Ex Parte Elliott et al

Patent Trial and Appeal Board

Oct 30, 2018

12440788 (P.T.A.B. Oct. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/440,788 11/06/2009
23117 7590 11/01/2018
NIXON & V ANDERHYE, PC
901 NORTH GLEBE ROAD, 11 TH FLOOR
ARLINGTON, VA 22203
FIRST NAMED INVENTOR
Robert Elliott
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
ES-4662-1080 6591
EXAMINER
QAZI, SABIHA NAIM
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
11/01/2018 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
PTOMAIL@nixonvan.com
pair_nixon@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte ROBERT ELLIOTT and GILBERT WEBER1
Appeal2017-010801
Application 12/440,788
Technology Center 1600
Before ULRIKE W. JENKS, JOHN G. NEW, and JOHN E. SCHNEIDER,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants identify DSM IP Assets B.V. as the real party-in-interest. App. Br. 3.
Appeal2017-010801
Application 12/440,788
SUMMARY
Appellants file this appeal under 35 U.S.C. § I34(a) from the Examiner's
Final Rejection of claims 1, 4, 6-9, and 11-13 as unpatentable under 35 U.S.C.
§ I03(a) as being obvious over the combination of De Luca (US 3,646,203,
February 29, 1972) ("De Luca"), Rebhan (US 4,931,290, June 5, 1990)
("Rebhan"), J. Kelly, Magnesium and Milk Fever, IN PRACTICE 168 (1988)
("Kelly"), and R. L. Horst et al., Role of Vitamin D in Calcium Homeostasis and
Its Use in Prevention of Bovine Periparturient Paresis, 97 ACTA VET. SCAND.
SUPPL. 35-50 (2003) ("Horst"). 2
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to the use of one or more vitamin D3
compounds chosen from the group I-a-hydroxy vitamin D3, 25-hydroxy vitamin
D3, 1-a-25-dihydroxy vitamin D3, in combination with one or more magnesium
salts to prevent milk fever in animals. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A method of substantially ameliorating milk fever in an
animal prior to calving comprising:
administering a dry food composition comprising:
2 Claims 17-22, rejected by the Examiner in the Final Office Action, have been
withdrawn as being directed to a non-elected species. Final Act. 13.
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Application 12/440,788
App. Br. 30.
from about 100 µg per kg to about 1000 µg per kilogram 25-
hydroxy vitamin D3, and one or more magnesium salts, to said
animal.
ISSUES AND ANALYSES
We expressly adopt the Examiner's findings, reasoning, and conclusion that
the claims are prima facie obvious over the combined cited prior art. We address
Appellants' arguments below.
A. Rejection of claims 1, 4, 6-8 and 13
Issue
Appellants argue these claims together as a group. App. Br. 8. Appellants
argue that the Examiner erred in concluding that the claims are obvious over the
combined cited prior art. App. Br. 8.
Analysis
The Examiner finds that De Luca teaches the use of 25-hydroxyvitamin D3
("25-0H D3") added to feed to prevent milk fever in cows, but does not teach or
suggest the addition of magnesium salts, dry food, and premix. Final Act. 9. The
Examiner finds that Rebhan teaches the addition of magnesium salt and vitamin D3
to animal feed compositions to prevent milk fever. Id.
The Examiner finds that Horst teaches that 25-0H D3 is preferable to
vitamin D3 due to its decreased toxicity. Final Act. 9. The Examiner finds Kelly
teaches the advantages of adding magnesium and calcium for treating and/or
preventing milk fever. Id.
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The Examiner concludes that it would have been obvious to a person
of ordinary skill in the art to add magnesium and calcium to a composition
comprising 25-0H D3 for the treatment and/or prevention of milk fever. Final Act.
9.
Appellants argue that De Luca teaches intravenous, intramuscular,
subcutaneous or bolus administration, but not oral administration of 25-0H D3.
