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 Objections
The claim objections are withdrawn due to applicant’s amendments
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.
The 112 rejections are withdrawn due to applicant’s amendments.
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.
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, 3,5-10 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Sanovo (WO 2014/146660; cited on IDS filed July 27, 2023) in view of Cunningham et al. (Cunningham et al., 1964 “Effect of Centrifuging Yolk-Contaminated Liquid Egg White on Functional Properties. Poultry Science, vol. 43, pp. 283-291).
Regarding claim 1,16, Sanovo teaches a process for treating egg whites contaminated with egg yolk, the process comprising adjusting the pH from 1 to 12, and in one embodiment, adjusting the pH from about 7 to 9 (p. 21 lines 24-26). These ranges encompass, or touch, the claimed range, thereby rendering the claimed pH range obvious. No pH adjustment is done after the initial step a) as required in claim 16.
Lipase is then added to the starting egg material to form a mixture (p. 21 lines 9-10).
Regarding the amount of egg yolk present, Sanovo teaches the egg yolk contamination can range from about 0.001% to about 5%(w/w) of the egg white composition (p.5,line 13-15). “About 5%” can include values over 5% egg yolk by weight as claimed. This overlaps and thereby renders obvious the claimed amount of egg yolk present in the starting material.
Sanovo is silent as to subjecting the digested mixture to a centrifugal separation, where at least two phase are formed and subsequently collecting the two phases separately.
Cunningham et al. teach the centrifugal separation of egg yolk-contaminated egg white in order to improve the functional characteristics of the egg white (p. 283 col. 2, 1st paragraph).
Therefore, where centrifugal separation of egg yolk-contaminated egg white was known in the art well before the instant invention, it would have been obvious to have utilized centrifugal separation as taught by Cunningham et al. following the lipase treatment of Sanovo in order to provide separate protein (i.e., egg white/albumin) and lipid (i.e., egg yolk) phases. Based on the teachings of Sanovo and Cunningham et al., this separation would have been expected to further improve the functionalities of the recovered egg white (i.e., protein) phase.
Regarding claim 3, Sanovo recites that the starting material is attained through egg breaking (p. 1 lines 28-30). Sanovo does not teach that the starting material is specifically from an egg breaking plant. However, where Sanovo teaches their process to be applied, generally, to any mixture of egg white contaminated with some amount of egg yolk, the source of the staring material is not considered to provide a patentable distinction where the starting material comprises egg white with some small amount of egg yolk as contamination.
Regarding claim 5, Sanovo does not specifically state that the egg white and egg yolk in the starting material “have been mixed and form an emulsion.” However, where the starting material of Sanovo is an egg starting material, and Sanovo teaches that enzyme is to be “sufficiently mixed” with the egg material (p. 20 lines 27-29), it would have been obvious to have further mixed the egg material prior to the addition of the phospholipase to ensure that the composition was uniformly mixed. Further, any order of forming process steps is prima facie obvious in the absence of a showing of criticality per MPEP § 2144.04(IV)C. Therefore, the mixing of the egg material prior to the pH adjusting step is considered to be prima facie obvious.
Regarding claim 6, where centrifugal separation is known to separate mixtures based on densities, by centrifuging the lipase treated mixture of modified Sanovo as detailed above with regard to claim 1, the mixture would have been expected to form three phases as claimed given the starting material (i.e., contaminated egg whites) and enzyme (i.e., lipase) treatment are the same as reported in the prior art.
Further, as stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. [citation omitted] Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products.
Regarding claim 7, Sanovo doesn’t specifically teach that the pH adjusting agent is food grade. However, where the product provided by Sanovo is taught to be utilized in foodstuffs including desserts (p. 9 line 34-p. 10 lines 3), it would have been obvious to have utilized a food grade pH adjusting agent where the resultant egg white product was to be included in foodstuffs. It would have been well within the abilities of one of ordinary skill in the art to have selected the appropriate pH adjusting agent depending on the intended use of the final product.
