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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 27, 2026 was filed after the mailing date of the Non Final Rejection mailed on December 11, 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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, 4-6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Tams et al. WO 2009/016257 (cited on Information Disclosure Statement filed October 22, 2025) in view of Loetzbeyer et al. US 2018/0020702, Yemoo’s Nourishing Cultures “Open or Closed Lid for Milk Kefir Fermenting” <https://www.yemoos.com/blogs/yemoos-blog/open-or-closed-lid-for-milk-kefir-fermenting?srsltid=AfmBOopscRutRg0qYMhTNYoaVep5ThLZTyIeKDJRmAyRWF50qHMyNgEi> (published November 5, 2019) (herein referred to as “Yemoo’s Nourishing Cultures”) and Nagaya et al. US 2015/0232813 (cited on Information Disclosure Statement filed August 25, 2023).
Regarding Claim 1, Tams et al. discloses a method for producing a fermented food or beverage (fermented milk drink) (‘257, Page 2, lines 19-22). The method comprises a saccharide oxidase action step (reducing the dissolved oxygen level of a milk substrate by using an oxygen scavenging enzyme of glucose oxidase or lactose oxidase) for allowing a saccharide oxidase (carbohydrate oxidase, glucose oxidase, or lactose oxidase) to act on a portion or the whole of a saccharide in a raw material (milk substrate) (‘257, Page 11, lines 34-38). The microorganisms used for the fermented milk product is an anaerobic lactic acid bacterium (‘257, Page 7, lines 18-28). Tams et al. further discloses the saccharide oxidase step (reducing the dissolved oxygen level of the milk substrate) being performed before the anaerobic fermentation step and/or simultaneously with the anaerobic fermentation step (‘257, Page 12, lines 2-4). Tams et al. also discloses the saccharide oxidase (oxygen scavenging enzyme) having a property of acting on saccharides of cellobiose or glucose or lactose (‘257, Page 11, lines 34-38).
Tams et al. discloses that the dissolved oxygen level of the milk substrate is reduced using an oxygen scavenging enzyme (‘257, Page 11, lines 34-38, which does not necessarily read on the claimed anaerobic conditions of fermentation as some levels of oxygen could be present and since anaerobic conditions require the lack of oxygen. Tams et al. is also silent regarding the saccharide oxidase having a property of acting on one or more saccharides selected from maltotriose, maltose, galactose, maltoteraose, and maltodextrin in addition to acting on glucose.
Loetzbeyer et al. discloses a method for the anaerobic fermentation wherein before and/or during the use of anaerobic microorganisms the removal of oxygen is carried out completely enzymatically by means of glucose oxidase and catalase reactions (‘702, Paragraph [0052]) in which the complete removal of oxygen by means of the enzymatic reaction processes of glucose oxidase and catalase reactions enables the production of an anaerobic reaction conditions (‘702, Paragraphs [0047] and [0053]) wherein the fermentation process is applied to foods or beverages (‘702, Paragraphs [0025] and [0065]). Loetzbeyer et al. also discloses a method of reduction of sugar substances (‘702, Paragraph [0001]) including glucose, galactose, or maltose (‘702, Paragraph [0009]) comprising an enzymatic degradation of glucose (‘702, Paragraph [0041]) and removal of oxygen before and/or during the use of anaerobic microorganisms enzymatically by means of the reaction processes of glucose oxidase and catalase reactions (‘702, Paragraph [0052]).
