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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 19, 2025 has been entered.
Claims 1-15 are pending examination.
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.
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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Giuseppin et al. (EP 1 920 662 A1).
Regarding claims 1, 3 and 6, Giuseppin et al. disclose a process of isolating native potato protease inhibitor comprising the steps of: (a) obtaining potato fruit juice from a potato factory (i.e., processing a potato to obtain potato processing water comprising native potato protease inhibitor); (b) adjusting the pH of the potato fruit juice to 6.0; (c) loading the pH adjusted potato fruit juice onto a Streamline Direct CST-1 column; (d) washing the column with 5 CV of 20 mM citrate buffer pH 6.0; (e) eluding protein isolate in 3CV 50 mM NaOH; (f) loading the eluate on an SDS-PAGE gel; (g) eluding the protease inhibitor factions having a pH of 3.2; and (h) concentrating the protease inhibitor factions by ultrafiltration using a 10 kDa membrane filter ([0067]/Method 2).
Giuseppin et al. is silent with respect to obtaining an aqueous solution comprising at least 15 wt% of native potato protease inhibitor as the sole type of potato protein. Here, the protease inhibitor fractions eluded from SDS-PAGE would be considered an aqueous solution and any concentrate resulting from the ultrafiltration of the protease inhibitor fractions could be in the form of an aqueous solution. One of ordinary skill in the art would have been motivated to form the concentrate resulting from ultrafiltration into an aqueous solution comprising a consistent concentration of potato protease inhibitor (e.g., at least 15 wt%) to obtain, when dried, a product with a uniform protein content.
Giuseppin et al. is silent with respect to temperature, it necessarily follows the process, as disclosed at paragraph [0067] (i.e., Method 2) of Giuseppin et al. would be conducted at ambient temperature which would prevent exposure of the potato protease inhibitor fraction to a temperature higher than 40°C.
Regarding claim 2, Giuseppin et al. disclose all of the claim limitations as set forth above. Giuseppin et al. is silent with respect to operating the method at a rate to produce at least 5 Kg of protein per hour.
However, the mere scaling up of the process disclosed by Giuseppin et al., which is capable of being scaled up, does not establish patentability in a claim to an old process so scaled (see MPEP §2144.04 IV A).
Regarding claims 4 and 5, Giuseppin et al. disclose all of the claim limitations as set forth above. Giuseppin et al. disclose potato fruit juice may be produced by washing and rasping potatoes and separating the starch and fibers by methods such as centrisieves, hydrocyclones and decanters ([0002]).
Regarding claim 7, Giuseppin et al. disclose all of the claim limitations as set forth above. Giuseppin et al. disclose a step of pre-treating the potato fruit juice with a divalent metal cation at a pH of 7-9 to flocculate undesired material, followed by a separation of the flocks by centrifugation ([0026]). Giuseppin et al. disclose that the pre-treatment removes undesired materials including glycoalkaloids ([0026]).
Regarding claim 8, Giuseppin et al. disclose all of the claim limitations as set forth above. Giuseppin et al. disclose the concentrates from step h) (wherein the potato protein inhibitor fractions are concentrated) can be made into dried from (i.e., powder)([0039]). Giuseppin et al. disclose the dry concentrates of protease inhibitors can be spray dried ([0045]).
Regarding claims 9 and 15, Giuseppin et al. disclose all of the claim limitations as set forth above. Given Giuseppin et al. disclose a process wherein the temperature never exceeds 40C, inherently the total temperature exposure (TTE) would be less than 200°C·hr.
Regarding claim 10, Giuseppin et al. disclose all of the claim limitations as set forth above. Giuseppin et al. disclose obtaining potato protease inhibitor fractions. Given Giuseppin et al. disclose obtaining potato protease inhibitor fractions using a process identical to that of claim 1, inherently the potato protein inhibitor fractions would exhibit a quantity of disulfide brides of 4-8 g/kg, expressed as g cysteine present as disulfide bridge per kg protein.
