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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/4/2026 has been entered.
Response to Arguments
All of Applicant arguments filed 6/4/2026 have been fully considered.
In view of the amendments to the claims, the 112(a) and 112(b) issues presented in the office action mailed 3/12/2026 have been resolved and the rejections are withdrawn.
103 Rejections over Edwards
The Examiner’s inherency argument is improperly applied
Applicant argues that Edwards examples exclusively use 1,25-dihydroxycholecalciferol and while 1-hydroxycholecalciferol is listed as a suitable alternative, listing a compound is not the same as demonstrating its effects.
This is not persuasive as the teaching of a reference are not limited to the exemplified or preferred embodiments. Edwards teaches both 1,25-dihydroxycholecalciferol and 1-hydroxycholecalciferol to be suitable for use and both selected from a finite number of options. They are recognized by Edwards to be art-recognized functional equivalents; thus, the selection of either alternative is prima facie obvious and expected to have similar properties. The effects of the claimed invention do flow from the prior art as the prior art makes obvious the performance of the claimed active method steps with the clamed composition (i.e. Edwards makes obvious the administration of the claimed composition in an effective amounts, to the claimed patient population (i.e. swine/pigs)), therefore the method claimed and the method of the prior art are expected to have the same function/properties, absent factual evidence to the contrary.
Applicant remarks that Edwards never tested any vitamin D3 derivatives in Pigs and the examiner’s inherency arguments relies on multiple inferential leaps.
This is not persuasive and is unsupported by factual evidence as Edwards explicitly teaches pigs to be a suitable for use and Edwards teaches 1,25-dihydroxycholecalciferol and 1-hydroxycholecalciferol to be art recognized equivalents both suitable for use. While the data presented by Edwards focuses on chickens, Edwards teaches the composition to be equally effective in other types of monogastric animals including swine, humans, poultry, turkeys, etc. (col. 6, lines 25-30), as such the composition of Edwards are expected to be equally effective in swine.
Applicant argues that the Examiner cannot assume that ATTD results in pigs flow from retention data in chickens.
This is not persuasive and is unsupported by factual evidence, as discussed above, Edwards teaches the composition to be equally effective in other types of monogastric animals including swine, humans, poultry, turkeys, etc. (col. 6, lines 25-30) and Edwards makes obvious the administration of the claimed composition to pigs, therefore the method claimed and the method of the prior art are expected to have the same function/properties.
Applicant argues that the Examiner cannot rely on Applicant’s own date to support inherency.
This is not persuasive as the instant specification shows that a composition as claimed, administered to pigs, have the claimed properties, therefore, as the prior art makes obvious the claimed composition and the claimed active steps of administration to a pig, the composition of the prior art would be expected to have the same claimed properties.
The specification provides the comparative data the examiner seeks
Applicant argues that example 1 provides the comparative analysis required by the Examiner (i.e. side by side analysis between the claimed invention and the closest prior art.”
This is not persuasive as the comparative composition in example 1 lacks a vitamin D3 derivative, which is shown by the spec to be a critical ingredient, however Edwards does teach the inclusion of a D3 derivative including the claimed compound and art recognized equivalents, as such Edwards is closer prior art than the comparative composition in example 1 and Applicant has not explained how a composition lacking a vitamin D3 derivative is closer prior art than a composition that includes this.
The claimed method produced unexpected results
Applicant argues that table 4 of the specification demonstrates the unexpected effect of increased ATTD gross energy.
This is not persuasive as an applicant bears the burden of proving unexpectedly good results. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). When unexpected results are used as evidence of non-obviousness, the results must be shown to be unexpected compared with the closest prior art. In re Baxter Travenol Labs, 952 F.2d 388, 392, 21 USPQ2d 1281, 1285 (Fed. Cir. 1991); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196, (Fed. Cir. 1984). Here, applicants have failed to provide a side by side analysis between the claimed invention and the closest prior art (Edwards). Furthermore, it is unclear how a change from 84.6/85.6 to 87.3/87.5 is unexpectedly superior as differences are expected, the issue is whether the properties differ to such an extent that the difference is really unexpected.
The Edwards/Zhou combination fails for claims 12-13 and 28
Applicant argues Zhou is using a much higher dosage of an unclaimed Vitamin D3 derivative than claimed and the examiner has not articulated why one of skill in the art would select alfacalcidol at the claimed narrow dosage range for administration to gestating cows.
This is not persuasive as Edwards makes obvious the claimed narrow range of alfacalcidol and the rejection is based on adding 25-hydroxycholecalciferol as taught by Zhou to the composition of Edwards which teaches the claimed alfacalcidol in an amounts that overlap with the claimed range and administer this improved formulation to gestational sows as Zhou teaches multiple benefits to supplementing feed with 25-hydroxycholecalciferol and Edwards teaches administration of feed to pigs containing D3 derivatives. One of skill in the art would have a reasonable expectation of success as the feed of Edwards includes hydroxylated vitamin D3 derivatives and is taught to be suitable for swine which would be recognized by a skilled artisan as including all swine including sows.
