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 .
EXAMINER’S REMARKS
Examiner notes that Claims 63-66 have all been repeated twice. Examiner notes that all claims should be listing only once.
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.
Claims 1, 4, 14-15, 42-43, 63-64, and 67-68 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “wherein the mashing produces a final mash viscosity of ≤ 100 cP” in lines 7-8. There was not adequate written description support at the time of filing for the specific final mash viscosity of ≤ 100 cP. This limitation constitutes new matter.
Claims 4, 14-15, 42-43, 63-64, and 67-68 are rejected as being dependent on a rejected base claim.
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 14-15, 42-43, 63-64, and 67-68 are rejected under 35 U.S.C. 103 as being unpatentable over Festersen et al. US 2007/0148741 in view of Dr. Lambic “Tannins in Sour Beer” <https://www.sourbeerblog.com/tannins-in-sour-beer/> (published August 2, 2015) (herein referred to as “Dr. Lambic”), Aerts et al. US 2007/0254063, Cuevas et al. US 2018/0163191 (cited on Information Disclosure Statement filed February 6, 2023), Hempen et al. US 2019/0367852, and Sanders US 2019/0055503.
Regarding Claim 1, Festersen et al. discloses a method for production of a brewer’s wort (‘741, Paragraph [0057]) mashing a grist comprising sorghum (‘741, Paragraph [0057]) in the presence of an exogenously supplied enzyme composition (‘741, Paragraph [0058]) comprising a tannin (polyphenol) enzyme to provide the brewer’s wort (‘741, Paragraph [‘741, Paragraphs [0027] and [0035]). Festersen et al. also discloses steeping by mixing the barley kernels with water then germinating the wet barley by maintaining at a suitable temperature and humidity level until adequate modification, i.e. degradation of the starch and activation of enzymes has been achieved wherein low temperature kilning is more appropriate for malts when it is essential to preserve enzymatic activity (‘741, Paragraph [0024]) and that the mashing process is conducted over a period of time at various temperatures to activate the endogenous malt enzymes responsible for the degradation of proteins and carbohydrates (‘741, Paragraph [0025]). Although Festersen et al. does not explicitly disclose the enzyme composition retaining at least 80% catalytic activity after incubation in a 2 mg/mL catechin solution measured by a turbidity cross linking assay, Festersen et al. establishes that adjusting the temperature at which the wet barley is germinated and adjusting the kilning temperature influences the enzymatic activity. Differences in the catalytic activity of the enzyme composition after incubation in a catechin solution will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such catalytic activity of the enzyme composition is critical. Where 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.).
Further regarding Claim 1, Festersen et al. is silent regarding the grist comprises at least 130 µM CAE per gram of grist in the presence of the exogenously supplied enzyme composition and the tannin uninhibited raw starch degrading α-amylase having at least 98% sequence identity to SEQ ID NO:2 or an amylase active fragment thereof to provide the brewer’s wort.
Dr. Lambic discloses a highly attenuated sour beer of gueuze comprising tannins adding structure and fullness to the body and mouthfeel of a sour beer as well as a dryness in the finish which are characteristic to the style (Dr. Lambic, Page 3) wherein flanders reds and a wide range of fruit sour beers also have moderate to high tannin content wherein flanders red tannins are extracted from wood during the beer’s long aging in oak or chestnut barrels whereas fruit sours like wine derive tannins directly from the skins and seeds of the fruit being added (Dr. Lambic, Page 4) wherein hydrolysable tannins are fairly large molecules which comes bound to sugar groups and produce a softer bitterness and astringency which is desirable in many sour beers which tannins occur in high concentration in oak and chestnut woods (Dr. Lambic, Pages 4-5) wherein tannins are extracted from grain during mashing (Dr. Lambic, Page 2). Aerts et al. discloses a method for brewing beer comprising the addition of polyphenol rich extracts prepared from hops at specific steps during or after the brewing process to enhance the mouthfeel, reducing power, and stability of the beer (‘063, Paragraph [0002]) comprising tannins (gallotannins) (‘063, Paragraph [0155]) wherein the content of different polyphenolic components is expressed as mg/100 g hop product except for procyanidin B3 and prodelphinidin B3 which are expressed in mg per 100 g hop product as catechin equivalents (‘063, Paragraph [0203]) wherein polyphenol extracts impart varying sensory impressions to beer depending on the varietal origin wherein the addition of total hop polyphenol extract affects the sensory properties of bitterness, fullness, astringency, and stickiness (‘063, Paragraph [0117]).
