DETAILED ACTION
Claims 1-11 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/28/24, 8/9/24, and 5/20/25 filed prior to the mailing date of a first Action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11 are rejected under 35 U.S.C. 101 as not satisfying the utility requirement because they are directed to a nature-based product.
Claims 1-11 are drawn to processes, which are one of the four categories of statutory subject matter. Therefore, whether the claims lack utility is determined by whether the claims are directed to a judicial exception, and, if so, whether the claims include additional elements that are sufficient to amount to significantly more than the judicial exception, using the Step 2A Prong One, Step 2A Prong Two, and Step 2B analysis. See MPEP 2106.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature or natural phenomenon?
This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(II), a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
Base claims 1, 10, and 11 are each directed to a method of comprising adding an effective amount of bagasse decomposition extract to a food or drink in order to improve flavor (claim 1), to enhance flavor (claim 10), or to reduce unpleasant flavor (claim 11). The bagasse decomposition extract has a natural origin. The present specification teaches that bagasse, from which the extract is obtained, is the portion of sugarcane that remains after the sugar juice has been removed (paragraph briding pages 15-16). Therefore, the claimed method is focused on the addition of naturally occurring ingredients to food or drink.
Since the process is focused on the administration of naturally-occurring components, the claim is ‘directed to’ a nature-based product. Since the claims recite a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart is naturally occurring sugarcane. There is no indication that the removal of sugar juice from the sugarcane would change the structure, function or other characteristics of the individual ingredients of the bagasse in any way. Rather, it is expected that they would retain their naturally-occurring structure and function based upon the evidence of record.
Therefore, claims 1 and 10-11 recite a product of nature exception. Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are “products of nature” which cannot be patented). Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d)II.
Claims 1-11 recite an additional element beyond the natural component of bagasse decomposition extract in that the component is part of a method of improving flavor by adding the extract to food or drink. The process steps of adding an effective amount of the bagasse decomposition extract are written at a high level of generality, and the process of adding the extract does not impart any distinct qualities or characteristics to the components. The recitations of the claim preambles to “flavor improving” (claim 1), “flavor enhancing” (claim 10), and “unpleasant flavor reducing” (claim 11) merely indicate the results of the methods but do not provide any further limit to the incorporation step. As a result, the active steps of the claims are broad and routine. The step of “adding” does not provide a technical improvement that clearly defines a practical application of the natural products and does not distinguish the invention from any purely natural phenomenon. The recitation of claim 2 that the extract is a liquid obtained by a decomposition treatment, and the limitations of claims 3-7 that the extract is obtained by passing the decomposed liquid through a column filled with a synthetic adsorbing agent do not alter the structures or characteristics of the components of the original bagasse based upon the evidence of record, and which would clearly define a practical application of the natural product and distinguish the invention from any purely natural phenomenon. Therefore, the process steps of claims 1-11 are routine and conventional in the art and do not integrate the product of nature exception into a practical application and the claim is therefore directed to the judicial exception.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As discussed with respect to Step 2A Prong Two, the process step of claims 1-11 are broad and routine and readily available to one of ordinary skill in the art and do not result in an alteration of the natural components. Therefore, claims 1-11 do not include any additional element which would amount to ‘significantly more’ than the judicial exception itself and thus the claims as a whole do not amount to significantly more than the judicial exception.
Conclusion: Claims 1-11 are not markedly different in structure or function as compared to the closest naturally-occurring counterpart. Consequently, claims 1-11 are directed toward a judicial exception under 35 USC 101. Claims 3-9 do not recite any element which would be considered to provide ‘significantly more’ than the judicial exception.
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.
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.
Claims 2-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as 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.
Claim 2 recites a “decomposed liquid is obtained by at least one decomposition treatment,” which is unclear because it is unknown what is undergoing the decomposition treatment in order to obtain the decomposed liquid. Is it the bagasse? Since dependent claims 3-7 do not clarify the point of confusion, they are also rejected.
Claim 3 recites that the bagasse decomposition extract is “a fraction obtained by allowing the decomposed liquid to pass through a column filled with a fixed carrier.” This limitation is unclear, because the identity of the bagasse decomposition extract is unknown. Is it the decomposed liquid after it has passed through the column. Is it a fraction that remains adsorbed to the column after passage of the decomposed liquid through the column? Clarification is required. Since dependent claims 4-6 do not clarify the point of confusion, they are also rejected.
Claim 7 recites that the bagasse decomposition extract is “a fraction obtained by allowing the decomposed liquid to pass through a column” and “eluting a component adsorbed on the synthetic adsorbing agent in a mixed solvent of ethanol and water.” This limitation is unclear, because the identity of the bagasse decomposition extract is unknown. Is it the component that is adsorbed and eluted in the mixed solvent of ethanol and water, or is it a fraction that remains adsorbed to the column after the recited component is eluted using a mixed solvent of ethanol and water? Clarification is required.
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 1-2 and 8-11 are rejected under 35 U.S.C. 103 as unpatentable over Inafuku et al. (US Pat. Pub. 2008/0248161).
As to claims 1-2 and 8-11, Inafuku discloses a bagasse decomposition extract comprising a dietary fiber, said extract being an aqueous liquid obtained by subjecting bagasse to a steam treatment followed by an explosion treatment (a “blasting treatment” of claim 2) (see Title and claim 1 of Inafuku). Inafuku further teaches a method of adding the bagasse decomposition extract to a food or a drink as a health supplement (paragraph bridging columns 6-7).
As to claims 1-2 and 8-11, Inafuku does not further expressly disclose that the method improves flavor (claim 1), enhances flavor (claims 8, 10), or reduces unpleasant flavor (claims 9 and 11). The bagasse decomposition extract that is added to the food by the Inafuku method, however, will improve the flavor of the food as recited by claim 1 by enhancing preferred flavors of the food as recited by claims 8 and 10 and by reducing unpleasant flavors in the food as recited by claims 9 and 11, 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.
Claims 1-11 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) and Ilag et al. (US Pat. Pub. 2014/0357583; of record in IDS).
As to claims 1-11, Heionen discloses the hydrolysis of biomass comprising lignocellulosic materials using an acid treatment (claim 2) 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 claim 3 that is a “synthetic adsorbing agent” as an “ion exchange resin” of claims 4 and 7, and which is also an unsubstituted aromatic resin of claims 6-7), 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 3, 5, and 7 (Sections 3 and 3.1 on pages 274-275 and Section 4.1.4 on page 291). 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 1-11, Heionen does not further expressly disclose a flavor improving method (claims 1-10) 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 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)
As to claims 1-11, 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.
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).
Claims 2-7 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) and Ilag et al. (US Pat. Pub. 2014/0357583) as applied to claims 1-11 above, and further in view of Lachos-Perez et al. (J. of Supercritical Fluids 108 (2016) 69-78).
The teachings of Heinonen, Zheng, and Illag are relied upon as discussed above, but they do not further expressly disclose that the decomposition treatment is a hydrothermal, alkaline, or subcritical water treatment as recited by claim 2. 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 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).
As to claims 2-7, 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 method of Heinonen, Zheng, and Illag as combined supra by obtaining the bagasse decomposition extract via an alkaline treatment or a subcritical water/hydrothermal hydrolysis treatment 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.
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 1-11 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) 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 or hydrothermal treatment 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 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.
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.
Conclusion
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600