BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Patent Trials and Appeals Board

Jun 2, 2020

2019005324 (P.T.A.B. Jun. 2, 2020)

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.
13/902,754 05/24/2013 Changfang Zhu BSNC-1-470.3 3246
50638 7590 06/02/2020
Boston Scientific Neuromodulation Corp.
c/o Lowe Graham Jones
701 Fifth Avenue
Suite 4800
Seattle, WA 98104
EXAMINER
CHOU, WILLIAM B
ART UNIT PAPER NUMBER
3795
NOTIFICATION DATE DELIVERY MODE
06/02/2020 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):
patentdocketing@lowegrahamjones.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHANGFANG ZHU, DONGCHUL LEE, and
KERRY BRADLEY
Appeal 2019-005324
Application 13/902,754
Technology Center 3700
Before CHARLES N. GREENHUT, BENJAMIN D. M. WOOD, and
ANNETTE R. REIMERS, Administrative Patent Judges.
GREENHUT, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 12, 15–17, 19–23, 27, and 29–33. See
Non-Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Boston Scientific
Neuromodulation Corporation. Appeal Br. 2.
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Application 13/902,754
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CLAIMED SUBJECT MATTER
The claims are directed to a combination electrical stimulation and
low-level laser therapy. Claim 12, reproduced below, is illustrative of the
claimed subject matter:
12. A method of treating a patient with an ailment, comprising:
conveying electrical energy to a first natural neuronal
element and a second natural neuronal element, thereby
modulating the first and second natural neuronal elements to treat
the ailment; and
conveying low-level laser energy having a wavelength in
the range of 600nm-2500nm to the first natural neuronal element,
thereby modulating the first natural neuronal element to decrease
a side-effect otherwise caused by the modulating of the first
natural neuronal element by the electrical energy.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Wagner ’053 US 2008/0046053 A1 Feb. 21, 2008
Wagner ’905 US 2013/0053905 A1 Feb. 28, 2013
Wells WO 2011/150430 A2 Dec. 1, 2011
REJECTION
Claims 12, 15–17, 19–23, 27, and 29–33 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Wells, Wagner ’053,2 and Wagner
’905.3 Non-Final Act. 3.

2 “Wagner” elsewhere in the record.
3 “Wagner2” elsewhere in the record.
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OPINION
Claims 12, 15–17, 19–23, and 34–37 are argued as a group (Appeal
Br. 5–8) for which claim 12 is representative under 37 C.F.R.
§ 41.37(c)(1)(iv).
The Examiner implies the subject matter of claim 12 would have been
obvious over Wells alone but, according to the Examiner, the Wagner
references are cited as additional evidence as to the level of skill in the art
and to expedite prosecution. Non-Final Act. 3–6. The main argument of
Appellant is as follows:
The effects of Wells cited on pages 4–5 of the Office Action, as
well as the effects cited from Wagner[’053] and Wagner[’905],
all appear to be primary effects (i.e., directed to treatment of an
ailment), not side-effects. Accordingly, none of the cited
references address using low-level laser energy to modulate the
first neuronal element to decrease a side-effect of caused [sic] by
the modulation using electrical energy, as recited in claim 12.
Appeal Br. 6. Thus, it is the “side-effect” language of claim 12 that
Appellant relies heavily on in an effort to distinguish over the prior art.
There is not, and cannot reasonably be, any dispute that Wells
discloses the conveyance of both electrical and low-level laser energy to
trigger a nerve action potential (NAP) in vivo. Non-Final Act. 3 (citing
Wells para. 268). Appellant does not raise any issues with the Examiner’s
reliance on Wells concerning conveying electrical energy to “first” and
“second” neuronal elements. See Non-Final Act. 3 (citing Wells para. 272).
Nor does Appellant raise any issues concerning the Examiner’s reliance on
Wells for the specific laser energy wavelength recited. See Non-Final Act. 4
(citing Wells para. 269). Lastly, Appellant does not dispute that the
triggering of NAPs in Wells is “to treat an ailment.” Indeed, Wells clearly
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discusses that the main objective of triggering the NAPs relates to ailment
mitigation. Paragraphs 14–17 of Wells discuss this in the context of spinal
cord injuries in particular. Paragraph 18 of Wells goes on to describe other
ailments that may be treated by generating NAPs via optical or electrical
stimulation or inhibition:
Besides such spinal-cord injuries, there are numerous other nerve
injuries and pathologies that need treatment. Thus, there is a need
to provide therapy (e.g., through stimulation of physiological
signals in the patient such as nerve action potentials (NAPs)) that
restores such sensations (signals towards the brain) to persons
having such injuries, as well as nerve stimulation and/or
inhibition for treatment of pain, obesity, epilepsy, depression,
and the like. There is also a need to provide therapy that restores
motor-nerve (muscle-control) signals from the brain towards
muscles or prostheses (through NAP stimulation, inhibition, or
both), for motor control as well as treatment of incontinence,
irregular heart rhythms, tremors or twitches, and the like.
Wells para. 18 (cited at Non-Final Action 4).
In the Background section of the Specification, Appellant
acknowledges diseases and disorders for which electrical stimulation has
proven therapeutic:
‒ cardiac conditions (e.g., arrhythmias)
‒ chronic pain syndromes
‒ angina pectoralis
‒ incontinence
‒ refractory chronic pain syndromes
‒ movement disorders and epilepsy
‒ paralyzed extremities in spinal cord injury
‒ various headaches, including migraine headaches, cluster
headaches, and cervicogenic headaches
‒ heart failure