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 (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.
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.
Claim(s) 1-5, 8-11, 27 and 29-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (US 5,316,770), as evidenced by SciFinder (Alfacalcidol).
Regarding claims 1 and 27: Edwards discloses vitamin D derivative feed compositions for enhancement of phytate phosphorous utilization, treatment and prevention of tibial dyschondroplasia in animals by administration of a feed containing a hydroxylated vitamin D3 derivative and is preferably administered to animal in feeds containing reduced levels of calcium and phosphorous (Abs).
Edwards teaches that the compositions and methods are equally effective in monogastric animals such has swine, chicks, turkeys, etc. (col. 6, lines 20-30), thus administration of the feed to swine is prima facie obvious.
Edwards teaches the vitamin D3 derivative to be fed to animals in amounts ranging from 1-10 µg/kg feed, preferably between 3 and 6 µg/kg feed, most preferably about 5 µg/kg feed (col. 6, lines 60-67). About 5 µg/kg feed of Edwards reads on the claimed 4.96.
Edwards teaches the vitamin D3 derivatives to include 1,25-dihydroxycholecalciferol and 1-hydroxycholecalciferol (Edwards – claim 1), also known as 1-alpha-hydroxycholecalciferol as evidenced by SciFinder, thus the use of 1-alpha-hydroxycholecalciferol is prima facie obvious.
Edwards teaches the feed to be effective at increasing Ca and P retention (table 3A), but doesn’t teach increased ATTD and a decrease in fecal excretion claimed. However, Edwards makes obvious the administration of the claimed composition in the claimed amounts, to the claimed patient population (i.e. swine/pigs), therefore the method claimed and the method of the prior art are expected to have the same functions of increasing ATTD and decreasing fecal excretion, absent evidence to the contrary.
Regarding claims 2-3: Edwards teaches the feed comprises lower levels of Ca and P (col. 5, lines 20-35) which reads on the Ca, P and vitamin D3 derivative being administered concurrently.
Regarding claims 4-5: Edwards teaches a preferred fed to comprise sources of energy such as corn, vitamin mixtures and trace mineral mixtures which include zinc, manganese, etc. (col. 7, lines 65-67 to col. 8, lines 1-17).
Regarding claims 8-11 and 30-31: As discussed above, Edwards make obvious the inclusion of about 5 µg/kg of the vitamin D3 derivative into the feed and Edwards makes obvious the administration of the claimed composition in an effective amounts, to the claimed patient population (i.e. swine/pigs), therefore the method claimed and the method of the prior art are expected to have the same function of increasing Ca and P digestibilty and retention in the amounts claimed, absent evidence to the contrary.
Regarding claim 29: Edwards teaches that since the compositions increase utilization of calcium and phytate phosphorous, this allows for a reduction in the amount of phosphorus and calcium supplied in the diet (col. 5, lines 20-35) which suggest that the diet is formulated to provide calcium and phosphorous at amounts below 100% of the nutritional requirement.
Claim(s) 1-5, 8-11, 12-13, 27, 28, and 29-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (US 5,316,770), as evidenced by SciFinder (Alfacalcidol), as applied to claims 1-5, 8-11, 27 and 29-31 above, and further in view of Zhou (2017). Zhou is cited on the 9/27/2022 IDS.
As discussed above, Edwards make obvious the limitations of claims 1-5, 8-11, 27 and 29-31 and teaches administration to swine, but does not teach specific administration to a sow in a gestation period s recited by instant claims 12-13.
Zhou teaches that supplementing the feed of Sows during gestation with 25-hydroxycholecalciferol, a hydroxylated vitamin D3 derivative (50 µg/kg feed) allows for improved reproductive performance, milk quality and bone status of sows as well as improved bone quality of newborn piglets (abs).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Edwards with those of Zhou. One of skill in the art would have been motivated to add 25-hydroxycholecalciferol to the formulation of Edwards as taught by Zhou and administer the resulting formulation to Sow’s in gestation as Zhou teaches multiple benefits to supplementing feed with 25-hydroxycholecalciferol and Edwards teaches administration of feed to pigs containing D3 derivatives. One of skill in the art would have a reasonable expectation of success as the feed of Edwards includes hydroxylated vitamin D3 derivatives and is taught to be suitable for swine which would be recognized by a skilled artisan as including all swine including sows.
Regarding claim 28: While the prior art doesn’t specifically identify “late gestation” the prior art makes obvious administration during gestation, as such it would be obvious to administer this during all stages of gestation with a reasonable expectation of success.
Conclusion
No claims are allowable.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613
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