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 .
Claim status
Claims 1-15 filed 12/27/2024 are pending in the application and are hereby examined on the merits.
Claim Objections
Claim 1 is objected to because of the following informalities: “in the hydrolysate” in line 5-6, 7-8 and 10-11 should read “in the fish protein hydrolysate”; and an “and” should follow “10 kDa” in line 9. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: all the species in Latin names should be written in italic form. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: a “the” should precede “fish protein hydrolysate”. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: a “the” should precede “alpha-s1-casein hydrolysate”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: a “the” should precede “fish protein hydrolysate”. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: “wax and maltitol and mixtures thereof” should read “wax, maltitol, and mixtures thereof”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 14-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because a claim directed to a “use” is considered to be an improper definition of a process per MPEP § 2173.05(q).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites peptides with a molecular weight strictly greater than 10kDa. The phase “strictly” renders the claim indefinite because it is unclear what the phrase imparts to the claim. In other words, it is unclear what the difference is between a peptide with a molecular weight that is strictly greater than 10 kDa, and a peptide with a molecular weight that is greater than 10 kDa, but not strictly. It is noted that the phrase strictly occurs another two times in the claims thus are rejected for the same reason. Appropriate correction is required.
Claims 2-15 depend from claim 1 and therefore necessarily incorporate the indefinite subject matter therein. Appropriate correction is required.
Claims 3, 4, 6, 7, 12, 13, 14 and 15 are rejected for being indefinite because they use the phrase “preferably”, thus not being clear whether the limitations following the phrase are part of the claimed invention. See MPEP 2173.05(d).
Claim 8 or claim 9 depends from claim 1 and recites “the filler”. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 10 depends from claim 1 and recites “the texturizing agent”. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 11 depends from claim 1 and recites “in which the concentration of texturizing agent is….”. However, given that claim 1 does not recite a texturizing agent, it is unclear whether the scope of claim 11 requires that a texturizing agent is present in the composition. Appropriate correction is required.
Claim 13 depends from claim 1 and recites “Composition or food supplement according to claim 1”. However, claim 1 does not recite a food supplement thus there is insufficient antecedent basis for this limitation in the claim. Claim 14 is rejected for the same reason. Appropriate correction is required.
Claim 14 claims a use of a composition, without any steps as to how the use is to be practiced. Therefore, it is unclear what steps must be present in order to meet the claim. Claim 15 is rejected for the same reason.
Allowable Subject Matter
Claims 1-13 are free from prior art. The references of record fail to teach or fairly suggest a composition comprising an alpha-s1-casein hydrolysate and a fish protein hydrolysate, wherein the peptide distribution of the fish protein hydrolysate being: at least 2% by weight of peptides with a molecular weight greater than 10 kDa, 25 -80% by weight of peptides with a molecular weight greater 1.5 kDa and less than or equal to 10 kDa, and 15-70% by weight of peptides with a molecular weight less than 1.5 kDa, relative to the total weight of peptides in the hydrolysate. To this end, it is known alpha-s1-casein hydrolysate such as alpha-casozepine is used as an anxiolytic agent in animals such as dogs, for example, Beata (cited in IDS submitted 12/17/2024), and Moreau WO2019/068989 A1 teach feeding dogs alpha-s1-casein hydrolysate to relieve stress or anxiety in the dogs. It is further known that some fish protein hydrolysates are anxiolytic agents in animals such as dogs, for example, each of Destaing US Patent Application Publication No. 2021/0008174 A1, Guerard US Patent Application Publication No. 2022/0279814 A1, Hafeez (cited in the IDS submitted 12/17/2024), and Landsberg (cited in the IDS submitted 12/17/2024) teaches that a specific fish protein hydrolysate is used to treat the fear and anxiety in dogs. However, it is found that the specific fish protein hydrolysates as disclosed by the references above do not have the peptides MW profile as recited in instant claim 1, for example, Destaing teaches that the fish protein hydrolysate used is such that less than 1% of the peptides have a MW greater than 10 kDa; Guerard teaches that the fish protein hydrolysate has at least 80% peptides (e.g., water soluble protein) with a MW of less than 1 kDa; and the fish protein hydrolysates as disclosed by Hafeez or Landsberg (e.g., Gabolysat or PTP55) are mostly low MW peptides (see [0100, 0140 and 0188] of Destaing, which evidence that the fish protein hydrolysates as used in Hafeez and Landsberg have the MW profile that less than 1% the peptides have a MW greater than 10 kDa) the peptides MW of which do not match that as recited in instant claims. Given that prior art provides no expectation that a fish protein hydrolysate with the peptides MW profile as recited in claim 1 also has anxiolytic function, there is no motivation for a skilled artisan to combine a reference that teaches using alpha-s1-casein hydrolysate as an anxiolytic agent with the fish protein hydrolysate of instant claim 1.
Conclusion
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/CHANGQING LI/Primary Examiner, Art Unit 1791
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