DETAILED ACTION
Notice of Pre-AlA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 26, 2026, has been entered.
Claim Disposition
3. Claims 2, 4, 6-7, 10-11, 13-18, 22, 25-27, 32-33 and 36 have been cancelled. Claims 1, 3, 5, 8-9, 12, 19-21, 23-24, 28-31, 34-35 and 37-39 are pending and are under examination.
Claim Objection
4. Claims 1, 3, 5, 8-9, 12, 19-21, 23-24, 28-31, 34-35 and 37-39are objected to because of the following informalities:
For clarity and precision of claim language it is suggested that claims 1, 23 and 30 are amended to read, “….temperature in the range of [[about]] 100-135….…….addition of the glycosyl-transferase, wherein the inorganic acid is hydrochloric acid”. The dependent claims hereto are also included.
Appropriate correction is required.
Claim Rejections - 35 USC §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.
5. Claims 1, 3, 5, 8-9, 12, 19-21, 23-24, 28-31, 34-35 and 37-39 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) contains 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.
The claimed invention as amended is directed to a process of producing a higher soluble dietary fiber composition from a starch comprising adding an inorganic acid to a soluble starch to achieve a pH of 1-3, mixing and heating the starch and inorganic acid at a temperature in the range of about 100-135 to get a starch substrate having polysaccharide glucosidic bonds (see also claims 23 and 30). The specification discloses hydrochloric acid, however, the claimed invention is devoid of a specific acid that is heated after mixing with the starch to form polysaccharide glucosidic bonds. The art recognizes that there are acids such as nitric acid, sulfuric acid, hydrochloric acid, phosphoric acid, hydrobromic acid, hydrofluoric acid, boric acid, carbonic acid, perchloric acid, sulfurous acid, acetic acid and iodic acid, to name a few. The instant claim language reads on strong acids or concentrated weak acids. It is well established in the art that the strong acids are perchloric acid, hydroiodic acid, hydrobromic acid, hydrochloric acid, nitric acid, chloric acid and sulfuric acid. The claimed invention requires a certain composition to get specific results and therefore, need to inform the ordinary skilled worker what is utilized to obtain said results such as the specific acid, enzyme and organism. For example, Chang et al. (Carbohydrate Polymers, vol. 79, iss. 3, Feb. 11, 2010, pages 762-768), teach rice starches differing in amylose content were treated in methanol with acid at 45 °C for 1 h, effects of acid type and concentration on the solubility and molecular size of starch were investigated. Significant differences were found in solubility and weight-average degree of polymerization (DPw) among starches treated with different acids at the equal normality…..and performed starch treated with HCl ……..(see abstract). Chang et al. also discloses that hydrochloric acid, nitric acid and sulfuric acid are strong acids… (see page 1). Therefore, the claimed invention is not adequately described and encompasses a large genus of acids that are not necessarily equivalent or equal. The ordinary skilled worker should not be guessing or invited to do trial and error to figure out what is used, and the limitations of the specification cannot be read into the claims, which are not limited necessarily to a strong acid. Furthermore, not all strong acids behave the same (they all fully disassociate in aqueous solutions, however can have different disassociation constant (Ka) and the resulting pH can vary). Thus the ordinary skilled worker needs to be informed what specific acid is mixed and heated with the starch to produce polysaccharide glucosidic bonds (the process must be adequately described). There is no demonstration of the large variable genus of strong acids or weak acids highly concentrated. Note also that independent claims 23 and 30 have the same issue of forming products from the mixture of starch and acid with high heat and a lack of adequate description of what starch, what acid, what environment to produce the desired results. Claims 37-39 are included in the rejection because although they recite the acid, they do not rectify all the missing information in the independent claims.
The claimed invention encompasses a large variable genus of products and the claim limitations are not commensurate in scope with the disclosure in the specification. The claimed invention is directed to large genus of products that are not adequately described (acids (any strong or weak acids), enzymes (any glycosyl-transferase) and organism (any Geobacillus)). The scope of the claims far exceed the scope of the specification. The claims are read in light of the specification, however, the limitations of the specification cannot be read into the claims, and the claims as presented are not adequately described.
The specification fails to provide any additional representative species of the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species which are adequately described are representative of the entire genus. The written description requirement for a claimed genus maybe satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
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.
6. 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.
7. Claim(s) 1,3, 5, 8-9, 12, 19-21, 23-24, 28-31, 34-35 and 37-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okada et al. (US 2014/0023748 issued on January 23, 2014 and filed on January 31, 2012) in view of Fuji and Wind.
