Ex Parte Poletto et al

Patent Trial and Appeal Board

Jul 5, 2016

13074808 (P.T.A.B. Jul. 5, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/074,808 03/29/2011
71996 7590 07/07/2016
SHUMAKER & SIEFFERT, P.A
1625 RADIO DRIVE, SUITE 100
WOODBURY, MN 55125
FIRST NAMED INVENTOR
CHRISTOPHER POLETTO
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.
1123-027US01/P0039189.00 1482
EXAMINER
HILL, KEVIN KAI
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
07/07/2016 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
Ex parte CHRISTOPHER POLETTO,
JONATHON E. GIFTAKIS, and
WILLIAM F. KAEMMERER
Appeal2014-006709
Application 13/074,808
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a
medical system. The Examiner rejected the claims as anticipated and as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as Medtronic, Inc.
(see App. Br. 3).
Appeal2014-006709
Application 13/074,808
Statement of the Case
Background
"Electrical stimulation of neural tissue serves as the core of many
neurological therapies, and can provide relief for a variety of disorders,
improving the quality of life for many patients" (Spec. i-f 2).
The Claims
Claims 27--44 and 46-52 are on appeal. 2 Independent claim 27 is
representative and reads as follows:
27. A medical system comprising:
a viral vector comprising a genetic agent encoding for
one or more light-sensitive proteins;
a biological vector delivery device configured to deliver
the viral vector to a delivery site within a patient, wherein the
viral vector comprises at least one of retrograde or anterograde
transport properties such that the viral vector is configured to
transduce the genetic agent into cells at the delivery site and
into cells in a plurality of sites proximal and remote to the
delivery site;
a sensor configured to sense a bioelectrical signal
indicative of a neurological condition of the patient; and
an optical stimulator configured to deliver light to one or
more of the cells transduced with the genetic agent by the viral
vector based on the bioelectrical signal sensed by the sensor.
The Issues
A. The Examiner rejected claims 27-35, 37, 39--44, 46, 48, and 51 under
35 U.S.C. § 102(b) as anticipated by Zhang3 (Final Act. 3--4).
2 Claims 1-26 and 45 were withdrawn (Br. 3).
3 Zhang et al., WO 2008/089003 A2, published July 24, 2008.
2
Appeal2014-006709
Application 13/074,808
B. The Examiner rejected claims 27--44, 46, 48, and 51under35 U.S.C.
§ 103(a) as obvious over Decharms,4 Zhang, and Liu5 (Final Act. 6-9).
C. The Examiner rejected claims 47, 49, 50, and 52 under 35 U.S.C.
§ 103(a) as obvious over Decharms, Zhang, Liu, and Pless6 (Final Act. 10-
12).
A. 35 U.S.C. § 102(b) over Zhang
The Examiner finds that:
Zhang et al disclose a medical system comprising: a) a device
configured to deliver a viral vector ... b) a sensor configured to
sense a bioelectrical signal related to a neurological condition
of a patient ... e.g. providing feedback that measures the
voltage or current across a cell membrane ... and c) an optical
stimulator configured to deliver light to one or more cells
transduced with the viral vector based on the bioelectrical
signal sensed by the sensor
(Final Act. 3--4). The Examiner finds that "Zhang et al disclose the viral
vector is an adeno-associated virus (AA V)" (id. 4).
The issue with respect to this rejection is: Does the evidence
of record support the Examiner's conclusion Zhang anticipates the
claims?
Findings of Fact
1. Zhang teaches
an implantable device delivers gene transfer vector, such as a
virus, which induces expression of photosensitive bio-
4 Decharms, WO 2006/055582 A2, published May 26, 2006.
5 Liu et al., US 2004/0101514 Al, published May 27, 2004.
6 Pless, US 2007/0213783 Al, published Sept. 13, 2007.
3
Appeal2014-006709
Application 13/074,808
molecular membrane proteins. The device has a light
generator, responsive to (for example, charged by or triggered
by) an external signal, to generate light and a biological
arrangement that includes the photosensitive bio-molecular
protein that responds to the generated light by interacting with
target cells in vivo. In this manner, the electronic portions of the
device may be used to optically stimulate target cells.
