Ex Parte Kaplan et al

Patent Trial and Appeal Board

Feb 5, 2018

13949051 (P.T.A.B. Feb. 5, 2018)

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.
13/949,051 07/23/2013 Gary KAPLAN 11710-0040-05000 3479
109610 7590 02/07/2018
Bookoff McAndrews, PLLC
2020 K Street, NW
Suite 400
Washington, DC 20006
EXAMINER
AVIGAN, ADAM JOSEPH
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
02/07/2018 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):
u sptomail @ borne ip .com
Kross @ bomcip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GARY KAPLAN, CHRISTOPHER J. DANEK,
WILLIAM WIZEMAN, TIMOTHY R. DALBEC,
NOAH D. WEBSTER, and HUY D. PHAN
Appeal 2017-001593
Application 13/949,051
Technology Center 3700
Before JEFFREY N. FREDMAN, TIMOTHY G. MAJORS, and
DAVID COTTA, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
of lung treatment. The Examiner rejected the claims as failing to comply
with the written description requirement. We have jurisdiction under 35
U.S.C. § 6(b). We reverse and enter a new ground of rejection.
Statement of the Case
Background
“Asthma is a chronic disorder, primarily characterized by persistent
airway inflammation . . . [and] further characterized by acute episodes of
1 Appellants identify the Real Party in Interest as Asthmatx, Inc., a wholly-
owned subsidiary of Boston Scientific Scimed, Inc. (see App. Br. 2).
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Application 13/949,051
additional airway narrowing via contraction of hyper-responsive airway
smooth muscle” (Spec. ^ 2). The Specification teaches “a new treatment for
asthma is showing promise. This treatment comprises the application of
energy to the airway smooth muscle tissue” (id. ^ 4).
The Claims
Claims 37-39, 41, 43, and 44 are on appeal. Independent claim 38 is
representative and reads as follows:
38. A method for treating a lung, comprising:
positioning an intraluminal device having an electrode
positioned radially outward of a balloon at a treatment location
in an airway of the lung such that the electrode contacts surface
tissue defining the airway; and
delivering energy from the electrode through the
contacted surface tissue defining the airway to nerve tissue
disposed radially outward of the contacted surface tissue so as
to damage the nerve tissue while absorbing heat from the
contacted surface tissue disposed radially between the electrode
and the nerve tissue, wherein absorbing heat from the surface
tissue includes flowing a cooling source into the balloon,
wherein delivering energy from the electrode through the
contacted surface tissue damages the contacted surface tissue,
wherein the contacted surface tissue includes epithelium.
The Issue
The Examiner rejected claims 37-39, 41, 43, and 44 under 35 U.S.C.
§112, first paragraph as failing to comply with the written description
requirement (Final Act. 2-9).
The Examiner finds Appellants “amended the claims to conflate two
separately disclosed methods that were not envisioned to be utilized
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simultaneously together at the time that the invention was made” (Final Act.
3). The Examiner finds:
The first method entails increasing airway diameter by
denervation which is represented by par. 67 of the original
disclosure. . . . The second method, represented by pars. 60-61,
entails increasing airway diameter by direct application of
energy to the mucosal layer in order to increase folding by
reducing the thickness of the mucosa.
(Final Act. 4). The Examiner finds “it is hard to rationalize how to combine
these two separately disclosed methods into a single simultaneous method,
especially since an objective of the first method is to protect surface tissue
such as epithelium, while an objective of the second method is to target
surface tissue such as epithelium” {id. at 6). The Examiner finds “there is no
disclosure in the specification that indicates that these separately disclosed
methods are simultaneously usable together” {id. at 6).
Appellants contend the “specification identifies several approaches,
usable together, for reducing resistance^] In particular, increasing airway
diameter and reducing the ability of the airway to contract are disclosed as
combinable approaches to reduce airflow resistance and thereby lessen
symptoms of obstructive pulmonary disease” (App. Br. 13-14). Appellants
contend the “plain meaning of the linking phrase ‘and/or’ is that such
approaches were contemplated to be usable together” {id. at 19). Appellants
also contend the “specification further discloses that, simultaneous with
energy delivery, cooling fluids for cooling the airway wall can be delivered
to the airway” (id. at 14).
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The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the claims lack descriptive support in
the Specification?
Findings of Fact
1. The Specification teaches
one way of improving airflow is to decrease the resistance to airflow
within the lungs. There are several approaches to reducing this
resistance, including but not limited to reducing the ability of the
airway to contract, increasing the airway diameter, reducing the
inflammation of airway tissues, and/or reducing the amount of mucus
plugging of the airway
(Spec. 1|51).
