Ex Parte Bonde et al

Patent Trial and Appeal Board

Oct 31, 2017

13305405 (P.T.A.B. Oct. 31, 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.
13/305,405 11/28/2011 Eric H. Bonde 1123-011US01/P034191.USU5 7874
71996 7590 11/02/2017
SHUMAKER & SIEFFERT , P.A
1625 RADIO DRIVE , SUITE 100
WOODBURY, MN 55125
EXAMINER
STICE, PAULA J
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
11/02/2017 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 ERIC H. BONDE and XUAN K. WEI
Appeal 2016-0073711
Application 13/305,405
Technology Center 3700
Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a system for electrical
stimulation of pelvic floor muscle of a patient. The Examiner rejected all
the claims under 35 U.S.C. § 112, second paragraph, as indefinite and § 103
as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-
PART and enter NEW GROUNDS OF REJECTION pursuant to our
authority under 37 C.F.R. § 41.50(b).
1 The Appeal Brief (“Appeal Br.”) identifies Medtronic pic of Dublin,
Ireland, as the real-party-in-interest (“Medtronic”). Appeal Br. 2.
Appeal 2016-007371
Application 13/305,405
STATEMENT OF THE CASE
Claims 14—27 are pending and stand rejected by the Examiner as
follows:
Claims 14—16 and 18—27 under pre-AIA 35 U.S.C. § 103(a) as
obvious in view of Gerber (U.S. Publ. Pat. Appl. 2007/0027494 Al, publ.
Feb. 1, 2007) and Surwit (U.S. Publ. Pat. Appl. 2009/0076565 Al, publ.
Mar. 19,2009). Answer (“Ans.”) 2.
Claim 17 under pre-AIA 35 U.S.C. § 103(a) as obvious in view of
Gerber, Surwit, and Zabara (U.S. Pat. No. 6,721,603 B2, iss. Apr. 13, 2004).
Id.
Claims 15, 19—23, and 25 under pre-AIA 35 U.S.C. § 112, second
paragraph, as indefinite for failing to particularly point out and distinctly
claim the subject matter which the inventors regard as the invention. Id.
Claim 14, representative of the claimed subject matter, is reproduced
below:
14. A system comprising:
at least one electrode configured for implantation
proximate to a nerve of a patient;
an electrical stimulation module electrically coupled to
the at least one electrode and configured to generate and deliver
electrical stimulation; and
a processor configured to receive input indicative of an
intent of the patient to contract a pelvic floor muscle of the
patient or an attempt by the patient to contract the pelvic floor
muscle, and to control the electrical stimulation generator to
deliver electrical stimulation via the at least one electrode to the
nerve of the patient in response to receiving the input, wherein
the electrical stimulation is configured to induce a contraction
in the pelvic floor muscle of the patient to strengthen the pelvic
floor muscle of the patient.
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Application 13/305,405
CLAIM INTERPRETATION
Claim 14 is directed to a system comprising (1) “at least one electrode
configured for implantation proximate to a nerve of a patient” and (2) a
processor.
The processor is (a) “configured to receive input indicative of an
intent of the patient to contract a pelvic floor muscle of the patient or an
attempt by the patient to contract the pelvic floor muscle.” In response to
the “input,” the processor is (b) configured “to deliver electrical stimulation
via the . . . electrode to the nerve of the patient.”
The Specification (“Spec.”) discloses that such “intent” or “attempt”
can be manifested by “select[ing] a particular button of patient programmer
22 ... or provide input to a touch screen of patient programmer 22.” Spec.
145. The Specification further discloses:
After receiving the input, patient programmer 22 may transmit a
signal to IMD [implantable medical device] 14 indicating that
patient 12 is attempting to or intending on contract one or more
pelvic floor muscles, and, in response to receiving the signal
from programmer 22, IMD 14 may deliver electrical
stimulation to a nerve of patient 12, e.g., a sacral or pudendal
nerve or branches thereof, based on receiving the signal.
Id.
In other words, the requirement that the processor is “configured to
receive input” is met by a “button” or “touch screen” that allows a patient to
manually turn the electrical stimulation on and stimulate the nerve to cause
contraction.
