Ex Parte Skelton et al

Patent Trial and Appeal Board

Aug 11, 2017

12110906 (P.T.A.B. Aug. 11, 2017)

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.
12/110,906 04/28/2008 Dennis M. Skelton 1023-643US01 6343
71996 7590 08/15/2017
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
DINGA, ROLAND
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
08/15/2017 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
Ex parte DENNIS M. SKELTON, JOSEPH J. NOLAN,
NATHAN A. TORGERSON, WENDE L. DEWING, TODD V. SMITH,
SHYAM GOKALDAS, STEVEN M. GOETZ, ANDREW H. HOUCHINS,
and JEFFREY T. KEACHER
Appeal 2015-003052
Application 12/110,906
Technology Center 3700
Before GEORGE R. HOSKINS, MICHAEL L. WOODS, and
AMANDA F. WIEKER, Administrative Patent Judges.
HOSKINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Dennis M. Skelton et al. (“Appellants”)1 appeal under 35 U.S.C.
§134 from the Examiner’s decision rejecting claims 1—60 in this
application. The Board has jurisdiction over the appeal under 35 U.S.C.
§ 6(b).
We REVERSE.
1 The Appeal Brief identifies Medtronic, Inc. as the real party in interest.
Appeal Br. 3.
Appeal 2015-003052
Application 12/110,906
CLAIMED SUBJECT MATTER
Claims 1, 21, 40, and 60 are independent. Claim 1 illustrates the
claimed subject matter, and it recites:
1. A method comprising:
delivering electrical stimulation via an electrode
combination comprising at least one active electrode in a first
array of electrodes and at least one active electrode in a second
array of electrodes, wherein the second array includes a greater
number of electrodes than the first array, wherein each
electrode of the first array is positioned at a respective level
within the first array, and wherein each electrode of the second
array is positioned at a respective level within the second array;
and
shifting the electrical stimulation to different electrode
combinations in a series of shift operations, wherein one of the
shift operations includes shifting a position of all active
electrodes in the second array while maintaining a position of
all active electrodes in the first array, and wherein shifting the
position of all active electrodes in the second array comprises
performing a single level shift of the position of all active
electrodes in the second array.
Supp. Appeal Br. (filed Sept. 16, 2014) (hereafter “Claims App.”), 2.
REJECTIONS ON APPEAL
Claims 1—60 stand rejected under 35 U.S.C. § 112, first paragraph, for
lack of enablement.
Claims 1—60 stand rejected under 35 U.S.C. § 112, first paragraph, for
lack of written description.
Claims 1—17, 19-36, 38—56, and 58—60 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Hull (US 5,417,719, iss. May 23, 1995),
Bradley (US 6,993,384 B2, iss. Jan. 31, 2006), Law (US 5,938,690, iss.
Aug. 17, 1999), and Woods (US 2004/0034394 Al,pub. Feb. 19, 2004).
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Application 12/110,906
Claims 18, 37, and 57 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Hull, Bradley, Law, Woods, and Armstrong
(US 7,366,571 B2, iss. Apr. 29, 2008).
ANALYSIS
A. Enablement (Claims 1—60)
In rejecting claims 1—60 for lack of enablement, the Examiner
determines Appellants’ Specification “does not reasonably provide
enablement for [shifting] all the active electrodes in one of the arrays.”
Final Act. 3; Ans. 2. According to the Examiner, undue experimentation
would be required to practice that claimed subject matter, because the
quantity of necessary experimentation would have been great, and
Appellants’ Specification provides insufficient direction, guidance, and
working examples. Final Act. 4 (applying In re Wands, 858 F.2d 731
(Fed. Cir. 1988)).
Appellants contend their Specification provides an enabling disclosure
for the claims, without requiring undue experimentation. Appeal Br. (filed
Sept. 2, 2014), 6—8. Appellants refer to the statement in paragraph 144 of
the Specification2 that “[programmer 20 may apply a general rule for
upward shifting to shift either an electrode(s) on the 8-count lead alone or
shift both the electrode(s) on the 8-count lead and the electrode(s) on the
4-count leads.” Id. at 7. Appellants also cite Figures 11A and 1 IB of their
Specification as illustrating shifting the position of all active electrodes on a
2 Appellants refer to the January 15, 2009 publication of the present
application. We instead refer to the corresponding passage of the
Specification filed on April 28, 2008.
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Application 12/110,906
larger (8-count) lead. Id. (citing Spec. Tflf 145—146). Appellants, moreover,
contend their Specification discloses “shifting] all active electrodes,” and
“programmer 20 may apply the upward or downward shifting rule to specify
whether all active electrodes should be shifted or just the active electrode(s)
on the larger-count lead should be shifted.” Id. (quoting Spec. Tflf 153, 150).
