Ex Parte Kleine et al

Patent Trial and Appeal Board

Sep 19, 2016

11445079 (P.T.A.B. Sep. 19, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111445,079 05/31/2006
45159 7590 09/21/2016
SQUIRE PB (Abbott)
275 BATTERY STREET, SUITE 2600
SAN FRANCISCO, CA 94111-3356
FIRST NAMED INVENTOR
Klaus Kleine
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.
085847.00057 7157
EXAMINER
TANNER, JOCELIN C
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
09/21/2016 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):
sfripdocket@squirepb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KLAUS KLEINE, DAVID C. GALE, FOZAN EL-NOUNOU,
SYED P.A. HOSSAINY, and FLORIAN LUDWIG
Appeal2014-004615
Application 11/445,079
Technology Center 3700
Before EDWARD A. BROWN, GEORGE R. HOSKINS, and
BRANDON J. WARNER, Administrative Patent Judges.
HOSKINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Klaus Kleine et al. ("Appellants") 1 appeal under 35 U.S.C. § 134 from
the Examiner's rejection of claims 1--49 in this application. The Board has
jurisdiction over the appeal under 35 U.S.C. § 6(b ).
We REVERSE.
1 The Appeal Brief identifies Abbott Cardiovascular Systems Inc. as the real
party in interest. Appeal Br. 2.
Appeal2014-004615
Application 11/445,079
CLAIMED SUBJECT MATTER
Claim 1 is the sole independent claim, and it recites (with
paragraphing added):
1. An implantable medical device, comprising:
a helical construct including a spiral coil and a therapeutic
substance for local in vivo application of the therapeutic
substance in a biological lumen,
wherein the helical construct is configured to apply less
than 0.75 Bar of pressure to a wall of the biological lumen when
the helical construct is deployed in the biological lumen and after
the helical construct is deployed and implanted in the biological
lumen,
wherein the helical construct is in an expanded
configuration, from a reduced configuration, and configured to
be in contact with the wall of the biological lumen post
deployment and when implanted in the biological lumen, and
wherein the helical construct includes a proximal free end
and a distal free end, both ends which are configured to be
positioned in the biological lumen when the helical construct is
expanded and implanted.
Appeal Br. 45 (Claims App.).
REJECTIONS ON APPEAL
Claims 1--49 stand rejected under 35 U.S.C. § 112, first paragraph, for
lack of enablement.
Claims 11 and 34 stand rejected under 35 U.S.C. § 112, second
paragraph, as indefinite.
Claims 1-5, 15, 16, 18, 20, 21, 23, 24, 36, 38, 41, and 42 stand
rejected under 35 U.S.C. § 103(a) as unpatentable over Wang
(US 6,379,379 Bl, iss. Apr. 30, 2002) and Herweck (US 2004/0236410 Al,
pub. Nov. 25, 2004).
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Application 11/445,079
Claims 6 and 19 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Wang, Herweck, and Datta (US 6,423,092 B2, iss.
July 23, 2002).
Claims 7, 8, 28, and 29 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Wang, Herweck, and Blanc (US 5,749,919, iss. May 12,
1998).
Claims 9 and 10 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Wang, Herweck, and Brown (US 2006/0079955 Al, pub.
Apr. 13, 2006).
Claims 11-14, 32, 34, and 35 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Wang, Herweck, and Gambale (US 6,458,092 Bl, iss.
Oct. 1, 2002).
Claims 17 and 37 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Wang, Herweck, and Furst (US 2006/0224237 Al, pub.
Oct. 5, 2006).
Claim 22 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Wang, Herweck, and Litvack (US 2005/0234538 Al, pub. Oct. 20,
2005).2
Claim 25 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Wang, Herweck, and Gellman (US 6,733,536 Bl, iss. May 11, 2004).
2 The Final Office Action refers to "Litvack et al. (US PGPub No.
7,229,471)." Final Act. 17. Appellants correctly note there is no such
reference. Appeal Br. 36; Reply Br. 2. Appellants additionally assume the
Examiner intended to rely on US 7,299,471 B2 to Gale et al. Appeal Br. 36.