Stimulation may be manifested as either upregulation (e.g.,
increased neuronal firing activity), or downregulation (e.g.,
neuronal hyperpolarization, or alternatively, chronic
depolarization) of activity at the target.
(Zhang 3: 16-25).
2. Zhang teaches that "the present invention has utility in the
treatment of a wide spectrum of medical conditions, from Parkinson's
disease and brain injuries to cardiac dysrh[y ]thmias, to diabetes, and muscle
spasm" (Spec. 4:5-7).
3. Zhang teaches, regarding viral vectors, that "gene transfer
vectors inducing the expression of photosensitive bio-molecules are used to
target a specific type of cell. For instance, viral-based proteins (e.g.,
lentiviruses, adeno-associated viruses or retroviruses) can created to target
specific types of cells" (Zhang 13:5-8).
4. The Specification teaches that a "number of viral vectors with
retrograde and/or anterograde transport properties may be employed in
examples according to this disclosure. In one example, an adeno-associated
viral (AA V) vector is capable of transduction of a genetic agent encoding for
light-sensitive protein(s)" (Spec. i-f 28).
5. Zhang teaches, regarding the light sensitive protein, that the
"targeted cells are then infected by the viral-based gene-transfer proteins,
4
Appeal2014-006709
Application 13/074,808
and begin to produce a new type of ion channel (for example ChR2), thereby
becoming photosensitive" (Zhang 13:9-11).
6. The Specification teaches that in "one example, a first opsin or
set of opsins, also referred to as a light-activated cation channel proteins (or
'LACC'), comprises the protein, or portions of the protein
Channelrhodopsin-2 (ChR2)" (Spec. i-f 33).
7. Zhang teaches, regarding the sensor, that "a sensor can be used
provide feedback to the light source 1602. For instance, this feedback could
be a measurement of the voltage or current across the cell membrane. Thus,
the light source could be configured to maintain a constant current or voltage
(e.g., clamp) across the cell" (Zhang 33:33 to 34:2). Zhang further teaches
that "feedback could monitor the voltage response of the target cells,
including the amount of action potential firing" (Zhang 34: 15-16).
8. The Specification teaches that the "sensor is configured to sense
a bioelectrical signal" (Spec. i-f 5).
9. Zhang teaches, regarding the optical stimulator, that "[f]iber
optic cable 1706 may include a bundle of optical cables, each capable of
carrying and directing light independently. Thus, fiber optic cable 1706 can
be configured to deliver light having one or more wavelengths to multiple
locations" (Zhang 34:9-11 ).
10. The Specification teaches that "[i]mplantable stimulator 4 may
be configured to deliver optical stimulation, such as light 15, to patient 6 via
implantable optical fibers 11" (Spec. i-f 20).
5
Appeal2014-006709
Application 13/074,808
Principles of Law
"An [] intended use or purpose usually will not limit the scope of the
claim because such statements usually do no more than define a context in
which the invention operates." Boehringer Ingelheim Vetmedica, Inc. v.
Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003).
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 3--4; FF 1-10) and agree that
the claims are anticipated by Zhang. We address Appellants' arguments
below.
Claims 2 7 and 44
Appellants contend that Zhang "fails to disclose or suggest that the
sensor is configured to sense a bioelectrical signal indicative of a
neurological condition of the patient" (App. Br. 7). Appellants contend that
"Zhang fails to disclose or suggest that the current or voltage across the
membrane of a single cell is a bioelectrical signal that is indicative of a
neurological condition of a patient" (id.). Appellants contend that the
"Examiner failed to provide any basis in fact to support the assertion that the
voltage or current across a cell membrane of a single cell 1608 disclosed by
Zhang is equivalent to the 'action potentials' disclosed in Applicant's
specification" (id. at 8-9).
