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 .
Status of the Application
Receipt of the Response and Amendment after Non-Final Office Action filed 29 September 2025 is acknowledged.
Applicant has overcome the following by virtue of amendment of the claims: (1) the 112(b) rejection of claim 24 has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 9-10, 12, 14, and 15-26
Withdrawn claims: None
Previously canceled claims: 11, 13, and 15
Newly canceled claims: 1-8
Amended claims: 9 and 24
New claims: 25-26
Claims currently under consideration: 9-10, 12, 14, and 15-26
Currently rejected claims: 9-10, 12, 14, and 15-26
Allowed claims: None
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 9-10, 12, 14, and 16-24 are rejected under 35 U.S.C. 103 as being unpatentable over Zha et al (CN 106689945 A) in view of Blake et al. (WO 2015021601 A1), Paulson et al. (US 2011/0244526 A1, US PGPub of WO 2010/036515 A1 cited on the IDS filed on 2 May 2022), and Cherry et al. (US 2005/0202533 A1).
Regarding claim 9, Zha teaches a method for obtaining a hydrolyzed oat material for the production of an oat-based food product (Abstract) which comprises:
(a) obtaining a slurry of a heat-treated oat material in water – “Weigh the amount of oat flour, plus water dissolved at room temperature, and then grinding with colloid mill to get oat paste” (¶ 6)/oatmeal slurry (¶ 7, line 2). Zha further teaches that oatmeal is first baked and ground to obtain oat flour (¶ 37, line 2). In this way, the oat material is heat-treated.
(b) liquefying and saccharifying the slurry of step (a) – “An appropriate amount of the enzyme preparation composition is added to the oatmeal slurry obtained in the above step (1), wherein the enzyme preparation composition comprises a starch liquefaction enzyme, a saccharifying enzyme…” (¶ 7, lines 1-3).
Zha does not teach that the liquefying and saccharifying of the slurry of step (a) is carried out in one step at a temperature of 70-90°C with at least one bacterial endo-alpha-amylase, wherein the bacterial endo-alpha-amylase has beta-glucanase side activity and at least 85% sequence identity to SEQ ID NO: 3, and at least one bacterial maltogenic alpha-amylase, wherein the bacterial maltogenic alpha-amylase has at least 85% sequence identity to SEQ ID NO: 4, wherein the hydrolyzed oat material obtained after step (b) comprises maltose:glucose in a ratio of at least 1 to no greater than 6.17 (w/w).
However, Blake teaches a method of simultaneous liquefaction and saccharification of a starch substrate using a starch-liquefying thermostable alpha-amylase (i.e., endo-alpha-amylase) and a thermoresistant maltose-producing enzyme (i.e., maltogenic amylase) to produce a high-maltose syrup (Abstract). The maltose-producing enzyme may be any beta-amylase, alpha-amylase, or maltogenic amylase, or the like, that retains 50% activity after treatment at 60°C for 10 minutes at a pH of 4.5-5.5, and is capable of producing at least 30% maltose in a simultaneous liquefaction and malto-saccharification process (p. 6, lines 12-16). The simultaneous liquefaction and saccharification method comprises: (i) contacting a starch composition, comprising liquefied starch, gelatinized starch, or granular starch, with a thermoresistant maltose-producing enzyme, and an alpha amylase; and (ii) malto-saccharifying the starch composition to produce a high-maltose composition at a temperature range of 75 °C - 85 °C (p. 17, lines 1-9). Blake therefore teaches liquefying and saccharifying a starch slurry in one step at a temperature between the claimed range of 70-90°C using an alpha amylase and a maltogenic amylase, which may be an alpha amylase.
Blake teaches that the hydrolyzed oat material obtained after step (ii) comprises maltose:glucose in a ratio of at least 1. Blake discloses that in some embodiments, the DP2 level is at least 45%, 50%, 60%, or 70% (p. 18, lines 2-3). Degree of polymerization (DP) refers to the number of anhydrous glucopyranose units in a given saccharide. For example, DP1 refers to monosaccharides, such as glucose, and DP2 refers to disaccharides, such as maltose (p. 8, lines 4-13). Accordingly, 50% DP2 and 50% DP1 corresponds to a maltose:glucose ratio of 1. Blake teaches that after the simultaneous liquefaction and saccharification step performed at 80°C for 1 hour, a sugar composition of circa 40% DP2 and <1% DP1 is achieved, with the remaining sugars being of the order DP3 or higher (p. 28, lines 8-9, p. 29, Table 5). In such an example, the maltose:glucose ratio is >40.
