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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/30/2026 has been entered.
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) 27-36,39-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Framroze(US 2019/0037882) in view of Lebatut(FR 2966016) and Hallaraker(US 2019/0015433).
Regarding claim 27,29, Framroze teaches a fish protein hydrolysate that has a 2 to 70% degree of hydrolysis(para 41). Framroze does not specifically teach that the degree of hydrolysis is measured by the pH stat method. However, since Framroze teaches a wide range of hydrolysis clearly encompassing the claimed range of at least 10% to less than 20%, one of ordinary skill in the art would expect Framroze to meet the claim.
Framroze does not specifically teach that at least 80% to less than 91.75% of water-soluble proteins with a molecular weight of less than 1000 Da.
However, Lebatut teaches protein hydrolysates from aquatic animals having 80% of water-soluble proteins with a molecular weight of less than 1000 Da. Lebatut teaches that the hydrolysates can be included in a variety of food and medical products(abstract). It would have been obvious to modify Framroze in view of Lebatut such that the hydrolysate has 80% of water-soluble proteins with a molecular weight of less than 1000 Da since these hydolysates are versatile in a variety of food and medical products. A range of at least 80% would overlap the claimed range of at least 80% to less than 91.75% and render it obvious.
Framroze teaches that the fish protein hydrolysate can be any form of fish or aquatic animal. Therefore, it would have been obvious to use any number of fish products, including bluefish, as the protein hydrolysate original composition.
Framroze does not specifically teach that the hydrolysate comprises at least 0.3% to no more than 3% phospholipids and at least 0.5% to a maximum of 5% of DHA and EPA. However, Hallaraker teaches a phospholipid supplement containing high amounts of EPA and DHA(about 40 to 50%) that can be incorporated into food products(abstract, para 8). Hallaraker teaches that the phospholipid composition can be incorporated in the food product in an amount of about 1% to about 99%(para 122). Therefore, the total amount of EPA and DHA is 0.1 to 44.55%(0.1x40 to 0.99x50), which overlaps the claimed range of at least 0.5% to a maximum of 5% of DHA and EPA and renders it obvious. Hallaraker further teaches that the supplement further can be combined with protein(para 111) and that EPA and DHA have important structural roles and anti-inflammatory roles in the body(para 6). It would have been obvious to include about 1% to about 99% phospholipid having high amounts(about 40 to about 50%) of DHA and EPA for a total content of 0.1 to 44.55% DHA and EPA in the protein hydrolysate composition of Framroze as taught in Hallaraker because EPA and DHA have important structural roles and anti-inflammatory roles in the body.
Framroze in view of Lebatut and Hallaraker teaches adding phospholipids comprising DHA and EPA to the protein hydrolysate and does not specifically teach that the phospholipids and the EPA are endogenously derived from the at least one protein source from bluefish.
However, it is noted that “[E]ven 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). Further, “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.
Therefore, absent evidence of criticality regarding the presently claimed process and given that Framroze in view of Lebatut and Hallaraker meets the requirements of the claimed protein hydrolysate, Framroze in view of Lebatut and Hallaraker clearly meets the requirements of the present claims.
In other words, whether the phospholipids and EPA are endogenous or added, the product of the prior art and of the claimed invention seem to be same, absent clear and convincing evidence to the contrary. As such, the total amount of phospholipids and EPA are the same in the prior art and in the claimed invention.
Regarding claim 28, Framroze teaches that the protein source can be in the form of fish heads(para 33).
Regarding claim 30, Framroze teaches that the protein hydrolysate is made by a method comprising the steps of: (para 34-51)
(a) providing a protein source;
(b) grinding said protein source;
(c) adjusting the pH;
(d) adding at least one hydrolysing enzyme;
(e) heating;
(f) separation; and
(g) drying.
Regarding claims 31-35,40-42, Framroze teaches that the protein hydrolysate can be included in a complete food, food supplement, pharmaceutical product, nutraceutical product, medicinal product, or pet food(para 59).
Regarding claim 36, Framroze teaches that the protein hydrolysate can be included in a complete food, food supplement, pharmaceutical product, nutraceutical product, medicinal product, or pet food(para 59). It would have been obvious to use the protein hydrolysate in cat or dog food since cats and dogs are well known and common pets.
Regarding claim 39, Framroze teaches that the protein hydrolysate can be included in a complete food, food supplement, pharmaceutical product, nutraceutical product, medicinal product, or pet food(para 59). It would have been obvious to include other common pet food ingredients such as proteins in with the protein hydrolysate in order to make a kit for pet food. It would have been obvious to put the protein hydrolysate and other pet food ingredients in separate containers in a single package, as is a common packaging method.
Response to Arguments
Applicant's arguments filed 1/30/2026 have been fully considered but they are not persuasive.
The applicant argues that Framroze in view of Hallaraker teaches adding phospholipids comprising DHA and EPA to the protein hydrolysate and does not specifically teach that the phospholipids and the EPA are endogenously derived from the at least one protein source from bluefish.
However, it is noted that “[E]ven 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). Further, “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.
Therefore, absent evidence of criticality regarding the presently claimed process and given that Framroze in view of Labatut and Hallaraker meets the requirements of the claimed protein hydrolysate, Framroze in view of Labatut and Hallaraker clearly meets the requirements of the present claims.
In other words, whether the phospholipids and EPA are endogenous or added, the product of the prior art and of the claimed invention seem to be same, absent clear and convincing evidence to the contrary. As such, the total amount of phospholipids and EPA are the same in the prior art and in the claimed invention.
Conclusion
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/KATHERINE D LEBLANC/Primary Examiner, Art Unit 1791