CTNF 18/279,251 CTNF 83936 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claim 9, 10, 20, and 21 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. Considering Claim 9 : A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation “the mixture of the ketoacid and water ranges in composition between 0% (v/v) water and 100% (v/v) water”, and the claim also recites “the mixture of the ketoacid and water ranges in composition between about 20% (v/v) water and 30% (v/v) water” which is the narrower statement of the range/limitation. Claim 9 recites the broad recitation “the mixture of the ketoester and water ranges in composition between 0% (v/v) water and 100% (v/v) water”, and the claim also recites “the mixture of the ketoester and water ranges in composition between about 20% (v/v) water and 30% (v/v) water” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. It is not clear if all five of the clauses of claim 9 are required, or if the clauses are different options with only one being required. For the purpose further examination, the clauses are being interpreted as being different options with only one being required. Considering Claim 20 : A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 20 recites the broad recitation “the mixture of the ketoacid and water ranges in composition between 0% (v/v) water and 100% (v/v) water”, and the claim also recites “the mixture of the ketoacid and water ranges in composition between about 20% (v/v) water and 30% (v/v) water” which is the narrower statement of the range/limitation. Claim 20 recites the broad recitation “the mixture of the ketoester and water ranges in composition between 0% (v/v) water and 100% (v/v) water”, and the claim also recites “the mixture of the ketoester and water ranges in composition between about 20% (v/v) water and 30% (v/v) water” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. It is not clear if all five of the clauses of claim 20 are required, or if the clauses are different options with only one being required. For the purpose further examination, the clauses are being interpreted as being different options with only one being required. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1 and 2 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Smit et al. (US 2016/0152736) . Considering Claims 1 : Smit et al. teaches a process comprising obtaining a lignocellulosic biomass (¶0012); adding ethyl levulinate/a gamma ketoester, water/a solvent, and sulfuric acid/a mineral acid to the lignocellulose biomass to obtain a mixture (¶0054, Table 6); treating and filtering the mixture to obtain an extraction filtrate (¶0039); and isolating lignin from the filtrate (¶0054). Smit et al. does not teach that the filtrate is free from cellulose, or that the lignin is stabilized by the ketoester. The Office realizes that all of the claimed effects or physical properties are not positively stated by the reference(s). However, the reference(s) teaches all of the claimed ingredients, in the claimed amounts, and teaches the composition as being made by a substantially similar process. The original specification does not provide any disclosure on how to obtain the claimed properties outside the components of the composition itself. Therefore, the claimed effects and physical properties, i.e. the absence of cellulose from the filtrate, the stabilization of the lignin, and the lignin being free of residual sugar and biomass fractions, would necessarily arise from a process with all the claimed ingredients in the claimed amounts, with the claimed processing steps. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant’s position; and (2) it would be the Office’s position that the application contains inadequate disclosure that there is no teaching enabling a person of ordinary skill in the art to obtain the claimed properties with only the claimed ingredients, absent undue experimentation. Considering Claim 2 : Smit et al. teaches the treating of the lignocellulose as occurring at 140 ºC for 2 hours (¶0054), followed by and filtering the mixture to obtain an extraction filtrate (¶0039) . 07-15 AIA Claim s 11-21 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Smit et al. (US 2016/0152736) . Considering Claims 11 and 12 : Smit et al. teaches a lignin prepared by a process comprising obtaining a lignocellulosic biomass (¶0012); adding ethyl levulinate/a gamma ketoester, water/a solvent, and sulfuric acid/a mineral acid to the lignocellulose biomass to obtain a mixture (¶0054, Table 6); treating and filtering the mixture to obtain an extraction filtrate (¶0039); and isolating lignin from the filtrate (¶0054). Smit et al. does not teach that the filtrate is free from cellulose, or that the lignin is stabilized by the ketoester. The Office realizes that all of the claimed effects or physical properties are not positively stated by the reference(s). However, the reference(s) teaches all of the claimed ingredients, in the claimed amounts, and teaches the composition as being made by a substantially similar process. The original specification does not provide any disclosure on how to obtain the claimed properties outside the components of the composition itself. Therefore, the claimed effects and physical properties, i.e. the absence of cellulose from the filtrate, the stabilization of the lignin, and the lignin being free of residual sugar and biomass fractions, would necessarily arise from a process with all the claimed ingredients in the claimed amounts, with the claimed processing steps. