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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 3, 2026 has been entered.
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).).
Further regarding Claim 1, the limitations “wherein the method shortens the fermentation time as, in the saccharide oxidase action step, the time for reaching to a dissolved oxygen level below 10% of that at the start of the fermentation is 0.3 hrs or less vs 2.5 hrs if without the saccharide oxidase action step” are limitations with respect to the properties of the saccharide oxidase action step affecting the fermentation time. 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 Tams et al. modified with Loetzbeyer et al., Yemoo’s Nourishing Cultures, and Nagaya et al. to behave in the same manner as claimed, i.e. the method shortens the fermentation time as, in the saccharide oxidase action step, the time for reaching to a dissolved oxygen level below 10% of that at the start of the fermentation is 0.3 hrs or less vs 2.5 hrs if without the saccharide oxidase action step, since the prior art combination is made of an identical composition as the claimed composition.
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).).
Further regarding Claim 8, the limitations “wherein the method shortens the fermentation time as, in the saccharide oxidase action step, the time for reaching to a dissolved oxygen level below 10% of that at the start of the fermentation is 0.3 hrs or less vs 2.5 hrs if without the saccharide oxidase action step” are limitations with respect to the properties of the saccharide oxidase action step affecting the fermentation time. 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 Tams et al. modified with Loetzbeyer et al., Yemoo’s Nourishing Cultures, and Nagaya et al. to behave in the same manner as claimed, i.e. the method shortens the fermentation time as, in the saccharide oxidase action step, the time for reaching to a dissolved oxygen level below 10% of that at the start of the fermentation is 0.3 hrs or less vs 2.5 hrs if without the saccharide oxidase action step, since the prior art combination is made of an identical composition as the claimed composition.
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).).
Further regarding Claim 1, the limitations “wherein the method shortens the fermentation time as, in the saccharide oxidase action step, the time for reaching to a dissolved oxygen level below 10% of that at the start of the fermentation is 0.3 hrs or less vs 2.5 hrs if without the saccharide oxidase action step” are limitations with respect to the properties of the saccharide oxidase action step affecting the fermentation time. 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 Westhuis et al. modified with Tams et al. and Nagaya et al. to behave in the same manner as claimed, i.e. the method shortens the fermentation time as, in the saccharide oxidase action step, the time for reaching to a dissolved oxygen level below 10% of that at the start of the fermentation is 0.3 hrs or less vs 2.5 hrs if without the saccharide oxidase action step, since the prior art combination is made of an identical composition as the claimed composition.
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).).
Further regarding Claim 1, the limitations “wherein the method shortens the fermentation time as, in the saccharide oxidase action step, the time for reaching to a dissolved oxygen level below 10% of that at the start of the fermentation is 0.3 hrs or less vs 2.5 hrs if without the saccharide oxidase action step” are limitations with respect to the properties of the saccharide oxidase action step affecting the fermentation time. 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 Westhuis et al. modified with Tams et al. and Nagaya et al. to behave in the same manner as claimed, i.e. the method shortens the fermentation time as, in the saccharide oxidase action step, the time for reaching to a dissolved oxygen level below 10% of that at the start of the fermentation is 0.3 hrs or less vs 2.5 hrs if without the saccharide oxidase action step, since the prior art combination is made of an identical composition as the claimed composition.
Response to Arguments
Applicant's arguments filed June 3, 2026 have been fully considered but they are not persuasive.
Applicant argues on Page 6 of the Remarks with respect to Claims 1 and 8 that the obviousness rejections based on the cited references does not address the newly presented limitations “wherein the method shortens the fermentation time as, in the saccharide oxidase action step, the time for reaching to a dissolved oxygen level below 10% of that at the start of the fermentation is 0.3 hrs or less vs 2.5 hrs if without the saccharide oxidase action step.”
Examiner argues the limitations “wherein the method shortens the fermentation time as, in the saccharide oxidase action step, the time for reaching to a dissolved oxygen level below 10% of that at the start of the fermentation is 0.3 hrs or less vs 2.5 hrs if without the saccharide oxidase action step” are limitations with respect to the properties of the saccharide oxidase action step affecting the fermentation time. 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 Tams et al. modified with Loetzbeyer et al., Yemoo’s Nourishing Cultures, and Nagaya et al. or alternatively Westhuis et al. modified with Tams et al. and Nagaya et al. to behave in the same manner as claimed, i.e. the method shortens the fermentation time as, in the saccharide oxidase action step, the time for reaching to a dissolved oxygen level below 10% of that at the start of the fermentation is 0.3 hrs or less vs 2.5 hrs if without the saccharide oxidase action step, since the prior art combination is made of an identical composition as the claimed composition.
Applicant argues on Pages 6-8 of the Remarks that Example 1 of the specification allegedly uncovers the advantages of the recited saccharide oxidase action step. Example 1 uses a prepared milk raw material mix using a mixture of cow milk, skimmed milk, and water, sterilizing the prepared milk raw material, cooling the sterilized milk raw material mix, combining with an enzyme containing saccharide oxidase in an amount of 5 to 120 U based on the milk raw material mix, combining with 2 v/v% of a lactic acid bacterium starter containing Lactobacillus delbrueckii subsp. Bulgaricus and Streptococcus thermophilus, and then fermenting for several hours at 37°C in a water bath. The pH and dissolved oxygen during the fermentation were monitored using a pH sensor and a DO sensor, respectively. Applicant concludes that Table 1 shows that the saccharide oxidase action step, the time for reaching to a dissolved oxygen level below 10% of that at the initiation of the fermentation is about one tenth (0.3 hrs or less vs. 2.5 hrs) of that when no saccharide oxidase action step was included and that the claimed method greatly shortened the fermentation process.
Examiner argues Table 1 shows the variable of the amount of saccharide oxidase added being adjusted to different concentrations. Claims 1 and 8 do not specify any particular saccharide oxidase concentration. Additionally, applicant asserts that the method comprises a step of combining a lactic acid bacterium starter containing Lactobacillus delbrueckii subsp. Bulgaricus and Streptococcus thermophilus. However, Claims 1 and 8 also do not recite a lactic acid bacterium starter. Applicant’s data in Experiment Example 1 of the specification and Table 1 is not commensurate in scope with the claimed invention. Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims in view of In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) (MPEP § 716.02(b).III.). Applicant has not provided data that is commensurate in scope with the claimed invention, i.e. Claims 1 and 8 do not recite at least a particular concentration of saccharide oxidase and/or a lactic acid bacterium starter, which are both present in Example 1 of applicant’s specification. Therefore, applicant’s allegations of unexpected results are not commensurate in scope with the claimed invention to rebut the obviousness rejections. Additionally, Tams discloses using a lactic acid bacterium starter including Lactobacillus delbrueckii subsp. Bulgaricus or Streptococcus thermophilus (‘257, Page 8, lines 21-23). Tams also discloses the enzyme being added in a suitable amount such as between 0.001 and 0,1 g/L milk substrate (‘257, Page 10, lines 19-21).
Conclusion
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/ERICSON M LACHICA/Examiner, Art Unit 1792
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