Ex Parte Simon et al

Patent Trial and Appeal Board

Aug 16, 2017

13329745 (P.T.A.B. Aug. 16, 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.
13/329,745 12/19/2011 Bruce J. Simon 5394.B25US2 8338
104326 7590 08/18/2017
Schwegman Lundberg & Woessner / Zimmer
P.O. Box 2938
Minneapolis, MN 55402
EXAMINER
EVANISKO, GEORGE ROBERT
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
08/18/2017 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):
SLW @ blackhillsip.com
USPTO@slwip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BRUCE J. SIMON and JEAN C. GAN
Appeal 2016-004197
Application 13/329,745
Technology Center 3700
Before JEFFREY N. FREDMAN, RYAN H. FLAX, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a
nonsurgical method of treating degenerative disc disease. The Examiner
rejected the claims as failing to comply with the written description
requirement, as indefinite, as anticipated, as obvious, and for double
patenting. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
“Degenerative disc disease (DDD), an irreversible process, is the most
common cause of back pain” (Spec. 1). “The intervertebral disc consists of
a gelatinous nucleus pulposus encapsulated by a fibrous annulus fibrosus. . .
1 Appellants identify the Real Party in Interest as EBI, LLC (see App. Br. 1).
Appeal 2016-004197
Application 13/329,745
with maturation, the tissue loses its gel-like properties becoming less
hydrated and ultimately more fibrous” (id.). “These changes result in the
development of cracks and cavities within the annulus fibrosus leading to
degeneration” (id.).
Anti-neuralgic and anti-inflammatory methods treat the
symptoms but do not eliminate the problem. Minimally
invasive percutaneous treatments . . . temporarily improve the
symptoms, but they do not prevent the progression of DDD and
may even accelerate it in the long term. Major surgeries . . .
eliminate structures, risk nerve injury during the operation, also
risk morbidity, and may result in accelerated disc degeneration
at adjacent segments in the long term.
(Spec. 2).
The Claims
Claims 1—5, 12—16, and 22—29 are on appeal. Claim 1 is
representative and reads as follows:
1. A nonsurgical method of treating degenerative disc
disease, comprising:
identifying an unfused disc in a state of degenerative disc
disease in a subject; and
nonsurgically treating the degenerative disc disease by
applying capacitively coupled electrical stimulation to the
identified unfused disc, intending to promote generation of disc
tissue as an alternative to spinal fusion, the electrical
stimulation characterized by an electric field created with an
electrical signal having a frequency within a range of 20 to 100
kHz and having a symmetrical waveform with an amplitude
within a range of 0.1 to 20 volts peak-to-peak.
2
Appeal 2016-004197
Application 13/329,745
The Issues
A. The Examiner denied priority to the prior-filed application US
11/176,588, as failing to provide support for one or more claims (Final Act.
2-3).
B. The Examiner rejected claims 28 and 29 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement (id.
at 3—4).
C. The Examiner rejected claims 22—26 under 35 U.S.C. § 112, second
paragraph, as indefinite (id. at 4).
D. The Examiner rejected claims 1—3, 12—14, and 22—29 under 35 U.S.C.
§ 103(a) as obvious over Goodwin2 (id. at 5—7).
E. The Examiner rejected claims 1—3, 12—14, and 22—29 under 35 U.S.C.
§ 102(b) as anticipated or under 35 U.S.C. § 103(a) as obvious over
Brighton3 (id. at 7—8).
F. The Examiner rejected claims 4, 5, 15, and 16 under 35 U.S.C.
§ 103(a) as obvious over Goodwin and Brighton ’7754 (id. at 8).
G. The Examiner rejected claims 4, 5, 15, and 16 under 35 U.S.C.
§ 103(a) as obvious over Brighton and Brighton ’775 (id. at 8—9).
H. The Examiner rejected claims 1—5, 12—16, and 22—29 on the ground
of nonstatutory obviousness-type double patenting as being unpatentable
over claims 1—5 ofU.S. Patent No. 8,082,038 (id. at 10).
