DETAILED ACTION
Claims 1 and 5-18 are pending and under consideration on the merits.
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 .
Status of the Rejections
The 101 rejection is withdrawn in light of the amendment and Applicant’s arguments. The decomposition treatment steps recited by amended base claims 1 and 10-11 result in the extract possessing markedly different structure than naturally occurring bagasse.
The 112(b) rejections are withdrawn in light of the amendment.
The 103 rejection over Heinonen, Zheng, Illag, and Lacho-Perez is revised and expanded to include additional claims in view of the amendment and the remaining 103 rejections are withdrawn in view of the amendment, and a new 103 rejection is applied over newly added claims 17-18.
The claims remain under a double patenting rejection.
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.
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.
Claims 1 and 5-16 are rejected under 35 U.S.C. 103 as unpatentable over Heinonen et al. (Advances in Chemical Engineering, Volume 42, Chapter 5 (2013); of record in IDS of 6/28/24) in view of Zheng et al. (Industrial crops and Products 101 (2017) 104-114; of record in IDS of 6/28/24), Ilag et al. (US Pat. Pub. 2014/0357583; of record in IDS), Lachos-Perez et al. (J. of Supercritical Fluids 108 (2016) 69-78), and Talha et al. (Biomed Res Intl. 2016 Sep 21;2016:8650597).
As to claims 1 and 5-16, Heinonen discloses the hydrolysis of biomass comprising lignocellulosic materials using an acid treatment to form a decomposed liquid, wherein the biomass may be bagasse from sugarcane (Abstract and Table 5.1 on page 265). The hydrolyzed bagasse is then fractionated using chromatographic/adsorption techniques in order to separate and recover the monosaccharide fraction, hydrolysis acid fraction, and byproduct/phenol fractions (“bagasse decomposition extracts”)(pages 262-264 and Section 4 on pages 285-286). The chromatographic technique may involve using polystyrene-divinylbenezene (PS-DVB) as the fixed carrier (a “fixed carrier” of the base claims and claim 7 that is a “synthetic adsorbing agent” and an “ion exchange resin” of claims 1, 7, 10-11, and 14-15 and which is also an unsubstituted aromatic resin of claims 6-7 and 16), and wherein the bagasse decomposition extract is a fraction obtained by allowing the decomposed liquid to pass through a column comprising the synthetic adsorbing agent and eluting an adsorbed component using a solvent comprising a mixture of water and an organic solvent such as ethanol as recited by claims 1, 5, 7, 10-11 (Sections 3 and 3.1 on pages 274-275 and Section 4.1.4 on page 291; Table 5.4 on page 316). Heinonen discloses that the purpose of adding ethanol to the aqueous solvent is to either increase or decrease the distribution coefficient of the adsorbing components between the bulk solution phase and solution phase inside the resin pores (first paragraph of Section 4.1.4 on page 291). Heinonen further discloses the influence of temperature on the chromatographic separation process, and teaches that when separating glucose monosaccharide and sulfuric acid using a PS-DVB resin, the highest efficiency was obtained at a temperature of 55 or 68 degrees Celsius, 55 degrees being within the range recited by claim 7 (page 308, 1st paragraph).
As to claims 1 and 5-16, Heionen does not further expressly disclose a flavor improving method as recited by claim 1 due to enhancing of preferred flavors in food or drink (claims 8 and 10) or reducing unpleasant flavors of food or drink (claim 9) or an unpleasant flavor reducing method (claim 11), wherein the method comprises adding an effective amount of the bagasse decomposition extract as an active ingredient to food or drinks. Nor does Heionen expressly teach that the decomposition treatment is a hydrothermal treatment using water or water vapor having a temperature higher than 130 degrees Celsius with an applied pressure of from 0.1 to 4 MPa (claims 1, 10-11, and 13), or an alkaline treatment at a temperature of 150 degrees Celsius in a 0.5% sodium hydroxide aqueous solution as recited by base claims 1 and 10-12, nor the volume ratio of ethanol/water in the mixed solvent is 50/50 to 60/40 as recited by claim 7.
