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 .
DETAILED ACTION
Claims 30, 32-33, 35, 38 and 40-41 are pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. §119(e) or under 35 U.S.C. §120, §121, or §365(c) is acknowledged. As noted in the Non-Final Office Action mailed 27 December 2024, the application is a 371 of PCT/JP2019/043722 and claims foreign priority under 35 U.S.C. §119(a)-(d).
Claims 30, 32-33, 35, 38 and 40-41 have the effective filing date of 08 November 2018.
Claim Rejections - 35 U.S.C. § 112
The following is a quotation of the first paragraph of 35 U.S.C. §112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. §112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 30, 32, 33, 35, 38, 40 and 41 are rejected under 35 U.S.C. §112(a) or 35 U.S.C. §112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contain(s) subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 30, 32-33, 35, 38 and 40-41 fail to comply with the written description requirement because they contain new matter. (See MPEP 608.04.) They recite limitations which are not described in the specification and/or which encompass a claim breadth which is not supported by the specification.
Claim 30, lines 5-6, recites: "..., to produce a first stage product consisting of...and 10 to 30 parts by weight of D-psicose;..."
However, the specification recites: "..., wherein the second-stage intended product is a composition having from 10 to 20 parts by weight of rare sugar D-psicose..." (originally filed specification, pg. 7, para. [0015], sub-para. (7)); "A rare sugar-containing composition having a taste quality equal to that of sugar, having from 10 to 20 parts by weight of rare sugar psicose..." (spec., pg. 8, para. [0016], sub-para. (14)); and "...the first-stage product is a mixture of D-fructose and rare sugar D-psicose" (spec., para. [0015], sub-para. (2)). Figures 3 and 4 specify D-allulose ("D-allu") (aka D-psicose) concentrations of 10% and 20%.
That is, there is no description of the amount of D-psicose in the first stage product; and the amount of D-psicose in the second stage product is not open-ended, but ranges from 10 to 20 parts by weight.
To overcome this rejection, Applicant may attempt to demonstrate (by means of argument or evidence) that the original disclosure establishes that he or she was in possession of the claim, or the claim may be amended to recite an amount of D-psicose that is supported by the specification.
Claim Rejections - 35 U.S.C. § 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 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 of this title, 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.
Claims 30, 32-33, 38 and 40-41 are rejected under 35 U.S.C. §103 as being unpatentable over Okuma et al. (US 2013/0274350 A1), as evidenced by Wong (Xylose Isomerase. In: Food Enzymes, Chap. 13. Copyright 1995 Springer Sci. + Bus. Media), in view of Lin et al. (CN106480125A; Pub. Date: 2017-03-08; see English machine translation (EngMT) as NPL for page/para. numbers and Figures).
Regarding claim 30, pertaining to a method of producing a sugar-containing composition consisting of D-glucose, D-fructose, and D-psicose,
Okuma et al. shows a composition (sweetener) including glucose, fructose, and psicose and a method for producing the same (pg. 1, column [0002]).
Further regarding claim 30, pertaining to contacting D-fructose as a raw material with ketose 3-epimerase which converts D-fructose to D-psicose, to produce a first stage product consisting of D-fructose and 10 parts by weight or more of D-psicose;
and contacting the D-fructose with D-xylose isomerase which converts the D-fructose to D-glucose, to further produce a second stage product consisting of D-glucose, D-fructose and D-psicose;
and D-psicose, D-fructose and D-glucose are not separated by simulated moving bed chromatography,
Okuma et al. shows an immobilized enzyme containing an isomerase and an epimerase packed into a suitable column. Degraded glucose liquid sugar is continuously poured thereinto. Glucose isomerase is an enzyme that acts on glucose to partially convert it to fructose. Ketohexose 3-epimerase is an enzyme that isomerizes OH in the 3-position of a ketohexose such as fructose. Known examples of ketohexose 3-epimerase are D-tagatose 3-epimerase and D-psicose 3-epimerase (pg. 3, para. [0060]-[0061]). Psicose is a kind of rare sugar that barely exists in nature, and is obtainable by treating fructose with a ketohexose 3-epimerase (pg. 3, cont. para. [0050]). When a mixed enzyme of glucose isomerase and tagatose 3-epimerase acted on glucose, unexpectedly, a mixture of 41 parts by weight of glucose, 48 parts by weight of fructose, and 11 parts by weight of psicose was obtained (pg. 3, para. [0062]).