The claimed invention is broadly directed to a process of producing a higher soluble dietary composition from a starch comprising of adding an inorganic acid to a soluble starch, mixing and heating the starch and acid to form a starch substrate, and placing the starch substrate in contact with a glycosyl-transferase to produce a soluble dietary fiber composition having a higher soluble dietary fiber content than a composition to which glycosyl-transferase was not added (Claim 1) wherein the glycosyl transferase is an enzyme protein from a microorganism belonging to the genus Geobacillus (Claim 5) and comprises the amino acid sequence in SEQ ID NO: 1 (Claim 8). The invention is directed to a process of increasing soluble dietary fiber content of a soluble dextrin comprising placing a soluble dextrin in contact with a glycosyl-transferase, thus increasing the soluble dietary fiber content of the soluble dextrin (Claim 30) and also wherein the glycosyl-transferase comprises the amino acid sequence of SEQ ID NO: 1 (Claim 34). The instant specification discloses that the glycosyl-transferase removes a maltotriose from a non-reducing end of dextrin and places it on the same or another molecule of dextrin as the glycosidic side chain (numbered page 7, paragraph 024, lines 1-3). For the purpose of application of the prior art, “a glycosyl-transferase” would be interpreted as including glycosyl-transferase having the above mentioned features and any other glycosyl-transferase known in the applicable prior arts.
In addition, based on the claim that higher soluble dietary fiber is achieved with glycosyl-transferase it inherently/necessarily would achieve these results even if not asserted in the reference and the claim language is construed as any inorganic acid at high temperature in the claimed range would produce 40-50% soluble starch conversion to soluble dietary fiber.
Okada teaches a production method for rice cakes using rice flour (numbered page 11, paragraph 0150), which reads on instant claim 1. Rice flour is a soluble starch as evidenced by instant claim 20. Acetic acid buffer (pH 5.3, i.e. an acid) was added to the rice flour as evident by the disclosure for the control group (numbered page 11, paragraph 0153, lines 1-4). It is also disclosed by Okada that the pH can be adjusted, for example about 3 to about 10 (see paragraph [0074]). Okada also disclosed that the acetic acid buffer (pH 5.3, i.e. an acid) was mixed with the rice flour and the enzyme maltotriosyl transferase (another name for glycosyl-transferase, because maltotriose transferase is a specific type of glycosyltransferase), (numbered page 11, paragraph 0151, lines 1-6). At paragraph [0002] Okada discloses that ‘known examples of industrially used glycosyltransferases include .alpha.-glucosidase (production of isomaltooligosaccharide or nigerooligosaccharide), .beta.-fructofuranosidase (production of fructooligosaccharide or lactosucrose), .beta.-galactosidase (production of galactooligosaccharide), .alpha.-glucosyltransferase (production of palatinose), cyclodextrin glucanotransferase (production of cyclodextrin or coupling sugar), and branching enzymes (production of highly branched cyclic dextrin). Alfa-glucosidase and branching enzymes act on polysaccharides and oligosaccharides containing .alpha.-1,4 bonds to catalyze transglucosylation. Alfa-glucosidase catalyzes transglucosylation of monosaccharides, and branching enzymes catalyze transglucosylation of oligosaccharides of four or more sugars or polysaccharides.
Okada discloses that the mixture was steamed with water vapor for 15 minutes (i.e. heated) (numbered page 11, paragraph 0151, lines 1-6), or 5-20 minutes or 30 minutes (see paragraphs [0092] and [0065]). The indigestible content was then measured (numbered page 11, paragraph 0157). Okada also teaches that the production method can produce a relatively high indigestible component content (i.e. higher soluble dietary content) of 50% or 60% or more (numbered pages 6-7, paragraph 0097, line 4 on numbered page 6 and lines 1-3 on numbered page 7, paragraph [0164]).
In regard to instant Claim 3, Okada teaches heat treatment is used to gelatinize the starch in the rice cake (numbered page 5, paragraph 0085, lines 1-4) which involves heating the rice cake dough with the enzyme to 80oC or more (numbered page 6, paragraph 0085, lines 13-14). The heat treatment, in addition to reducing the risk of microbial contamination, produces an indigestible saccharide (i.e. soluble dietary fiber content), when used with maltotriosyl transferase (glycosyl-transferase) (numbered page 12, paragraph 0162, lines 1-6).
In regard to instant Claim 5, Okada teaches the production method for rice cakes wherein the maltotriosyl transferase (another name for glycosyl-transferase) is an enzyme derived from a microorganism (Claim 18; numbered page 2, paragraph 0036) from Geobacillus species (Claim 19; numbered page 2, paragraph 0037).