Festersen et al. discloses a method of making any type of beer (‘741, Paragraph [0063]). Festersen et al., Dr. Lambic, and Aerts et al. are all directed towards the same field of endeavor of methods of producing beer. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the concentration of tannin associated with sour beers as taught by Dr. Lambic based upon the type of beer desired to be made as well as to adjust the structure and fullness to the body and mouthfeel and the desired dryness in the finish characteristic to the desired style of beer (Dr. Lambic, Page 3). Additionally, although Aerts et al. does not explicitly disclose the grist comprising the claimed concentration of CAE per gram of grist, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the concentration of CAE per gram of grist of modified Festersen et al. and adjust said concentration to the claimed amounts since differences in concentration of catechins in the grist will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration of catechins in the grist is critical. Where 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.). Aerts et al. establishes that polyphenols such as tannins imparts varying sensory impressions to the beer such as bitterness, fullness, astringency, and stickiness. One of ordinary skill in the art at the time of the invention would adjust the catechin concentration in the grist of modified Festersen et al. based upon the desired bitterness, fullness, astringency, and stickiness levels as suggested by Aerts et al.
Further regarding Claim 1, Festersen et al. discloses steeping barley kernels with water to activate the metabolic processes of the dormant kernel at a suitable temperature until adequate modification using degradation of starch and activation of enzymes wherein the temperature regime in the kiln and amount of enzymes which survive for use in the mashing process determines the color of the barley malt wherein low temperature kilning is more appropriate for malts when it is essential to preserve enzymatic activity (‘741, Paragraph [0024]) wherein the mashing process is conducted over a period of time at various temperatures in order to activate the endogenous malt enzymes responsible for the degradation of proteins and carbohydrates (‘741, Paragraph [0025]) wherein traditional lager beer has often been brewed using a step infusion method which is a mashing procedure involving a series of rests at various temperatures each favoring one of the necessary endogenous enzyme activities comprising preparing two separate mashes utilizing a cereal cooker for boiling adjuncts and a mash tun for well modified, highly enzymatically active malts (‘741, Paragraph [0026]) wherein the mash contains tannins (‘741, Paragraph [0028]) and the enzyme is alpha amylase (‘741, Paragraph [0025]). The disclosure of a mash containing well modified, highly enzymatically active malts reads on the claimed uninhibited raw starch degrading α-amylase.
Further regarding Claim 1, Festersen et al. discloses the process reducing the viscosity of the mash containing an aqueous solution comprising a starch hydrolysate (‘741, Paragraphs [0055]-[0056]) wherein increased wort viscosity reduces filterability (‘741, Paragraph [0028]). However, Festersen et al. modified with Dr. Lambic and Lambic is silent regarding the mashing producing a final mash viscosity of ≤ 100 cP.
Hempen et al. discloses a process of reducing the viscosity in a brewing process comprising the steps of preparing a mash from malt and adjunct and reducing viscosity to allow faster downstream filtration steps in the brewing process (‘852, Paragraph [0014]). Sanders discloses a mashing to convert grain starches to simpler fermentable sugars wherein a final escalation to mash out temperatures are used to reduce wort viscosity to facilitate lautering and to denature enzymes to fix the wort sugar profile (‘503, Paragraph [0069]).
Although Festersen et al. does not explicitly disclose mashing to the claimed final mash viscosity of ≤ 100 cP, Festersen et al. teaches reducing the viscosity of the mash (‘741, Paragraphs [0055]-[0056]) since increased wort viscosity has the disadvantage of reduced filterability. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the final mash viscosity of modified Festersen et al. since differences in the final mash viscosity will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such final mash viscosity is critical. Where 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.). One of ordinary skill in the art would adjust the final mash viscosity of the process of modified Festersen et al. to be sufficiently low in order to have good filterability already suggested by Festersen et al. that allows faster downstream filtration steps in the brewing process as taught by Hempen et al. (‘741,Paragraph [0028]). Furthermore, reduced viscosity of the final mash facilitates lautering and denatures and fixes the wort sugar profile as taught by Sanders (‘503, Paragraph [0069]).
Further regarding Claims 1 and 42, Festersen et al. modified with Dr. Lambic and Aerts et al. is silent regarding the tannin uninhibited enzyme being a raw starch degrading enzyme having at least 98% sequence identity to SEQ ID NO:2 or an amylase active fragment thereof. Claims 1 and 42 contemplates wherein the alpha amylase is represented by the polypeptide sequence set forth in SEQ ID NO: 2.
Cuevas et al. teaches an alpha amylase variant sharing 100% identity relative to SEQ ID NO: 2 (see sequence alignment below). It should be noted that the sequence depicted in the alignment below is described in Example 4 of Cuevas et al. In Example 4, Cuevas et al. specifically teaches a Cytophaga alpha amylase; namely C16E-AY-Y301A, comprising S360A/R375Y mutations. These are highlighted in the sequence alignment. Introducing these mutations into parent sequence of Cuevas et al. (i.e. SEQ ID NO: 1) yield the C16E-AY-Y301A variant which shares 100% identity with instant SEQ ID NO: 2.