Regarding claim 11, Giuseppin et al. disclose all of the claim limitations as set forth above. Giuseppin et al. disclose that the potato protein inhibitor fractions have a glycoalkaloid concentration of less than 150 ppm ([0031]).
Regarding claim 12, Giuseppin et al. disclose all of the claim limitations as set forth above. Giuseppin et al. also disclose food product comprising the potato protease inhibitor fractions ([0051]).
Regarding claim 13, Giuseppin et al. disclose all of the claim limitations as set forth above. While Giuseppin et al. disclose a solution having a pH of 3.2, a prima face case of obviousness exists where the claimed range or amounts do not overlap with the prior art but are merely close (MPEP 2144.04).
Regarding claim 14, Giuseppin et al. disclose all of the claim limitations as set forth above. Given Giuseppin et al. disclose washing the potatoes, it necessarily follows that a combination of water was included in the processing to obtain the potato juice (i.e., potato processing water).
Response to Amendment
The Declaration under 37 CFR 1.132 filed September 19, 2025 is insufficient to overcome the rejection of claims 1-15 based upon Giuseppin et al. (EP 1 920 662 A1) as set forth in the last Office action.
At paragraph 4, Declarant submits, as biochemist at Avebe, he was an inventor on European patent EP 1 920 662.
At paragraphs 5-7, Declarant explains the present application is directed to ways to stabilize native protease inhibitor solutions at high concentrations. Declarant notes high concentrations of protease inhibitors are described to result in gelation, which can be avoided by applying the sequence of steps recited in claim 1 of the present application.
At paragraph 9, Declarant explains the present application teaches that avoiding high temperatures exposure of concentrated solutions (of more than 15 wt% concentration) avoids the breaking of disulfide bonds which stabilize the protein three dimensional structure.
At paragraph 12, Declarant notes “[t]he Examiner expressed the opinion that protease inhibitor fractions from SDS-PAGE would be an aqueous solution of protease inhibitor proteins from potato processing water, which hence inherently would comprise at least 15 wt% of protease inhibitor.”
At paragraph 13, Declarant explain the “source” of the protein (potato processing water) is of no relevance for the concentration of the protein. The concentration is strictly determined by the processing steps, in particular the concentration – and dilution steps. The Declarant argues the assumption that the SDS-PAGE solution would contain at least 15 wt% of the protease inhibitor is erroneous. At paragraph 14, Declarant states the SDS-PAGE solutions of Giuseppin et al. were further concentrated at pH 3.2 using UF and the concentration is to more than 14 wt%”. Declarant submit “[i]n reality, this means that eluates are concentrated by UF to more than, but no much more than 14 wt% concentration.” At paragraph 16, Declarant states that at protein concentrations above 14 wt%, the risk that gelation occurs increases, which would make further processing of the solutions impossible.
In this case, Giuseppin et al. does not disclose a high temperature process. Given Giuseppin et al. does not disclose temperature, it can be inferred that the process is conducted at ambient temperature (i.e., about 20°C). The person of ordinary skill in the art supplied the disclosure of Giuseppin et al. would not necessarily be concerned about the concentration of protein since the disulfide bonds of the potato protease inhibitor would be expected to be intact under ambient temperature processing.
Regarding the concentration of protein, see new grounds of rejection set forth above. While the concentration of protein in the solutions of potato protease inhibitor resulting from UF concentration may not be an inherent property, one of ordinary skill in the art would be motivated to standardize the protease inhibitor product resulting from the concentration process to make a more consistent dried product, including a solution have 15 wt% or more protein. Giuseppin et al. clear disclose aqueous solutions comprising a protein content overlapping the presently claimed amount of 15 wt% or more. Giuseppin et al. disclose concentrating the eluates by ultrafiltration to obtain a dry matter content of more than 14% ([0076]).
Response to Arguments
Applicant's arguments filed September 19, 2025 have been fully considered but they are not persuasive.
See Response to Amendment set forth above.
Conclusion
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759