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‒ obesity
‒ asthma
‒ diabetes
‒ constipation
Spec. para. 3. Appellant further acknowledges that laser or optical
stimulation has demonstrated success in treating pain (Spec. para. 6) and that
“low-level laser energy at a wavelength of 600–900nm suppresses the
activity of neurons” (Spec para. 7).
As can be readily observed from the preceding paragraphs, Wells
sought to employ combination electrical and optical therapy to treat many of
the same ailments that Appellant also sought to treat.
Wells describes a challenge associated with electrical stimulation
(ES):
One disadvantage of using electrical stimulation is that the
electrical signal applied to stimulate one nerve fiber will
generally stimulate a plurality of surrounding nerve fibers (even
nerve fibers in other fascicles than the fascicle containing the
nerve of interest) to also trigger NAP signals in those other nerve
fibers:
. . .
neuromodulation applications such as hand-grasp, sensory-
stimulation applications for artificial prostheses, and control of
autonomic functions such as cardiac rate via Vagus-nerve
stimulation, require, in some cases, selection of at most one
fascicle and even greater sub-fascicular spatial selectivity (i.e.,
selection of a single axon or just a few axons but not all the axons
in the single fascicle) than is typically possible using electrical
stimulation alone, such that separate signals are delivered to
different axons within one fascicle.
Wells paras. 2–3. More specifically, Wells explains:
Because electrical current spreads in the body, most if not all ES-
based neural prostheses wind up stimulating other nerves in the
area besides the intended target (e.g. fine movements cannot be
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Application 13/902,754
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made with a motor prosthesis, and multiple sensations, such as
touch and temperature, may be felt incorrectly from a sensory
feedback device). Furthermore, the presence of a stimulation
artifact can obfuscate signals elsewhere along the nerve, and it
also precludes stimulating and recording electrical nerve activity
in the same location, as needed for a closed-loop sensorimotor
limb prosthesis.
Wells para. 51 (emphasis added).
Appellant, albeit more briefly, describes a problem very similar to that
described by Wells:
electrical neural modulation may compromise selectivity due to
the spread of current.
Spec. para. 18.
because electrical energy is relatively unfocused, the right DR
nerve fiber may be inadvertently stimulated, thereby causing a
side-effect (e.g., motor movement or painful sensations).
Spec para. 113 (cited at Ans. 9).
There does not appear to be any dispute that, in the context of claim
12, “side-effect” generally refers to some additional, perhaps unintended or
undesirable, result of the electrical energy modulating the first natural
neuronal element beyond the result primarily intended. Although the
examples do not necessarily rise to the level of lexicographic definitions of
the recited term “side-effect,” they are instructive. Reading the claim in light
of the Specification requires us to make an effort to include these examples
within the meaning we afford to the recited term “side-effect” absent good
reasons not to do so. See, e.g., Vitronics Corp. v. Conceptronic, Inc., 90 F.3d
1576, 1583 (Fed. Cir. 1997) (claim interpretation excluding the preferred
embodiment is rarely, if ever, correct and would require highly persuasive
evidentiary support).
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As emphasized above in the quoted portion of paragraph 51 of Wells,
Wells also considers “side-effects” of the treatment, such as incorrect
sensations, signal obfuscation, and most similar to the principal side effects
discussed in Appellant’s Specification of “[inadvertent] motor movement”
or “painful sensations,” Wells describes “stimulating other nerves in the area
besides the intended target.” Wells expressly indicates in the parenthetical
immediately after mentioning excessive stimulation that such stimulation
may result in additional (i.e., not sufficiently “fine”) motor movements.
Although not expressly stated in this portion of Wells, we think one skilled
in the art would also understand that nerve stimulation exceeding that
intended may also result in pain. See In re Jacoby, 309 F.2d 513, 516
(CCPA 1962) (A skilled artisan must be presumed to know something about
the art apart from what the references expressly disclose.). As Wells
mitigates problems essentially the same as those mitigated by Appellant with
Wells’s laser treatment technique, we think it is fair to regard Wells’s
technique as including “conveying low-level laser energy. . . thereby
modulating the first natural neuronal element to decrease a side-effect
otherwise caused by the modulating of the first natural neuronal element by
the electrical energy” as required by claim 12. See Non-Final Act. 4.
The Examiner also articulates an even broader view of Wells in that
many of the ailments discussed in Wells, can themselves, in appropriate
circumstances, be considered side-effects. Non-Final Act. 4–5; Ans. 9–10.
There is substantial merit to the Examiner’s position in this regard as well.
Again, skill is an attribute that must be attributed the hypothetical person
described in 35 U.S.C. § 103(a). In re Sovish, 769 F. 2d 738, 743 (Fed. Cir.
1985). If a medical provider used Wells’s technique to treat a primary
