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 .
DETAILED ACTION
2. Applicants’ arguments and amendments filed on 1/27/2026, overcomes the rejections of record, however, the new grounds of rejection as set forth below are necessitated by applicants’ amendment and therefore, the following action is Final.
Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn.
Status of the application
3. Claims 1, 2, 4, 6-7, 9-12, 14-23 are pending in this office action.
Claim 1, 12 have been amended.
Claims 14-23 are new.
Claims 1, 2, 4, 6-7, 9-12, 14-23 are rejected.
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
5. Claim 19 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 19 depends on independent claim 1. Claim 1 claims lactic acid bacteria in the Markush group. These are identical bacteria as claimed in claim 19. Also claim 19 claims “one or more” and independent claim 1 claims any one (Markush) of them. Therefore, claim 19 is improper dependent form for failing to further limit the subject matter of the claim upon which it depends. This Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
6. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action.
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
7. 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(a) are summarized as follows:
a. Determining the scope and contents of the prior art.
b. Ascertaining the differences between the prior art and the claims at issue.
c. Resolving the level of ordinary skill in the pertinent art.
d. Considering objective evidence present in the application indicating obviousness or non-obviousness.
8. Claims 1, 2, 4, 6-7, 11-12, 15 and 19, are rejected under 35 U.S.C. 103(a) as being unpatentable over Beckmann et al. WO 2010/136320 A1 in view of Yura et al. (WO 2006/043478 A1).
9. Regarding claims 1, 2, 4, 12, 19, Beckmann et al. discloses that “Fermentation of soy protein containing substrates with thermophilic lactic acid bacteria may be known to provide beneficial flavor components to such soy protein preparations, which, when untreated, suffer from off-flavors. The presence of such positive "dairy" and "yoghurt" notes may mask soy off flavors to some extent, but there is a desire for improvement, also as such thermophilic bacteria have a limited ability to reduce the level of components which are present which are responsible to part of the off-flavor. Surprisingly, it was found that undesired soy off notes is more efficiently removed when a mesophilic culture is added to a thermophilic culture mix (at least under “Detailed Description of the Invention”, second paragraph-fourth paragraph). Therefore, the removal of soy off-note and a positive dairy and yogurt note makes soy fermented product of Beckmann et al. to be used as yogurt. Therefore, Beckmann et al. meets the claim limitation of claimed combined lactic acid bacteria as claimed in claim 1.
Beckmann et al. also discloses that “ The term "lactic acid bacteria" as used herein refers to acid tolerant, non-sporulating, non-respiring rod-shaped Gram -positive bacilli or cocci that produce lactic acid as the major metabolic end product of carbohydrate fermentation” (at least under “Detailed Description of the Invention”, sixth paragraph). Beckmann et al. also discloses that the duration depends on the ratio of two microorganisms used and “The duration of the fermentation herein typically lies in the range of 1-12 hours, more preferably of 2- 10 hours and preferably, it does not exceed 8 hours (at least under “Detailed Description of the Invention”, seventh and ninth paragraphs) which is considered as short acidification time and therefore, the method provides an increased acidification speed of lactic acid bacteria as claimed in claims 1, 12.
Beckmann et al. also discloses that the substrate that is fermented in the disclosed method, i.e. the aqueous liquid containing 0.5-15 wt.% of dissolved soy protein is preferably prepared from a soy protein source selected from the group consisting of soy isolate also as soy protein source which reads on “plant (soy) protein is prepared from plant (soy) protein isolate” as claimed in claim 1.
As discussed above, Beckmann et al. discloses that "lactic acid bacteria" as used herein refers to acid tolerant, non-sporulating, non-respiring rod-shaped Gram positive bacilli or cocci that produce lactic acid as the major metabolic end product of carbohydrate fermentation” (.at least under “Detailed Description of the Invention”, sixth paragraph) and duration of fermentation is short e.g. it typically lies in the range of 1-12 hours, more preferably of 2- 10 hours and preferably, it does not exceed 8 hours (at least under “Detailed Description of the Invention”, seventh and ninth paragraphs).