Zheng teaches that sugarcane bagasse is a promising raw material for recovering bioactive substances (Abstract). Zheng teaches that bagasse is abundant with phytochemicals such as phenolics, triterpenoids, phytosterols, and lignins, and that previous work had shown that bagasse-derived products have antioxidant, antibiotic, antiproliferative, anti-mutation, and DNA-damage protecting activity (paragraph bridging pages 104-105). Zheng assessed and identified the phenolic content of bagasse using UHPLC-HR-TOFM. Id. Zheng found that ethanolic extracts of bagasse exhibited dose-dependent antioxidant activity resulting from phenolic content (Section 3.3) and concludes that sugarcane bagasse is an excellent source of antioxidants for use in the cosmetic and pharmaceutical industries (Section 4 on page 114).
Ilag is directed to extracts produced from sugar cane (paragraph 1) including sugar cane extracts with a high abundance of polyphenols (paragraphs 14-15), and further teaches incorporating said extracts into a food composition in methods of decreasing body fat and improving energy levels and post-prandial satiety (paragraphs 38-42).
Lachos-Perez discloses that breaking down the lignocellulosic complex of sugarcane bagasse is usually achieved by hydrolysis of the cellulose and hemicellulose components into sugars, and that the methods usually employed for the hydrolysis include acid or alkaline treatments, but that these techniques are corrosive, use toxic solvents, and require neutralization of the medium after reaction, generating solid waste (Introduction section on page 69). Lachos-Perez teaches that “subcritical water” is also known as “hydrothermal water,” and is defined as water at a temperature ranging from between 100 and 374 degrees Celsius (which encompasses the temperature recited by the present claims) and maintained under sufficiently high pressure to maintain the water in its liquid state (page 70, 1st paragraph). Lachos-Perez discloses that subcritical water hydrolysis is an environmentally innocuous, non-toxic, and safe proves that can be used as an alternative to acid or alkaline treatment for the breaking down of the cellulose and hemicellulose biopolymers in bagasse (Abstract; page 70, 2nd paragraph; and Section 4).
Talha discloses an alkaline pretreatment of sugarcane bagasse to enhance its degradation, the pretreatment comprising treating the bagasse with 1 N NaOH at 100 degrees Celsius (Abstract).
As to claims 1 and 5-16, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the teachings of Heionen by adding it to a food, because Heionen expressly teaches obtaining phenolic fractions from the bagasse and Zheng teaches that bagasse possesses polyphenols having beneficial effects including antioxidant, antibiotic, antiproliferative, anti-mutation, and DNA-damage protecting activity such that bagasse is useful for administration via cosmetics and pharmaceuticals, and Ilag also teaches that a sugarcane extract comprising polyphenols has beneficial effects such as improving energy and enhancing fat loss and that to obtain these benefits in a subject the sugar cane extract may be formulated into a food, such that the skilled artisan would have reasonably expected that the beneficial effects of the Heionen polyphenol-rich bagasse sugarcane extract also could be obtained by incorporating it into a food for oral consumption for administration to the subject, and that incorporation into a food would have the advantage of making the administration to the subject more appealing than if the extract were incorporated into the form of a nutraceutical or a pharmaceutical, such as a pill requiring swallowing.
It further would have been prima facie obvious to obtain the bagasse decomposition extract via an alkaline treatment or a hydrothermal treatment as recited by claims 1 and 10-11 with a reasonable expectation of success, because Lachos-Perez teaches that alkaline and subcritical water/hydrothermal hydrolysis are known suitable alternatives to the use of an acid treatment for obtaining a bagasse decomposition extract, and further teaches that a subcritical water/hydrothermal has the advantage of being more environmentally sound than an acid treatment.
