Ex Parte Sansoucy

Patent Trial and Appeal Board

Apr 25, 2018

13542173 (P.T.A.B. Apr. 25, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/542, 173 07/05/2012
143331 7590 04/27/2018
Medtronic, Inc./RCS Shumaker
60 Middletown A venue
c/o Legal - Mailstop MS 54
North Haven, CT 06473
FIRST NAMED INVENTOR
Michael Sansoucy
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.
H-KN-02304US/1214-097US01 3569
EXAMINER
FARRAR, LAUREN PENG
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
04/27/2018 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):
SurgicalUS@covidien.com
medtronic_mitg-rcs_docketing@cardinal-ip.com
pairdocketing@ssiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL SANSOUCY
Appeal2017-003130
Application 13/542, 173
Technology Center 3700
Before LYNNE H. BROWNE, MICHELLE R. OSINSKI, and
PAUL J. KORNICZKY, Administrative Patent Judges.
OSINSKI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Michael Sansoucy ("Appellant") 1 appeals under 35 U.S.C. § 134(a)
from the Examiner's decision rejecting claims 1-11 and 13-21. 2 We have
jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM-IN-PART.
1 Appellant identifies the real party in interest as "Medtronic plc of Dublin,
Ireland, which is the ultimate parent entity of the assignee of record,
Covidien LP." Appeal Br. 3.
2 Claim 12 is cancelled. Amendment (Dec. 21, 2015).
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Application 13/542, 173
THE CLAIMED SUBJECT MATTER
Claims 1, 17, and 21 are independent. Claim 1, reproduced below, is
representative of the claimed subject matter on appeal.
l, A split-tip catheter comprising:
a body defining first and second lumens and first and
second separated dista1 tip portions, each of the separated distal
tip portions defining a lurnen which communicates with one of
the first or second lumens,
each of the separated distal tip pmiions including at least
one distally located normally closed, one-way valve, each of the
distally located one-way valves being configured to open in
response to an increase in pressure within a respective one of the
first and second 1umens to enable fluid to be discharged from the
respective first or second lumen; and
at least one proximally 1ocated normally closed, one-way
valve associated with each of the first and second lumens, each
of the proximally located one-way valves being spaced
proximally of the distally located one-way valves and being
configured to open in response to a decrease in pressure within a
respective one of the first and second lurnens to enable fluid to
enter the respective first or second lumen,
EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Dye
Spencer
Makower
Ash
Matson
Malhi
us 3,726,283
us 3,888,249
US 2006/0184089 Al
US 2007 /0225682 Al
US 2010/0081986 Al
US 2013/0085478 Al
2
Apr. 10, 1973
June 10, 1975
Aug. 17, 2006
Sept. 27, 2007
Apr. 1, 2010
Apr. 4, 2013
Appeal2017-003130
Application 13/542, 173
THE REJECTIONS
I. Claims 1-5, 8-10, 13-15,3 and 17-21 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Matson, Spencer, and
Ash. Final Act. 2--4.
II. Claims 6 and 7 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Matson, Spencer, Ash, and Malhi. Id. at 5.
III. Claim 11 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Matson, Spencer, Ash, and Makower. Id.
IV. Claim 16 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Matson, Spencer, Ash, and Dye. Id. at 5---6.
OPINION
Rejection I
Claims 1-3, 8-10, and 14
Appellant argues claims 1-3, 8-10, and 14 as a group. Appeal Br. 6-
10. We select claim 1 as the representative claim, and claims 2, 3, 8-10, and
14 stand or fall therewith. 37 C.F.R. § 41.37(c)(l)(iv).
The Examiner relies on Matson for the limitations of claim 1, except
for (i) the body of the catheter defining separated distal tip portions and (ii)
each of the separated distal tip portions including at least one distally located
one-way valve. Final Act. 2-3. The Examiner relies on Spencer's teaching
3 Even though the Examiner failed to include reference to claims 13 and 14
in the heading for this rejection (see Final Act. 2), the Examiner references
claim 13 within the body of the rejection (see id. at 3-4) and finds that
rviatson discloses the features of claim 14 (see id. at 6). \Ve consider the
Examiner's oversight in the heading to be a typographical eITor, and
therefore, we list claims 13 and 14 as being subject to this ground of
rejection. Appellant also considers claims 13 and 14 to be subject to this
ground of rejection. Appeal Br. 6, 10, 12-14.