Beckmann et al. also discloses that while comparing short fermentation times (e.g. 3 hours) compared to more than 8 hours fermentation time, the dairy character is quite prominent due to higher levels of dacetyl and acetaldehyde, and by adjusting e.g. the ratio between the mesophilic and thermophilic microorganisms and the fermentation time, the taste profile can be steered towards a desired one, be it bland or dairy or something in between (at least on page 9 last paragraph and page 10, first paragraph). Therefore, it would have been obvious that the quick fermentation within 8 hours’ time generates quick fermented acidified product including yogurt and therefore, provides ‘fast acidification speed’ as claimed in claims 1, 12.
Beckmann et al. is silent about phytate removal by incubating plant protein with phytase enzyme as claimed in claim 1.
Yura et al. discloses a method of making a fermented food product (Yura et al. [0020] e.g. yogurt) from soymilk ([0019]) as soy protein source ([0019]) using lactic acid bacteria: Lactobacillus bulgaricus, Streptococcus thermophilus etc. (at least in Example 1, of Yura et al., and claim 1 of Yura et al.) which product is free of phytic acid. Therefore , it meets claim 1, and new claim 19.
Yura et al. discloses that phytate can be removed by treating with phytase during fermentation of soymilk ([0019]) as soy protein source ([0019]) to make the fermented product free of phytic acid.
Yura et al. also discloses that phytase treatment reduces/removes phytic acid from soy protein which provides an improved nutrition such as an improved mineral absorption ([0004]) . Therefore, the fermented product ,free of phytic acid, provides benefit of an improved nutritional quality such as an improved mineral absorption by removing the interference of phytic acid in this respect.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Beckmann et al. by considering phytase treatment to make the soy protein free from phytase in order to reducing/removing phytic acid from soy protein which provides an improved nutrition such as an improved mineral absorption ([0004]) property for the final fermented product derived from soy protein isolate by removing the interference of phytic acid in this respect.
It is to be noted that it would have been obvious that phytase will generate inorganic phosphate from any sodium phytate including “in excess” as residual and , by definition, “One FTU is the activity of phytase that generates 1 umol of inorganic phosphorus per minute from an excess of sodium phytate at pH 5.5 and 37° C” as claimed in claims 1, 12, is considered as definition of 1 FTU unit used to specify specific activity (in units) of a particular enzyme. It is within the skill of one of ordinary skill in the art to consider the amount of enzyme in terms of unit activity (20 FTU) to be added per gm of plant protein based on the unit.
Yura et al. does not specifically teach the claim limitation of “wherein the phytase is added in an amount of at least 20 FTU per gram of plant protein” as claimed in claims 1, 12.
However, Yura et al. discloses that the enzyme having phytic acid degrading activity is added in an amount of 0.01 to 10% by weight of the soymilk weight (at least in [0016]) in order to have phytic acid content less than 1.5% by weight ([0007] #1). Therefore, Yura et al. discloses the broad range amount in terms of weight of the enzyme to be used. As because it is “at least”, therefore, it can be concentrated enzyme having at least 20 FTU enzyme unit activity present within 0.01 to 10% by weight of the enzyme.
Yura et al. does not specify any specific unit. Rather, Yura et al. discloses that the enzyme can be used from various sources and the amount of enzyme added, processing temperature, pH, time, etc. can be determined appropriately according to the enzyme used (at least in [0016]).
Therefore, it is within the skill of one of ordinary skill in the art to select the amount of the enzyme having “at least 20 FTU in the disclosed 0.01 to 10% enzyme” in order to have minimal/nil phytic acid present in soy protein and it depends on the source, degree of purity, amount of enzyme to be added (e.g. less unit will need more enzyme). One of ordinary skill in the art would have been motivated to do so having concentrated form with reasonable expectation of success in order to have much less amount needed if it has more unit per mg enzyme protein. It is also optimizable.
Absent showing of unexpected results, the specific amount of unit of enzyme is not considered to confer patentability to the claims. As amount of the enzyme which depends on the concentration (unit of the enzyme) of the enzyme and it depends on the source, degree of purity, amount of enzyme to be added (e.g. less unit will need more enzyme) are variables that can be modified, among others, by adjusting the amount of enzyme , the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical.
Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the unit amount of enzyme in Beckmann in view of Yura et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired FTU unit to have no/minimal phytic acid in the plant protein as disclosed by Yura et al. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
10. Regarding claims 1, 12, in addition to the discussion made for claim 12 above, it is also to be noted that the disclosed method steps of fermenting phytase treated soy protein to make yogurt is identical to the claimed method steps as claimed in independent claim 12, and therefore, the final product will have identical claimed property which is the earlier completion of the fermentation in presence of phytase due to an increase in the acidification speed of lactic acid bacteria in a solution comprising a plant protein” as claimed in claim 12. It is also to be noted that and as discussed above, the disclosed duration of the fermentation herein typically lies in the range of 1-12 hours, more preferably of 2- 10 hours and preferably, it does not exceed 8 hours as disclosed by Beckmann et al. (at least under “Detailed Description of the Invention”, seventh and ninth paragraphs) which is considered as short acidification time and therefore, the method provides an increased acidification speed of lactic acid bacteria as claimed in claims 1, 12.
Beckmann et al. also discloses that in the process according to the present invention, the bacteria of the mesophilic LAB and the bacteria of the thermophilic LAB are inoculated in a ratio Cfu of mesophilic LAB to thermophilic LAB of between 10:1 and 1 :100, preferably 1 :1 to 1 :40, and more preferably between 1 :1 and 1 :20 and the specific ratio can vary for short fermentation e(page 5, first paragraph). Therefore, this is optimizable.
Absent showing of unexpected results, the specific percent amount of increasing the acidification step i.e. short time fermentation is not considered to confer patentability to the claims. As the acidification speed is variable that can be modified, among others, by adjusting the amount of lactic acid bacteria, their ratio (in Beckmann, page 5, first paragraph), and amount of starting soy protein substrate, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of increased acidification time in Beckmann, to amounts, including that presently claimed, in order to obtain the desired effect e.g. fast completion of fermentation with increased acidification etc. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding amended claim 1 and new claim 15, amended claim 1 recites “ wherein incubating the solution with phytase and fermenting the solution with lactic acid bacteria results in a reduction of time to reach a pH below 5, which is at least 10% when compared to an otherwise identical solution incubated with lactic acid bacteria only” and new claim 15 recites “ wherein the plant protein is soy protein isolate, and the reduction of time to reach pH 4.6 is at least 60% when compared to an otherwise identical method which does not comprise an incubation with phytase”.
It is to be noted that even if Yura and Beckmann do not mention specifically “wherein incubating the solution with phytase and fermenting the solution with lactic acid bacteria results in a reduction of time to reach a pH below 5, which is at least 10% when compared to an otherwise identical solution incubated with lactic acid bacteria only” as claimed in amended claim 1, and “wherein the plant protein is soy protein isolate, and the reduction of time to reach pH 4.6 is at least 60% when compared to an otherwise identical method which does not comprise an incubation with phytase” as claimed in new claim 15, however, the disclosed method steps of fermenting phytase treated soy protein with the combined microorganisms Lactobacillus and Streptococcus spp. as disclosed by Yura et al. and Beckmann et al., to make yogurt (Yura et al. [0020]) is identical to the claimed method steps as claimed in independent claim 1, and dependent claim 15 and therefore, the final product will have identical claimed property including the abovementioned claimed property of amended claim 1 and new claim 15.
Also, it is to be noted that Yura et al. discloses that the enzyme having phytic acid degrading activity is added in an amount of 0.01 to 10% by weight of the soymilk weight (at least in [0016]) in order to have phytic acid content less than 1.5% by weight ([0007] #1).
One of ordinary skill in the art can correlate the amount of the enzyme with the “at least 20 FTU within the disclosed “0.01 to 10% by weight enzyme” by evaluating the strength in relation to inorganic phosphorous generation as claimed in claim 1.
Therefore, one of ordinary skill in the art can optimize the percent by weight of enzyme which will correlate with 20 FTU or more unit of enzyme in order to achieve desired reduction of time to reach desired pH as claimed in claims 1, 15. Therefore, it is optimizable.
It is to be noted that even if Yura et al. does not specifically recognize claimed ‘20 FTU or more as a variable affecting acidification speed’, however, the adjustment of phytase enzyme from disclosed range amounts of 0.01 to 10% phytase enzyme, which correlates “at least 20 FTU or more, can also affect any property including “claimed ‘20 or more FTU as a variable affecting acidification speed’.
Therefore, claimed ‘20 or more FTU as a variable affecting acidification speed’ is also considered an art recognized variable.