Tams et al. already discloses the fermentation process using an anaerobic bacterium of lactic acid (‘257, Page 7, lines 18-22) and also reducing the oxygen levels of the milk substrate using an oxygen scavenging enzyme of a glucose oxidase and an enzyme having a catalase activity (‘257, Page 11, lines 34-38). Both Tams et al. and Loetzbeyer et al. are directed towards the same field of endeavor of methods of fermentation of foods or beverages comprising a step of reducing oxygen enzymatically by means of glucose oxidase and catalase reactions. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Tams et al. that reduces the oxygen levels of the milk substrate using glucose oxidase and an enzyme having a catalase activity and completely remove the oxygen before and/or during the use of anaerobic microorganisms in an anaerobic fermentation method since Loetzbeyer et al. teaches that it was known and conventional in the food fermentation art to anaerobically ferment foods or beverages. Furthermore, Yemoo’s Nourishing Cultures teaches that fermenting food or beverages such as milk can be done with aerobic fermentation or anaerobic fermentation based on personal preference. Some bacteria strains within milk grains thrive in anaerobic (non-oxygen) environments. Additionally, one of the biggest benefits of anaerobic ferments is that it prevents airborne yeast or mold contamination. It also would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Tams et al. that reduces the oxygen levels of the milk substrate using glucose oxidase and an enzyme having a catalase activity and completely remove the oxygen before and/or during the use of anaerobic microorganisms in an anaerobic fermentation method as taught by Loetzbeyer et al. based upon the personal preference of an individual consumer and to prevent airborne yeast or mold contamination as taught by Yemoo’s Nourishing Cultures.
Further regarding Claim 1, Loetzbeyer et al. discloses a method for the anaerobic fermentation wherein before and/or during the use of anaerobic microorganisms the removal of oxygen is carried out completely enzymatically by means of glucose oxidase and catalase reactions (‘702, Paragraph [0052]). However, Tams et al. in view of Loetzbeyer et al. and Yemoo’s Nourishing Cultures is silent regarding the saccharide oxidase having a property of acting on one or more saccharides selected from maltotriose, maltose, galactose, maltoteraose, and maltodextrin in addition to acting on glucose.
Nagaya et al. discloses a method of making a food product comprising the step of using a protein for oxidizing a saccharide in the food product (‘813, Paragraph [0080]) comprising a saccharide oxidase action step for allowing a saccharide oxidase to act on a portion of a saccharide in a raw material wherein the saccharide oxidase has a property of acting on glucose and maltotriose, maltose, galactose, and maltotetraose saccharides (‘813, Paragraphs [0023]-[0026] and [0105]).
Both modified Tams et al. and Nagaya et al. are directed towards the same field of endeavor of methods of making food products using a protein for oxidizing a saccharide in the food product. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of modified Tams et al. and use a saccharide oxidase that acts on saccharides of maltotriose, maltose, galactose, and maltotetraose in addition to glucose as taught by Nagaya et al. since the selection of a known material (the saccharide acting on the claimed saccharides in addition to glucose) based on its suitability for its intended use (to allow for a saccharide oxidase action step for allowing a saccharide oxidase to act on saccharides) 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 saccharide oxidase to act on the claimed saccharides in addition to glucose) for another (using a saccharide oxidase acting only on glucose) to obtain predictable results is prima facie obviousness (MPEP § 2143.I.(B).).
Regarding Claim 4, Nagaya et al. discloses a method of fermenting a food or beverage (‘813, Paragraph [0166]) comprising a step of producing lactobionic acid by oxidizing lactose (‘813, Paragraph [0184]) with a protein with carbohydrate activity sharing 100% identity relative to instant SEQ ID NO:1 (see sequence alignment below):
US-14-428-105-10
Sequence 10, US/14428105
Publication No. US20150232813A1
GENERAL INFORMATION
APPLICANT: Amano Enzyme Inc.