2 Goodwin et al., A Double-Blind Study of Capacitively Coupled Electrical
Stimulation as an Adjunct to Lumbar Spinal Fusions, 24 Spine 1349—56
(1999).
3 Brighton et al., WO 03/004092 A2, published Jan. 16, 2003.
4 Brighton et al., US 4,535,775, issued Aug. 20, 1985.
3
Appeal 2016-004197
Application 13/329,745
A. Priority
The Examiner finds “the prior-filed application, Application No.
11/176588, fails to provide adequate support or enablement in the manner
provided by the first paragraph of 35 U.S.C. 112” (Final Act. 2).
Appellants contend that passages in the original specification of the
’588 application, “taken in context, reasonably convey to those skilled in the
art that the treatment of DDD according to the present invention is instead
of, not in addition to, spinal fusion surgery” (App. Br. 8).
While the Examiner and Appellants dispute whether the claims
receive benefit of priority to parent application US 11/176,588, all of the
cited prior art documents remain applicable irrespective of whether priority
is granted or not. “Thus, the dispute . . . call[s] for an impermissible
advisory opinion.” GAF Building Materials Corp. v. Elk Corp., 90 F.3d
479, 482 (Fed. Cir. 1996). Consequently, we decline to render an advisory
opinion on this priority issue.
B. 35 U.S.C. § 112, first paragraph, written description
The issue with respect to the written description issue is: Does the
evidence of record support the Examiner’s finding that the limitations to the
capacitively coupled electrical stimulation treatment of “nucleus pulposus”
or “annulus fibrosus” tissue in claims 28 and 29 lack descriptive support in
the Specification?
Findings of Fact
1. The Specification states:
This invention relates to methods for treating
degenerative disc disease, and more particularly to methods for
4
Appeal 2016-004197
Application 13/329,745
treating degenerative disc disease noninvasively. Degenerative
disc disease (DDD), an irreversible process, is the most
common cause of back pain. The intervertebral disc consists of
a gelatinous nucleus pulposus encapsulated by a fibrous
annulus fibrosus and the end-plates. The nucleus pulposus
plays an important role in weight transmission. When this gel­
like fluid is subjected to load, the nucleus pulposus is
pressurized deforming to establish an equilibrating pressure
between the annulus fibrosus and vertebral end-plates.
(Spec. 1 (emphasis added)).
2. The Specification states: “There are 3 therapeutic approaches to
date: 1) Anti-neuralgic and anti-inflammatory; 2) Minimally invasive
percutaneous treatments such as discectomy, intradiscal electrothermy,
nucleoplasty and percutaneous radioffequency application; and 3) Major
surgeries such as fusions, laminectomy and nucleus/disc replacements”
(Spec. 1).
3. The Specification states: “The device may be used as an adjunct
to other treatments such as implantation of cells (e.g., stem cells from
various sources and intervertebral disc cells), biological factors (e.g., growth
factors, peptides), scaffolds or materials (e.g., collagen, polymers, ceramics)
and gene therapy” (Spec. 3).
4. The Specification states:
Among other advantages of the present invention, it is a
noninvasive and simple approach to relieving pain associated
with the disc, ft is simple to use, surgery is not required, the
treatment can be administered early to prevent further
progression of DDD, and it may regenerate the disc.
Regeneration of the disc restores the mechanical properties of
the spine, and thus, unlike other treatments such as spinal
5
Appeal 2016-004197
Application 13/329,745
fusions, the present invention will not cause accelerated disc
degeneration at adjacent segments in the long term.
(Spec. 3).
5. The Specification states:
it is believed that the invention promotes disc tissue
regeneration and/or inhibits further progression of DDD by
enhancing the proliferation and matrix synthesis of
chondrocytes and stimulating the production of inflammatory
cytokine antagonists, such as TGF-p. As indicated above, the
invention may be used as an adjunct to other treatments such as
implantation of cells, biological factors, scaffolds or materials,
and gene therapy.
(Spec. 5—6).
Principles of Law
“[I]t is the [Specification itself that must demonstrate possession.
