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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/21/2025 has been entered.
Office Action is in response to Applicant’s amendments/remarks filed 11/21/2025. Claims 59, 61, 63, 67-69, and 72-81 are presently pending and are presented for examination.
Response to Arguments
In light of the applicant’s amendments, the previous rejections under 35 USC 112 have been withdrawn. Applicant’s arguments, filed 11/21/2025, with respect to the rejections of claims 59, 61, 63, 67-69, and 72-81 under 35 U.S.C. 103 as being unpatentable over Bullard (US Pat. 11,350,640) in view of Harvey (US Pub. 2012/0244261) have been fully considered but are not persuasive.
Applicant argues that none of the relied upon prior art references Bullard or Harvey, alone or in proper combination, make obvious “wherein the application region comprises the fluid composition comprising a pH of about 10.0 to about 13.0, wherein the oxidizer comprises a concentration of about 10 ppm to about 500 ppm, and wherein the oxidizer comprises peracetic acid”. Applicant has referred to a declaration pursuant to 37 C.F.R. 1.132, filed 2/7/25, to support their arguments.
The position of the Examiner is that the claimed pH range of 10.0 to 13.0 has not been demonstrated to achieve unexpected results relative to the range of disclosed by Bullard. Bullard discloses a pH range of about 7 to about 12 (col. 4, lines 16-26), which overlaps the claimed range, and claims a pH range of 7 to about 10 (claim 1), which abuts the claimed range. “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists … Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” MPEP 2144.05.
Applicant argues that the pH range of 7 to about 12 disclosed by Bullard is so broad as to not invite optimization. The position of the examiner is that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)(A). Further, it is noted that applicant’s own claimed range was initially quite broad, being that of “at least about 9” with not recited maximum, i.e. from about 9 to 14. Applicants may, of course, narrow a claimed range during prosecution. However, the initial, broader claimed range does not suggest that the later, narrower claimed range is critical.
Applicant argues that the claimed pH range of 10-13 is shown to be critical based on unexpected technical effects, as demonstrate by Tables I and II in the present specification. The position of the Examiner is that the tables do not provide sufficient samples to demonstrate the criticality of the claimed range. That is, the pH samples in the tables are: 10 (provided twice), 10.2 and 10.7 (Table I), and 8.2 and 11.2 (Table II). It is not clear how six pH samples ranging from 8.2 to 11.2 demonstrate the criticality of the claimed pH range of 10-13. Applicant’s showing is not commensurate in scope with the claims and therefore it not persuasive to establish criticality.
Applicant asserts that claimed pH range solves a long felt but unsolved need in the industry – decreasing the number of USDA Salmonella positives during production. Applicant offers the Kroitsch Declaration as evidence that long standing problems with field production sites were solved when the disinfection process was changed from a low pH system (pH of 7.0 - 8.5) to a high pH system (pH of 10.0 - 11.5), and asserts that the high pH system is commensurate in scope with the range of amended claim 67. The position of the Examiner is that the declaration does not provide sufficient samples to demonstrate the criticality of the claimed range. That is, the claimed range is pH of 10 – 13 (and pH of 9 -13 prior to amendment), whereas the declaration range alleged to demonstrate the unexpected results, i.e. the high range, is merely pH of 10.0 – 11.5. It is not clear how this evidence supports unexpected results for a pH range of 11.6 – 13. It is also unclear whether the declaration would have also covered the criticality of a pH range of 9 -10 (which range was included in the original claim pH range of 9 -13), or whether this range would be considered as belonging to the declaration low pH system. Again, the applicant’s showing is not commensurate in scope with the claims and therefore it not persuasive to establish criticality.
Applicant argues that Bullard teaches away from the claimed pH values in amended claim 67 (pH of about 10 – about 13) since, it is alleged, Bullard describes broadly a pH range of 7 – 12, discloses a preferred pH range of about 7 – about 10, and states that “[i]t would be advantageous to properly monitor and maintain the pH of PAA during processing to determine the proper active PAA compared to peracetate ions in the solution during processing” because “of the importance of pH in driving the equilibrium equation to proper concentrations of PAA”. This is not found to be persuasive. The position of the Examiner is that disclosed examples do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. MPEP 2123(II). Further, Bullard does not teach away from the claimed range at least because the Bullard explicitly discloses a range that overlaps the presently claimed range.
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.
