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 1/16/2026.
Response to Arguments
All of Applicant arguments filed 1/16/2026 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the 112(a) and 112(b) issues presented in the office action mailed 7/21/2025 have been resolved and the rejections are withdrawn.
103 Rejections over Edwards
Edwards does not teach or suggest the claimed invention as a whole
Applicant argues that Edwards primarily discloses and exemplifies 1,25-dihydroxycholecalciferol, not alfacalcidol, these compounds have structural and metabolic differences especially in swine.
This is not persuasive as Edwards specifically teaches that alfacalcidol is a suitable vitamin D3 derivative for use. Even if not exemplified, exemplified embodiments do not teach away from using those which are non-exemplified. Applicant remarks regarding structural and metabolic differences in swine is not persuasive as it is unsupported by factual evidence and Edwards specifically teaches administration to swine.
Applicant remarks that Edwards does not mention ATTD or nutrient retention in pigs and mainly focuses on poultry.
This is not persuasive as discussed in the rejection below Edwards teaches the feed to be effective at increasing Ca and P retention (table 3A) in pigs, but doesn’t teach increased ATTD and a decrease in fecal excretion as 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 function of increasing ATTD, absent evidence to the contrary.
Edwards dosage ranges are non-overlapping
Applicant argues that the dosage ranges of Edwards that overlap with vitamin D3 derivatives are not specific to alfacalcidol.
This is not persuasive as alfacalcidol is taught to be a suitable vitamin D3 derivative for use and Edwards teaches using vitamin D3 derivatives in amounts of 3-6 ug/kg, preferably about 5, and teaches that the composition can be administered to swine, thus the use of any of the suitably taught Vitamin D3 derivatives (i.e. alfacalcidol) in the taught amounts in compositions for swine is obvious. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Criticality of Ranges
In summary, Applicant argues that the amounts of 3.46 and 4.96 ug/kg are critical as detailed in Ex. 1 and table 1-3 wherein the instantly claimed composition are compared with composition not comprising alfacalcidol.
Applicant data presented in not persuasive. 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).
SciFinder fails to cure the deficiencies of Edwards
Applicants arguments are not persuasive for the same reasons discussed above.
Unexpected results and non-obivousness
Applicant argues that species differences make digestive physiology and vitamin D metabolism unpredictable.
This is unpersuasive as it is unsupported by factual evidence and 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 is expected to be effective in swine.
Applicant argues that the claimed method provides significant economic and environmental advantages.
This is not persuasive as it is unsupported by factual evidence.
103 Rejections over Edwards and Zhou
The prior art fails to teach or suggest the claimed method for pigs
Applicant argues that Edwards is directed exclusively to poultry. Applicant cites various references and concludes that there are many factors between species that affect nutritional absorption.
This is not persuasive and unsupported by factual experimental data as 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 effective in swine.
Applicant reiterates that the claimed method represents a non-obvious and unexpected advancement over the prior.
This is not persuasive for the same reasons discussed above.
Applicant reiterated SciFinder does not cure the deficiencies of the prior art.
This is not persuasive for the same reasons discussed above.
The claimed dosage range is narrow and non-obvious
Applicant arguments regarding the range of Zhou are not persuasive as the rejection is not based on using the amounts of Zhou. The rejection is based on using the amounts of Edwards and Edwards teaches using the vitamin D3 derivatives in amounts of 3-6 ug/kg, preferably about 5, which is a narrow range that significantly overlaps with the claimed range.
The claimed functional result is not taught or suggested in the prior art
Applicant arguments are not persuasive, as discussed in the rejection below 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 as claimed. 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 function of increasing ATTD, absent evidence to the contrary.
Species difference preclude a reasonable expectation of success
Applicant arguments are not persuasive for the same reasons discussed above.
New Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-5, 8-13 and 27-31 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “about 3.46” and “about 4.96” while the specification provides sufficient support for 3.46 and 4.96, there is no support for the use of “about” with respect to these amounts. Claims 2-5, 8-13 and 27-31 are rejected in view of their dependency on claim 1 as they do not cure the deficiencies of claim 1 and are deficient for the same reasons.
Claim 29 recites “at or below 100% of a nutritional requirement,” the originally filed specification provides support for 100% and 75% nutritional requirement, this does not provide sufficient support for “at or below 100.”
New Claim Rejections - 35 USC § 112(b)
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.
Claims 4 and 30-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites “the feed composition” it is unclear if this is referring back to the feed composition comprising the 1-alpha-hydroxycholecalciferol or if its referring back to the supplemental feed composition comprising the calcium and phosphorous source.
Claims 30 and 31 recites the limitation "the vitamin D compound". There is insufficient antecedent basis for this limitation in the claim as the claim from which it depends recites 1-alpha-hydroxycholecal.
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 (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 about 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 as 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 function of increasing ATTD, 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. This supported by tables 2-3 which show that 4.96 µg/kg of 1-alpha-hydroxycholecalciferol is effective at obtaining the claimed digestibility and retention and about 5 reads on about 4.96 and is expected to have similar properties 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.
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