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of "distal slit valves (24 )" on an arterial infusion catheter and concludes that
it would have been obvious to one of ordinary skill in the art "to modify the
device of Matson to include distal valves as taught by Spencer for the
purpose of delivering medication out of the catheter." Id. at 2 (citing
Spencer col. 2). More particularly, the Examiner determines that "a simple
substitution to have an alternate means of delivery medication out of a
catheter would be within the skill of one of ordinary skill in the art." Ans. 2.
Alternatively, the Examiner points to Spencer's teaching that distal valves
"provide uniformity and improved diffusion into the bloodstream" and
concludes that "[t]herefore, there is direct motivation ... for having the
distal valves [of Spencer] in combination with the device of Matson." Id.
(citing Spencer 2:50-52).
The Examiner relies on Ash's teaching of "separated tip portions" and
reasons that it would have been obvious to one of ordinary skill in the art "to
modify the device of [Matson ]/Spencer with the separated distal tip portions
as taught by Ash for the purpose of allowing the two lumens to be operated
independently of one another." Final Act. 3 (citing Ash Fig. 17, i-f 16). The
Examiner further finds that "it would ... be within the skill of one of
ordinary skill in the art to look to the split distal ends as a substitute
configuration for the two lumens" and "the separated distal tip portions of
Ash proves the ability for the user to manipulate ... the two lumens
individually[,] thus allowing for greater flexibility." Id. at 6.
With respect to the modification based on the teachings of Spencer,
Appellant argues that "the Examiner has not shown that Matson' s openings
84, 86 and openings with Spencer's 'distal valves' provide the same function
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or serve the same purpose." Reply Br. 3 (footnote omitted). Appellant,
thus, asserts that
the Examiner's reliance on the "simple substitution" rationale is
in error, at least because the Examiner has not shown that "all the
claimed elements were known in the prior art and one skilled in
the art could have combined the elements as claimed by known
methods with no change in their respective functions, and the
combination yielded nothing more than predictable results to one
of ordinary skill in the art."
Id. at 4 (citing Manual of Patent Examining Procedure (MPEP)
§ 2143(I)(A)). We are not persuaded of error by the Examiner in that a
rationale based on simple substitution does not require that there be no
change in the function of the substituted element, but rather that "the
substituted components and their functions were known in the art" and that
"the results of the substitution [of one known element for another] would
have been predictable." MPEP § 2143(I)(B); see also KSR Int'! Co. v.
Teleflex Inc., 550 U.S. 398, 416 (2007) (recognizing "that when a patent
claims a structure already known in the prior art that is altered by the mere
substitution of one element for another known in the field, the combination
must do more than yield a predictable result"). Here, Appellant has not
persuaded us that the function of distal valves as taught by Spencer were
unknown in the art or that the Examiner's proposed substitution would yield
more than predictable results to the ordinary artisan.
Appellant also argues that "the Examiner has not established that a
person having ordinary skill in the art would have understood the device of
Matson to have suffered from a lack of uniformity or poor diffusion of
medication delivered through the device of Matson." Reply Br. 4.
Appellant seems to be arguing that in order for the proposed combination to
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be proper, Matson must disclose a need for the proposed modification or
must disclose that a certain improvement would be advantageous. We do
not agree. The Supreme Court has rejected the rigid requirement of
demonstrating a teaching, suggestion, or motivation to combine known
elements in order to show obviousness. KSR, 550 U.S. at 419. Rather,
rejections based on obviousness must be supported by "some articulated
reasoning with some rational underpinning" to combine known elements in
the manner required by the claim. Id. at 418 (citing In re Kahn, 441 F.3d
977, 988 (Fed. Cir. 2006)). As described above, the evidence before us
shows that distal valves were known in the art, and the Examiner's proposed
modification to replace open ends with distal valves does not appear to
amount to "more than the simple substitution of one known element for
another" and is therefore obvious. KSR, 550 U.S. at 417 (internal citation
omitted).
Appellant additionally argues that the Examiner has not shown that
Spencer's distal valves (i) would provide more uniformity and improved
diffusion relative to Matson's openings 84, 86 specifically and (ii) would not
frustrate the principle of operation of Matson's catheter by failing to permit
fluid flow to the same extent as Matson's openings 84, 86. Reply Br. 4--5.
For the same reasons described above, we remain unpersuaded that the
Examiner's articulated reasoning in support of the conclusion of
obviousness-simple substitution of one known element for another-lacks
rational underpinnings. Although tradeoffs may be required in balancing the
benefits and drawbacks of distal valves in place of open end arrangements,
such tradeoffs do not necessarily prevent the proposed combination or
negate the obviousness of the claimed subject matter. See
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Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) ("a given course of
action often has simultaneous advantages and disadvantages, and this does
not necessarily obviate motivation to combine").
