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 .
This office action is in response to the reply filed 9/16/2025.
Response to Arguments
All of Applicant’s arguments filed 9/16/2025 have been fully considered and are not persuasive.
In summary, Applicant argues that Holzgraefe discloses dry feed compositions and provides no guidance for incorporating any of the dry feed ingredients into the compositions of Musser or Costello.
This is not persuasive as Musser already teaches the inclusion of glucose as a peroxidase source and Holzgraefe is just cited to teaches that dextrose (i.e. D-glucose), which is a specific type of glucose, is known in the art to be used in animal feed compositions. As Musser already teaches the inclusion of glucose, which embraces dextrose, into liquid feeds, the use of dextrose in Musser is obvious with a reasonable expectation of success. The expectation of success in using dextrose in Musser comes from the fact that Musser teaches that glucose can be used.
Modified/Maintained 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 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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Musser et al. (US 2016/0000104 A1) in view of Calf Sessions by Rob Costello, October 3, 2017, "Effect of Acidified Milk Replace on the Calf's Digestive Tract," Hebeda (US 4,132,595) and Holzgraefe (US 2009/0191307), as evidenced by Fischer (US 2014/0294742).
Claim ---12 recites "milk replacer composition consisting essentially of" language. However, the specification fails to provide a clear disclosure regarding what would materially change the composition, therefore, absent this disclosure, "consisting essentially of" is interpreted to be "comprising" language.
MPEP 2111.03: For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of applicant’s invention.
Musser is directed to feeding young animals such as calf with milk replacer that contains
fat, hydrogen peroxide source such as sodium percarbonate; the age of the calf is from 2 to 5 days and treatment is conducted for at least 6 weeks (see the whole document, and with emphasis on the abstract; paragraphs [0007]-[0009], [0017], [0027], [0031], [0041]-[0044]).
Musser teaches that sources of hydrogen peroxide are those that decompose into hydrogen peroxide or those that react to form hydrogen peroxide. Sodium percarbonate reduced into hydrogen peroxide and hydrogen peroxide has antimicrobial properties [0017]. Musser teaches that the sources of hydrogen peroxide include one or more of sodium percarbonate and glucose combined with glycose oxidase (selected from a finite number of options) (Musser – claim 3), as such it would have been prima facie obvious to use multiple sources of hydrogen peroxide such as sodium percarbonate and glucose combined with glycose oxidase with a reasonable expectation of success, this reads on the claimed antibacterial system.
Regarding claim 2, the young animal is a calf [0007].
Regarding claims 1, 3, 9, 11 and 13, Musser discloses offering 0.25 gram to 2.5 gram peroxide per feeding (also .00055 and .0055 lbs.; paragraph [0020]) and 0.75 pounds milk replacer powder is used for making milk replacer (paragraph [0019]) such that for a feed containing 0.75 pounds (.000375 tons), then the feed would contain from 1.46 lbs. peroxide source/ton milk replacer powder to 14.67 lbs. peroxide source/tons milk replacer powder which overlaps with the claimed ranges. Furthermore, the use of range of peroxide indicates that the feed mixture can be optimized to afford a milk replacer that would afford the desired health improvement and feed efficiency for the calves.
Regarding claims 19 and 20, the level of the fat content in the milk replacer 15-31 wt.% of the milk replacer powder (paragraph [0027]) and the protein content in the milk replacer is 20-30 wt.% of the milk replacer powder (paragraph [0008]) or 20-25 wt.% or 25-31 wt.% of the milk replacer powder (paragraph [0027]); these amounts overlap with the claimed ranges and overlapping ranges are obvious absent evidence showing the claimed ranges to be critical.
Regarding claim 5, the 2-5 days old calf reads on from birth to 7 weeks of age [0041].
Regarding claims 4 and 14, the milk replacer of Musser contains vegetable proteins such as soy proteins (paragraph [0028]) which meet the limitation of non-milk proteins.
Regarding claim 6, Musser teaches feeding the young animals daily (paragraphs [0030], [0042], [0044]).
Regarding claim 7, Musser teaches using starter feed (paragraph [0046]) and it is reasonable to expect that the starter feed is administered as often as needed.
Regarding claims 8 and 16, Musser teaches that the milk replacer does not contain lactoperoxidase (paragraph [0050]).
Regarding claim 15, Musser teaches that the non-milk protein is present at about 50-65% (paragraph [0028]).
Regarding claim 18, the milk replacer of Musser is not taught to comprise supplemental palatants, such as lactoperoxidase (paragraph [0050]).