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Application 13/305,405
REJECTION BASED ON GERBER & SURWIT
The Examiner found that Gerber describes (1) an electrode implanted
into a nerve of a patient as required by the claim. Final Action (“Final
Act.”) 5. The Examiner also found that “Gerber further discloses a patient
programmer comprising a user interface, and the processor of the medical
device can receive input from the patient via the user interface (0030).” Id.
Thus, the Examiner found that Gerber describes (2) a processor as required
by the claim. The Examiner stated that Gerber discloses that “the controller
[(i.e., a processor) is] configured to control stimulation to the electrodes after
receiving input (pgs, 0021, 0023, 0045 and 0048).” Id.
The Examiner found that Gerber does not specifically disclose that the
processor “is configured to receive an input indicative of the patient
contracting the pelvic floor muscle and to control the electrical stimulation
to deliver electrical stimulation in response to the received input” by the
patient as required by claim 14. Id. at 6 (emphasis added). However,
despite this statement, the Examiner referred to paragraph 30 of Gerber
which contains such a teaching.
As disclosed in paragraph 30, Gerber teaches a sensing device which
transmits information regarding a bladder condition to an external
programmer and stimulator. The stimulator “may activate or adjust
stimulation to prevent involuntary urine leakage” (Gerber 130), namely, by
causing the pelvic floor muscle to contract for muscle tone strengthening (id.
6, 21). When the sensing device determines that the bladder is full,
Gerber teaches that “external programmer 22 may signal patient 12 that
bladder 14 should be voided based on the bladder condition information.”
Id. 130. Gerber teaches that “[o]nce stimulator 18 receives confirmation
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from patient 12 to void bladder 14, the stimulator may temporarily cease
stimulation to allow urine to exit bladder 14.” Id. Thus, patient input is
used to turn the stimulator off to empty the bladder. When voiding is ended,
Gerber teaches that the sensing device can be used to turn the stimulator
back on {id.) to resume contraction of the bladder and pelvic floor muscle to
prevent urine leakage. However, Gerber also discloses another embodiment
in the same paragraph:
In other embodiments, patient 12 may signal stimulator 18
through external programmer 22 that voiding has completed.
This signal may allow stimulator 18 to restart simulation if
necessary.
Id.
In this embodiment, the patient turns the stimulator on through the
external programmer. Thus, “in response to receiving the input” from the
patient (“patient 12 may signal stimulator 18 through external programmer
22”), the system is configured “to deliver electrical stimulation via the at
least one electrode to the nerve of the patient” as required by claim 14.
Gerber teaches that the programmer is in communication with the
processor that controls the stimulator. Id. Tflf 62, 69, 70, Figs. 6 & 7. The
processor is therefore (a) “configured to receive input indicative of an intent
of the patient to contract a pelvic floor muscle of the patient or an attempt by
the patient to contract the pelvic floor muscle” and (b) configured “to deliver
electrical stimulation via the . . . electrode to the nerve of the patient” in
response to the input.
The external programmer in Gerber receives patient input and thus
meets the corresponding limitation of claim 16 of a patient programmer.
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Gerber also teaches the external programmer can deliver the
stimulation:
Although processor 56 is described in this example as adjusting
stimulation parameters, it is noted that the adjustments
alternatively may be generated by external programmer 22 and
transmitted to stimulator 18 as parameter or program changes.
Gerber 171.
Thus, the external programmer itself can serve as the processor to
receive input and deliver electrical stimulator.
Claim 24 specifies that the nerve “comprises at least one of a sacral
nerve, at least one branch of the sacral nerve, a pudendal nerve, or at least
one branch of the pudendal nerve.” Gerber teaches stimulating these same
nerves. Id. Tffl 22, 65
We find that Surwit is unnecessary to the rejection because Gerber
alone teaches all the limitations of claim 14. Gerber thus anticipates claim
14.2 Claim 26 has similar limitations as recited in claim 14, and thus is
anticipated as well.
Accordingly, we reverse the obviousness rejection of claims 14—16
and 18—27 based on Gerber and Surwit. Pursuant to 37 C.F.R. § 41.50(b),
we set forth a new ground of rejection under pre-AIA 35 U.S.C. § 102(b) of
claims 14, 16, 24, and 26 as anticipated by Gerber.