That assumption, however, is inconsistent with the Examiner's citation to
paragraph numbers 37, 42, and 65 in the reference. Final Act. 18. Those
citations are, rather, consistent with US 2005/0234538 Al to Litvack et al.,
cited in the Non-Final Office Action dated November 5, 2010.
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Application 11/445,079
Claims 26 and 43 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Wang, Herweck, and Barclay (US 2002/0077693 Al, pub.
June 20, 2002).
Claims 27 and 40 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Wang, Herweck, and Wu (US 2004/0052859 Al, pub.
Mar. 18, 2004).
Claim 30 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Wang, Herweck, and Dickson (US 2004/0034405 Al, pub. Feb. 19,
2004).
Claims 31 and 33 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Wang, Herweck, Gambale, and Sirhan
(US 2003/0033007 Al, pub. Feb. 13, 2003).
Claim 39 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Wang, Herweck, and Gale '680 (US 2005/0209680 Al, pub. Sept. 22,
2005).
Claims 44, 45, 48, and 49 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Wang, Herweck, and Hossainy (US 6,783,793 Bl, iss.
Aug. 31, 2004).
Claim 46 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Wang, Herweck, Hossainy, and Gale '868 (US 2006/0058868 Al, pub.
Mar. 16, 2006).
Claim 47 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Wang, Herweck, and Udipi (US 2004/0215336 Al, pub. Oct. 28,
2004).
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Application 11/445,079
ANALYSIS
A. Enablement of Claims 1--49
The Examiner's rejection of claim 1 as lacking enablement focuses on
the limitation requiring the helical construct to be "configured to apply less
than 0.75 Bar of pressure to a wall of the biological lumen." Final Act. 6-8.
The Examiner's position is that Appellants have "merely discovered the
concept of applying only a certain amount of pressure to the interior of a
body lumen with a deployed construct in order to avoid damage to the lumen
without actually inventing a particular structure to accomplish that feat."
Id. at 6 (emphasis added). The Examiner acknowledges Appellants'
Specification discloses "several structural variables" to be considered when
making a helical construct for implanting into a biological lumen, but the
Examiner concludes "the number of design parameters alone" necessitates
an undue amount of experimentation to make and use the claimed invention.
Id. at 6-7. The Examiner notes the lack of working or prophetic examples in
the Specification, and further concludes "the prior art does not provide any
substantial direction" to enable the claimed invention. Id. at 7-8.
Appellants argue a person of ordinary skill in the art would not require
undue experimentation to make and use the claimed invention as of the
May 31, 2006, filing date of the application. Appeal Br. 9-14. Appellants
assert claim 1 is "directed to a relatively simple medical device." Id. at 10.
Appellants note "[t]he advancement in the art" at the time of their invention,
as evidenced by the several references cited by the Examiner in support of
various obviousness rejections. Id. at 11. Appellants further rely on the
level of ordinary skill in the art at the time of their invention, which
Appellants characterize as a person with a Bachelor of Science degree in
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mechanical or chemical engineering and experience in the stent art. Id.
Appellants assert their Specification "provides a rather detailed disclosure on
design" including several pertinent structural variables and materials that
may be used to make and use the claimed invention. Id. at 11-12.
Appellants additionally rely on the Papp Declaration3 and the Stankus
Declaration4 in support of enablement. Id. at 12-19.
We determine the Examiner has failed to establish a person of
ordinary skill in the art, upon review of the Specification, would require
undue experimentation to practice the invention recited in claim 1.
"Enablement is not precluded by the necessity for some experimentation."
In re Wands, 858 F.2d 731, 736-37 (Fed. Cir. 1988) (emphasis added).