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 59, 61, 63, 67-69, and 72-81 are rejected under 35 U.S.C. 103 as being unpatentable over US Pat. 11,350,640 to Bullard et al. (hereinafter “Bullard”) in view of US Pub. 2012/0244261 to Harvey et al. (hereinafter “Harvey”).
Regarding claim 67,
Bullard discloses a system comprising:
an application region (101) configured to receive a foodstuff substrate (carcass) for treatment [Fig. 1; col. 6, lines 1-10];
a supply of a basic fluid (112a comprising alkalizing pH adjustment product) [Fig. 1; col. 6, lines 15-55; col. 11, lines 29-35];
a supply of an oxidizer (114b comprising oxidizing intervention chemistry, e.g. peracetic acid) [Fig. 1; col. 6, lines 15-55; col. 1, lines 44-56]; and
a premixing region (at 108) configured to receive the basic fluid (112a) and the oxidizer (114b), wherein the premixing region is upstream of the application region, wherein the premixing region is configured to mix the basic fluid and the oxidizer to provide a fluid composition (processing solution 112b) [Fig. 1; col. 6, lines 42-64]; and
a first inlet (at 104, coupled to 108) configured to deliver to the application region the basic fluid and the oxidizer [Fig. 1; col. 6, lines 61-64],
wherein the application region comprises the fluid composition comprising a pH of about 10.0 to about 13.0 (resulting fluid composition 112b [i.e. ‘processing solution’] supplied to application region 101 “having the desired pH between about 7 and 12”) [col. 4, lines 21-23], and wherein the oxidizer comprises peracetic acid having a concentration of about 10 ppm to about 500 ppm (processing solution has a concentration of PAA between about 20 ppm and 50 ppm) [col. 1, lines 53-55; col. 9, lines 23-42].
Bullard does not explicitly teach that the composition [i.e. processing solution] has a pH of about 10.0 to about 13.0 as claimed. Bullard discloses the composition (processing solution 112b) may have a pH between about 7 and 12, or between about 7.5 and about 11 (col. 4, lines 21-23), which overlap the claimed range (about 10.0 to about 13.0) of claim 67. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists [see MPEP 2144.05]. Therefore, absent evidence of criticality and/or unexpected results, the claimed pH range(s) is/are considered obvious in view of the prior art.
Furthermore, Bullard discloses that the basic fluid (112a) and the oxidizer (114b) are mixed to provide a fluid composition (processing solution 112b) to the application region (101) having “the desired pH between about 7 and 12” [Fig. 1; col. 4, lines 21-23], and an oxidizer concentration e.g. “between about 20 ppm and 50 ppm” [col. 9, lines 23-42], wherein the oxidizer comprises peracetic acid [col. 1, lines 53-55]. Since the apparatus of Bullard is capable of operation wherein the fluid composition present at the application region comprises a pH of about 10.0 to about 13.0 (e.g. pH ~11.0, within the pH range disclosed by Bullard), wherein the oxidizer comprises a concentration of about 10 ppm to about 500 ppm (e.g. ~30 ppm, within the concentration range disclosed by Bullard), and wherein the oxidizer comprises peracetic acid (disclosed by Bullard), the claim is therefore met. Applicant has not established on this record any structural distinction between apparatus within the scope of the rejected claims and the apparatus fairly described by Bullard, and no such structural distinction is apparent.
Bullard teaches that the premixing region (at 108) is configured to mix the basic fluid (112a) and the oxidizer (114b) upstream of the application region (101) to provide a fluid composition (112b) [Fig. 1; col. 6, lines 42-64], but does not expressly teach that the premixing region comprises a mixer selected from the group consisting of baffles and paddles. However, such a mixer as claimed is commonly known in the art; for example, Harvey similarly discloses a system using peracetic acid to treat a foodstuff substate (carcass) comprising a premixing region upstream of an application region (195), wherein the premixing region comprises a mixing device, e.g. a static mixer (e.g. 125) comprising baffles that is configured to mix fluid components to provide a fluid composition for treatment [Fig. 1; ¶0087]. Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to modify the premixing region of Bullard to include a static mixer comprising baffles, as disclosed by Harvey, in order to predictably mix the basic fluid and the oxidizer to provide the mixed fluid composition to the application region.