In regard to instant Claim 8, Okada teaches the maltotriosyl transferase (another name for glycosyl-transferase) is composed of amino acid SEQ ID NO: 3 (Claim 22; numbered page 2, paragraph 0043, lines 1-7). SEQ ID NO: 3 is 100% identical to the instant SEQ ID NO: 1 as follows:
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In regard to instant Claim 30, Okada teaches a method for the preparation of indigestible saccharide (i.e. higher soluble dietary content) by adding maltotriosyl transferase (also known as glycosyl-transferase) to dextrin (numbered page 11, paragraphs 0158 and 0159, lines 1-2 in paragraph 0159; Claims 8 and 11) and measurement was done for the content of the indigestible component (numbered page 12, paragraph 0160, lines 3-5). The indigestible component content was 49.5 % (numbered page 12,Table 8). The dextrin is a saccharide and a starch hydrolysate (numbered page 6, paragraph 0096, line 7) which means it is soluble dextrin.
In regard to instant Claim 34, Okada teaches the same as for instant Claim 8 which is discussed above herein.
Additionally in regard to instant claim 1, rice flour is a soluble starch and Okada teaches the glycosyl-transferase must be mixed thoroughly with the whole of the rice cake dough to achieve uniform softness (numbered page 6, paragraph 0085, lines 7-9). Okada also teaches the time of adding the present enzyme (the glycosyl-transferase) is not particularly limited as long as the dough containing the enzyme is subjected to heat treatment (numbered page 6, paragraph 0090, lines 1-4) and the enzyme may be added before or during the heat treatment (numbered page 6, paragraph 0090, lines 16-20). Okada teaches achieving softness (numbered page 6, paragraph 0085, lines 7-9) by mixing of the enzyme with the rice flour (numbered page 11, paragraph 0151, lines 1-5). Okada also teaches the mixing to achieve heat treatment is used to gelatinize the starch in the rice cake (numbered page 5, paragraph 0085, lines 1-4) which involves heating the rice cake dough with the enzyme to 80oC or more (numbered page 6, paragraph 0085, lines 13-14), which reads on the recited ‘about’ 100-135 degrees since ‘about’ 100 can be 80 degrees. The heat treatment, in addition to reducing the risk of microbial contamination, can produce an indigestible saccharide (i.e. soluble dietary fiber content), when used with maltotriosyl transferase (glycosyl-transferase) (numbered page 12, paragraph 0162, lines 1-6).
Regarding claim 3, Okada teaches heat treatment is used to gelatinize the starch in the rice cake (numbered page 5, paragraph 0085, lines 1-4) which involves heating the rice cake dough with the enzyme to 80oC or more (numbered page 6, paragraph 0085, lines 13-14). The heat treatment, in addition to reducing the risk of microbial contamination, produces an indigestible saccharide (i.e. soluble dietary fiber content), when used with maltotriosyl transferase (glycosyl-transferase) (numbered page 12, paragraph 0162, lines 1-6).
Claim 9 is obvious because Okada teaches the enzyme (glycosyl-transferase) which could be a premixed powder (numbered page 6, paragraph 0090, line 11; page 11, paragraph 0149, line 7). Okada also teaches 0.67, 1, 3, 10, 30, and 70% w/v of maltotetraose (a type of glycotransferase) (numbered page 10, paragraph 0143, lines 5-6) and also for the substrate concentrations, i.e. 0.67, 1, 3, 10, 30, and 70% w/v of the substrate (numbered page 10, paragraph 0143, lines 5-6). Due to these equivalent concentrations, these translate into glycotransferase of 0.67, 1, 3, 10, 30, and 70% w/w of the substrate.
Okada teaches the addition of a buffer to the ‘collected fraction’ containing the active maltotriosyl transferase (numbered page 9, paragraph 0119), see instant claim 12. ‘Collected fraction’ means the maltotriosyl transferase (also known as glycosyl transferase) is in the form of a liquid. Okada teaches mixing the starch, buffer and maltotriosyl transferase (glycosyl-transferase), along with the heat treatment can produce an indigestible saccharide (numbered page 12, paragraph 0162, lines 1-6), i.e. soluble dietary fiber content.
Okada further teaches a pH of 5.3 for acetic acid as the buffer that was mixed with the rice flour and the enzyme maltotriosyl transferase (another name for glycosyl-transferase) (numbered page 11, paragraph 0151, lines 1-6). Thus, the enzyme reaction for the glycosyl-transferase occurs at pH of 5.3 due to the buffer.
Okada teaches adding maltotriosyl transferase (also known as glycosyl-transferase) to dextrin along with MES buffer (see instant claim 19). The reaction was carried out at 60oC for 66 hours (numbered page 12, paragraph 0160), i.e. the reaction was carried out in an agitated reactor . Dextrin is produced when starch is heated in the presence of acid and moisture. Okada also teaches the heat treatment, in addition to reducing the risk of microbial contamination, can produce an indigestible saccharide, when used with maltotriosyl transferase (glycosyl-transferase) (numbered page 12, paragraph 0162, lines 1-6 and numbered page 12, Table 8).