It would have been prima facie obvious to use 0.5% wt% NaOH as the type of alkaline treatment and to select a temperature of 150 degrees Celsius for the treatment, because Talha expressly teaches that sodium hydroxide aqueous solution may be used as the type of alkaline treatment used to degrade sugarcane bagasse, and because the sodium hydroxide is the hydrolysis agent for the bagasse such that its amount is a result effective variable that will affect its ability to hydrolyze the bagasse and because the skilled artisan would recognize that the temperature is a result effective variable that will affect the efficacy of the hydrolysis because higher temperatures will provide more energy to hydrolyze the bonds within the bagasse, and with a reasonable expectation of success because the skilled artisan would have been optimizing these amounts for the same function (of obtaining a bagasse decomposition extract) that the sodium hydroxide and enhanced temperature are providing in the presently claimed method. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
It further would have been prima facie obvious to select a pressure for the hydrothermal treatment that is within the presently claimed range, because the pressure is a result effective variable that will affect the ability to maintain the water in its liquid state as taught by Lachos-Perez, and with a reasonable expectation of success because the skilled artisan would have been optimizing this amount for the same function that the pressure is providing in the presently claimed method (i.e., to obtain a hydrolyzed bagasse decomposition extract). Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The bagasse decomposition extract that is added to the food by the resulting method will improve the flavor of the food as recited by claim 1 by enhancing preferred flavors of the food as recited by claim 8 and by reducing unpleasant flavors in the food as recited by claim 9, because it is the same product recited by the claims and a product cannot be separated from its properties. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
Regarding claim 7, it further would have been prima facie obvious to select a ratio of ethanol to water that is within the recited range, since Heionen teaches that the ethanol will alter the distribution coefficient of the adsorbing components between the bulk solution phase and solution phase inside the resin pores, such that the skilled artisan would recognize the amount of ethanol relative to the water as being a result effective variable that will affect the ability to successfully separate the acid, monosaccharide, and byproduct fractions, and there would be a reasonable expectation of arriving at the claimed ratio because the Heionen adds ethanol to the water solvent for the same purpose as the present invention, to alter the distribution coefficient of the adsorbing components between the bulk solution phase and solution phase. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Applicant’s Arguments
Applicant’s arguments will be addressed to the extent they may be relevant to the new grounds of rejection.
Applicant argues that Lachos-Perez does not disclose the 0.1 to 4 Mpa pressure range recited by the claims as amended.
In response, this is not persuasive because, as discussed in the new grounds of rejection, It would have been prima facie obvious to select a temperature of 150 degrees Celsius and to use a concentration of 0.5% wt% for the sodium hydroxide in the alkaline treatment, because the sodium hydroxide is the hydrolysis agent for the bagasse such that its amount is a result effective variable that will affect its ability to hydrolyze the bagasse and because the skilled artisan would recognize that the temperature is a result effective variable that will affect the efficacy of the hydrolysis because higher temperatures will provide more energy to hydrolyze the bonds within the bagasse, and with a reasonable expectation of success because the skilled artisan would have been optimizing these amounts for the same function of obtaining a hydrolyzed bagasse decomposition extract that the sodium hydroxide and enhanced temperature are providing in the presently claimed method. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
New Rejection
Claims 17-18 are rejected under 35 U.S.C. 103 as unpatentable over Heinonen et al. (Advances in Chemical Engineering, Volume 42, Chapter 5 (2013); of record in IDS of 6/28/24) in view of Zheng et al. (Industrial crops and Products 101 (2017) 104-114; of record in IDS of 6/28/24), Ilag et al. (US Pat. Pub. 2014/0357583; of record in IDS), Lachos-Perez et al. (J. of Supercritical Fluids 108 (2016) 69-78), and Talha et al. (Biomed Res Intl. 2016 Sep 21;2016:8650597) as applied to claims 1 and 5-16 above, and further in view of JP2011032240A as evidenced by the English translation thereof.
The teachings of Heinonen, Illag, Lachos-Perez, and Talha are relied upon as discussed above, but they do not further expressly disclose that the synthetic adsorbing agent comprisies an acrylic acid-based methacrylic resin (claim 17) or an acrylonitrile aliphatic resin (claim 18).
JP2011032240 discloses extracts obtained from sugarcane bagasse via extraction with a solvent (paragraph 7), followed by passage of the extraction mixture through a column packed with a synthetic adsorbent such as an aromatic, methacrylic acrylic acid, or aliphatic acrylonitrile resins (paragraphs 24-25).