Absent showing of unexpected results, the specific amount of FTU unit and percent increasing the acidification step ( i.e. short time fermentation time ) is not considered to confer patentability to the claims. As the 20 FTU unit can be correlated with the disclosed 0.01-10% by weight phytase enzyme, which is variable that can be modified, among others, by adjusting the amount of 20 FTU unit containing percent enzyme from within the disclosed 0.01-10% by weight phytase enzyme, “the precise amount of enzyme in terms of 20 FTU unit 20 or more with respect to reduction of fermentation time by at least 10% to reach pH below 5.0” would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of increased acidification time in Beckmann, to amounts, including that presently claimed, in order to obtain the desired effect e.g. fast completion of fermentation with increased acidification etc. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
11. Regarding claim 2, Yura et al. also discloses that the enzyme is allowed to act at least until the fermented soymilk is finally made into a product (at least in [0018]) which can read on “during fermenting of the solution” as claimed in claim 2. Yura et al. also discloses that the phytase enzyme can be treated using appropriate amount of the enzyme to remove all phytase and followed by inactivating the enzyme, therefore, it meets “prior to fermentation” also ([0018], [0019]).
12. Regarding claims 6, 7, as discussed above, Beckmann et al. also discloses that while comparing short fermentation times (e.g. 3 hours) compared to more than 8 hours fermentation time, the dairy character is quite prominent due to higher levels of dacetyl and acetaldehyde, and by adjusting e.g. the ratio between the meso and thermophilic microorganisms and the fermentation time, the taste profile can be steered towards a desired one, be it bland or dairy or something in between (at least on page 9 last paragraph and page 10, first paragraph).
Regarding claim 6, it is to be noted that even if Yura and Beckmann do not mention specifically “ fermentation time is 10% reduced compared to a lactic acid bacteria alone” as claimed in claim 6, however, the disclosed method steps of fermenting phytase treated soy protein with the combined microorganisms Lactobacillus and Streptococcus spp. as disclosed by Yura et al. and Beckmann et al., to make yogurt (Yura et al. [0020]) is identical to the claimed method steps as claimed in independent claim 1, and therefore, the final product will have identical claimed property which is “wherein incubating the solution with phytase and fermenting the solution with lactic acid bacteria results in a reduction of [[the]] time to reach a pH below 5” as claimed in claim 6.
Regarding claim 7, it is also to be noted that the disclosed method steps of fermenting phytase treated soy protein to make yogurt (Yura [0020]) is identical to the claimed method steps as claimed in independent claim 1, and therefore, the final product will have identical claimed property which is the earlier completion of the fermentation in presence of phytase as can be interpreted from the claim limitation of “further comprising stopping said fermenting [[step]] by cooling at least 30 minutes earlier when compared to an otherwise identical method of claim 1 which does not comprise an incubation with phytase” as claimed in claim 7.
13. Regarding claim 11, examiner notes that claim 11 is also product-by-process claim.
Therefore, it is to be noted that, in this case, the courts have held that when the prior art factor appears to differ from the claimed factor only in the method of obtaining the factor, the burden of persuasion was on applicant to show that the claimed product exhibited unexpected properties compared with that of the prior art. The courts further noted that “no objective evidence has been provided establishing that no method was known to those skilled in this field whereby the claimed material might have been synthesized.” 10 USPQ2d at 1926.
The courts also held that “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). See MPEP §2113.
Lastly the courts have held that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). The examiner further notes that “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP §2113.
14. Claims 9, 10 are rejected under 35 U.S.C. 103(a) as being unpatentable over Beckmann et al. WO 2010/136320 A1 in view of Yura et al. (WO 2006/043478 A1) as applied to claim 1 and further in view of Yangisawa et al. (WO 2007/116772 A1).
15. Regarding claims 9, 10, Yura et al. is silent about “starch degrading enzyme”.
Yangisawa et al. discloses that soy protein can be treated with various enzymes e.g., phytase, amylase (i.e., starch degrading enzyme) in order to have an excellent physical property of this enzymes treated soy powder ([0008]) which is suitable to make food and drinks including yogurt ([0027]).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Beckmann et al. in view of Yura et al. with the teaching of Yangisawa et al. who discloses that soy protein can be treated with various enzymes e.g., phytase, amylase (i.e., starch degrading enzyme) in order to have an excellent physical property of this enzymes treated soy powder ([0008]) which is suitable to make food and drinks including yogurt ([0027]).