Wong evidences that xylose isomerase is also known as glucose isomerase, which catalyzes the reversible isomerization of D-xylose and D-glucose to, minimally, D-fructose (pg. 358, para. 1).
Further regarding claim 30, pertaining to an amount of the unconverted D-fructose after the second stage being 35 to 40 parts by weight per 100 parts by weight of the total of D-glucose, D-fructose and D-psicose,
Okuma et al. shows that the novel sweetener of the described invention preferably has a ratio of fructose to the (total of glucose and psicose) of 80 to 20 parts by weight: 20 to 80 parts by weight (pg. 3, para. [0052]). In one example, a composition containing a ratio of glucose to fructose to psicose of 60:35:5 was examined for its physiological effect using rats (pg. 6, para. [0093]). A specific embodiment is a novel sweetener having fructose in an amount of 20 to 80 parts (pg. 2, para. [0049]).
Further regarding claim 30, pertaining to collecting the sugar-containing composition, wherein said composition has a taste quality equal to that of sugar,
Okuma et al. shows that an object of the described invention is to provide a sweetener closely similar to sucrose in sweetness and taste, which is obtained by improvement of the taste of D-psicose (pg. 1, para. [0014]).
Further regarding claim 30, pertaining to said composition is used to produce a final product,
Okuma et al. shows that the sweetener of the described invention can be applied to any products that need sweetness, examples thereof including, minimally, foods, food materials, food additives, beverages, drugs, and feeds for diseased domestic animals and/or diseased animals (pg. 3, para. [0067] thru pg. 4, cont. para. [0067]).
Okuma et al., as evidenced by Wong, does not specifically show: 1) a separate first stage in which D-fructose is contacted with ketose 3-epimerase [Claim 30]; 2) a separate second stage in which D-fructose is contacted with xylose isomerase [Claim 30]); and 3) D-fructose is the only sugar in the raw material [Claim 30].
Lin et al. shows a method for producing D-psicose with low cost. The method uses a solid D-psicose-3-epimerase to convert fructose to D-psicose (pg. 1, Abstract [nexus to Okuma et al.- produce D-psicose from D-fructose using an epimerase enzyme]).
Regarding claim 30, pertaining to separate first and second stages; D-fructose is the only sugar in the raw material,
Lin et al. shows one embodiment of the method of preparing a high concentration D-psicose solution. In Example 3, a solid D-psicose 3-epimerase as catalyst is added to a fructose solution. After the reaction, the catalyst is removed to give a D-psicose and D-fructose solution. Solid glucose isomerase is then added to the D-psicose/D-fructose solution which converts part of the D-fructose into D-glucose. The glucose isomerase is removed to obtain a mixed solution containing D-fructose, D-glucose and D-psicose (pg. 15, Example 3, thru pg. 16, cont. Example 3 [nexus to Okuma et al.- a sugar-containing composition consisting of D-glucose, D-fructose and D-psicose]).
Lin et al. does not specifically show that psicose 3-epimerase is a ketose 3-epimerase, as recited in instant claim 30.
Okuma et al. teaches that known examples of ketohexose 3-epimerase are D-tagatose 3-epimerase and D-psicose 3-epimerase (pg. 3, para. [0061] (see above)).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the method of producing a sugar-containing composition consisting of D-glucose, D-fructose and D-psicose, as shown by Okuma et al. as evidenced by Wong, by substituting the glucose liquid sugar, shown by Okuma et al., with the D-fructose, shown by Lin et al., as the starting raw material [Claim 30], with a reasonable expectation of success.
Okuma et al. shows that the glucose liquid sugar is contacted with a glucose isomerase enzyme which partially converts the glucose to fructose in the solution, which is followed by treating the fructose in the solution with a ketohexose 3-epimerase (i.e., tagatose 3-epimerase) to convert the fructose to D-psicose. That is, the glucose isomerase enzymatic reaction, shown by Okuma et al., results in the production of fructose, and Lin et al. shows a composition identical to that shown by Okuma et al. which can be produced by using only fructose as the starting raw material (MPEP 2143 (I)(G)).
