Ex Parte BUCK et al

Patent Trial and Appeal Board

Jun 19, 2018

13467414 (P.T.A.B. Jun. 19, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/467,414 05/09/2012
23117 7590 06/21/2018
NIXON & V ANDERHYE, PC
901 NORTH GLEBE ROAD, 11 TH FLOOR
ARLINGTON, VA 22203
FIRST NAMED INVENTOR
Neil Robert BUCK
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-4662-2206 3443
EXAMINER
QAZI, SABIHA NAIM
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
06/21/2018 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
Ex parte NEIL ROBERT BUCK, WOUTER CLAERHOUT,
BRUNO H. LEUENBERGER, ELISABETH STOECKLIN,
KAI URBAN, and SWEN WOLFRAM 1
Appeal2017-005108
Application 13/467,414
Technology Center 1600
Before LORA M. GREEN, RICHARD M. LEBOVITZ, and
JOHN G. NEW, 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.
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Application 13/467,414
SUMMARY
Appellants file this appeal under 35 U.S.C. § I34(a) from the
Examiner's Final Rejection of claims 1 and 2 as unpatentable under 35
U.S.C. § I03(a) as being obvious over, Chung et al. (WO 2007/020042 Al,
February 22, 2007) ("Chung"), Tritsch et al. (US 2003/0170324 Al,
September 11, 2003) ("Tritsch"), and H. A. Bischoff-Ferrari, Vitamin D and
muscle function, 1297 INT'L CONGRESS SERIES 143--47 (2007) ("Bischoff-
F errari "). 2
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
NATURE OF THE CLAIMED INVENTION
Appellants' claimed invention is directed to the use of 25-
hydroxyvitamin D3 ("25-0H D3" or "calcifediol") and Vitamin D3 to
increase muscle strength, muscle function. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A pharmaceutical, nutraceutical, food supplement
or food composition comprising 25-hydroxyvitamin D3 (25-0H
D3) and Vitamin D3 in a ratio of 1:6 to 6: 1 in an amount
sufficient to increase or retain or prevent the loss of muscle
function or muscle strength in a human, wherein the amount of
25-0H D3 is selected from the group consisting of:
2 The Examiner also rejected claims 1 and 2 as unpatentable under 35 U.S.C.
§ I03(a) as being obvious over the combination of Bishop et al. (US
8,361,488 B2, January 29, 2013) and Bischoff-Ferrari. Final Act. 3. The
Examiner has withdrawn this rejection. Ans. 2.
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Application 13/467,414
a weekly dose of 7 µg - 350 µg, and
a monthly dose of 30 µg - 1500 µg.
App. Br. 24.
ISSUE AND ANALYSIS
Issue
Appellants argue that the Examiner erred in finding that the combined
cited prior art references teach or suggest all of the limitations of claims 1
and 2. App. Br. 14.
Analysis
The Examiner finds that Chung discloses a combination of both 25-
0H D3 and vitamin D3 in a ratio which overlaps the ratios recited in the
claims. Final Act. 7. The Examiner first points to Example 3 of Chung, in
which the concentrations of both vitamin D3 and 25-0H D3 ("ROVIMIX
Hy-D® 1.25 %") is 0.0800%. Id. The Examiner then points to Example 1
of Chung, which teaches a food composition containing vitamin D3 1000
IU/kg which is supplemented by mixing 50-80 µg (200-3200 IUs3) of 25-
0H D3 per kg of food. Id. (citing Chung, 3, 33, Table 1). The Examiner
also cites Example 4 of Chung, which teaches a conventional dog food
comprising 1200 IUs of vitamin D3, supplemented by 400-3200 IUs of 25-
0H D3 (ROVIMIX Hy-D®, "ROVIMIX")) per kg of food. Id. at 8 (citing
Chung Table 3). The Examiner maintains that Chung teaches dietary
supplements for consumption by humans and animals, which may be a
3 1 µg = 40 IU s.
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prepared and packaged human food ( e.g., mayonnaise, salad dressing, bread,
or cheese food) or an animal feed ( e.g., extruded and pelleted animal feed,
coarse mixed feed or pet food composition). Id.
