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
Claims 50-60 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/04/2025.
Applicant’s election without traverse of Group I, claims 41-49 in the reply filed on 12/04/2025 is acknowledged.
Claim Objections
Claims 47 and 49 are objected to because of the following informalities: It is suggested to add “by weight” before “peptides” in line 3. The same change is suggested for claim 49. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 42 and 47 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.
Claims 42 and 47 include the limitation “from about 20% to about 79% of peptides”. Claims 42 and 47 depend from claim 41 which states “less than about 79% by weight of peptides”. The phrase “about 79%” encompasses amounts above and below 79%. The phrase “less than about 79%” has an upper limit that is necessarily below the scope of “about 79%”, thus, the upper limits of claims 42 and 47 go beyond the upper limit of claim 41. Here, the dependent claims have a scope that goes beyond the scope of the claim from which they depend, meaning claims 42 and 47 fail to include all the limitations of the claim upon which they depend.
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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 41 and 48 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over EP 0467482 (Klarenbeek) (cited on IDS filed 07/23/2024).
Klarenbeek discloses a milk protein isolate (MPI) with low calcium content of below 0.4wt% (page 2, lines 40-42; page 3, lines 33-35). The protein content may be more than 90% (page 3, lines 38-39; page 4, lines 3-4) and the composition is subjected to hydrolysis up to a degree of 3.3% (0.7-3.3%). This degree of hydrolysis indicates a high degree of breakage of the proteins into smaller peptides in a manner similar to that illustrated in the instant specification (0.1-1.4%). Thus, it is reasonably expected that the MPI of Klarenbeek comprises less than 79 wt% of peptides having an MW of greater than about 20kDa.
Regarding claim 48, Klarenbeek discloses the MPI in the form of a powder (table on page 4, Example 1).
Claim(s) 41 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over ES 2804249 (Havea) in view of JP H10248495 (Tomita) (cited on IDS filed 07/23/2024).
Havea discloses a whey-protein concentrate (milk protein concentrate) where the calcium may be adjusted including depletion by ion exchange thus obviating the removal of calcium. Havea discloses that in some embodiments, dry modified WPC or WPI has 50-95% of total solids as whey protein, more preferably 52-90%; thus, the limitation of comprising at least about 40wt% total protein to dry matter is met. Havea also discloses that in general, it is desirable that less than 1% of the peptide has a molecular weight> 20 kDa, thus the limitation of less than about 79wt% of peptides having an MW of greater than 20kDa is met.
Havea discloses removal of Ca via ion exchange but does not expressly disclose less than 2g or less than 1.4 g per 100 g total protein. Tomita discloses a milk concentrate subjected to ion exchange to provide a calcium content of less than 700mg/100g protein which falls within the claimed range of less than 2g or less than 1.4 g/100g protein. Tomita discloses that reducing calcium content removes the inhibition of enzymatic decomposition and prevents precipitation of the protein hydrolysate during heating. The hydrolysate is subsequently formed into a powder (Example 1). It would have been obvious to one of ordinary skill in the art to remove the calcium from the whey protein as taught by Havea to the degree disclosed by Tomita as Tomita indicates that this is the optimal amount of removal to remove inhibition of hydrolysis via enzymes and prevent precipitation of the protein hydrolysates during heating.
Claim(s) 41-49 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0179609 (Henle) and EP 1973429 (Blanton) (both cited on IDS filed 07/23/2024) in view of JP H10248495 (Tomita) (cited on IDS filed 07/23/2024).
Regarding claims 41 and 49, Henle discloses enzymatic hydrolysis of whey protein isolate comprising powder which contains the whey protein hydrolysate according to the invention preferably in a quantity of 50% by weight up to 98% by weight [0057], and discloses that hydrolysis is carried out until more than 50% of the contained protein has a molecular weight of less than 4 kDa [0045]. Henle does not expressly disclose calcium depletion. Tomita discloses a milk concentrate subjected to ion exchange to provide a calcium content of less than 700mg/100g protein which falls within the claimed range of less than 2g or less than 1.4 g/100g protein. Tomita discloses that reducing calcium content removes the inhibition of enzymatic decomposition and prevents precipitation of the protein hydrolysate during heating. The hydrolysate is subsequently formed into a powder (Example 1 of Tomita). It would have been obvious to one of ordinary skill in the art to remove any calcium that may be present in the whey protein concentrate of Henle to the degree disclosed by Tomita as Tomita indicates that this is the optimal amount of removal to remove inhibition of hydrolysis via enzymes and prevent precipitation of the protein hydrolysates during heating.
Further regarding the molecular weight distribution of claim 41 and 42, Table 4 of Henle discloses the progression of hydrolyzation of the whey protein and depending upon the length of time of hydrolyzing, the molecular weight (peptide sizes) change. For instance, after 10 minutes, no more than 67.5wt% is above 4kDa and 30.8 wt% is in the range of 24-66 kDa. This is seen to meet the limitation of 20-79wt% is above 20kDa since only 30.8wt% is above 24kDa after 10 minutes. The amounts progressively decrease with the increase in time.
Regarding claim 43, Table 4 shows that the range of 4-24 kDa varies from 8.2-37.5wt% depending upon the amount of time allowed for hydrolyzing the proteins.
