Ex Parte Von Borstel

Board of Patent Appeals and Interferences

Jul 23, 2010

09763955 (B.P.A.I. Jul. 23, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
09/763,955 02/28/2001 Reld W. Von Borstel 1331-334 3848
23117 7590 07/26/2010
NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON, VA 22203
EXAMINER
LEWIS, PATRICK T
ART UNIT PAPER NUMBER
1623
MAIL DATE DELIVERY MODE
07/26/2010 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte REID W. VON BORSTEL
__________

Appeal 2009-015179
Application 09/763,955
Technology Center 1600
__________

Before ERIC GRIMES, LORA M. GREEN, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for treating diseases associated with mitochondrial dysfunction. The
Examiner has rejected the claims for nonenablement and, provisionally,

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2009-015179
Application 09/763,955

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for obviousness-type double patenting. We have jurisdiction under 35
U.S.C. § 6(b). We reverse the nonenablement rejection and affirm the
provisional double patenting rejection.
STATEMENT OF THE CASE
Claims 48-50, 55, 62-64, and 68 are on appeal. Claim 48 is
representative and reads as follows:
48. A method for treating a congenital mitochondrial disease selected
from the group consisting of Mitochondrial Encephalomyopathy, Lactic
Acidemia, Lerber’s Hereditary Optic Neuropathy; Mitochondrial
neurogastrointestinal encephalomyopathy; Progressive External
Ophthalmoplegia; Leigh's Disease; in a mammal comprising administering
to said mammal in need of such treatment an effective amount of a
pyrimidine nucleotide precursor selected from the group consisting of
uridine, an acyl derivative of uridine, cytidine and an acyl derivative of
cytidine.
I.
The Examiner has provisionally rejected claim 55 for obviousness-
type double patenting based on claims 31, 32, and 38-41 of application
09/930,494 (Answer 7). Appellant does not dispute the merits of the
rejection but state that he “will consider filing a Terminal Disclaimer when
otherwise allowable subject matter is indicated” (Appeal Br. 13). Because
Appellant has not disputed the merits of the Examiner’s provisional
rejection, we affirm it.
II.
Issue
The Examiner has rejected claims 48-50, 55, 62-64, and 68 under 35
U.S.C. § 112, first paragraph, on the basis that the Specification does not
Appeal 2009-015179
Application 09/763,955

3
enable a skilled worker to practice the claimed method without undue
experimentation (Answer 3). The Examiner finds that the treatment of
mitochondrial disorders was ineffective and unpredictable at the time of the
invention and cites Przyrembel2 as supporting evidence (id. at 4-5), as well
as the Specification’s statement that metabolic cofactors and vitamins have
not been generally useful as therapeutics (id. at 6). The Examiner
acknowledges the Specification’s working examples but finds that they are
limited to triacetyluridine (id. at 7) and concludes that they “are not
sufficient to support applicant’s claim of the treatment of the instantly
claimed disorders” (id.).
Appellant contends that Przyrembel does not support the rejection
because it was “published in 1987, approximately eight years before the
priority date of the present application” (Appeal Br. 11) and is not indicative
of the state of the art at the relevant time (id. at 12). Appellant also contends
that “Examples 1, 3, 7, 8 and 9 of the present application all deal with
respiratory chain defects and further support enablement of the invention as
claimed” (id.).
The issue with respect to this rejection is: Has the Examiner provided
evidence or sound scientific or logical reasoning sufficient to support a
conclusion that practicing the claimed method would require undue
experimentation?

2 Przyrembel, Therapy of Mitochondrial Disorders, 10 J. INHER. METAB.
DIS. 129-146 (1987).
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Findings of Fact
1. The Specification states that “[t]reatment of diseases involving
mitochondrial dysfunction has heretofore involved administration of
vitamins and cofactors. . . . However, while useful in isolated cases, no such
metabolic cofactors or vitamins have been shown to have general utility in
clinical practice in treating mitochondrial diseases.” (Spec. 2.)
2. The Specification states that “administration of pyrimidine
nucleotide precursors is effective in treatment of a large variety of symptoms
and disease states related to mitochondrial dysfunction” (id. at 8).
3. The Specification states that “compounds and compositions of the
invention are useful for treatment of a very broad spectrum of signs and
symptoms in mitochondrial diseases with different underlying molecular
pathologies” (id. at 22).
4. The Specification states that “functional or conditional pyrimidine
deficiency underlies a wide variety of dominant symptoms in patients with
mitochondrial diseases and . . . pyrimidine supplementation is sufficient to
improve or ameliorate a broad variety of symptoms in such patients” (id. at
23).
5. The Specification provides a working example that describes
treatment of a patient with multisystem mitochondrial disorder with
triacetyluridine (id. at 40). The Specification states that the treatment
“caused improvements in virtually all features of a complex multisystem
disease related to mitochondrial dysfunction in a variety of tissues” (id. at
41).
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Application 09/763,955

