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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17602747, filed on 10/09/2021.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The terms “low” and “lower” refereeing to glycaemic index in claim 1 are relative terms that render the claim indefinite. The terms “low” and “lower” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 2-15 included in the rejection as depending from claim 1.
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Laws et al (EP 0 169 068) in view of Severini et al (Effect of enzymatic and technological treatments on solubilisation of arabinoxylans from brewer's spent grain) and beerconnoisseur.com (Beer 101: The Fundamental Steps of Brewing, published June 30, 2016).
Claim 1 recites the following limitations:
A brewing process for obtaining a low glycaemic index beer, the brewing process comprising the steps of:
1) adding water and a brewer’s spent grain hydrolysate, in a mashing tun,
2) adding ground malt, thus proceeding to the mashing,
3) filtering the wort resulting from step 2),
4) boiling the wort and adding hops,
5) separating the wort from hops and fermenting in the presence of yeasts,
6) separating the yeasts and solid residues from the beer thus obtained, and optionally
7) letting the beer to age,
wherein the brewer’s spent grain hydrolysate is obtained by a preparation process comprising the steps of:
mixing brewer’s spent grain and water, in a weight ratio of 1:1 to 1:5,
ii) adding to the mixture thus obtained up to 2 wt%, based on the weight of the mixture, of an enzyme consisting of:
xylanase, or b) an enzymatic complex of xylanase, amylase and glucanase,
and letting to react for 1-6 hours at a temperature of 45-65°C and pH of 4-6,
iii) deactivating the enzyme of step ii), by increasing the temperature to 80-90°C for at least 5 minutes, and
iv) separating the liquid component from the solid component obtained at the end of step iii), thus keeping the liquid component, which is the brewer’s spent grain hydrolysate,
and wherein the low glycaemic index beer is a beer having a lower glycaemic index than a beer obtained without adding in step 1) the brewer’s spent grain hydrolysate.
Claim 1 is directed to the process for brewing beer wherein brewer’s spent grain hydrolysate is used in a mashing. In regard to claims 1, Laws et al discloses that “[s]pent grains and waste products from malting process can be converted into valuable fermentable materials by hydrolysis (Abstract). Laws et al discloses several embodiments where brewer’s spent grain hydrolysate is used for the preparation of an alcoholic beverage (page 3 lines 15-20). Examiner is relying upon the embodiment of using brewer’s spent grain hydrolysate (“the broth”) in mashing:
The broth provides a raw material for the fermentation 5industries and after any necessary decolorization, it is particularly suitable for use in brewing. Alternatively the broth can be used as a total or partial replacement of the treated water (mashing liquor) used for mashing a grist consisting of barley malt, often together with cereal adjuncts such as wheat flour, maize, or raw barley. Alternatively, it can itself be fermented to produce a solution for ethanol recovery.
Hence, Laws et al meets the limitation of “1) adding water and a brewer's spent grain hydrolysate, in a mashing tun, 2) adding ground malt, thus proceeding to the mashing”.
Laws et al discloses brewing of beer (page 4 lines 4-5, page 9 17-20, Example 8).
It is further noted that the recited steps of:
1) adding water in a mashing tun,
2) adding ground malt, thus proceeding to the mashing,
3) filtering the wort resulting from step 2),
4) boiling the wort and adding hops,
5) separating the wort from hops and fermenting in the presence of yeasts,
6) separating the yeasts and solid residues from the beer thus obtained, and optionally
7) letting the beer to age,
are conventional/traditional method steps of the beer brewing. In regard to the steps (1)-(7) as recited in claim 1, Laws et al discloses “kettle, the hop separator, whirlpool separator or fermentation vessel” and a mashing process (page 3 lines 33-36). It is inferred that at least the steps of mashing, filtering after mashing to obtain wort, boiling of wort, separating and fermenting of wort are disclosed by Laws et al. However, another prior art reference to beerconnoisseur.com is made as a teaching of conventional brewing steps that might not be explicitly disclosed by Laws et al. Beerconnoisseur.com discloses the following “fundamental steps of brewing:
Mashing
The first step in the beer-making process is mashing, in which the grist, or milled malt, is transferred to the mash tun. Mashing is the process of combining the grist and water, also known as liquor, and heating it to temperatures usually between 100 degrees Fahrenheit up to 170 degrees Fahrenheit.
Lautering
Lautering is the process of separating the wort from spent grain as efficiently as possible. Generally, it is done in a separate lauter tun, although the process of mash filtering can now be done by large-scale or small-scale brewers.
