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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1 and 23-36) in the reply filed on 26 March 2026 is acknowledged. Claims 37-41 have been withdrawn from consideration.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 23-36 are rejected under 35 U.S.C. 103 as being unpatentable over Henderson et al. (herein referred to as Henderson, US 20070141688 A1) in view of Conrad (US 4282319 A)
With regard to Claim 1, Henderson teaches a process of liquefying starch-containing material (abstract). Henderson teaches wherein the starch containing material is processed using a liquefying step with at least one amylase (i.e., step a) and then subsequently saccharifying the liquefied material (i.e., step b) obtained in the pervious step with a carbohydrate-generating enzyme ([0012]-[0016]). Henderson teaches suitable alpha-amylases include BAN ([0088]). One with ordinary skill in the art would recognize BAN is a well-known endo alpha-amylase. Henderson teaches the liquefying step (i.e., step a) is carried out between 20-105℃ ([0040]). See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Henderson teaches the liquefaction process can be carried out as a multi-stage process wherein the temperature of the reaction is adjusted (i.e., step b) ([0041]). Henderson teaches the saccharifying step can include an acid-alpha amylase with other enzymes ([0073]) and the process is often carried out at temperatures from about 30 to 65℃ ([0073]). MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
However, Henderson is silent the saccharifying step utilizing a maltogenic saccharifying alpha-amylase and an endoprotease and adjusting the temperature to inactivate the enzymes and pasteurize. In addition Henderson is silent to the starch-containing material being oats.
Conrad teaches process for the preparation of hydrolyzed products from whole grain, and such derived products, wherein the whole grain may be oat (abstract). Conrad teaches substantially all the essential, nutritionally important proteins of the grain are present in water soluble state substantially as peptides, preferably together with the water soluble starch hydrolysis products (col 1 lines 39-43). Conrad teaches enzymatic treatment using a proteolytic enzyme which transforms the water insoluble proteins to water soluble degraded products (col 2 lines43-45) and an alpha-amylase for the transformation of water insoluble starch to water soluble degraded products of starch (Col 2 lines 54-56) simultaneously (Col 2 lines 43-69, col 3 lines 5-8). Conrad teaches the reaction temperature ranges can vary, but include temperatures ranging from 50℃ to 75℃ (examples 1-14). See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Conrad teaches the proteolytic enzyme may be Neutrase which is an endoprotease (col 3 line 67 – col 4 line 2). In some embodiments, Conrad teaches utilizing “Fungamyl 1600” which is a widely known maltogenic saccharifying alpha-amylase (Col 5 lines 40-68, example 1). Conrad teaches after enzymatic treatment the suspension may be further heated to sterilize the solution (Col 5 lines 40-68, example 1). One with ordinary skill in the art would recognize if the solution is being sterilized the enzymes would be inactivated in the solution. Conrad thus reads on steps c) and d) of the present claim.
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the saccharifying step as taught by Henderson to utilize the process as taught by Conrad to transforms the water insoluble proteins to water soluble degraded products and for the transformation of water insoluble starch to water soluble degraded products of starch to obtain product and/or products from whole grain, whereby especially substantially all the essential, nutritionally important proteins of the grain are present in water soluble state substantially as peptides together with the water soluble starch hydrolysis products.
Conrad imparts reasoning for obviousness because the teaching shows the process described above is not only applicable for corn (Henderson, [0011]) but other starch-containing materials such as oats (Conrad, Col 2 lines 18-21). Thus it would have been obvious to one of ordinary skill in the art to use this method for oats on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to Claims 23 and 25, Henderson teaches the liquefaction process (step a) may be carried out as a multi-stage hot slurry process, such as a three stage process, carried out at different temperatures and holding times ([0010]). Henderson teaches step a is performed for a period of at least 10 minutes ([0042]). Henderson teaches step a can be performed in the range of 10-120 minutes ([0042]). MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
With regard to Claims 24 and 26, Henderson is silent to the time in which step c is performed.
In one embodiment Conrad teaches wherein step c) is performed for 3 hours (i.e., 180 minutes) (Col 7 lines 10-37). See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Conrad teaches after the reaction time all proteins and all starch has been transformed into soluble form (Col 7 lines 14-15).
