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 1-17 are pending and under examination herein.
This application, filed on 2/13/2025, is a 371 of PCT/US2023/030588 filed on 8/18/2023, which claims benefit of 63/399,020 filed on 8/18/2022.
The effective filing date of the current application is August 18, 2023.
Drawings
The drawings are objected to because the figures are not properly labeled.
37 CFR 1.84 (u)(1) states “The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear.”
In the instant case, there is only one figure, which is labeled with the abbreviation "FIG.1". A corrected drawing sheet removing the label will obviate this objection.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Information Disclosure Statement
The information disclosure statement filed on 2/13/2025 complies with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. All references were considered.
Claim Objections
Claims 11-12 are objected to because of the following informalities:
Claim 11 recites “between 50-60 C” in line 2, which is missing a degree sign between “60” and “C”, and should be amended to recite “between 50-60°C”.
Claim 12 recites “55 C” in line 2, which is missing a degree sign between “55” and “c”, and should be amended to recite “55°C”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 7, 9 and 16-17 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 7 recites: the method of claim 4, wherein the living microorganism is capable of surviving said mechanical disruption. There is insufficient antecedent basis for “the living microorganism”. Claim 7 depends from claim 4, which does not recite a living microorganism. Claim 4 depends from claim 1, which recites “a microbial culture” but does not recite “a living microorganism”.
Claim 9 recites: wherein the living microorganism is thermophilic, lignocellulose-fermenting anaerobic bacterium or coculture thereof. There is insufficient antecedent basis for “the living microorganism”. Claim 9 depends from claim 2, which does not recite a living microorganism. Claim 2 depends from claim 1, which recites “a microbial culture” but does not recite “a living microorganism”.
It is further unclear what the term “coculture” encompasses or refers to, as claim 1 recites “a microbial culture”, claim 9 recites “anaerobic bacterium”, and the term “coculture” is not defined in the current specification. It is suggested that the claim be amended to delete the phrase “or coculture thereof” in the last line to obviate this rejection.
Claim 16 recites: the method of claim 9, wherein the microorganisms are pure culture or co-culture of microorganisms selected from the group consisting of Clostridium thermocellum, Clostridium claraflavum, Caldicellusiruptor bescii, Thermoanaerobacterium saccharolyticum, Thermoanaerobacterium thermosaccharolyticum, and combination thereof. There is insufficient antecedent basis for “the microorganism”. Claim 16 depends from claim 9, which recites “the living microorganism”. Claim 9 depends from claim 2, which does not recite any microorganism. Claim 2 depends from claim 1, which recites “a microbial culture” but does not recite “a microorganism”.
It is further unclear what the phrase “co-culture of microorganisms” refers to, as claim 1 recites “a microbial culture”, claim 9 recites “anaerobic bacterium”, and the term “co-culture” is not defined in the current specification. It is suggested that the claim be amended to delete the phrase “or co-culture of microorganisms” to obviate this rejection.
Claim 17 recites: the method of claim 9, wherein the microorganism does not include yeast, or Zymomonas mobilis. There is insufficient antecedent basis for “the microorganism”. Claim 17 depends from claim 9, which recites “the living microorganism”. Claim 9 depends from claim 2, which does not recite any microorganism. Claim 2 depends from claim 1, which recites “a microbial culture” but does not recite “a microorganism”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-13 and 16-17 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being clearly anticipated by Lynd et al. (US 2016/0168596 A1, published on June 16, 2016).
Regarding claim 1, Lynd teaches a method for converting biomass into ethanol or other desired products, said method comprising:
a) adding said biomass comprising lignocellulosic particles and at least one microorganism to a reactor, said at least one microorganism being capable of fermenting said biomass,
b) mechanically disrupting said lignocellulosic particles of said biomass after said biomass is partially solubilized, and
c) fermenting said biomass with said microorganism to produce ethanol or other desired products (i.e. without first separating liquid and solid) (p.10, claim 12).
Lynd further teaches lignocellulosic particles of biomass that are disrupted by means selected from the group consisting of metal balls, metal beads, glass balls, glass beads, knife mill, disc mill, roller mill, hammer mill, a device allowing said biomass to flow through an orifice, a cyclone containing milling media with disruption carried out in the fermentor, and combination thereof (p.10, claim 15).
Lynd teaches more than 60% of sugar in biomass that is solubilized after 5-day with incubation with intermittent mechanical disruption (i.e. sugar-rich feedstock) (p.10, claim 19).
Regarding claim 2, Lynd teaches plant biomass may include sugar cane bagasse and energy cane (p.4, [0052]).
Regarding claim 4, Lynd teaches the system may be configured such that the biomass is simultaneously or intermittently subject to both mechanical disruption by the disrupting means and fermentation without reinoculation following mechanical disruption and fermentation by the microorganism (p.2, [0016]).
Regarding claim 5, Lynd teaches said lignocellulosic particles of said biomass are disrupted by means of metal balls, disc mill, or roller mill (p.10, claim 15).
Regarding claim 6, Lynd teaches one or more microorganisms may be used and the microorganisms are capable of fermenting the biomass to desired products (i.e. the microbial culture comprises one or more living microorganisms) (p.2, [0022]). Lynd teaches adding 2% inoculum (p.5, [0062]).
Regarding claim 7, Lynd teaches bacteria are shown to be resistant to mechanical attack (p.1, [0014]).
Regarding claim 8, Lynd teaches Clostridium thermocellum is insensitive to mechanical attack at intensities sufficient to markedly increase solubilization (i.e. mechanical disruption does not substantially slow the metabolism of the organism) (p.1, [0014]).