Boiling
Once a brewer has wort, it is sterilized through a boiling process in a brew kettle, which halts enzyme activity and condenses the liquid. During the boil, which typically lasts from 60 to 120 minutes, hops are added.
Whirlpooling
Once the boil is complete, the whirlpool phase further clarifies the wort by removing protein and hop solids through settling. These solids are known as trub. Although the boiling kettle can also be used as a whirlpool, many brewers use a separate, specially designed container.
Fermentation
Wort is transferred to a fermentation vessel and the yeast is pitched, or added.
Conditioning
During the conditioning process for ales and lagers, the beer will mature and smooth, and by-products of fermentation will diminish. It is possible to dry hop during this stage for added aroma, and other methods such as barrel aging can further introduce complexity.
Therefore, beerconnoisseur.com teaches that the steps of 1) adding water in a mashing tun, 2) adding ground malt, thus proceeding to the mashing, 3) filtering the wort resulting from step 2), 4) boiling the wort and adding hops, 5) separating the wort from hops and fermenting in the presence of yeasts, 6) separating the yeasts and solid residues from the beer thus obtained, and 7) letting the beer to age, are conventional/traditional method steps of the beer brewing.
Claim 1 also includes limitations directed to a distinct process for production of the brewer's spent grain hydrolysate:
i) mixing brewer’s spent grain and water, in a weight ratio of 1:1 to 1:5,
ii) adding to the mixture thus obtained up to 2 wt%, based on the weight of the mixture, of an enzyme consisting of:
a) xylanase, or b) an enzymatic complex of xylanase, amylase and glucanase,
and letting to react for 1-6 hours at a temperature of 45-65°C and pH of 4-6,
iii) deactivating the enzyme of step ii), by increasing the temperature to 80-90°C for at least 5 minutes, and
iv) separating the liquid component from the solid component obtained at the end of step iii), thus keeping the liquid component, which is the brewer’s spent grain hydrolysate.
Laws et al does not disclose the process for production of the brewer's spent grain hydrolysate as claimed. In regard to claims 1, Severini et al discloses hydrolysing fresh BSG (brewer’s spent grain) with three different commercial xylanases (page 164 section 3.2. Effect of enzymatic treatments on BSG). Therefore, Severini et al meets the limitation of “[a] process for the preparation of a brewer’s spent grain hydrolysate”.
In regard to step (i), Severini et al discloses mixing 1.5 g of wet BSG (brewer’s spent grain) with 3.4 mL of sodium acetate buffer (100 mM, pH 5.5) (page 163 section 2.6. Enzymatic solubilisation method). It is noted that sodium acetate buffer is a solution of acetic acid and sodium acetate intended to adjust pH to a desired level of 5.5. Hence, this step reads on mixing brewer’s spent grain and water. In regard to the recitation of brewer’s spent grain and water weight ratio of 1:1 to 1:5, it is noted that combination of 1.5 g of wet BSG and 3.4 mL of sodium acetate buffer (100 mM, pH 5.5) is within claimed range absent any evidence to the contrary.
In regard to step (ii), Severini et al discloses 0.1 mL of enzyme solution containing 2 and 5 units of xylanases (VS, RL and RE) was added to the BSG suspension in the water solution of acetic acid and sodium acetate (page 163 section 2.6. Enzymatic solubilisation method). In regard to the VS, RL and RE xylanases, Severini et al discloses “[t]he enzymes Rohalase WL (RL), Rohament GE (RE) and Veron Special (VS) were EC 3.2.1.8 xylanases provided by AB Enzymes (Darmstadt, Germany)” (page 163 section 2.1. Materials). Further in regard to step (ii), Severini et al discloses letting BSG to react with xylanase for 15, 45, 90, 150 and 240 min (i.e 0.25, 0.75, 1.5, 2.5 and 4 hours) at a temperature of 50°C while being suspended in sodium acetate buffer of pH 5.5 (page 163 section 2.6. Enzymatic solubilisation method). This reads on the enzymatic treatment of BSG being performed at pH of 4-6 as claimed.
In regard to step (iii), Severini et al discloses boiling enzymatically treated BSG (page 163 section 2.6. Enzymatic solubilisation method). It is noted that boiling temperature is around 100°C and this leads to the deactivation of enzyme. One of ordinary skill in the art would have been motivated to perform this heat treatment for a period of time that is sufficient to cause the deactivation of enzyme.
In regard to step (iv), Severini et al discloses centrifuging enzymatically treated BSG that leads to a separation of liquid and solid fraction and further analyzing supernatant (liquid fraction) which reads on claimed limitation of separating the liquid component from the solid component obtained at the end of step iii), thus keeping the liquid component, which is the brewer’s spent grain hydrolysate (page 163 section 2.6. Enzymatic solubilisation method).