We are not persuaded. The phrase "configured to sense a bioelectrical
signal indicative of a neurological condition" merely states an intended use
or purpose for the claimed sensor. Appellants do not identify any necessary
structural difference between the sensor of Zhang and the claimed sensor,
6
Appeal2014-006709
Application 13/074,808
with both sensors detecting bioelectric signals (FF 7-8). Appellants' use of
the detected bioelectric signals as "indicative of a neurological condition" is
reasonably interpreted as an intended use recitation for this system claim,
because Appellants fail to provide any specific structure or configuration of
the sensor itself in the claim that serves to distinguish Zhang' s bioelectric
signal detecting sensor (FF 7) or that performs the intended use function of
indicating "a neurological condition". "It is well settled that the recitation of
a new intended use for an old product does not make a claim to that old
product patentable." In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
Appellants contend that
Zhang also fails to disclose the optical stimulator of
Applicant's claim 27. The Examiner characterized a light
source disclosed by Zhang as the optical stimulator of claim 27.
Zhang, however, fails to disclose or suggest that the light
source is configured to deliver light to one or more of the cells
based on a bioelectrical signal indicative of a neurological
condition
(App. Br. 9).
We are not persuaded. The "configured to deliver light ... based on
the bioelectrical signal" merely states an intended use or purpose for the
optical stimulator. Appellants do not identify any necessary structural
difference between the optical stimulator of Zhang and the claimed optical
stimulator, and both are composed of optical fibers for light delivery (FF 9-
10). Zhang expressly teaches that the "sensor can be used provide feedback
to the light source" where the "feedback could monitor the voltage response
of the target cells" (FF 7), thereby expressly teaching that the optical
stimulator delivers light based on the bioelectric signal detected by the
7
Appeal2014-006709
Application 13/074,808
sensor. Therefore, the "configured" language simply represents one
intended use of the optical stimulator. Schreiber, 128 F.3d at 1477.
Claim 46
Appellant contends that the "Examiner asserted that Zhang anticipates
claim 46, but admitted that Zhang does not disclose a sensor configured to
sense a bioelectrical signal related to epilepsy. On this admission alone, the
rejection of claim 46 under 35 U.S.C. § 102(b) as allegedly being anticipated
by Zhang should be reversed" (App. Br. 11 ).
We are not persuaded. Claim 46 recites "a sensor configured to sense
a bioelectrical signal related to epilepsy", but imposes no specific
requirements on the sensor that distinguish sensors "configured" for
detection of electrical signals associated with epilepsy from Zhang' s sensor
for detection of electrical signals (FF 7). As discussed above, this
"configured to" language merely represents an intended use of the sensor.
Appellants do not, in their arguments, contend or evidence that the claim or
Specification provides any detailed guidance on particular "configurations"
of a sensor which function to separately distinguish epilepsy or other
neurological conditions. Therefore, the "configured" language simply
represents one intended use of the sensor. Schreiber, 128 F.3d 1477.
Despite failing to provide any guidance on using bioelectrical signals
for epilepsy detection in their own Specification, Appellants further contend
that "even if 'action potentials' may reasonably be characterized as a
bioelectrical signal related to epilepsy, the Examiner failed to establish that
Zhang discloses a sensor configured to sense such 'action potentials"' (App.
Br. 12).
8
Appeal2014-006709
Application 13/074,808
This statement is incorrect. Zhang teaches that "feedback could
monitor the voltage response of the target cells, including the amount of
action potential firing" (FF 7). Thus, consistent with Appellants' admission
that "action potentials" are bioelectrical signals related to epilepsy, Zhang
teaches a sensor that measures action potential firing (FF 7), thereby
demonstrating the functional capacity to satisfy the "configured to" intended
use language.
