Ex Parte Blatcher et al

Patent Trial and Appeal Board

Feb 5, 2019

12355486 (P.T.A.B. Feb. 5, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/355,486 01/16/2009 Stephen Blatcher
76831 7590 02/07/2019
Squire Patton Boggs (PAL Office)
275 Battery Street
Suite 2600
San Francisco, CA 94111
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.
113550.00004 6838
EXAMINER
CERIONI, DANIEL LEE
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
02/07/2019 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
frank. bernstein@ squirepb. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEPHEN BLATCHER,
RICHARD HARLEY GRENVILLE OWEN,
JOSEPH PETER CORRIGAN, THOMAS NEUDECK,
ANDREW PETER SCUDAMORE, and
YANNICK PIERRE LOUIS HOURMAND 1
Appeal2018-000990
Application 12/355,486
Technology Center 3700
Before STEVEN D.A. McCARTHY, MICHAEL L. HOELTER,
and JAMES P. CALVE, Administrative Patent Judges.
CAL VE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the Office Action
finally rejecting claims 1, 3, 6-8, 10-21, 28, 30-34, and 36-45. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 PlaqueTec Limited is identified as the real party in interest. Appeal Br. 3.
Appeal2018-000990
Application 12/355,486
CLAIMED SUBJECT MATTER
Claims 1 and 43 are independent. Claim 1 is reproduced below.
1. A vascular catheter for taking a plurality of
discrete blood samples in vivo from within a length of a blood
vessel, the vascular catheter including:
an elongate central body arranged to be inserted, over a
guidewire, into the blood vessel;
a plurality of longitudinally spaced blood collection areas
defined along the elongate central body, the plurality of
collection areas configured for collecting the discrete blood
samples from the lumen of the blood vessel, each of the blood
collection areas having at least one blood collection port; and
at least one static mixer comprising a respective plurality
of mixing elements extending radially outwardly of the
elongate central body and arranged at successive positions
along and at corresponding successive angles around the
elongate central body, the at least one static mixer being in non-
contiguous contact with the blood vessel wall so as to maintain
at least one open region between the plurality of mixing
elements of the at least one static mixer and the blood vessel
wall for blood flow, the at least one static mixer arranged to
create a flow of blood from a boundary layer at a wall of the
blood vessel, around the entire periphery of the blood vessel, to
the elongate central body so as to enable the plurality of
longitudinally spaced blood collection areas to collect the
discrete blood samples from the boundary layer.
Appeal Br. A-1 (Claims App.).
REJECTIONS
Claims 14--17 are rejected under 35 U.S.C. § 112, second paragraph,
for being indefinite.
Claim 43 is rejected under 35 U.S.C. § 102(b) as anticipated by
Schulte (US 3,626,950, iss. Dec. 14, 1971).
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Application 12/355,486
Claims 1, 3, 6-8, 10-20, 28, 30-34, 36-42, 44, and 45 are rejected
under 35 U.S.C. § I03(a) as unpatentable over Schulte and Gruhl (US 2004/
0082861 Al, pub. Apr. 29, 2004)
Claim 21 is rejected under 35 U.S.C. § I03(a) as unpatentable over
Schulte, Gruhl, and Fogarty (US 4,762,130, iss. Aug. 9, 1988).
ANALYSIS
Claims 14-17 For Indefiniteness
Claim 14 depends from claim 1 and recites "wherein each of the blood
collection areas includes at least one collection port located at a respective
position along the elongate central body for collecting a respective sample at
that position." The Examiner determines that it is unclear whether "at least
one collection port" in claim 14 is the same element as "at least one blood
collection port" in claim 1. Final Act. 3; Ans. 19. The Examiner reasons
that if antecedence exists for "at least one collection port" in claim 14, then
the "at least one blood collection port" of claim 1 "would be further limited
to be located at a respective position along the elongate central body for
collecting a respective discrete blood sample at that position." Ans. 19. The
Examiner reasons that if antecedence is lacking for "at least one collection
port" in claim 14, then the "at least one blood collection port" of claim 1 is
not limited by claim 14, and, therefore, claim 14 recites collection ports in
addition to the "at least one blood collection port" of claim 1. Id.
Appellants argue that each blood collection area has "at least one
collection port," and claim 14 specifies a position of each collection port.
Appeal Br. 7. Appellants argue that claim 14 recites the same or a different
collection port from the blood collection port of claim 1 depending on how a
skilled artisan would understand the lack of antecedent basis. See id. at 8.