Alignment of Instant SEQ NO: 2 against the Sequence described in Example 4 of ‘191
Query Match 100.0%; Score 2655; Length 483;
Best Local Similarity 100.0%;
Matches 483; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AATNGTMMQYFEWYVPNDGQQWNRLRTDAPYLSSVGITAVWTPPAYKGTSQADVGYGPYD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AATNGTMMQYFEWYVPNDGQQWNRLRTDAPYLSSVGITAVWTPPAYKGTSQADVGYGPYD 60
Qy 61 LYDLGEFNQKGTVRTKYGTKGELKSAVNTLHSNGIQVYGDVVMNHKAGADYTENVTAVEV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 LYDLGEFNQKGTVRTKYGTKGELKSAVNTLHSNGIQVYGDVVMNHKAGADYTENVTAVEV 120
Qy 121 NPSNRYQETSGEYNIQAWTGFNFPGRGTTYSNWKWQWFHFDGTDWDQSRSLSRIFKFHGK 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 NPSNRYQETSGEYNIQAWTGFNFPGRGTTYSNWKWQWFHFDGTDWDQSRSLSRIFKFHGK 180
Qy 181 AWDWPVSSENGNYDYLMYADYDYDHPDVVNEMKKWGVWYANEVGLDGYRLDAVKHIKFSF 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 AWDWPVSSENGNYDYLMYADYDYDHPDVVNEMKKWGVWYANEVGLDGYRLDAVKHIKFSF 240
Qy 241 LKDWVDNARAATGKEMFTVGEYWQNDLGALNNYLAKVNYNQSLFDAPLHYNFYAASTGGG 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 LKDWVDNARAATGKEMFTVGEYWQNDLGALNNYLAKVNYNQSLFDAPLHYNFYAASTGGG 300
Qy 301 AYDMRNILNNTLVASNPTKAVTLVENHDTQPGQSLESTVQPWFKPLAYAFILTRSGGYPA 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 AYDMRNILNNTLVASNPTKAVTLVENHDTQPGQSLESTVQPWFKPLAYAFILTRSGGYPA 360
Qy 361 VFYGDMYGTKGTTTYEIPALKSKIEPLLKARKDYAYGTQRDYIDNPDVIGWTREGDSTKA 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 VFYGDMYGTKGTTTYEIPALKSKIEPLLKARKDYAYGTQRDYIDNPDVIGWTREGDSTKA 420
Qy 421 KSGLATVITDGPGGSKRMYVGTSNAGEIWYDLTGNRTDKITIGSDGYATFPVNGGSVSVW 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 KSGLATVITDGPGGSKRMYVGTSNAGEIWYDLTGNRTDKITIGSDGYATFPVNGGSVSVW 480
Qy 481 VQQ 483
|||
Db 481 VQQ 483
Both modified Festersen et al. and Cuevas et al. are directed towards the same field of endeavor of methods of making beer beverages comprising an α-amylase enzyme. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the generic alpha amylase used in the grist of modified Festersen et al. to have 100% sequence identity as set forth in SEQ ID NO:2 as taught by Example 4 of Cuevas et al. since the selection of a known material (the sequence as set forth in the claimed SEQ ID NO:2) based on its suitability for its intended use (an alpha amylase used in a beer brewing process) supports a prima facie obviousness determination in view of Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (MPEP § 2144.07). Furthermore, the simple substitution of one known element (using a generic alpha amylase in a beer brewing method) for another (using alpha amylase having a sequence as set forth in the claimed SEQ ID NO:2) to obtain predictable results is prima facie obvious (MPEP § 2143.I.(B)).
Regarding Claim 14, Festersen et al. discloses the grist further comprising corn, barley, wheat, rye, millet, or rice (‘741, Paragraph [0057]).
Regarding Claim 15, Festersen et al. discloses extraction recovery, filterability, and wort clarity is affected by the standard of the grist, e.g. the barley malt and the types of adjunct as well as the applied mashing procedure. However, Festersen et al. modified with Dr. Lambic is silent regarding the grist comprising at least 140 or 150 µM CAE/g of grist.
Aerts et al. discloses a method for brewing beer comprising the addition of polyphenol rich extracts prepared from hops at specific steps during or after the brewing process to enhance the mouthfeel, reducing power, and stability of the beer (‘063, Paragraph [0002]) comprising tannins (gallotannins) (‘063, Paragraph [0155]) wherein the content of different polyphenolic components is expressed as mg/100 g hop product except for procyanidin B3 and prodelphinidin B3 which are expressed in mg per 100 g hop product as catechin equivalents (‘063, Paragraph [0203]) wherein polyphenol extracts impart varying sensory impressions to beer depending on the varietal origin wherein the addition of total hop polyphenol extract affects the sensory properties of bitterness, fullness, astringency, and stickiness (‘063, Paragraph [0117]).
