Ex Parte Armstrong

Patent Trial and Appeal Board

Sep 27, 2012

11260836 (P.T.A.B. Sep. 27, 2012)

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.
11/260,836 10/27/2005 Randolph K. Armstrong 2294-02100 7420
41332 7590 09/27/2012
CYBERONICS, INC.
LEGAL DEPARTMENT, 6TH FLOOR
100 CYBERONICS BOULEVARD
HOUSTON, TX 77058
EXAMINER
ALTER, ALYSSA MARGO
ART UNIT PAPER NUMBER
3762
MAIL DATE DELIVERY MODE
09/27/2012 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 PATENT TRIAL AND APPEAL BOARD
____________________
Ex parte RANDOLPH K. ARMSTRONG
____________________

Appeal 2010-004591
Application 11/260,836
Technology Center 3700
____________________

Before: PHILLIP J. KAUFFMAN, LYNNE H. BROWNE, and
HYUN J. JUNG, Administrative Patent Judges.

KAUFFMAN, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF CASE
Appellant appeals under 35 U.S.C. § 134 from a rejection of
claims 1-11 and 13-24. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.

THE INVENTION
Appellant’s claimed invention “relates generally to implantable
medical devices and more particularly to implantable medical devices that
have multiple sequenced therapy protocols.” Spec. para. [0001]. Claims 1,
10, 14, 20, and 22 are the independent claims on appeal. Claim 1,
reproduced below, is illustrative of the claimed subject matter:
1. A method of operating an implantable medical device (IMD)
to provide neurostimulation comprising:
(a) storing a plurality of neurostimulation therapy
programs comprising a therapy sequence in storage in the IMD
before operating any of the neurostimulation therapy programs;
(b) operating a first therapy program from the therapy
sequence for a first therapy program time;
(c) the IMD automatically operating a second therapy
from the therapy sequence in the IMD for a second therapy time
following the first therapy time; and
the IMD automatically repeating the therapy programs in
said therapy sequence.

REJECTIONS1
Appellant seeks review of the following rejections:
1. Claims 1-11 and 13-24 under 35 U.S.C. § 103(a) as unpatentable over

1 The Examiner withdrew the rejection of claims 1-11 and 13-24 as
anticipated by Stypulkowski. Ans. 3.
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Stypulkowski2 (US 7,050,856 B2; iss. May 23, 2006).
2. Claims 1-11 and 13-24 under 35 U.S.C. § 102(e) as anticipated by
Marchal (US 6,853,862 B1; iss. Feb. 8, 2005).
3. Claims 1-11 and 13-24 under 35 U.S.C. § 103(a) as unpatentable over
Boveja (US 6,668,191 B1; iss. Dec. 23, 2003).

OPINION3
Claims 1-11 and 13-24 as unpatentable over Stypulkowski
In the Office Action that is the subject of this appeal, these claims
were rejected as anticipated by, and alternatively as unpatentable over
Stypulkowski. Office Action dated Jan. 27, 2009, at p. 2. Then, in the
Examiner’s Answer, the Examiner withdraws the rejection of these claims as
anticipated by Stypulkowski. Ans. 2-3. Because the anticipation rejection
has been withdrawn, it is not before us on appeal. However, in evaluating
the obviousness rejection, we are mindful that if Stypulkowski discloses
each and every element of the claims at issue, such disclosure would render
the claimed subject matter obvious. See In re McDaniel, 293 F.3d 1379,
1385 (Fed. Cir. 2002) (“It is well settled that ‘anticipation is the epitome of
obviousness.’” (citations omitted)).
Claims 1-9
Independent claim 1 is directed to a method of operating an IMD that
calls for operating a first therapy program from the therapy sequence, the
IMD automatically operating a second therapy from the therapy sequence,