Appellants further assert the Examiner’s application of only three of the
eight Wands factors (quantity of experimentation, direction or guidance
presented, and absence of working examples) is improper under MPEP
§ 2164.01(a). Id. at 7-8.
In answer, the Examiner determines Appellants’ Specification
contains working examples in which “the second array contains only one
active negative polarity electrode and only that singular active electrode is
shifted.” Ans. 2. The Examiner also determines Appellants’ Specification
does not contain any working examples “in which the second array contains
more than one active electrode.” Id. at 2—3 (citing Spec., Figs. 7 and 10A—
12C, and Tflf 144, 146, 147). Based on those determinations, the Examiner
concludes Appellants’ Specification “solely provides support for a single
electrode to be shifted on the second array” and therefore “fails to disclose at
least one method of making and using the claimed invention that bears a
reasonable correlation to the entire scope of’ claim 1. Id. at 3.
We note, preliminarily, that the enablement rejection considers all
sixty pending claims together as a group. See Final Act. 3^4; Ans. 2—\.
This makes it difficult for Appellants, and for the Board on review, to
determine which claim limitation(s) are actually at issue in each claim. The
only limitation in independent claims 1,21,40, and 60 that reasonably
appears to be at issue is “shifting a position of all active electrodes in the
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Application 12/110,906
second array,” as representatively recited in claim 1. See, e.g., Final Act. 3.
We will consider the enablement rejection on that basis.
At the same time, the enablement rejection appears to rely on several
limitations that do not appear in any one of the independent claims 1, 21, 40,
and 60. See Final Act. 4. These include “moving multiple active electrodes
in first and second arrays”; shifting “more than two active electrodes in one”
array and “more than one active electrode” in the other array; and, shifting
all active electrodes in one array and shifting all active electrodes in the
other array. Id. To the extent these limitations might appear in one or more
of the fifty-six dependent claims on appeal, the Examiner has not provided
sufficient notice to Appellants regarding which claim(s) and limitation(s) are
at issue so that Appellants might prepare a cogent response. See Final
Act. 3^4; Ans. 2-4. We, therefore, will review the rejection only as to the
four independent claims.
As a matter of claim construction, the independent claims do not
require more than one active electrode in the second array. There may be
one active electrode, or two or more active electrodes, in the second array.
See Claims App. 2, 6, 10, 15.
Appellants’ Figure 11A illustrates one embodiment of one active
electrode in the second array. Specifically, Figure 11A shows one negative
polarity electrode at position “7” on lead “1”, which is an 8-count electrode
array. Spec. 143—145. Figures 11 A—1 IB illustrate shifting the position
of that single active electrode in the second array from position “7” to
position “6”, while maintaining a position of two positive polarity electrodes
in the smaller 4-count lead array “0”, as required by the independent claims.
Id. H 144—145. Based on that disclosure, the Examiner determines
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Application 12/110,906
Appellants’ Specification describes and enables shifting the position of one
active electrode in the second array. See Ans. 2—3. We agree with that
determination.
The Examiner further determines, however, Appellants’ Specification
fails to enable shifting the position of two or more active electrodes in the
second array. Id. This determination is based largely on the Examiner’s
finding that the Specification fails to describe such an embodiment. Id. The
issue of whether Appellants have provided a sufficient written description in
this regard is considered below. Presently, we are concerned with
enablement. See AriadPharm., Inc. v. EliLilly & Co., 598 F.3d 1336, 1344
(Fed. Cir. 2010) (enbanc) (35 U.S.C. § 112 11 contains two separate
requirements, written description and enablement).
Given the Specification’s enablement of shifting the position of one
active electrode in the second array, we conclude it would not have required
undue experimentation for a person of ordinary skill in the art to practice
shifting the position of two or more active electrodes in the second array.
What can be done for one active electrode, can be done for all active
electrodes, given the nature of the invention, the relative skill of those in the
art, and the predictability of the art. See Wands, 858 F.2d at 737 (setting
forth factors to consider when determining whether undue experimentation
would be required to practice the claimed invention). In this regard, the
Examiner does not challenge Appellants’ enablement of shifting the position
of two active electrodes in the first array (i.e., lead “0”) as illustrated in
Appellants’ Figures 1 IB—11C. Spec. 1146. We do not perceive any reason,
and the Examiner does not explain, why it would require undue
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Application 12/110,906
experimentation to do the same thing in the second array, despite that the
second array includes a greater number of electrodes than the first array.
For the foregoing reasons, we do not sustain the enablement rejection
of claims 1—60.