Regarding claim 44, after 10 minutes, 31.6wt% of the proteins are 4kDa or less.
Regarding claim 45, after 10 minutes, after 10 minutes, 11.7wt% are 1-4kDa.
Regarding claim 46, after 10 minutes, 7.2wt% have less than 0.175kDa and 12.7wt% from 0.175-1 kDa for a total of 19.9wt%.
Regarding claims 47 and 49, claims 43-46 as discussed above address the amounts claimed.
Note that the instant ranges of kDa use the phrase “about” and have overlap at 20kDa, 5kDa and 1kDa. The ranges of Henle also have overlap at 24, 4, 1 and 0.75 kDa. Henle discloses that as the hydrolyzation time lapses, generally in increase in the smaller MW and decrease in the larger MW is seen. The general amounts disclosed by Henle and the overlap in the ranges are seen to obviate the instant ranges. Further, Blanton discloses that the size of the protein hydrolysates affects taste. Specifically, Blanton explains the protein hydrolysates may have an average weight of about 2000 to about 10,000 Daltons. The protein hydrolysates may have about 67% or less of the proteins having a weight below 6000 Daltons. Embodiments also include protein hydrolysates may have an average weight of about 2000 to about 5000 Daltons. In general, smaller protein hydrolysates tend to have larger Q-values, indicating a higher probability of having a bitter taste. The greater the percentage of the hydrolysate products having smaller molecular weights (e.g., less than about 2000 Daltons) the greater the chance a consumer will notice a bitter taste. As the molecular weight profile data below shows, hydrolysate products with about 45% or less of protein hydrolysates weighing less than 2000 Daltons, have little or no detectable bitterness [0038]. One of ordinary skill in the art would have found it obvious to alter and optimize the MW profile of Henle by altering the extent of hydrolyzation of the proteins depending upon the desired taste of the product as indicated by Blanton.
Claim(s) 42-47 and 49 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over EP 0467482 (Klarenbeek) (cited on IDS filed 07/23/2024) in view of US 2014/0179609 (Henle) and EP 1973429 (Blanton) (both cited on IDS filed 07/23/2024).
Klarenbeek discloses a milk protein isolate (MPI) with low calcium content of below 0.4wt% (page 2, lines 40-42; page 3, lines 33-35). The protein content may be more than 90% (page 3, lines 38-39; page 4, lines 3-4) and the composition is subjected to hydrolysis up to a degree of 3.3% (0.7-3.3%). Klarenbeek does not expressly disclose the MW distribution but does disclose a similar hydrolysis degree as that of applicant.
Table 4 of Henle discloses the progression of hydrolyzation of the whey protein and depending upon the length of time of hydrolyzing, the molecular weight (peptide sizes) change. For instance, after 10 minutes, no more than 67.5wt% is above 4kDa and 30.8 wt% is in the range of 24-66 kDa. This is seen to meet the limitation of 20-79wt% is above 20kDa since only 30.8wt% is above 24kDa after 10 minutes. The amounts progressively decrease with the increase in time.
Regarding claim 43, Table 4 shows that the range of 4-24 kDa varies from 8.2-37.5wt% depending upon the amount of time allowed for hydrolyzing the proteins.
Regarding claim 44, after 10 minutes, 31.6wt% of the proteins are 4kDa or less.
Regarding claim 45, after 10 minutes, after 10 minutes, 11.7wt% are 1-4kDa.
Regarding claim 46, after 10 minutes, 7.2wt% have less than 0.175kDa and 12.7wt% from 0.175-1 kDa for a total of 19.9wt%.
Regarding claims 47 and 49, claims 43-46 as discussed above address the amounts claimed.
Note that the instant ranges of kDa use the phrase “about” and have overlap at 20kDa, 5kDa and 1kDa. The ranges of Henle also have overlap at 24, 4, 1 and 0.75 kDa. Henle discloses that as the hydrolyzation time lapses, generally in increase in the smaller MW and decrease in the larger MW is seen. The general amounts disclosed by Henle and the overlap in the ranges are seen to obviate the instant ranges. Further, Blanton discloses that the size of the protein hydrolysates affects taste. Specifically, Blanton explains the protein hydrolysates may have an average weight of about 2000 to about 10,000 Daltons. The protein hydrolysates may have about 67% or less of the proteins having a weight below 6000 Daltons. Embodiments also include protein hydrolysates may have an average weight of about 2000 to about 5000 Daltons. In general, smaller protein hydrolysates tend to have larger Q-values, indicating a higher probability of having a bitter taste. The greater the percentage of the hydrolysate products having smaller molecular weights (e.g., less than about 2000 Daltons) the greater the chance a consumer will notice a bitter taste. As the molecular weight profile data below shows, hydrolysate products with about 45% or less of protein hydrolysates weighing less than 2000 Daltons, have little or no detectable bitterness [0038]. One of ordinary skill in the art would have found it obvious to alter and optimize the MW profile of Klarenbeek by altering the extent of hydrolyzation of the proteins depending upon the desired taste of the product as indicated by Henle and Blanton.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER C MCNEIL whose telephone number is (571)272-1540. The examiner can normally be reached M-F 9-5.
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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1793
/Jennifer McNeil/ Primary Examiner, Art Unit 1793