16. Claims 14, 21, 22 rejected under 35 U.S.C. 103(a) as being unpatentable over Beckmann et al. WO 2010/136320 A1 in view of Yura et al. (WO 2006/043478 A1) and further in view of Yangisawa et al. (WO 2007/116772 A1) as applied to claim 9 and further in view of Triantafyllou et al. US 2002/0081367 A1.
17. Regarding claims 14, 21, 22 , Beckmann et al. in view of Yura et al. are silent about amyloglucosidase for claims 14, 22 and alpha-amylase for claim 21.
Triantafyllou et al. discloses that plant protein e.g. oat milk can be treated for making various products including yogurt, ice-cream etc. ([0013]) by treating plant protein with alpha amylase, beta amylase ([0016]), and in combination with amyloglucosidase enzyme ([0049], [0050], [0052], [0062]) in order to have desired amount of end product glucose and fructose due to the conversion of intermediate product maltose into glucose and fructose by amyloglucosidase enzyme while maltose is produced by alpha and beta amylase enzymes from plant raw material e.g. oat suspension ([0075]).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Beckmann et al. in view of Yura et al. and Yangisawa et al. to include the teaching of Triantafyllou et al. to consider combined treatment with starch degrading enzymes including alpha amylase, beta amylase and amyloglucosidase ( at least in [0049], [0050], [0052], [0062] and [0075]) in order to have desired amount of end product glucose and fructose due to the conversion of intermediate product maltose into glucose and fructose by amyloglucosidase enzyme while maltose is produced by alpha and beta amylase enzymes from plant raw material e.g. oat suspension (at least in [0075]).
18. Claims 16, 18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Beckmann et al. WO 2010/136320 A1 in view of Yura et al. (WO 2006/043478 A1) as applied to claim 1 and further in view of Boufassa et al. US 2003/0031756 A1,
19. Regarding claims 16, 18, Beckmann et al. in view of Yura et al. are silent about almond flour as claimed in claim 16 and oat flour as claimed in claim 18.
Boufassa et al. discloses that the fermentation can be carried out using oat /soy mixture (Examples) and fermenting with Lactobacillus bulgaricus , Streptococcus thermophilus which provides the fresh and light taste ([0059] having a smooth and brilliant texture and a taste (at least in Ex 4) and also provides smooth and soft and pale yellow in color; it resembles a stirred yoghurt, it has an unctuous, very light mouthfeel and the fresh and light taste resembles contributed by oat when oats is mixed with soy ([0059]). Boufassa et al. also discloses that it can include almond (at least in Example 8, claim 1 of Boufassa et al.) which provides desired nutritional quality of almond with an almond flavor and slightly acidic almond taste ( at least in Example 7).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Beckmann et al. in view of Yura et al. by including the teaching of Boufassa et al. to perform the method with oats is mixed with soy ([0059]) and almond (at least in Example 8, claim 1 of Boufassa et al.) and fermenting with Lactobacillus bulgaricus , Streptococcus thermophilus which provides the fresh and light taste ([0059] having a smooth and brilliant texture and a taste resembling oat flakes (at least in Ex 4) which is contributed by oat and added almond (at least in Example 8, claim 1 of Boufassa et al.) contributes desired nutritional quality of almond with an almond flavor and slightly acidic almond taste ( at least in Example 7) contributes to make the fermented product.
20. Claim 17 is rejected under 35 U.S.C. 103(a) as being unpatentable over Beckmann et al. WO 2010/136320 A1 in view of Yura et al. (WO 2006/043478 A1) as applied to claim 1 and further in view of NPL Schindler et al. (in Food Biotechnology , Vol 26 (1): pgs 58-74, 2012).
21. Regarding claim 17, Beckmann et al. in view of Yura et al. are silent about pea protein.
NPL Schindler et al. discloses that Lactic acid fermentation of pea protein extract improves the aroma of pea protein extracts by reducing or masking off-flavors (at least under Conclusion, page 72) and it is appropriate to replace fermented dairy product with a plant pea protein containing fermented products e.g. yogurt because fermented pea protein has similar storage stability, high functionality comparable to whey protein ( page 63 Under Storage stability”, last paragraph).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Beckmann et al. in view of Yura et al. to include the teaching of NPL Schindler et al. to consider pea protein isolate for lactic acid fermentation because improves the aroma of pea protein extracts by reducing or masking off-flavors (at least under Conclusion, page 72) and it is appropriate to replace fermented dairy product with a plant pea protein containing fermented products e.g. yogurt because fermented pea protein has similar storage stability, high functionality comparable to whey protein ( page 63 Under Storage stability”, last paragraph).