2. The Specification teaches a
process for increasing the airway diameter is by denervation. A
resting tone of smooth muscle is nerve regulated by release of
catecholamines. Thus, by damaging or eliminating nerve tissue
in the airways the resting tone of the smooth muscle is reduced,
and the airway diameter is increased. Resting tone may also be
reduced by directly affecting the ability of smooth muscle tissue
to contract.
(Spec. T| 67).
3. The Specification teaches a
way to increase the effective stiffness of the airway wall is to
alter the submucosal folding of the airway upon narrowing.
The mucosal layer includes the epithelium . . . The mucosal
folding can also be increased by encouraging a greater number
of smaller folds by reducing the thickness of the mucosa and/or
submucosal layer. The decreased thickness of the mucosa or
submucosa may be achieved by application of energy which
either reduces the number of cells in the mucosa or submucosal
layer or which prevents replication of the cells in the mucosa or
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submucosal layer. A thinner mucosa or submucosal layer will
have an increased tendency to fold and increased mechanical
stiffening caused by the folds.
(Spec, im 59, 61).
4. Figures 5M and 5N of the Specification are reproduced below:
i tty
/
fi4, 5H fik, SN
[A]s shown in the cross sectional view of FIGS. 5M and 5N, a
balloon member 171 may also be deployed inside the basket
108 and inflated to prevent inward deflection of the electrode
legs 160. Further, the balloon member 171 may utilize its
inflation lumen to receive cooling fluids so as to cool the
electrode 160 and airway wall.
(Spec. If 113).
5. The Specification teaches
additional lumens 134 within the device shaft 104 may be
utilized for fluid delivery of. . . cooling fluids (e.g., cooled
saline, cooled sterile water, or other fluids for cooling the
airway wall), electrically conductive fluids (e.g., saline),
thermally conductive fluids, or fluids to increase the viscosity
of mucus so it can be more easily suctioned (e.g., saline), or for
suctioning of delivered fluids or excretions within the airway
(e.g., mucus).
(Spec. H 93).
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6. The Specification teaches: “irrigation and/or suctioning may be
carried out simultaneously or sequentially with energy delivery to the airway
wall while the device is within the airway” (Spec. ^ 93).
7. The Specification teaches
embodiments of the invention may also include the additional
step of reducing or stabilizing the temperature of lung tissue
near to a treatment site. This may be accomplished for example,
by injecting a cold fluid into lung parenchyma or into the
airway being treated .... One benefit of reducing or stabilizing
the temperature of the lung may be to prevent excessive
destruction of the tissue, or to prevent destruction of certain
types of tissue such as the epithelium, or to reduce the systemic
healing load upon the patient’s lung.
(Spec. T| 94).
8. The Specification teaches: “Patterned treatment can also
achieve desired results with decreased morbidity, preservation of
epithelium” (Spec. ^ 55).
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.” Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co.,
598 F.3d 1336, 1352 (Fed. Cir. 2010) (citation omitted.).
Analysis
This is a very close case, where we view the evidence of record as
almost in equipoise. However, compelled to decide, we find that the
evidence slightly favors Appellants’ position. Not only does the
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Specification use the conjunctions “and/or” when describing approaches to
decreasing resistance to airflow in the lungs (FF 1-3), but the Specification
contemplates simultaneous delivery of energy from electrodes while cooling
through a balloon (FF 4-5). The Specification explains “irrigation . . . may
be carried out simultaneously . . . with energy delivery to the airway wall”
(FF 6) and “injecting a cold fluid into lung parenchyma or into the airway
being treated ... to prevent excessive destruction of the tissue” (FF 7).
We are not persuaded by the Examiner’s finding that “there is no
indication as to whether the epithelium itself is damaged. Therefore, the
claims are reciting a more specific limitation than that which is disclosed by
the specification” (Ans. 3) because we agree with Appellants that inherently
“at least some cells of the epithelium that are in direct contact with the
electrode would be killed or damaged during energy delivery” (Reply Br. 3).
The Specification supports this understanding by teaching the treated
“mucosal layer includes the epithelium” (FF 3); that the patterned treatment
improves “preservation of epithelium” (FF 8); and that using a cold fluid
may “prevent destruction of certain types of tissue such as the epithelium”
(FF 7). We agree with Appellants that the recitation in claim 37 that “the
contacted epithelium is damaged by the energy” and in claim 38 that the
“contacted surface tissue includes epithlium” are reasonably supported by
the disclosure of the Specification.
We are not persuaded by the Examiner’s finding that “there is no
support in the specification for a single method which damages both
epithelium and nervous tissue in a simultaneous manner” (Ans. 3) because
we agree with Appellants that the Specification’s method of damaging
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nervous tissue (FF 2) involves the application of energy to tissues that
inherently include epithelial cells (FF 3) while simultaneously cooling to
protect a portion of those epithelial cells (FF 7-8).