APPLICANT: NAGAYA, Miho
APPLICANT: SUGITA, Akiko
APPLICANT: MATSUMOTO, Naoki
APPLICANT: Okada, Masamichi
TITLE OF INVENTION: Proteins with carbohydrate oxidase activity,
TITLE OF INVENTION: production methods of the proteins and uses the
TITLE OF INVENTION: proteins
FILE REFERENCE: P1626
CURRENT APPLICATION NUMBER: US/14/428,105
CURRENT FILING DATE: 2015-03-13
NUMBER OF SEQ ID NOS: 10
SEQ ID NO 10
LENGTH: 505
TYPE: PRT
ORGANISM: Acremonium chrysogenum
Query Match 100.0%; Score 2645; Length 505;
Best Local Similarity 100.0%;
Matches 505; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MRSLAPLLSIAALARASPVDTSLLTRQETLNTCLEAAELSYVDVNSEDWEDAIVPHNLRV 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MRSLAPLLSIAALARASPVDTSLLTRQETLNTCLEAAELSYVDVNSEDWEDAIVPHNLRV 60
Qy 61 PVVPRAVVYATATEQIQAAVKCAVESEIRVSAKSGGHSYASMGLGGEDGSLVIQLDHWHD 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 PVVPRAVVYATATEQIQAAVKCAVESEIRVSAKSGGHSYASMGLGGEDGSLVIQLDHWHD 120
Qy 121 VTLRDDNTAVVSAGTRLGVVALELYAQGKRGISHGTCPSVGVGGHVVHGGYGFSSHTHGL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VTLRDDNTAVVSAGTRLGVVALELYAQGKRGISHGTCPSVGVGGHVVHGGYGFSSHTHGL 180
Qy 181 ALDAVVGANVVLADGSLVHASETENTDLFWALRGGGSSFGIVAEFEFETFDVSHNFSYFS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 ALDAVVGANVVLADGSLVHASETENTDLFWALRGGGSSFGIVAEFEFETFDVSHNFSYFS 240
Qy 241 IDSDISQETAEEATASLLAFQDALEEGLMDRKLNMRLSLGRPKVTLEAVYHGAKEDGRKA 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 IDSDISQETAEEATASLLAFQDALEEGLMDRKLNMRLSLGRPKVTLEAVYHGAKEDGRKA 300
Qy 301 LELFDDILGLNWSSNRTRANEADWLTMLESWTYGDPLNITYPYEGHDNAYTSSLVTRHIP 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 LELFDDILGLNWSSNRTRANEADWLTMLESWTYGDPLNITYPYEGHDNAYTSSLVTRHIP 360
Qy 361 EDAMASFMTYWKGVGQDRETPNWWLQMDVHGDANSRISEVDADSTAYSHRDKLWLFQFSS 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 EDAMASFMTYWKGVGQDRETPNWWLQMDVHGDANSRISEVDADSTAYSHRDKLWLFQFSS 420
Qy 421 PLNPLRPDPEAAFALVNGYMDSIKDHLGDGEWGRYANYIDSELSREDAQTQYWSDHLDKL 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 PLNPLRPDPEAAFALVNGYMDSIKDHLGDGEWGRYANYIDSELSREDAQTQYWSDHLDKL 480
Qy 481 QAIKAELDPTQVFYNPQSIDPAAVE 505
|||||||||||||||||||||||||
Db 481 QAIKAELDPTQVFYNPQSIDPAAVE 505
Both modified Tams et al. and Nagaya et al. are directed towards the same field of endeavor of methods of producing a fermented food or beverage wherein the method comprises a saccharide oxidase action step for allowing a saccharide oxidase derived from acremonium chrysogenum to act on a portion or the whole of a glucose saccharide in a raw material of a food or beverage. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of modified Tams et al. to have 100% sequence identity as set forth in SEQ ID NO:1 as taught by Nagaya et al. since the selection of a known material (the sequence as set forth in the claimed SEQ ID NO:1) based on its suitability for its intended use (to allow for a saccharide oxidase action step for allowing a saccharide oxidase of acremonium chrysogenum to act on a saccharide in a raw food material) 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 saccharide oxidase to act on a saccharide in a raw material of food in fermentation processes) for another (using a saccharide oxidase having a sequence as set forth in the claimed SEQ ID NO:1) to obtain predictable results is prima facie obviousness (MPEP § 2143.I.(B).).
Regarding Claim 5, Tams et al. discloses performing a lactic acid fermentation in the anaerobic fermentation step (‘257, Page 7, lines 11-13).
Regarding Claim 6, Tams et al. discloses the fermented food or beverage being a fermented milk (‘257, Page 7, lines 15-19).
Regarding Claim 8, Tams et al. discloses a method for producing a fermented food or beverage (fermented milk drink) (‘257, Page 2, lines 19-22). The method comprises a saccharide oxidase action step (reducing the dissolved oxygen level of a milk substrate by using an oxygen scavenging enzyme of glucose oxidase or lactose oxidase) for allowing a saccharide oxidase (carbohydrate oxidase, glucose oxidase, or lactose oxidase) to act on a portion or the whole of a saccharide in a raw material (milk substrate) (‘257, Page 11, lines 34-38). The microorganisms used for the fermented milk product is an anaerobic lactic acid bacterium (‘257, Page 7, lines 18-28). Tams et al. further discloses the saccharide oxidase step (reducing the dissolved oxygen level of the milk substrate) being performed before the anaerobic fermentation step and/or simultaneously with the anaerobic fermentation step (‘257, Page 12, lines 2-4).