Paulson teaches a method for obtaining a hydrolyzed oat material which comprises:
(a) obtaining a slurry of a heat-treated oat material in water – “The milled starch-containing material will be combined with water and recycled thin stillage resulting in an aqueous slurry” ([0244]). The starch substrate may be obtained from oats ([0023]). Paulson further teaches that the slurry is incubated with an enzyme blend at a temperature in the range of 40-115°C for 5 min to 8 hours as a pretreatment ([0247]).
(b) liquefying the slurry of step (a) at a temperature of 70-90°C ([0250]) with an alpha-amylase blend comprising at least one bacterial endo-alpha-amylase ([0011]) and saccharifying the slurry ([0256]). The alpha amylase blend comprises AmyS ([0012]).
Paulson teaches that the bacterial endo-alpha-amylase has at least 85% sequence identity to SEQ ID NO: 3. Paulson discloses that the AmyS endo-alpha-amylase may be selected from enzymes comprising the polypeptide sequence of SEQ ID NO: 9 ([0015]). SEQ ID NO: 3 of the instant application and SEQ ID NO: 9 of Paulson share 100% identity.
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Regarding the beta-glucanase side activity, the instant specification (p. 5, line 30 – p. 6, line 3) provides:
In a preferred embodiment, the enzyme preparation having beta-glucanase activity is a preparation of an endo-alpha-amylase obtained from Bacillus, preferably from Bacillus amyloliquefaciens, having beta-glucanase side activity.
Such endo-alpha-amylase may have at least 70% sequence identity, such as at least 75%, such as at least 80%, such as at least 85%, such as at least 86%, such as at least 87%, such as at least 88%, such as at least 89%, such as at least 90%, such as at least 91%, such as at least 92%, such as at least 93%, such as at least 94%, such as at least 95%, such as at least 96%, such as at least 97%, such as at least 98%, such as at least 99% or even 100% sequence identity to SEQ ID NO: 3.
Therefore, the instant specification provides evidence that the enzyme disclosed by Paulson in SEQ ID NO: 9 has beta-glucanase side activity.
Cherry teaches a thermostable variant of a bacterial maltogenic alpha-amylase ([0163]) with high activity at 80°C ([0338]-[0340]). This enzyme is applied to prolonging the freshness of baked goods by preventing retrogradation of starch ([0363]-[0364]). Cherry teaches that the bacterial maltogenic alpha-amylase has at least 85% sequence identity to SEQ ID NO: 4. SEQ ID NO: 2 of Cherry and SEQ ID NO: 4 of the instant application share 100% identity. Therefore, any modifications disclosed in Cherry that have at least 85% identity SEQ ID NO: 2 also have at least 85% identity to SEQ ID NO: 4 of the instant application. The variants disclosed in Example 3 of Cherry have at most six amino acid substitutions of the 719 residues ([0340], Table), resulting in 99% identity to SEQ ID NO: 2, and therefore to SEQ ID NO: 4 of the instant application.