ailment among those listed as examples, and a secondary ailment, or “side-
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effect,” was induced which was among those listed by Wells, we agree with
the Examiner that it would have been obvious to a professional in the
medical arts to also use Wells’s technique to treat the secondary ailment or
“side-effect.”
The main point of divergence between Appellant’s disclosed
technique and Wells’s is that Appellant provides the laser stimulation in an
inhibitory manner to “thereby decreas[e] the excitability of the right DR
nerve fiber that may otherwise be inadvertently be stimulated by the
conveyance of the electrical energy from the neuromodulation lead 12(1)”
Spec. paras. 113–114. The cited embodiment of Wells, on the other hand,
teaches decreasing side-effects by applying sub-threshold electrical
stimulation and additional focused laser stimulation to trigger a NAP:
The electrical-stimulation signal and the optical-stimulation
signal are each at a level that is substantially sub-threshold (i.e.,
almost all of the time (i.e., at least 90%) they will not trigger a
NAP) if either is applied alone, but when applied together (either
simultaneously or sufficiently close to one another in time), the
combination of electrical- and optical-stimulation signals is
sufficient to trigger a NAP (i.e., almost all of the time (i.e., at
least 90%) the combination will trigger a NAP).
Wells para. 270 (cited at Non-Final Act. 4).
Appellant does not apprise us of any language, and no language is
apparent, in claim 12 that necessarily introduces this distinction into the
claim. “The invention disclosed in [Appellant’s] written description may be
outstanding in its field, but the name of the game is the claim.” In re Hiniker
Co., 150 F. 3d 1362, 1369 (Fed. Cir. 1998). Limitations not appearing in the
claims cannot be relied upon for patentability. In re Self, 671 F.2d 1344,
1348 (CCPA 1982).
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We think the foregoing discussion suffices to establish that the subject
matter of claim 12 would have been obvious over the teachings of Wells.
Although perhaps not necessary for purposes of claim 12, the Examiner,
citing Wagner ’905 or “Wagner2” goes on to discuss, how one skilled in the
art would have understood electrical and laser energy could be employed in
an excitatory or inhibitory way. Non-Final Act. 6. The Examiner’s findings
in this regard are consistent with the, albeit brief, suggestion in Wells that
stimulation, inhibition or both could be employed in Wells’s method:
In some embodiments, the method provides therapy that restores
motor-nerve (muscle-control) signals from the brain towards
muscles or prostheses (through NAP stimulation, inhibition, or
both), for motor control as well as treatment of incontinence,
irregular heart rhythms, tremors or twitches, and the like.
Wells para. 122. Wagner ’905 provides additional and more specific
evidence that, in addition to knowing how to add stimulatory energies as
Wells does, the skilled artisan would also have known how to combine
stimulatory and inhibitory energies to arrive at a desired stimulation:
The methods and devices of this disclosure involve providing a
first type of energy to a region of tissue, in which the first type is
provided in an amount that inhibits cellular function within the
region of tissue, and providing a second type of energy to the
region of tissue, in which the second type is provided in an
amount that facilitates cellular function within the region of
tissue, wherein the combined effect stimulates cellular function
within the tissue.
Wagner ’905 para. 43 (cited at Non-Final Act. 6).
We think the Examiner’s reliance on Wagner ’905 suffices to cement
the Examiner’s conclusion of obviousness with respect to claim 12, to the
extent these additional teachings of Wagner ’905 are even necessary to
support the Examiner’s rejection of claim 12. In any case, this teaching of
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Wagner ’905 addresses the more specific modulation aspect of claim 27 that
“only a portion of action potentials . . . is conveyed . . . to the second target
side” (Appeal Br. 10–11) and of claim 29 where “action potentials are
blocked at the second target site” (Appeal Br. 11–12). Appellant makes
similar arguments concerning claims 27 and 29 as those addressed above
with regard to claim 12. Appeal Br. 10–12. The only additional argument
attacks the Examiner’s failure to reproduce the specific claim language in
question regarding claims 27 and 29. Appeal Br. 10–12. As alluded to above
regarding claim 12, the Examiner appears to have reached a conclusion of
obviousness, and articulated reasoning in support thereof, based on what is
arguably an overly narrow reading of claim 12.4 However, in doing so, the
Examiner sufficiently demonstrated the obviousness of the subject matter
defined by claims 27 and 29 as well, despite not reproducing the specific
language therefrom. We think Appellant was provided with adequate notice
as to the basis for the Examiner’s rejection of claims 27 and 29 based on the
Examiner’s discussion in the Non-Final Action. See In re Jung, 637 F. 3d
1356, 1363 (Fed. Cir. 2011).
In light of the issues raised for our review, to sustain the Examiner’s
rejection of claims 12, 27 and 29, we see no need to cite or discuss any
further evidence from Wagner ’503, which the Examiner regards as merely
further demonstrating the level of skill in the art.