2 This reference was published as US 2003/0135248 A1 on Jul. 17, 2003.
3 Though the Examiner indicates that Appellant has mischaracterized the
claimed subject matter, we discern no mischaracterization relevant to our
analysis here. See Ans. 5.
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and the IMD automatically repeating the therapy programs in the therapy
sequence. In other words, claim 1 requires operation of a first therapy
program, a second therapy program, and repetition of that sequence.
The Examiner found that Stypulkowski discloses a finite set of
options for therapy that repeat in a pseudo-random rather than a random
pattern, so that the iteration of Stypulkowki’s process would invariably
repeat the therapy programs in the therapy sequence as called for in
independent claim 1. Ans. 3-4, 6-7. Alternatively, the Examiner concludes
that if Stypulkowski does not disclose repeating the therapy programs in the
therapy sequence as called for in independent claim 1, modification of
Stypulkowski to repeat the therapy programs of the therapy sequence would
have been obvious to a person of ordinary skill in the art. Ans. 4, 6-7. For
the reasons that follow, we cannot agree with this finding or the alternative
conclusion.
To begin, the finding is deficient on its face in that it does not identify
the therapy programs in Stypulkowski that correspond to the claimed first
and second therapy programs. Further, Stypulkowski does not expressly
disclose a method of operating a first and a second therapy program and
repeating that therapy sequence. Stypulkowski, passim.
Stypulkowski discloses that “[e]xperience with deep-brain stimulation
(DBS) in the treatment of movement disorders and epilepsy has indicated
that, in some cases, patients develop a tolerance or adaptation to the
stimulation.” Stypulkowski, col. 1, ll. 30-33. In order to minimize loss of
therapeutic efficacy due to a patient developing physiologic tolerance to
therapeutic stimulation, Stypulkowski discloses a method of dynamically
changing various neural-stimulation-treatment parameters. Stypulkowski,
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col. 1, ll. 6-11; see also, Abstract; col. 2, ll. 58-62. Stypulkowski discloses
that these parameter variations could produce a virtually infinite number of
electrode combinations and stimulus-parameter settings to promote the
desired clinical efficacy. Stypulkowski, col. 7, ll. 10-30. In other words,
Stypulkowski’s method is designed to vary treatment (stimulation) to avoid
repetition that can lead to tolerance or adaptation to that stimulation. See
Stypulkowski, col. 7, ll. 10-11.
Specifically, Stypulkowski’s method of operating an IMD includes a
clinician programming ranges of values for parameters of a patient’s
treatment plan. Stypulkowski, col. 5, l. 61-col. 6, l. 1; fig. 6 (steps 602, 604,
606 and 608). Following this programming, neuro-stimulation therapy in
accordance with those parameters is provided to the patient. Stypulkowski,
col. 6, ll. 8-9; fig. 6 (step 610); see also col. 2, l. 66-col. 3, l. 3.
Following this, at least a first stimulation parameter is pseudo-
randomly varied, and a second stimulation parameter is changed based upon
the pseudo-random variation of the first parameter and a predetermined
relationship between the first and second parameters and that variation.
Stypulkowski, col. 5, ll. 13-25; col. 6, ll. 9-10, 35-41; fig. 6 (steps 612, 614);
see also col. 3, ll. 3-9. The consequence of Stypulkowski’s pseudo-random
variation is that two of the stimulation parameters of this therapy program
differ from that of the first neuro-stimulation therapy program.
After the pseudo-random therapy is completed, the pseudo-random
therapy is repeated. Stypulkowski, fig. 6 (see the line with an arrow from
after step 614 indicating a loop back to before step 612).
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In light of this, Stypulkowski’s initial neuro-stimulation therapy is
followed by pseudo-random therapy, and subsequent therapies are pseudo-
randomly generated.
If the Examiner intended to find that Stypulkowski’s initial neuro-
stimulation therapy corresponds to a first therapy program as claimed, and
the pseudo-random therapy corresponds to a second therapy as claimed, we
cannot agree. In Stypulkowski’s method the first and second therapies are
followed by additional pseudo-random therapies rather than a repetition of
the first and second therapy sequence as called for in claim 1.
If the Examiner intended to find that Stypulkowski’s first pseudo-
random therapy (after the initial therapy) corresponds to a first therapy
program as claimed, and that a subsequent pseudo-random therapy
corresponds to a second therapy as claimed, such finding is also in error.
The third iteration of Stypulkowski’s pseudo-random therapy is intentionally
designed to be different from prior therapies such as the first iteration of the
pseudo-random therapy. Therefore, Stypulkowski’s method will not repeat
the first and second therapies.
Nor can we agree with the Examiner’s alternative conclusion that it
would have been obvious to modify Stypulkowski to repeat a therapy
sequence. Such a modification would result in a method that produces the
very thing that Stypulkowski seeks to avoid (repetition of the therapy
sequence). See App. Br. 11-13.
Accordingly, we cannot sustain the rejection of independent claim 1
and its dependent claims 2-9.