We also recognize, but find unpersuasive, Appellants contention that
"the Examiner has failed to establish that Zhang necessarily discloses a
sensor configured to sense a bioelectrical signal related to epilepsy, and an
optical stimulator configured to deliver light based on the bioelectrical
signal" (App. Br. 13). These arguments do not interpret the "configured to"
limitation as an intended use, but rather as a structural limitation. However,
the Examiner has established that the sensor can detect bioelectrical signals
such as action potentials, and that the sensor can feedback this information
to the optical stimulator for treatment (FF 7, 9). Appellants, in contrast,
have provided no evidence that any specific "configuration" is disclosed in
the Specification that structurally distinguishes the device of Zhang, nor
have Appellants provided any evidence rebutting the Examiner's findings
that Zhang teaches the required elements of the claim (see Ans. 16).Claim
51
Appellants contend that "[i]t is improper for the Examiner to rely on
Appellant's specification to support the assertion that the AA V disclosed by
Zhang has anterograde transport properties" (App. Br. 14).
9
Appeal2014-006709
Application 13/074,808
We are not persuaded. It is appropriate to consult the Specification to
confirm an inherent property of product. In re Huai-Hung Kao, 639 F.3d
1057, 1070 (Fed. Cir. 2011) ("substantial evidence supports the Board's
finding of inherency. The Office further responds that the Board's reliance
upon the specification of the '859 Application to support this conclusion is
entirely proper. . . . This court agrees with the Office"). Just as Kao relied
upon the Specification to demonstrate inherency, the Examiner here properly
relies upon Appellants' Specification to evidence that adeno-associated
viruses (AA V) inherently have anterograde transport properties (FF 4). The
Examiner reasonably finds that the AA V disclosed by Zhang will
necessarily and inherently have the same properties as the identical AA V
disclosed in the Specification (FF 3--4, see Ans. 17). "Products of identical
chemical composition can not have mutually exclusive properties." In re
Spada, 911 F.2d 705, 708 (Fed. Cir. 1990).
Conclusion of Law
The evidence of record supports the Examiner's conclusion Zhang
anticipates the claims.
B. 35 U.S.C. § 103(a) over Decharms, Zhang, and Liu
The Examiner finds that Decharms teaches
a medical system comprising: a) a device configured to deliver
a therapeutic agent (Figure l; [0034, 150-151, 155]), b) a sensor
configured to sense a bioelectrical signal related to a
neurological condition of a patient [0046, 49], to wit, epilepsy
[ 00141], and c) an optical stimulator configured to deliver light
to one or more target cells based on the bioelectrical signal
sensed by the sensor [0012-13].
10
Appeal2014-006709
Application 13/074,808
(Final Act. 6-7). The Examiner acknowledges that "De[]charms does not
disclose a delivery device that comprises a viral vector" (Id. at 7) but relies
upon Zhang as discussed above to teach AA V viral vectors comprising light
sensitive proteins (id. at 8).
The Examiner finds it obvious
to substitute a first delivery device capable of delivering a viral
vector, as taught by De[]charms, with a second delivery device
comprising a viral vector (Zhang et al), ... in a medical system
with a reasonable expectation of success because the simple
substitution of one known element for another would have
yielded predictable results to one of ordinary skill.
(Final Act. 9).
The issue with respect to these rejection is: Does the evidence of
record support the Examiner's conclusion that Decharms, Zhang, and Liu
render the claims obvious?
Findings of Fact
11. Decharms teaches "a system for stimulating target tissue
comprising: a light source for providing stimulation pulses; an implantable
light conducting lead coupled to said light source adapted for stimulation of
a predetermined site in a subject. In one aspect, the light conducting lead is
an optical fiber" (Decharms i-f 12).
12. Decharms teaches that "stimulating said at least one
predetermined site in said nervous system of said body using said at least
one light-emitter. In one aspect of the invention, the disorder being treating
is Parkinson's disease, Alzheimer's disease, depression, or epilepsy"
(Decharms i-f 13).