In paragraph [0024], Musser discloses that the milk replacer is phosphate buffer at pH 6.0 without specifically stating that the pH of the milk replacer is at 6.0.
However, the difference between Musser and the instant claims is that Musser does not specifically state that the pH of the milk replacer is at about 5.8 as recited by instant claims 1 and 12.
It is noted that about 5.8 reads on 6.0. It could however be inferred that the pH of the milk replacer is at 6.0. However, it is known in the art that the normal pH of milk replacer is at 6.0 and that pH of acidified products range from 5.8 to 4.2 (see at least the second full paragraph of the article, Calf Sessions, by Rob Costello). Therefore, at the effective date of the invention, the artisan would be motivated to ensure the pH of the milk replacer was about 5.8 to reduce the activity of bacteria and reduction in activity of bacteria is described as being beneficial to calf health by adding one or more organic acids (reading on claim 17) to the composition of Musser as Rob Costello teaches that the addition of organic acids to the milk replacer controls bacterial growth.
The presence of percarbonate, dextrose and glucose as the peroxide source in the composition reads on the claimed antibacterial system consisting of the percarbonate, dextrose and glucose. Regarding claim 12, the presence of percarbonate, dextrose and glucose as the peroxide source and the organic acid in the composition reads on the claimed antibacterial system consisting of the percarbonate, dextrose, glucose and organic acid.
The claimed method requires the steps of reducing salmonella in a milk replacer by admixing therewith an organic acid and an antibacterial system. As discussed above, the prior art teaches a milk replacer comprising the claimed antibacterial system and makes obvious adding an organic acid, which results in a composition comprising both the organic acid and the antibacterial system mixed together. It is noted that claim 1 recites “method comprising” which permits the inclusion of additional ingredients into the milk replacer.
While Musser makes obvious the inclusion of glucose and glucose oxidase, Musser does not teach specifically teach dextrose.
Hebeda teaches dextrose production and teaches that dextrose is oxidized by glucose oxidase to form hydrogen peroxide (col. 5, lines 15-25). Holzgraefe teaches animal feeds comprising dextrose and teaches dextrose is a generic term for glucose monohydrate [0015].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Musser and substitute glucose with dextrose as these are taught to be equivalent sugars that when combined with glucose oxidase form hydrogen peroxide and the prior art teaches that dextrose is also known as glucose monohydrate. One of skill in the art would have a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention, dextrose (also glucose monohydrate) is known to be used in animal feed and Musser teaches the inclusion of glucose.
As recognized by MPEP §2144.06, it is prima facie obvious to substitute art-recognized equivalents, and an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).
Instant claims 1 and 12 appear to be stating the obvious that when the milk replacer containing sodium percarbonate, which is the milk replacer of claim 12 used in the method of instant claim 1 and disclosed by Musser, is compared with milk replacer that does not contain sodium percarbonate, the milk replacer of claims 1 and 12 would have reduced Salmonella concentration over an 8 hour period. Because the milk replacer of Musser contains sodium percarbonate, it flows that, the milk replacer of Musser would also been expected to have reduced concentration of Salmonella over an 8 hour period and hence would have been contaminated with salmonella as required by claim 10.
The express, implicit, and inherent disclosures of a prior art reference may be relied upon
in the rejection of claims under 35 U.S.C. 102 or 103. "The inherent teaching of a prior art
reference, a question of fact, arises both in the context of anticipation and obviousness." In re
Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C.
103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731,739,218 USPQ 769, 775 (Fed. Cir. 1983).
Musser teaches that hydrogen peroxide has antimicrobial properties and Musser makes obvious a composition comprising sodium percarbonate, dextrose and glucose oxidase which is taught to reduce into hydrogen peroxide, therefore, the composition of Musser reads on “antimicrobial systems.” This is supported by Fischer, who provides evidence that sodium percarbonate is an anti-bacterial compound (Fischer – claim 2).
Musser in view of Rob Costello renders claims 1-20 prima facie obvious.
Instant claim 1 recites “antibacterial system consisting of a dextrose, sodium percarbonate and glucose,” as discussed Musser is directed to feeding young animals a peroxide source such as percarbonate and teaches the peroxide source to have antimicrobial properties [0017], this reads on antibacterial system as claimed. The halide component of Musser is not taught to be part of the antibacterial system, furthermore, the milk replacer in claim 1 recites “method comprising,” the comprising language is open-ended and allows for the inclusion of the additional ingredients such as halide of Musser along with the peroxide sources.
Conclusion
No claims are allowable.
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 Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613