Regarding claim 9, Lynd teaches the microbial system may include pure culture or co-culture of microorganisms such as Clostridium thermocellum, Clostridium claraflavum, Thermoanaerobacterium saccharolyticum, Thermoanaerobacterium thermosaccharolyticum or similar saccharolytic thermophilic bacteria (i.e. thermophilic, lignocellulose-fermenting anaerobic bacterium) (p.2, [0022]).
Regarding claim 10, Lynd teaches that the present disclosure shows that microbial conversion with no added enzymes and in conjunction with mechanical disruption is possible without negatively impacting fermentation (p.4, [0049]).
Regarding claim 11, Lynd teaches an increased hydrolysis temperature of 50°C (p.3, [0038]; FIG. 11).
Regarding claim 12, Lynd teaches an increased hydrolysis temperature of 50°C (p.3, [0038]; FIG. 11). As the specification does not define what range is encompassed by the term “about”, 50°C is being interpreted as being encompassed by the range limitation, about 55°C.
Regarding claim 13, Lynd teaches disruption may be accomplished by pressure cycling, which may lead to formation of bubbles due to supersaturated CO2 (p.2, [0025]).
Regarding claim 16, Lynd teaches the microorganism is at least one member selected from the group consisting of Clostridium thermocellum, Clostridium claraflavum, Clostridium cellulolyticum, Caldicellusiruptor bescii, Thermoanaerobacterium saccharolyticum, Thermoanaerobacterium thermosaccharolyticum and combination thereof (p.2, [0022]; p.11, claim 20).
Regarding claim 17, Lynd teaches the method does not utilize yeast (p.11, claim 21).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over by Lynd et al. (US 2016/0168596 A1, published on June 16, 2016) as applied to claim 1 above, and further in view of Macrelli et al. (“Techno-economic evaluation of 2nd generation bioethanol production from sugar cane bagasse and leaves integrated with the sugar-based ethanol process”, Biotechnology for Biofuels, 2012, Vol. 5, Article 22, 18 pages).
The teachings of Lynd et al. are discussed above.
Regarding claim 3, Lynd teaches sugar cane bagasse (p.4, [0052]).
Lynd does not teach whole sugar cane.
However, Macrelli teaches bioethanol produced from the lignocellulosic fractions of sugar cane bagasse and leaves (title/abstract). Macrelli teaches that improvements in plant design can lower the production cost, providing better profitability and competitiveness if the conversion of the whole sugar cane is considered (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the sugar cane bagasse taught by Lynd with whole sugar cane taught by Macrelli in the method of Lynd, because Macrelli teaches that considering whole sugar cane conversion would lower production cost and increase profitability.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over by Lynd et al. (US 2016/0168596 A1, published on June 16, 2016) as applied to claim 1 above, and further in view of Pratto et al. (“Biobutanol production from sugarcane straw: Defining optimal biomass loading for improved ABE fermentation”, Industrial Crops & Products, 2020, Vol. 48, Article 112265, 9 pages).
The teachings of Lynd et al. are discussed above.
Regarding claims 14-15, Lynd does not teach that the mixture produced in step (a) has a carbohydrate concentration of 100 g/L.
However, Pratto teaches biobutanol production from sugarcane straw (title). Pratto teaches investigating 10 and 15% w/v biomass loading, and that 10% w/v solid load was more favorable in both separated hydrolysis and fermentation and simultaneous saccharification and fermentation (abstract). Pratto further teaches that for 15% w/v, the synergistic effect of weak acids and phenolic compounds made the sugarcane straw hydrolysate poorly fermentable.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the carbohydrate loading to 10% w/v solid load, which is 100 g/L, as taught by Pratto in the method of Lynd, because Pratto teaches a 10% w/v loading was more favorable in fermentation. One of ordinary skill in the art would have found it beneficial to have a 100 g/L biomass loading to promote favorable fermentation conditions.
Double Patenting
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 7, 9-10 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 10,533,194 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the instant claims.
Claim 1 of patent ‘194 recites “a method for converting biomass into ethanol or other products, said method comprising, in sequential order:
a) adding said biomass and at least one microorganism to a reactor to form a suspension comprising said biomass and said at least one microorganism,
b) fermenting said biomass with the at least one microorganism to form a first fermented product comprising fermented biomass and the at least one microorganism, which is a lignocellulosic particle-containing slurry in the reactor,
c) mechanically disrupting said first fermented product of step (b), wherein the mechanically disrupting comprises mechanical milling (relevant to instant claim 1a),
d) fermenting the mechanically disrupted product of step (c) in the reactor of step (b) (relevant to instant claim 1b),
wherein said steps (b)-(d) are repeated N times before obtaining said ethanol or other products, N being an integer equal to or greater than 1 (relevant to instant claim 1).
Claim 7 of patent ‘194 recites the method of claim 1, wherein said at least one microorganism is at least one member selected from the group consisting of Clostridium thermocellum, Clostridium claraflavum, Clostridium cellulolyticum, Caldicellusiruptor bescii, Thermoanaerobacterium saccharolyticum, Thermoanaerobacterium thermosaccharolyticum and combination thereof (relevant to instant claims 9, and 16).
Claim 8 of patent ‘194 recites the method of claim 1, wherein the method does not utilize yeast or purified cellulase (relevant to instant claims 10 and 17).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEEPA MISHRA whose telephone number is (571) 272-6464. The examiner can normally be reached Monday - Friday 8:30am - 1:30pm EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/DEEPA MISHRA/Examiner, Art Unit 1657