Ex Parte Betzold et al

Board of Patent Appeals and Interferences

Aug 28, 2012

11538711 (B.P.A.I. Aug. 28, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ROBERT A. BETZOLD and JAMES W. BUSACKER
__________

Appeal 2011-011011
Application 11/538,711
Technology Center 3700
__________

Before LORA M. GREEN, MELANIE L. McCOLLUM, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

SNEDDEN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
implantable medical device. The Examiner has rejected the claims as
indefinite, anticipated and obvious. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm.
STATEMENT OF THE CASE
According to Appellants, the invention relates to an implantable
medical device having a replacement timer that defines a replacement time
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period. (App. Br. 3.) The replacement time period begins when an
operational characteristic of the battery reaches a selected value and ends at
a time determined to be the time the device should be replaced. (Id.) The
device also provides a status indicative of remaining time of the replacement
time period. (Id.)
Claims 1-18 and 21-22 are on appeal. The claims stand rejected as
follows:
I. Claims 4-14 stand rejected under 35 U.S.C. §112, second
paragraph.
II. Claims 1-2, 4-8, 11, 12, 14-18, and 22 stand rejected under 35
U.S.C. §103(a) as being unpatentable over Ekwall (U.S. Patent
No. 5,193,538, issued Mar. 16, 1993) in view of Gurewitsch
(U.S. Patent No. 6,400,988 B1, issued Jun. 4, 2002).
III. Claims 3, 9-13, 18, and 21 stand rejected under 35 U.S.C.
§103(a) as being unpatentable over Gurewitsch or Ekwall in
view of Gurewitsch.
IV. Claims 1, 5-7, 9, 11-12, 14-18, and 22 stand rejected under 35
U.S.C. §102(e) as being anticipated by Gurewitsch.
V. Claims 1-18 stand rejected on the ground of nonstatutory
obviousness-type double patenting over claims 1-35 of U.S.
Patent No. 7,123,964.
With regard to Rejection II, Appellants present a separate argument
for claims 4, 8, 11, and 12 (claims 11 and 12 are argued together), but
otherwise argue against the rejection of claims 1-2, 4-8, 11-12, 14-18, and
22 without regard to any particular claim. (App. Br. 26-36.) Thus, in
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accordance with 37 C.F.R. § 41.37(c)(1)(vii), dependent claims 2, 5-7, 14-18
and 22 stand or fall with representative claim 1. We address claims 4, 8 and
11-12 separately. Claims 11 and 12 fall or stand together and claim 11 is
representative of claim 12.
Regarding Rejection III, the claims have not been argued separately
and therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii). Claim 11
is representative.
Representative claims 1 and 11 provide as follows:
1. An implantable medical device, the implantable medical device
comprising:
a battery to power the implantable medical device; and
a replacement indicator timer defining a replacement time period,
wherein the replacement time period is the time from the start of the
replacement time period to a determined replacement date for the
implantable medical device, wherein the determined replacement date
is the date at which the implantable medical device should be
replaced,
wherein the replacement indicator timer is configured such that the
replacement indicator timer is activated to start the replacement time
period when an operational characteristic of the battery reaches a
selected value, and
further wherein the implantable medical device is configured to
make a status indicative of a remaining time of the replacement time
period available after the replacement indicator timer has been
activated.

11. The implantable medical device of claim 1 wherein the replacement
indicator timer varies a counting rate when an operation of the
implantable medical device is modified by a clinician.

Claims 4 and 8 provide as follows:
4. The implantable medical device of claim 1 wherein the replacement
time period is selectable by a clinician.
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8. The implantable medical device of claim 1 wherein the implantable
medical device goes into a lower power mode when the determined
replacement date is reached if the implantable medical device has not been
communicated with during the replacement time period.

