Ex Parte Davis et al

Patent Trial and Appeal Board

Feb 23, 2016

12433551 (P.T.A.B. Feb. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/433,551 0413012009
71996 7590 02/25/2016
SHUMAKER & SIEFFERT, P.A
1625 RADIO DRIVE, SUITE 300
WOODBURY, MN 55125
FIRST NAMED INVENTOR
Jon P. Davis
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.
1023-839US01/P0034690.00 9338
EXAMINER
PORTER, JR, GARY A
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
02/25/2016 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):
pairdocketing@ssiplaw.com
medtronic _neuro _ docketing@cardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
ExparteJONP. DAVIS, DENNIS M. SKELTON, SHYAM GOKALDAS,
and RAJEEV SAHASRABUDHE
Appeal 2013-008071
Application 12/433,551 1
Technology Center 3700
Before STEFAN STAICOVICI, WILLIAM A. CAPP, and
BRANDON J. WARNER, Administrative Patent Judges.
STAICOVICI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Jon P. Davis et al. (Appellants) appeal under 35 U.S.C. § 134(a) from
the Examiner's final decision rejecting under 35 U.S.C. § 112, first
paragraph, claims 34-36 as failing to comply with the written description
requirement and under 35 U.S.C. § 103(a) claims 1-36 as being
unpatentable over Singhal (US 2005/0060001 Al, pub. Mar. 17, 2005) and
According to Appellants, the real party in interest is Medtronic, Inc.
Appeal Br. 3 (filed Jan. 11, 2013).
Appeal 2013-008071
Application 12/433,551
Miesel (US 2007/0255118 Al, pub. Nov. 1, 2007). We have jurisdiction
over this appeal under 35 U.S.C. § 6(b ).
SUMMARY OF DECISION
We AFFIRM-IN-PART.
INVENTION
Appellants' invention relates to a programmable implantable medical
device ("IMD") and method for applying therapy. Spec iJ 2.
Claims 1, 16, 30, and 32 are independent. Claim 1 is illustrative of
the claimed invention and reads as follows:
1. A method comprising:
programming a first set of one or more therapy parameter
values of a medical device during a programming session while
the medical device is in a first mode, the first set of one or more
therapy parameter values being associated with a posture state;
during the programming session, activating a second
mode of the medical device to deliver posture responsive
therapy to a patient, wherein the posture responsive therapy is
suspended while the medical device is in the first mode, and
wherein, while the medical device is in the second mode, the
medical device delivers posture responsive therapy to the
patient by at least delivering therapy to the patient in
accordance with the first set of one or more therapy parameter
values in response to detecting the posture state; and
programming a second set of one or more therapy
parameter values of the medical device based on efficacy of the
posture responsive therapy delivered to the patient with therapy
parameter values including the first set of one or more therapy
parameter values while the second mode of the medical device
is activated.
ANALYSIS
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The lack of written description rejection
The Examiner finds that the limitation of "the first and second sets of
one or more therapy parameter values include at least one common therapy
parameter value" constitutes new matter. See Final Act. 3.
Appellants argue that paragraph 57 of the Specification provides
support for the above-recited limitation. See Appeal Br. 7. According to
Appellants, because the Specification states that during a first phase of
programming both first and second sets of therapy parameter values may be
modified, ''the combination of the first and second sets of therapy parameter
values ... may correspond to the 'first set of one more therapy parameter
values' recited in claim 1." Reply Br. 5-6 (citing Spec. iii! 50, 51, 56, and
57). Appellants further note that because the Specification states that in a
second programming phase both first and second set of therapy parameter
values may be modified, "[t]he modified combination of the first and second
sets of therapy parameter values may correspond to the 'second set of one
more therapy parameter values' recited in claim 1." Id. at 6. Thus, because
paragraph 57 of the Specification states that only the second set of therapy
parameter values are modified, Appellants conclude that "[i]n those
examples, the 'first set of therapy parameters' would remain the same,
resulting in a 'second set of one more therapy parameter values' having at
least one common therapy parameter value as the 'first set of one more
therapy parameter values'." Id. As such, Appellants contend that "'the
second set of therapy parameter values' discussed in paragraph [0057] is not
necessarily the same as the 'second set of one or more therapy parameter
values' recited in claim 1, nor is there a requirement that the two sets be the
same." Appeal Br. 8; see also Reply Br. 6-7.