11
Appeal2014-006709
Application 13/074,808
13. Dec harms teaches that: "Pharmacological treatment, as used
herein, refers to the administration of any type of drug or medication"
(Decharms i-f 34).
14. Decharms teaches that "[t]his method provides for stimulation
within or adjacent to epileptic tissue in order to disrupt or prevent an
epileptic seizure. Seizure activity may be monitored through measurement
of brain electrical activity" (Decharms i-f 141 ).
15. Dec harms teaches that
the methods disclosed here may be used to stimulate fibers
synapsing onto a group of neurons whose activation is
measured electrically, including glutamatergic synapsing fibers.
The electrical potential in a target cell or population of cells
may be recorded that results from light stimulation of the fibers
using this method. Then, a drug such as a potential glutamate
antagonist may be applied, for example in fluid 35 through
catheter 34. The electrical potential may be compared in the
presence and absence of the drug to determine the drugs effect.
Similarly, methods may be used to monitor the effect of a drug
on a physiological response induced using light stimulation in
VIVO.
(Decharms i-f 155).
Principles of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 6-9; FF 1-15) and agree that
12
Appeal2014-006709
Application 13/074,808
the claims are rendered obvious by Decharms, Zhang, and Liu. We address
Appellants' arguments below.
Claims 27, 44, and 46
Appellants contend that
the applied art fails to provide any basis for asserting that the
light delivered by the Decharms device would have caused the
proteins induced by the gene transfer vector disclosed by Zhang
to respond, and, thus, the gene transfer vector disclosed by
Zhang would have served no apparent purpose in the Decharms
system.
(App. Br. 15).
We are not persuaded. Decharms teaches a system for light
stimulation of neural tissue for treatment of diseases including epilepsy (FF
12) and specifically teaches that light stimulation effects electrical potential
of cells treated with a pharmacologic agent (FF 15). Zhang teaches a system
using a viral vector to introduce a protein responsive to light stimulation (FF
1) for treatment of a wide variety of diseases (FF 2) where the treatment
effects electrical potential of cells and may be monitored by a sensor (FF 7).
We agree with the Examiner that the "optical device of both
Decharms and Zhang et al are configured to modulate the electrical impulses
of neural target cells. Thus, the Examiner maintains the position that the
gene transfer vector of Zhang et al would, in fact, serve purpose in the
Decharm[s'] system" (Ans. 18). Our obviousness conclusion is consistent
with Wrigley, where the Federal Circuit found a "strong case of obviousness
based on the prior art references of record. [The claim] recites a
combination of elements that were all known in the prior art, and all that was
required to obtain that combination was to substitute one ... agent for
13
Appeal2014-006709
Application 13/074,808
another." Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356,
1364 (Fed. Cir. 2012).
Appellants contend that "[ o ]ne having ordinary skill in the art would
not have considered the 'drugs or pharmacological agents' disclosed by
Decharms and the gene transfer vector disclosed by Zhang to be 'equivalents
known in the prior art for the same purpose"' because "the light disclosed by
Zhang controls the proteins induced by the gene transfer vector, whereas the
optical energy disclosed by Decharms causes an electrical impulse to
propagate in the neurons" (App. Br. 16).
We are not persuaded. Decharms expressly teaches a system that is
open to any "drug or medication" (FF 13), a broad disclosure that
encompasses Zhang' s specific treatment with AA V that expresses "ion
channel (for example ChR2), thereby becoming photosensitive" (FF 5) in
order to enhance light treatment of neuronal stimulation (FF 1 ). Thus,
Zhang directly evidences a medicament identified as useful in the treatment
of medical conditions including neural conditions, demonstrating the
equivalence for the purpose of treatment (FF 2).
Appellants contend that the "Examiner has impermissibly used
Appellant's claim as a roadmap to find references that allegedly disclose the
features of claims 27. This reliance on hindsight has resulted in a proposed
modification to Decharms that lacks a rational underpinning" (App. Br. 17).