Both modified Festersen et al. and Aerts et al. are directed towards the same field of endeavor of methods of brewing beer. Although Aerts et al. does not explicitly disclose the grist comprising the claimed concentration of CAE/g of grist, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the concentration of CAE/g of grist of modified Festersen et al. and adjust said concentration to the claimed amounts since differences in concentration of catechins in the grist will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration of catechins in the grist is critical. Where 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.). Aerts et al. establishes that polyphenols such as tannins imparts varying sensory impressions to the beer such as bitterness, fullness, astringency, and stickiness. One of ordinary skill in the art at the time of the invention would adjust the catechin concentration in the grist of modified Festersen et al. based upon the desired bitterness, fullness, astringency, and stickiness levels as suggested by Aerts et al.
Regarding Claim 43, Festersen et al. discloses the exogenously supplied enzyme composition (‘741, Paragraph [0058]) further comprising a protease (‘741, Paragraph [0059]).
Regarding Claims 63-64, Festersen et al. discloses fermenting the brewer’s wort to obtain an alcoholic beverage of beer (‘741, Paragraph [0062]).
Regarding Claim 67, Festersen et al. discloses steeping by mixing the barley kernels with water then germinating the wet barley by maintaining at a suitable temperature and humidity level until adequate modification, i.e. degradation of the starch and activation of enzymes has been achieved wherein low temperature kilning is more appropriate for malts when it is essential to preserve enzymatic activity (‘741, Paragraph [0024]) and that the mashing process is conducted over a period of time at various temperatures to activate the endogenous malt enzymes responsible for the degradation of proteins and carbohydrates (‘741, Paragraph [0025]). Although Festersen et al. does not explicitly disclose the enzyme composition of α-amylase retaining at least 90% catalytic activity after incubation in a 2 mg/mL catechin solution, Festersen et al. establishes that adjusting the temperature at which the wet barley is germinated and adjusting the kilning temperature influences the enzymatic activity. Differences in the catalytic activity of the enzyme composition after incubation in a catechin solution will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such catalytic activity of the enzyme composition is critical. Where 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.).
Regarding Claim 68, Cuevas et al. discloses the α-amylase having the claimed sequence identity of SEQ ID NO:2. The limitations “wherein the α-amylase exhibits a specific catechin cross-linking activity ≤ 2AU/µg” are limitations regarding the properties of the claimed α-amylase. Since Cuevas et al. uses the same enzyme with the same SEQ ID as claimed, where the claimed and prior products are identical or substantially identical in structure or composition, a prima facie case of obviousness has been established in view of In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (MPEP § 2112.01.I.). Products of identical chemical composition can not have mutually exclusive properties in view of In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (MPEP § 2112.01.II.). One of ordinary skill in the art would expect the α-amylase disclosed by Cuevas that is identical to that claimed to behave in the same manner as claimed.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Festersen et al. US 2007/0148741 in view of Dr. Lambic “Tannins in Sour Beer” <https://www.sourbeerblog.com/tannins-in-sour-beer/> (published August 2, 2015) (herein referred to as “Dr. Lambic”), Aerts et al. US 2007/0254063, Cuevas et al. US 2018/0163191 (cited on Information Disclosure Statement filed February 6, 2023), Hempen et al. US 2019/0367852, and Sanders US 2019/0055503 as applied to claim 1 above in further view of Dianabuja “Brewing Sorghum Beer in Burundi, 19th Century and Now” <https://dianabuja.wordpress.com/2011/05/18/brewing-sorghum-beer-in-burundi-19th-century-and-now> (published May 18, 2011) (herein referred to as “Dianabuja”).
Regarding Claim 4, Festersen et al. discloses the grist comprising sorghum (‘741, Paragraph [0057]). However, Festersen et al. modified with Dr. Lambic, Aerts et al., Cuevas et al., Hempen et al., and Sanders is silent regarding the grist comprising red sorghum.
Dianabuja discloses a method of brewing beer made from sorghum comprising the steps of placing red sorghum into cold water to swell and germinate then drying in the sun and then pounding into flour, pouring the flour into boiling water to make a porridge that is continually stirred while progressively adding cold water (Dianabuja, Page 1).
Both modified Festersen et al. and Dianabuja are directed towards the same field of endeavor of methods of making beer. The beers of modified Festersen et al. and Dianabuja are both derived from sorghum. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the beer brewing method of modified Festersen et al. and use red sorghum as a component of the grist as taught by Dianabuja since the selection of a known material (red sorghum) based on its suitability for its intended use (to make beer) supports a prima facie obviousness determination in view of Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (MPEP § 2144.07). Dianbuja teaches that there was known utility in the beer making art to make beer from red sorghum.