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The fundamental factual inquiry is whether the Specification conveys
with reasonable clarity to those skilled in the art that, as of the filing date
sought, applicant was in possession of the invention as now claimed. See
Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). In
this case, Appellants' Specification describes a "first set of therapy
parameters values" as parameters that "provide efficacious therapy to a
patient in a particular patient posture." Spec. ii 46. 2 Appellants'
Specification further describes a "second set of therapy parameter values" as
parameter values that "define the manner in which the IMD detects a posture
transition and modifies therapy delivery to a patient." Id. ii 51. 3 Hence,
each of the first and second sets of therapy parameter values measures and
controls different aspects of therapy. Such an interpretation is consistent
Appellants' Specification, which explicitly states that "[t]he first and second
sets of stimulation parameter values are different." Id (emphasis added).
Accordingly, because Appellants' Specification explicitly states that first
and second sets of therapy parameter values are different, we do not agree
with Appellants' position that the Specification supports the limitation that
''the first and second sets of one or more therapy parameter values include at
least one common therapy parameter value."
2 "[T]he first set of therapy parameters may include, for example, a
current or voltage amplitude, signal duration (e.g., pulse width in the case of
stimulation pulses), frequency (e.g., pulse rate in the case of stimulation
pulses), electrode combination (e.g., selected electrodes and respective
polarities for delivering stimulation), and/or duty cycle."
3 "For example, the second set of therapy parameter values may include
the modification profiles with which the IMD switches between therapy
parameter settings (e.g., therapy pro grams) associated with different patient
postures."
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Although we appreciate Appellants' own interpretation that the
modified first and second sets of therapy parameter values constitutes the
claimed "second set of one or more therapy parameter values," we note that
Appellants' Specification does not support such an interpretation. As noted
above, Appellants' Specification clearly delineates what parameters
constitute each of the first and second set of therapy parameter values.
Moreover, even assuming arguendo that the modified first and second sets
of therapy parameter values constitute the claimed "second set of one or
more therapy parameter values," we agree with the Examiner that "[t]he
process of modifying a parameter set strictly implies that the set is different
(e.g. there is no commonality)." Ans. 19. In other words, merely modifying
the second set of therapy parameter values, without modifying the first set of
therapy parameter values does not necessarily mean that the two sets have at
least one common therapy parameter value, as required by each of claims
34-36, because the modification is "based on the efficacy of a particular
parameter set." Id.
In conclusion, for the foregoing reasons, we sustain the rejection
under 35 U.S.C. § 112, first paragraph, of claims 34-36 as failing to comply
with the written description requirement.
The obviousness rejection
In arguing the rejection of claims 1-36 as unpatentable over the
combined teachings of Singhal and Miesel, Appellants have grouped the
claims into nine separate groups. See Appeal Br. 9-22.
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Application 12/433,551
According to Appellants, claims 1-6, 13-15, and 34 form Group I
(see id. at 9-14); claims 7 and 11 form Group II (see id. at 14-16); claims 8-
10 form Group III (see id. at 16-17); claim 12 is Group IV (see id. at 17-
18); claims 16-23, 27-29, and 35 form Group V (see id. at 18-19); claims
24 and 26 form Group VI (see id. at 19-20); claim 25 is Group VII (see id.
at 20); claims 30, 31, and 36 form Group VIII (see id. at 20-21); and claims
32 and 33 form Group IX (see id. at 21-22).
Group I: Claims 1-6, 13-15, and 34
Appellants have not presented arguments for the patentability of
claims 2-6, 13-15, and 34 apart from claim 1. See Appeal Br. 9-14. In
accordance with 37 C.F.R. § 41.37(c)(l)(iv) (2015), we select independent
claim 1 as the representative claim to decide the appeal of the rejection of
these claims, with claims 2-6, 13-15, and 34 standing or falling with claim
1.
The Examiner finds that Singhal discloses a method for programming
an IMD including programming in a first mode, namely, a learning mode, a
first set of therapy parameter values that are associated with different
postures and in a second mode delivering posture responsive therapy4 in
which the first set of therapy parameter values are automatically adjusted
depending on the patient's posture. See Final Act. 4 (citing Singhal iii! 29-
33). However, the Examiner also finds that Singhal fails to disclose
programming a second set of one or more therapy parameter values, as
4 Appellants' Specification describes "posture responsive therapy" as
modifying therapy parameter values ''when a patient transitions between
different posture states." Spec. iJ 36.