Therefore, it would have been obvious to one of ordinary skill in the art of producing a sugar-containing composition as instantly claimed to have substituted the glucose liquid sugar shown by Okuma et al. with the fructose shown by Lin et al., with the reasonably predictable expectation that the final composition would have consisted of glucose, fructose and psicose, because Okuma et al. and Lin et al. show using a ketohexose 3-epimerase to convert fructose to psicose (MPEP 2143 (I)(B)(3)).
One of ordinary skill in the art would have been motivated to have made that modification, because substituting the glucose liquid sugar shown by Okuma et al. with the fructose shown by Lin et al. would have eliminated the need for the extra step which requires converting glucose to fructose using a different enzyme. Therefore, the substitution would expedite the production of the final glucose/fructose/psicose composition, reduce the cost of production by eliminating the need of one enzyme, and provide more control over the final ratio of the three sugars/carbohydrates in the final composition.
It would have been further obvious to have performed the method in two stages in which the epimerase enzyme is applied in a first stage, and the isomerase enzyme is applied in a second stage [Claim 30], with a reasonable expectation of success.
Okuma et al. shows that a single column containing both the ketose 3-epimerase and glucose/xylose isomerase as immobilized enzymes can be used to produce a composition containing D-glucose, D-fructose and D-psicose. Therefore, one of ordinary skill in the art would have understood that the two different enzymes could have been used in two consecutive or tandem column chromatography steps rather than one, barring a showing of criticality for the specific limitation (MPEP 2143 (I)(G)).
In addition, Okuma et al. does show a method for producing a sweetener having the sweetness and taste of sucrose, including a production line for fructose/glucose liquid sugar on which an isomerase acts and a production line for psicose on which an epimerase acts, the production lines being continuous (pg. 2, para. [0026]). That is, a two-stage method is suggested.
In addition, Lin et al. shows a method in which the ketohexose 3-epimerase enzyme is removed from the first reaction (of converting fructose to psicose) before the glucose isomerase enzyme is added to the fructose/psicose solution to convert part of the fructose to glucose, after which the isomerase enzyme is removed.
That is, the method shown by Lin et al. is akin to immobilizing the ketohexose 3-epimease enzyme onto a chromatographic resin, such that it does not end up in the outflow solution, and immobilizing the glucose/xylose isomerase onto a second chromatographic resin so as to receive said outflow solution, such that this enzyme does not end up in its outflow solution consisting of glucose, fructose and psicose. That is, Lin et al. describes a two-stage production method, as instantly claimed.
One of ordinary skill in the art would have been motivated to have made that modification, because, although the use of a single chromatography column might be a more (time) efficient way to produce the D-glucose, D-fructose and D-psicose composition, performing the enzymatic steps separately would enable one of ordinary skill in the art to better control the efficiency of each of the enzyme steps, by way of optimizing the amount of D-fructose and D-psicose produced at each step, in order to maximize the sweetness level of the collected product (e.g., such that it is akin to sugar/sucrose). For example, Okuma et al. teaches that when the sweetness of D-psicose is about 70% of that of sucrose, the degree and quality of sweetness thereof will differ from the case of sucrose (pg. 1, para. [0007]).
On the other hand, Okuma et al. teaches that the described sweetener including glucose, fructose, and D-psicose at a specific ratio is similar to sucrose in the degree and quality of sweetness (pg. 1, para. [0018]). In addition, Okuma et al. teaches that other methods have been employed wherein D-fructose is first produced and then D-psicose is produced (pg. 1, para. [0005]).
That is, Okuma et al. does suggest the possibility of employing a variation on the described method (e.g., as a two-stage process) in order to produce the same product; i.e., having a taste quality equal to that of sugar.
Regarding claim 32, pertaining to continuously,
Okuma et al. shows an immobilized enzyme containing an isomerase and an epimerase packed into a suitable column. Degraded glucose liquid sugar is continuously poured thereinto (pg. 3, para. [0060]).