I.
Issue
The Examiner has rejected claims 4-14 under 35 U.S.C. § 112, second
paragraph, as indefinite. The Examiner finds that “the claims are attempting
to further limit functional limitations and not further limit the positively
recited elements” and thus lack clarity. (Ans. 14.)
Appellants contend that there is no legal basis presented in the
Examiner's Answer to support the Examiner's rejections. (Reply Br. 4).
The issue with respect to this rejection is: Whether claims 4-14,
reciting functional-like language, are prima facie indefinite?
Findings of Fact
FF1. The Examiner has asserted one or more of the following: the
claim is vague since it is more like a method step; there is no structure
presented; the claim is not further limiting since there is not any further
structural limitation; and that the claim is incomplete for omitting an
element. (See Final Office Action 3-4; See also, Ans. 14.)
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Principles of Law
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Analysis
“There is nothing inherently wrong with defining some part of an
invention in functional terms. Functional language does not, in and of itself,
render a claim improper.” MPEP § 2173.05(g), citing In re Swinehart, 439
F.2d 210 (CCPA 1971). Examiners should not make per se technical
rejections on the basis that a claim may contain functional language. See
MPEP § 2173.02. Here, the Examiner appears to reject the claims on the
basis that they contain functional, rather than structural limitations, without
any analysis as to why the skilled artisan would not understand the meets
and bounds of the structure that would meet the function. Thus, the
rejections appear to be per se rejections, which are improper as explained
above.
Conclusion of Law
We conclude that the Examiner has not met the burden of establishing
a prima facie case of indefiniteness.
We thus reverse the rejections of claims 4-14 under 35 U.S.C. § 112,
second paragraph.