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Regarding the simultaneous liquefaction and saccharification step, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Zha with the teachings of Blake to carry out the liquefaction and saccharification steps simultaneously. First, Zha discloses an enzymatic hydrolysis process for making an oat plant protein beverage comprising incubating an oat slurry with a starch liquefaction enzyme and a saccharifying enzyme, heating 1 – 2 ℃ per min to 45 – 55 ℃, incubating 30 – 50 min, and then increasing the temperature of 1 – 2 ℃ per minute to continue to heat up to 55 – 65 ℃, incubating 30 – 40 min; adjusting the pH; and then heating up to 90 – 95 ℃ for 10 – 20 min; and then cooling the oat slurry cooled to 65 – 75 ℃ (¶ 7). As these steps are both time- and energy intensive, one of ordinary skill in the art would have been motivated to consult Blake to find ways to save time and energy costs by combining liquefaction and saccharification. One of ordinary skill in the art would have had a reasonable expectation of success for doing so because Blake teaches that their method of simultaneous liquefaction and saccharification steps conducted at a temperature of 75 – 85 °C using a starch-liquefying thermostable alpha-amylase (i.e., endo-alpha-amylase) and a thermoresistant maltose-producing enzyme (i.e., maltogenic amylase) (p. 17, lines 1-9), addresses previously unmet needs of saving time by eliminating one of the steps in producing maltose, and saving energy by reducing jet cooking (p. 3, lines 18-24).
Regarding the enzymes, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the teachings of Zha to use at least one bacterial endo-alpha-amylase and at least one bacterial maltogenic alpha-amylase in the simultaneous liquefaction and saccharification step by simple substitution of one known element for another to obtain predictable results. See MPEP § 2143(I)(B). First, Zha discloses an enzymatic hydrolysis process for making an oat plant protein beverage comprising incubating an oat slurry with a starch liquefaction enzyme and a saccharifying enzyme, but is silent as to the specific enzymes. Blake teaches a simultaneous liquefaction and saccharification step employing a starch-liquefying thermostable alpha-amylase (i.e., endo-alpha-amylase) and a thermoresistant maltose-producing enzyme (i.e., maltogenic amylase) as described above. Paulson discloses a similar method to Zha in the related art of ethanol production from starch slurry ([0244]) that comprises liquefying the slurry ([0250]) with an alpha-amylase blend comprising at least one bacterial endo-alpha-amylase ([0011]) and saccharifying the slurry ([0256]). The alpha amylase blend comprises AmyS ([0012]). Paulson discloses that the AmyS may be selected from enzymes comprising the polypeptide sequence of SEQ ID NO: 9 ([0015]). It has been established above that SEQ ID NO: 3 of the instant application and SEQ ID NO: 9 of Paulson share 100% identity, and as evidenced by the instant specification, the enzyme disclosed by Paulson in SEQ ID NO: 9 is an endo-alpha-amylase from the bacterium Bacillus amyloliquifaciens having beta-glucanase side activity. Finally, Cherry teaches a thermostable variant of a bacterial maltogenic alpha-amylase ([0163]) with high activity at 80°C ([0338]-[0340]) and as indicated above, SEQ ID NO: 4 of the instant application and SEQ ID NO: 2 of Cherry share 100% identity. The variants disclosed in Example 3 of Cherry have at most six amino acid substitutions of the 719 residues ([0340], Table), resulting in 99% identity to SEQ ID NO: 2. This enzyme is applied to prolonging the freshness of baked goods by preventing retrogradation of starch ([0363]-[0364]), indicating thermostability and starch degradation suitable for the intended purpose of hydrolyzing oat material at a high temperature. Substitution of these enzymes as described would have yielded the predictable result of hydrolyzing starch at high temperatures because Paulson teaches liquefaction at 70-90°C using the enzyme blend comprising the AmyS enzyme ([0249]-[0250]), and Cherry teaches that the bacterial maltogenic alpha-amylase has high activity at 80°C ([0338]-[0340]).
Regarding the maltose:glucose ratio of at least 1 to no greater than 6.17 (w/w), Blake teaches that after the simultaneous liquefaction and saccharification step performed at 80°C for 1 hour, a sugar composition of circa 40% DP2 and <1% DP1 is achieved, with the remaining sugars being of the order DP3 or higher (p. 28, lines 8-9, p. 29, Table 5). In such an example, Blake teaches that the maltose:glucose ratio is >40. The simultaneous liquefaction and saccharification method comprises contacting a starch composition with a thermoresistant maltose-producing enzyme, and an alpha amylase (p. 17, lines 1-9). Since Paulson and Cherry provide obvious substitutions for the enzymes disclosed by Blake, one of ordinary skill in the art would have had a reasonable expectation of success for attaining a maltose:glucose ratio of at least 1 by incorporating the endo-alpha-amylase of Paulson, the maltogenic alpha-amylase of Cherry and the simultaneous liquefaction and saccharification step of Blake into the method of Zha as described above.