Regarding new claim 17, it is also to be noted that new claim 17 recites “ wherein the plant protein comprises pea protein isolate, and the reduction of time to reach pH 4.6 is at least 35% when compared to an otherwise identical method which does not comprise an incubation with phytase”. It is to be noted that even if Yura and Beckmann do not mention specifically mention the above claim limitation of new claim 17, however, the disclosed method steps of fermenting phytase treated soy protein with the combined microorganisms Lactobacillus and Streptococcus spp. as disclosed by Yura et al. and Beckmann et al., to make yogurt (Yura et al. [0020]) is identical to the claimed method steps as claimed in dependent claim 17 and therefore, the final product will have identical claimed property including the abovementioned claimed property of new claim 17.
22. Claim 20 is rejected under 35 U.S.C. 103(a) as being unpatentable over Beckmann et al. WO 2010/136320 A1 in view of Yura et al. (WO 2006/043478 A1) as applied to claim 1 and further in view of Ljuk et al. (RU 2412600 C2).
23. Regarding claim 20, Beckmann et al. in view of Yura et al. are silent about the amount of starter culture.
Ljuk et al. discloses that Soy milk was inoculated with a starter culture from Streptococcus thermophilus + Lactobacillus delbrueckii ssp. Bulgarians + Bifidobacterium animalis ssp. Lactis (CNCM 1-2494, 2 .Math. 10 .sup.7 cfu / ml) (Example 5, above claims).
It is understood that the disclosed 2x 10 7 cfu/ml starter culture is very small weight with respect to the total fermentation medium. It is also to be noted that it is the cfu/ml which is the important factor . It is to be noted that it is within the skill of one of ordinary skill in the art to consider the disclosed cfu/ml of the bacteria in a suitable amount of medium to have desired weight including claimed 0.01-0.02% by weight to be considered for fermentation.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Beckmann et al. in view of Yura et al. to include the teaching of Ljuk et al. to consider lactic acid bacteria 2 x 10 .sup.7 cfu / ml) (Example 5, above claims) in a small amount of liquid medium which will contribute minimal weight containing starter culture to start the fermentation.
24. Claim 23 is rejected under 35 U.S.C. 103(a) as being unpatentable over Beckmann et al. WO 2010/136320 A1 in view of Yura et al. (WO 2006/043478 A1) as applied to claim 12 and further in view of Triantafyllou et al. US 2002/0081367 A1.
25. Regarding claim 23, Triantafyllou et al. discloses that plant protein e.g. oat milk can be treated for making various products including yogurt, ice-cream etc. ([0013]) by treating plant protein with alpha amylase, beta amylase ([0016]), and in combination with amyloglucosidase enzyme ([0049], [0050], [0052], [0062]) in order to have desired amount of end product glucose and fructose due to the conversion of intermediate product maltose into glucose and fructose by amyloglucosidase enzyme while maltose is produced by alpha and beta amylase enzymes from plant raw material e.g. oat suspension ([0075]).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Beckmann et al. in view of Yura et al. and Yangisawa et al. to include the teaching of Triantafyllou et al. to consider treatment with starch degrading enzymes comprising amyloglucosidase ( at least in [0049], [0050], [0052], [0062] and [0075]) in order to have desired amount of end product glucose and fructose due to the conversion of intermediate product maltose into glucose and fructose by amyloglucosidase enzyme while maltose is produced by alpha and beta amylase enzymes from plant raw material e.g. oat suspension (at least in [0075]).
Response to Arguments
26. Applicants’ arguments and amendments have been considered. Applicants’ arguments and amendments primarily based on the arguments made for amended claim limitation of claim 1 and claim 12.
Examiner maintained the prior combinations of prior arts of record which can be used to address the amended claims 1, 12. However, examiner has used new secondary prior arts for the new claims 14, 16-23.
Applicants’ arguments are discussed below.