Regarding claim 33, Okuma et al. shows that when the amount of psicose is not less than 5 parts by weight based on 100 parts by weight of the total amount of glucose and psicose, the resulting sweetener has the sweetness and taste of sucrose (pg. 3, para. [0053]). In one embodiment, after a 20hr enzyme reaction time, the collected sugar solution contained 41 parts by weight of D-glucose, 42 parts by weight of D-fructose, and 17 parts by weight of D-psicose. This therefore shows that by the method (2) using a mixed enzyme, a sugar solution having a psicose content as high as 10% or more can be easily produced (pg. 5, para. [0086]).
Regarding claim 38, the sweetener of the described invention may be used as it is, or in the form of a dilution with water or the like, or a suspension in oil, an emulsion or a mixture with a carrier (pg. 4, para. [0068]).
One of ordinary skill in the art would have considered that the sugar-containing composition collected at the second stage of the method would be akin to a ‘syrup’ (if used 'as it is') because the collected composition contains the three sugars, D-glucose, D-fructose and D-psicose and would be in a solution of some sort.
An American English dictionary definition of the word ‘syrup’ is: a thick, sticky solution of sugar and water.
Regarding claim 40, pertaining to foods, pharmaceuticals,
Okuma et al. shows that the sweetener of the described invention can be applied to any products that need sweetness, examples thereof including, minimally, foods, food materials, food additives, beverages, drugs, and feeds for diseased domestic animals and/or diseased animals (pg. 3, para. [0067] thru pg. 4, cont. para. [0067]).
Regarding claim 41, pertaining to an equilibrium state,
Lin et al. shows Figure 1 in which a graph shows that the solid enzyme catalyzed D-fructose to generate D-psicose to reach an equilibrium state (pg. 9, para. 2, Figure 1; and Fig. 1).
Regarding claim 41, pertaining to converting D-fructose to D-psicose and converting D-fructose to D-glucose without changing the D-psicose content, Okuma et al. shows that fructose/glucose liquid sugar is produced from starch or glucose, and ketose 3-epimerase acts thereon to produce psicose (pg. 3, para. [0056]). Degraded fructose/glucose liquid sugar is produced in the usual method using starch such as corn, potato, and sweet potato as a raw material (pg. 3, para. [0058]).
Okuma et al. further teaches that isomerization of glucose to fructose by glucose isomerase is an equilibrium reaction, and that the ratio between glucose and fructose in isomerized sugar is usually about 58:42 (pg. 1, para. [0003]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the method of producing a sugar-containing composition consisting of D-glucose, D-fructose and D-psicose, as shown by Okuma et al. as evidenced by Wong, as applied to claims 30-32, 33, 38 and 40 above, by conducting the first stage and second stage reactions so that equilibrium states could be reached between D-fructose and D-psicose, and between D-fructose and D-glucose, respectively, with a reasonable expectation of success, because both Okuma et al. and Lin et al. show that equilibrium states can be reached in converting D-fructose to D-psicose, and D-fructose to D-glucose, respectively (MPEP 2143 (I)(G)).
Claim 35 is rejected under 35 U.S.C. §103 as being unpatentable over Okuma et al. as evidenced by Wong in view of Lin et al., as applied to claims 30, 32-33, 38 and 40-41 above, and further in view of Shimada et al. (U.S. Pub. No.US 2018/0077958 A1; Pub. Date: Mar. 22, 2018).
Okuma et al. as evidenced by Wong in view of Lin et al. do not show: 1) the reactions in the first and second stages are performed by passing substrate solutions through immobilized enzyme columns, respectively, while adjusting a flow rate of the substrates [Claim 35].
Shimada et al. shows a method for enzymatically manufacturing a sweetener composition containing glucose, fructose and allulose (pg. 1, para. [0001] [nexus to Okuma et al.- a method for producing a composition containing glucose, fructose and psicose]). Allulose is a kind of rare sugar also called psicose (pg. 1, para. [0004]). A sweetener composition containing glucose, fructose and allulose and having a high allulose content rate can be continuously and efficiently manufactured by immobilizing glucose isomerase and allulose epimerase on a column (pg. 2, para. [0018] [nexus to Okuma et al.- use column-immobilized isomerase and epimerase to produce the composition]). A sweetener composition having a content ratio among glucose, fructose and allulose of 50:37:13 to 43:42:15 can be obtained (pg. 2, para. [0035] [nexus to Okuma et al.-sugar-containing composition with 15 to 20 parts psicose]).