Regarding claim 8, Sanovo teaches an amount of lipase added is from about 10 U to about 106 U per 1 kg of egg white composition (p. 21 lines 11-13).
Sanovo does not report the amount of lipase as % by weight of total starting material. Sanovo does state that “A person skilled in the art will know that conditions for enzymatic reactions can be adjusted to the required performance.” This includes the amount of enzyme added to the composition (p. 21 lines 28-34). Therefore, one of ordinary skill would have recognized that the amount of enzyme to be included in the preparation could be adjusted based on the desired amount of lipolysis to occur and the conditions (e.g., time and temperature) under which the reaction was occurring. Thus, arriving at an enzyme amount as claimed would have required no more than routine experimentation, and would have been expected to provide a desired result of a sufficient amount of lipolysis in the starting egg composition.
Regarding claim 9, Sanovo does not require a fermentation process before the lipase is added (p. 22 line 32-p. 23 line3).
Regarding claim 10, modified Sanovo does not speak to the amount of fat in the protein phase obtained in step (e). However, given both the prior art and the instant invention start with an egg white composition contaminated with a small amount of egg yolk, treat the egg composition with lipase, and then separate the egg composition using centrifugation, the protein phase of the process of the prior art is considered to have a fat content as claimed in the absence of convincing arguments or evidence to the contrary.
As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products.
Regarding claim 12, Sanovo teaches a process for treating egg whites contaminated with egg yolk, the process comprising adjusting the pH from 1 to 12, and in one embodiment, adjusting the pH from about 7 to 9 (p. 21 lines 24-26). where Sanovo teaches adjusting the pH to a range of about 7 to about 9(p.21, line 25), the claimed range of “between 5 and 6.5” is considered to touch the pH range of the prior art and thereby be rendered obvious in the absence of a showing that the difference in pH of “6.5” and “about 7” provides an unexpected result. Further, one of ordinary skill would have recognized that different enzymes will have different optimum pH and would have been able to have selected the appropriate pH through no more than routine experimentation depending on the specific lipase being utilized, as Sanovo also teaches that optional additives to the egg white composition may reduce or increase the performance of the enzymes (p. 21 line 33-p. 22 line 1).
Regarding claim 13, Sanovo teaches a process for treating egg whites contaminated with egg yolk, the process comprising adjusting the pH from 1 to 12, and in one embodiment, adjusting the pH from about 7 to 9 (p. 21 lines 24-26). Where Sanovo teaches adjusting the pH to a range of about 7-9, the claimed range of “between 6 to 6.5” is considered to touch the pH range of the prior art and thereby be rendered obvious in the absence of a showing that the difference in pH of “6.5” and “about 7” provides an unexpected result. Further, one of ordinary skill would have recognized that different enzymes will have different optimum pH and would have been able to have selected the appropriate pH through no more than routine experimentation depending on the specific lipase being utilized, as Sanovo also teaches that optional additives to the egg white composition may reduce or increase the performance of the enzymes (p. 21 line 33-p. 22 line 1).
Regarding claims 14 and 15, Sanovo does not specifically teach that the lipase has an optimal pH at 7 or higher or that is derived from the claimed fungi. However, since Sanovo teaches adjusting the pH of the egg white composition to about 7 to about 9(p.21 lines 24-26), it would have been obvious to select a lipase that optimal pH at 7 or higher. It would have been obvious to select the proper fungi source in order to provide a lipase that has optimum activity against the egg white composition.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Sanovo (WO 2014/146660; cited on IDS filed July 27, 2023) in view of Cunningham et al. (Cunningham et al., 1964 “Effect of Centrifuging Yolk-Contaminated Liquid Egg White on Functional Properties. Poultry Science, vol. 43, pp. 283-291) as applied to claim 1 above, and further in view of Johnson (US 3857980).