We are not persuaded. While we are fully aware that hindsight bias
often plagues determinations of obviousness, Graham v. John Deere Co.,
383 U.S. 1, 36 (1966), we are also mindful that the Supreme Court has
clearly stated that the "combination of familiar elements according to known
14
Appeal2014-006709
Application 13/074,808
methods is likely to be obvious when it does no more than yield predictable
results." KSR, 550 U.S. at 416. The combination of Zhang's system of light
treatment using AA V delivery for neuronal diseases with Decharms' system
of light treatment for neuronal diseases such as epilepsy is just such a
predictable combination, with both systems using delivery systems (FF 3,
13), optical stimulators (FF 9, 11 ), sensors to monitor electrical activity (FF
7, 14) with Decharms' suggesting delivery of medicaments generally (FF
13) while Zhang teaches the use of a specific viral vector medicament that
encodes a light sensitive protein (FF 5). Thus, the Examiner's obviousness
rejection simply demonstrates that familiar elements in Decharms and Zhang
would have been predictably combined to obtain the system required by
claims 27, 44, and 46. Appellants provide no evidence of unexpected results
or other secondary considerations to rebut this finding.
Claim 51
We find Appellants' argument regarding the anterograde transport
properties of AA V unpersuasive for the reasons already given.
Conclusion of Law
The evidence of record supports the Examiner's conclusion that
Decharms, Zhang, and Liu render the claims obvious.
C. 35 U.S.C. § 103(a) over Decharms, Zhang, Liu, and Pless
Claims 47, 49, and 52
Appellants do not separately argue claims 47, 49, and 52, relying upon
their reasons regarding claims 27 and 46. We remain unpersuaded by this
argument. Having affirmed the obviousness rejection of claims 27 and 46
15
Appeal2014-006709
Application 13/074,808
over Decharms, Zhang, and Liu for the reasons given above, we also find
that the further obvious combinations render the remaining claims obvious
for the reasons given by the Examiner (see Final Act. 10-12).
Claim 50
Appellants contend that the "Examiner's assertion that a processor
disclosed by Pless has the ability to select one or more optical fibers from
the plurality of optical fibers to deliver the light based on a sensed
bioelectric signal is insufficient to establish that Pless discloses a processor
configured to do so" (App. Br. 21 ).
We are not persuaded. Pless teaches that "different patients and
different targets will react differently to different light colors, intensities,
stimulation pulse widths, and stimulation burst durations" (Pless i-f 89) and
that while it "is possible to use a single device ... with multiple leads to
reach multiple detection and therapy targets in the body. However, remote
modules do facilitate combination therapies, with stimulation and drugs
being used in different areas to maximum effect" (Pless i-f 121 ).
We agree with the Examiner that the ordinary artisan, interested in
treating different targets within a patient with different stimulation protocols
in different areas of the body would have found it obvious to configure the
processor to deliver the appropriate signal by selecting optical fibers in the
correct body area with the correct stimulation parameters (see Ans. 23).
"[T]he test [for obviousness] is what the combined teachings of the
references would have suggested to those of ordinary skill in the art." In re
Keller, 642 F.2d 413, 425 (CCPA 1981).
16
Appeal2014-006709
Application 13/074,808
SUMMARY
In summary, we affirm the rejection of claims 27, 44, 46, and 51
under 35 U.S.C. § 102(b) as anticipated by Zhang. Claims 28-35, 37, 39-
43, and 48 fall with claims 27, 44, 46, and 51.
We affirm the rejection of claims 27, 44, 46, and 51under35 U.S.C.
§ 103(a) as obvious over Decharms, Zhang, and Liu. Claims 28--43, and 48
fall with claims 27, 44, 46, and 51.
We affirm the rejection of claims 47, 49, 50, and 52 under 35 U.S.C.
§ 103(a) as obvious over Decharms, Zhang, Liu, and Pless.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
17