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 .
This office action was written in response to the Applicants Remarks filed 3/6/26. Claims 1, 3, 7, 10-12, 14-17, 19, 23, 27-29 are pending and have been examined on the merits. Claims 2, 4-6, 8, 9, 13, 18, 20-22, 24-26, 30-40 have been cancelled.
Withdrawn Rejections
The 112(b) rejection of claim 4 has been withdrawn due to the cancellation of the claim .
The 102(a)(a) rejections of claims 1-3, 16-19 over Osaka et al. (US 3,937,843) have been withdrawn due to the amendments to the claims.
The 103(a) rejections of claims 4-6, 20, 21, and 26-28 over Osaka et al. (US 3,937,843) in view of Tategaki et al.(US 2019/0045819) as evidenced by GJERMANSEN (WO 2016/075078) have been withdrawn due to the amendments to claim 1.
The 103(a) rejections of claims 7, 10, 11, 12, 14-16, and 23 over Osaka et al. (US 3,937,843) in view of Tategaki et al.(US 2019/0045819) as evidenced by GJERMANSEN (WO 2016/075078) and Eisele et al. (US 2018/0042253) have been withdrawn due to the amendments to claim 1.
The 103(a) rejection of claim 29 over Osaka et al. (US 3,937,843) as applied to claim 3 above, and further in view of Tategaki et al.(US 2019/0045819) as evidenced by GJERMANSEN (WO 2016/2016075078) and Schmidt et al. (US 2020/0060310) has been withdrawn due to the amendment to claim 17.
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 1, 3, 7, 10-12, 14-17, 19-21, 23, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Osaka et al. (US 3,937,843) as applied to claim 3 above, and further in view of Tategaki et al.(US 2019/0045819) as evidenced by GJERMANSEN (WO 2016/2016075078) and Eisele et al. (US 2018/0042253).
Regarding Claims 1, and 23: Osaka discloses a method of preparing a fermented plant based product [abstract]. Osaka discloses a liquid plant based substrate containing protein and also discloses liquid plant substrates with a protein content of 9% [col. 2, lines 32-39; col. 4, lines 47-56; Ex. 4]. Osaka discloses treating the plant based substrate with a protease and with a microorganism to produce a fermented plant based product [abstract; col. 4, lines 31-42]. Osaka discloses a pH of fermented milk of no more than 4 [col. 5, lines 9-19]. Osaka discloses a pH below about 6.0 [pg. 3, lines 19-25].
Osaka does not disclose wherein said protease is an M4 metalloprotease having the amino acid sequence of SEQ ID NO:1 or a variant having at least 95% sequence identity thereto, the metalloprotease exhibiting at least a 10-fold reduction in protease activity at pH 4.6-4.8 compared to pH 6.6. and added in an amount of 0.5-5 ppm based on total protein and a microorganism; wherein said protease wherein said protease has at least 96, 97, 98, 99 or 100% sequence identity to SEQ ID NO:1.(claim 23).
Tategaki discloses a fermented food products by applying protease and lactic acid bacteria [abstract; 0081; 0082]. Tategaki discloses that the protease is a metalloprotease [abstract; 0055]. Tategaki discloses endo-metalloproteases [0056; 0057; 0060-0062]. Tategaki discloses applying the method to dairy and vegetable substrates/starting materials [0025; 0082]. Gjermansen teaches metalloproteases and that M4 family metalloproteases contain mainly endo metalloprotease [pg. 8, lines 5-26]. It is known in the art that endo-metalloproteases have an enzyme classification of 3.4.24.
Eisele discloses a fermented milk product [abstract]. Eisele discloses storage stable neutral metalloproteases [0013]. Eisele discloses proteases from the M4 family [0014]. Eisele discloses that the protease is a metalloprotease [0015]. Eisele discloses metalloprotease with Seq ID 3 that’s corresponds 100% with the instant Seq Id 1 [0016; Seq ID 3]. Eisele discloses solving solubility problems with high protein products where the protein content is 10% or higher [0007; 0011; 0123]. Eisele discloses a pH of 4.6 to 4.8 as a level that reduces or inactivates low pH sensitive peptidase [0093]. Eisele discloses that the activity level of the metalloprotease is at least 10 times lower at a pH of 4.5-4.8 compared to a pH of 6.5-6.7 [0157; 0158]. Eisele discloses including a peptidase enzyme at 1 -10,000 ppb (0.001 ppm-10 ppm) [0239].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Osaka to include the metalloprotease of Tategaki since it is applicable to dairy and non-dairy proteins and is useable in conjunction with fermentation processes.
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to further modify the protease of Osaka for the Seq Id 3 metalloprotease of Eisele since Eisele discloses that the metalloprotease is able to treat a high protein substrate and favorably produce a high protein product.