Additionally, Zha teaches that the oatmeal protein beverage prepared by their invention has excellent taste and flavor that can be achieved through a combination of enzymes, including a starch liquefaction enzyme, a saccharifying enzyme, a maltose enzyme, and a neutral protease, acting on oat flour, and does not require the addition of milk powder and white sugar that is typical in producing oat beverages (¶ 41). That is, the sweetness can be modulated to consumer preference by the enzymes, and does not require the addition of sugar. Well-known process parameters for modulating enzyme activity, and therefore the amount of product (in this case sugars including maltose and glucose) produced, include the amounts and proportions of each enzyme, incubation temperature, and incubation time. It would have been obvious for one of ordinary skill in the art to modulate these parameters in order to achieve the desired sweetness of the product, including a maltose:glucose ratio of 1-6.17, by no more than routine experimentation.
Therefore, claim 9 is rendered obvious in view of the prior art.
Regarding claim 10, Zha, Blake, Paulson and Cherry teach the method of claim 9.
Zha does not teach that the bacterial endo-alpha-amylase is obtained from Bacillus.
However, Paulson also teaches that the bacterial endo-alpha amylase is obtained from Bacillus. Paulson discloses that the AmyS may be selected from enzymes comprising the polypeptide sequence of SEQ ID NO: 9 ([0015]). It has been established above that SEQ ID NO: 3 of the instant application and SEQ ID NO: 9 of Paulson share 100% identity, and as evidenced by the instant specification, the enzyme disclosed by Paulson in SEQ ID NO: 9 is an endo-alpha-amylase from the bacterium Bacillus amyloliquifaciens.
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to use a bacterial endo-alpha-amylase obtained from Bacillus with the same motivation and with the same expectation of success as described regarding claim 9 above.
Claim 10 is therefore rendered obvious.
Regarding claim 12, Zha, Blake, Paulson and Cherry teach the method of claim 9.
Zha does not teach that the bacterial maltogenic alpha-amylase is obtained from Bacillus stearothermophilus.
However, the bacterial maltogenic alpha-amylase disclosed by SEQ ID NO: 2 of Cherry is obtained from Bacillus stearothermophilus. As evidenced by the instant specification, SEQ ID NO: 4 of the instant application is a maltogenic alpha-amylase from Bacillus stearothermophilus (p. 12, lines 1-2).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to use a bacterial maltogenic alpha-amylase obtained from Bacillus stearothermophilus with the same motivation and with the same expectation of success as described regarding claim 9 above.
Claim 12 is therefore rendered obvious.
Regarding claim 14, Zha, Blake, Paulson and Cherry teach the method of claim 9.
Zha does not teach that step (b) is performed for 5-60 minutes.
However, Blake teaches that the simultaneous liquefaction and saccharification may be carried out for 1 hour with success (p. 29, Table 5). Therefore, modifying the method of Zha to incorporate a simultaneous liquefaction and saccharification as taught by Blake, as described regarding claim 9, would be met with a reasonable expectation of success when performed for the claimed time duration.
Claim 14 is therefore rendered obvious.
Regarding claim 16, Zha, Blake, Paulson and Cherry teach the method of claim 9.
Zha also teaches that the oat material is oat flour – “Weigh the amount of oat flour, plus water dissolved at room temperature, and then grinding with colloid mill to get oat paste (¶ 6).
Claim 16 is therefore rendered obvious.
Regarding claim 17, Zha, Blake, Paulson and Cherry teach the method of claim 9.
Zha also teaches that in the slurry of step (a), the ratio of at material to water is 1:3 to 1:8 (w/w) – “the mass ratio of the oat flour to the normal temperature water is 1: (4 to 8).” (¶ 11).
Claim 17 is therefore rendered obvious.
Regarding claim 18, Zha, Blake, Paulson and Cherry teach the method of claim 9.
Zha does not teach that the bacterial maltogenic alpha-amylase is classified in EC 3.2.1.133.