Response to Amendment
The affidavit under 37 CFR 1.132 filed March 20, 2026 is insufficient to overcome the obviousness rejection of Claim 1 under 35 USC 103(a) based upon the obviousness rejection rationale as set forth in the last Office action because of the following:
Applicant argues on Paragraphs 7-9 on Pages 2-3 of the affidavit that experiments were performed as described in Example 4 of the Specification in which multiple α-amylases were evaluated for liquefaction performance in high tannin red sorghum and that Table 3 shows the CsAA enzyme produced a final viscosity of 60 cP while comparator amylases produced dramatically higher final viscosities ranging from 940 cP to 7274 cP under comparable conditions and that achieving a final mash viscosity of ≤ 100 cP in such high tannin sorghum is not characteristic of conventional amylases and not predictable from their general liquefaction profiles. Applicant continues that Example 6 of the application quantifies the extent to which tannins inactivate or aggregate α-amylase enzymes and that Table 7 shows CsAA exhibits a specific catechin cross linking activity of 1.2 AU/µg to be substantially lower than the comparator enzymes and that these measurements allegedly confirm that CsAA is substantially less inhibited by catechin and retains its activity in high tannin environments such as red sorghum mashes.
Examiner argues the new rejection relies upon a new combination of references. The secondary reference of Hempen et al. discloses a method of mashing raw cereals to make wort using an alpha amylase (‘852, Paragraph [0001]) to hydrolyze starch in order to decrease the viscosity of a mash (‘852, Paragraph [0055]). Hempen et al. teaches that it was known in the food and beverage art to decrease the viscosity of a mash containing an alpha amylase. Applicant has not provided any data that is unexpected over the prior art combination. Furthermore, Festersen et al. discloses the process reducing the viscosity of the mash containing an aqueous solution comprising a starch hydrolysate (‘741, Paragraphs [0055]-[0056]) wherein increased wort viscosity reduces filterability (‘741, Paragraph [0028]). However, Festersen et al. modified with Dr. Lambic and Lambic is silent regarding the mashing producing a final mash viscosity of ≤ 100 cP. Hempen et al. discloses a process of reducing the viscosity in a brewing process comprising the steps of preparing a mash from malt and adjunct and reducing viscosity to allow faster downstream filtration steps in the brewing process (‘852, Paragraph [0014]). Sanders discloses a mashing to convert grain starches to simpler fermentable sugars wherein a final escalation to mash out temperatures are used to reduce wort viscosity to facilitate lautering and to denature enzymes to fix the wort sugar profile (‘503, Paragraph [0069]). Although Festersen et al. does not explicitly disclose mashing to the claimed final mash viscosity of ≤ 100 cP, Festersen et al. teaches reducing the viscosity of the mash (‘741, Paragraphs [0055]-[0056]) since increased wort viscosity has the disadvantage of reduced filterability. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the final mash viscosity of modified Festersen et al. since differences in the final mash viscosity will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such final mash viscosity is critical. Where 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.). One of ordinary skill in the art would adjust the final mash viscosity of the process of modified Festersen et al. to be sufficiently low in order to have good filterability already suggested by Festersen et al. that allows faster downstream filtration steps in the brewing process as taught by Hempen et al. (‘741,Paragraph [0028]). Furthermore, reduced viscosity of the final mash facilitates lautering and denatures and fixes the wort sugar profile as taught by Sanders (‘503, Paragraph [0069]). Applicant has not provided any objective data showing the unexpected properties from the claimed final mash viscosity of ≤ 100 cP. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show criticality of the claimed range in view of In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960) (MPEP § 716.02(d).II.). Applicant has provided no such comparison. The prior art teaches adjusting the viscosity of a mash containing an alpha amylase to have a reduced viscosity for better filtering. An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness in view of In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979) (MPEP § 716.02(e)). With respect to applicant’s data in Example 6 which results are shown in Table 7, it is noted that applicant discloses cross linking is enhanced by increased enzyme concentration (Specification, Paragraph [00110]). Claim 1 does not specify any particular enzyme concentration. Applicant’s data in Example 6 are not commensurate in scope with the claimed invention since Claim 1 does not specify any particular enzyme concentration, which enzyme concentration influences cross linking as disclosed by applicant. Therefore, applicant’s affidavit is not effective to rebut the obviousness rejection as the affidavit does not provide objective evidence showing the allegations of unexpected or critical results of the newly claimed final mash viscosity.
Response to Arguments
Examiner notes that the previous indefiniteness rejections under 35 USC 112(b) have been withdrawn in view of the amendments.