Regarding claim 35, Shimada et al. shows that the space velocity (SV) of the glucose solution to be passed is 0.2 to 1.0, preferably 0.3 to 0.5 from the viewpoint of more effectively increasing the content rates of fructose and allulose in the sweetener composition to be manufactured (pg. 5, para. [0082]). When the space velocity is too high, however, the content rates of fructose and allulose tend to decrease (pg. 5, para. [0084]). The flow velocity is set so that the isomerization rate falls within the range of 0.39 to 0.44 (pg. 3, para. [0041]). The content rate of allulose in the sweetener composition can be more efficiently increased by setting the space velocity of the glucose solution when being passed through the column (pg. 2, para. [0018]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the method of producing a sugar-containing composition consisting of D-glucose, D-fructose and D-psicose, as shown by Okuma et al. as evidenced by Wong in view of Lin et al., as applied to claims 30, 32-33, 38 and 40-41 above, by: 1) adjusting the flow rate of the substrate(s) [Claim 35], as shown by Shimada et al., with a reasonable expectation of success.
Shimada et al. shows that the epimerase and isomerase content of the chromatography column can be adjusted to a specific ratio, and that the flow rate of the initial glucose solution through said column can be adjusted according to a specific ‘space velocity’ within the context of a method for producing a sugar-containing composition containing D-glucose, D-fructose and D-psicose, which is the method, shown by Okuma et al.(MPEP 2143 (I)(G)).
One of ordinary skill in the art would have been motivated to have made that modification, because Shimada et al. teaches, from the viewpoint of further increasing the content rate of allulose in the sweetener composition to be manufactured, that the specific activity is 100 U/ml or more preferably 100 to 150 U/ml, or more preferably 100 to 200 U/ml (pg. 4, para. [0062]). Shimada et al. also shows that the content rate of allulose in the sweetener composition can be more efficiently increased by setting the space velocity of the glucose solution when being passed through the column (pg. 2, para. [0018]). In particular, when the specific activity of the immobilized glucose isomerase satisfies the described range, and when the space velocity at the time of passing the glucose solution in step B is set within the described range, the content rate of allulose in the sweetener composition to be manufactured is 13% or more, and a sweetener composition having a content ratio among glucose, fructose and allulose of 50:37:13 to 43:42:15 can be efficiently manufactured (Shimada et al., pg. 4, para. [0062]).
That is, by adjusting the enzymatic activity of both epimerase and isomerase, as well as adjusting the flow rate of the initial sugar solution through the enzyme-immobilized column, the content of psicose/allulose in the collected sugar-containing composition can be optimized, and the overall “sugar quality” of said composition (via the ratio of glucose: fructose: psicose) can also be optimized.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Arguments
Applicant’s arguments, pp. 5-11, filed 26 December 2025, with respect to the 35 U.S.C. §112(a) rejection, and the prior art references cited in the 35 U.S.C. §103 rejections), have been fully considered, but they are not persuasive.
1. Applicant remarks (pp. 6-7), with regard to the 112(a) rejection, that the recited range of "10 to 30 parts by weight" of D-psicose cited in the instantly-amended claim is adequately supported by the specification as originally filed. As shown in the diagrams shown, the first reaction with DAE produces a mixture consisting of D-fructose and D-psicose at the ratio of 70:30 at the equilibrium state of the reaction, and then, the second reaction with DXI converts the 70-parts portion of D-fructose to D-glucose and produces a mixture of these sugars at the ratio of 35:35 (D-glu: D-fru) at the equilibrium state of the reaction. Thus, the ratio of the three sugars in the second stage product will be 35:35:30 (=D-glu: D-fru: D-allu (D-psicose)) as each reaction reaches equilibrium. Thus, the amount of D-psicose would theoretically be up to 30 parts by weight using DAE.
However, in response to Applicant, the diagram does not show that the percentages of D-fructose and D-allulose/D-psicose as the first stage product in Reaction 1 of the diagram. The claimed subject matter, as amended, recites: "... produce a first stage product consisting of unconverted D-fructose and 10 to 30 parts by weight of D-psicose,..." On the other hand, it appears as though after Reaction 1, no more D-allulose is made; i.e., all of the D-allulose that is made is produced from D-fructose by an immobilized epimerase. Therefore, the final sugar-containing composition should contain the percentage of allulose produced in Reaction 1, which, according to Applicant's diagram is 30%.