"However, experimentation needed to practice the invention must not be
undue experimentation." Id. at 737 (emphasis added). Whether undue
experimentation would be necessary is not a single, simple factual
determination, but rather is a conclusion reached by weighing many factual
considerations, such as: (1) the quantity of experimentation necessary,
(2) the amount of direction or guidance presented, (3) the presence or
absence of working examples, (4) the nature of the invention, (5) the state of
the prior art, ( 6) the relative skill of those in the art, (7) the predictability or
unpredictability of the art, and (8) the breadth of the claims. Id. Although
we appreciate that the Specification sets forth many design considerations
for making a helical construct, and thus requires experimentation to
3 Declaration of John Papp (dated Dec. 11, 2012), attached to the Appeal
Brief as Appendix C.
4 Declaration of John J. Stankus (dated Dec. 10, 2012), attached to the
Appeal Brief as Appendix D.
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implement, it does not appear that such experimentation would be undue for
a person of ordinary skill in the art given the simple nature of the invention
recited in claim 1.
In so deciding, we do not find it necessary to rely further on either the
Papp Declaration or the Stankus Declaration as providing persuasive
evidence of enablement. Moreover, the Declarations establish only that a
person of ordinary skill in the art could make a helical construct including a
spiral coil and a therapeutic substance, and use such a construct by
implanting it within a biological lumen, without undue experimentation.
Papp Deel. i-fi-1 5-8; Stankus Deel. i-fi-1 6-9. As to the critical pressure
application limitation, Mr. Papp states he "believe[ s] that the coil [that he
made] is capable of collapsing at pressures below 0.75 Bar" (Papp Deel.
i1 6), and he is "of the opinion" that, when helical constructs he made or
could make are delivered into an appropriately-sized biological lumen, "a
pressure of less than 0.75 Bar will be applied" (id. i-f 11). Mr. Papp further
offers the following opinion:
[Helical construct design variables] can be readily identified
without undue experimentation such that a helical construct
including a spiral coil can be routinely made and used to apply
less than 0.75 Bar of pressure to a wall of a biological lumen
when the helical construct is deployed in the biological lumen
and after the helical construct is deployed and implanted in the
biological lumen. In my opinion one could have made and used
the helical construct as claimed and disclosed in [the present
application] on or prior to May 31, 2006. Making, delivering and
using such devices merely requires routine experimentation.
Id. i-f 12. Mr. Stankus offers similar opinions. Stankus Deel. i-fi-16-9. These
conclusory opinions, while apparently offered by persons of ordinary skill in
the art, are of little probative value because they are unsupported by any
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Application 11/445,079
technical reasoning or other factual evidence, such as actual test results
performed on an actual helical construct, to establish that the construct
would satisfy the critical pressure application limitation.
Mr. Papp describes two testing regimens, pressure collapse testing
(Papp Deel. i-f 9) and "an off the shelf iris-type radial stent loading chamber"
(id. i-f 10), which in his opinion could be used to determine whether a helical
construct would satisfy the pressure application limitation. However,
Mr. Papp does not provide any evidence that he actually applied either test
to an actual helical construct. Moreover, we are not persuaded that a person
of ordinary skill would equate a minimum applied pressure at which a
helical construct will collapse (id. i-fi-1 9-10) with the claimed helical
construct configured to apply pressure of less than 0.75 Bar to a wall of a
biological lumen when implanted therein. These seem to be, or rely on,
different properties of the helical construct. Appellants do not point to
disclosure in the Specification that would indicate the two are the same, and
the conclusory nature of Mr. Papp' s opinion is insufficient to persuade us
that a person of ordinary skill in the art would equate the two.
Based on the foregoing, we do not sustain the rejection of claim 1, and
claims 2--49 which incorporate the limitations of claim 1, 5 for lack of
enablement.
5 This includes claim 21, and claims 22-27 and 44--49 depending therefrom,
even though these claims are directed to a method of treating a vascular
disorder, rather than an implantable device as in claim 1. See Appeal Br. 4 7
(Claims App., claim 21 ). Claim 21 recites "implanting the device of claim 1
in a human patient" (id.), thereby incorporating by reference the device of
claim 1.
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B. Indefiniteness of Claims 11 and 34
Claim 11 depends from claim 1 to require the helical construct to
include first spiral coils having "a counter helical configuration than" second
spiral coils. Appeal Br. 46 (Claims App.) (emphasis added). Claim 34
contains a similar limitation. Id. at 48.