And while the description requirement does not demand any particular form
of disclosure ... or that the [Specification recite the claimed invention in
haec verba, a description that merely renders the invention obvious does not
satisfy the requirement.” AriadPharmaceuticals, Inc. v. Eli Lilly and Co.,
598 F.3d 1336, 1352 (Fed. Cir. 2010).
In finding that [the] disclosure failed to sufficiently describe the
proposed sub-genus, the Board again recognized that the
compounds of the proposed count were not. . . preferred, and
that [the] application contained no blazemarks as to what
compounds, other than those disclosed as preferred, might be of
special interest.
Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996).
6
Appeal 2016-004197
Application 13/329,745
Analysis
The Examiner finds the “subject matter not described in the original
disclosure is the use of applying capacitively coupled stimulation to promote
generation of nucleus pulposus or annulus fibrosus tissue, in combination
with the other steps in the claim(s)” (Final Act. 3—4).
Appellants contend “claims 28 and 29 satisfy the written description
requirement for the reasons stated above” (App. Br. 13). Appellants
specifically contend:
It is respectfully submitted that one skilled in the art
would know from the fact that the invention is designed to
promote generation of disc tissue for treatment of degeneration
thereof, and from the fact that the nucleus pulposus and annulus
fibrosus degenerate as described in the above original
disclosure, that the method is designed to promote generation of
nucleus pulposus and annulus fibrosus tissue. This is enough to
satisfy the written description requirement.
(App. Br. 13).
We find that the Examiner has the better position. Nowhere does the
Specification specifically suggest generation of either “nucleus pulposus” or
“annulus fibrosus” tissue as the disc tissue being treated (FF 1—5). We
recognize the Murray Declaration5 states: “Disc tissue is different from
bone tissue” (Murray Deck 114). However, as the Examiner points out,
the specification is clear that the appellants are unsure
themselves how the system functions as seen on page 5 of the
specification “[Wjhile the invention is not limited to any one
theory of operation, it is believed that the invention promotes
disc tissue regeneration and/or inhibits further progression of
5 Declaration of Dr. Hallie B. Murray, dated Sept. 12, 2013.
7
Appeal 2016-004197
Application 13/329,745
DDD by enhancing the proliferation and matrix synthesis of
chondrocytes and stimulating the production of inflammatory
cytokine antagonists, such as TGF-B”.
(Ans. 4; cf. FF 5). Not only does the Specification not identify the precise
mechanism by which the electrical stimulation therapy operates, but the
Specification never specifically identifies which tissues within the disc are
subject to regeneration. Consequently, while either “nucleus pulposus” or
“annulus fibrosus” tissue may represent obvious possible tissues, a
“description that merely renders the invention obvious does not satisfy the
[written description] requirement.” Ariad, 598 F.3d at 1352.
Conclusion
The evidence of record supports the Examiner’s finding that the
limitations to the capacitively coupled electrical stimulation treatment of
“nucleus pulposus” or “annulus fibrosus” tissue in claims 28 and 29 lack
descriptive support in the Specification.
C. 35 U.S.C. § 112, second paragraph, indefiniteness
The Examiner finds: “In claim 22, line 3, ‘diagnosed state ...’ is
vague and in the passive voice. It is unclear if the applicant is claiming a
state to diagnosing DDD and/or whether the claim or prior art requires a
diagnosis of DDD” (Ans. 4). The Examiner also finds: “In claims 25 and
26, ‘intending to promote ... ’ is vague and it is unclear if this is a separate
step apart from the applying or is a result of the applying” (id.).
Appellants contend:
Regarding claim 22 and the term “diagnosed state, ” it is
respectfully submitted that the term is not vague or unclear and
8
Appeal 2016-004197
Application 13/329,745
is not in the passive voice. The limitation does not require a
diagnosing step. Claims 25 and 26 are likewise believed to be
clear and definite. Regarding claims 25 and 26, Appellants
respectfully submit that the limitation ‘intending to promote’ is
not the result of the “applying” step and is not a separate step.
It is an integral part of the “applying” step. Appellants
respectfully submit that the scope of the claim is clear to those
skilled in the art.