With respect to the modification of Matson/Spencer based on the
teachings of Ash, Appellant argues that "[b ]ecause Matson already describes
independent operation as defined by the Examiner [e.g., separated fluid flow
(Ans. 2)], a person having ordinary skill in the art would not have looked to
Ash to solve the purported problem of independent operation." Reply Br. 6.
Appellant, however, does not point out any flaw in the Examiner's reasoning
relating to individual manipulation of the two lumens for greater flexibility
(Final Act. 6), which is distinguishable from mere individual operation.
As to Appellant's additional argument that Ash's catheter does not
include openings that are both opposed and "arranged in a diametrical
fashion" (Reply Br. 7), we are not persuaded of Examiner error in that the
Examiner's rejection is not based on bodily incorporation of Ash's catheter
into the Matson/Spencer catheter, but rather based on modifying the device
of Matson/Spencer so as to have separated distal tip portions. See In re
Keller, 642 F.2d 413, 425 (CCPA 1981) (citations omitted) ("The test for
obviousness is not whether the features of a secondary reference may be
bodily incorporated into the structure of the primary reference. . . . Rather,
the test is what the combined teachings of the references would have
suggested to those of ordinary skill in the art."). Appellant does not
persuade us that the Examiner's modification of Matson/Spencer with Ash's
teachings would result in openings that are "simply opposed," but not
"diametrically opposed." Reply Br. 7. As acknowledged by Appellant,
Matson already teaches openings or ports that are diametrically opposed to
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each other (Appeal Br. 8-9), and modification so as to provide separated
distal tips will not prevent the diametrical opposition of Matson' s tips.
For the foregoing reasons, we do not find that the Examiner erred in
concluding that the subject matter of independent claim 1 is rendered
obvious by Matson, Spencer, and Ash. We sustain the rejection of claim 1,
and claims 2, 3, 8-10, and 14 falling therewith, under 35 U.S.C. § 103(a) as
unpatentable over Matson, Spencer, and Ash.
Claim 4
Claim 4 recites that the catheter "further compris[ es] a support
structure formed in the body adjacent at least one of the proximally located,
one-way valves." Appeal Br. 22 (Claims App.). The Examiner determines
that "any of the catheter body [of Matson] located adjacent the slit could be
considered a support structure." Final Act. 3. Based on this determination,
the Examiner finds that Matson discloses a "support structure formed in the
body adjacent at least one of the proximally located, one-way valves," as
claimed. Id.
Appellant argues that "the Examiner has not ... identified any
structure adjacent the adjacent inner portion 62 of Matson's catheter member
that would be reasonably understood by a person having ordinary skill in the
art to have been a support structure." Appeal Br. 10. To construe the
limitation of a "support structure" of a catheter as merely any portion of the
catheter body would effectively render the claim limitation superfluous, and
thus would be improper. See Stumbo v. Eastman Outdoors, Inc., 508 F .3d
1358, 1362 (Fed. Cir. 2007) (denouncing claim constructions which render
phrases in claims superfluous). That is, under the Examiner's interpretation,
the claim limitation is construed so broadly that every catheter would have a
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support structure by virtue of it having a catheter body, whereas Appellant
takes the position this would be unreasonable. Although we appreciate the
Examiner's statement that "[t]here is not additional structure defining the
support" (Ans. 3), the term "support structure" must be construed in a way
that gives the term effect. Merely selecting any portion of the catheter body
as a "support structure" fails to give the term any effect, because every
catheter would have a catheter body. Therefore, the Examiner's position
fails to give proper weight to the limitation of claim 4.
For the foregoing reasons, we find that the Examiner erred in
concluding that the subject matter of claim 4 is rendered obvious by Matson,
Spencer, and Ash. We do not sustain the rejection of claim 4 under
35 U.S.C. § 103(a) as unpatentable over Matson, Spencer, and Ash.
Claim 5
Claim 5 recites that "each of the proximally located one-way valves
includes tapered inwardly deformable flaps." Appeal Br. 23 (Claims App.).
The Examiner finds that "Matson discloses wherein each of the proximally
located one-way valves includes tapered inwardly deformable flaps (see
element 9[4] in Fig. 12)." Final Act. 3. More particularly, the Examiner
states "the claim was interpreted to read that the flap would taper inwardly"
and that "when ... flap 94 is opened[,] the flap is pushed inwardly[,] thereby
creating a taper inward toward the center of the catheter body." Ans. 3. The
Examiner continues that "[t]he claims as currently recited do not prevent
such an interpretation" and that "[ fJurther limitations regarding the actual
flap being tapered itself would be needed to overcome the current rejection."