Regarding claim 59,
Bullard in view of Harvey discloses the system of claim 67, wherein Bullard discloses that the system comprises one or more mixing modalities in the application region (mixing occurs in the application region via auger [see Fig. 2-4], flow from 208, and flow from 218 [Fig. 2]), the one or more mixing modalities being configured to effect mixing of the basic fluid and the oxidizer [see Fig. 2; col. 7, lines 19-31].
Regarding claim 61,
Bullard in view of Harvey discloses the system of claim 67, wherein Bullard discloses that the application region is configured to contact the substrate by way of a spray, a dip (application region 101 is a “dip tank”) [Fig. 1; col. 6, lines 1-4], a stream (e.g. via 208, 218) [Fig. 2; col. 7, lines 27-31], a curtain, or any combination thereof with the basic fluid and the oxidizer.
Regarding claim 63,
Bullard in view of Harvey discloses the system of claim 67, wherein Bullard discloses that wherein the system is capable of modulating the duration of the substrate's exposure to the fluid composition (e.g. by changing the processing rate, i.e. rate of conveyance through the application region [col. 10, lines 1-3]).
Regarding claim 68,
Bullard in view of Harvey discloses the system of claim 67, wherein Bullard discloses that the basic fluid comprises sodium hydroxide, potassium hydroxide, magnesium hydroxide, calcium hydroxide, sodium hypochlorite, or any combination thereof (e.g. sodium hydroxide and/or potassium hydroxide) [col. 11, lines 29-35].
Regarding claim 69,
Bullard in view of Harvey discloses the system of claim 67, wherein Bullard discloses that the oxidizer further comprises hydrogen peroxide, an inorganic peroxide, a halogen, a percarbonate, an organic persulfate, or any combination thereof [col. 1, lines 44-66].
Regarding claim 72,
Bullard in view of Harvey discloses the system of claim 61, wherein Bullard discloses that the application region comprises a spray cabinet or other spray modality (outlet of 108 is capable of spraying pressurized process solution 112b in the application region 101) [Fig. 1; col. 6, lines 15-55].
Regarding claim 73,
Bullard in view of Harvey discloses the system of claim 67, wherein Bullard discloses that the application region may be a chiller tank (202) [Fig. 2; col. 7, lines 19-22], but does not expressly teach a chiller tank before or after the substrate has passed through the application region. However it is known in the art to provide chill tanks before or after treating a substrate. For example, Harvey discloses: using a “prechill tank” to soak the carcasses in before placing them into the primary chill tank and to begin lowering the temperature of the carcasses early in the processing of the poultry [¶0020]; and/or using a “finishing chill tank” to soak the carcasses in after they are removed from the primary chill tank to give the carcasses a final sanitization using near-freezing water [¶0021]. It would have been obvious to one having ordinary skill in the art at the time of filing to modify the apparatus of Bullard to further include a chiller tank positioned to receive the foodstuff substrate before and/or after passing through the application region (i.e. prechill tank and/or finishing chill tank), as disclosed by Harvey, in order to predictably and beneficially soak and chill the carcasses prior/subsequent to being treating in the application region.
Regarding claim 74,
Bullard in view of Harvey discloses the system of claim 73, wherein Harvey discloses that the chiller tank is configured to receive substrate after the substrate has passed through the application region (“finishing chill tank” to soak the carcasses in after they are removed from the primary chill tank to give the carcasses a final sanitization using near-freezing water [¶0021]).
Regarding claim 75
Bullard in view of Harvey discloses the system of claim 74, wherein in the modified system the substrate passes through the application region (101) of Bullard and is subsequently received by the chiller tank (“finishing chill tank”) of Harvey; therefore, the application region (101) of Bullard meets the requirements of a pre-chiller tank as recited in claim 75. Bullard is silent as to the temperature of the process fluid in the chiller tank. However, the claimed process fluid temperatures are common in the chiller tank art and would have been obvious to one of ordinary skill in the art with the expectation of providing the desired chilling effect in Bullard. Furthermore, the determination of process parameters, like temperatures, would have been obvious to one of ordinary skill in the art through routine experimentation and thus the applicant’s claimed temperature range would have been obvious through such routine experimentation, absent a showing of criticality.
Regarding claim 76,
Bullard in view of Harvey discloses the system of claim 73, wherein Harvey discloses that the chiller tank is configured to receive substrate before the substrate has passed through the application region (“prechill tank” to soak the carcasses in before placing them into the primary chill tank and to begin lowering the temperature of the carcasses early in the processing of the poultry [¶0020]).