(App. Br. 13 (emphasis added)).
We find the Examiner has the better position, in part, because of
Appellants’ argument. The phrase “diagnosed state” in claims 22, 25, and
26 would ordinarily be reasonably interpreted as requiring that the treatment
is applied to patients with a “diagnosed state of degenerative disc disease,”
consistent with the statement in the Specification that the invention is for
treating “a subject diagnosed as having degenerative disc disease” (Spec. 3).
However, Appellants’ argument disclaims this interpretation, and
instead Appellants contend: “The limitation does not require a diagnosing
step” (App. Br. 13). We find Appellants’ contention to be inconsistent with
the Specification. Consequently, we agree with the Examiner that claims 22,
25, and 26 are indefinite because it is unclear what is meant by a “diagnosed
state” if, as Appellants’ here contend, no diagnosis step is necessary there­
for. That is, it is unclear how a diseased tissue or a patient having the same
can be in a “diagnosed state” without a preliminary step of evaluation that
determines the “diagnosis.” “[Djuring patent prosecution when claims can
be amended, ambiguities should be recognized, scope and breadth of
language explored, and clarification imposed.” In re Zletz, 893 F.2d 319,
322 (Fed. Cir. 1989). Appellants’ claim language, in concert with their
9
Appeal 2016-004197
Application 13/329,745
arguments, have created ambiguity as to the meaning of “diagnosed state”
and we, therefore, affirm the Examiner’s indefiniteness rejection.
D. 35 U.S.C. § 103(a) over Goodwin
The Examiner finds Goodwin teaches the “claimed method but does
not disclose identifying an unfused disc in a state of DDD to apply the
therapy to or applying it to a disc that is ‘untreated by spinal fusion surgery’,
‘capable of substantially normal relative motion’, and ‘as an alternative, not
an adjunct, to spinal fusion’” (Final Act. 6). The Examiner finds it obvious
to modify the device and method as taught by Goodwin,
with applying the therapy before/without surgery . . . since it
would provide the predictable results of an effective therapy for
DDD, an alternate DDD treatment for an unfused or not
surgically modified disc (i.e. native state disc), and treating a
patient with a known non-invasive therapy before surgery is
performed, so as to not cause longer recuperating times or more
pain to the patient due to surgery, to see if the noninvasive
therapy treats the patient.
(Ans. 6—7).
The issue with respect to the priority issue is: Does the evidence of
record support the Examiner’s conclusion that Goodwin renders the claims
obvious?
Findings of Fact
6. Goodwin teaches:
The concept of electrical stimulation as an adjunct to spinal
fusion is a natural extension of the work on healing recalcitrant
fractions initiated in the 1970s. Several techniques of
delivering therapeutic currents have emerged . . . capacitively
10
Appeal 2016-004197
Application 13/329,745
coupled electrical stimulation . . . has been used for nonunion
fractures since 1986.
(Goodwin 1349, col. 2; citations omitted).
7. Goodwin teaches a “device (SpinalPak system from Biolectron,
Inc., Hackensack, NJ) consists of a small microprocessor-controlled
stimulator weighing approximately 100 grams (4 ounces) that delivers
current via flexible cables to hydrogel surface electrodes. The stimulator
delivers a sinusoidal waveform at a frequency of 60 kHz” (Goodwin 1349,
col. 2).
8. Goodwin teaches:
The study was designed to include adult patients with
primary lumbar fusions in the following clinical range: one- or
two-level fusion; posterior lumbar interbody fusion (PLIF
group), anterior lumbar interbody fusion (ALIF group), or
posterolateral fusion; autograft, allograft, or a mixture of graft
materials; and any type of internal fixation except interbody
fusion cages.
(Goodwin 1350, col. 2).
9. Goodwin teaches “this study produced clear evidence of
benefits from capacitively coupled stimulation . . . The greatest
improvement came when capacitively coupled stimulation was used on
posterolateral fusions” (Goodwin 1355, col. 2).
10. Goodwin teaches the “patients were randomized within three
weeks of fusion surgery. They were instructed to use the stimulator 24
hours per day until healing occurred, or for 9 months if healing was delayed”
(Goodwin 1350, col. 2 to 1351, col. 1).
