Ex Parte Buck et al

Patent Trials and Appeals Board

May 24, 2019

12867305 - (D) (P.T.A.B. May. 24, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/867,305 11/02/2010
23117 7590 05/29/2019
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-4662-1630 9068
EXAMINER
QAZI, SABIHA NAIM
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
05/29/2019 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, ELIZABETH STOECKLIN,
KAI URBAN, and SWEN WOLFRAM1
Appeal 2018-003 517
Application 12/867,305
Technology Center 1600
Before RICHARD M. LEBOVITZ, JOHN G. NEW, and
ELIZABETH A. LA VIER, 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.
Appeal 2018-003 517
Application 12/867,305
SUMMARY
Appellants file this Appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1, 3, 7-15, 17, and 19 as unpatentable
under 35 U.S.C. § 103(a) as being obvious over the combination of Bishop
et al. (US 8,361,488 B2, January 29, 2013) ("Bishop"),2 Bishop et al. (WO
2007/092755 A2, August 16, 2007) ("Bishop II"), H.A. Bischoff-Ferrari,
The 25-hydroxyvitamin D Threshold for Better Health, 103 J. STEROID
BIOCHEM. & MOL. BIOL. 614-19 (2007) ("Bischoff-Ferrari"), and M. Visser
et al., Low Vitamin D and High Parathyroid Hormone Levels as
Determinants of Loss of Muscle Strength and Muscle Mass (Sarcopenia):
The Longitudinal Aging Study Amsterdam, 88(12) J. CLIN. ENDOCRIN. &
METAB. 5766-772 (2003) ("Visser").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
2 Some confusion reigns amidst the Final Office Action and the briefs. In
the Final Office Action, the Examiner points to Bishop as teaching
limitations of the claims and citing to various paragraph numbers. See,
e.g., Final Act. 3-4. However, as Appellants point out, the Bishop patent
has no numbered paragraphs, and the numbered paragraphs of Bishop II
do not correspond to those teachings cited by the Examiner. Appellants
contend instead that the Examiner must, in fact, be citing to the parent
application of Bishop, viz., Tabash et al. (US 2009/0176748 Al, July 9,
2009) ("Tabash"). See App. Br. 11. We agree with Appellants, and a
comparison of the texts of Bishop and Tabash permits us to identify the
corresponding text in Bishop (identified by column and line numbers) to
those paragraphs cited by the Examiner. In our analysis, we use the
former to identify the text of Bishop cited in support of the Examiner's
findings of fact.
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Application 12/867,305
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to a method of using 25-hydroxy
vitamin D3 ("25-0H D3") ( calcifediol) to increase muscle strength, muscle
function, or both. Abstr.
REPRESENTATIVE CLAIM
Claim 1 is illustrative of the claims on appeal and recites:
1. A method of increasing or retaining, or preventing the loss of
muscle strength or muscle function in a human comprising orally
administering a combination of 25-hydroxyvitamin D3 ("25-0H D3")
and Vitamin D3 to the human in an amount sufficient to increase
muscle strength, muscle function or both, wherein the Vitamin D3 to
25-0H D3 ratio ranges from 6: 1 to 1 :6; and increasing the expression
of a gene selected from the group consisting of: calsequestrin 2;
dystrophin, muscular dystrophy; myocyte enhancer factor 2C; myocyte
enhancer factor 2D; myomesin 1; myosin X; myosin, heavy
polypeptide 6; myosin, heavy polypeptide 8; myotubularin related
protein 1; nebulin; sarcoglycan, beta; similar to myosin, heavy
polypeptide 4; titin; troponin C; troponin I; and a combination thereof.
App. Br. 26.
ISSUES AND ANALYSES
We are persuaded by, and expressly adopt, the Examiner's findings,
reasoning, and conclusion that Appellants' claims are primafacie obvious
over the combined cited prior art. We address the arguments raised by
Appellants below.
Issue 1
Appellants argue that the Examiner erred in finding that the combined
cited prior art neither teaches nor suggests the limitation of claim 1 reciting:
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"orally administering a combination of 25-hydroxyvitamin D3 ('25-0H D3 ')
and Vitamin D3 to the human in an amount sufficient to increase muscle
strength, muscle function or both, wherein the Vitamin D3 to 25-0H D3
ratio ranges from 6:1 to 1:6." App. Br. 10.
Analysis
Appellants argue that the passages of Bishop cited by the Examiner do
not support the Examiner's conclusion that Bishop teaches the disputed
limitation of claim 1. App. Br. 11-12 ( citing Bishop cols. 2-3, 11. 60-4; col.
20,11.29-31).3
Appellants argue further that Bishop teaches away from administering
a combination of Vitamin D3 and 25-0H D3 via oral administration. App.
Br. 12. According to Appellants, Bishop teaches that use of quick-release,
high-dosage oral Vitamin D3 tablets are not desirable because they have a
number of disadvantages. Id. (Bishop cols. 4-5, 11. 34-11 ). Appellants
argue that Bishop solves these perceived problems by developing a
controlled-release form of a Vitamin D compound tablet/capsule. Id. at 13.
