DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 15-17, 22-23) in the reply filed on 6/26/26 is acknowledged.
Claims 18-21, 24-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/26/26.
Specification
The disclosure is objected to because of the following informalities:
In page 8, line 24 “known to to be used” should read “known to be used”.
In page 23, line 23 “simulateously” should read “simultaneously”.
In page 24, line 11 “Commision” should read “Commission”.
In page 33, line 29 “sodiumdodecyl-” should read “sodium dodecyl-”.
In page 33, line 30 “o-phtalaldehyde” should read “o-phthalaldehyde”.
In page 33, line 32 “substracted” should read “subtracted”.
In page 37, line 16 “denaturated” should read “denatured”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 15-16, 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knippels et al. [US20180110811A1], hereinafter Knippels, in view of Knippels et al. [US20150246090A1], hereinafter Knippels 090’ and Nutten et al. [Peptide size profile and residual immunogenic milk protein or peptide content in extensively hydrolyzed infant formulas, (2019)], hereinafter Nutten.
Regarding claim 1, Knippels teaches whey protein hydrolysate composition having the following characteristics:
comprising peptides with a molecular weight of 2500 Da (5kDa=5,000 Da at most, or 2.4-4kDa=2,400-4,000 Da) or above [Knippels, 0027] in an amount of 7.5% by weight of the total protein content or less (since the composition may comprise extensively hydrolysed protein, which relates to protein that has been hydrolysed and has less than 3% of peptides with a molecular weight of above 5,000 Da), (which reads on the claimed peptides with molecular weight of 2500 Da or above) in amounts of less than 3% wt of said peptides having a molecular weight of 5,000 Da or above, and/or wherein these extensive protein hydrolysates comprise almost no peptides with a size over 1,500 Da (which reads on the claimed 7.5% by weight of the total protein content or less of said peptides with molecular weight of 2500 Da or above) [Knippels, 0032].
an allergenicity corresponding to a concentration of beta-lactoglobulin (BLG) being less than 500 mg BLG/kg protein (since the composition comprises 10 µg BLG/g (10 mg BLG/kg) protein, or 50-250 µg BLG/g (50-250 mg BLG/kg) protein of the beta-lactoglobulin-derived peptide per gram of total protein) [Knippels, 0037];
comprising essentially no intact protein [Knippels, 0034], (extensively hydrolysed protein relates to protein which has been hydrolysed and has less than 3 wt % of peptides with a size above 5 kDa [Knippels, 0032]).
If it could have been construed that Knippels was not clear regarding the amount of peptides having a molecular weight of 2500 Da or above in an amount of 7.5% by weight of the total protein content or less, then it is noted that;
Knippels 090’ teaches whey protein hydrolysate [Knippels 090’, 0044] compositions for infant nutrition [Knippels 090’, abstract] comprising partially and extensively hydrolyzed protein, thus having allergy-preventing effect [Knippels 090’, 0027, 0042], wherein the desired peptide size distribution and peptide molecular weight distribution of the partial protein hydrolyzate can be obtained/determined by methods known to person of ordinary skill in the art [Knippels 090’, 0050, 0054].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include whey protein hydrolysate composition having peptides with a molecular weight of 5,000 Da or above in amounts of less than 3% by weight (i.e., lower amounts of high molecular weight peptides) of the total protein or less, and/or wherein the protein hydrolysates comprise almost no peptides with a size over 1,500 Da as already taught by Knippels, and/or selecting the desired peptide size distribution and peptide molecular weight distribution of the protein hydrolyzate as taught by Knippels 090’, into the protein hydrolyzate of Knippels, because Knippels 090’ teaches that peptide size and molecular weight distribution determination techniques are known to be common and routine methods used by ordinarily skilled artisans [Knippels 090’, 0054].
Knippels teaches the whey protein hydrolysate composition with an allergenicity corresponding to a concentration of beta-lactoglobulin (BLG) being less than 500 mg BLG/kg protein as discussed above, but does not explicitly teach this is measured in an RBL cell assay as required by element ii).