Id.
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Appellant argues that "the Examiner appears to interpret any flap that
is pushed inwards as being a tapered flap" and "fail[ s] to give claim 5 the
'broadest reasonable interpretation consistent with the specification."'
Reply Br. 10 (emphasis and citation omitted). The Specification refers to
"proximal one-way slit valves 220 ... includ[ing] tapered inwardly
deformable flaps 220a" and subsequently states that "the slits are defined by
the tapered flaps 220a." Spec. i-f 58; see also id. Fig. 5A. We agree with
Appellant that, under a broadest reasonable interpretation consistent with the
Specification, the claim would be interpreted as requiring the flaps
themselves to be tapered, not merely that they be capable of being pushed
inward toward the center of the catheter body. The Examiner's finding that
Matson discloses that "each of the proximally located one-way valves
includes tapered inwardly deformable flaps," as recited in claim 5 (Final
Act. 3) is not adequately supported by the reference when this claim
language is given its broadest reasonable interpretation in light of the
Specification.
For the foregoing reasons, we find that the Examiner erred in
concluding that the subject matter of claim 5 is rendered obvious by Matson,
Spencer, and Ash. We do not sustain the rejection of claim 5 under
35 U.S.C. § 103(a) as unpatentable over Matson, Spencer, and Ash.
Claim 13
Claim 13 recites that "each of the separated tip portions include at
least one of the proximally located one-way valves." Appeal Br. 23 (Claims
App.). The Examiner states in the Answer that "Matson already teaches
proximal one way valves" and that "Ash is simply used to show that each
separated distal tip[] can contain multiple one way valves on the outer
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body." Ans. 3--4. Accordingly, we understand the Examiner to be
explaining why the proposed modification to the Matson/Spencer device so
as to have separated tips would result in both Matson's proximally located
one-way valves and Matson's distally located one-way valves being on
separated tip portions.
Appellant acknowledges that Ash shows two valves 616 "as shown by
the lead lines in FIG. 17." Reply Br. 12. Even if "neither of the two valves
616 shown in FIG. 17 are distal or proximal with respect to each other" as
asserted by Appellant (id.), we do not view the Examiner's rejection as
hinging on a characterization of valves 616 as distal and proximal relative to
each other. Rather, we view the Examiner as relying on Ash for the concept
of having multiple valves on a separated distal tip, in support of the
Examiner's conclusion that one of ordinary skill in the art would separate
the tip of the Matson/Spencer device in a way so that each of the separated
tip portions include at least one of the proximally located one-way valves 94
of Matson, as well as the distally located one-way valves of Matson/Spencer.
For the foregoing reasons, we do not find that the Examiner erred in
concluding that the subject matter of claim 13 is rendered obvious by
Matson, Spencer, and Ash. We sustain the rejection of claim 13 under
35 U.S.C. § 103(a) as unpatentable over Matson, Spencer, and Ash.
Claim 15
Claim 15 recites that
each of the proximally located one-way valves includes a
membrane supported within the respective one of the first and
second lumens of the body, the membrane being positioned to
cover a throughbore formed in the body and being inwardly
movable to enable fluid to enter the throughbore, at least a
portion of the membrane being secured to the body.
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Appeal Br. 24 (Claims App.). The Examiner finds that Matson's element 94
meets these claims limitations (Final Act. 4 (citing Matson Fig. 12) ),
explaining that "a membrane is simply interpreted as a thin piece of
material" and "flap portion 94 of Matson could be considered a membrane"
(Ans. 4).
Appellant argues that "Matson nowhere describes or suggests that
valve member 94 is or includes a membrane, or otherwise functions like a
membrane." Appeal Br. 14--15. Appellant has not persuaded us that the
Examiner's interpretation of a membrane is unreasonable, and, thus,
Appellant has not persuaded us that the Examiner's finding that Matson's
element 94 constitutes a membrane is not supported by a preponderance of
the evidence.
For the foregoing reasons, we do not find that the Examiner erred in
concluding that the subject matter of claim 15 is rendered obvious by
Matson, Spencer, and Ash. We sustain the rejection of claim 15 under
35 U.S.C. § 103(a) as unpatentable over Matson, Spencer, and Ash.
Claims 17-21
In contesting the rejection of claims 17-21, Appellant relies on the
same arguments and reasoning we found unpersuasive in connection with
independent claim 1. See Appeal Br. 16-17. Accordingly, we also sustain
the rejection of claims 17-21 under 35 U.S.C. § 103(a) as unpatentable over
Matson, Spencer, and Ash.