Tams et al. discloses the dissolved oxygen level of the milk substrate is reduced using an oxygen scavenging enzyme (‘257, Page 11, lines 34-38, which does not necessarily read on the claimed anaerobic conditions of fermentation as some levels of oxygen could be present and since anaerobic conditions require the lack of oxygen. Tams et al. is also silent regarding the saccharide oxidase having a property of acting on one or more saccharides selected from maltotriose, maltose, galactose, maltoteraose, and maltodextrin in addition to acting on glucose.
Loetzbeyer et al. discloses a method for the anaerobic fermentation wherein before and/or during the use of anaerobic microorganisms the removal of oxygen is carried out completely enzymatically by means of glucose oxidase and catalase reactions (‘702, Paragraph [0052]) in which the complete removal of oxygen by means of the enzymatic reaction processes of glucose oxidase and catalase reactions enables the production of an anaerobic reaction conditions (‘702, Paragraphs [0047] and [0053]) wherein the fermentation process is applied to foods or beverages (‘702, Paragraphs [0025] and [0065]). Loetzbeyer et al. also discloses a method of reduction of sugar substances (‘702, Paragraph [0001]) including glucose, galactose, or maltose (‘702, Paragraph [0009]) comprising an enzymatic degradation of glucose (‘702, Paragraph [0041]) and removal of oxygen before and/or during the use of anaerobic microorganisms enzymatically by means of the reaction processes of glucose oxidase and catalase reactions (‘702, Paragraph [0052]).
Tams et al. already discloses the fermentation process using an anaerobic bacterium of lactic acid (‘257, Page 7, lines 18-22) and also reducing the oxygen levels of the milk substrate using an oxygen scavenging enzyme of a glucose oxidase and an enzyme having a catalase activity (‘257, Page 11, lines 34-38). Both Tams et al. and Loetzbeyer et al. are directed towards the same field of endeavor of methods of fermentation of foods or beverages comprising a step of reducing oxygen enzymatically by means of glucose oxidase and catalase reactions. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Tams et al. that reduces the oxygen levels of the milk substrate using glucose oxidase and an enzyme having a catalase activity and completely remove the oxygen before and/or during the use of anaerobic microorganisms in an anaerobic fermentation method since Loetzbeyer et al. teaches that it was known and conventional in the food fermentation art to anaerobically ferment foods or beverages. Furthermore, Yemoo’s Nourishing Cultures teaches that fermenting food or beverages such as milk can be done with aerobic fermentation or anaerobic fermentation based on personal preference. Some bacteria strains within milk grains thrive in anaerobic (non-oxygen) environments. Additionally, one of the biggest benefits of anaerobic ferments is that it prevents airborne yeast or mold contamination. It would have also been obvious to one of ordinary skill in the art at the time of the invention to modify the process of Tams et al. that reduces the oxygen levels of the milk substrate using glucose oxidase and an enzyme having a catalase activity and completely remove the oxygen before and/or during the use of anaerobic microorganisms in an anaerobic fermentation method as taught by Loetzbeyer et al. based upon the personal preference of an individual consumer and to prevent airborne yeast or mold contamination as taught by Yemoo’s Nourishing Cultures.
Further regarding Claim 8, Loetzbeyer et al. discloses a method for the anaerobic fermentation wherein before and/or during the use of anaerobic microorganisms the removal of oxygen is carried out completely enzymatically by means of glucose oxidase and catalase reactions (‘702, Paragraph [0052]). However, Tams et al. in view of Loetzbeyer et al. and Yemoo’s Nourishing Cultures is silent regarding the saccharide oxidase having a property of acting on one or more saccharides selected from maltotriose, maltose, galactose, maltoteraose, and maltodextrin in addition to acting on glucose.