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6. The Specification provides a working example that describes
treatment of a patient with Leigh’s Syndrome who displayed renal tubular
acidosis (id. at 42). The Specification states that “[w]ithin several hours
after beginning intragastric treatment with triacetyluridine . . . , her renal
tubular acidosis resolved” and other symptoms improved (id.).
7. The Specification provides a working example describing
treatment of a mouse model for Huntington’s disease with triacetyluridine
(TAU) (id. at 46). The Specification states that “[t]here was decreased
mortality . . . in the mice treated with TAU compared to the controls” (id.) as
well as decreased motor impairment (id. at 47).
8. Przyrembel discloses that
[m]itochondrial disorders . . . are heterogenous in clinical
picture and in response to therapeutic attempts. Defects of fatty
acid metabolism are amenable to therapy by dietary means . . .
and in some cases with vitamins. Defects in pyruvate
metabolism do not respond to therapy except in some special
cases. Therapeutic attempts include dietary measures, vitamins
as coenzyme precursors. Defects in the respiratory chain
appear to respond to treatment only in exceptional cases.
(Przyrembel 129, abstract.)
Principles of Law
When rejecting a claim under the enablement requirement of
section 112, the PTO bears an initial burden of setting forth a
reasonable explanation as to why it believes that the scope of
protection provided by that claim is not adequately enabled by
the description of the invention provided in the specification of
the application; this includes, of course, providing sufficient
reasons for doubting any assertions in the specification as to the
scope of enablement.
In re Wright, 999 F.2d 1557, 1561-62 (Fed. Cir. 1993).
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Application 09/763,955

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“Section 112 does not require that a specification convince persons
skilled in the art that the assertions therein are correct.” In re Armbruster,
512 F.2d 676, 678 (CCPA 1975).
Analysis
The Specification states that the claimed method is useful in treating
“a very broad spectrum of signs and symptoms in mitochondrial diseases”
(FF 3) and to “ameliorate a broad variety of symptoms” in patients with
mitochondrial disease (FF 4). As a basis for doubting these assertions, the
Examiner cites Przyrembel (Answer 5).
However, as Appellant points out, Przyrembel was published in 1987
and therefore has little weight as evidence of the state of the art in 1998, the
apparent effective filing date of the instant application. In addition, the
Examiner has not pointed to any discussion in Przyrembel of the claimed
method of treating mitochondrial disease using pyrimidine supplementation.
The fact that other treatments may have proved ineffective is scant evidence
that the claimed method would not be effective. The same is true of the
Specification’s statement that metabolic cofactors and vitamins have not
been generally useful for treating mitochondrial disease (FF 1).
The Examiner also points out that all of the working examples in the
Specification use a single compound (triacetyluridine) (Answer 7). The
Examiner does not, however, provide any evidence that the results obtained
with triacetyluridine are not indicative of the results that would be obtained
using other acyl derivatives of uridine or cytidine, or with uridine or cytidine
themselves, as recited in the claims. The Examiner therefore has not shown
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Application 09/763,955

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that the working examples are not representative of the full scope of the
claimed method.
In short, the Examiner has not carried the burden of providing an
adequate basis for concluding that the full scope of the claims on appeal are
not adequately enabled by the instant Specification. See In re Wright, 999
F.2d at 1561-62.
SUMMARY
We affirm the provisional rejection of claim 55 for obviousness-type
double patenting, but reverse the rejection of claims 48-50, 55, 62-64, and
68 for nonenablement.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED-IN-PART

cdc

NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON, VA 22203