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II.
Issue
The Examiner has rejected claims 1-2, 4-8, 11-12, 14-18, and 22
under 35 U.S.C. § 103(a) as obvious. The Examiner finds that “it would
have been obvious to one having ordinary skill in the art at the time the
invention was made to include in the device and method as taught by Ekwall
with the use of making the remaining time available, such as the date of
[recommended replacement time] for an [implantable medical device], as
taught by Gurewitsch since such a modification would provide the
predictable results of allowing the physician with the suggested time for
replacing the [implantable medical device].” (Ans. 9.)
Appellants contend that that “Ekwall and Gurewitsch, taken alone or
together, fail to teach or suggest all the claim elements recited in
independent claim 1 because nothing has been identified by the Examiner
within either of Ekwall or Gurewitsch that describes a replacement indicator
timer defining a replacement time period” as defined by the claims. (Reply
Br. 8).
The issue with respect to this rejection is: Whether the combination of
Ekwall and Gurewitsch renders obvious all elements of claims 1, 4, 8 and
11.
Additional Findings of Fact
FF2. The implantable medical device of the present claims includes a
timer that defines a replacement time period with a start and ending point.
The replacement time period begins when the operational characteristic of
the battery (e.g., battery impedance or output voltage) reaches a selected
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value and ends on a determined replacement date, the date at which the
device should be replaced. (See claim 1; see also Specification, ¶ [0036].)
FF3. Ekwall discloses an implantable medical device that defines a
“safety time”, which is the time between an elective replacement time (ERT)
and the end of life (EOL) time. (See Ekwall at column 2, lines 20-34.)
FF4. Ekwall teaches that the ERT is the point at which the battery
capacity approaches a critical first threshold value, the ERT value. (See
Ekwall, col. 2, ll. 20-22.)
FF5. Ekwall teaches that the EOL is the point at which the battery
capacity approaches a lower second threshold value, the EOL value. (See
Ekwall, col. 2, ll. 23-25.)
FF6. Ekwall teaches that the EOL value may be adjusted such that the
“EOL-value can be set so low that the pacemaker ceases to function when it
reaches this value” or it may be set “somewhat above this value.” (Ekwall,
col. 2, ll. 30-34.)
FF7. Ekwall teaches that an alarm function may be linked to the
EOL-value. (See Ekwall, col. 2, ll. 33-34.)
FF8. It is an object of the invention of Ekwall “to achieve a constant
safety time between the appearance of the ERT-value and the EOL-value.”
(Ekwall, col. 2, ll. 52-55.) To keep the safety time constant, the device may
be restricted to reduced energy consumption modes of operation. (See
Ekwall, col. 3, ll. 33-35.)
FF9. Ekwall teaches that a timing circuit is activated after the
appearance of the ERT-value. (See Ekwall, col. 7, ll. 38-40.)
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FF10. The Examiner finds that Ekwall discloses a device with a timer
that defines a replacement time period, defined as a “safety time” by Ekwall.
(Ans. 10, 17.)
FF11. The Examiner finds that Ekwall teaches that the patient can be
reminded to see a physician to replace the implantable device, but that
Ekwall does not specifically disclose a timer being configured to make a
status indicative of the remaining time available. (Ans. 10, 17.)
FF12. The Examiner finds that the missing element is found in
Gurewitsch, which discloses that a recommended replacement time (RRT)
can be made available and stored in the memory of the device to be made
available and read out to a display to allow the physician to know when to
replace the implantable device. (Ans. 10, 19-20.)
FF13. The Examiner finds that Ekwall teaches a device that
determines the end of life of the device, which “represents when the device
needs replaced.” (Ans. 10.)
FF14. Regarding claim 4, the Examiner finds that “Ekwall or
Gurewitsch both select an initial period for the safety time, for the time t2, or
for the RRT and therefore these periods are capable of being selected by a
clinician when initially programmed.” (Ans. 17-18.)
FF15. Regarding claim 8, the Examiner finds that “Ekwall discusses
going into a lower power mode (i.e. reduced energy consumption mode)
when the t2 time period has been met and the battery is below the third
threshold” and that “[w]hether the device has been communicated to or not
does not matter since the claim is open-ended, and the device goes in the low
power mode either way.” (Ans. 18.)
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FF16. Regarding claim 11, the Examiner finds that “Ekwall discloses
that different programmed stimulating modes programmed by a clinician
cause more or less power to be consumed by the IMD (e.g. figure 3, col. 4,
lines 24-32 and 50) and therefore changes/„varies‟ when the ERT threshold
is reached to start the safety time or the time t2.” (Ans. 18.)
Principles of Law
The words of the claim must be given their plain meaning unless the
plain meaning is inconsistent with the specification. See In re Zletz, 893 F.2d
319, 321 (Fed. Cir. 1989). We determine the scope of the claims not solely
on the basis of the claim language, but upon giving claims their broadest
reasonable construction in light of the specification as it would be
interpreted by one of ordinary skill in the art. In re Am. Acad. of Sci. Tech.
Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004); In re Prater, 415 F.2d 1393,
1395-96 (CCPA 1969).
Section 103 forbids issuance of a patent when „“the differences
between the subject matter sought to be patented and the prior art are such
that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains.”‟ KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406
(2007). The question of obviousness is resolved on the basis of underlying
factual determinations including (1) the scope and content of the prior art,
(2) any differences between the claimed subject matter and the prior art, (3)
the level of ordinary skill in the art, and (4) where in evidence, so-called
secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17-18
(1966). See also KSR at 407 (“While the sequence of these questions might
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be reordered in any particular case, the [Graham] factors continue to define
the inquiry that controls.”)
Analysis Regarding Independent Claim 1
Appellants contend that that Ekwall and Gurewitsch fail to teach or
suggest an implantable medical device having “a replacement indicator timer
defining a replacement time period, wherein the replacement time period is
the time from (1) the start of the replacement time period to (2) a determined
replacement date, and wherein the determined replacement date is the date at
which the implantable medical device should be replaced as recited in
independent claim 1.” (Reply Br. 8). We disagree.
The Examiner correctly asserts that Ekwall discloses a device with a
timer that defines a replacement time period, defined by Ekwall as a “safety
time.” (FF3.) The “safety time” has a beginning point, the elective
replacement time (ERT), and an end point, the end of life (EOL) time, which
defines a time period that is activated and determined by the operational
characteristics of the battery. (FF4 and FF5.) The EOL time is adjustable
and is fairly interpreted as the time the device should be replaced. (FF3,
FF6, FF13.) While the device of Ekwall does not necessarily fix an EOL-
value or date, the EOL-value is used to limit power consumption of the
device in order to achieve a safety time period that is constant. (FF8.) As
such, the EOL date of the device in Ekwall is reasonably fixed and
establishes a date for which the device should be replaced. We thus agree
with the Examiner, for the reasons set forth in the Examiner‟s Answer, that
the values for the beginning and end points of the safety time are determined
based on operational characteristics of the battery and that it would have
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been obvious to configure the device with status function indicative of time
remaining in the safety period. (See Ans. 9-10, 17-18.)
Appellants additionally argued that the EOL time as described in
Ekwall is not the date at which the device “should be replaced”, but rather it
is the date at which an alarm is sounded or the patient and/or physician is
made aware that the time to replace the device is near. (See Reply Br. 9-10.)
We do not agree, however, that the phrase “should be replaced” can be so
narrowly construed to exclude the date at which an alarm is sounded and all
interested parties are “reminded” that the device should be replaced. The
“safety time” of Ekwall is constant, where the EOL time is adjustable, and
where the device may be configured to signal the EOL of the battery with an
alarm. (FF3 to FF7.) It seems a matter of logistics as to whether or not the
device can be replaced once the alarm has sounded indicating that the device
should be replaced. We thus agree with the Examiner that Ekwall teaches or
suggests this element of the claims and are not persuaded by Appellants‟
argument to the contrary.
Analysis Regarding Dependent Claim 4
Appellants argue that the Examiner merely asserts that Ekwall and
Gurewitsch disclose that their respective time periods are capable of being
selectable by a physician and that the Examiner does not properly consider
this functional claim limitation. (Reply Br. 10.) We disagree. It is well
established that while the features of an apparatus claim may be recited
functionally, the apparatus must be distinguished from the prior art in terms
of structure, rather than function. See In re Schreiber, 128 F.3d 1473, 1477
(Fed. Cir. 1997). Further, recitation of a new intended use for an old product
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does not make a claim to that old product patentable. See In re Spada, 911
F.2d 705, 708 (Fed.Cir.1990).
Here, claim 4 recites the same device of claim 1 with an added
functional limitation, namely that the “replacement time period is selectable
by a clinician.” As the claim sets forth a functional limitation, the Examiner
is required to give such functional language weight to the extent that the
prior art is or is not capable of meeting the functional limitation. See In re
Schreiber, 128 F.3d 1473, at 1478-1479 (Fed. Cir. 1995). In this regard, the
examiner found that both Ekwall and Gurewitsch disclose time periods
capable of being selected by a clinician when initially programmed. (FF14.)
At this point, the burden shifts to Appellants to show that the prior art
structure does not inherently possess the functionally of the claimed
apparatus. See In re Schreiber at 1478, citing In re Spada, 911 F.2d at 708
(Fed.Cir. 1990); In re King, 801 F.2d 1324, 1327 (Fed.Cir.1986); In re Best,
562 F.2d 1252, 1254-55 (CCPA 1976). In the present case, Appellants have
not made any showing of why the prior art structures of the implantable
medical devices in either Ekwall or Gurewitsch do not inherently possess the
functionality recited in claim 4, and hence Appellants fail to meet its burden
of rebutting the prima facie case of unpatentability established by the
examiner.
Claim 4 depends from claim 1, so we incorporate our analysis of
claim 1 supra into the treatment of claim 4. Thus, for these reasons, and the
reasons discussed supra, we find Appellants‟ argument not persuasive as to
error in the rejection.