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Claims 10, 11, and 13
Independent claim 10 is directed to a method that includes the steps of
operating a first therapy program, automatically sequencing through
additional therapy programs, and subsequently operating and continuing the
first therapy program.
The Examiner’s finding is deficient in that it does not identify which
therapy program in Stypulkowski corresponds to a first therapy program as
claimed. Ans. 3-4, 6-7. Further, as explained in the analysis of independent
claim 1, supra, Stypulkowski’s method does not repeat therapy programs,
and thus does not operate and continue a first therapy program as called for
in claim 10.
Accordingly, we cannot sustain the rejection of independent claim 10
and its dependent claims 11 and 13 as anticipated by Stypulkowski.

Claims 14-21
Independent claims 14 and 20 are similar to independent claim 1 in
that each method calls for repeating a therapy sequence. As explained in the
analysis of claim 1, supra, Stypulkowski does not disclose repeating a
therapy sequence.
Accordingly, we cannot sustain the rejection of independent claims 14
and 20 and their respective dependent claims 15-19 and 21 as anticipated by
Stypulkowski.

Claims 22-24
Independent claim 22 is directed to a method of operating a
neurostimulator that includes the step of interrupting the automatic
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sequencing of the therapy sequence. The Examiner makes no finding
regarding this limitation. See Ans. 3-4, 7; see also App. Br. 13-14
(identifying this omission); Reply Br. 3. Accordingly, we cannot sustain the
rejection of independent claim 22 and its dependent claims 23 and 24 as
anticipated by Stypulkowski.

Claims 1-11 and 13-24 as anticipated by Marchal4
Claims 1-9
The Examiner made the generalized finding that Marchal’s first and
second therapies are followed by “an additional therapy,” while in contrast,
claim 1 more specifically calls for repeating the therapy programs in the
therapy sequence (i.e., the first and second therapy sequences). See Ans. 4,
(citing Marchal Figures 3, 8a, 8b), 8 (referring to Figure 8 as a subset of
Figure 9). For the reasons that follow, this finding is not adequately
supported by the reference.
Marchal’s Figure 3 depicts a gastroelectric stimulator, and does not
disclose a method of operating an IMD. Marchal, col. 2, ll. 17-18; col. 3, ll.
64-65.
Marchal’s Figures 8a and 8b depict operating a therapy sequence
(therapy 97) that includes operating a first therapy (therapy A), operating a
second therapy (therapy B) and repeating a first therapy (therapy A).
Marchal, col. 2, l. 26; col. 5, l. 60; col. 6, ll. 6-9; figs. 8a, 8b. However, this
method differs from that of claim 1 in that the second therapy (therapy B) of
the therapy sequence (therapy 97) is not repeated.

