by the instant invention and as claimed in claims 1-20 and 30-32 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 1-20 and 30-32 are rejected under 35 U.S.C. 103(a) as being unpatentable over Rosenberger et al., (US 2014/0065685 A1, in IDS) and in view of Palve et al., (Sustainable Bioconversion of Waste to Value Added Products, Advances in Science, Technology & Innovation, 2021, pages 1-22), Bleyer et al., (US 2015/0191750 A1, in IDS), Veit et al., (US 2010/0317091 A1, in IDS), Bonk et al., (US 2022/0033860 A1, in IDS) and Bijl et al., (US 2014/0134697 A1).
Double Patenting rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Amended claims 1-20 and 30-32 (dated 08/21/2024) of the instant invention are provisionally rejected on the ground of nonstatutory double patenting over amended claims 1-18 and 28-30 (dated 08/20/2024) of co-pending Application No. 18/840,008 (US 20250179535 A1). This is a provisional double patenting rejection because the patentably indistinct claims have not in fact been patented.
The subject matter claimed in the instant application is fully disclosed in the referenced co-pending application and would be covered by any patent granted on that co-pending application, since the referenced co-pending application and the instant application are claiming common subject matter; instant application claims as interpreted are directed to “a process for the production of any fermentation product (genus of products) and any biogas (genus of biogas), said process comprising a genera of enzymes and a genus microorganisms/strains including microorganisms of undefined and unlimited phenotype/genotype or strains including naturally-occurring and genetically modified microorganisms; examiner reiterates claim 1 is not clear and concise, and contains a multitude of "and/or" options, such that hundreds of different processes are encompassed within a single claim. This way of claiming renders the claim lengthy and it is difficult to understand for the reader what are the essential (non-optional) features of the claimed process and the desired patent protection; further, most of the options are repeated in the dependent claims (also see claims objections, 35 U.S.C. 112(b) and 35 U.S.C. 112(d) rejections above for claim interpretation)” and furthermore, the instant application claims and co-pending application claims recite “comprising” and is an open language and includes unrecited elements, and the claimed common subject-matter is as follows: The recited amended claims 1-18 and 28-30 (dated 08/20/2024) of co-pending Application No. 18/840,008 (US 20250179535 A1) encompass “a method for carrying out the combined operation of a bioethanol production unit and a biogas unit, wherein: a) milled grain from a dry milling step is mashed with whole stillage and/or thin stillage and/or outflow from the biogas unit, b) the mash from 1a) is fed to a cooking stage with mash temperatures below the gelatinization temperature of the starch in the milled grain, followed by an ethanol-forming fermentation step and then feeding the fermented mash to a distillation step to produce a whole stillage; wherein the whole stillage from 1b) is fed to the mashing step in 1a) and/or to the biogas unit and/or to a solid-liquid separation step to generate thin stillage and wet cake; and/or wherein the thin stillage is fed to the mashing step in 1a) and/or to the biogas unit and/or used to make corn oil and residual materials resulting from purification of the corn oil; and/or wherein the residual materials resulting from purification of the corn oil are fed to the biogas unit; and/or…”, and the subject-matter as claimed in amended claims 1-20 and 30-32 (dated 08/21/2024) of the instant application, falls entirely within the scope of co-pending claims in co-pending reference application.
Allowable Subject Matter/Conclusion
None of the claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHIRAMA RAGHU whose telephone number is (571)272-4533. The examiner can normally be reached on M-F 8:30am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
Prosecution Insights