However, further in response to Applicant, the specification does not recite the range "10-30" parts by weight of D-psicose/allulose as the amount in the reaction 1 or first stage product or as the amount in the final sugar-containing composition. The 2-part diagram that Applicant presents is labeled "Fig. 1" and does show a "D-allu" concentration of 30% in a separate adjacent drawing. However, Applicant's originally-filed drawings (including Figure 1) do not show this adjacent drawing in which the actual percentages of sugar production are shown, and in which D-allulose concentration is described as 30%.
Originally-filed Figure 3 shows a D-allulose concentration in the final sugar-containing composition of 20%. Figure 4 shows the same 20% D-allulose concentration in the final sugar-containing composition. The affidavit filed 12 August 2025 also shows Figure 3 in which the D-allulose concentration in the final sugar-containing composition is 20%. Therefore, to overcome this rejection, Applicant may attempt to demonstrate (by means of argument or evidence) that the original disclosure establishes that he or she was in possession of the claim, or the claim may be amended to recite an amount of D-psicose that is supported by the specification.
2. Applicant remarks (pg. 8, para. 3), with regard to the 103 rejection, that, in the primary reference of Okuma, a raw/starting material is a fructose/glucose liquid sugar (hereinafter, "glucose liquid sugar"), as the object of Okuma's invention is to improve the taste of the glucose liquid sugar. Thus, Okuma does not produce a composition consisting of D-fructose, D-psicose and D-glucose at the recited amounts.
However, in response to Applicant, Okuma et al. shows a method of producing a sugar-containing composition using an epimerase and isomerase comprising glucose, fructose and psicose. Okuma et al. shows that the novel sweetener/sugar-containing composition has a ratio of fructose to both glucose and psicose of from 80 to 20 parts (by wt) to 20 to 80 parts (by wt). In one embodiment, the sweetener contains a ratio of glucose to fructose to psicose of 60:35:5. In another embodiment, the sweetener has a ratio of glucose to fructose to psicose of 41:48:11. In a specific embodiment, the sweetener has fructose in an amount of 20 to 80 parts (see 103 rejection above). This compares to the claimed amounts of the sugars as 10-30 parts D-psicose, and 35 to 40 parts D-fructose (per instant claim 30). That is, Okuma et al. shows that the final sugar-containing composition may contain several different ratios of glucose to fructose to psicose, presumably by modifying the enzymatic parameters of the method; e.g., the amount of time that the sugar is in contact with either the epimerase or the isomerase, or the amount of each enzyme.
That is, although Okuma et al. does not explicitly show one embodiment in which the sugar-containing composition consists of 10-30 parts psicose and 35-40 parts fructose, it would have been obvious to have expected that the method of Okuma et al. could have produced a sugar-containing composition consisting of these amounts, in parts by wt.
3. Applicant remarks (pg. 8, para. 4 thru pg. 9) that Okuma also fails to disclose that first and second reactions with epimerase and isomerase are performed in the claimed order. Okuma fails to specifically disclose use of ketose 3-epimerase (KE) and D-xylose isomerase (XI) in the claimed order (KE→XI).
However, in response to Applicant, in view of the application of two enzymes in one chromatography step in the method shown by Okuma et al., one of ordinary skill in the art would have understood that the two different enzymes could have been used in two consecutive or tandem column chromatography steps rather than one, barring a showing of criticality for the specific limitation or a showing of improved, unexpected or surprising results (MPEP 2143 (l)(G)). In addition, Okuma et al. does show a method for producing a sweetener having the sweetness and taste of sucrose, including a production line for fructose/glucose liquid sugar on which an isomerase acts and a production line for psicose on which an epimerase acts, the production lines being continuous (pg. 2, para. [0026]). That is, a two-stage method is suggested.
