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 .
DETAILED ACTION
Status of Claims
Note: The amendment of July 7th 2026 has been considered.
Claims 1 and 11 have been amended.
Claims 3 and 12 are cancelled.
Claims 1, 2, 4-11 and 13-20 are pending in the current application.
Claims 1, 2 and 4-10 are withdrawn from consideration.
Claims 11 and 13-20 are examined in the current application.
Any rejections not recited below have been withdrawn.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35 of the U.S. Code not included in this action can be found in a prior Office action.
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 11 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al (USPatPub. 2013/0280369 A1) in view of Cook et al (USPatPub. 2007/0275152 A1).
Regarding claims 11 and 13-16 : Miller discloses feeding young animals, such as piglets, milk replacer comprising about 30wt% protein that are milk and/or soy based on a daily basis during the first several weeks of life in order to improve the performance (see Miller abstract; paragraphs [0009]-[0016] and [0028]), but fails to disclose an isoflavone supplementation; However, Cook discloses of supplementing domestic animal feed (e.g., piglet feed) with soy isoflavone extracts which are known to include genistein, daidzin and glycitein, specifically 200ppm to 1400ppm (i.e., 0.02% to 0.14%) genistein aglycone (a soy-derived isoflavone), and between 250-1400ppm of soy isoflavone at growth stages including pre-weaning period, in order to impart the consuming animal the health benefits and improved performance associated with genistein aglycone intake (see Cook abstract; paragraphs [0001], [0003], [0006], [0011]-[0012] and [0006]-[0018]; Examples 1 and 2; claims 6 and 18). Which reads on claims 11, 15 and 16: “a milk replacer…comprising at least…50wt% genistein, up to…40wt% daidzein, and a remainder of glycitein…wherein the milk replacer comprises about 700 mg/kg to about 5000 mg/kg of the isoflavone extract”, because a milk replacer comprising 700mg/kg to 5000mg/kg of an extract comprising at least 60wt% or 70wt% genistein and up to 40wt% or 30wt% daidzein is a milk replacer comprising more than 420ppm, or 490ppm to 3000ppm, or 3500ppm of genistein and less than 280ppm, or 210ppm to 2000ppm, or 1500ppm daidzein. Accordingly, it would have been obvious to a skilled artisan at the time the invention was made, to have modified Miller and to have supplemented the milk replacer with the soy derived aglycone in order to impart the health benefits and improved performance associated with genistein aglycone intake to the consuming animal, and thus arrive at the claimed limitations.
As to the formulation of the milk replacer composition to improve one or more of a total weight gain, an average daily gain, a feed intake, or a feed to gain ratio of the young animal in the pre-weaning phase recited in claim 11: While Miller in view of Cook fails to disclose the claimed improvements imparted by milk replacer composition, given the fact Miller modified by Cook discloses a composition with the same constituents at similar amounts, it is examiner’s position the claimed improvements are inherently present in the milk replacer in Miller in view of Cook. As set forth in MPEP §2112.01, "where...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 USC 102, on "prima facie obviousness" under 35 USC 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. See In re Brown, 59 CCPA 1036, 459 F.2d 531,173 USPQ 685 (1972)." In re Best, Bolton and Shaw 195 USPQ 430 (CCPA 1977).
Regarding claim 17-20: Miller discloses of feeding young animals, such as piglets, milk replacer comprising about 30wt% protein that are milk and/or soy based (see Miller abstract; paragraphs [0009]-[0016] and [0028]).
Especially
Response to Arguments
Applicant's arguments filed on July 7th 2026 have been fully considered but they are not persuasive.
Note: With regards to the Applicant initiated interview on July 2nd 2026, the examiner confirmed that an amendment to claim 1 reciting the presence of a remainder of glycitein rather than its exclusion, as previously claimed, would overcome the obviousness rejection on record. As detailed above, similarly to the previous Office action, claims 11 and 13-20 are rejected under 35 USC §103 over Miller et al (USPatPub. 2013/0280369 A1) in view of Cook et al (USPatPub. 2007/0275152 A1); However, currently the claims are not further rejected in view of NPL Jiang et al., as Jiang was used to meet previously claimed exclusion of glycitein limitation. Accordingly, the current rejection is a new rejection.
Applicant argues on page 6 of the “Remarks” the prior art references fail to render the claimed invention obvious, because neither Miller, Cook, nor Jiang, disclose the isoflavone contents recited in the amended claims. The examiner respectfully disagrees.
As stated above, Miller discloses feeding young animals, such as piglets, milk replacer comprising about 30wt% protein that are milk and/or soy based on a daily basis during the first several weeks of life in order to improve the performance (see Miller abstract; paragraphs [0009]-[0016] and [0028]), but fails to disclose an isoflavone supplementation; However, Cook discloses of supplementing domestic animal feed (e.g., piglet feed) with soy isoflavone extracts which are known to include genistein, daidzin and glycitein, specifically 200ppm to 1400ppm (i.e., 0.02% to 0.14%) genistein aglycone (a soy-derived isoflavone), and between 250-1400ppm of soy isoflavone at growth stages including pre-weaning period, in order to impart the consuming animal the health benefits and improved performance associated with genistein aglycone intake (see Cook abstract; paragraphs [0001], [0003], [0006], [0011]-[0012] and [0006]-[0018]; Examples 1 and 2; claims 6 and 18). Which reads on claims 11, 15 and 16: “a milk replacer…comprising at least…50wt% genistein, up to…40wt% daidzein, and a remainder of glycitein…wherein the milk replacer comprises about 700 mg/kg to about 5000 mg/kg of the isoflavone extract”, because a milk replacer comprising 700mg/kg to 5000mg/kg of an extract comprising at least 60wt% or 70wt% genistein and up to 40wt% or 30wt% daidzein is a milk replacer comprising more than 420ppm, or 490ppm to 3000ppm, or 3500ppm of genistein and less than 280ppm, or 210ppm to 2000ppm, or 1500ppm daidzein.
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 ASSAF ZILBERING whose telephone number is (571)270-3029. The examiner can normally be reached M-F 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASSAF ZILBERING/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