Although Eisele does not explicitly disclose 0.5 ppm to 5 ppm one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Eisele overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
Regarding the recitation of “wherein fermentation proceeds to a pH of 4.6-4.8, thereby inactivating at least 90% of the metalloprotease activity, and wherein metalloprotease addition at ≥10 ppm results in a viscosity lower than that obtained at 0.5-5 ppm”, allowing the treated substrate to ferment to produce the fermented plant-based product, wherein fermentation proceeds to a pH of 4.6-4.8, thereby inactivating at least 90% of the metalloprotease activity, and wherein metalloprotease addition at ≥10 ppm results in a viscosity lower than that obtained at 0.5-5 ppm, “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding Claim 3: Osaka discloses as discussed above in claim 1. Osaka discloses using a soybean as the plant material [abstract]. Osaka discloses a method of preparing a fermented plant based product [abstract]. Osaka discloses a liquid plant based substrate containing protein and also discloses liquid plant substrates with a protein content of 9% [col. 2, lines 32-39; col. 4, lines 47-56; Ex. 4]. Osaka discloses treating the plant based substrate with a protease and with a microorganism to produce a fermented plant based product [abstract; col. 4, lines 31-42].
Regarding Claim 7: Osaka discloses as discussed above in claim 3. Osaka does not disclose wherein said protease wherein said protease has at least 96, 97, 98, 99 or 100% sequence identity to SEQ ID NO:1.
Eisele discloses a method of making a fermented milk product [abstract]. Eisele discloses storage stable neutral metalloproteases [0013]. Eisele discloses proteases from the M4 family [0014]. Eisele discloses that the protease is a metalloprotease [0015]. Eisele discloses metalloprotease with Seq ID 3 that’s corresponds 100% with the instant Seq Id 1 [0016; Seq ID 3]. Eisele discloses solving solubility problems with high protein products where the protein content is 10% or higher [0007; 0011; 0123].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to further modify the protease of Osaka for the Seq Id 3 metalloprotease of Eisele since Eisele discloses that the metalloprotease is able to treat a high protein substrate and favorably produce a high protein product.
Regarding Claim 10: Osaka discloses as discussed above in claim 7. Osaka discloses treating with the protease before the microorganism [col. 4, lines 23-25].
Regarding Claim 11: Osaka discloses as discussed above in claim 7. Osaka discloses treating with the protease simultaneously with the microorganism [col. 4, lines 23-25].
Regarding Claim 12: Osaka discloses as discussed above in claim 7. Osaka does not explicitly disclose treating with a protease after microorganism treatment.
Tategaki discloses treating a protein substrate with the metalloprotease before or after treating with the microorganism [0016; 0042-0044; 0052; 0054].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the method of Osaka to apply the enzyme treatment after the fermentation step as in Tategaki since any order would be effective for producing the desired end results and since the order of including the ingredients would have been prima facie obvious. Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F. 2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in absence of new or unexpected results); In re Gibson, 39 F. 2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.
Regarding Claim 14: Osaka discloses as discussed above in claim 12. Osaka discloses that the microorganisms are lactic acid bacterium [col. 2, lines 57-59].
Regarding Claim 15: Osaka discloses as discussed above in claim 12. Osaka discloses that the microorganisms are Lactobacilli, Streptococci, Leuconostoc, [col. 2, lines 57-68].
Regarding Claim 16: Osaka as modified discloses a fermented plant based product as discussed in claim 15 [abstract].
Further regarding the process steps of the claim, since there is no evidence that the recited process produces a product that is materially different from what is disclosed in the prior art, claim 16 has been considered regarding its disclosure of fermented plant based product.
“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 art was made by a different process.” In re Thorpe, 777 F.2d 695, 698.
Regarding Claim 17: Osaka discloses a fermented plant based product [abstract]. Osaka discloses a liquid plant based substrate containing protein and also discloses liquid plant substrates with a protein content of 9% [col. 2, lines 32-39; col. 4, lines 47-56; Ex. 4]. Osaka discloses treating the plant based substrate with a protease and with a microorganism to produce a fermented plant based product [abstract; col. 4, lines 31-42].
Osaka does not disclose comprising an M4 metalloprotease having the amino acid sequence of SEQ ID NO:1 or a variant having at least 95% sequence identity thereto, wherein the residual metalloprotease activity is less than 10% of its activity at pH 6.6 due to fermentation to pH 4.6-4.8, and an exogenous microorganism.
Tategaki discloses a method of making a fermented food products by applying protease and lactic acid bacteria [abstract; 0081; 0082]. Tategaki discloses that the protease is a metalloprotease [abstract; 0055]. Tategaki discloses endo-metalloproteases [0056; 0057; 0060-0062]. Tategaki discloses applying the method to dairy and vegetable substrates/starting materials [0025; 0082]. Gjermansen teaches metalloproteases and that M4 family metalloproteases contain mainly endo metalloprotease [pg. 8, lines 5-26]. It is known in the art that endo-metalloproteases have an enzyme classification of 3.4.24.
