Ex Parte Buck et al

Patent Trial and Appeal Board

Jun 17, 2016

12867372 (P.T.A.B. Jun. 17, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/867,372 11/09/2010
23117 7590 06/21/2016
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-4662-1633 9557
EXAMINER
QAZI, SABIHA NAIM
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
06/21/2016 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 WOLFRAM1
Appeal2014-003362
Application 12/867,372
Technology Center 1600
Before LORA M. GREEN, MELANIE L. McCOLLUM, and
JOHN G. NEW, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1Appellants state the real party-in-interest is DSM IP ASSETS B.V. App.
Br. 3.
Appeal2014-003362
Application 12/867,372
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 7-102 as unpatentable under 35 U.S.C.
§ 103(a) as being obvious over the combination ofNduaka et al. (US
2005/0101578 Al, May 12, 2005) ("Nduaka") and Tritsch et al. (US
2003/0170324 Al, September 11, 2003) ("Tritsch").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
REPRESENTATIVE CLAIM
Claim 7 is representative of the claims on appeal and recites:
7. A kit comprising multiple, separate dosages of
a) Vitamin D and
b) 25-0H D3.
App. Br. 12.
ISSUES AND ANALYSES
We agree with, and adopt, the Examiner's findings and conclusion
that the appealed claims are prima facie obvious over the cited prior art
references. Final Act. 4-9. We address the arguments raised by Appellants
on appeal below.
2 Claims 1-6 and 11-20 are withdrawn. App. Br. 11-15.
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Application 12/867,372
Issue 1
Appellants argue the Examiner erred because a person of ordinary
skill would have had no reason to combine the teachings ofNduaka and
Tritsch. App. Br 8.
Analysis
The Examiner finds Nduaka teaches kits for use by a consumer to
treat hypercalemic tetany or hyperparathyroidism. Final Act. 4. The
Examiner finds Nduaka teaches the kits comprise a) a pharmaceutical
composition comprising a 2-alkylidene-19-nor-vitamin D derivative and, in
particular, 2-methylene-19-nor-20(S)-la, 25-dihydroxyvitamin D3, and a
pharmaceutically acceptable carrier, vehicle or diluent; and b) instructions
describing a method of using the pharmaceutical composition to treat
hypercalcemic tetany or hyperparathyroidism. Id. (citing Nduaka ii 69).
The Examiner finds Tritsch teaches the combination of vitamin D3
and 25-dihydroxyvitamin D3. Final Act. 6. The Examiner finds Tritsch
teaches that vitamin D3 can be added to a composition containing 25-
hydroxyvitamin D3. Id. (citing, e.g., Tritsch ii 63; Example 7).
The Examiner concludes it would have been obvious to one skilled in
the art to prepare a kit for the combination of vitamin D3 and 25-
hydroxyvitamin D3 at the time the invention was filed because Nduaka
teaches vitamin D and 25-hydroxyvitamin D and various type of kits and
detail description of the instruction and Tritsch teaches a combination of
both vitamins as presently claimed. Final Act. 7. The Examiner finds a
person of ordinary skill in the art would know how to prepare a kit of known
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Application 12/867,372
active ingredients and how to use them, and concludes that the claims are
therefore prima facie obvious. Id.
Appellants argue N duaka teaches treating hypocalcemic tetany or
hypoparathyroidism by administering a therapeutic amount of 2-methylene-
l 9-nor-20(S)-l a, 25-dihydroxyvitamin D3. App. Br. 6-7. According to
Appellants, the Examiner relies upon paragraphs 69-73 as teaching a "kit"
for use in the method of treatment as required by claim 7. Id. at 7.
However, Appellants argue, the Examiner admits Nduaka does not teach the
combination of Vitamin D and 25-0H D3. Id. (citing Final Act. 6).
Appellants assert the Examiner provides no reasoning as to why a person of
ordinary skill in the art would have added Vitamin D and 25-0H D3 to
Nduaka's kit containing the vitamin D3 derivative. Id.
Appellants contend Tritsch does not cure the deficiencies ofNduaka.
App. Br. 7. Appellants assert Tritsch teaches a composition comprising 25-
0H D3 for animal feed. Id. (citing Tritsch iJ 63; Example 7) ("Suitable
vitamins include all vitamins and derivatives thereof [including] ( ... Vitamin
D3, ... and combinations thereof))." Appellants point to Example 7, which,
they assert, teaches a premix composition containing 25-0H D3 and vitamin
D3, as well as other components. Id. (citing Tritsch Table 4). Appellants
contend Example 7 is directed only to the determination of the composition,
and further argue that Tritsch teaches including Vitamin D and 25-0H D3 in
the composition had no effect on stability. Id. at 7-8. Appellants contend
that a person of ordinary skill in the art would therefore have had no reason
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Application 12/867,372
to include both Vitamin D3 and 25-0H D3 in the kit taught by Nduaka. Id.
at 8.
With respect to Example 8 of Tritsch, Appellants argue Tritsch
teaches the stability of 25-0H D3 was less than that of Vitamin D3, whereas
the complete premix (which does not contain the combination of Vitamin D3
and 25-0H D3) results in "dramatically different" stability of 25-0H D3, as
shown in Tritsch's Figure 8. App. Br. 8 (citing Tritsch Table 4, ,-i 100).
Appellants contend that Tritsch thus teaches that its feed should not
comprise both Vitamin D3 and 25-0H D3 due to reduced stability. Id.
Appellants next argue a person of ordinary skill in the art would not
have had a reasonable expectation of success in combining Nduaka and