B. Written Description (Claims 1—60)
The Examiner determines Appellants’ Specification fails to
demonstrate possession, at the time of filing, of‘“shifting a position of all
active electrodes’ in both the first or second arrays,” which the Examiner
determines is required by each independent claim 1, 21, 40, and 60. Final
Act. 4—5.
Appellants respond that the Examiner misconstrues the independent
claims as reciting shifting the position of all active electrodes in both arrays.
Appeal Br. 9-10. Appellants contend the claims, instead, require shifting
the position of all active electrodes in only one array (i.e., the second array).
Id.
Appellants also assert their Specification demonstrates possession,
regardless of how the claims are construed in that regard. Id. at 10.
Appellants cite their Figures 11A—1 IB, and paragraphs 144—146, 150, and
153 of their Specification, as already discussed above in connection with the
enablement rejection. Id. Appellants, moreover, contend their Specification
“repeatedly discusses shifting ‘only the active electrode(s)’ in the larger
array in certain instances, and shifting ‘all active electrodes’ on both arrays
in other instances” (id. (citing Spec. Tflf 144, 147, 150, 152, 155, 157)) and
“explicitly states that ‘all active electrodes on all leads are shifted’” (id.
(quoting Spec. 1147)).
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Application 12/110,906
The Examiner answers by relying on the written description analysis
provided in connection with the enablement rejection, summarized above.
Ans. 4.
We determine Appellants’ Specification demonstrates possession, at
the time of filing, of shifting the position of all active electrodes in the
second array. As already discussed above, Appellants’ Figures 11A and 1 IB
disclose shifting the position of one active electrode in the second array.
Spec. 11 143-146.
Appellants’ Specification, further, demonstrates possession of shifting
the position of two or more active electrodes in the second array. The
Specification states: “[F]or an upward shift, programmer 20 may apply the
upward or downward shifting rule to specify whether all active electrodes
[i.e., in the first and second arrays] should be shifted or just the active
electrode(s) on the larger-count lead [i.e., the second array] should be
shifted.” Spec. 1150 (emphases added). A person of ordinary skill in the
art would appreciate the “(s)” in the term “electrode(s)” denotes that one,
two, or more active electrodes are present in the second array, and each of
their positions is shifted. A similar convention is found in paragraph 152 of
Appellants’ Specification, which describes “shift[ing] only the electrode(s)
on the lead with the greater electrode count,” as well as paragraph 144 of
Appellants’ Specification.
For the foregoing reasons, we do not sustain the written description
rejection of claims 1—60.
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Application 12/110,906
C. Obviousness over Hull, Bradley, Law, and Woods
(Claims 1—17, 19—36, 38—56, and 58—60)
Independent Claim 1
In rejecting claim 1 as having been obvious, the Examiner finds Hull
discloses an electrical stimulation method using a first array of two
electrodes (i.e., the top two electrodes in lead paddle 16 of Figure 6), and a
second array of three electrodes (i.e., the center three electrodes in lead
paddle 16 of Figure 6). Final Act. 5; see also Hull, 8:27-42 (describing
Figure 6 as illustrating three columns of electrodes). The Examiner finds
Hull discloses “shift[ing] the electrical stimulation to different electrode
combinations in a series of shift operations.” Final Act. 6 (citing Hull, 5:14—
54). The Examiner acknowledges Hull does not disclose the specific
shifting operation of active electrodes recited in claim 1. Id.
The specific shifting operation of active electrodes recited in claim 1
is:
shifting a position of all active electrodes in the second array
while maintaining a position of all active electrodes in the first
array, and wherein shifting the position of all active electrodes
in the second array comprises performing a single level shift of
the position of all active electrodes in the second array.
Claims App. 2. The Examiner cites Bradley, Faw, and Woods in connection
with this recited shifting operation, as follows:
Bradley teaches movement of all active electrodes,
groups of electrodes (Fig. 10; Col. 10,11. 31—45).
Faw teaches a shift operation that includes shifting the
position of the active electrode in the second array while
maintaining a position of the active electrode in the first array
(Figs. 9A-9C).
Woods teaches wherein shifting the position of the active
electrode in the second array comprises performing a single
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Application 12/110,906
level shift of the position of the active electrode in the second
array, moving selected electrodes up one level along the array
[0084],
Final Act. 6. These findings establish, in the Examiner’s view, that “[a]ll of
the component parts [of claim 1] are known in the art.” Id.
Appellants argue the Examiner errs in relying on Law as disclosing
shifting a position of active electrodes in the second array while maintaining
a position of active electrodes in the first array. Appeal Br. 13—14.
Appellants contend Figures 9A—9C of Law instead show “at least some of
the active electrodes are shifted in both the first and second leads.” Id. at 13;
Reply Br. 7—8. Appellants further assert nothing in the other cited
references (Hull, Bradley, and Woods) cures this deficiency in Law. Appeal
Br. 13—14; Reply Br. 8.