It is important to note that the 180 minutes taught by Conrad is greater than the 10-120 minute time range limited in Claim 26. However, it would be obvious to one with ordinary skill in the art to adjust the reaction time to achieve the desired amount of protein and starch transformed into soluble form. One who is familiar with enzymatic reactions would appropriately decrease the reaction time to achieve the desired result. See MPEP 2144.05(II)(A) see Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");
Thus, it would have been obvious to one with ordinary skill in the art to modify Henderson to utilize the reaction time as taught by Conrad to transform the desired amount of proteins and starch into soluble form.
With regard to Claim 27, Henderson teaches a process of liquefying starch-containing material (abstract). Henderson teaches wherein the starch containing material is processed using a liquefying step with at least one amylase (i.e., step a) and then subsequently saccharifying the liquefied material (i.e., step b) obtained in the pervious step with a carbohydrate-generating enzyme ([0012]-[0016]). Henderson teaches suitable alpha-amylases include BAN ([0088]). One with ordinary skill in the art would recognize BAN is a well-known endo alpha-amylase. Henderson teaches the liquefying step (i.e., step a) is carried out between 20-105℃ ([0040]). ([0010]). Henderson teaches liquefaction process (step a) is performed for a period of at least 10 minutes ([0042]). See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Henderson teaches the liquefaction process can be carried out as a multi-stage process wherein the temperature of the reaction is adjusted (i.e., step b) ([0041]). Henderson teaches the saccharifying step can include an acid-alpha amylase with other enzymes ([0073]) and the process is often carried out at temperatures from about 30 to 65℃ ([0073]). MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
However, Henderson is silent the saccharifying step utilizing a maltogenic saccharifying alpha-amylase and an endoprotease and adjusting the temperature to inactivate the enzymes and pasteurize. In addition Henderson is silent to the starch-containing material being oats.
Conrad teaches process for the preparation of hydrolyzed products from whole grain, and such derived products, wherein the whole grain may be oat (abstract). Conrad teaches substantially all the essential, nutritionally important proteins of the grain are present in water soluble state substantially as peptides, preferably together with the water soluble starch hydrolysis products (col 1 lines 39-43). Conrad teaches enzymatic treatment using a proteolytic enzyme which transforms the water insoluble proteins to water soluble degraded products (col 2 lines43-45) and an alpha-amylase for the transformation of water insoluble starch to water soluble degraded products of starch (Col 2 lines 54-56) simultaneously (Col 2 lines 43-69, col 3 lines 5-8). Conrad teaches the reaction temperature ranges can vary, but include temperatures ranging from 50℃ to 75℃ (examples 1-14). See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In one embodiment Conrad teaches wherein step c) is performed for at least 10 minutes (Col 7 lines 10-37). Conrad teaches the proteolytic enzyme may be Neutrase which is an endoprotease (col 3 line 67 – col 4 line 2). In some embodiments, Conrad teaches utilizing “Fungamyl 1600” which is a widely known maltogenic saccharifying alpha-amylase (Col 5 lines 40-68, example 1). Conrad teaches after enzymatic treatment the suspension may be further heated to sterilize the solution (Col 5 lines 40-68, example 1). One with ordinary skill in the art would recognize if the solution is being sterilized the enzymes would be inactivated in the solution. Conrad thus reads on steps c) and d) of the present claim.
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the saccharifying step as taught by Henderson to utilize the process as taught by Conrad to transforms the water insoluble proteins to water soluble degraded products and for the transformation of water insoluble starch to water soluble degraded products of starch to obtain product and/or products from whole grain, whereby especially substantially all the essential, nutritionally important proteins of the grain are present in water soluble state substantially as peptides together with the water soluble starch hydrolysis products.
Conrad imparts reasoning for obviousness because the teaching shows the process described above is not only applicable for corn (Henderson, [0011]) but other starch-containing materials such as oats (Conrad, Col 2 lines 18-21). Thus it would have been obvious to one of ordinary skill in the art to use this method for oats on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to Claim 28, Henderson teaches the first alpha-amylase is not produced in a genetically modified organism ([0077]-[0079]) and Conrad teaches the second alpha-amylase and the endoprotease are also not produced in a genetically modified organism (whole document).
With regard to Claim 29, the combination of Henderson and Conrad teaches the process as instantly claimed. Therefore the modified oat base produced via the process would inherently exhibit an increase stability in hot acidic beverages. See MPEP 2112.01(I) Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
With regard to Claim 30, Henderson teaches suitable first liquefying alpha-amylase includes BAN ([0088]).