11
Appeal 2016-004197
Application 13/329,745
Principles of Law
A prima facie case for obviousness requires “a reason that would have
prompted a person of ordinary skill in the relevant field to combine the
elements in the way the claimed new invention does.” KSR Int 7 Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007).
Analysis
The Examiner finds: “There are only two options of when Goodwin’s
stimulation could be applied, before or after surgery, and it would be
obvious to try the method before surgery” (Ans. 6).
Appellants contend
Whether or not physical therapy is beneficial as a nonsurgical
treatment in cases of DDD, it would not give a person of
ordinary skill in the art any reason to expect capacitively
coupled electrical stimulation to have any effect on DDD in a
patient who has not had spinal fusion surgery.
(App. Br. 15). Appellants also contend “there would have been no
reasonable expectation that capacitively coupled electrical stimulation by
itself would be an effective therapy for DDD” (App. Br. 14).
We find that Appellants have the better position. While Goodwin
generally suggests that electrical stimulation has been used for therapy (FF
6—7), Goodwin never suggests treatment with electrical stimulation alone, in
lieu of spinal fusion, or even prior to fusion surgery (FF 8—9). Indeed,
Goodwin’s entire therapeutic trial relied upon patients treated with fusion
surgery who then “were instructed to use the stimulator 24 hours per day
until healing occurred” (FF 10). Even Goodwin’s title indicates that its
disclosed stimulation therapy is an adjunct to spinal fusion.
12
Appeal 2016-004197
Application 13/329,745
Thus, Goodwin provides no sufficient reason to use the stimulation
before surgery, because the stimulation is intended to improve healing
necessitated by the surgery, not as a treatment for the degenerative disc
disease by itself (FF 8—10). We, therefore, agree with Appellants, and the
Murray Declaration, that “Goodwin would not give a person of ordinary
skill in the art any reason to expect capacitively coupled electrical
stimulation by itself to be effective in any way in cases of DDD” (App.
Br. 14).
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Goodwin renders the claims obvious.
E. 35 U.S.C. § 102(b) or 103(a) over Brighton
The Examiner finds Brighton teaches “the use of capacitively coupled
electrodes and a sine wave of 60 kHz, 5-10 volts peak to peak . . . and the
use of his system to treat and address the needs of patients suffering from
degenerative disk disease . . . and therefore would necessarily identify an
unfused DDD disc” (Final Act. 7). The Examiner finds Brighton “uses the
same pulse parameters as the applicant, and applies his field over the disc
(e.g. figures 3 and 6) and to increase tissue, his system and method will meet
the step of promoting/intending generation of disc tissue, nucleus pulposus
tissue, and annulus fibrosus tissue” (id.).
The Examiner finds Brighton “performs his method ‘without surgery’
or ‘nonsurgically’ since his electrodes are applied to the skin . . . and
13
Appeal 2016-004197
Application 13/329,745
nowhere does Brighton state that surgery is performed” (id.). The Examiner
also finds, in the alternative, that it would have been obvious
to modify the device and method as taught by Brighton
. . . since it would provide the predictable results of an effective
therapy for DDD, an alternate DDD treatment for an unfused or
not surgically modified disc (i.e. native state disc), and treating
a patient with a known non-invasive therapy before surgery is
performed so as to not cause longer recuperating times or more
pain to the patient due to surgery, to see if the non-invasive
therapy treats the patient.
(Final Act. 7—8).
The issue with respect to the priority issue is: Does the evidence of
record support the Examiner’s conclusion that Brighton either anticipates or
renders the claims obvious?
Findings of Fact
11. Brighton teaches: “There continues to be a great need to be
able to use electricity in its various forms to fuse multiple spinal levels as in
spinal scoliosis, degenerative disk disease at multiple levels . . . The present
invention addresses these needs” (Brighton 1).