App. Br. 13. Appellants also note that De Luca teaches that the application is
only most effective in a short time before calving and that treatment practices,
including unnecessary dosing, are unsound, expensive and should be avoided. Id.
at 10. According to Appellants, Rebhan does not discuss administration of
magnesium salts or (optionally) vitamin D3 prior to calving. Id. at 13.
Appellants argue that Kelly teaches intravenous administration and not to
oral administration. App. Br. 13-14. Appellants argue that Horst teaches
intramuscular administration of 25-0H D3. Id. at 14. Appellants acknowledge that
Horst teaches the addition of vitamin D in the diet, Appellants contend that the
claims are directed to 25-0H D3, and not to vitamin D. Id. Therefore, Appellants
argue, the combination of the cited references does not teach the administration of
the claimed 25-0H D3 in a dry food prior to calving. Id.
We disagree. "[O]ne cannot show non-obviousness by attacking references
individually where ... the rejections are based on combinations of references." In
re Keller, 642 F.2d 413,426 (C.C.P.A. 1981). Contrary to Appellants' arguments,
De Luca expressly teaches the administration of 25-0H D3 orally prior to calving.
Claims 1, 2, and 4 of De Luca teach:
Having thus described the invention what is claimed is:
1. The method of treatment and prophylaxsis [sic] for milk
fever disease (parturient paresis) in dairy cattle which comprises
internally administering to the cattle 25-hydroxycholecalciferol [i.e.,
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25-0H D3J in an amount sufficient to induce said treatment and
prophylaxsis [sic].
2. The method of claim 1 in which the treatment comprises
administering from about 200 to about 400 µg of 25-
hydrocholecalciferol to each cow at least one day prior to calving.
4. The method of claim 1 in which the treatment is oral.
(Emphases added). De Luca thus expressly teaches oral administration of 25-0H
D3.
We agree with Appellants that Rebhan is directed to the treatment of cows,
immediately postpartum, with:
An effective quantity of a water-soluble calcium compound
( desirably providing at least about 40 grams and preferably at
least about 75 grams of calcium), and an effective quantity of a
compound capable of forming a water-insoluble complex with
phosphorus.. . . the compound capable of forming a water
insoluble complex with serum phosphorus is preferably an oxide,
hydroxide or salt of magnesium ....
And that: "The dosages referred to above desirably also include Vitamin D3, each
dosage including preferably at least 20,000 USP units of Vitamin D3," and that the
purpose of such administration is: "for treating postpartum dairy cows to reduce
the propensity of the cows to develop severe milk fever. Rebhan col. 2, 11. 13-15,
20-23, 5---6. Furthermore, Rebhan teaches that its composition: "may also be
sprinkled on or combined with feed such as hay." Id. at col. 5, 11. 42--43.
Although Rebhan does not teach prepartum administration of its
composition, and only teaches administering its composition immediately
postpartum and thereafter (see Rebhan col. 2, 11. 8-9), Rebhan does teach that it
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was known in the art to use prepartum treatments as well, including administering
25-0H D3, to prophylactically prevent the postpartum onset of milk fever:
Methods of combating milk fever included feeding prepartal
diets low in calcium, adjusting the dietary calcium-to-
phosphorus ratio, feeding acidic diets, mineral acids, or
ammonium chloride prepartum, short term administration of 90
to 100 g of calcium chloride daily, feeding massive doses of
vitamin D prepartum, and prepartum administration of 25-
hydroxy-cholecalciferol.
Rebhan, col. 1, 11. 36-43 (describing prior art; emphasis added). We agree with the
Examiner that it would have been within the skill of an ordinary artisan to combine
the teachings of Rebhan (and Rebhan's cited prior art) with the other cited
references to administer a combination of 25-0H D3 and magnesium salts
prepartum.
We also disagree with Appellants' contention that Kelly is directed to
intravenous, but not oral, administration of magnesium. Kelly is directed to the
relationship between magnesium and the prevention of milk fever. See Kelly, title,
Fig. 1. Kelly expressly teaches that: "Calcined magnesite in cereal or concentrate
may be [the] most reliable way of ensuring [a] regular supply of magnesium."