As to claims 17-18, it would have been prima facie obvious to modify the method of Heinonen, Illag, Lachos-Perez, and Talha as combined supra by replacing the aromatic resin in the column with a methacrylic acrylic acid or aliphatic acrylonitrile resin, because JP2011032240 teaches that these resins are suitable alternatives to an aromatic resin for use as a synthetic adsorbing agent in a column when filtering a sugarcane extract, such that the skilled artisan reasonably would have expected they could be used to filter the sugarcane bagasse extract in the modified prior art method discussed above. Such a modification is merely the simple substitution of one known element for another according to known methods to achieve predictable results, which is prima facie obvious. MPEP 2143.
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 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.
Claims 1 and 5-18 are rejected on the ground of nonstatutory double patenting as unpatentable over claims 1-14 of US Pat. No. 12,036,311 and in view of Zheng et al. (Industrial crops and Products 101 (2017) 104-114)), Lachos-Perez et al. (J. of Supercritical Fluids 108 (2016) 69-78), JP2011032240A as evidenced by the English translation thereof, and/or Ilag et al. (US Pat. Pub. 2014/0357583 where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a deodorant composition comprising a bagasse decomposition extract obtained by allowing a decomposed liquid obtained by subjecting the bagasse to an alkaline treatment at a temperature of 150 degrees Celsius in a 0.5 wt% sodium hydroxide aqueous solution or hydrothermal treatment using water having a temperature higher than 130 degrees Celsius and allowing the decomposed liquid to pass through a column filled with a synthetic adsorbing agent or ion exchange resin fixed carrier such as an unsubstituted aromatic resin, wherein the column has a temperature of 20-60 degrees Celsius and a volume ratio of ethanol and water of 50/50 to 60/40 is used as the solvent eluting agent.
Although the reference claims do not recite that the pressure used during the hydrothermal treatment is within the presently claimed range, it would have been prima facie obvious to select such a pressure because the pressure is a result effective variable that will affect the ability to maintain the water in its liquid state as taught by Lachos-Perez, and with a reasonable expectation of success because the skilled artisan would have been optimizing this amount for the same function that the pressure is providing in the presently claimed method (i.e., to obtain a hydrolyzed bagasse decomposition extract). Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Although the reference claims do not recite a flavor improving method comprising adding the extract to a food or drink, it would have been prima facie obvious to do so in light of the fact that Zheng teaches that bagasse possesses polyphenols having beneficial effects including antioxidant, antibiotic, antiproliferative, anti-mutation, and DNA-damage protecting activity such that bagasse is useful for administration via cosmetics and pharmaceuticals, and Ilag also teaches that a sugarcane extract comprising polyphenols has beneficial effects such as improving energy and enhancing fat loss and that to obtain these benefits in a subject the sugar cane extract may be formulated into a food, such that the skilled artisan would have reasonably expected that the beneficial effects of the bagasse sugarcane extract of the reference claims also could be obtained by incorporating it into a food for oral consumption for administration to the subject, and that incorporation into a food would have the advantage of making the administration to the subject more appealing than if the extract were incorporated into a pharmaceutical, such as a pill requiring swallowing.
Although the reference claims do not recite that the synthetic adsorbing agent comprisies an acrylic acid-based methacrylic resin or an acrylonitrile aliphatic resin, it would have been prima facie obvious to replace the aromatic resin with a methacrylic acrylic acid or aliphatic acrylonitrile resin, because JP2011032240 teaches that these resins are suitable alternatives to an aromatic resin for use as a synthetic adsorbing agent in a column when filtering a sugarcane extract, such that the skilled artisan reasonably would have expected they could be used to filter the sugarcane bagasse extract in the reference claims. Such a modification is merely the simple substitution of one known element for another according to known methods to achieve predictable results, which is prima facie obvious. MPEP 2143.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case.
Response to Applicant’s Arguments
Applicant argues that the amended claims are not rendered obvious by the reference claims.
In response, Applicant’s arguments are conclusory and do not specify why the amended claims are not obvious. The claims are considered obvious for the reasons discussed in the rejection, which is therefore maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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