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Application 12/355,486
"The specification shall conclude with one or more claims particularly
pointing out and distinctly claiming the subject matter which the inventor or
a joint inventor regards as the invention." 35 U.S.C. § 112(b). For pending
applications that have not issued as a patent, "[a] claim is indefinite when it
contains words or phrases whose meaning is unclear." In re Packard, 751
F.3d 1307, 1310, 1314 (Fed. Cir. 2014). Furthermore,
[ d]uring patent examination the pending claims must be
interpreted as broadly as their terms reasonably allow .... The
reason is simply that during patent prosecution when claims can
be amended, ambiguities should be recognized, scope and
breadth of language explored, and clarification imposed ....
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 Zietz, 893 F.2d 319, 321-22 (Fed. Cir. 1989) (quoted in Packard, 751
F.3d at 1313). Because applicants are in the best position to resolve any
ambiguity in the patent claims, patent examiners should demand that they do
so in appropriate circumstances so the application can be amended during
prosecution rather than attempting to resolve the ambiguity in litigation.
Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255 (Fed. Cir.
2008) (quoted in Packard, 751 F.3dat 1313).
Here, Appellants admit that claim 14 can be interpreted two different
ways because of a lack of antecedence. Appellants argue that if the lack of
antecedent basis for "at least one collection port" in claim 14 makes a skilled
artisan think the "at least one blood collection port" in claim 1 is a different
element, then there would be two collection ports in each blood collection
area. Appeal Br. 8. If not, then there would be at least one. Id.
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Application 12/355,486
Therefore, claim 14 can be interpreted to mean the blood collection
area has (1) "at least one blood collection port" ( claim 1) and "at least one
collection port" (claim 14) or (2) "at least one blood collection port" (claim
1) at a position recited for the "at least one collection port" in claim 14. This
lack of clarity renders claim 14 ( and its dependent claims 15-17) indefinite.
This lack of clarity is increased because claim 1 recites "at least one
blood collection port" whereas claim 14 recites "at least one collection port."
The difference in terminology tends to indicate that the lack of antecedence
in claim 14 is intentional. In other words, "at least one collection port" in
claim 14 is a different feature than "at least one blood collection port" in
claim 1. Therefore, even if claim 14 recited "the at least one collection port"
it would be unclear whether this feature drew antecedence from "at least one
blood collection port" in claim 1.
Claims 15 and 17 depend from claim 14 and recite "the at least one
collection port." This reliance on "at least one collection port" of claim 14
for antecedent basis also indicates "at least one collection port" in claim 14
is a different element than "at least one blood collection port" in claim 1.
The Specification discloses each collection area 14 having a collection
port 16 for collecting an individual sample, but each collection area 14 may
include more than one collection port. Spec. 12:29-33. Accordingly, claim
1 recites "at least one blood collection port." However, it is unclear whether
claim 14 recites a different port(s) (i.e., "at least one collection port") than
"at least one blood collection port" recited in claim 1.
Accordingly, we sustain the rejection of claim 14 and claims 15-17,
which depend therefrom, as being indefinite.
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Application 12/355,486
Claim 43 Anticipated by Schulte
The Examiner finds that Schulte discloses a vascular catheter that is
capable of sampling blood from a blood vessel with a flexible catheter body
(elongated tube 11) for insertion over a guidewire (thrust rod 33), a plurality
of blood collection ports (perforations 25) for capturing discrete blood
samples, and a static mixer ( circumferential fins 20, 21) for continuously
mixing blood across the entire radial extent of the blood vessel. Final Act. 4.
The Examiner finds that Schulte' s catheter is a structural equivalent of
the claimed "vascular catheter" because it has a channel for conveying body
fluid and is capable of use in the blood channels of differently-sized animals
where claim 43 is not limited to a particular animal's vasculature. Ans. 21.
The Examiner also finds that Schulte's catheter body 11 is capable of being
inserted over a guide wire into a blood vessel because the catheter body has
a lumen for insertion of thrust rod 33. Id. at 21-22. The Examiner interprets
claim 43 as requiring a catheter structure for insertion over a guidewire into
a blood vessel but not requiring a guidewire as an element of the claim. Id.
The Examiner also finds that Schulte's fins 20, 21 have almost identical
structure to static mixers 18 disclosed in Appellants' Figure 1 and thus are
structural equivalents that can mix fluid while standing still. Id. at 22-23.
Appellants argue that Schulte is a catheter for draining fluid from the
brain and shows no structure to indicate it can be inserted into a vein via a
guidewire, and a skilled artisan would appreciate that a catheter is inserted
over a guidewire by the guidewire going in first and the catheter sliding in
over the guidewire. Appeal Br. 10-11; Reply Br. 3. Appellants argue that
Schulte' s device would have to be altered "to provide a hole at the end of the
catheter, rather than a closed tip 13." Appeal Br. 11; see also Reply Br. 6-7.