Rejections 11-111
The Examiner rejects, under 35 U.S.C. § 103(a), claims 6 and 7 as
unpatentable over Matson, Spencer, Ash, and Malhi, and claim 11 as
unpatentable over Matson, Spencer, Ash, and Makower. Final Act. 5. In
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addition to relying on the same arguments and reasoning we found
unpersuasive in connection with independent claim 1 (Appeal Br. 17-19),
Appellant argues that Matson, Spencer, Ash, and Malhi "fails to disclose or
suggest a split-tip catheter 'wherein each of the proximally located one-way
valves includes a slit which extends through the body and a concavity
formed about the slit,' as recited by claim 6" (id. at 17) and that Matson,
Spencer, Ash, and Makower "fails to disclose or suggest a split-tip catheter
'wherein each of the proximally located one-way valves is a duckbill valve,'
as recited by claim 11" (id. at 18). The additional arguments amount to the
recitation of the claim elements and a "naked assertion" that the elements are
not in the prior art. Such reasoning is not persuasive. See 37 C.F.R.
§ 41.37(c)(l)(iv); In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir 2011) (holding
that the Board had reasonably interpreted the same language in the prior rule
under 3 7 C.F .R. § 41.3 7 ( c )( 1 )(vii) as requiring "more substantive arguments
in an appeal brief than a mere recitation of the claim elements and a naked
assertion that the corresponding elements were not found in the prior art").
For the foregoing reasons, we do not find that the Examiner erred in
concluding that the subject matter of claims 6, 7, and 11 is rendered obvious.
We sustain the rejection, under 35 U.S.C. § 103(a), of claims 6 and 7 as
unpatentable over Matson, Spencer, Ash, and Malhi and claim 11 as
unpatentable over Matson, Spencer, Ash, and Makower.
Rejection IV
Claim 16 recites that the catheter "further includ[ es] a support rib
extending across the throughbore, the support rib being positioned to prevent
outward movement of the membrane." Appeal Br. 24 (Claims App.). The
Examiner determines that although "Matson/Spencer/ Ash teaches a
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through[]bore, ... [it] does not teach a support rib." Final Act. 6. The
Examiner finds that "Dye teaches a support rib (see portion of lumen that
abuts the end of the flap valve (501 in Fig. 8) extending across the
through[]bore[,] the support rib being positioned to prevent outward
movement of the membrane." Id. The Examiner reasons that it would have
been obvious "to modify the device of Matson/Spencer/ Ash with the support
rib as taught by Dye for the purpose of preventing outward movement of the
membrane in order to seal the opening when pressure is applied to the
lumen." Id. (citing Dye 5:9-45).
In addition to relying on the same arguments and reasoning we found
unpersuasive in connection with independent claim 1 (Appeal Br. 20),
Appellant argues that "the Examiner failed to establish a person having
ordinary skill in the art would have understood the portion of the drainage
lumen 420 of Dye characterized by the Examiner as being 'a support rib
extending across [a] throughbore,' a recited by claim 16" (Reply Br. 14 ).
Appellant does not adequately explain how the Matson/Spencer/ Ash device,
as modified by Dye, would fail to include a portion that extends across the
throughbore in at least one direction (i.e., in the same direction as the
proximal edge of Matson's flap 94 engaging with the portion of the catheter
when in a closed position). Having the portion extend across the
throughbore just as the proximal edge of Matson's flap 94 extends across the
throughbore prevents outward movement of flap 94 in accordance with the
Examiner's articulated rationale.
For the foregoing reasons, we do not find that the Examiner erred in
concluding that the subject matter of claim 16 is rendered obvious by
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Matson, Spencer, Ash, and Dye. We sustain the rejection of claim 16 under
35 U.S.C. § 103(a) as unpatentable over Matson, Spencer, Ash, and Dye.
DECISION
The Examiner's decision to reject claims 1-3, 8-10, 13-15, and 17-
21under35 U.S.C. § 103(a) as unpatentable over Matson, Spencer, and Ash
is affirmed.
The Examiner's decision to reject claims 4 and 5 under 35 U.S.C.
§ 103(a) as unpatentable over Matson, Spencer, and Ash is reversed.
The Examiner's decision to reject claims 6 and 7 under 35 U.S.C.
§ 103(a) as unpatentable over Matson, Spencer, Ash, and Malhi is affirmed.
The Examiner's decision to reject claim 11 under 35 U.S.C. § 103(a)
as unpatentable over Matson, Spencer, Ash, and Makower is affirmed.
The Examiner's decision to reject claim 16 under 35 U.S.C. § 103(a)
as unpatentable over Matson, Spencer, Ash, and Dye is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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