Applicant’s arguments on Pages 5-6 of the Remarks with respect to the obviousness rejection of Claim 1 under 35 USC 103(a) with respect to the new limitations regarding the newly claimed final mash viscosity of ≤ 100 cP has been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The rejection has been modified with respect to the newly claimed final mash viscosity that Festersen et al. discloses the process reducing the viscosity of the mash containing an aqueous solution comprising a starch hydrolysate (‘741, Paragraphs [0055]-[0056]) wherein increased wort viscosity reduces filterability (‘741, Paragraph [0028]). However, Festersen et al. modified with Dr. Lambic and Lambic is silent regarding the mashing producing a final mash viscosity of ≤ 100 cP. Hempen et al. discloses a process of reducing the viscosity in a brewing process comprising the steps of preparing a mash from malt and adjunct and reducing viscosity to allow faster downstream filtration steps in the brewing process (‘852, Paragraph [0014]). Sanders discloses a mashing to convert grain starches to simpler fermentable sugars wherein a final escalation to mash out temperatures are used to reduce wort viscosity to facilitate lautering and to denature enzymes to fix the wort sugar profile (‘503, Paragraph [0069]).
Although Festersen et al. does not explicitly disclose mashing to the claimed final mash viscosity of ≤ 100 cP, Festersen et al. teaches reducing the viscosity of the mash (‘741, Paragraphs [0055]-[0056]) since increased wort viscosity has the disadvantage of reduced filterability. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the final mash viscosity of modified Festersen et al. since differences in the final mash viscosity will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such final mash viscosity is critical. Where 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.). One of ordinary skill in the art would adjust the final mash viscosity of the process of modified Festersen et al. to be sufficiently low in order to have good filterability already suggested by Festersen et al. that allows faster downstream filtration steps in the brewing process as taught by Hempen et al. (‘741,Paragraph [0028]). Furthermore, reduced viscosity of the final mash facilitates lautering and denatures and fixes the wort sugar profile as taught by Sanders (‘503, Paragraph [0069]).
Applicant's arguments filed March 20, 2026 with respect to the obviousness rejections under 35 USC 103(a) have been fully considered but they are not persuasive.
Applicant argues on Page 6 of the Remarks that applicant’s specification allegedly demonstrates that achieving a final viscosity ≤ 100 cP in high tannin sorghum is not routine and is not inherent to α-amylases generally. Applicant contends that Example 4 shows that only the claimed tannin uninhibited enzyme (SEQ ID NO:2) achieves dramatic viscosity reduction of a final viscosity of 60 cP in high tannin red sorghum whereas other commercial α-amylases yield viscosity of from 940 cP to over 7000 cP under comparable conditions and that these results are allegedly unexpected. Applicant continues that the Examiner reliance on inherency from Cuevas is not supported as Cuevas allegedly does not test or contemplate catechin inhibition, tannin rice substrates quantified by CAE, or mash viscosity behavior and that structural identity alone cannot establish inherency of a process level result arising from enzyme tannin interactions in a high tannin mash and that the In re Aller optimization rationale does not apply because the art does not disclose brewing in a quantified high tanning environment or identify viscosity reduction as a parameter to be optimized.
Examiner argues that the primary reference Festersen et al. discloses that increased wort viscosity reduces filterability (‘741, Paragraph [0028]). Hempen et al. discloses a process of reducing the viscosity in a brewing process comprising the steps of preparing a mash from malt and adjunct and reducing viscosity to allow faster downstream filtration steps in the brewing process (‘852, Paragraph [0014]). Sanders discloses a mashing to convert grain starches to simpler fermentable sugars wherein a final escalation to mash out temperatures are used to reduce wort viscosity to facilitate lautering and to denature enzymes to fix the wort sugar profile (‘503, Paragraph [0069]). Furthermore, Cuevas is being relied upon to teach the limitations regarding the tannin uninhibited raw starch degrading α-amylase having at least 98% sequence identity to SEQ ID NO:2 or an amylase active fragment thereof as disclosed in Example 4 of Cuevas. Claims 1 and 42 contemplates wherein the alpha amylase is represented by the polypeptide sequence set forth in SEQ ID NO: 2. Cuevas is not being relied upon to render obvious the limitations regarding the concentration of high tannin sorghum mash. Aerts et al. is being relied upon to render obvious the limitations regarding the concentration of high tannin sorghum mash. Aerts et al. discloses a method for brewing beer comprising the addition of polyphenol rich extracts prepared from hops at specific steps during or after the brewing process to enhance the mouthfeel, reducing power, and stability of the beer (‘063, Paragraph [0002]) comprising tannins (gallotannins) (‘063, Paragraph [0155]) wherein the content of different polyphenolic components is expressed as mg/100 g hop product except for procyanidin B3 and prodelphinidin B3 which are expressed in mg per 100 g hop product as catechin equivalents (‘063, Paragraph [0203]) wherein polyphenol extracts impart varying sensory impressions to beer depending on the varietal origin wherein the addition of total hop polyphenol extract affects the sensory properties of bitterness, fullness, astringency, and stickiness (‘063, Paragraph [0117]). Both modified Festersen et al. and Aerts et al. are directed towards the same field of endeavor of methods of brewing beer. Although Aerts et al. does not explicitly disclose the grist comprising the claimed concentration of CAE/g of grist, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the concentration of CAE/g of grist of modified Festersen et al. and adjust said concentration to the claimed amounts since differences in concentration of catechins in the grist will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration of catechins in the grist is critical. Where 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.). Aerts et al. establishes that polyphenols such as tannins imparts varying sensory impressions to the beer such as bitterness, fullness, astringency, and stickiness. One of ordinary skill in the art at the time of the invention would adjust the catechin concentration in the grist of modified Festersen et al. based upon the desired bitterness, fullness, astringency, and stickiness levels as suggested by Aerts et al. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). With respect to applicant’s assertion that structural identify alone from Cuevas cannot establish inherency of a process level result, where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of obviousness has been established in view of In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) (MPEP §2112.01.I.).