4 Because this is an anticipation rejection, we do not consider the Examiner’s
conclusion that “repetition of steps is considered obvious within routine skill
in the art.” See Ans. 4.
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Figure 9 depicts a diagram of a method of influencing pancreatic
secretions. Marchal, col. 2, ll. 27-28; col. 7, ll. 31-32; fig. 9. In this method,
the degree of pancreatic influence 106 is measured 108 and used to adjust
the stimulation 106 to achieve the desired pancreatic influence 106.
Marchal, col. 7, ll. 42-44; fig. 9. While such a method is iterative, Marchal
does not disclose which therapy program is administered. Further, Marchal
does not explicitly disclose that Figures 8a and 8b are a subset of Figure 9.
Marchal, passim; contra Ans. 8.
As such, the Examiner has not established by a preponderance of the
evidence that Marchal discloses operating a first therapy program from the
therapy sequence, the IMD automatically operating a second therapy from
the therapy sequence, and the IMD automatically repeating the therapy
programs in the therapy sequence as called for in independent claim 1. See
App. Br. 14; Reply Br. 4-6. Accordingly, we cannot sustain the rejection of
independent claim 1 and its dependent claims 2-9 as anticipated by Marchal.

Claims 10, 11, and 13
Independent claim 10 is directed to a method that includes the steps of
operating a first therapy program, automatically sequencing through
additional therapy programs, and subsequently operating and continuing the
first therapy program.
The Examiner finds that this limitation is “clearly and explicitly
recited in column 5, lines 25-40 of the Marchal reference.” Ans. 8. We
cannot agree.
This cited portion of the reference discloses that a stimulation signal
52 can consist of a first stimulation signal 90 and a second stimulation signal
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92 different from the first, and that there can also be additional stimulation
signals 52 with parameters different from the first and second signals 90, 92.
Marchal, col. 5, ll. 25-40; fig. 6a. Thus, Marchal discloses a sequence of
three different therapy programs. Marchal does not disclose subsequently
operating and continuing the first therapy program (first stimulation signal
90) as called for in claim 10. See App. Br. 14; Reply Br. 4-6.
Accordingly, we cannot sustain the rejection of independent claim 10
and its dependent claims 11 and 13 as anticipated by Marchal.

Claims 14-19
Independent claim 14 calls for repeating a therapy program sequence.
As detailed in the analysis of claim 1, supra, Marchal only discloses
repeating a first therapy (therapy A) and does not disclose repeating a
therapy sequence as called for in independent claim 14. See App. Br. 15;
contra. Ans. 4. Accordingly, we cannot sustain the rejection of claim 14
and its dependent claims 15-19.

Claim 20 and 21
Independent claim 20 calls for repeating a first therapy program after
implementing a plurality of therapy programs. As detailed in the analysis of
claim 1, supra, Marchal discloses repeating a first therapy (therapy A) after
a second therapy (therapy B) as opposed to repeating a first therapy (therapy
A) after implementing a plurality of therapy programs as called for in
independent claim 21. See App. Br. 15; contra. Ans. 4, 8. Accordingly, we
cannot sustain the rejection of claim 20 and its dependent claim 21.

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Claims 22-245
Independent claim 22 is directed to a method of operating a
neurostimulator that includes the step of interrupting the automatic
sequencing of the therapy sequence.
The Specification does not provide a lexicographical definition of
“interrupt,” which is commonly understood to mean “to break the continuity
of (something) in time.”6 The Specification states that a person may cause
the controller to interrupt the sequencing process so that it continues to
operate the current therapy rather than progressing to the next sequential
therapy. Spec. para. [0033]. In another variation, a user interrupts the
sequencing to return to a preceding therapy. Spec. para. [0034]; see also
App. Br. 9 (identifying this as the claimed subject matter). These examples
are consistent with the ordinary meaning in that the action of the person
breaks the continuity of the automatic sequence. Claim 22 does not specify
the cause of the interruption, and we do not import into the claim the
example from the Specification that a person causes the interruption. See,
e.g., In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993) (Although the
claims are interpreted in light of the specification, limitations from the
specification are not read into the claims.). Therefore, claim 22 calls for the
continuity of the automatic sequence to be broken.

5 Appellants argue claims 22-24 as a group, and we select claim 22 as
representative. App. Br. 15; see 37 C.F.R. § 41.37(c)(1)(vii)(2011).
6 Interrupt: To break in upon (an action, process, or condition, esp. speech or
discourse); to break the continuity of (something) in time; to break off, to
hinder the course or continuance of, cause to cease or stop (usually
temporarily); v. trans., def. 1.a., OXFORD ENGLISH DICTIONARY (1989)
(available at http://www.OED.com). We discern nothing in the
Specification inconsistent with this ordinary meaning.