Eisele discloses a method of making a fermented milk product [abstract]. Eisele discloses storage stable neutral metalloproteases [0013]. Eisele discloses proteases from the M4 family [0014]. Eisele discloses that the protease is a metalloprotease [0015]. Eisele discloses metalloprotease with Seq ID 3 that’s corresponds 100% with the instant Seq Id 1 [0016; Seq ID 3]. Eisele discloses solving solubility problems with high protein products where the protein content is 10% or higher [0007; 0011; 0123]. Eisele discloses a pH of 4.6 to 4.8 as a level that reduces or inactivates low pH sensitive peptidase [0093]. Eisele discloses that the activity level of the metalloprotease is at least 10 times lower at a pH of 4.5-4.8 compared to a pH of 6.5-6.7 [0157; 0158]. Eisele discloses including a peptidase enzyme at 1 -10,000 ppb (0.001 ppm-10 ppm) [0239].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Osaka to include the metalloprotease of Tategaki since it is applicable to dairy and non-dairy proteins and is useable in conjunction with fermentation processes.
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to further modify the protease of Osaka for the Seq Id 3 metalloprotease of Eisele since Eisele discloses that the metalloprotease is able to treat a high protein substrate and favorably produce a high protein product.
Although Eisele does not disclose a residual metalloprotease activity is less than 10% of its activity at pH 6.6 due to fermentation to pH 4.6-4.8, Eisele does disclose that the activity is more than 10x lower at a pH of 4.6-4.8 versus 6.6, one having ordinary skill in the art at the effective filing date of the invention would have considered the invention to have been obvious because the range taught by Eisele overlaps the instantly claimed range and therefore is considered to establish a prima facie case of obviousness. In re Malagari 182 USPQ 549,553.
Regarding Claim 19: Osaka discloses as discussed above in claim 17. Osaka discloses using a soybean as the plant material [abstract].
Regarding Claim 27: Osaka discloses as discussed above in claim 17. Osaka discloses that the microorganisms are lactic acid bacterium [col. 2, lines 57-59].
Regarding Claim 28: Osaka discloses as discussed above in claim 17. Osaka discloses that the microorganisms are Lactobacilli, Streptococci, Leuconostoc, [col. 2, lines 57-68].
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Osaka et al. (US 3,937,843) as applied to claim 3 above, and further in view of Tategaki et al.(US 2019/0045819) as evidenced by GJERMANSEN (WO 2016/2016075078) and Eisele et al. (US 2018/0042253) as applied to claim 28 above and in further view of Schmidt et al. (US 2020/0060310).
Regarding Claim 29: Osaka as modified discloses as discussed above in claim 28. Osaka as discussed above discloses fermented products and also discloses cheese and coagulated fermented products [col. 3, lines 19-30; Ex. 3; Ex. 7]. Osaka does not explicitly disclose wherein the fermented product is high protein yogurt, Greek yogurt, labneh or sour cream.
Schmidt discloses plant based fermented products [abstract; 0072]. Schmidt discloses analog yogurt and analog sour cream [0072]. Schmidt discloses vegan Greek yogurt [0301].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the products of Osaka to include the Greek yogurt, yogurt and sour cream of Schmidt since Osaka discloses coagulated soy milk products and the level of protein could have been modified by conventional means to reach the level of Greek yogurt or high protein.
Response to Arguments
The 112(b) rejection of claim 4 has been withdrawn due to the cancellation of the claim .
The 102(a)(a) rejections of claims 1-3, 16-19 have been withdrawn due to the amendments to the claims.
The 103(a) rejections of claims 4-6, 20, 21, and 26-28 have been withdrawn due to the amendments to claim 1.
The 103(a) rejections of claims 7, 10, 11, 12, 14-16, and 23 over Osaka et al. (US 3,937,843) in view of Tategaki et al.(US 2019/0045819) as evidenced by GJERMANSEN (WO 2016/075078) and Eisele et al. (US 2018/0042253) have been withdrawn due to the amendments to claim 1.
The 103(a) rejection of claim 29 Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Osaka et al. (US 3,937,843) as applied to claim 3 above, and further in view of Tategaki et al.(US 2019/0045819) as evidenced by GJERMANSEN (WO 2016/2016075078) and Schmidt et al. (US 2020/0060310) has been withdrawn due to the amendment to claim 17.
The Examiner maintains that although Eisele does not disclose plant proteins, the Examiner maintains that Tategaki discloses using metalloproteases for the hydrolyzation of dairy and plant proteins. Therefore, although Eisele, which discloses the specifically claimed protease, does not disclose plant proteins, Tategaki discloses and gives motivation as to why would use metalloprotease with plant proteins.
Conclusion
11. 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.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FELICIA C TURNER whose telephone number is (571)270-3733. The examiner can normally be reached Mon-Thu 8:00-4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Felicia C Turner/Primary Examiner, Art Unit 1793
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