The Examiner rejects claims 11 and 34 as indefinite, on the basis that
it is unclear exactly what it means for first spiral coils to have a counter
helical configuration "than" second spiral coils. Final Act. 8-9, 25; Ans. 25.
The Examiner proposes replacing "than" with "with respect to" or "relative
to." Final Act. 9, 25.
Appellants argue there is nothing confusing in the claims, when read
in light of Appellants' Figure 3 "and accompanying description thereof."
Appeal Br. 19-20. Appellants particularly assert the claimed "counter
helical configuration" specifies "a clockwise rotation" versus "a counter
clockwise rotation" of the spiral coils. Id. at 20.
We agree with Appellants. We appreciate the Examiner's point that
claims 11 and 34 would be easier to read and understand if "than" were
replaced by "with respect to" or "relative to." Nonetheless, "[t]he test for
definiteness under 35 U.S.C. § 112, second paragraph, is whether 'those
skilled in the art would understand what is claimed when the claim is read in
light of the specification."' Ex Parte Miyazaki, 89 USPQ2d 1207, 1210
(BP AI 2008) (precedential) (quoting Orthokinetics, Inc. v. Safety Travel
Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986)). We determine, when
read in light of the Specification, claims 11 and 34 are sufficiently clear in
requiring the first spiral coils to have an opposite helicity to the second spiral
coils (i.e., right-handed helicity versus left-handed helicity). See Spec. 5:9-
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11, 9:10-18, Fig. 3. Thus, we do not sustain the indefiniteness rejection of
claims 11 and 34.
C. Obviousness based on Wang and Herweck of
Claims 1-5, 15, 16, 18, 20, 21, 23, 24, 36, 38, 41, and 42
The Examiner finds Wang (Figure 6) discloses a helical construct
exhibiting most of the limitations recited in claim 1. Final Act. 9-10 (citing
Wang, 2:36-47, 2:65-3:7, 5:31--45, 9:55-59). The exception is that Wang
fails to disclose its helical construct being "configured to apply less than
0.75 Bar of pressure to" a biological lumen wall after deployment and
implantation of the helical construct in the lumen, as claimed. Id. at 10.
The Examiner finds Herweck (Figures 1 and 2) discloses expandable
balloon device 10 that may be used to expand a medical device such as
stent 6 illustrated in Herweck (Figure 6A). Final Act. 10 (citing Herweck
i-fi-169-70, 77). The Examiner finds Herweck's expandable device 10 is
capable of being expanded "within the range of up to 6 atmospheres or
another desired range of pressure such that the stent is expanded against a
lumen wall ... and wherein up to 6 atmospheres would include the
application of zero to 6 Bar of pressure." Id. The Examiner determines it
would have been obvious to have provided Wang's helical construct with
Herweck's expandable device 10 "to control expansion to provide non-
traumatic expansion of [Wang's] helical construct." Id. (citing Herweck
i1 70). The Examiner further reasons, in support of rejecting dependent
claims 7, 8, 28, and 29 as obvious over Wang, Herweck, and Blanc:
If the construct is deployed within [a] vessel having an inner
diameter larger than the outer diameter of the construct, then the
pressure applied to the vessel may be zero, which is within the
claimed range.
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Application 11/445,079
Id. at 26.
Appellants argue "[b ]alloon inflation pressure," such as disclosed in
Herweck, "cannot be correlated and does not translate to degree of pressure
[applied] by" a stent or helical construct to a vessel wall during deployment
and after implantation, as claimed. Appeal Br. 21-22. Thus, in Appellants'
view, Herweck's disclosure of applying pressure within expandable
device 10 to expand a stent or helical construct only during deployment of
the stent or helical construct does not satisfy the pressure limitation of
claim 1. Id. at 22. As to deploying a helical construct within a vessel having
an inner diameter larger than the outer diameter of the construct, Appellants
assert the Examiner fails to address the claim language reciting that the
pressure is applied once the helical construct is "implanted" within the
biological lumen, and is "in contact with" the lumen wall. Id. at 26-27.