2 The Board may rely upon fewer than all the references cited by the
Examiner. See In re May, 574 F.2d 1082, 1090 (CCPA 1978).
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NEW GROUND OF REJECTION UNDER 35 USC § 103 BASED ON
GERBER
As indicated above, claim 14 is a system comprising an implanted
electrode and a processer that can receive input to turn the electrical
stimulation on and deliver stimulation through the electrode. Claim 26 has
similar features. In our view, it would have been obvious to install a manual
means for controlling pelvic floor muscle contractions and tone to ensure
that urine does not leak out, e.g., when the bladder sensing unit in Gerber is
faulty, as an adjunct or backup to a sensing unit feedback, or to turn it back
on manually after voiding has been completed. It would have been obvious
to one of ordinary skill in the art to modify a bladder control device to
permit the patient to operate it manually, e.g., to turn it on after the bladder
is emptied or when urine leakage has unexpectedly occurred, despite the
presence of a sensing device to detect bladder fullness. No one wants to
smell like urine.
In counseling that courts “need not seek out precise
teachings directed to the specific subject matter of the
challenged claim,” the Supreme Court clarified that courts may
look to a wider diversity of sources to bridge the gap between
the prior art and a conclusion of obviousness. KSR, 550 U.S. at
418, 127 S.Ct. 1727. We previously noted that “[t]he reason,
suggestion, or motivation to combine may be found explicitly
or implicitly: 1) in the prior art references themselves; 2) in the
knowledge of those of ordinary skill in the art that certain
references, or disclosures in those references, are of special
interest or importance in the field; or 3) from the nature of the
problem to be solved ...” Ruiz v. A.B. Chance Co., 234 F.3d
654, 665 (Fed. Cir. 2000). KSR expanded the sources of
information for a properly flexible obviousness inquiry to
include . . . “any need or problem known in the field of
endeavor at the time of invention and addressed by the patent”;
and the background knowledge, creativity, and common sense
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of the person of ordinary skill. 550 U.S. at 418—21, 127 S.Ct.
1727.
Perfect Web Technologies, Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1329 (Fed.
Cir. 2009).
Pursuant to 37 C.F.R. § 41.50(b), we set forth a new ground of
rejection under 35 U.S.C. 103(a) of claims 14, 16, 24, and 26 as obvious in
view of Gerber.
CLAIMS 15, 18-23,25,27
Dependent claims 15, 18—23, 25, and 27 recite specific parameters for
electrical stimulation. Appellants argue that some of these claims recite
specific structures that distinguish their subject matter over the prior art.
Appeal Br. 15. For example, Appellants stated: “claim 19 recites a specific
structure that has not been shown to have been disclosed by Gerber or
Surwit.” Id. Appellants did not identify the so-called “structure.”
Claim 19, like claim 15, 18, 20-23, and 25, recites specific
stimulation conditions. One of ordinary skill in the art is well aware of how
an electrical stimulator works, namely delivering electric pulses of desired
amplitude, voltage, periodicity, and time to a target nerve. The structure of
electrical simulators was known in the art at the time of invention, and the
Specification provides no information on the stimulator itself that would
distinguish it from any conventional stimulator, such as the one described in
Gerber.
To the extent Appellants mean the algorithm or circuit that the
stimulator utilizes to produce the desired activity when they refer to a
“specific structure,” Gerber teaches that it was conventional to make
“simulation parameter adjustments” to control the pelvic muscle tone.
Gerber 19. For example, Gerber teaches:
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Application 13/305,405
Stimulation may be increased or decreased by adjusting one or
more stimulation parameters such as amplitude (current or
voltage), pulse width or pulse rate. Adjustment also may
include selection of different electrodes or polarities.
Id. 130. There are numerous statements in Gerber about adjusting
stimulation parameters to achieve the desired muscle tone, etc. See, e.g., id.