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The Examiner found that Marchal discloses that sequencing can be
interrupted by the patient. Ans. 8 (citing Marchal, col. 4, ll. 4-6; col. 5, ll.
60-67; fig. 8b); see also Ans. 4
Marchal discloses that processor 58 can make changes in the
stimulation signal 52 based upon input 70 from a sensor 54 that measures a
patient parameter (e.g., temperature). Marchal, col. 4, ll. 1-19; fig. 4. This
change of stimulation signal 52 by processor 58 from the sequence to
another therapy (altered stimulation signal 52) is an interruption as called for
in claim 22.
Appellant argues that “[a]djusting a stimulation signal is not the same
as interrupting an automatic sequencing.” Reply Br. 6. This conclusory
assertion is unaccompanied by a cogent explanation of how adjusting
stimulation as disclosed by Marchal differs from an interruption as claimed,
and is unpersuasive of error in the Examiner’s finding.
Accordingly, we sustain the rejection of claims 22-24 as anticipated
by Marchal.

Claims 1-11 and 13-24 as unpatentable over Boveja
Claims 1-11 and 13-21
Independent claim 1 calls for storing a plurality of neurostimulation
therapy programs comprising a therapy sequence in storage in the IMD.
Independent claims 10, 14, and 20 similarly call for the programs to be
stored in the IMD.
The Examiner found that Boveja’s medical device is capable of being
implanted. Ans. 5, 9. The Examiner provides no citation to the reference or
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technical reasoning in support of this finding. Id. For the reasons that
follow, this finding is not supported by a preponderance of the evidence.
Boveja does not explicitly disclose that external stimulator 42 may be
implanted. Boveja, passim.
Boveja’s system and method utilizes an implanted-lead receiver and
an external stimulator 42 that stores the predetermined programs. Boveja,
Abstract; col. 1, ll. 49-57; col. 10, ll. 38-40. External stimulator 42 may be
clipped on a belt or stored in a pocket or other carrying device. Boveja, col.
10, ll. 38-42; fig. 10. External stimulator 42 includes a light emitting diode
that turns “on” to indicate that its external coil 46 is correctly positioned
relative to coil 48. Boveja, col. 10, l. 66-col. 11, l. 2. The fact that such an
indicator must be seen by a patient suggests that the device is not intended to
be implanted in a patient.
Therefore, we agree with Appellant that Boveja does not disclose
storing a plurality of neurostimulation therapy programs comprising a
therapy sequence in an IMD as called for in independent claim 1. See App.
Br. 15. As such, we do not sustain the rejection of independent claims 1, 10,
14, and 20 and their respective dependent claims 2-9, 11, 13, 15-19, and 21.

Claims 22-24
Appellant presents no argument for claims 22-24. App. Br. 15-16,
passim; Reply Br. passim. For that reason, we affirm the rejection of these
claims. See Ex Parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010)
(precedential) (citing Hyatt v. Dudas, 551 F.3d 1307, 1313-14 (Fed. Cir.
2008) for the proposition that the Board may treat arguments appellant failed
to make as waived).
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DECISION
We reverse the Examiner’s decision to reject claims 1-11 and 13-24
under 35 U.S.C. § 103(a) as unpatentable over Stypulkowski.
We reverse the Examiner’s decision to reject claims 1-11 and 13-21
under 35 U.S.C. § 102(e) as anticipated by Marchal.
We affirm the Examiner’s decision to reject claims 22-24 under 35
U.S.C. § 102(e) as anticipated by Marchal.
We reverse the Examiner’s decision to reject claims 1-11 and 13-21
under 35 U.S.C. § 103(a) as unpatentable over Boveja.
We affirm the Examiner’s decision to reject claims 22-24 under 35
U.S.C. § 103(a) as unpatentable over Boveja.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED-IN-PART

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