The Examiner answers as follows:
When a helical construct is placed within a lumen having a
specific diameter which contacts the helical construct, as
pressure is applied [to a balloon] to expand the construct, the
balloon inflation pressure will translate to the degree of pressure
the construct applies to the vessel wall. Therefore, the inflation
pressure correlates to the degree of pressure of the helical
construct of the combination of Wang and Herweck.
Ans. 25-26. The Examiner further indicates the Papp Declaration at page 9
"states that the inner diameter of the vessel can be less than as well as
greater than the helical construct's outer diameter." Id. at 26.
We determine the Examiner's rejection applies an unreasonably broad
construction of claim 1. Our reviewing court has instructed that:
[U]nder the broadest reasonable interpretation, the Board's
construction "cannot be divorced from the specification and the
record evidence," In re NTP, Inc., 654 F.3d 1279, 1288 (Fed. Cir.
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2011 ), and "must be consistent with the one that those skilled in
the art would reach," In re Cortright, 165 F.3d 1353, 1358 (Fed.
Cir. 1999). A construction that is "unreasonably broad" and
which does not "reasonably reflect the plain language and
disclosure" will not pass muster.
Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2015)
(quoting In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2010)).
Claim 1 specifies that the helical construct is configured to apply less than
0.75 Bar "after the helical construct is deployed and implanted in the
biological lumen." Appeal Br. 45 (Claims App.) (emphasis added).
Consistent with claim 1, the Specification indicates the invention of claim 1
is thereby directed to the helical construct applying the recited pressure,
after the construct is deployed and implanted in a biological lumen, for
example after a balloon catheter that is used to deploy the helical construct is
removed from the lumen. See Spec. 6: 19-7: 10 (helical construct 10 applies
pressure "subsequent to the retraction of the catheter which delivers the
construct"), 16: 19-21 ("spiral construct 10 can be balloon expandable such
that application of radial pressure causes the radial expansion of the
coils 12"). Thus, a person of ordinary skill in the art would understand
claim 1 to require the recited pressure be applied by the helical construct
without the aid of a balloon.
The Examiner's reasoning relies on pressure applied by Herweck's
balloon while it is used to expand Wang's helical construct, not on pressure
applied by Wang's helical construct without the aid of Herweck's balloon.
The Examiner has not identified a preponderance of evidence to support a
finding that Wang's helical construct would apply the claimed pressure
without the aid of a balloon.
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We further note claim 1 requires the helical construct to be
"configured to be in contact with" the lumen wall "post deployment and
when implanted." Appeal Br. 45 (Claims App.). Wang's helical construct,
when so implanted, would necessarily apply some amount of pressure to the
lumen wall. Thus, the Examiner's construction of claim 1 as encompassing
"zero" pressure to the lumen wall (Final Act. 26) is unreasonable, because it
overlooks the requirement for the construct to be in contact with the wall.
The Examiner's finding that the helical construct may apply "zero" pressure
to the lumen wall is not commensurate with the claim.
For the foregoing reasons, we do not sustain the rejection of claim 1
as unpatentable over Wang and Herweck. The Examiner's additional
consideration of claims 2-5, 15, 16, 18, 20, 21, 23, 24, 36, 38, 41, and 42,
which incorporate the limitations of claim 1, does not cure the noted
deficiency as to claim 1. See Final Act. 9-11. We, therefore, likewise do
not sustain the rejection of those claims as unpatentable over Wang and
Herweck.
D. Other Obviousness Rejections
The Examiner's further consideration of claims 6-14, 17, 19, 22, 25-
35, 37, 39, 40, and 43--49 in connection with Wang and Herweck and one or
more of Datta, Blanc, Brown, Gambale, Furst, Litvack, Gellman, Barclay,
Wu, Dickson, Sirhan, Gale '680, Hossainy, Gale '868, and Udipi does not
cure the deficiencies noted above in connection with claim 1. See Final
Act. 11-24. We therefore do not sustain the remaining obviousness
rejections.
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DECISION
The Examiner's decision to reject claims 1--49 is reversed.
REVERSED
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