Modified Sanovo teaches a process for providing a protein phase and a lipid phase from a starting egg composition as detailed above with regard to claim 1.
Modified Sanovo is silent as to the starting material being prepared from eggs not suitable for human consumption.
Johnson teaches eggs not suitable for human consumption were known to be further processed into protein products for pet food (col. 1 lines 12-17).
Therefore, where modified Sanovo teaches a process for providing lipid and protein fractions from an egg starting material, it would have been obvious to have utilized eggs not suitable for human consumption as the starting material, as taught by Johnson, where the final protein product could subsequently be utilized in pet foods. This would have required no more than routine experimentation, as egg material not suitable for human consumption was known to be utilized as a protein supplement in pet foods before the instant invention. By utilizing the process of modified Sanovo with the starting material of Johnson, one would have been able to have provided an improved egg protein product for addition to pet foods.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Sanovo (WO 2014/146660; cited on IDS filed July 27, 2023) in view of Cunningham et al. (Cunningham et al., 1964 “Effect of Centrifuging Yolk-Contaminated Liquid Egg White on Functional Properties. Poultry Science, vol. 43, pp. 283-291) as applied to claim 1 above, and further in view of Van Eeden (US 2020/0170282).
Modified Sanovo teaches a process for providing a protein phase and a lipid phase from a starting egg composition as detailed above with regard to claim 1.
Modified Sanovo is silent as to adding the protein phase to an animal feed to provide the animal feed with at least 0.1% egg protein.
Van Eeden teaches a bird feed (i.e., animal feed) comprising at least about 10% by mass protein [0035], and where the protein source may be egg white or whole egg protein [0009].
Therefore, where Van Eeden teaches an animal feed comprising greater than 0.1% egg protein, it would have been obvious to have utilized the egg protein provided by the process of modified Sanovo in the animal feed of Van Eeden in order to provide an animal feed having an egg protein content as claimed. This would have required no more than routine experimentation, as it was known in the art well before the instant invention to include egg protein in animal feed.
Allowable Subject Matter
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Sanovo teaches the egg yolk contamination can range from about 0.001% to about 5%(w/w) of the egg white composition (p.5,line 13-15) and does not teach more than 10% egg yolk by weight of solids as claimed.
Response to Arguments
Applicant's arguments filed 4/3/2026 have been fully considered but they are not persuasive.
The applicant argues that Sanovo does not teach newly amended claim 1 and an egg yolk content of more than 5% by weight of total solids. Sanovo teaches the egg yolk contamination can range from about 0.001% to about 5%(w/w) of the egg white composition (p.5,line 13-15). “About 5%” can include values over 5% egg yolk by weight as claimed. This overlaps and thereby renders obvious the claimed amount of egg yolk present in the starting material.
The applicant argues that Sanovo teaches a pH range of 7 to 9 and does not overlap the claimed ranges for claims 12 and 13. However, Sanovo teaches a process for treating egg whites contaminated with egg yolk, the process comprising adjusting the pH from 1 to 12, and in one embodiment, adjusting the pH from about 7 to 9 (p. 21 lines 24-26). Where Sanovo teaches adjusting the pH to a range of about 7-9, the claimed range of “between 6 to 6.5” of “between 5 and 6.5” is considered to touch the pH range of the prior art and thereby be rendered obvious in the absence of a showing that the difference in pH of “6.5” and “about 7” provides an unexpected result. Further, one of ordinary skill would have recognized that different enzymes will have different optimum pH and would have been able to have selected the appropriate pH through no more than routine experimentation depending on the specific lipase being utilized, as Sanovo also teaches that optional additives to the egg white composition may reduce or increase the performance of the enzymes (p. 21 line 33-p. 22 line 1).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D LEBLANC whose telephone number is (571)270-1136. The examiner can normally be reached 8AM-4PM EST M-F.
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/KATHERINE D LEBLANC/Primary Examiner, Art Unit 1791