12. Brighton teaches a
14
Appeal 2016-004197
Application 13/329,745
method of electrically inducing osteogenesis in the spine
by placing electrodes on either side of the patient’s spine and
applying at least one of a first electrical signal to any electrodes
in a treatment area of the lumbar region of the patient’s spine, a
second electrical signal to any electrodes in a treatment area of
the thoracic region of the patient’s spine, and a third electrical
signal to any electrodes in a treatment area of the cervical
region of the patient’s spine effective to induce osteogenesis in
at least one of the respective treatment areas of the patient’s
spine.
(Brighton 2).
13. Brighton teaches “the voltage and signal characteristics are the
20 kHz to 100 kHz, 60 kHz, 5 to 10 volts peak to peak sine wave
(symmetric) and non-symmetric variations of these quantities” (Brighton
11).
14. Brighton teaches
The inventors considered two possible ways to increase
the extent of an effective E field in the human vertebra: one is
to use multiple electrode pairs with each pair powered by its
own power supply but phased locked; the other solution is to
use strip electrodes, one on each side of the spine, running the
length of the vertebral segments to be fused.
(Brighton 5).
15
Appeal 2016-004197
Application 13/329,745
15. Figure 6 of Brighton is reproduced below:
Figure 6 illustrates strip electrode placement for multiple spine
level fusion using strip electrodes 140a; 140b in accordance
with a second embodiment of the invention . . . Strip electrodes
for each region (lumbar, thoracic, cervical spine) may be
separate and plug into the appropriately marked port on the
power device 150. The power device 150 is designed such that
each region would receive the amount of current for that region
(e.g., 7-10 mA for L, 4.7-6.7 mA for T, and 3.4-4.5 mA for C).
(Brighton 10—11).
16. Brighton teaches:
If one wants to treat multiple vertebral levels and/or vertebral
levels extending across more than one region of the spine (i.e.,
thoracolumbar), one has two choices: 1) use multiple pairs of
16
Appeal 2016-004197
Application 13/329,745
electrodes (one pair for every 2 levels fused: thus, to fuse Li to
L5 two electrode pairs would be used with one pair centered
over L2 and one pair centered over L4).
(Brighton 7).
Principles of Law
“An essential purpose of patent examination is to fashion claims that
are precise, clear, correct, and unambiguous. Only in this way can
uncertainties of claim scope be removed, as much as possible, during the
administrative process.” In re Zletz, 893 F.2d at 322.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR, 550 U.S. at 416. “If a person of ordinary skill can implement a
predictable variation, § 103 likely bars its patentability.” Id. at 417.
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 4; FF 4—6) and agree that the claims
are anticipated and obvious over Brighton. We address Appellants’
arguments below.
Claim 22
Appellants contend
Brighton then states: “The present invention addresses
the above-mentioned needs in the art by determining the proper
[conditions for] electric signals in the human spine to aid in
spine fusion at multiple levels.” The use of the word “aid”
presupposes a primary agent which causes spine fusion. Those
skilled in the art would know that that primary agent is surgery.
17
Appeal 2016-004197
Application 13/329,745
(App. Br. 18). Appellants contend: “There is no mention of treating DDD
without spinal fusion, and various forms of the word ‘fusion’ (fusion, fuse,
fused, and fusing) permeate the Brighton reference. Only two embodiments
are described and both involve fusion” (id.). Appellants contend: “Spinal
fusion surgery is understood as the prerequisite for Brighton’s electrical
stimulation method for cases of DDD” (App. Br. 19).
We are not persuaded. Brighton teaches “to use electricity in its
various forms to fuse multiple spinal levels as in . . . degenerative disk
disease” (FF 11). The reasonable interpretation of this phrase is that the
electricity itself causes the fusion, not that some previously unmentioned and
uncontemplated surgery causes the fusion (and the words “surgery,”
“operation,” or “surgeon” do not appear in Brighton). Brighton further
supports this interpretation by teaching “use multiple pairs of electrodes (one
pair for every 2 levels fused: thus, to fuse Li to L5 two electrode pairs would
be used” (FF 16).