32, 33, 59, 64, 65. In addition, specific parameters are disclosed in
Gerber. Id. H 65—68. Appellants did not even appear to attempt to
distinguish their recited parameters from those in Gerber. The “law is
replete with cases in which the difference between the claimed invention and
the prior art is some range or other variable within the claims.. .in such a
situation, the applicant must show that the particular range is critical,
generally by showing that the claimed range achieves unexpected results
relative to the prior art range.” In re Woodruff, 919 F.2d 1575, 1578 (Fed.
Cir. 1990).
Appellants have not established that the recited parameters are critical
or significant to the claimed invention and distinguishable from those
disclosed in prior art. Accordingly, we affirm the Examiner’s obviousness
rejection of dependent claims 15, 18—23, 25, and 27. However, since a new
ground of rejection was designated for the independent claims from which
these claims depend, we shall also designate the obviousness rejection based
on Gerber alone of claims 15, 18—23, 25, and 27 as a new ground of
rejection.
CLAIM 17
Claim 17, which depends from claim 14, further recites that, inter
alia, “a motion sensor integral with the implantable medical device, wherein
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the motion sensor is configured to generate a signal indicative of tapping of
the implantable medical device.” The Examiner further cited Zabara for
teaching a tap sensor. Final Act. 7. Appellants made the same arguments as
they did in the rejection based on Gerber and Surwit. Appeal Br. 12. We
affirm the rejection, but designate it as a new ground because claim 14, from
which claim 17 depends, was subject to a new ground of rejection.
SECTION 112 REJECTION
The Examiner rejected claims 15, 19—23, and 25 as indefinite under
§112 because of the recitation of the terms “approximately” and
“substantially.” Final Act. 3^4.
We agree that the terms are indefinite. The recited terms characterize
the parameters used in the stimulation mode. We interpret the stimulation
parameters (including the timing of claim 25) to be effective “to induce a
contraction in the pelvic floor muscle of the patient to strengthen the pelvic
floor muscle of the patient” as recited in claim 14. However, Appellants
have offered no guidance on how one of ordinary skill in the art would
understand the breadth of the claim — for example, does “approximate”
include a two-fold difference, a ten-fold difference, etc.? Independent claim
14 is already broad in having no restriction on the stimulation parameters
other than that stimulation is effective to induce muscle contraction.
Narrowing the claim, for instance, to a duration of approximately 10 seconds
(claim 21), or approximately 3 seconds (claim 22) introduces imprecision
into the claim and indefmiteness because it is not clear what values would be
tolerated by the claim and still be approximately 3 or approximately ten. For
example, we have not been informed by Appellants in their argument (see
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Appeal Br. 9) how a 3 second duration is any different or achieves any
different function or effect than a 10 second duration, or 100 second
duration, etc. This same rationale applies to the other claims, as well,
including claim 25 in reciting “substantially immediately” because it is
unclear of what significance or critically is the time period between
receiving input to delivering stimulation.
SUMMARY
1. The obviousness rejection of 14—16 and 18—27 based on Gerber
and Surwit is reversed.
2. The obviousness rejection of claim 17 based on Gerber, Surwit,
and Zabara is reversed.
3. Claims 14, 16, 24, and 26 are rejected under 35 U.S.C. pre-AIA
§ 102(b) as anticipated by Gerber. This is a new ground of rejection.
4. Claims 14—16 and 18—27 are rejected under pre-AIA 35 U.S.C.
§ 103(a) as obvious in view of Gerber. This is a new ground of rejection.
5. Claim 17 is rejected under 35 U.S.C. pre-AIA § 103(a) as obvious
in view of Gerber and Zabara. This is a new ground of rejection.
6. The 112, second paragraph, rejection of claims 15, 19—23, and 25
is affirmed.
Pursuant to 37 C.F.R. § 41.50(b), we enter a NEW GROUND OF
REJECTION of claims 14—27 under 35 U.S.C. § 102(b) as being anticipated
by Gerber and § 103(a) as being obvious over Gerber and Zabara.
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of
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rejection pursuant to this paragraph shall not be considered final for judicial
review.” 37 C.F.R. § 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant, within
two months from the date of the decision, must exercise one of the following
two options with respect to the new ground of rejection to avoid termination
of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the
claims, appellant may again appeal to the Board pursuant to this
subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
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)(l)(iv).
AFFIRMED-IN-PART: 37 C.F.R, § 41.500?)
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