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Analysis Regarding Dependent Claim 8
Appellants contend that the Examiner “has not established a prima
facie case of obviousness with respect to dependent claim 8 because nothing
has been identified within Ekwall and Gurewitsch, taken alone or together,
that teaches or suggests that the implantable medical device goes into a
lower power mode when the determined replacement date is reached if the
implantable medical device has not been communicated with during the
replacement time period as recited in dependent claim 8.” (App. Br. 32.)
We disagree. As explained by the Examiner, the device of Ekwall enters
into a low power mode once the elective replacement time (ERT) is
activated and this occurs whether or not the device is not communicated
with, which is enough to meet the conditional limitation of claim 8. (FF8;
Ans. 18.) Accordingly, we find that the cited references disclose the
additional element of claim 8.
Claim 8 depends from claim 1, so we incorporate our analysis of
claim 1 supra into the treatment of claim 8. Thus, for these reasons, and the
reasons discussed supra, we find Appellants‟ argument not persuasive as to
error in the rejection.
Analysis Regarding Dependent Claim 11
Appellants argue that “Ekwall never describes a time period that is
activated beyond the moment t2, and as a result, no counting rate or
replacement time period may be varied because no counting or time period
exists after moment t2.” (Reply Br. 11.) We disagree. Ekwall teaches that
the EOL value may be adjusted and the device configured to achieve a
constant safety time period, defined by the ERT value and EOL value. (FF6;
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FF8.) As the end point of the safety time period is adjustable, the “count”
for that time period may be varied.
Claim 11 depends from claim 1, so we incorporate our analysis of
claim 1 supra into the treatment of claim 11. Thus, for these reasons, and the
reasons discussed supra, we find Appellants‟ argument not persuasive as to
error in the rejection.
Conclusion of Law
The rejection of claims 1, 2, 4-8, 11, 12, 14-18, and 22 under 35
U.S.C. § 103(a) as obvious is affirmed.