We have considered the Murray Declaration’s statement that
“Brighton states that this technology has been applied as an adjunct to the
treatment of localized spine fusion” (Murray Deck 149), but find this
statement unpersuasive regarding Brighton. The mere use of the words
“adjunct” and “fusion” does not necessarily imply surgical fusion or an
adjunct thereto, particularly where Brighton never discusses surgical fusion
and does directly suggest fusion performed with pairs of electrodes (FF 16).
We agree with the Examiner that: “Nowhere does Brighton discuss that his
method and system are used as an adjunct to spinal fusion surgery or that
spinal fusion surgery is performed” (Ans. 7).
18
Appeal 2016-004197
Application 13/329,745
We also recognize, but find unpersuasive, the Murray Declaration’s
statement that “Brighton repeatedly refers to the current level of 7-10 in A
for the lumbar region. This is the same level specified by Goodwin for
lumbar spinal fusions (page 1349, last line). This is a further indication that
the electrical stimulation in Brighton (WO03) has the same application as in
Goodwin: an adjunct to spinal fusion” (Murray Decl. 1 52).
Neither the Murray Declaration nor Appellants’ arguments identify a
teaching in Brighton that directly refers to Goodwin or otherwise indicates
that Brighton was relying upon Goodwin’s disclosure in any way. Thus, we
find this argument mere speculation, without evidentiary foundation. The
only reference cited by Brighton is US 4,535,775, an earlier patent also to
Brighton, in which a “capacitively coupled electric signal applied to a single
pair of surface electrodes placed on the skin on each side overlying a bone
defect, nonunion fracture, delayed union fresh fracture, or fracture at risk
produced an internal electric field in the bone that resulted in healing of the
bone” (Brighton 1). This suggests that the electric signal directly causes
bone healing and fusion of fractures, and does not imply that fusion surgery
has been performed or was performed to treat fractures previously.
We have considered the Murray Declaration, but find it insufficient to
overcome the prima facie case of anticipation and/or obviousness over
Brighton because the internal evidence in Brighton (FF 11—16) does not
support the Declarant’s position that surgical fusion is necessarily performed
on patients with degenerative disc surgery either prior or subsequent to
treatment with the electrical signals disclosed by Brighton. See In re
American Academy of Science Tech Center, 367 F.3d 1359, 1370 (Fed. Cir.
19
Appeal 2016-004197
Application 13/329,745
2004) (“[T]he Board is entitled to give such weight to declarations as it
deems appropriate.”)
Claim 12
We recognize, but find unpersuasive, Appellants’ contention that
“Brighton does not teach or suggest applying capacitively coupled electrical
stimulation to a human intervertebral disc in a state of DDD untreated by
spinal fusion surgery. Nor would there have been any reasonable
expectation of success from doing so” (App. Br. 20). As discussed above,
Brighton teaches the electrical treatment directly causes fusion, teaching that
“to fuse Li to L5 two electrode pairs would be used” (FF 16). Brighton’s
express teaching of this function also provides a reasonable expectation of
success. “Obviousness does not require absolute predictability of success
... all that is required is a reasonable expectation of success.” In re Kubin,
561 F.3d 1351, 1360 (Fed. Cir. 2009) (citation omitted). And Appellants
provide no evidence of results when the claimed methods are applied, much
less evidence of unexpected results sufficient to persuasively rebut the
Examiner’s conclusion of obviousness.
Claim 1
We recognize, but find unpersuasive, Appellants’ contention that “the
issue is not whether Brighton's signal would result in the generation of disc
tissue when used to induce osteogenesis in the spine. It is whether Brighton
discloses stimulation ‘intending’ to promote generation of disc tissue. It
does not” (App. Br. 21).
Because Brighton teaches applying the precisely the same electrical
signal of 20 to 100 kHz with the same symmetrical waveform with the same
20
Appeal 2016-004197
Application 13/329,745
amplitude of 5 to 10 volts peak-to-peak (FF 13) to patients with the same
condition, degenerative disc disease (FF 11) in the same physical location on
the patient’s body (FF 12, 14), with no indication that the patients have
previously undergone or will undergo surgery, Brighton will inherently
obtain the same result as that required by claim 1 because “efficacy is
inherent in carrying out the claim steps.” In re Montgomery, 677 F.3d 1375,
1381 (Fed. Cir. 2012). Brighton’s stated purpose does not control the
inherency analysis, and in Montgomery, the Court was “skeptical that a
proper interpretation of the claims would include an efficacy requirement.”