Regarding claim 77,
Bullard in view of Harvey discloses the system of claim 76, wherein in the modified system the substrate passes through the chiller tank (“prechill tank”) of Harvey and is subsequently received by the application region (101) of Bullard; therefore, the application region (101) of Bullard meets the requirements of a post-chiller tank as recited in claim 77. Bullard is silent as to the temperature of the process fluid in the chiller tank. However, the claimed process fluid temperatures are common in the chiller tank art and would have been obvious to one of ordinary skill in the art with the expectation of providing the desired chilling effect in Bullard. Furthermore, the determination of process parameters, like temperatures, would have been obvious to one of ordinary skill in the art through routine experimentation and thus the applicant’s claimed temperature range would have been obvious through such routine experimentation, absent a showing of criticality.
Regarding claim 78,
Bullard in view of Harvey discloses the system of claim 76, wherein in the modified system the substrate may sequentially pass through: the pre-chiller tank (“prechill tank” of Harvey, ¶0020), the chiller tank (application region 202 of Bullard, Fig. 2), and the post-chiller tank (“finishing tank” of Harvey, ¶0021); therefore, Bullard in view of Harvey meets the requirements of the application regions as recited in claim 78. Bullard is silent as to the temperature of the process fluid in the chiller tank. However, the claimed process fluid temperatures are common in the chiller tank art and would have been obvious to one of ordinary skill in the art with the expectation of providing the desired chilling effect in Bullard. Furthermore, the determination of process parameters, like temperatures, would have been obvious to one of ordinary skill in the art through routine experimentation and thus the applicant’s claimed temperature range would have been obvious through such routine experimentation, absent a showing of criticality.
Regarding claims 79-81,
Bullard does not explicitly teach that the composition [i.e. processing solution] has pH limitations of “wherein the fluid composition comprises a pH of about 10.3 to about 12.7”, “wherein the fluid composition comprises a pH of about 10.5 to about 12.5”, and “wherein the fluid composition comprises a pH of about 10.7 to about 12.3” as claimed. Bullard discloses the composition (processing solution 112b) may have a pH between about 7 and 12, or between about 7.5 and about 11 (col. 4, lines 21-23), which overlap the claimed range (about 10.0 to about 13.0) of claim 67. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists [see MPEP 2144.05]. Therefore, absent evidence of criticality and/or unexpected results, the claimed pH range(s) is/are considered obvious in view of the prior art. Furthermore, since the apparatus of Bullard is capable of operation wherein the fluid composition present at the application region comprises a pH of about 10.7 to about 12.3 (e.g. pH ~11.0, within the pH range disclosed by Bullard), the claim is therefore met. Applicant has not established on this record any structural distinction between apparatus within the scope of the rejected claims and the apparatus fairly described by Bullard, and no such structural distinction is apparent.
Claim 72 is rejected under 35 U.S.C. 103 as being unpatentable over US Pat. 11,350,640 to Bullard et al. (hereinafter “Bullard”) in view of US Pub. 2012/0244261 to Harvey et al. (hereinafter “Harvey”) as applied to claim 61 above, and further in view of US Pub. 2018/0279635 to Walsh et al. (hereinafter “Walsh”).
Regarding claim 72,
Bullard in view of Harvey discloses the system of claim 61, wherein Bullard discloses that pipe (108) supplies processing solution (112b) to the application region (101) [Fig. 1; col. 6, lines 15-55], but does not explicitly teach a spray cabinet or other spray modality. However, the use of spray cabinets/modalities is commonly known in the art; for example, Walsh discloses a system for treating a foodstuff substrate: comprising a spray bar (29) for spraying a fluid composition within an application region (10) [Fig. 1; ¶0026]; or, alternatively, wherein the application region is a spray cabinet (110) comprising nozzles (119a-123a) for spraying a fluid composition [Fig. 5; ¶0035-¶0036]. Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to modify the application region of Bullard to be a spray cabinet, or to include a spray modality such as a spray bar, as disclosed by Walsh, in order to predictably provide a high velocity flow of fluid composition to the substrate for effective contact/treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL BARR whose telephone number is (571)272-1414. The examiner can normally be reached M-F, 6:30-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Barr can be reached at 571-272-1414. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MICHAEL BARR
Supervisory Patent Examiner
Art Unit 1711
/MICHAEL E BARR/Supervisory Patent Examiner, Art Unit 1711
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