We are not persuaded that the Examiner’s “interpretation is in
accordance with the [Appellants’] own arguments, [based] in the interview
dated 3/26/15 in which [Appellants] successfully argued that same excerpt in
Haugaard2. . . taught against a method which provided cooling and which
also damaged epithelium tissue simultaneously” (Ans. 7). While the
interview summary does not record Appellants’ precise statements,
Appellants currently contend “Haugaard is silent to simultaneously cooling
while delivering energy. Because Haugaard is silent to at least this aspect of
the claims, Haugaard cannot be interpreted in the same manner as the
present [Specification and claims” (App. Br. 17).
We agree with Appellants that claim 38 requires simultaneous steps of
cooling and heating because while the energy is being delivered, there is a
requirement of “flowing a cooling source into the balloon.” The Office
action lacks a disclosure in Haugaard suggesting the simultaneous treatment
of a single site with both energy and a cooling source, while the
Specification clearly contemplates such simultaneous treatment by teaching
“irrigation and/or suctioning may be carried out simultaneously or
sequentially with energy delivery” (FF 6). We will address claim 37 below.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the claims lack descriptive support in the Specification.
2 Danek et al., WO 02/32334 Al, published Apr. 25, 2002 (“Haugaard”).
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New Ground of Rejection
Under the provisions of 37 C.F.R. § 41.50(b), we enter the following
new ground of rejection.
Claim 37 is rejected under 35 U.S.C. § 103(a) as obvious over
Haugaard.
Findings of Fact
9. Haugaard teaches “by damaging or eliminating nerve tissue in
the airways the resting tone of the smooth muscle is reduced, and the airway
diameter is increased” (Haugaard 18:23-25).
10. Haugaard teaches the “energy transfer element of the invention
may include an element that directly heats tissue by delivering current such
as an RF based electrode” Haugaard 5:21-22).
11. Haugaard teaches: “Patterned treatment can also achieve
desired results with decreased morbidity, preservation of epithelium”
(Haugaard 15:25-26).
12. Haugaard teaches “Series wiring has an added advantage in that
all current will pass through each energy transfer element. By design, this
configuration equalizes the heat dissipated at each leg through construction
of legs with equal resistance” (Haugard 35:29-31).
Principles of Law
“[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).
“We have recognized that inherency may supply a missing claim
limitation in an obviousness analysis. . . . [T]he concept of inherency must
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be limited when applied to obviousness, and is present only when the
limitation at issue is the ‘natural result’ of the combination of prior art
elements.” Par Pharm., Inc. v. TWIPharm. Inc., 773 F.3d 1186, 1194-1195
(Fed. Cir. 2014).
Analysis
We begin with claim interpretation because before a claim is properly
interpreted, its scope cannot be compared to the prior art. In this case, claim
37 recites the step of “damaging nerve tissue” by “increasing a temperature
of the nerve tissue to a first temperature with energy delivered by an energy
delivery element while a portion of a wall defining the airway is at a second
temperature that is less than the first temperature.”
Unlike Claim 38, which requires an active cooling step, Claim 37
does not require that the “second temperature” is generated by an active
cooling step. Claim 37 encompasses the situation where portions of the
airway wall not in direct contact with the energy delivery element or
electrode will necessarily and inherently be at temperatures lower than the
temperatures in direct contact with the energy delivery element. We
therefore interpret the “second temperature” as encompassing the situation
where heat passively dissipates such that an area not being directly heated
will be cooler than areas being directly heated.
Haugaard teaches damaging nerve tissue in airways (FF 9) by
increasing temperature with an electrode energy delivery device (FF 10) that
damages portions of the epithelium while leaving other portions undamaged
(FF 11). Haugaard evidences the well known physical fact that heat
dissipates (FF 12), resulting in the inherent result that the temperature of a
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wall portion adjacent an energy delivery element will be at an elevated first
temperature and a wall portion in the airway further from the energy
delivery element will inherently have a dissipated second temperature that is
less than the first temperature.
Unlike claim 38, which requires an active step of “flowing a cooling
source into the balloon”, claim 37 encompasses the natural result obtained
by performing the process of Haugaard to damage nerve tissue in an airway
using an electrode (FF 9-12). Therefore, Haugaard reasonably renders
claim 37 obvious.
SUMMARY
In summary, we reverse the rejection of claims 37-39, 41, 43, and 44
under 35 U.S.C. § 112, first paragraph as failing to comply with the written
description requirement.
We enter a new ground of rejection of claim 37 over Haugaard
pursuant to 37 C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new
ground of rejection pursuant to this paragraph shall not be considered final
for judicial review.” Section 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
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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.
REVERSED; 37 C.F.R, § 41.50(b)
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