Nutten, directed to peptide size profile and residual immunogenic milk protein or peptide content in extensively hydrolyzed infant formulas [Nutten, p. 1446, Title], teaches performing peptide size distribution, and quantification of immunogenic peptides or protein (IPP) derived from bovine beta-lactoglobulin (BLG) (equivalent to a concentration of beta-lactoglobulin (BLG)) as measured in an RBL cell assay [Nutten, p.1446, left col., par.2; p.1446, right col., par.3], and further teaches a hydrolyzed protein sample Nutrilon® Pepti 1 having peptides with molecular weight below 2,400 Da in an amount of 98% and a concentration of beta-lactoglobulin (BLG) being less than 500 mg BLG/kg (425 µg BLG/g=425 mg BLG/kg) protein as measured in an RBL cell assay [Nutten, p.1447; Table 1].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have determined an allergenicity corresponding to a concentration of beta-lactoglobulin (BLG) as measured in an RBL cell assay as taught by Nutten, in the protein hydrolyzate of Knippels, because Nutten teaches that this particular RBL cell assay is suitable for quantification of immunogenic peptides [Nutten, p.1446, left col., par.2; p.1446, right col., par.3].
Knippels teaches the whey protein hydrolysate composition may comprise partially and extensively hydrolysed protein where extensively hydrolysed protein relates to proteins that have been hydrolyzed to achieve peptides with a molecular mass of 5,000 Da and above, wherein these peptides are in the whey protein hydrolysate composition in amounts of less than 3wt%, and further teaches that the whey protein hydrolysate composition may comprise almost no peptides with a molecular mass over 1,500 Da [Knippels, 0032], (which implicitly teach a high level of hydrolysis, i.e., lower molecular size peptides indicates high degree of hydrolysis and higher molecular size peptides indicates lower degree of hydrolysis), but does not explicitly teach the degree of hydrolysis is at least 17%.
Knippels 090’ teaches the whey protein hydrolysate composition [Knippels 090’, 0044] discussed above, and further teaches that the whey protein hydrolysate composition contains a protein hydrolysate with a degree of hydrolysis of 5 to 25%, and/or of 7.5 to 21% [Knippels 090’, 0052].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide whey protein hydrolysate compositions with a degree of hydrolysis of 5 to 25%, and/or of 7.5 to 21% as taught by Knippels 090’, in the whey protein hydrolysate composition of Knippels, because both Knippels and Knippels 090’ teach using partially and extensively hydrolyzed proteins [Knippels, 0032; Knippels 090’, 0042], which would provide a whey protein hydrolysate composition with an improved oral tolerance, in particular providing an improved primary allergy-preventing effect, against dietary proteins in humans, in particular humans at risk for developing a food allergy [Knippels 090’, 0013].
Knippels does not explicitly teaches:
an immunogenicity based on the serum IgG titre of immunised animals that is essentially the same as for non-hydrolysed whey protein.
Nutten, who teaches peptide size distribution analysis performed on commercially available whey protein characterized as an extensively hydrolyzed whey formula (EHF-W) [Nutten, p.1446, left col., par.1-2], wherein said extensively hydrolyzed whey formula comprise peptides with molecular weights larger than 1,200 Da, which are peptides having immunogenicity (Immunogenic Peptides or Proteins-IPP) [Nutten, p.1446, left col., par.2] as similarly shown by the whey protein hydrolysate of the instant invention (WPHinvention) in page 35, lines 24-34, page 36, lines 1-29, and page 37, lines 1-2. Therefore, there is reasonable basis to conclude that the whey protein hydrolysate composition of modified Knippels satisfy element iii) of having an immunogenicity based on the serum IgG titre of immunised animals that is essentially the same as for non-hydrolysed whey protein. Since the PTO cannot conduct experiments the proof of burden is shifted to the applicants to establish an unobviousness difference, see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide whey protein hydrolysate compositions having an immunogenicity based on the serum IgG titre of immunised animals that is essentially the same as for non-hydrolysed whey protein because modified Knippels already teaches a whey protein hydrolysate composition having the claimed characteristics recited in elements i), ii), and iv), which would provide a product for use in inducing oral tolerance, and/or treatment, prevention or reducing the risk of allergy in a subject, in particular cow's milk protein allergy [Knippels, abstract].