Nagaya et al. discloses a method of making a food product comprising the step of using a protein for oxidizing a saccharide in the food product (‘813, Paragraph [0080]) comprising a saccharide oxidase action step for allowing a saccharide oxidase to act on a portion of a saccharide in a raw material wherein the saccharide oxidase has a property of acting on glucose and maltotriose, maltose, galactose, and maltotetraose saccharides (‘813, Paragraphs [0023]-[0026] and [0105]).
Both modified Tams et al. and Nagaya et al. are directed towards the same field of endeavor of methods of making food products using a protein for oxidizing a saccharide in the food product. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of modified Tams et al. and use a saccharide oxidase that acts on saccharides of maltotriose, maltose, galactose, and maltotetraose in addition to glucose as taught by Nagaya et al. since the selection of a known material (the saccharide acting on the claimed saccharides in addition to glucose) based on its suitability for its intended use (to allow for a saccharide oxidase action step for allowing a saccharide oxidase to act on saccharides) 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 saccharide oxidase to act on the claimed saccharides in addition to glucose) for another (using a saccharide oxidase acting only on glucose) to obtain predictable results is prima facie obviousness (MPEP § 2143.I.(B).).
Claims 1, 4-6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Weusthuis et al. US 2018/0016604 in view of Tams et al. WO 2009/016257 (cited on Information Disclosure Statement filed October 22, 2025) and Nagaya et al. US 2015/0232813 (cited on Information Disclosure Statement filed August 25, 2023).
Regarding Claim 1, Weusthuis et al. discloses a method for producing a fermented food or beverage (‘604, Paragraph [0013]). The method comprises the step of producing itaconic acid by fermentation (‘604, Paragraph [0001]) by growing E. coli in bioreactors under anaerobic conditions with glucose as a carbon source (‘604, Paragraph [0118]). Weusthuis et al. discloses the conversion of glucose to itaconate is an oxidation reaction (‘604, Paragraph [0006]). Therefore, the disclosure of a particular example wherein E. coli is grown in bioreactors under anaerobic conditions with glucose as the carbon source (‘604, Paragraph [0118]) reads on the claimed saccharide oxidase action step for allowing a saccharide oxidase to act on a portion or the whole of a saccharide in a raw material. Weusthuis et al. also discloses an anerobic fermentation step for performing anaerobic fermentation (‘604, Paragraphs [0010] and [0065]).
Weusthuis et al. is silent regarding the saccharide oxidase step being performed before the anaerobic fermentation step and/or simultaneously with the anaerobic fermentation step.
Tams et al. discloses a method for producing a fermented food or beverage (fermented milk drink) (‘257, Page 2, lines 19-22). The method comprises a saccharide oxidase action step (reducing the dissolved oxygen level of a milk substrate by using an oxygen scavenging enzyme of glucose oxidase or lactose oxidase) for allowing a saccharide oxidase (carbohydrate oxidase, glucose oxidase, or lactose oxidase) to act on a portion or the whole of a saccharide in a raw material (milk substrate) (‘257, Page 11, lines 34-38) and a fermentation step for performing fermentation (‘257, Page 12, lines 2-5). Tams et al. further discloses the saccharide oxidase step (reducing the dissolved oxygen level of the milk substrate) being performed before the fermentation step and/or simultaneously with the fermentation step (‘257, Page 12, lines 2-4).
Both Weusthuis et al. and Tams et al. are directed towards the same field of endeavor of methods of producing fermented foods or beverages by a saccharide oxidase action step for allowing a saccharide oxidase to act on a saccharide in a raw material. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the fermentation process of Weusthuis et al. and perform the saccharide oxidase action step before the fermentation step or simultaneously with the anaerobic fermentation step as taught by Tams et al. since the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results in view of In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (MPEP § 2144.04.IV.C.). Tams et al. teaches that there was known utility in the fermentation art to perform the saccharide oxidase action step before the fermentation step or to perform the saccharide oxidase action step simultaneously with the fermentation step.