27. Applicants argued on second page that “Beckmann et al. does not teach adding phytase” .
In response, the examiner agrees and notes that is why secondary prior art by Yura et al. is used. It is to be noted that Beckmann and Yura et al. are analogous because Yura has [0018] lactic acid bacteria fermentation, fermentation. time short [3-48 hours pH 5.0 [0021]) which matches with Beckmann. Detailed are discussed in the office action above.
28. Applicants argued on third page, last paragraph that “ Yura's broad 0.01-10% w/w addition is expressed relative to soymilk weight and is taught solely in the context of achieving a phytic acid content <1.5% by weight to improve flavor/texture and nutrition. Yura does not disclose activity-normalized dosing in FTU per gram of plant protein or the FTU assay definition recited in claim 1. In contrast, instant claim 1 requires dosing based on plant protein content at ≥20 FTU per gram of plant protein. The instant claims define FTU under specific assay conditions: excess sodium phytate, pH 5.5, 37°C. Yura does not specify enzyme activity in FTU or under the same assay. Yura does not teach adjusting wt.% by protein content to achieve an activity- normalized target, and does not teach phytase addition to increase acidification speed. Rather, Yura discloses broad fermentation durations (i.e., 3-48 h) 10 without any comparative speed reduction against a no-phytase control”.
In response, phytase is disclosed by Yura et al. to remove phytic acid. As the disclosed phytase and claimed phytase have identical it will therefore have identical function, including the claimed function. Therefore, the presence of phytase is sufficient to reduce the time to reach desired claimed pH compared to absence of phytase. It is to be noted that claimed phytase 20 FTU per gram of plant protein merely represents the definition with respect to unit of the enzyme. This determines strength of the enzyme based on the unit of enzyme present in the added amount of the enzyme in the composition to remove phytate. This is applicable for ‘time reduction’ to achieve claimed “less than pH 5.0’ because phytase enzyme is identical as discussed above. If the unit is more, less time needed to reduce specific amount of phytate, therefore, more time reduction compared to without phytate treated group in order to reach a claimed pH of less than 5 as claimed at least in independent claim 1. These parameters are broadly claimed in claim 1. Therefore, the dosing is optimizable. One of ordinary skill in the art may consider 20 FTY phytase per gm plant protein in order to achieve a certain pH by continuing the fermentation until a certain time.
It is not an issue that Yura et al. does not teach or suggest the claimed FTU- based dosing regimen or the comparative speed performance requirement. The reason is it is optimizable. The reduction of time depends on unit of enzyme and type of plant protein is to be used as is also evidenced by applicants’ specification and discussed below.
Applicants may consider to establish criticality of the claimed invention with respect to the specific amount of unit of enzyme (FTU) for specified value and reduction of time. At this time, unexpected result has not been found persuasive. The unexpected result as presented in remarks on page 11 is unpersuasive and discussed below.
29. Applicants also argued on fourth page first paragraph that “With regard to instant claim 12, Yura also teaches inactivation/removal of enzyme, and thus does not disclose a finished yogurt comprising active phytase in an amount "at least 20 FTU per gram of plant protein" as claimed”.
In response, Yura also teaches the action of phytase generates free phosphate (Abstract). Claim 12 is broad. Claim 12 recites open ended “comprising” transitional phrase. Therefore, it can include further steps. Also, the phrase “excess of sodium phytate” can be interpreted as no or minimal phytate is present after phytase action. This is taught by Yura et al. Yura et al. teaches that the enzyme having phytic acid degrading activity is added in an amount of 0.01 to 10% by weight of the soymilk weight (at least in [0016]) in order to have phytic acid content less than 1.5% by weight ([0007] #1). Therefore, one of ordinary skill in the art can optimize the amount of enzyme (including FTU unit) necessary to eliminate all phytate which reads on “excess of sodium phytate” in the composition. It is known that the phytase action generates inorganic phosphorous.
30. Applicants argued on fourth page, fourth paragraph that “ Thus, the combination of Beckmann and Yura lacks a teaching or motivation to add phytase for the purpose of accelerating fermentation in plant protein yogurt prepared from plant protein isolates, and does not disclose the claimed comparative reduction in time to reach a pH below 5 (or in the range of 4.4-4.8, as in claim 6)”.
In response, this is discussed above. In brief, the disclosed phytase is identical to claimed phytase and will have identical claimed property including the property of the claimed comparative reduction in time to reach a pH below 5 (or in the range of 4.4-4.8, as in claim 6)”.