The Examiner concludes Appellants’ argument “amounts to a
piecemeal analysis of the rejection.” Ans. 5. The Examiner states:
Law is relied upon to teach the general concept of maintaining
an [active] electrode in one array while moving an [active]
electrode in another array (Figs. 9A—9C). Woods is relied upon
to teach the concept of moving groups of electrodes together
(Paragraph [0084]). Taking the teachings of the two references
together, it is seen that the claim limitations “shifting a position
of all the active electrodes in the second array while
maintaining a position of all the active electrodes in the first
array” are rendered obvious.
Id.
We agree with Appellants’ argument that the Examiner has not
established, by a preponderance of the evidence, a disclosure in the prior art
of shifting a position of all active electrodes in one array while maintaining a
position of all active electrodes in another array. The Final Office Action
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Application 12/110,906
cites only Figures 9A—9C of Law as disclosing that subject matter. Final
Act. 6. Those Figures are reproduced below:
PHYSIOLOGICAL
MIDLIME
C0M8G 1
physiological
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MlOliNE
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m m
{+}
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COMBO 2
PHYSIOLOGICAL
MIDLIME
COMBO 3
FIG. 9A FIG. 9B FIG. 9C
These Figures illustrate “the movement of a basic electrode combination
along the electrodes of. . . two eight electrode leads.” Law, 12:30-39.
Figure 9A shows a beginning electrode row combination in which the
distal-most row is an anode (+), the next lower electrode row is a cathode (—),
and the next lower electrode row is an anode (+). Id. at 12:39-45.
Figures 9B and 9C show “the basic electrode row configuration merely
‘changing position[.]’” Id. at 12:52—63. As can be seen in the Figures, the
changing of the position of the electrode rows shifts the position of three
active electrodes in both of the eight electrode leads. Thus, Law does not
disclose shifting a position of all active electrodes in one array while
maintaining a position of all active electrodes in another array.
The Answer suggests this deficiency of Law is cured by its
combination with Woods. Ans. 5 (citing Woods 1 84). This suggestion is
not supported by a preponderance of the evidence. The Examiner cites the
disclosure in Woods that a joystick may be used to “move a group selection
of electrodes up and down within the array.” Woods 1 84 (emphasis added).
Woods also discloses this group movement may be “one level.” Id. This
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Application 12/110,906
disclosure does not reflect shifting a position of all active electrodes in one
array while maintaining a position of all active electrodes in another array.
Thus, the rejection does not establish, by a preponderance of the
evidence, a disclosure in the prior art of shifting a position of all active
electrodes in one array while maintaining a position of all active electrodes
in another array. The rejection, further, does not present any technical
reasoning or other basis for concluding such a shift would have been
obvious from what was disclosed in the prior art. Therefore, we do not
sustain the rejection of claim 1 as having been obvious over Hull, Bradley,
Law, and Woods.
Independent Claims 21, 40, and 60
The other independent claims on appeal, claims 21, 40, and 60, each
require (like claim 1) shifting a position of all active electrodes in one array
while maintaining a position of all active electrodes in another array.
Claims App. 6, 10, 15. The Examiner relies on the same findings and
reasoning discussed above in connection with claim 1 when determining
these claims would have been obvious over Hull, Bradley, Law, and Woods.
See Final Act. 5—7. For the reasons provided above in connection with
claim 1, we do not sustain this rejection of claims 21, 40, and 60.
Dependent Claims 2—17, 19, 20, 22—36, 38, 39, 41—56, 58, and 59
The Examiner’s additional consideration of dependent claims 2—17,
19, 20, 22—36, 38, 39, 41—56, 58, and 59 does not cure the above-noted
deficiencies as to the independent claims. See Final Act. 7—10. Therefore,
for the reasons provided above in connection with the independent claims,
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Application 12/110,906
we do not sustain the rejection of claims 2—17, 19, 20, 22—36, 38, 39, 41—56,
58, and 59 as having been obvious over Hull, Bradley, Law, and Woods.
D. Obviousness over Hull, Bradley, Law, Woods, and Armstrong
(Claims 18, 37, and 57)
The Examiner’s additional consideration of dependent claims 18, 37,
and 57, in light of Armstrong, does not cure the above-noted deficiencies as
to the independent claims. See Final Act. 10—11. Therefore, for the reasons
provided above in connection with the independent claims, we do not sustain
the rejection of claims 18, 37, and 57 as having been obvious over Hull,
Bradley, Law, Woods, and Armstrong.
DECISION
The Examiner’s decision to reject claims 1—60 is reversed.
REVERSED
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