Kelly 170. We find that a person of ordinary skill in the art would understand that
adding calcined magnesite to cereal, which is ingested orally, constitutes oral
administration of magnesium.
Finally, we disagree with Appellants that Horst is directed only to the
administration of vitamin D. The Examiner relies upon Horst as teaching that
vitamin D3 is a prohormone of the active form, and is converted, first to its
metabolite 25-0H D3 and then subsequently to the active form of the hormone,
1,25 dihydroxyvitamin D3. Horst 36. Horst expressly teaches that: "There is no
question that the active metabolites and analogues work and have advantages over
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the parent compounds vitamin D2 and vitamin D3 because of their shorter half-life
and reduced toxicity." Id. at 45. We therefore agree with the Examiner that a
person of ordinary skill in the art would be motivated to substitute 25-0H D3 for
vitamin D, as suggested elsewhere in the art, due to its reduced toxicity and shorter
half-life.
Appellants next argue that the combined cited prior art neither teaches nor
suggests administration of 25-0H D3 and one or more magnesium salts in dry food.
App. Br. 15. We disagree. As we have explained supra, De Luca teaches oral
administration. See De Luca claim 4. Rebhan teaches adding its composition of
25-0H D3 and magnesium salts to feed. See Rebhan col. 5, 11. 42--43. Kelly
teaches the addition of magnesium salts to cereals in the diet. See Kelly 170. We
agree with the Examiner that the combined teachings of the references would lead
a person of ordinary skill in the art to conclude that it would be obvious to add
Appellants' claimed composition to a dry food composition to prevent milk fever
prior to calving.
Appellants next argue that the Examiner ignored unexpected and beneficial
results arising from their claimed invention. App. Br. 16. According to
Appellants, because the claimed method involve administration via food, there is
no need for manual administration for example, by injection or by pill which is
more expensive at least because (1) a human has to perform the administration,
(2) a human has to keep notes on which animals are administered a composition,
and (3) a human has to ensure that the administration is correctly done (i.e., the
bolus was swallowed or the injection was to the correct location in the animal);
( 4) a human has to determine the correct time (i.e., before calving) for
administration. Id. Appellants contend that, in cases where an injection or
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determining calving time is involved, a veterinarian is required, further driving up
the cost. Id.
Appellants further assert that manual administration also introduces
unnecessary risks and stresses: any interaction between humans and animals - such
as in an injection or the feeding of a bolus - increases the risks of stress and injury
both to the animal and to the human. Id. Appellants contend that, in contrast to
the art prior to Appellants' invention, the claimed method only comprises adding a
premix to the feed, reducing expenses, risks, and stress for both the animal and for
personnel. Id.
We are not persuaded. As we have explained supra, the prior art cited by
the Examiner teaches the addition of the composition to animal feed. Furthermore:
"[W]hen unexpected results are used as evidence of nonobviousness, the results
must be shown to be unexpected compared with the closest prior art." In re Baxter
Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). Appellants point to no
unexpected results of their claimed method compared to the methods taught by
the prior art, which expressly contemplate oral administration by adding the
compositions to feed. At best, Appellants point to entirely predictable
conveniences, and reductions of cost and stress, that would have been obvious to a
person of ordinary skill in the art, insofar as the method of adding 25-0H D3 and
magnesium salt compositions to feed was already well known the prior art.
Because we are not persuaded by Appellants' arguments that the Examiner
has failed to establish a prima facie case of obviousness, we affirm the Examiner's
rejection of claims 1, 4, 6-8 and 13.
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B. Rejection of claims 9, 11, and 12
Appellants present essentially identical arguments with respect to claims 9,
11, and 12 as were presented supra with respect to claims 1, 4, 6-8, and 13. See
App. Br. 17-28. For the reasons we have explained, we similarly affirm the
Examiner's rejection of claims 9, 11, and 12.
DECISION
The Examiner's rejection of claims 1, 4, 6-9, and 11-13 as unpatentable
under 35 U.S.C. § 103(a) is affirmed.
No time period for taking any subsequent action in connection with this
appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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