Id. at 13 80.6 However, even if efficacy is required, Brighton would have
been expected to effectively promote generation of disc tissue because the
same steps were performed as those required by the claim (FF 11—16).
Claims 28 and 29
We recognize, but find unpersuasive, Appellants’ contention that
“there is not even a hint in Brighton regarding generation of nucleus
pulposus tissue or annulus fibrosus tissue, and that the rejection of these
claims should be reversed” (App. Br. 21).
As stated in In re Cruciferous Sprout Litig., 301 F.3d 1343, 1350
(Fed. Cir. 2002), “[i]t matters not that those of ordinary skill heretofore may
not have recognized the[ ] inherent characteristics of the [prior art].” Here,
6 See also In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (“It is a
general rule that merely discovering and claiming a new benefit of an old
process cannot render the process again patentable.”) Appellants’ emphasis
on a mental state behind the treatment — the claimed “intending to promote
generation of disc tissue” — merely puts into writing the benefit of an old
process that the inventors purportedly discovered. On the record here, we
are unpersuaded claim 1 patentably distinguishes over the art.
21
Appeal 2016-004197
Application 13/329,745
Brighton’s treatment would have been expected to inherently generate the
same disc tissue as that claimed because the same parameters and same
patient populations were treated (FF 11—16). As the Court explained
“[njewly discovered results of known processes directed to the same purpose
are not patentable because such results are inherent.” Bristol-Myers Squibb
Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Brighton either anticipates or renders the claims obvious.
F. 35 U.S.C. § 103(a) over Goodwin and Brighton ’775
The Examiner does not rely upon Brighton ’775 to anticipate or
render obvious claims 1 and 12, but rather solely relies upon Brighton ’775
for the waveform shape (see Final Act. 8). Therefore, we reverse this
rejection for the same reasons as those given in the reversal of the Goodwin
obviousness rejection discussed above.
G. 35 U.S.C. § 103(a) over Brighton and Brighton ’775
Appellant does not separately argue this rejection. The Examiner
provides sound fact-based reasoning explaining why Brighton and Brighton
’775 render the rejected claims obvious (see Final Act 9). Having affirmed
the rejection of claims 1 and 12 over Brighton for the reasons given above,
we also find Brighton and Brighton ’775 render claims 4, 5, 15, and 16
obvious for the reasons given by the Examiner.
22
Appeal 2016-004197
Application 13/329,745
H. Double Patenting
We summarily affirm the obviousness-type double patenting rejection.
See Manual of Patent Examining Procedure § 1205.02 (“If a ground of
rejection stated by the examiner is not addressed in the appellant’s brief, that
ground of rejection will be summarily sustained by the Board.”)
SUMMARY
In summary, we affirm the rejection of claims 28 and 29 under 35
U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
We affirm the rejection of claims 22—26 under 35 U.S.C. § 112,
second paragraph, as indefinite.
We reverse the rejection of claims 1—3, 12—14, and 22—29 under 35
U.S.C. § 103(a) as obvious over Goodwin.
We affirm the rejection of claims 1—3, 12—14, and 22—29 under 35
U.S.C. § 102(b) as anticipated or under 35 U.S.C. § 103(a) as obvious over
Brighton.
We reverse the rejection of claims 4, 5, 15, and 16 under 35 U.S.C.
§ 103(a) as obvious over Goodwin and Brighton ’775.
We affirm the rejection of claims 4, 5, 15, and 16 under 35 U.S.C.
§ 103(a) as obvious over Brighton and Brighton ’775.
We affirm the rejection of claims 1—5, 12—16, and 22—29 on the
ground of nonstatutory obviousness-type double patenting as being
unpatentable over claims 1—5 ofU.S. Patent No. 8,082,038.
23
Appeal 2016-004197
Application 13/329,745
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
24