The Examiner finds that Tritsch is directed to compositions
comprising 25-0H D3, and teaches compositions comprising combinations
of 25-0H D3 and vitamin D3. Final Act. 9. The Examiner points to
Example 5 of Tritsch, which the Examiner finds teaches a premix for animal
feed comprising 0.032% ROVIMIX and 0.08% vitamin D3, which the
Examiner finds corresponds to the range of ratios of vitamin D3 to 25-0H
D3 recited in claim 1. Id. The Examiner also points to Example 7 of
Tritsch, which teaches ROVIMIX and vitamin D3 at weight percentages of
1.00 and 0.64, respectively. Id.
Appellants argue that Chung is directed to fertility treatments and not
a method of strengthening muscles. App. Br. 14. Furthermore, Appellants
point out that Chung teaches: "For example, a tablet may be supplemented
with 25-hydroxy vitamin D3 in an amount to satisfy a daily dosage of 25-
hydroxy vitamin D3 from about 5 to 15 [µ Jg per kg body weight, wherein
the usual daily dose is 1 or 2 tablets." Id. (quoting Chung, 3). Appellants
calculate that, for the average 70 kg human, these values correspond to 350-
1050 µg per day, which is much greater than the doses of 7-350 µg per week
or 30-1500 µg per month recited in claim 1.
Appellants also argue that Chung fails to teach or suggest the range
ratios of vitamin D3 to 25-0H D3 of 1:6 to 6:1 that are recited in the claims.
App. Br. 15. Appellants point to Example 3 of Chung, which teaches that
ROVIMIX, which constitutes 0.08% of the premix mixture comprises only
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1.25% 25-0H D3, whereas the vitamin D3, also constituting 0.08% of the
mixture, is present at 100%. The resulting ratio, Appellants contend, is 1: 80.
Appellants argue that Tritsch is similarly not directed to the
strengthening of muscle. Appellants contend that Tritsch teaches a 1.25%
25-0H D3 composition in a beadlet formulation that is particularly stable.
App. Br. 16 ( citing Tritsch ,r 97). Appellants assert that the premix of Table
3 of Tritsch, therefore, which contains 0.64 wt% of the 1.25% 25-0H D3
beadlet, contains only 80 µgs of 25-0H D3 per gram of the premix
composition. Id.
Appellants argue further that Bischoff-Ferrari does not cure the
defects of Chung and Tritsch. App. Br. 17. Appellants contend that
Bischoff-Ferrari neither teaches nor suggests the claimed weekly and
monthly dosages or the claimed range of ratios of vitamin D3 to 25-0H D3.
Id.
We agree with Appellants that the Examiner has failed to establish a
prima facie case of obviousness. Specifically, we conclude that the
Examiner has not explained how the compositions of the prior art teach or
suggest the composition of claim 1 that contains 7 µg to 350 µg of 25-0H
D3, or 30 µg to 1500 µg of 25-0H D3.
Chung is directed to additives to animal food for the purpose of
increasing fertility rather than increasing muscle strength. See Chung 1
("The present invention relates to the use of 25-hydroxy vitamin D3 to
improve animal fertility").
Chung teaches:
For the purposes of the invention, 25-[0HJ D3 is suitably
administered in amounts from about 0.112 [µJg to about 1.120
[µJg, especially about 0.560 [µJg to about 0.784 [µJg per kg body
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weight of an individual animal per day. Thus, 25-[0HJ vitamin
D3 is suitably added to the food in an amount to satisfy such
dosage requirement. Typically, a boar food may contain from
about 10 [µ Jg to about 100 [µ Jg, especially of from about 50 [µ Jg
to about 80 [µJg 25-[0HJ vitamin D3 per kg food.
Chung 3. Chung also teaches further dosages of approximately 0.125-1.00
µg/kg body mass/ day for dogs, 0 .112-1.120 µg/kg body mass/ day for horses,
and 5-15 [µJg/kg body mass/day for humans. Id. With respect to the latter,
by way of example, if we assume that the average mass of a human adult is
70 kg (although average body masses are not taught by Chung), then Chung
teaches a daily dosage of 350-1050 µg/day, or 2450-7350 µg/week of25-
0H D3. This greatly exceeds the weekly dosage recited in the claims of 7-
350 µg/week or 30-1500 µg/month. Furthermore, these daily dosages
contain more 25-0H D3 than is recited in the claims for the composition.
Moreover, none of these examples teach 25-0H D3 administered in
combination with Vitamin D.