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called for by claim 1. See id. at 4-5. Nonetheless, the Examiner finds that
Miesel discloses a method for programming an IMD including programming
a second set of therapy parameter values based on the efficacy of responsive
posture therapy using a set of first set of therapy parameter values. See id. at
5 (citing Miesel iJ 132, Fig. 10). 5 The Examiner concludes that,
Id.
[I]t would have been obvious to one of ordinary
skill in the art to modify the invention of Singhal et
al. to program a second set of one or more therapy
parameter values of the medical device based on
efficacy of the posture responsive therapy
delivered to the patient with therapy parameter
values including the first set of one or more
therapy parameter values while the second mode
of the medical device is activated, so that the
patient's symptoms are continually managed even
as the patient's physiological parameters and
symptoms change.
Appellants argue that Singhal fails to disclose "suspending posture
responsive therapy during the learning mode." Appeal Br. 13 (citing Singhal
iJ 30). Appellants further argue that Miesel fails to disclose "determining the
efficacy of posture responsive therapy." Id. According to Appellants,
Miesel's perturbation of baseline therapy parameters does not constitute
programming a set of therapy parameters based on the efficacy of posture
responsive therapy, as called for by claim 1. See id. at 12 (citing Miesel iii!
130-132); see also Reply Br. 11.
5 Appellants' Specification describes "efficacy" as "combination of
complete or partial alleviation of symptoms alone, or alleviation of
symptoms in combination with a degree ofundesirable side effects." Id. iJ
31.
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We are not persuaded by Appellants' arguments because
nonobviousness cannot be established by attacking Singhal and Miesel
individually when the rejection as articulated by the Examiner is based on a
combination of Singhal and Miesel. See In re Merck & Co. Inc., 800 F.2d
1091, 1097 (Fed. Cir. 1986). Moreover, obviousness does not require that
all of the features of the secondary reference be bodily incorporated into the
primary reference. See In re Keller, 642 F.2d 413, 425 (CCPA 1981). In
this case, the Examiner uses Singhal to disclose a first set of parameter
values associated with different patient postures for delivering "posture
responsive therapy," and uses Miesel to disclose checking and adjusting,
based on metric values, a set of previously determined therapy parameter
values (e.g., "baseline therapy parameters"). See Ans. 21-22.
In other words, the Examiner employs Singhal to disclose "posture
responsive therapy," not Miesel, as Appellants argue. See Appeal Br. 11.
As the Examiner correctly finds, Singhal discloses a learning mode for
selecting appropriate therapy parameter values for specific postures and a
therapy mode in which the selected therapy parameter values are
automatically adjusted depending on the patient's posture. See Ans. 27
(citing Singhal ~~ 30-33). We agree with the Examiner that because Singhal
states that therapy is delivered to the patient in an automatic manner ''when
no longer operating in the learning mode," Singhal discloses suspending
posture responsive therapy during the learning mode, as called for by claim
1. See Ans. 27-28 (citing Singhal ~ 35). Furthermore, the Examiner is
correct in that Singhal fails to disclose further adjusting/modifying the
therapy parameters selected in the learning mode, when using Singhal's
device in the therapy mode. See id. at 25. Thus, the Examiner turns to
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Application 12/433,551
Miesel for adjusting previously selected therapy parameters of an
implantable medical device "based on a determined efficacy of treatment."
Id. at 24. According to Miesel, after determining a baseline therapy
parameter set, 6 the parameters are perturbed in order to determine the
efficacy of the treatment by monitoring posture/activity metrics and when
such perturbations result in an improvement, the therapy parameters are
updated. Id. at 25; see also Miesel iii! 130-132. As such, in contrast to
Appellants' position (see Appeal Br. 12), ''the Examiner is not relying on the
baseline parameters of Miesel as the claimed 'second set of one or more
therapy parameter values,"' but rather on the adjustments made to the
baseline therapy parameters. See Ans. 23. In other words, the Examiner
relies on "adjustment or reprogramming of parameters during a posture
responsive therapy mode," as the claimed "second set of one or more
therapy parameter values." Id. Moreover, because Singhal discloses
"posture responsive therapy" and Miesel discloses determining the efficacy
of a treatment by monitoring posture/activity metrics, the combined
teachings of Singhal and Miesel disclose "determining the efficacy of
posture responsive therapy." Therefore, the combined teachings of Singhal
and Miesel disclose programing a second set of therapy parameter values, as
called for by claim 1.