Tritsch to produce a kit for human therapeutics, because Nduaka teaches, in
one example, only the administration of dihydroxyvitamin Ds, and not
Vitamin D3, to vitamin D-deficient immature rats to measure intestinal
calcium transport. Id. at 7-8 (citing Nduaka ,-i 133; Table 1 ).
We are not persuaded by Appellants' arguments. The inventive
concept of claims 7-10 is not the chemical compositions of Vitamin D3 and
25-0H D3, both of which are well-known in the art and which Tritsch
teaches may be used in combination. Nor is the inventive concept a method
or process. Rather the inventive concept of the claims is a "kit" containing
the named chemicals, with instructions for use (claim 8) and with at least
seven (claim 9) or at least thirty (claim 10) dosages contained therein.
Nduaka teaches:
Advantageously, the present invention also provides kits
for use by a consumer to treat hypocalcemic tetany or
hypoparathyroidism.
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Application 12/867,372
A "kit" as used in the instant application includes a
container for containing the pharmaceutical compositions and
may also include divided containers such as a divided bottle or a
divided foil packet. The container can be in any conventional
shape or form as known in the art which is made of a
pharmaceutically acceptable material.
It may be desirable to provide a written memory aid, where
the written memory aid is of the type containing information
and/or instructions for the physician, pharmacist or patient, e.g.,
in the form of numbers next to the tablets or capsules whereby
the numbers correspond with the days of the regimen which the
tablets or capsules so specified should be ingested or a card
which contains the same type of information.
Nduaka ,-i,-i 69-72. Nduaka thus teaches a "kit" for dispensing various
amounts of dosages and containing instructions. Moreover, Nduaka teaches
Vitamin D and 1, 25 (OH)2D3 as agents in the treatment of hypocalcemic
tetany and hypoparathyroidism. Nduaka ,-i,-i 133-134.
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Moreover, "[i]f a
person of ordinary skill can implement a predictable variation, § 103 likely
bars its patentability." Id. at 417. In this instance, Tritsch teaches well-
known chemicals administered together and Nduaka teaches their inclusion
in a kit with features that teach the limitations of claims 7-10. Appellants
make no persuasive argument that packaging the Vitamin D and 25-0H D3
must be done separately in the claimed kit. We consequently affirm the
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Examiner's rejection of the claims as being obvious over the combined cited
prior art.
Issue 2
Appellants contend the Examiner erred because the combination of
Vitamin D3 and 25-0H D3 exhibit unexpected results. App. Br. 6.
Analysis
Appellants contend that 25-hydroxylated metabolites (25-0H D) of
either Vitamin D2 or Vitamin D3 in plasma increase synergistically when a
combination of Vitamin D and 25-0H D3 is administered to a human
subject. App. Br. 6 (citing Spec 3). According to Appellants, the
combination of Vitamin D and 25-0H D3 also acts synergistically to
regulate several Vitamin D-responsive genes. Id. Therefore, Appellants
argue, this combination provides two significant advantages: (1) a rapid and
synergistic increase in the plasma response of 25-0H D; and (2) an
unexpectedly pronounced and long plateau in the plasma 25-0H D level. Id.
Appellants assert these are important goals for the treatment of Vitamin D
deficiency; the rapid effects provide acute bioavailability, while the latter
effects ensure extended bioavailability. Id. (citing Spec 7). Appellants
assert the clinical study described on pages 17-20 of the Specification
provides confirmation of the claimed invention's efficacy. Id.
We are not persuaded. Although secondary considerations, including
unexpected results, must be taken into account, they do not necessarily
control the obviousness conclusion. Newell Cos., Inc. v. Kenney Mfg. Co.,
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864 F.2d 757, 768 (Fed. Cir. 1988). Moreover, unexpected results must also
be "commensurate in scope with the degree of protection sought by the
claimed subject matter." In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005).
In the appeal before us, even assuming, arguendo, that Appellants'
experimental results do demonstrate a synergistic effect, the scope of the
claims on appeal constitutes a kit containing the two claimed compounds.
Appellants do not claim a method of administering the compounds for the
treatment of Vitamin D deficiency, nor do they claim that the kit per se
possesses any unusual features or results. They claim merely a kit
containing Vitamin D and 25-0H D3, which defines the scope of their
claims. The treatment of Vitamin D deficiency by administration of the
claimed compounds from the kit is not commensurate in scope with
Appellants' claims. In addition, Appellants have not shown that packaging
as a "kit" the two compounds, as disclosed in combination in Tritsch,
provides unexpectedly superior results. We therefore conclude that
Appellants' cited results do not overcome the Examiner's prima facie case
of obviousness.
DECISION
The Examiner's rejection of claims 7-10 as unpatentable under 35
U.S.C. § 103(a) is affirmed.
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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. § l.136(a)(l). See 37 C.F.R.
§ l.136(a)(l )(iv).
AFFIRMED
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