However, Cherry teaches, as described regarding claim 9 above, that the bacterial maltogenic alpha-amylase of SEQ ID NO: 2 shares 100% sequence identity with SEQ ID NO: 4 of the instant application. As evidenced by the instant specification, “a ‘maltogenic alpha-amylase’ is understood as an enzyme classified in EC 3.2.1.133.” (p. 7, line 32). Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to use a bacterial maltogenic alpha-amylase as classified in EC 3.2.1.133 with the same motivation and with the same expectation of success as described regarding claim 9 above.
Claim 18 is therefore rendered obvious.
Regarding claim 19, Zha, Blake, Paulson and Cherry teach the method of claim 18.
Zha does not teach that step (b) is performed for 5-60 minutes.
However, Blake teaches that the simultaneous liquefaction and saccharification may be carried out for 1 hour with success (p. 29, Table 5). Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to perform step (b) for 5-60 minutes with the same motivation and with the same expectation of success as described regarding claim 18 above.
Claim 19 is therefore rendered obvious.
Regarding claim 20, Zha, Blake, Paulson and Cherry teach the method of claim 9.
Zha also teaches that after step (b), the hydrolyzed oat material is separated into a liquid and a solid phase, and the liquid phase is collected – Step 3 of the process of Zha indicates that after enzymatic hydrolysis, the oat slurry is centrifuged and the sediment is discarded (¶ 28).
Claim 20 is therefore rendered obvious.
Regarding claim 21, Zha, Blake, Paulson and Cherry teach the method of claim 20.
Zha also teaches that the liquid phase is formulated with oil and flavoring agents and homogenized – “The oil composition was added to the oat puree obtained in the above step (3) (i.e., the liquid phase after centrifugation)…it is also possible to add a seasoning adjuvant to the oat raw pulp obtained in the above step (3), and the flavoring ingredient includes at least one of edible salt, sodium citrate, calcium salt, B vitamins and the like.” (¶ 29). “The oatmeal vegetable beverage semi-finished product prepared in the above step (4) is subjected to a second homogenization treatment…” (¶ 30).
Claim 21 is therefore rendered obvious.
Regarding claim 22, Zha, Blake, Paulson and Cherry teach the method of claim 20.
Zha also teaches that the liquid phase is ultra-high temperature (UHT) treated and aseptically packed – “[Step] (5) Sterilization Filling: … 135-145 ℃ for 10-30s UHT sterilization…filling” (¶ 30). Filling is presumed to be under aseptic conditions since the oat beverage was just sterilized by UHT.
Claim 22 is therefore rendered obvious.
Regarding claim 23, Zha, Blake, Paulson and Cherry teach the method of claim 20.
Zha also teaches that the liquid phase is sold as an oat-based beverage – “…the invention has the advantages of broad market prospect and market [sic] by optimizing the preparation method and the raw material formula so that the prepared oat plant protein beverage has the characteristics of color milky white, smooth taste, natural, strong flavor and nutrient richness benefit.” (¶ 21). Broad market prospect indicates that the oat-based beverage is sold.
Claim 23 is therefore rendered obvious.
Regarding claim 24, Zha, Blake, Paulson and Cherry teach the method of claim 9.
It is noted that the phrase, “wherein the method produces a hydrolysed oat material for the production of an oat-based food product, wherein the oat-based food product is less sweet compared to a similar method which does not comprise a bacterial endo-alpha-amylase comprising beta-glucanase side activity and an amino acid sequence with at least 85% sequence identity to SEQ ID NO: 3 and a bacterial maltogenic alpha-amylase comprising an amino acid sequence with at least 85% sequence identity to SEQ ID NO: 4” is a statement of intended use for the product of the method. The method is directed toward obtaining a hydrolyzed oat material. The method is not toward producing an oat-based food product as there are no positively recited method steps for producing an oat-based food product from the hydrolyzed oat material obtained by the method.
A statement with regard to the intended use of an invention is not further limiting insofar as the structure of the invention is concerned. In order to patentably distinguish the claimed invention from the prior art, a claimed intended use must result in a structural difference between the claimed invention and the prior art. See MPEP § 2111.02(II).