Further regarding Claim 1, Weusthuis et al. discloses the saccharide oxidase having a property of acting on saccharides of glucose (‘604, Paragraphs [0114] and [0118]). However, Weusthuis et al. in view of Tams et al. is silent regarding the saccharide oxidase having a property of acting on one or more saccharides selected from maltotriose, maltose, galactose, maltoteraose, and maltodextrin in addition to acting on glucose.
Nagaya et al. discloses a method of making a food product comprising the step of using a protein for oxidizing a saccharide in the food product (‘813, Paragraph [0080]) comprising a saccharide oxidase action step for allowing a saccharide oxidase to act on a portion of a saccharide in a raw material wherein the saccharide oxidase has a property of acting on glucose and maltotriose, maltose, galactose, and maltotetraose saccharides (‘813, Paragraphs [0023]-[0026] and [0105]).
Both modified Weusthuis et al. and Nagaya et al. are directed towards the same field of endeavor of methods of making food products using a protein for oxidizing a saccharide in the food product. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of modified Weusthuis et al. and use a saccharide oxidase that acts on saccharides of maltotriose, maltose, galactose, and maltotetraose in addition to glucose as taught by Nagaya et al. since the selection of a known material (the saccharide acting on the claimed saccharides in addition to glucose) based on its suitability for its intended use (to allow for a saccharide oxidase action step for allowing a saccharide oxidase to act on saccharides) 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 saccharide oxidase to act on the claimed saccharides in addition to glucose) for another (using a saccharide oxidase acting only on glucose) to obtain predictable results is prima facie obviousness (MPEP § 2143.I.(B).).
Regarding Claim 4, Weusthuis et al. modified with Tams et al. is silent regarding the saccharide oxidase consisting of a polypeptide having a sequence identity of 90% or more to the amino acid sequence represented by SEQ ID NO:1 in the amino acid sequence represented by SEQ ID NO:1 and which exhibits a substrate specificity equivalent to that of the polypeptide consisting of the amino acid sequence represented by SEQ ID NO:1.
Nagaya et al. discloses a protein with carbohydrate activity sharing 100% identity relative to instant SEQ ID NO:1 (see sequence alignment below):
US-14-428-105-10
Sequence 10, US/14428105
Publication No. US20150232813A1
GENERAL INFORMATION
APPLICANT: Amano Enzyme Inc.
APPLICANT: NAGAYA, Miho
APPLICANT: SUGITA, Akiko
APPLICANT: MATSUMOTO, Naoki
APPLICANT: Okada, Masamichi
TITLE OF INVENTION: Proteins with carbohydrate oxidase activity,
TITLE OF INVENTION: production methods of the proteins and uses the
TITLE OF INVENTION: proteins
FILE REFERENCE: P1626
CURRENT APPLICATION NUMBER: US/14/428,105
CURRENT FILING DATE: 2015-03-13
NUMBER OF SEQ ID NOS: 10
SEQ ID NO 10
LENGTH: 505
TYPE: PRT
ORGANISM: Acremonium chrysogenum
Query Match 100.0%; Score 2645; Length 505;
Best Local Similarity 100.0%;
Matches 505; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MRSLAPLLSIAALARASPVDTSLLTRQETLNTCLEAAELSYVDVNSEDWEDAIVPHNLRV 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MRSLAPLLSIAALARASPVDTSLLTRQETLNTCLEAAELSYVDVNSEDWEDAIVPHNLRV 60
Qy 61 PVVPRAVVYATATEQIQAAVKCAVESEIRVSAKSGGHSYASMGLGGEDGSLVIQLDHWHD 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 PVVPRAVVYATATEQIQAAVKCAVESEIRVSAKSGGHSYASMGLGGEDGSLVIQLDHWHD 120
Qy 121 VTLRDDNTAVVSAGTRLGVVALELYAQGKRGISHGTCPSVGVGGHVVHGGYGFSSHTHGL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 VTLRDDNTAVVSAGTRLGVVALELYAQGKRGISHGTCPSVGVGGHVVHGGYGFSSHTHGL 180
Qy 181 ALDAVVGANVVLADGSLVHASETENTDLFWALRGGGSSFGIVAEFEFETFDVSHNFSYFS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 ALDAVVGANVVLADGSLVHASETENTDLFWALRGGGSSFGIVAEFEFETFDVSHNFSYFS 240