Okada also teaches that the method for producing an indigestible saccharide wherein the saccharide (starch is a saccharide) is from a group consisting of corn, wheat, rice, barley, potatoes, and corn starch (see instant claim 20). Examples of starch include cassava starch in addition to corn starch (page 6, paragraph 0096, lines 9-11).
In regard to instant Claims 23, 24, 30, and 36, Okada teaches increasing the dietary fiber in beer or beer-like beverage (numbered page 12, paragraphs 0163 and 0164). After adding an aqueous solution of calcium sulfate into the saccharification bath, the temperature was increased to 50oC and then malt, barley, and maltotrisyl transferase (also known as glycosyl transferase) was added. Calcium sulfate has the ability to act as a pH buffer. The mixture was subjected to 50oC for one hour and then the temperature was increased to 65oC and eventually to 76oC for 10 minutes. As a result of this treatment, the indigestible component content was 49.5 % compared to 2.6% for the enzyme-free (that is, in the absence of glycosyl-transferase) (numbered page 12, Table 8).
In regard to instant Claim 28, Okada teaches the maltotriosyl transferase (another name for glycosyl-transferase) is composed of amino acid SEQ ID No: 3 (Claim 22; numbered page 2, paragraph 0043, lines 1-7).
In regard to instant Claim 29, Okada also teaches that the method for producing an indigestible saccharide wherein the saccharide (starch is a saccharide) is from a group consisting of corn, wheat, rice, barley, potatoes, and corn starch (Claim 16). Examples of starch include cassava starch in addition to corn starch (page 6, paragraph 0096, lines 9-11).
In regard to instant Claim 35, Okada also teaches the saccharide is a dextrin (Claim 7), selected from the group consisting of dextrin (numbered page 2, paragraph 0028, lines 2-4) and is selected from a group consisting of barley, wheat, corn, rice, and potato (numbered page 2, 0033) for the method of producing an indigestible saccharide.
Okada does not per se teach HCL which is known in the art to be a strong acid and would achieve a pH of 1-3. However, Fukui teaches a process to produce a beer-flavored alcoholic beverages with water-soluble dietary fiber (paragraph 0023, lines 1-2). In regard to instant claims 23 and 24, Fukui teaches corn starch added and mixed with hydrochloric acid. This was homogenized through a grinder and then stirred. The temperature was then increased to 160oC for 30 minutes to yield roasted dextrin (Example 1, paragraph 0040). The roasted dextrin was dissolved in water and alpha amylase was added (Example 3, paragraph 0044). The reaction was hydrolyzed at 90oC for 30 minutes and then quenched at 130oC for 10 minutes (Example 3, paragraph 0044). Fukui also teaches a yield 53.2% of dietary fiber content (paragraph 0045). Would be obvious to modify Okada to use the strong acid of Fukui with a high expectation of success.
Further, Wind teaches cyclodextrin glycosyl-transferase and alpha amylase. In regard to instant claims 23 and 24, Wind teaches cyclodextrin glycosyl-transferase and alpha amylase both belong to the glycosyl hydrolase family 13 (first page, first column, lines 1-2) and cyclodextrin glycosyl-transferase and alpha amylase are functionally closely related and both catalyze the degradation of starch (first page, first column, lines 4-5).
In regard to instant claim 21 regarding the solids content of the starch substrate is between about 35-55%, since Okada teaches a starch substrate comprising each claimed component thereby constituting the starch substrate and thus, the same steps being performed as claimed (i.e., the solids content of the starch substrate is between about 35-55%), the starch substrate as claimed and known from Okada’s teachings are necessarily the same and thus, the same product is expected as a result. The discovery of a previously unappreciated property of a prior art composition, or a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new chemical property (i.e., the solids content of the starch substrate is between about 35-55%) which is necessarily present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 4333 (CCPA 1977). Additionally and/or alternatively, properties are the same when the structure and composition are the same. Thus, burden shifts to applicant to show unexpected results, by declaration or otherwise. In re Fitzgerald, 205 USPQ 594. In the alternative, the claimed properties would have been present once the composition was employed in its intended use. In re Best, 195 USPQ 433. Therefore, the starch substrate taught by Okada satisfies the claim limitation with respect to where the solids content of the starch substrate is between about 35-55% as recited in instant claim 21.