Examples 1, 4, and 5 of Chung disclose combining 25-0H D3 with
Vitamin D. Example 1 teaches adding "50 to 80 µg of 25-[0HJ D3 per kg of
food" to a food composition comprising, in relevant part of 1000 IU s of
Vitamin D3 per kg of food, or 25 µg of Vitamin D3 per kg. 4 Chung 3--4,
Table 1. This results in ratios of 25-0H D3 to Vitamin D of 1:2-1:3.2,
which is within the range of ratios required by the claims. However, without
knowing the amount of food daily consumed by the subject, or the identity
4 Chung specifies that: The food as specified [in Table 1 J is supplemented
with 25-hydroxy vitamin D3 by mixing 50 to 80 mg of 25-hydroxy vitamin
D3 (4 to 6.4 g ofROVIMIX® Hy-D® 1.25% [ ... ])together with the
remaining food items. Chung 4.
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of the subjects (which information is not disclosed by Chung) it is
impossible to know the daily, weekly, or monthly dosage administered.
Thus, although the amount might fall within the claimed amounts, it is not
known from Chung how much total vitamin would be applied to the food.
The Examiner did not adequately explain, in the absence of such knowledge,
why one of ordinary skill in the art would have had reason to formulate a
composition with the claimed amounts.
Examples 4 and 5 of Chung yield similar results; Example 5 teaches a
supplement to a horse food composition in amount to satisfy a daily dosage
of 25-hydroxy vitamin D3 of approximately 0.112-1.120 µg/kg body weight
mixed with an "inclusion level" of 3000 IUs vitamin D3 (75 µg). See Chung
Table 5. Again, the Examiner did not establish, based upon these teachings
of Chung, how this recipe translates into a weekly or monthly dosage of
vitamin D3 or whether it conforms to the required dosage ratios.
We encounter the same problems with the teachings of Tritsch.
Tritsch teaches a premix for use in animal feed compositions comprising
1.00 wt% 25-0H D3 and 0.64 wt% vitamin D3, which is within the range of
ratios required by claim 1. 5 However, although this is a premixture to be
added into the food, the amount of animal feed it is to be added to is
unspecified, and the Examiner did not provide adequate reasoning as to why
5 We do not find persuasive Appellants' argument that this formulation of
Tritsch teaches 1.00 wt% of 1.25% 25-0H D3, with the actual
concentration of 25-0H D3 being therefore much less, i.e., 1.25% of 1.00
wt%. The concentrations are listed in Table 4 under the heading
"VITAMIN" and we interpret this to mean that the value of 1. 00 wt%
refers to the actual concentration of 25-0H D3 in the premixture.
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the premixture would comprise an amount overlapping with the claimed
amount. See Tritsch ,r,r 97-101.
The sole example of Tritsch combining the premixture with animal
feed is obtained by mixing the premixture with a poultry feed. It is unclear
as to the ratios of premixture to feed that is taught by Tritsch, but even if we
assume that it is a 1: 1 mixture ratio, and that vitamin D3 and 25-0H D3 thus
constitute 0.64 and 1.00 wt%, respectively, of the overall composition, the
Examiner did not establish why the claimed amounts would have been
obvious, particularly, without knowing the mass of the poultry (chicken,
duck, or turkey?) and the amount of food consumed per day.
Fischer-Bischoff reviews a number of studies employing
administration of vitamin D as a means of increasing muscle strength and
preventing bone fractures. Fischer-Bischoff Abstr. Fischer-Bischoff does
not generally distinguish between vitamin D3 ( cholecalciferol) and vitamin
D2 ( ergocalciferol) and does not teach administration of 25-0H D3 in any
human patient studies, although it does cite to studies measuring serum
levels of 25-0H D3, the active metabolite of vitamin D.
In summary, we find that the Examiner has failed to demonstrate that
the combined cited prior art teaches or suggests all of the limitations of
claim 1 and claim 2, which depends from claim 1. We therefore conclude
that the Examiner has failed to establish a prima facie case of obviousness
and we reverse the rejection of the claims.
DECISION
The Examiner's rejection of claims claims 1 and 2 as unpatentable
under 35 U.S.C. § 103(a) is reversed.
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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). See 37 C.F.R.
§ 1.136(a)(l )(iv).
REVERSED
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