Qy 241 IDSDISQETAEEATASLLAFQDALEEGLMDRKLNMRLSLGRPKVTLEAVYHGAKEDGRKA 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 IDSDISQETAEEATASLLAFQDALEEGLMDRKLNMRLSLGRPKVTLEAVYHGAKEDGRKA 300
Qy 301 LELFDDILGLNWSSNRTRANEADWLTMLESWTYGDPLNITYPYEGHDNAYTSSLVTRHIP 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 LELFDDILGLNWSSNRTRANEADWLTMLESWTYGDPLNITYPYEGHDNAYTSSLVTRHIP 360
Qy 361 EDAMASFMTYWKGVGQDRETPNWWLQMDVHGDANSRISEVDADSTAYSHRDKLWLFQFSS 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 EDAMASFMTYWKGVGQDRETPNWWLQMDVHGDANSRISEVDADSTAYSHRDKLWLFQFSS 420
Qy 421 PLNPLRPDPEAAFALVNGYMDSIKDHLGDGEWGRYANYIDSELSREDAQTQYWSDHLDKL 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 PLNPLRPDPEAAFALVNGYMDSIKDHLGDGEWGRYANYIDSELSREDAQTQYWSDHLDKL 480
Qy 481 QAIKAELDPTQVFYNPQSIDPAAVE 505
|||||||||||||||||||||||||
Db 481 QAIKAELDPTQVFYNPQSIDPAAVE 505
Both modified Weusthuis et al. and Nagaya et al. are directed towards the same field of endeavor of methods of producing a fermented food or beverage wherein the method comprises a saccharide oxidase action step for allowing a saccharide oxidase derived from acremonium chrysogenum to act on a portion or the whole of a glucose saccharide in a raw material of a food or beverage. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of modified Weusthuis et al. to have 100% sequence identity as set forth in SEQ ID NO:1 as taught by Nagaya et al. since the selection of a known material (the sequence as set forth in the claimed SEQ ID NO:1) based on its suitability for its intended use (to allow for a saccharide oxidase action step for allowing a saccharide oxidase of acremonium chrysogenum to act on a saccharide in a raw food material) 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 saccharide oxidase to act on a saccharide in a raw material of food in fermentation processes) for another (using a saccharide oxidase having a sequence as set forth in the claimed SEQ ID NO:1) to obtain predictable results is prima facie obviousness (MPEP § 2143.I.(B).).
Regarding Claim 5, Weusthuis et al. discloses the method comprising a step of anaerobic fermentation having main fermentation produces of lactate and pyruvate (‘604, Paragraphs [0118]-[0119]). Tams et al. discloses the method comprising conversion of lactose to lactic acid (‘257, Page 7, lines 11-13). Therefore, the combination of Weusthuis et al. modified with Tams et al. teaches a lactic acid fermentation being performed.
Regarding Claim 6, Weusthuis et al. discloses the fermentation method being applied to make a fermented food (‘604, Paragraphs [0013] and [0070]). Tams et al. discloses the method being used to make a fermented milk drink (‘257, Page 2, lines 19-22). It would have been obvious to one of ordinary skill in the art to apply the method of making a fermented food of Weusthuis et al. to make a fermented milk as taught by Tams et al. based upon the particular type of food or beverage desired to be made using the disclosed fermentation processes.
Regarding Claim 8, Weusthuis et al. discloses an anaerobic fermentation method (‘604, Paragraphs [0010] and [0063]). The method comprises the step of producing itaconic acid by fermentation (‘604, Paragraph [0001]) by growing E. coli in bioreactors under anaerobic conditions with glucose as a carbon source (‘604, Paragraph [0118]). Weusthuis et al. discloses the conversion of glucose to itaconate is an oxidation reaction (‘604, Paragraph [0006]). Therefore, the disclosure of a particular example wherein E. coli is grown in bioreactors under anaerobic conditions with glucose as the carbon source (‘604, Paragraph [0118]) reads on the claimed saccharide oxidase action step for allowing a saccharide oxidase to act on a portion or the whole of a saccharide in a raw material.