Further in regard to the concentration and temperature recitations, it is noted that:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05, II A).
Further, regarding the concentration, temperature and time ranges as examined above, it is noted that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Laws et al discloses making and using the brewer's spent grain hydrolysate. One of ordinary skill in the art would have been motivated to modify Laws et al in view of Severini et al and to employ any known process for the production of the brewer's spent grain hydrolysate including the one disclosed by Severini et al.
In regard to the recitation of “wherein the low glycaemic index beer is a beer having a lower glycaemic index than a beer obtained without adding in step 1) the brewer's spent grain hydrolysate” in claim 1 and the concentrations of pentosans, xylose, arabinose and ferulic acid in claim 2, it is noted that although the references do not specifically disclose every possible quantification or characteristic of its product, these characteristics would have been expected to be as claimed absent any clear and convincing evidence and/or arguments to the contrary. The reference discloses the same starting materials and methods as instantly (both broadly and more specifically) claimed, and thus one of ordinary skill in the art would recognize that the reduction of a glycaemic index and concentrations of pentosans, xylose, arabinose and ferulic acid, among many other characteristics of the product obtained by referenced method, would have been an inherent result of the process disclosed therein. The Patent Office does not possess the facilities to make and test the referenced method and product obtain by such method, and as reasonable reading of the teachings of the references has been applied to establish the case of obviousness, the burden thus shifts to applicant to demonstrate otherwise.
In regard to claim 3, Severini et al discloses “[t]he enzymes Rohalase WL (RL), Rohament GE (RE) and Veron Special (VS) were EC 3.2.1.8 xylanases provided by AB Enzymes (Darmstadt, Germany)” (page 163 section 2.1. Materials).
In regard to claim 4, Severini et al discloses 0.1 mL of enzyme solution containing 2 and 5 units of xylanases (VS, RL and RE) was added to the BSG suspension in the water solution of acetic acid and sodium acetate (page 163 section 2.6. Enzymatic solubilisation method).
In regard to claims 5, Severini et al discloses mixing 1.5 g of wet BSG (brewer’s spent grain) with 3.4 mL of sodium acetate buffer (100 mM, pH 5.5) (page 163 section 2.6. Enzymatic solubilisation method). It is noted that sodium acetate buffer is a solution of acetic acid and sodium acetate intended to adjust pH to a desired level of 5.5. Hence, this step reads on mixing brewer’s spent grain and water. In regard to the recitation of brewer’s spent grain and water weight ratio of 1:1 to 1:5, it is noted that combination of 1.5 g of wet BSG and 3.4 mL of sodium acetate buffer (100 mM, pH 5.5) is within claimed range absent any evidence to the contrary.
In regard to claim 6, Severini et al discloses letting BSG to react with xylanase for 15, 45, 90, 150 and 240 min (i.e 0.25, 0.75, 1.5, 2.5 and 4 hours) at a temperature of 50°C (page 163 section 2.6. Enzymatic solubilisation method).
In regard to claim 7, Severini et al discloses centrifuging enzymatically treated BSG that leads to a separation of liquid and solid fraction (page 163 section 2.6. Enzymatic solubilisation method). Severini et al disclose filtration employed in tocopherol analysis (page 163 section 2.4. Tocopherol analysis). One of ordinary skill in the art would have been motivated to perform any conventional liquid/solid separation technique including filtration.
In regard to claims 8-15, it is noted that the instant claims are directed to the process of making beer. Claims 8-15 are directed to a distinct process for production of the brewer's spent grain hydrolysate. Further in this regard, it is noted that although the reference does not specifically disclose every possible quantification or characteristic of brewer's spent grain hydrolysate (as recited in claims 8-15), these characteristics would have been expected to be as claimed absent any clear and convincing evidence and/or arguments to the contrary. The reference discloses the same starting materials and methods as instantly (both broadly and more specifically) claimed, and thus one of ordinary skill in the art would recognize that the characteristics as recited in claims 8-15 among many other characteristics of the product obtained by referenced method, would have been an inherent result of the process disclosed therein. The Patent Office does not possess the facilities to make and test the referenced method and product obtain by such method, and as reasonable reading of the teachings of the reference has been applied to establish the case of obviousness, the burden thus shifts to applicant to demonstrate otherwise.
Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to VERA STULII whose telephone number is (571)272-3221. The examiner can normally be reached Monday-Friday 5:30AM-3:30PM.
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/VERA STULII/ Primary Examiner, Art Unit 1791