In regard to claim 23, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to combine the teachings of Okada with the teachings of Fukui and Wild on increasing the dietary fiber in beer and beer-like beverages by adding an aqueous solution of calcium sulfate to the saccharification bath, increasing the temperature to 50oC and then adding malt, barley, and maltotrisyl transferase (also known as glycosyl transferase) and heating this mixture for one hour because Fukui established that adding alpha amylase to the roasted dextrin yielded 53.2% dietary fiber content and Wild established that cyclodextrin glycosyl-transferase and alpha amylase are functionally closely related and both catalyze the degradation of starch. A person of ordinary skill before the effective filing date of the invention would have been motivated to combine the teachings of Okada, Fukui, and Wild because adding alpha amylase to the roasted dextrin yielded 53.2% dietary fiber content and cyclodextrin glycosyl-transferase and alpha amylase are functionally closely related and both catalyze the degradation of starch. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Okada, Fukui, and Wild because adding an acid to a starch, mixing and heating the acidified starch to form a starch substrate, roasting the starch, allowing acidic thermal reaction to form a roasted starch intermediate (dextrin), and adding glycosyl transferase to the roasted starch intermediate (dextrin) would yield a higher dietary fiber content than a composition without the glycosyl-transferase treatment.
In regard to instant claim 24, Fukui teaches a temperature of 90oC for 30 minutes. The temperature and duration range in the instant Claim 24 is 50-135oC for about 30-90 minutes. The teachings on the temperature and duration of 90oC for 30 minutes by Fukui touches with the temperature and duration range in the instant Claim 24. A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection. MPEP § 2144.05.
Additionally in regard to claim 24, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to combine the teachings of Okada with the teachings of Fukui and Wild on the temperature and duration for increasing the dietary fiber in beer or beer-like beverage because Fukui established that the reaction at 90oC for 30 minutes containing alpha amylase and the roasted dextrin yielded 53.2% dietary fiber content and Wild established that cyclodextrin glycosyl-transferase and alpha amylase are functionally closely related and both catalyze the degradation of starch. A person of ordinary skill before the effective filing date of the invention would have been motivated to combine the teachings of Okada, Fukui, and Wild because hydrolyzing the reaction at 90oC for 30 minutes yielded 53.2% dietary fiber content and cyclodextrin glycosyl-transferase and alpha amylase are functionally closely related and both catalyze the degradation of starch. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Okada, Fukui, and Wild because mixing and heating in the range of 80-135oC for about 30-90 minutes in the process comprising adding an acid to a starch, mixing and heating the acidified starch to form a starch substrate, roasting the starch, allowing acidic thermal reaction to form a roasted starch intermediate (dextrin), and adding glycosyl transferase to the roasted starch intermediate (dextrin) would yield a higher dietary fiber content than a composition without the glycosyl-transferase treatment.
In regard to instant claim 28, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant application to combine the teachings of Okada with the teachings of Fukui and Wild on the method for producing an indigestible saccharide wherein the glycosyl-transferase comprises the amino acid sequence SEQ ID NO: 1 because Fukui established that adding alpha amylase to the roasted dextrin yielded 53.2% dietary fiber content and Wild established that cyclodextrin glycosyl-transferase and alpha amylase are functionally closely related and both catalyze the degradation of starch. A person of ordinary skill in the art before the effective filing date of the invention would have been motivated to combine the teachings of Okada with the teachings of Fukui and Wild because the SEQ ID NO: 1 is a 100% match of SEQ ID NO: 3 of Okada and also cyclodextrin glycosyl-transferase and alpha amylase are functionally closely related and both catalyze the degradation of starch. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Okada with the teachings of Fukui, and Wild because adding glycosyl-transferase of SEQ ID NO: 1 to the roasted starch intermediate (dextrin) would yield a higher dietary fiber content than a composition without the glycosyl-transferase treatment.
In regard to instant claim 29, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant application to combine the teachings of Okada with the teachings of Fukui and Wild on the method for producing an indigestible saccharide wherein the saccharide (starch is a saccharide) is from a group consisting of corn, wheat, rice, barley, potatoes, and corn starch and examples of starch also include cassava starch in addition to corn starch because Fukui established that adding alpha amylase to the roasted dextrin yielded 53.2% dietary fiber content and Wild established that cyclodextrin glycosyl-transferase and alpha amylase are functionally closely related and both catalyze the degradation of starch. A person of ordinary skill in the art before the effective filing date of the invention would have been motivated to combine the teachings of Okada with the teachings of Fukui and Wild because the saccharide (starch is a saccharide) from a group consisting of corn, wheat, rice, barley, potatoes, and corn starch and also including cassava starch yielded 53.2% dietary fiber content and cyclodextrin glycosyl-transferase and alpha amylase are functionally closely related and both catalyze the degradation of starch. The person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Okada with the teachings of Fukui, and Wild because the starch from the group consisting of corn, wheat, rice, cassava, barley, sorghum bean and potato, and combinations thereof because mixing and heating in the range of 50-135oC for about 30-90 minutes in the process comprising adding an acid to a starch, mixing and heating the acidified starch to form a starch substrate, roasting the starch, allowing acidic thermal reaction to form a roasted starch intermediate (dextrin), and adding glycosyl transferase to the roasted starch intermediate (dextrin) would yield a higher dietary fiber content than a composition without the glycosyl-transferase treatment.