Applicant argues on Pages 6-7 of the Remarks that the declaration under 37 CFR 1.132 by Jacob Flyvholm Cramer allegedly provides factual evidence concerning the behavior of the claimed tannin uninhibited α-amylase in high tannin sorghum mashes and the unexpected viscosity and anti-tannin performance results reported in the specification. Applicant contends that the declaration confirms that achieving a final mash viscosity of ≤ 100 cP in sorghum comprising at least 130 µM CAE/g is not characteristic of conventional raw starch degrading α-amylases that correlates with the reduced catechin cross linking activity measured for the claimed enzyme and the cited references does not suggest the ability of α-amylase including those structurally similar to SEQ ID NO:2 to overcome catechin mediated inhibition to produce the claimed viscosity outcome.
Examiner argues the new rejection relies upon a new combination of references. The secondary reference of Hempen et al. discloses a method of mashing raw cereals to make wort using an alpha amylase (‘852, Paragraph [0001]) to hydrolyze starch in order to decrease the viscosity of a mash (‘852, Paragraph [0055]). Hempen et al. teaches that it was known in the food and beverage art to decrease the viscosity of a mash containing an alpha amylase. Applicant has not provided any data that is unexpected over the prior art combination. Furthermore, Festersen et al. discloses the process reducing the viscosity of the mash containing an aqueous solution comprising a starch hydrolysate (‘741, Paragraphs [0055]-[0056]) wherein increased wort viscosity reduces filterability (‘741, Paragraph [0028]). However, Festersen et al. modified with Dr. Lambic and Lambic is silent regarding the mashing producing a final mash viscosity of ≤ 100 cP. Hempen et al. discloses a process of reducing the viscosity in a brewing process comprising the steps of preparing a mash from malt and adjunct and reducing viscosity to allow faster downstream filtration steps in the brewing process (‘852, Paragraph [0014]). Sanders discloses a mashing to convert grain starches to simpler fermentable sugars wherein a final escalation to mash out temperatures are used to reduce wort viscosity to facilitate lautering and to denature enzymes to fix the wort sugar profile (‘503, Paragraph [0069]). Although Festersen et al. does not explicitly disclose mashing to the claimed final mash viscosity of ≤ 100 cP, Festersen et al. teaches reducing the viscosity of the mash (‘741, Paragraphs [0055]-[0056]) since increased wort viscosity has the disadvantage of reduced filterability. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the final mash viscosity of modified Festersen et al. since differences in the final mash viscosity will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such final mash viscosity is critical. Where 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 view of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP § 2144.05.II.A.). One of ordinary skill in the art would adjust the final mash viscosity of the process of modified Festersen et al. to be sufficiently low in order to have good filterability already suggested by Festersen et al. that allows faster downstream filtration steps in the brewing process as taught by Hempen et al. (‘741,Paragraph [0028]). Furthermore, reduced viscosity of the final mash facilitates lautering and denatures and fixes the wort sugar profile as taught by Sanders (‘503, Paragraph [0069]). Applicant has not provided any objective data showing the unexpected properties from the claimed final mash viscosity of ≤ 100 cP. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show criticality of the claimed range in view of In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960) (MPEP § 716.02(d).II.). Applicant has provided no such comparison. The prior art teaches adjusting the viscosity of a mash containing an alpha amylase to have a reduced viscosity for better filtering. An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness in view of In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979) (MPEP § 716.02(e)). With respect to applicant’s data in Example 6 which results are shown in Table 7, it is noted that applicant discloses cross linking is enhanced by increased enzyme concentration (Specification, Paragraph [00110]). Claim 1 does not specify any particular enzyme concentration. Applicant’s data in Example 6 are not commensurate in scope with the claimed invention since Claim 1 does not specify any particular enzyme concentration, which enzyme concentration influences cross linking as disclosed by applicant. Therefore, applicant’s affidavit is not effective to rebut the obviousness rejection as the affidavit does not provide objective evidence showing the allegations of unexpected or critical results of the newly claimed final mash viscosity.