In the present case, there is no difference between the method suggested in the prior art and the claimed method because all structural limitations required by the method (i.e., the limitations of claim 9) have been rendered obvious in view of the prior art as set forth regarding claim 9.
Claim 24 is therefore rendered obvious.
Regarding claims 24 and 25, Zha, Blake, Paulson and Cherry teach the method of claim 9.
Zha does not teach that the bacterial endo-alpha-amylase comprising beta- glucanase side activity and an amino acid sequence with at least 90% sequence identity to SEQ ID NO: 3 and a bacterial maltogenic alpha-amylase comprising an amino acid sequence with at least 90% sequence identity to SEQ ID NO: 4 (re: claim 24) or that the bacterial endo-alpha-amylase comprising beta- glucanase side activity and an amino acid sequence with at least 95% sequence identity to SEQ ID NO: 3 and a bacterial maltogenic alpha-amylase comprising an amino acid sequence with at least 95% sequence identity to SEQ ID NO: 4 (re: claim 26).
However, as described regarding claim 9, SEQ ID NO: 9 of Paulson shares 100% sequence identity to SEQ ID NO:3 of the instant application, and SEQ ID NO: 2 of Cherry shares 100% identity with SEQ ID NO:4 of the instant application. Therefore, claims 24 and 25 are obvious for the same reasons as described regarding claim 9.
Response to Arguments
Claim Rejections – 35 U.S.C. § 112:
Applicant has overcome the 35 U.S.C. § 112(b) rejection of claim 24 based on amendment to the claim. Accordingly, the 35 U.S.C. § 112(b) rejection has been withdrawn.
Claim Rejections – 35 U.S.C. § 103: Applicant’s arguments filed on 29 September 2025 have been fully considered, but they are not persuasive.
Applicant first argued that the Examiner has failed to establish a prima facie case of obviousness because no motivation has been provided to combine the cited references to arrive at the claimed invention, and that the Examiner selectively identified various pieces of art to arrive at an approximation of the present claims, then combined the art and argued that it was obvious to do so (p. 5, ¶ 5).
In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Zha teaches a base method of liquefying and saccharifying an oat slurry with a starch liquefaction enzyme, a saccharifying enzyme, a maltase, and a neutral protease, but teaches that the liquefaction and saccharification are conducted as separate, time and energy intensive steps. Blake teaches simultaneous liquefaction and saccharification of a starch substrate and that a maltose:glucose ratio greater than 1 is achieved. In the rejection of claim 9, the motivation to combine the simultaneous liquefaction and saccharification of Blake with the method of Zha to save time and energy costs is provided. Regarding the claimed enzymes, Paulson teaches the claimed bacterial endo-alpha-amylase with beta-glucanase side activity, and Cherry teaches the claimed bacterial maltogenic alpha amylase. MPEP § 2143 provides:
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. In Ball Aerosol v. Ltd. Brands, 555 F.3d 984, 89 USPQ2d 1870 (Fed. Cir. 2009), the Federal Circuit offered additional instruction as to the need for an explicit analysis. The Federal Circuit explained that the Supreme Court’s requirement for an explicit analysis does not require record evidence of an explicit teaching of a motivation to combine in the prior art.
…Office personnel are to continue to make appropriate findings of fact as explained in MPEP § 2141 and § 2143, and must provide a reasoned explanation as to why the invention as claimed would have been obvious to a person of ordinary skill in the art at the relevant time. This requirement for explanation remains even in situations in which Office personnel may properly rely on common sense or ordinary ingenuity. In re Van Os, 844 F.3d 1359, 1361, 121 USPQ2d 1209, 1211 (Fed. Cir. 2017) ("Absent some articulated rationale, a finding that a combination of prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating the combination ‘would have been obvious.’").
MPEP § 2143(I)(B) provides “simple substitution of one known element for another to obtain predictable results” as a rationale supporting a prima facie case of obviousness. The findings required by this rationale are provided in the rejection of claim 9. Therefore, a prima facie case of obviousness has been established, and Applicant’s argument is not persuasive.