31. Applicants also argued on sixth page, second paragraph that “ The specific comparative limitation in claim 1-that incubating with phytase and fermenting results in "at least 10%" reduction in time to reach a pH below 5 (between 4.4- 4.8 in dependent claim 6)-cannot be dismissed as "optimization of result-effective variables." The references do not recognize phytase as a variable affecting acidification speed, nor do they teach comparative performance targets. Absent a teaching that phytase accelerates acidification, one cannot assert inherency or routine optimization to reach the claimed comparative outcome”.
In response, the response remains the same. It is to be noted that and as discussed in the office action above that Yura et al. discloses that the enzyme having phytic acid degrading activity is added in an amount of 0.01 to 10% by weight of the soymilk weight (at least in [0016]) in order to have phytic acid content less than 1.5% by weight ([0007] #1).
One of ordinary skill in the art can correlate the amount of the enzyme with the “at least 20 FTU within the disclosed “0.01 to 10% by weight enzyme” by evaluating the strength in relation to inorganic phosphorous generation as claimed in claim 1.
Therefore, one of ordinary skill in the art can optimize the percent by weight of enzyme which will correlate with 20 FTU or more unit of enzyme in order to achieve desired degree of reduction of time to reach desired pH of the claimed invention as claimed in claims 1,15. Therefore, it is art recognized result effective variable and is therefore optimizable.
It is to be noted that even if Yura et al. does not specifically recognize claimed ‘20 FTU or more as a variable affecting acidification speed’, however, the adjustment of phytase enzyme from disclosed range amounts of 0.01 to 10% phytase enzyme, which correlates “at least 20 FTU or more, can also affect any property including that disclosed above, which would also effect the claimed 20 or more FTU.
32. Unexpected Result:
Applicants argued on sixth page where applicants
presented results from Example 1 with respect to reduction of time and its relation to the phytase enzyme unit used and the values for different proteins like soy, almond and pea protein.
In response, applicants’ arguments related to unexpected result have been
considered.
However, the arguments are insufficient to overcome the rejections of record because:
(A) Applicants have not compared the claimed invention to the teachings of the closest prior art reference. In this instance, Yura et al. discloses fermentation of soy protein source ([0019]) using lactic acid bacteria (at least in Example 1, of Yura et al., and claim 1 of Yura et al.) and phytase enzyme is used to make the final product is free of phytic acid. Yura et al. is the closest prior art.
(B) Evidence of unexpected results must be commensurate in scope with the subject matter claimed. In re Linder 173 USPQ 356. More importantly, the evidence of unexpected results must be clear and convincing. In re Lohr 137 USPQ 548. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside (i.e. as well as the upper and lower limits) the claimed range to show the criticality of the claimed range. In re Hill 284 F.2d 955, 128 USPQ 197 (CCPA 1960). See MPEP 716.02.
In this instance, if we consider Example 1 and Table 1 from specification as argued by the applicants (in Remarks, Sixth page), it is to be noted that
(a) First, Table 1 does provide data on time reduction to reach pH 4.6 for the soy isolate and almond flour at 6 FTU and 20 FTU. Table 1 shows that both the 6 FTU/g plant protein and 20 FTU/gm plant protein for soy isolate and almond flour which is ‘more than 10% time reduction” compared to ‘no enzyme group’ for soy isolate and almond flour. However, it does not establish criticality by showing that “at least 20 FTU/gm plant protein” is critical. The reason is 6 FTU/g plant protein group which is less than 20 FTU /gm plant protein has similar trend of more than 10% time reduction” compared to ‘no enzyme group’ for soy isolate and almond flour. Therefore, criticality of claimed ‘at least 20 FTU /gm DW’ has not been established (Table 1).
(b) Second, at least independent claim 1 broadly claims “plant protein”. Applicant’s does not provide any data on time reduction for the pea protein and Oat flour (10% and 15%) at 20 FTU/g plant protein in order to establish criticality. Also the point below 20 FTU/gm plant protein is missing for oat flour (10% and 15%) group.
Therefore, the data presented in example 1 and Table 1 does not establish criticality and is not commensurate with the scope of the at least for independent claims 1, 12.
The rejection is maintained and made final.
Conclusion
33. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning the communication or earlier communications from the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful, examiner’s supervisor Erik Kashnikow, can be reached on 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571 -272-1000.
/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
Prosecution Insights