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding claim 15, see claim 1 rejection above where Knippels teaches the whey protein hydrolysate composition with peptides having a molecular mass of 5,000 Da and above, in amounts of less than 3wt% and/or almost no peptides with a molecular mass over 1,500 Da [Knippels, 0032], (which implicitly teach a high level of hydrolysis), and Knippels in view of Knippels 090’ teaches whey protein hydrolysate compositions comprising a protein hydrolysate with a degree of hydrolysis of 5 to 25% [Knippels 090’, 0052], which is a range that falls within the claimed range of 17-30%.
Regarding claim 16, see claim 1 rejection above where Knippels teaches the whey protein hydrolysate composition comprising an allergenicity corresponding to a concentration of beta-lactoglobulin (BLG) being less than 500 mg BLG/kg protein (since the composition comprises 10 µg BLG/g (10 mg BLG/kg) protein, or 50-250 µg BLG/g (50-250 mg BLG/kg) protein of the beta-lactoglobulin-derived peptide per gram of total protein), and Knippels in view of Nutten teaches quantification of immunogenic peptides or protein (IPP) derived from bovine beta-lactoglobulin (BLG) (equivalent to a concentration of beta-lactoglobulin (BLG)) measured using an ELISA assay [Nutten, p.1446, left col., par.2; p.1446], and further teaches a hydrolyzed protein sample Nutrilon® Pepti 1 having a concentration of beta-lactoglobulin (BLG) being less than 500 mg BLG/kg (425 µg BLG/g=425 mg BLG/kg) protein [Nutten, p.1447; Table 1].
Regarding claims 22-23, Knippels teaches a food product comprising the whey protein hydrolysate (infant formula (infant nutritional product) or follow-on formula, medical food, and enteral composition) according to claim 1 [Knippels, 0019, 0057].
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knippels [US20180110811A1], in view of Knippels 090’ [US20150246090A1] as applied to claim 1 above, and further in view of Paulsen et al. [US20040156969A1], hereinafter Paulsen.
Regarding claim 17, Knippels teaches the whey protein hydrolysate according to claim 1, but does not teach the whey protein hydrolysate comprises an amount of ash in the range of 6.0% by weight or less of the solid content.
Paulsen teaches whey protein hydrolysate compositions [Paulsen, abstract], comprising an amount of ash in the range of 6.0% by weight [Paulsen, 0045, Example 1], or less (4.5% by weight) of the solid content (since the final protein composition is in powder form [Paulsen, 0041], as well as the starting protein material (Provon® 190) [Paulsen, 0030]) [Paulsen, 0069, Example 8, Table 11].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide whey protein hydrolysate compositions having an ash amount of 6% by weight or less of the solid content as taught by Paulsen, in the whey protein hydrolysate composition of Knippels, because Paulsen teaches that this would allow for the preparation of a variety of whey protein hydrolysate compositions useful for different applications (i.e., mixtures of both hydrolyzed and unhydrolyzed whey proteins [Paulsen, 0068], in the form of powders to be incorporated into solid and liquid food compositions as a source of whey proteins [Paulsen, 0041]) such as protein bars [Paulsen, 0063] and protein beverages [Paulsen, 0053] amongst others which would have different ingredient/nutrition profiles.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUIS EUGENIO DIOU BERDECIA whose telephone number is (571)270-0963. The examiner can normally be reached Monday-Friday 7:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUIS EUGENIO DIOU BERDECIA/Examiner, Art Unit 1792
/ERIK KASHNIKOW/ Supervisory Patent Examiner, Art Unit 1792
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