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant’s position; and (2) it would be the Office’s position that the application contains inadequate disclosure that there is no teaching enabling a person of ordinary skill in the art to obtain the claimed properties with only the claimed ingredients, absent undue experimentation. Considering Claim 13 : Smit et al. teaches the treating of the lignocellulose as occurring at 140 ºC for 2 hours (¶0054), followed by and filtering the mixture to obtain an extraction filtrate (¶0039). Considering Claim 14 : The instant claim is a product by process claim. "[E]ven though product-by-process claims are limited by and defined by the process, 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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). There is no evidence that the claimed concentrating and drying steps materially alter the structure of the lignin itself. As such, the process of Smit et al. would substantially have the same structure as the claimed lignin. Considering Claims 15-17 : Smit et al. teaches the ketoester as being ethyl levulinate. Considering Claim 18 : Smit et al. teaches a composition comprising the lignin (¶0054). Considering Claim 19 : Smit et al. teaches the solvent as being a mixture of ethyl levulinate and water at 50:50 ratio (Table 6). Considering Claim 20 : Smit et al. teaches the mineral acid as being sulfuric acid (¶0054) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-22-aia AIA Claim 3-10 is rejected under 35 U.S.C. 103 as being unpatentable over Smit et al. (US 2016/0152736) as applied to claim 1 above, and further in view of Holtz et al. (Separation and Purification Technology 236 (2020) 116295) . Considering Claim 3: Smit et al. teaches the process of claim 1 as shown above. Smit et al. teaches isolating the lignin by mixing with an antisolvent. However, Smit et al. does not teach the claimed isolation procedure. Holtz et al. teaches isolating lignin from an organosolv process by pre-evaporation of the solvent at reduced pressure, addition of an antisolvent to isolate the lignin, followed by drying the isolated lignin at 40 ºC/about 45 ºC and 10 mbar pressure for 24 hours (Fig. 1, Section 2.3.2). Holtz et al. does not teach the claimed pre-evaporation conditions. Generally, differences in concentration or temperature 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). See MPEP § 2144.05. A person of ordinary skill in the art would recognize the pressure, temperature and reaction time as controlling the degree of evaporation and the amount of energy needed for the process. It would have been obvious to a person of ordinary skill in the art to have used the precipitation process of Holtz et al., and to optimize the evaporation conditions, as the precipitation process of Smit et al., and the motivation to do so would have been, as Holtz et al. suggests, to provide low energy consumption and effective antisolvent recovery (Abstract). Considering Claim 4 : Smit et al. does not teach that the filtrate is free from residual sugars and biomass fractions. The Office realizes that all of the claimed effects or physical properties are not positively stated by the reference(s). However, the reference(s) teaches all of the claimed ingredients, in the claimed amounts, and teaches the composition as being made by a substantially similar process. The original specification does not provide any disclosure on how to obtain the claimed properties outside the components of the composition itself. Therefore, the claimed effects and physical properties, i.e. the lignin being free of residual sugar and biomass fractions, would necessarily arise from a process with all the claimed ingredients in the claimed amounts, with the claimed processing steps. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant’s position; and (2) it would be the Office’s position that the application contains inadequate disclosure that there is no teaching enabling a person of ordinary skill in the art to obtain the claimed properties with only the claimed ingredients, absent undue experimentation. Considering Claims 5-7 : Smit et al. teaches the ketoester as being ethyl levulinate. Considering Claims 8 and 9 : Smit et al. teaches the solvent as being a mixture of ethyl levulinate and water at 50:50 ratio (Table 6). Considering Claim 10 : Smit et al. teaches the mineral acid as being sulfuric acid (¶0054) . 07-22-aia AIA Claim s 14-21 is rejected under 35 U.S.C. 103 as being unpatentable over Smit et al. (US 2016/0152736) as applied to claim 13 above, and further in view of Holtz et al. (Separation and Purification Technology 236 (2020) 116295) . Note: The following rejection is an alternative to the product-by-process rejection of claim 14 set forth above. Considering Claim 14: Smit et al. teaches the lignin of claim 13 as shown above. Smit et al. teaches isolating the lignin by mixing with an antisolvent. However, Smit et al. does not teach the claimed isolation procedure. Holtz et al. teaches isolating lignin from an organosolv process by pre-evaporation of the solvent at reduced pressure, addition of an antisolvent to isolate the lignin, followed by drying the isolated lignin at 40 ºC/about 45 ºC and 10 mbar pressure for 24 hours (Fig. 1, Section 2.3.2). Holtz et al. does not teach the claimed pre-evaporation conditions. Generally, differences in concentration or temperature 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). See MPEP § 2144.05. A person of ordinary skill in the art would recognize the pressure, temperature and reaction time as controlling the degree of evaporation and the amount of energy needed for the process. It would have been obvious to a person of ordinary skill in the art to have used the precipitation process of Holtz et al., and to optimize the evaporation conditions, as the precipitation process of Smit et al., and the motivation to do so would have been, as Holtz et al. suggests, to provide low energy consumption and effective antisolvent recovery (Abstract). Considering Claims 15-17 : Smit et al. teaches the ketoester as being ethyl levulinate. Considering Claim 18 : Smit et al. teaches a composition comprising the lignin (¶0054). Considering Claim 19 : Smit et al. teaches the solvent as being a mixture of ethyl levulinate and water at 50:50 ratio (Table 6). Considering Claim 20 : Smit et al. teaches the mineral acid as being sulfuric acid (¶0054). Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIAM J HEINCER whose telephone number is (571)270-3297. The examiner can normally be reached M-F 7:30-5:00. 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, Mark Eashoo can be reached at 571-272-1197. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /LIAM J HEINCER/Primary Examiner, Art Unit 1767 Application/Control Number: 18/279,251 Page 2 Art Unit: 1767 Application/Control Number: 18/279,251 Page 3 Art Unit: 1767 Application/Control Number: 18/279,251 Page 4 Art Unit: 1767 Application/Control Number: 18/279,251 Page 5 Art Unit: 1767 Application/Control Number: 18/279,251 Page 6 Art Unit: 1767 Application/Control Number: 18/279,251 Page 7 Art Unit: 1767 Application/Control Number: 18/279,251 Page 8 Art Unit: 1767 Application/Control Number: 18/279,251 Page 9 Art Unit: 1767