Applicant next argued that although Zha, Blake, Paulson, and Cherry teach different aspects of various parts of the claimed method, it is only in the disclosures of the present specification that a hydrolyzed oat material specifically with a maltose:glucose ratio of at least 1 to no greater than 6.17 (w/w) is described and identified as ideal, with both a sufficient level of viscosity (not too high and not too low), and excellent mouthfeel (not too sandy and not too watery) (p. 6, ¶¶ 1 &3).
Applicant’s argument has been considered, but it is not persuasive. Zha, Blake Paulson, and Cherry render the process and enzymes required by claim 9 obvious. Zha teaches that the oatmeal protein beverage prepared by their invention has excellent taste and flavor that can be achieved through a combination of enzymes, including a starch liquefaction enzyme, a saccharifying enzyme, a maltose enzyme, and a neutral protease, acting on oat flour, and does not require the addition of milk powder and white sugar that is typical in producing oat beverages (¶ 41). That is, the sweetness can be modulated to consumer preference by the enzymes, and does not require the addition of sugar. Blake, Paulson, and Cherry teach the claimed enzymes. Well-known process parameters for modulating enzyme activity, and therefore the amount of product (in this case sugars including maltose and glucose) produced, include the amounts and proportions of each enzyme, incubation temperature, and incubation time. In the method provided by the combination of the prior art described in the rejection of claim 9, it would have been obvious for one of ordinary skill in the art to modulate these parameters in order to achieve the desired sweetness of the product, including a maltose:glucose ratio of 1-6.17, as well as other organoleptic properties, by no more than routine experimentation.
Applicant next argued that Zha does not teach a one-step liquefaction and saccharification process (p. 6, ¶ 2). Applicant has argued against Zha individually.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Therefore, Applicant’s argument cannot be found to be persuasive.
Applicant further argued that contrary to the Examiner’s assertion, the evidence provided by Example 3 is commensurate in scope with the claimed invention since a person of skill in the art would know and appreciate that amounts of enzyme added, incubation temperature, and length of time of the incubation of an enzymatic reaction can vary within a reasonable range to achieve a desired result, with each of the parameters adjustable within ranges and in relation to each other to provide the same product (pp. 6-7, bridging ¶). Applicant has limited the scope of the maltose:glucose ratio to at least 1 to no greater than 6.17 (w/w), which is supported by the data in Example 3.
However, Applicant’s argument has been considered, but it is not found to be persuasive. MPEP § 2145 states, “If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc)”, and “[r]ebuttal evidence may include evidence of ‘secondary considerations,’ such as ‘commercial success, long felt but unsolved needs, [and] failure of others.’ Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 4459, 467. See also, e.g., In re Piasecki, 745 F.2d 1468, 1473, 223 USPQ 785, 788 (Fed. Cir. 1984) (commercial success). Rebuttal evidence may also include evidence that the claimed invention yields unexpectedly improved properties or properties not present in the prior art. Rebuttal evidence may consist of a showing that the claimed compound possesses unexpected properties. Dillon, 919 F.2d at 692-93, 16 USPQ2d at 1901. A showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997)”. However, as provided by MPEP § 2145(II), “[m]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979)”, and “‘[t]he fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.’ Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)”. Furthermore, “[e]vidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978).” See MPEP § 716.02(c)(I). “‘Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof.; In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967)”. See MPEP § 716.02(c)(II).
In the present case, while the claimed maltose:glucose ratio may be important contributing to the viscosity, mouthfeel, and sweetness of the resulting product, to overcome an obviousness rejection, it must be unexpected or shown to be critical. No unexpected results have been shown, and no evidence of criticality has been demonstrated. The claimed maltose:glucose of at least 1 to no greater than 6.17 (w/w) is achievable by adjusting parameters affecting enzyme activity/starch conversion, including the amounts and proportions of each enzyme, incubation temperature, and incubation time, as is well-known in the art, and admitted by Applicant, by no more than routine experimentation.
Applicant’s arguments are therefore not found to be persuasive, and claims 9-10, 12, 14, and 15-24 remain rejected. New claims 25 and 26 are rejected as presented hereinabove.
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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/JAMES P. SHELLHAMMER/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793