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 .
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, 43, and 63-64 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 step results in a mash having a final viscosity of no more than 60 cP” in lines 8-9. There was not adequate written description support at the time of filing for the entire range of the mash final viscosity of no more than 60 cP. There was only written description support at the time of filing for an example of a final mash viscosity of 60 cP. The disclosure does not provide support for the entire mash final viscosity range of no more than 60 cP. The claims encompasses very low mash final viscosity, e.g. 1 cP. However, the disclosure at the time of filing does not provide adequate written description support for the entire mash final viscosity range of no more than 60 cP as claimed.
Claims 43 and 63-64 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, 43, and 63-64 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), 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”), 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]) wherein the method comprises performing a mashing step (‘741, Paragraphs [0023]-[0024]) by combining 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 150 µM CAE per gram of grist in the presence of the exogenously supplied enzyme composition and the tannin uninhibited raw starch degrading α-amylase comprising the amino acid sequence of SEQ ID NO:2 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. modified with Dr. Lambic and Aerts et al. is silent regarding the tannin uninhibited enzyme being a raw starch degrading enzyme comprising the amino acid sequence of SEQ ID NO:2. Claim 1 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, i.e. comprise the amino acid sequence of 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)).
Further regarding Claim 1, Festersen et al. discloses the grist comprising sorghum (‘741, Paragraph [0057]). However, Festersen et al. modified with Dr. Lambic, Aerts et al., and Cuevas et al. 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). Dianabuja teaches that there was known utility in the beer making art to make beer from red sorghum.
Further regarding Claim 1, Festersen et al. modified with Dr. Lambic, Aerts et al., Cuevas et al., and Dianabuja is silent regarding the mashing step resulting in a mash having a final viscosity of no more than 60 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 modified Festersen et al. does not explicitly disclose mashing step resulting in the claimed final mash viscosity of no more than 60 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]).
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]).
Response to Arguments
Examiner notes that a new matter rejection under 35 USC 112(a) has been made in view of the amendments.
Applicant’s arguments with respect to the previous obviousness rejections under 35 USC 103(a) under 35 USC 103(a) have 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 secondary references of Hempen et al. and Sanders are being relied upon to render obvious the newly presented limitations regarding the mashing step having a final viscosity of no more than 60 cP.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERICSON M LACHICA/Examiner, Art Unit 1792
Prosecution Insights