Appellants contend that the only combination of "Vitamin D compounds" in
such a controlled-release tablet/capsule taught by Bishop is a combination of
25-0H D3 and 25-0H D2. Id. Appellants assert that one of ordinary skill in
the art would not have been motivated to combine vitamin D3 and 25-0H D3
( as claimed) in oral administration, because Bishop discourages such use.
Id.
3 Corresponding to Tabash ,i,i 13, 112.
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Application 12/867,305
We are not persuaded by Appellants' arguments. In the Final Action,
the Examiner points, inter alia, to paragraphs [0085]-[0086], [0091 ]-[0093 ],
and [O 112] of Tabash as teaching the administration of a combination of
Vitamin D3 and 25-0H D3 at the constructive dosages (i.e., in "an amount
sufficient to increase muscle strength, muscle function or both") and ratios
recited in the claims. We agree with the Examiner.
Bishop is directed to a: "stable, controlled release formulation for oral
dosing of vitamin D compounds." Bishop Abstr. Bishop also teaches that it
was well known in the art that: "Reduced serum levels of 1, 25-
dihydroxyvitamin D also can cause muscle weakness and growth retardation
with skeletal deformities ( most often seen in pediatric patients)." 4 Bishop
col. 3, 11. 13-16); see also K. Ziambaras et al., Reversible Muscle Weakness
in Patients with Vitamin D Deficiency, 167(6) WJM 435-39 (1997)
("Ziambaras").
Bishop expressly teaches that:
Any vitamin D compound suitable for prophylactic and/or
therapeutic use, and combinations thereof, are contemplated for
inclusion in the formulation described herein. Vitamin D, 25-
hydroxyvitamin D, 1,25-dihydroxyvitamin D, and other
metabolites and analogs of Vitamin D are also useful as active
compounds in pharmaceutical compositions. Specific examples
include, but are not limited to, Vitamin DJ (cholecalciferol),
Vitamin D2 (ergocalciferol), 25-hydroxyvitamin DJ ....
4 1, 25-dihydroxyvitamin D is the biologically active metabolite of 25-0H
vitamin D, which is, in tum, the metabolite of Vitamin D (i.e., vitamin D2
and/or D3). Vitamin D3 is thus metabolically converted to 25-0H D3 in the
liver, which is, in tum, converted to 1, 25-dihydroxyvitamin D3, the
metabolically active hormonal form. See, e.g., Spec. 1.
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Bishop col. 14, 11. 51-59 (emphases added); see also id. at col. 20, 11. 32-40.
Bishop thus expressly teaches compositions comprising a combination of
Vitamin D3 and 25-0H D3.
With respect to the recited constructive effective dosage, Appellants'
Specification discloses a daily dosage containing:
Vitamin D or 25-0H D3 in an amount from about 1 µg to about
50 µg, preferably about 5 µg and 25 µg. Alternatively, a single
daily dosage having both Vitamin D and 25-0H D3 contains
each active ingredient in an amount from about 1 µg to about 50
µg, preferably about 5 µg and 25 µg.
Spec. 14. The Specification also teaches comparable weekly (7 µg to about
350 µg, and preferably from about 35 to 175 µg) and monthly (30 µg to
about 1500 µg, preferably about 75 µg to about 500 µg) dosages. Id. We
therefore find that a person of ordinary skill in the art would have
understood that dosages at or above these levels would constitute "an
amount sufficient to increase muscle strength, muscle function or both."
Claim 1 also requires that: "the Vitamin D3 to 25-0H D3 ratio ranges from
6: 1 to 1 :6."
Bishop teaches:
Compositions comprising Vitamin D3 at a dose of greater than
5,000 IU, or greater than 7,500 IU, or greater than 10,000 IU are
contemplated. Compositions comprising a combination of
cholecalciferol and ergocalciferol at a unit dose of at least 1,500
IU ( combined), or at least 2,000, 2,500, 3,000, 4,000, 5,000,
6,000, 7,000, 7,500, 8,000, 9,000, 10,000, 11,000, 12,000 or
12,500 IU are contemplated. Such unit doses less than 200,000
IU, or less than 100,000 or 75,000 or 50,000 IU are also
contemplated.
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Application 12/867,305
Bishop col. 15, 11. 32-40. The Examiner finds that 40 IUs is equal to 1.0 µg.
See Final Act. 3. Bishop thus teaches administering Vitamin Din dosages of
approximately 50 to 300 µg (when IUs are converted into micrograms).
Bishop also teaches:
The controlled release compositions intended for oral
administration in accordance with the invention preferably are
designed to contain concentrations of the 25-
hydroxyvitaminD2/25-hydroxyvitamin D3 of 1 to 1000 µg per
unit dose and are prepared in such a manner as to effect
controlled or substantially constant release of the 25-
hydroxyvitamin D2/25-hydroxyvitamin D3, .... Preferred dosages
include 1 to 1000 µg per unit dose, 1 to 600 µg, 1 to 400 µg, 1 to
200 µg, 1 to 100 µg, 5 to 90 µg, 30 to 80 µg, 20 to 60 µg, 30 to
60 µg, 35 to 50 µg, 5 to 50 µg, and 10 to 25 µg, for example 20
µg, 25 µg, 30 µg, 40 µg, 50 µg, 60 µg, 70 µg, 80 µg, 90 µg, and
100 µg.