4 Of course, addressing more than is required according to a claim’s broadest
reasonable scope does not constitute reversible error in the context of an
obviousness rejection. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 419–20
(2007) (“What matters is the objective reach of the claim. If the claim
extends to what is obvious, it is invalid under § 103.” KSR, 550 U.S. at 419).
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Claims 33 and 37 are argued as a group (Appeal Br. 12–13) for
which claim 33 is representative. These are the only other claims for which
separate arguments are presented. Appellant’s arguments quote a portion of
the Examiner’s analysis addressing claim 33 and assert that it is incomplete.
“Filing a Board appeal does not, unto itself, entitle an appellant to de novo
review of all aspects of a rejection.” See Ex Parte Frye, 94 USPQ2d 1072,
1075 (BPAI 2010)(precedential)(citations omitted). “[T]he Board will not,
as a general matter, unilaterally review those uncontested aspects of the
rejection.” Id at 1075–76 (citations omitted). The only specific language of
claim 33 to which Appellant draws our attention relates to “on different
nerve fibers of the vagus nerve.” Appeal Br. 13 (emphasis omitted).
Appellant argues that neither Wagner reference mentions the vagus nerve.
Appeal Br. 13. However, it is Wells the Examiner relies on regarding such
subject matter. Non-Final Act. 8. Wells clearly indicates the disclosed
technique could be applied to the vagus nerve. Wells paras. 3, 86–89 (cited
at Non-Final Act. 7). The remaining aspects of the method set forth in claim
33 are discussed above. Wells’s failure to expressly use the vagus as the
subject of treatment in the specific examples given does not undermine a
rejection predicated on 35 U.S.C. § 103(a). Just as “a person of ordinary skill
often will be able to fit the teachings of multiple patents together like pieces
of a puzzle,” (KSR, 550 U.S. at 420) a person of ordinary skill will be able to
fit the teachings arising from different parts of the same reference together in
a similar manner, particularly where the reference itself suggests doing so.
CONCLUSION
The Examiner’s rejection is AFFIRMED.
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DECISION SUMMARY
Claim(s) 35 U.S.C. § Basis/Reference(s) Affirmed Reversed
12, 15–17,
19–23, 27,
29–33
103(a) Wells, Wagner
’053, Wagner ’905
12, 15–17,
19–23, 27,
29–33

TIME PERIOD FOR RESPONSE
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)(1)(iv).
AFFIRMED