Applicant argues on Pages 7-8 of the Remarks with respect to Claim 4 that Dianabuja merely describes traditional sorghum beer production in Burundi and notes that red sorghum was one of the grains used and does not disclose tannin content, quantity catechin equivalents, and provides no information about enzyme inhibition or enzyme selection.
Examiner argues Dianabuja is being relied upon to teach a method of brewing beer made from sorghum comprising the steps of placing red sorghum into cold water to swell and germinate then drying in the sun and then pounding into flour, pouring the flour into boiling water to make a porridge that is continually stirred while progressively adding cold water (Dianabuja, Page 1). Both modified Festersen et al. and Dianabuja are directed towards the same field of endeavor of methods of making beer. The beers of modified Festersen et al. and Dianabuja are both derived from sorghum. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the beer brewing method of modified Festersen et al. and use red sorghum as a component of the grist as taught by Dianabuja since the selection of a known material (red sorghum) based on its suitability for its intended use (to make beer) supports a prima facie obviousness determination in view of Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (MPEP § 2144.07). Dianbuja teaches that there was known utility in the beer making art to make beer from red sorghum. The Office Action relies upon Festersen et al. modified with Dr. Lambic, Aerts et al., Cuevas et al., Hempen et al., and Sanders. The other references render obvious the other limitations pointed out by applicant. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Therefore, this argument is not found persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lok et al. US 2021/0062120 discloses an aqueous extract obtained during mashing having a viscosity sufficiently low to allow good filterability of the mash mixture (‘120, Paragraph [0247]).
Blichman US 10,767,147 discloses a mash out is employed to stop enzyme activity, lock in the sugar profile, and reduce viscosity of the mash (‘147, Column 1, lines 51-53).
Skadhauge et al. US 2020/0002657 discloses an aqueous extract obtained during mashing having a viscosity sufficiently low to allow good filterability of the mash mixture wherein soluble β-glucans contribute to high viscosity of an aqueous extract (‘657, Paragraph [0192]).
Cramer et al. US 2019/0330577 discloses a method for hydrolyzing starch containing material comprising contacting starch containing material with a liquid to form a mash and hydrolyzing starch in the mash to form a liquefact by contacting the mash with an enzyme cocktail comprising a thermostable serine protease (‘577, Paragraphs [0020]-[0022]) wherein during the mash enzymes present convert the starches in the grain into smaller molecules or simple sugars in a process called saccharification to produce a sugar rich liquid or wort which is then strained through the bottom of the mash turn in a process known as lautering, i.e. separating, wherein prior to separating the mash temperature is raised in a mashout to free up more starch and reduce mash viscosity (‘577, Paragraph [0504]).
Svetlichny et al. US 2019/0211291 discloses a method of using an enzyme composition in a beer mash after fermentation and before distillation to reduce the viscosity of the beer mash through the degradation of fibers and/or the fermentative microorganisms in the beer wherein the reduction of the fibers in the beer results in a reduction of the fiber content in the by products wherein the lower viscosity results in lower drying temperatures and also in a shorter drying time resulting in an improved quality of the by products (‘291, Paragraph [0104]).
Lorensen et al. US 2017/0009220 discloses a method of reducing the viscosity or not increase the viscosity of wort, barley mash, barley malt or a combination thereof (‘220, Paragraph [0292]) wherein high viscosity has a negative impact on ethanol production since it limits the solid concentration used in mashing and reduces the energy efficiency of the process (‘220, Paragraph [0406]) wherein lower viscosity is achieved using synthetic xylanases resulting in higher dry substance mash, higher solids content of the final syrup, better heat transfer, lower energy requirements, reduced evaporator fouling, increased final ethanol yields, improved quality of DDGS by product, and better separation between the solid and liquid part during stillage separation after distillation (‘220, Paragraphs [0411]-[0418]).
Glenister US 4,285,975 discloses an enzyme aqueous mash mixture maintained at a temperature of 82°C-88°C for a sufficient time to liquefy a substantial portion of cereal starch in the mash by desired gelatinization and reduction in viscosity (‘975, Column 3, lines 14-19).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICSON M LACHICA whose telephone number is (571)270-0278. The examiner can normally be reached M-F, 8:30am-5pm, EST.
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/ERICSON M LACHICA/Examiner, Art Unit 1792