Finally, Appellants argue that the Examiner "fail[ s] to provide a
proper rationale for the proposed modification to a method disclosed by
Singhal in view of Mies el." Reply Br. 11. According to Appellants, "the
6 We agree with the Examiner's finding that Miesel's determination of
a baseline therapy parameter set based on posture or activity metric values is
similar to Singhal's learning mode. See Ans. 22 (citing Miesel iJ 126).
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Application 12/433,551
Examiner is attempting to rely on a rationale that the proposed modification
to Singhal is simply a combination of known techniques used in the same
way to improve similar devices." Id. Appellants contend that, "[t]he
Examiner has failed to establish that the sensitivity analysis disclosed by
Miesel could be used to 'allow the patient's symptoms to be continually
managed even as the patient's physiological parameters and systems change'
while providing posture responsive therapy." Id. at 11-12.
We are not persuaded by Appellants' arguments because the
Examiner's modification is an improvement to Singhal's programming
method by determining the efficacy of Singhal's posture responsive therapy
and then adjusting/modifying the therapy parameters, as taught by Miesel, to
lead to the predictable result of continually managing the patient's
symptoms as the patient's physiological parameters and symptoms change,
and the modification is well within the skill of one having ordinary skill in
this art. See KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) ("[I]f a
technique has been used to improve one device, and a person of ordinary
skill in the art would recognize that it would improve similar devices in the
same way, using the technique is obvious unless its actual application is
beyond his or her skill."). Moreover, because both of Singhal's and Miesel's
implantable medical devices are programmed to provide therapy to a patient
by programming parameter values, the Examiner is on solid ground in
finding sufficient similarity that monitoring posture/activity metrics for
determining the efficacy of a treatment, as taught by Miesel, is applicable to
Singhal's posture responsive therapy. Hence, Appellants have the burden of
establishing that those features would not be present. See In re Spada, 911
F.2d 705, 708 (Fed Cir. 1990).
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Application 12/433,551
In conclusion, for the foregoing reasons, we sustain the rejection
under 35 U.S.C. § 103(a) of claim 1, and claims 2-6, 13-15, and 34 falling
with claim 1, as unpatentable over Singhal and Miesel.
Group II: Claims 7 and 11
The Examiner finds that paragraph 125 ofMiesel discloses
"programming a second therapy parameter that differs from the first therapy
parameter." Final Act. 7 (emphasis added). According to the Examiner,
"[t]he therapy parameter choices disclosed by Miesel ... differs from the
therapy parameter choices disclosed by Singhal." Id.
Although we appreciate that parameter values are different in the
programming method of Singhal as modified by Miesel, we do not agree that
the actual parameters being adjusted are different. Limitations not appearing
in the claims cannot be relied upon for patentability. In re Self, 671 F.2d
1344, 1348 (CCPA 1982). In this case, both Singhal and Miesel disclose
parameters for providing therapy to a patient (i.e., pulse amplitude, pulse
width, and pulse rate). Compare Singhal ii 23, with Miesel ii 125. The
Examiner's rejection is premised on Singhal's selection of appropriate
therapy parameter values for specific postures based on the efficacy of the
therapy in a first mode and in a second mode, automatically adjusting these
parameter values as a function of the patient's posture, and then, in view of
Miesel, further adjusting these parameter values in the second mode based
on determining the efficacy of the parameter values during therapy (e.g.,
posture responsive therapy). See Ans. 21-22. In other words, although the
values of the parameters are different because they are adjusted, the actual
parameters being adjusted are the same as the parameters selected during the
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learning mode of the programming method of Singhal as modified by
Miesel. Hence, we do not agree with the Examiner's position that adjusted
parameters in the programming method of Singhal, as modified by Miesel,
"necessarily . . . are different in some manner than the initial baseline
parameters." Ans. 28-29.
In conclusion, for the foregoing reasons, we do not sustain the
rejection under 35 U.S.C. § 103(a) of claims 7 and 11 as unpatentable over
Singhal and Miesel.