In regard to instant claim 30, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant application to look at the teachings of Okada for increasing the dietary fiber content of a soluble dextrin by adding calcium sulfate (i.e. buffer) to the soluble dextrin before adding the glycosyl-transferase to the soluble dextrin. A person of ordinary skill in the art before the effective filing date of the invention would have been motivated to do so because Okada teaches that adding calcium sulfate (i.e. buffer) to the soluble dextrin before adding the glycosyl-transferase to the soluble dextrin increases the soluble dietary content by 49.5 % compared to 2.6% for the enzyme-free (that is, in the absence of glycosyl-transferase). The person of ordinary skill in the art would have had a reasonable expectation of success to look at the teaching of Okada on adding calcium sulfate (i.e. buffer) to the soluble dextrin before adding the glycosyl-transferase to the soluble dextrin to increase the soluble dietary content of the soluble dextrin.
Instant claim 31 regarding the soluble dextrin has a dextrose equivalent (DE) (which is a measure of the amount of reducing sugar present in the product) of at least 5, since Okada teaches a soluble dextrin comprising each claimed component thereby constituting the soluble dextrin and its treatment with glycosyl-transferase which converts it to reducing sugar and the amount of reducing sugar is a measure of dextrose equivalent, the chemical property (i.e., the soluble dextrin has a dextrose equivalent (DE) of at least 5) of the soluble dextrin as claimed and known from Okada’s teachings are necessarily the same. The discovery of a previously unappreciated property of a prior art composition, or a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new chemical property (i.e., the soluble dextrin has a dextrose equivalent (DE) of at least 5) which is necessarily present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 4333 (CCPA 1977). Additionally and/or alternatively, properties are the same when the structure and composition are the same. Thus, burden shifts to applicant to show unexpected results, by declaration or otherwise. In re Fitzgerald, 205 USPQ 594. In the alternative, the claimed properties would have been present once the composition was employed in its intended use. In re Best, 195 USPQ 433. Therefore, the soluble dextrin in the teaching by Okada satisfies the claim limitation with respect to where the soluble dextrin has a dextrose equivalent (DE) of at least 5.
In regard to instant claim 35, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant application to look at the teachings of Okada on the method of increasing soluble dietary fiber content of a soluble dextrin wherein the soluble dextrin is derived from a group consisting of barley, wheat, corn, rice, and potato. A person of ordinary skill in the art before the effective filing date of the invention would have been motivated to do so because Okada teaches using a soluble dextrin from a group consisting of barley, wheat, corn, rice, and potato increased the soluble dietary fiber content of a soluble dextrin by 49.5%. The person of ordinary skill in the art would have had a reasonable expectation of success to look at the teaching of Okada on the soluble dextrin from the starch from a group consisting of barley, wheat, corn, rice, and potato consisting of corn, wheat, rice, barley, potatoes, and corn starch and use the soluble dextrin from the group consisting of corn, wheat, rice, cassava, barely, sorghum bean and potato and combinations thereof to produce a higher soluble dietary fiber composition than a composition without the addition of the glycosyl-transferase.
In regard to instant Claims 23, 24, 30, and 36, Okada teaches increasing the dietary fiber in beer or beer-like beverage (numbered page 12, paragraphs 0163 and 0164). After adding an aqueous solution of calcium sulfate into the saccharification bath, the temperature was increased to 50oC and then malt, barley, and maltotrisyl transferase (also known as glycosyl transferase) was added. Calcium sulfate has the ability to act as a pH buffer. The mixture was subjected to 50oC for one hour and then the temperature was increased to 65oC and eventually to 76oC for 10 minutes. As a result of this treatment, the indigestible component content was 49.5 % compared to 2.6% for the enzyme-free (that is, in the absence of glycosyl-transferase) (numbered page 12, Table 8).
In regard to instant Claim 28, Okada teaches the maltotriosyl transferase (another name for glycosyl-transferase) is composed of amino acid SEQ ID No: 3 (Claim 22; numbered page 2, paragraph 0043, lines 1-7).
In regard to instant Claim 29, Okada also teaches that the method for producing an indigestible saccharide wherein the saccharide (starch is a saccharide) is from a group consisting of corn, wheat, rice, barley, potatoes, and corn starch (Claim 16). Examples of starch include cassava starch in addition to corn starch (page 6, paragraph 0096, lines 9-11).