With regard to Claim 31, Henderson teaches a preferred acid fungal alpha-amylase is a Fungamyl-like alpha-amylase but is silent to the enzyme being utilized in the saccharification step.
Conrad teaches utilizing “Fungamyl 1600” which is a widely known maltogenic saccharifying alpha-amylase (Col 5 lines 40-68, example 1). It is important to note that Fungamyl 1600 is a discontinued product. Therefore it would have been obvious to one with ordinary skill in the art to select another type of Fungamyl, such as Fungamyl 800L, as a suitable replacement on the basis of a similar intended use.
In this case, Conrad imparts reasoning for obviousness because the teaching shows that the claimed fungamyl enzyme was known for such a thing to have been successfully utilized and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select the desired fungamyl enzyme product for a saccharification process, because it would have been obvious for one with ordinary skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to Claim 32, Henderson is silent to the step comprising an endoprotease.
Conrad teaches enzymatic treatment using a proteolytic enzyme and an alpha-amylase simultaneously (Col 2 lines 43-69, col 3 lines 5-8). Conrad teaches the proteolytic enzyme may be Neutrase which is a metalloendoprotease (col 3 line 67 – col 4 line 2).
Therefore, Conrad imparts reasoning for obviousness because the teaching shows the use of a metalloendoprotease was known for such a thing to have been successfully achieved and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select a metalloprotease because it would have been obvious to one with ordinary skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to Claim 33, Henderson teaches suitable first endo alpha-amylase includes BAN ([0088]). It is important to note that Henderson does not specifically state “BAN 480L” but merely discloses “BAN”. It would have been obvious to one with ordinary skill in the art to select the species of BAN most appropriate for the application. See MPEP 2144.08(II) In re Jones, 958 F.2d 347, 350, 21 USPQ2d 1941, 1943 (Fed. Cir. 1992) (Federal Circuit has "decline[d] to extract from Merck [& Co. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989)] the rule that... regardless of how broad, a disclosure of a chemical genus renders obvious any species that happens
Continuing, Henderson teaches a preferred acid fungal alpha-amylase is a Fungamyl-like alpha-amylase but is silent to the enzyme being utilized in the saccharification step.
Conrad teaches utilizing “Fungamyl 1600” which is a widely known maltogenic saccharifying alpha-amylase (Col 5 lines 40-68, example 1). It is important to note that Fungamyl 1600 is a discontinued product. Therefore it would have been obvious to one with ordinary skill in the art to select another type of Fungamyl, such as Fungamyl 800L, as a suitable replacement on the basis of a similar intended use. Again See MPEP 2144.08(II) In re Jones, 958 F.2d 347, 350, 21 USPQ2d 1941, 1943 (Fed. Cir. 1992) (Federal Circuit has "decline[d] to extract from Merck [& Co. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989)] the rule that... regardless of how broad, a disclosure of a chemical genus renders obvious any species that happens to fall within it.").
In this case, Conrad imparts reasoning for obviousness because the teaching shows that the claimed fungamyl enzyme was known for such a thing to have been successfully utilized and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select the desired fungamyl enzyme product for the saccharification step, because it would have been obvious for one with ordinary skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
Lastly, Henderson is silent to the step comprising an endoprotease wherein the endoprotease is a metalloendoprotease.
Conrad teaches enzymatic treatment using a proteolytic enzyme and an alpha-amylase simultaneously (Col 2 lines 43-69, col 3 lines 5-8). Conrad teaches the proteolytic enzyme may be Neutrase which is a metalloendoprotease (col 3 line 67 – col 4 line 2).
Therefore, Conrad imparts reasoning for obviousness because the teaching shows the use of a metalloendoprotease was known for such a thing to have been successfully achieved and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select a metalloprotease because it would have been obvious to one with ordinary skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to Claim 34, Henderson teaches the liquefying step (i.e., step a) is carried out between 20-105℃ ([0040]). See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
With regard to Claim 35, the combination of Henderson and Conrad teaches the process as instantly claimed. Therefore the modified oat base produced via the process would inherently not change the bitterness of a hot acidic beverage when it is incorporated. See MPEP 2112.01(I) Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
With regard to Claim 36, Henderson teaches the first alpha-amylase is not produced in a genetically modified organism ([0077]-[0079]) and Conrad teaches the second alpha-amylase and the endoprotease are also not produced in a genetically modified organism (whole document). Therefore the process if free from genetically modified enzymes and/or enzymes produced in a genetically modified organism.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Inglett et al. US 4996063
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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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