Group III: Claims 8-10
Claims 8-10 depend from claim 7. See Appeal Br. 25-26. The
Examiner's findings do not remedy the deficiency of Singhal and Miesel
discussed supra. See Final Act. 7-8. Accordingly, for the reasons discussed
above, we also do not sustain the rejection under 35 U.S.C. § 103(a) of
claims 8-10 as unpatentable over Singhal and Miesel.
Group IV: Claim 12
Appellants argue that the combined teachings of Singhal and Miesel
fail to disclose the ''wherein" clauses of claim 12. See Appeal Br. 17.
According to Appellants, "the Examiner overlooked [this] language of claim
12." Id.
We are not persuaded that the Examiner overlooked the ''wherein"
clauses of claim 12 because "Miesel discloses determining the efficacy of
treatment and altering therapy during an automatic stimulation mode in
order to allow the patient's symptoms to be continually managed even as the
patient's physiological parameters and symptoms change." Ans. 32 (citing
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Miesel il 132). We thus agree with the Examiner that ''Miesel meets the
limitation of altering therapy based on efficacy while not in the first mode
(e.g. learning mode)." Id. Moreover, as noted above, the Examiner's
rejection is premised on Singhal's selection of appropriate therapy parameter
values for specific postures based on the efficacy of the therapy in a first
mode and in a second mode, automatically adjusting these parameter values
as a function of the patient's posture, and then, in view ofMiesel, further
adjusting these parameter values in the second mode based on determining
the efficacy of the parameter values during therapy (e.g., posture responsive
therapy). See Ans. 21-22.
As such, for the foregoing reasons, we sustain the rejection under 35
U.S.C. § 103(a) of claim 12 as unpatentable over Singhal and Miesel.
Group V: Claims 16-23, 27-29, and 35
Appellants' reiterate the limitations of independent claim 16 and then
rely on the arguments presented supra with respect to the rejection of
independent claim 1 (Group I). See Appeal Br. 18-19;7 see also In re Lovin,
99 USPQ2d 1373, 1379 (Fed. Cir. 2011). Accordingly, for the same reasons
as discussed above in Group I, we sustain the rejection under 35 U.S.C.
§ 103(a) of claims 16-23, 27-29, and 35 as unpatentable over Singhal and
Mies el.
Groups VI and VII: Claims 24-26
Claims 24-26 require a limitation similar to that of claim 7, namely,
"programming a second therapy parameter that differs from the first therapy
7 "For at least the reasons discussed with respect to independent claim 1
above (Group I), the Examiner failed to establish that Singhal in view of
Miesel discloses the system of claim 16." Appeal Br. 18.
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parameter." Appeal Br. 30 (emphasis added). Therefore, for the reasons set
forth supra with respect to Group II, we also do not sustain the rejection
under 35 U.S.C. § 103(a) of claims 24-26 as unpatentable over Singhal and
Miesel.
Group VIII: Claims 30, 31, and 36
Appellants reiterate the limitations of independent claim 30 and then
rely on the arguments presented supra with respect to the rejection of
independent claim 1 (Group I). See Appeal Br. 20-21. Accordingly, for the
same reasons as discussed above in Group I, we sustain the rejection under
35 U.S.C. § 103(a) of claims 30, 31, and 36 as unpatentable over Singhal
and Miesel.
Group IX· Claims 32 and 33
Appellants reiterate the limitations of independent claim 32 and then
rely on the arguments presented supra with respect to the rejection of
independent claim 1 (Group I). See Appeal Br. 20-21. Accordingly, for the
same reasons as discussed above in Group I, we sustain the rejection under
35 U.S.C. § 103(a) of claims 30, 31, and 36 as unpatentable over Singhal
and Miesel.
SUMMARY
The Examiner's decision to reject under 35 U.S.C. § 112, first
paragraph, claims 34-36 as failing to comply with the written description
requirement is affirmed.
The Examiner's decision to reject under 35 U.S.C. § 103(a) claims 1-
36 as being unpatentable over Singhal and Miesel is affirmed as to claims 1-
6, 12-23, and 27-36 and reversed as to claims 7-11 and 24-26.
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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. § 1.136(a)(l)(iv).
AFFIRMED-IN-PART
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