Weusthuis et al. is silent regarding the saccharide oxidase step being performed before an anaerobic fermentation step and/or simultaneously with the anaerobic fermentation step.
Tams et al. discloses a fermentation method (fermented milk drink) (‘257, Page 2, lines 19-22). The method comprises a saccharide oxidase action step (reducing the dissolved oxygen level of a milk substrate by using an oxygen scavenging enzyme of glucose oxidase or lactose oxidase) for allowing a saccharide oxidase (carbohydrate oxidase, glucose oxidase, or lactose oxidase) to act on a portion or the whole of a saccharide in a raw material (milk substrate) (‘257, Page 11, lines 34-38) and a fermentation step for performing fermentation (‘257, Page 12, lines 2-4). Tams et al. further discloses the saccharide oxidase step (reducing the dissolved oxygen level of the milk substrate) being performed before the fermentation step and/or simultaneously with the fermentation step (‘257, Page 12, lines 2-4).
Both Weusthuis et al. and Tams et al. are directed towards the same field of endeavor of methods of producing fermented foods or beverages by a saccharide oxidase action step for allowing a saccharide oxidase to act on a saccharide in a raw material. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the fermentation process of Weusthuis et al. and perform the saccharide oxidase action step before the fermentation step or simultaneously with the fermentation step as taught by Tams et al. since the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results in view of In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (MPEP § 2144.04.IV.C.). Tams et al. teaches that there was known utility in the fermentation art to perform the saccharide oxidase action step before the fermentation step or to perform the saccharide oxidase action step simultaneously with the fermentation step.
Further regarding Claim 8, Weusthuis et al. discloses the saccharide oxidase having a property of acting on saccharides of glucose (‘604, Paragraphs [0114] and [0118]). However, Weusthuis et al. in view of Tams et al. is silent regarding the saccharide oxidase having a property of acting on one or more saccharides selected from maltotriose, maltose, galactose, maltoteraose, and maltodextrin in addition to acting on glucose.
Nagaya et al. discloses a method of making a food product comprising the step of using a protein for oxidizing a saccharide in the food product (‘813, Paragraph [0080]) comprising a saccharide oxidase action step for allowing a saccharide oxidase to act on a portion of a saccharide in a raw material wherein the saccharide oxidase has a property of acting on glucose and maltotriose, maltose, galactose, and maltotetraose saccharides (‘813, Paragraphs [0023]-[0026] and [0105]).
Both modified Weusthuis et al. and Nagaya et al. are directed towards the same field of endeavor of methods of making food products using a protein for oxidizing a saccharide in the food product. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the process of modified Weusthuis et al. and use a saccharide oxidase that acts on saccharides of maltotriose, maltose, galactose, and maltotetraose in addition to glucose as taught by Nagaya et al. since the selection of a known material (the saccharide acting on the claimed saccharides in addition to glucose) based on its suitability for its intended use (to allow for a saccharide oxidase action step for allowing a saccharide oxidase to act on saccharides) 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 saccharide oxidase to act on the claimed saccharides in addition to glucose) for another (using a saccharide oxidase acting only on glucose) to obtain predictable results is prima facie obviousness (MPEP § 2143.I.(B).).
Response to Arguments
Applicant’s arguments with respect to the previous anticipation rejections under 35 USC 102 and the previous obviousness rejections 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 current rejection is an obviousness rejection under 35 USC 103(a) to Tams et al. in view of Loetzbeyer et al., Yemoo’s Nourishing Cultures, and Nagaya et al., which was necessitated by amendment. Claim 1 incorporates newly presented limitations regarding the saccharide oxidase having a property of acting on glucose and one or more saccharides selected from maltoriose, maltose, galactose, maltotetraose, and maltodextrin. The previous claimed amendment filed November 14, 2025 previously recites in Claim 3 the saccharide oxidase having a property of acting on one or more saccharides selected from glucose, maltotriose, maltose, galactose, maltoteraose, lactose, cellobiose, and maltrodextrin. The current amendment requires the saccharide oxidase acting on glucose and an additional saccharide from the claimed list. The new combination of references in the obviousness rejection was necessitated by amendment.
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.
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/ERICSON M LACHICA/Examiner, Art Unit 1792