DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
CONTINUING DATA
This application has PRO 63/353,051 06/17/2022
This application has PRO 63/313,785 02/25/2022
Claims 21-37 are pending.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 21-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen (US 20200046008A1, cited on IDS) in view of Buchholt (WO 2015/091629 A1, cited on IDS).
Hansen teaches a process wherein citrus peel was activated by contacting with 60% isopropyl alcohol and nitric acid under mechanical energy at 70°C [0125]. The acid treatment is done at a pH of about 1 to 2 [0077]. This corresponds to current claim steps (a) and (b).
Next, the sample mixture was drained using a Vincent press [0127], corresponding to step (c). The activated pectin-containing biomass composition can be dried into a dry particulate form [0033]].
Next, the drained sample was washed with 60% isopropyl alcohol at pH 3.5, dried, and milled [0127], corresponding to claimed step (d) and (e). The washing pH in another example was 4.0 [0131]. The pH was adjusted using sodium carbonate. The washing can be carried out using aqueous solution of alcohol containing as low as 35% alcohol, and the pH of the washing liquid is about 4.5 [0070]. The washing can be carried out more than once [0144].
Hansen’s aqueous mixture in claimed step (d) contained more than 10% of alcohol. Regarding current claims 22-23, Hansen does not teach adjustment of the pH before step (c). Regarding current claims 33-35, Hansen does not teach multiple extraction steps after (d).
Buchholt teaches acid extraction of pectin from citrus peels at pH 2.0. Excess liquid was separated by sieve and the first residuum was washed with water. After a second sieving, the second residuum was further extracted at pH 3.8. The mixture was separated by centrifugation and the third residuum washed again with water. The product was dried and milled. Paragraph bridging pages 25-26. Using more extraction steps increases the yield of pectin. End of page 29. The pH of the second extraction should be higher than the pH of the first extraction. End of page 34. Washing more than once improves the purity. Top of page 36. At the first low pH, a major amount of calcium tolerant pectin but only a minor amount of CSP will be extracted. Page 7. Having a second extraction results in the release of an extra amount of pectin, and the pH of the second or third extractions must be higher than the pH of the first extraction. Page 11. Pectin can be isolated from each extract separately. Page 9, lines 19-24.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to carry out Hansen’s washing step using aqueous alcohol of no more than 10% because Hansen teaches that varying amounts of alcohol may be used for the washing step, and Buchholt teaches that water itself can be used for washing. Hansen and Buchholt together teach washing using 0% alcohol, or 35% alcohol, or 60% alcohol, or more. The combined teachings suggest a range (0 to 60% or more) which overlaps with the claimed 0-10%. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. A range can be disclosed in multiple prior art references instead of in a single prior art reference. MPEP 2144.05.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to gradually increase the pH as recited in current claims 22-23 because Buchholt teaches that multiple extraction steps of increasing pH provide increased yield of pectin.
The skilled artisan would have optimized the solids content in step (c) using routine experimentation in order to obtain the optimal amount of soluble pectin from the mixture. MPEP 2144 states that differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating that such concentration is critical.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to further extract the solid fraction after step (d) because an additional extraction step would be expected to provide more pectin which might have been left behind from the first extraction step.
The limitation of claim 25 was inherently met because Hansen teaches extraction of the same biomass using the same acidic conditions.
The “wherein” clauses in claims 29 and 36-37 do not require steps to be performed and only recite intended results of the method, and so do not limit claim scope. Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure, and a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. MPEP 2111.04.
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 21-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10287366 in view of Hansen and Buccholdt.
The ‘366 patent claims mixing pectin-containing biomass with an aqueous solution of alcohol and acid at a pH of 0.5-2.5, wherein the amount of alcohol is greater than 40 weight percent, and wherein mechanical energy is applied. Claim 1. Drying and milling the activated pectin-containing biomass is claimed (claim 13). The starting material is citrus peel (claim 15).
The ‘366 patent does not claim current steps (d) and (e).
Hansen and Buccholdt teach as set forth above.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to carry out the ‘366 method followed by current steps (d) and (e) because Hansen teaches further processing of the activated pectin, including washing, isolating, and drying. The skilled artisan would have carried out the additional steps in order to obtain purified pectin.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to carry out the washing step using aqueous alcohol of no more than 10% because Hansen teaches that varying amounts of alcohol may be used for the washing step, and Buchholt teaches that water itself can be used for washing. Hansen and Buchholt together teach washing using 0% alcohol, or 35% alcohol, or 60% alcohol, or more. The combined teachings suggest a range (0 to 60% or more) which overlaps with the claimed 0-10%. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. A range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case. MPEP 2144.05.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to gradually increase the pH as recited in current claims 22-23 because Buchholt teaches that multiple extraction steps of increasing pH provide increased yield of pectin.
The skilled artisan would have optimized the solids content in step (c) using routine experimentation in order to obtain the optimal amount of soluble pectin from the mixture. MPEP 2144 states that differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating that such concentration is critical.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to further extract the solid fraction after step (d) because an additional extraction step would be expected to provide more pectin from any that might have been left behind from the first extraction step.
The limitation of claim 25 would have been inherently met because the reference patent claims extraction of the same biomass using the same acidic conditions.
The “wherein” clauses in claims 29 and 36-37 do not require steps to be performed and only recite intended results of the method, and so do not limit claim scope. Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure, and a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. MPEP 2111.04.
Conclusion
No claims are allowed.
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/LAYLA D BERRY/ Primary Examiner, Art Unit 1693