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 .
Status of the Application
The status of the claims stands as follows:
Pending claims: 13-30
Canceled claims: 1-12
Claims currently under consideration: 13-30
Currently rejected claims: 13-30
Allowed claims: None
Claim Objections
Applicant is advised that should claims 16 and 17 be found allowable, claims 24 and 25 will be objected to under 37 CFR 1.75 as being substantial duplicates thereof, respectively. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
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 13-30 are rejected under 35 U.S.C. 103 as being unpatentable over Akimitsu et al. (hereinafter, “Akimitsu I”) (WO2020/096006, with citations to US 2021/0324434 A1 as the English translation) in view of Akimitsu et al. (hereinafter, “Akimitsu II”) (WO2020/105709, with citations to US 2021/0395718 A1 as the English translation)
Regarding claim 1, Akimitsu I discloses a method for producing a sweetener containing D-glucose, D-fructose, and D-allulose, the sweetener having functionality of D-allulose (in that the mixed sweetener may be used in a comparable manner as D-allulose for purposes of sweetening food products) and having a taste quality close to that of sugar ([0016]), the method comprising: (i) providing a raw material containing D-glucose and D-fructose ([0019]), (ii) performing isomerization of D-fructose in the raw material using a ketose 3-epimerase ([0019]) that may be D-allulose 3-epimerase ([0210], Fig. 1) and terminating the reaction at a stage when the D-allulose content reaches a target concentration (where the reaction will necessarily cease when equilibrium is reached or subsequent processing produces conditions no longer conducive to enzymatic activity), and (iii) obtaining an intended product having a D-fructose content ([0019]), where the method is performed without using simulated moving bed chromatography ([0019], where no such step is disclosed).
Regarding the scale of the claimed method, MPEP 2144.04 IV A indicates that changes in size/proportion are not sufficient to patentably distinguish over the prior art. The limitations requiring (i) the method to be for “mass-producing” the sweetener and (ii) achieving world-scale mass production thus do not distinguish the claimed method from the prior art and are consequently considered obvious, since the prior art method is presumably capable of being scaled up.
Regarding the limitations requiring “an inexpensive composition” and “sufficient price competitiveness”, MPEP 2145 VII indicates that economic factors do not weigh into consideration of patentability, where there is a technical or other reason to perform a method in a particular manner. Further, “sufficient price competitiveness” would not necessarily be consistent, in that the price of performing the claimed method may decrease with reduced raw material costs, efficiencies of increased scale, or lowered demand due to lack of consumer acceptance or alternative superior products. As such, the claimed limitations requiring “an inexpensive composition” and “sufficient price competitiveness” are considered obvious to a skilled practitioner.
The claimed limitation requiring the D-fructose content in the intended product to be “in a range that compensates for a weak point of D-allulose in a sweetness degree and gives the intended product a taste quality close to that of sugar in cooperation with D-allulose and D-glucose” does not require any real limitation on the method absent any required component concentrations, so long as D-fructose, D-allulose, and D-glucose are present in the intended product. That is, any concentration of D-fructose may be said to “compensate for a weak point of D-allulose in sweetness degree” and synergistically interact with the other two components upon consumption, at least to some minimal degree, which would fall within the scope of the limitation. The claimed limitation is thus deemed obvious.
Akimitsu I does not disclose the enzyme as being “D-allulose 3-epimerase having high heat resistance and high productivity and derived from Arthrobacter histidinolovorans”.
However, Akimitsu II discloses D-allulose 3-epimerase having high heat resistance and high productivity and being derived from Arthrobacter histidinolovorans ([0019], [0021], [0029]).
It would have been obvious to one having ordinary skill in the art to incorporate the enzyme disclosed in Akimitsu II into the method disclosed in Akimitsu I. First, Akimitsu I indicates broadly that the enzyme may be a ketose 3-epimerase ([0019]). A skilled practitioner would be prompted to consult Akimitsu II for more detailed instruction regarding a suitable enzyme. Since Akimitsu II discloses the enzyme as “having the highest epimerization activity on position 3 of D-allulose among D- or L-ketohexoses” ([0024]), a skilled practitioner would be motivated to use the enzyme disclosed in Akimitsu II in the method disclosed in Akimitsu I, which renders the use of “D-allulose 3-epimerase having high heat resistance and high productivity and derived from Arthrobacter histidinolovorans” obvious. The effect of such an enzyme would be inherent, such that the claimed result of “realiz[ing] total productivity depending on the high heat resistance and high durability (long life span) of the enzyme” would necessarily occur. MPEP 2112.01 II.