III.
Regarding rejection III, representative claim 11 was subject to the
same grounds of rejection with the same references in Rejection II, which is
affirmed. As claims 3, 9, 10, 12, 13, 18, and 21 stand or fall with claim 11,
for the reasons discussed supra, the rejection of claims 3, 9-13, 18, and 21
under 35 U.S.C. § 103(a) as obvious is also affirmed.

IV.
Issue
The Examiner has rejected claims 1, 5-7, 9, 11-12, 14-18, and 22
under 35 U.S.C. § 102(e) as anticipated by Gurewitsch. The Examiner finds
that the device in Gurewitsch is “„capable‟ of meeting the functional use
recitations of „when an operational characteristic of the battery reaches a
selected value‟ and does not provide for an actual
determination/measurement of the battery at selected values.” (Ans. 7).
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Appellants contend that “[t]he ICD of Gurewitsch, however, does not
include a replacement indicator timer, or equivalent circuitry, that may be
activated to start a replacement time period when an operational
characteristic of the battery reaches a selected value” and does not describe
“a replacement time period, i.e., the time from the start of the replacement
time period to a determined replacement date.” (Reply Br. 7; emphasis in
original.)
The issue with respect to this rejection is: Whether Gurewitsch
discloses a device having a timer that is activated when an operational
characteristic of the battery reaches a selected value?
Additional Findings of Fact
FF17. The device of Gurewitsch continually calculates an end-of-life
(EOL) date that is then used to establish a recommended replacement date
(RRT). (Gurewitsch, col. 2, ll. 5-11.)
Principles of Law
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d
628, 631 (Fed. Cir. 1987).
Analysis
Appellants argue that Gurewitsch fails to disclose a timer that is
activated when the operational characteristic of the battery reaches a
particular threshold. We agree. The calculation of neither the EOL nor RRT
is activated upon the battery achieving a threshold value for an operational
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characteristic. Rather, the EOL and RRT values of the device of Gurewitsch
are continually calculated and determined without regard to the status of the
battery falling below a certain performance indicator. (FF17.) As such, we
do not find that Gurewitsch teaches all elements of claim 1.
Conclusion of Law
The preponderance of evidence on this record fails to support the
Examiner‟s conclusion that the cited reference teaches all elements of claim
1. The rejection of claim 1 under 35 U.S.C. §102(e) as being anticipated by
Gurewitsch is reversed. As claims 5-7, 9, 11-12, 14-18, and 22 are all
dependent on claim 1, and thus incorporate all of the limitations of claim 1,
we reverse the rejection as to those claims as well.

V.
Regarding Rejection V, Appellants present no arguments against the
Examiner's rejection based on the judicially created doctrine of obviousness-
type double patenting. (App. Br. 5.) Accordingly, we presume that
Appellants acquiesce to this rejection and thus summarily affirm.

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SUMMARY
The rejections of claims 4-14 under 35 U.S.C. § 112, second
paragraph are reversed.
The rejection of claims 1-2, 4-8, 11-12, 14-18, and 22 under 35 U.S.C.
§ 103(a) as obvious is affirmed. The rejection of claims 3, 9-13, 18, and 21
under 35 U.S.C. § 103(a) as obvious is also affirmed.
The rejection of claims 1, 5-7, 9, 11-12, 14-18, and 22 under 35
U.S.C. §102(e) as being anticipated by Gurewitsch is reversed.
The rejection of claims 1-18 stand rejected on the ground of
nonstatutory obviousness-type double patenting is affirmed.

AFFIRMED

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