Id. at col. 16, 11. 32-44. Finally, Bishop teaches that:
Advantageously, 25-hydroxyvitamin D2, 25-hydroxyvitamin D3
or combinations thereof together with other therapeutic agents
can be orally or intravenously administered in accordance with
the above described embodiments in dosage amounts of from 1
to 100 µg per day, with the preferred dosage amounts of from 5
to 50 µg per day, for example about 10 to 25 µg.
Id. at cols 16-17, 11. 66-5. Bishop thus teaches administration ofa
combination of Vitamin D3 and 25-hydroxyvitamin D3 for, inter alia, muscle
weakness at concentrations at or above what the Specification discloses as
"an amount sufficient to increase muscle strength, muscle function or both"
and at the ratios of 6: 1 to 1 :6 recited in the claims.
Finally, with respect to Appellants' argument that Bishop teaches
away from Appellants' claimed invention, the passages of Bishop cited by
Appellants and reciting the disadvantages of Vitamin D3 administration are
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Application 12/867,305
directed explicitly to: "[h ]igh doses of immediate[-]release Vitamin D
supplements." Bishop col. 4, 1. 44. However, Bishop is directed primarily
to, as we have noted, a: "stable, controlled release formulation for oral
dosing of vitamin D compounds." Bishop Abstr.
Appellants' claim 1 recites: "A method of increasing or retaining, or
preventing the loss of muscle strength or muscle function in a human
comprising orally administering a combination of 25-hydroxyvitamin D3
('25-0H D3 ') and Vitamin D3 to the human in an amount sufficient to
increase muscle strength, muscle function or both .... " (emphasis added).
The use of the transitional claim term "comprising" indicates that additional
elements to Appellants' claimed invention are ere not precluded by the scope
of the claim. See Crystal Semiconductor Corp. v. Tri Tech Microelectronics
Int'!, Inc., 246 F.3d 1336, 1348 (Fed. Cir. 2001) (holding that use of the
transition "comprising" in the language of a claim creates a presumption that
the claim does not exclude additional, unrecited elements). Appellants'
claim does not, therefore, exclude the administration of a combination of 25-
hydroxyvitamin D3 and Vitamin D3 in a stable, controlled-release
formulation for oral dosing, as taught by Bishop. We consequently conclude
that Bishop does not teach away from administering combinations of
Vitamin D3 and 25-hydroxyvitamin D3, in the claimed amounts and ratios, in
a stable, controlled-release formulation, and which falls within the scope of
the claims.
We conclude that the cited prior art teaches or suggests all of the
limitations of the claims on appeal, and does not teach away from
Appellants' claimed invention.
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Issue 2
Appellants also argue that the Examiner erred because none of the
prior art cited by the Examiner teaches or suggests any form of increasing
gene expression of the recited genes. App. Br. 16.
Analysis
Analysis of Appellants' arguments in this respect need not delay us
long. Appellants contend that administration of the claimed composition
increases the expression of certain genes from a group consisting of:
"calsequestrin 2; dystrophin, muscular dystrophy; myocyte enhancer factor
2C; myocyte enhancer factor 2D; myomesin 1; myosin X; myosin, heavy
polypeptide 6; myosin, heavy polypeptide 8; myotubularin related protein 1;
nebulin; sarcoglycan, beta; similar to myosin, heavy polypeptide 4; titin;
troponin C; troponin I; and a combination thereof." See claim 1; see also
Spec. 25-27. Appellants argue that the cited prior art is silent with respect
to this limitation. App. Br. 16.
We have explained supra why we agree with the Examiner that
Bishop teaches administration of the claimed composition, in the dosages
and ratios recited in the claims, to increase muscle strength, muscle function
or both. The fact that administration of the claimed composition, as recited,
also increases the expression of certain genes does not render the claims
patently distinguishable from the teachings of the prior art. In other words,
Bishop teaches administration of the claimed composition, as recited in the
claims, for the purposes recited by the claims. The fact that practicing the
claim as recited also (and perhaps causally) increases expression of the
recited genes is not sufficient to render the claims patentable over the prior
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art, because discovery of an inherent property of a compound used in the
prior art for the same purpose does not distinguish it from the prior art. In re
Baxter Travenol Labs., 952 F.2d 388 (Fed. Cir. 1991) ("Mere recognition of
latent properties in the prior art does not render nonobvious an otherwise
known invention." Baxter, at 392). We consequently affirm the Examiner's
rejection of the claims.
DECISION
The Examiner's rejection of claims 1, 3, 7-15, 17, and 19 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. § l.136(a)(l). See 37 C.F.R.
§ l.136(a)(l)(iv) (2010).
AFFIRMED
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