As for claim 14, Akimitsu I discloses the component concentrations may be altered as desired and tailored according to the intended application ([0206]-[0207]) and that the composition may be combined with other sweeteners ([0047], [0150]), which would include any of D-allulose, D-fructose, or D-glucose individually or in combination. MPEP 2112.01 II indicates that “[a] chemical composition and its properties are inseparable”, such that the properties of the three saccharides would be inherent characteristics. Akimitsu I discloses the sweetness intensity of D-allulose ([0015]), D-fructose, and D-glucose ([0193]), which correspond with the claimed ranges, as well as the characteristics of the respective saccharides ([0016], [0046], [0152]). Performing the method of claim 13 wherein the contents of individual ingredients are determined to obtain an appropriate composition suited for a purpose after consideration of the sweetness and ancillary effects of the components would thus be obvious to a skilled practitioner.
As for claim 15, Akimitsu I discloses the raw material is a composition containing D-glucose and D-fructose ([0019]) and that such a composition may be produced by acting D-xylose isomerase on D-glucose produced from starch and allowing isomerization to proceed to equilibrium between D-glucose and D-fructose ([0029]-[0032], Fig. 1, where “DXI” facilitates isomerization of D-glucose and D-fructose and is thus presumed to be D-xylose isomerase).
As for claims 16 and 24, Akimitsu I discloses the raw material may be an isomerized sugar ([0019], [0029]-[0032]). The limitation requiring the sugar to be “inexpensive” carries no patentable weight as noted previously in relation to claim 13. Akimitsu I discloses the intended product as being an improved isomerized sugar or invert sugar having functionality of D-allulose, having a taste quality close to that of sugar, and exhibiting an excellent physiological effect without causing a disease by continuous intake ([0016], [0034]).
As for claims 17 and 25, Akimitsu I discloses a fructose-glucose syrup as being the raw material ([0019], [0032]).
As for claim 18, Akimitsu I discloses the D-allulose content of the intended product may be attained by adjusting the enzyme activity of the D-allulose 3-epimerase ([0121], [0124]).
As for claim 19, Akimitsu I discloses isomerization may be performed by passing a substrate solution through an immobilized enzyme column ([0136]), such that the intended product may be obtained by adjusting the flow rate of the substrate ([0207]).
As for claim 20, obtaining a 100% intended product using an immobilized enzyme reaction with the raw material as a substrate without producing a by-product would be obvious, at least because no limitation is required regarding the nature of the intended product—it may be any potential combination of the required saccharides, including whatever mixture may be produced upon performance of the isomerization reaction.
As for claim 21, Akimitsu I discloses treating a mixture with D-xylose isomerase to facilitate isomerization between D-fructose and D-glucose ([0032], Fig. 1). Performing such a treatment on a mixture comprising D-fructose, D-glucose, and D-allulose would be obvious in order to manipulate the component concentrations as desired ([0121]).
As for claim 22, Akimitsu I discloses a high fructose syrup as being used as the raw material ([0033], [0109]).
As for claim 23, Akimitsu I discloses the raw material is a composition containing D-glucose and D-fructose ([0019]) and that such a composition may be produced by acting D-xylose isomerase on D-glucose produced from starch and allowing isomerization to proceed to equilibrium between D-glucose and D-fructose ([0029]-[0032], Fig. 1).
As for claim 26, Akimitsu I discloses the D-allulose content of the intended product may be attained by adjusting the enzyme activity of the D-allulose 3-epimerase ([0121], [0124]).
As for claim 27, Akimitsu I discloses isomerization may be performed by passing a substrate solution through an immobilized enzyme column ([0136]), such that the intended product may be obtained by adjusting the flow rate of the substrate ([0207]).
As for claim 28, obtaining a 100% intended product using an immobilized enzyme reaction with the raw material as a substrate without producing a by-product would be obvious, at least because no limitation is required regarding the nature of the intended product—it may be any potential combination of the required saccharides, including whatever mixture may be produced upon performance of the isomerization reaction.
As for claim 29, Akimitsu I discloses treating a mixture with D-xylose isomerase to facilitate isomerization between D-fructose and D-glucose ([0032], Fig. 1). Performing such a treatment on a mixture comprising D-fructose, D-glucose, and D-allulose would be obvious in order to manipulate the component concentrations as desired ([0121]).
As for claim 30, Akimitsu I discloses a high fructose syrup as being used as the raw material ([0033], [0109]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY P MORNHINWEG whose telephone number is (571)270-5272. The examiner can normally be reached 8:30AM-5:00PM.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793