In addition, Lin et al. shows a method in which the ketohexose 3-epimerase enzyme is removed from the first reaction (of converting fructose to psicose) before the glucose isomerase enzyme is added to the fructose/psicose solution to convert part of the fructose to glucose, after which the isomerase enzyme is removed. That is, the method shown by Lin et al. is akin to immobilizing the ketohexose 3-epimease enzyme onto a chromatographic resin, such that it does not end up in the outflow solution, and immobilizing the glucose/xylose isomerase onto a second chromatographic resin so as to receive said outflow solution, such that this enzyme does not end up in its outflow solution consisting of glucose, fructose and psicose. That is, Lin et al. describes a two-stage production method, as instantly-claimed.
4. Applicant remarks (pg. 9, last para. thru pg. 10) that there are significant differences in the purpose and method of using D-xylose isomerase (=D-glucose isomerase) between Lin and the present invention. The purpose of the D-xylose isomerase reaction in Lin is completely different in that Lin's method aims to convert D-fructose to D-glucose and remove them for crystallizing the conversion solution to obtain the high concentration D-psicose crystal. Lin is directed to such invention that involves performing the D-glucose isomerase reaction multiple times for removing unconverted D-fructose as D-gluconic acid from the reaction system and extracting pure D-psicose as crystals. The method of Lin is irrelevant to producing a sugar mixture similar to sucrose. The method of Okuma and the method of Lin use different starting materials and completely different reaction schemes, which makes it impossible to modify Okuma in view of Lin in the alleged manner.
However, in response to Applicant, Lin et al. was cited to show that the starting raw material to be used in the method could be D-fructose only (per claim 30). Lin et al. shows an embodiment of the method of preparing a high concentration D-psicose solution in which D-fructose is the starting raw material. At one point in the method, a mixed solution containing D-fructose, D-glucose and D-psicose is obtained (Lin et al., pg. 5, para. 4; and pg. 8, para. 4). Although the method of Lin et al. is intended to produce a high D-psicose product, the method could be modified to produce a product comprising a glucose to fructose to psicose ratio.
In addition, it is well known that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
5. Applicant remarks (pg. 10, para. 2 thru pg. 11) that if the method of Okuma is modified to change their starting material from the glucose liquid sugar to pure D-fructose, it would dramatically change the operation and make it unsatisfactory for its intended purpose.
However, in response to Applicant, this comment appears to be opinion evidence; and it is well known that the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) (MPEP 716.01(c)(I)(II)). Lin et al. shows that at one point in the method a solution comprising glucose, fructose and psicose is obtained. The method of Okuma et al. shows a starting raw material of a fructose/glucose liquid sugar. In view of Lin et al., one of ordinary skill in the art would recognize that the method of Okuma et al. could be modified so as to use only fructose as a starting material, and still produce a solution comprising a mixture of glucose, fructose and psicose. The ratios could be determined by adjusting enzymatic parameters, as noted above.
6. Applicant remarks (pg. 11, para. 1) that, in the present invention, the amount of D-psicose, D-fructose, and D-glucose can also be adjusted in a system using a column with the immobilized enzymes, for example, by changing the flow velocity. This system is simple but effective in producing a sugar mixture containing a higher amount of D-psicose from D-fructose only at a low cost in that manner which none of the cited references suggests. Also, Okuma and Lin do not teach a method capable of producing a product containing as much as 30 parts by weight D-psicose.
However, in response to Applicant, it is not clear that Applicant has written description support for a composition comprising 30 parts by weight D-psicose (see 112(a) rejection above). In addition, Okuma et al. shows that, in general, the total amount of glucose and psicose is 20 parts to 80 parts by wt of the final sweetener. The amount of psicose is not less than 5 parts by weight (based on 100 parts of the total amount of glucose and psicose) (Okuma et al., pg. 3, para. [0053]). Although Okuma et al. does not explicitly show 30 (or 20) parts by wt D-psicose in a single embodiment, the method of Okuma et al. could be used to produce a sugar-containing composition with that amount of psicose, given the general psicose concentration shown by Okuma et al.- and also in view of the fact that other prior art methods show the use of an epimerase and an isomerase to produce a sweetener composition with glucose, fructose, and D-allulose/D-psicose in which the concentration of D-psicose is >30% (pg. 1; and pg. 16, para. 2) (see Li et al., CN107955825A, Pub. Date: 2018-04-24, pp. 1-24; see NPL as English machine translation (EngMT) for page/para. numbers).
Conclusion
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/SMP/ Examiner, Art Unit 1657