In regard to instant Claim 35, Okada also teaches the saccharide is a dextrin (Claim 7), selected from the group consisting of dextrin (numbered page 2, paragraph 0028, lines 2-4) and is selected from a group consisting of barley, wheat, corn, rice, and potato (numbered page 2, 0033) for the method of producing an indigestible saccharide.
Fukui teaches a process to produce a beer-flavored alcoholic beverages with water-soluble dietary fiber (paragraph 0023, lines 1-2). In regard to instant Claims 23 and 24, Fukui teaches corn starch added and mixed with hydrochloric acid. This was homogenized through a grinder and then stirred. The temperature was then increased to 160oC for 30 minutes to yield roasted dextrin (Example 1, paragraph 0040). The roasted dextrin was dissolved in water and alpha amylase was added (Example 3, paragraph 0044). The reaction was hydrolyzed at 90oC for 30 minutes and then quenched at 130oC for 10 minutes (Example 3, paragraph 0044). Fukui also teaches a yield 53.2% of dietary fiber content (paragraph 0045).
Wind teaches cyclodextrin glycosyl-transferase and alpha amylase. In regard to instant Claims 23 and 24, Wind teaches cyclodextrin glycosyl-transferase and alpha amylase both belong to the glycosyl hydrolase family 13 (first page, first column, lines 1-2) and cyclodextrin glycosyl-transferase and alpha amylase are functionally closely related and both catalyze the degradation of starch (first page, first column, lines 4-5).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention as a whole because the combined teaching of the references renders the claimed invention as obvious. Motivation exists to combine the references because they are analogous art. Okada teaches a temperature range of 80oC or more for heating the rice cake dough with the enzyme. The temperature range in the instant claims is about 100-135oC. The temperature range in Okada’s teaching touches the temperature range with the open language of ‘about’. A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection. MPEP § 2144.05. Additionally, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant application to look at the teachings of Okada on the temperature range of 80oC or more for heating the rice cake dough with the enzyme. A person of ordinary skill in the art before the effective filing date of the invention would have been motivated to do so because Okada teaches the heat treatment in addition to gelatinizing the starch and reducing the risk of microbial contamination, produces an indigestible saccharide (i.e. soluble dietary fiber content) when used with maltotriosyl transferase (glycosyl-transferase). The person of ordinary skill in the art would have had a reasonable expectation of success to look at the teaching of Okada on the heat treatment on the temperature range of 80oC or more and use the temperature range of about 100-135oC in the instant claims to produce a higher soluble dietary fiber composition than a composition without the addition of the glycosyl-transferase. Okada teaches glycosyl-transferase in the form of a powder at 0.67, 1, 3, 10, and 70% w/w of the starch substrate. The range in the claims for the glycosyl-transferase in the form of a powder is 0.001-2.0% w/w of the starch substrate. The concentration for the glycosyl-transferase in the form of a powder in Okada’s teaching touches the concentration range for the glycosyl-transferase in the form of a powder in the instant claims.
Additionally, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant application to look at the teachings of Okada on the glycosyl-transferase in the form of a powder at 0.67, 1, 3, 10, and 70% w/w of the starch substrate. A person of ordinary skill in the art before the effective filing date of the invention would have been motivated to do so because Okada teaches the production method using glycosyl-transferase in the form of a powder at 0.67, 1, 3, 10, and 70% w/w of the starch substrate produces a relatively high indigestible saccharide content (i.e. soluble dietary fiber content). The person of ordinary skill in the art would have had a reasonable expectation of success to look at the teaching of Okada on the glycosyl-transferase in the form of a powder at 0.67, 1, 3, 10, and 70% w/w of the starch substrate and use the concentration range of about 0.001-2.0% w/w of the starch substrate in the instant Claim 9 to produce a higher soluble dietary fiber composition than a composition without the addition of the glycosyl-transferase.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant application to look at the teachings of Okada on the glycosyl-transferase in the form of a liquid. A person of ordinary skill in the art before the effective filing date of the invention would have been motivated to do so because Okada teaches mixing the starch, buffer, and the glycosyl-transferase (from a collected fraction meaning it is a liquid form) produces a relatively high indigestible saccharide content (i.e. soluble dietary fiber content). The person of ordinary skill in the art would have had a reasonable expectation of success to look at the teaching of Okada on the glycosyl-transferase in the form of a liquid (the collected fraction) and use the glycosyl-transferase in the form of a liquid to produce a higher soluble dietary fiber composition than a composition without the addition of the glycosyl-transferase.
Okada teaches a pH of 5.3 for acetic acid as the buffer. The pH range in the instant invention is 5-7 in instant claim 1 and claim 23. The pH range in the teachings of Okada touches with the pH ranges recited in the claims. A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection. MPEP § 2144.05.
In addition, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant application to look at the teachings of Okada on the pH of 5-7 for acetic acid as the buffer at which the enzyme reaction occurs. A person of ordinary skill in the art before the effective filing date of the invention would have been motivated to do so because Okada teaches mixing the acetic acid as the buffer of pH 5-7 with the starch and the glycosyl-transferase for the enzyme reaction produces a relatively high indigestible saccharide content (i.e. soluble dietary fiber content). The person of ordinary skill in the art would have had a reasonable expectation of success to look at the teaching of Okada on the acetic acid as the buffer of pH 5-7 and use it as the buffer so that the enzyme reaction of the glycosyl-transferase and the starch substrate occurs in the range of about 5.0-7.0 to produce a higher soluble dietary fiber composition than a composition without the addition of the glycosyl-transferase.
Okada teaches a temperature of 50oC for 66 hours. The temperature and duration range in the instant claim 19 is 50-60oC for about 5-40 hours. The temperature in the teachings of Okada touches the temperature range in instant claims. A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection. MPEP § 2144.05.
Additionally, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant application to look at the teachings of Okada on the enzyme reaction of the glycosyl-transferase and the starch carried out at 60oC for 66 hours, i.e. carried out in an agitated reactor. A person of ordinary skill in the art before the effective filing date of the invention would have been motivated to do so because Okada teaches the enzyme reaction of the glycosyl-transferase and the starch carried out at 60oC for 66 hours in an agitated reactor, in addition to gelatinizing the starch and reducing the risk of microbial contamination, produces an indigestible saccharide (i.e. soluble dietary fiber content). The person of ordinary skill in the art would have had a reasonable expectation of success to look at the teaching of Okada on the enzyme reaction of the glycosyl-transferase and the starch reaction carried out at 60oC for 66 hours and use the temperature range of about 50-60oC for about 5-40 hours in the instant Claim 19 to produce a higher soluble dietary fiber composition than a composition without the addition of the glycosyl-transferase.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant application to look at the teachings of Okada on the method of producing an indigestible saccharide wherein the saccharide (starch is a saccharide) is from a group consisting of corn, wheat, rice, barley, potatoes, and corn starch. A person of ordinary skill in the art before the effective filing date of the invention would have been motivated to do so because Okada teaches the method of producing rice cake using maltotriosyl transferase (glycosyl-transferase) and starch from a group consisting of corn, wheat, rice, barley, potatoes, and corn starch produces an indigestible saccharide (i.e. soluble dietary fiber content). The person of ordinary skill in the art would have had a reasonable expectation of success to look at the teaching of Okada on starch from a group consisting of corn, wheat, rice, barley, potatoes, and corn starch and use this group consisting of corn, wheat, rice, cassava, barely, sorghum bean and potato and combinations thereof to produce a higher soluble dietary fiber composition than a composition without the addition of the glycosyl-transferase.
Moreover, the Supreme Court pointed out in KSR, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 127 S. Ct. at 1741. The Court thus reasoned that the analysis under 35 U.S.C. 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the “inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 1741. The Court further advised that “[a] person of ordinary skill is…a person of ordinary creativity, not an automation.” Id. at 1742. Therefore, the claimed invention was obvious to make and use at the time the invention was made and was prima facie obvious.
Response to Arguments
8. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that based on claim amendments the rejections of record have been altered to reflect those amendments. Regarding the 112, first paragraph rejection, applicant opine that the claims were amended to recite inorganic acid, but this language remains broad and encompasses a genus not adequately described. Note that a reference has been provided to demonstrate that specifics are needed in the claim language based on variability that can affect outcome. The claimed invention is directed to large genus of products that are not adequately described (acids, enzymes and organism). The claimed invention reads on a strong acid and there are several or a concentrated weak acid and there are several, any glycosyl-transferase (see independent claims) and a genus of Geobacillus. Thus the rejection remains under 112 first paragraph because the arguments were not persuasive and note the instituted objections for the reasons set forth above.
Upon due reconsideration a 103 rejection has been re-instated for the reasons set forth above and herein. The claimed invention remains very broad and the combined teaching of the references reads on the claimed limitations (as noted the acidic pH can be achieved by a strong acid or a weak concentrated acid; and the about language in the claims read on temperature of 80 degrees and the art cites 80 and more; and further a glycosyl-transferase is disclosed in the art and the use of HCL. Thus for these reasons the rejection remains relevant. The examiner made attempts via phone to reach applicant’s representative Andrew Niles to reduce the remaining issues.
Conclusion
9. No claims are presently allowable.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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