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Application 12/355,486
Appellants' arguments are not commensurate with claim 43, which
recites "a vascular catheter" rather than a method of inserting a vascular
catheter into a blood vessel over a guidewire. Further, claim 43 recites "a
flexible catheter body for insertion over a guidewire into the blood vessel" in
contrast to claim 1, which recites "an elongate central body arranged to be
inserted, over a guidewire." Thus, claim 43 recites an intended use of the
catheter rather than structure that defines over Schulte. Claim 43 does not
require the flexible catheter body to be open at both ends so a guidewire can
be inserted completely through each opening and the interior of the catheter
body. Instead, claim 43 simply recites "for insertion over a guidewire."
Appellants do not explain how Schulte' s catheter is not insertable over a
guidewire like thrust rod 33 of Schulte. Thus, we are not persuaded that
claim 43 requires "open-endedness." See Reply Br. 6.
In addition, as indicated above, claim 43 does not recite a guidewire
as part of the vascular catheter. See Ans. 22. Instead, claim 43 recites "a
flexible catheter body for insertion over a guidewire." The Examiner finds
that Schulte' s catheter 10 is capable of being inserted over a guidewire
because it is inserted over thrust rod element 33, which has similar or the
same structure as a guidewire. Id.; see Schulte, 2:33-38, Figs. 1, 2, 5.
The Specification discloses that the vascular catheter is inserted into a
blood vessel using standard Percutaneous Coronary Intervention equipment
such as introducers, guidewires and guide catheters. Spec. 25 :25-29. "Such
introduction may be via over-the-wire (OTW) or via rapid exchange (Rx)
techniques." Id. at 25:29-30. There is no disclosure of using different
catheters for different introduction techniques. Inserting a catheter over an
introducer corresponds to Schulte's insertion of catheter 10 via thrust rod 33.
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Application 12/355,486
Therefore, it is not clear that the catheter body must be open on both
ends just because its intended use is for insertion over a guidewire. In this
regard, the Specification discloses catheters with dedicated guidewire lumen
162/163 in addition to separate lumen 160 for collecting samples. Id. at
23:11-36, Figs. 19(a}-(f). Claim 43 does not recite this feature, however.
Nor does the language of claim 43 indicate an intent to limit claim 43 to the
embodiments of Figure 19. Nor is there a disclosure in any of Appellants'
drawings of a vascular catheter being inserted over a guidewire and into a
blood vessel. See 37 C.F.R. § 1.83(a) (the drawings in a nonprovisional
application must show every feature specified in the claims).
For all the foregoing reasons, we treat this limitation as a statement of
intended use that does not require the catheter body to be open on both ends.
Appellants' many arguments that Schulte' s catheter is not a "vascular
catheter" (Reply Br. 3---6) do not address the Examiner's finding that Schulte
discloses a catheter having the structure of the claimed vascular catheter and
therefore is capable of being inserted into blood vessels. Ans. 21-22. The
Examiner finds that claim 43 is not limited to particular animal vasculature
so Schulte' s catheter is capable of being used in veins and arteries (blood
channels) of animals of different sizes. Id. at 21. Appellants do not address
or rebut these findings. See Reply Br. 3-6.
It is well-settled that an applicant may claim the elements of a device
with structural or functional limitations; however, if the applicant chooses to
use functional features, the Examiner may find that the prior art inherently
performs the claimed functions because the prior art possesses all of the
claimed structure for performing the claimed functions. See Ans. 21-22; see
also In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997).
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Application 12/355,486
The Examiner had a sound basis for this finding based on the plain
language of claim 43, which does not recite any particular blood vessel size
or any particular vascular catheter size. Schulte further shows catheter 10
inserted into a blood vessel at a neck/shoulder region of a child in Figure 3.
See Schulte, 2:5-9. Drawings may not be relied on for precise dimensions
absent a written description to support such findings or the drawings being
to scale, but drawings can be relied on for what they show. In re Aslanian,
590 F.2d 911, 914 (CCPA 1979) (holding that drawings in a utility patent
can be cited against claims of a utility patent application including features
in the drawing that are unexplained in the specification of the reference).
The Examiner therefore had a sound basis for finding that Schulte' s
catheter 10 has the structure of the claimed vascular catheter and also can be
inserted into a blood vessel. Appellants have not explained persuasively that
Schulte's catheter does not provide this function. See Schreiber, 128 F.3d at
1478 (once PTO established that the prior art structure inherently disclosed
claimed function, the burden shifted to applicant to show that the prior art
structure did not possess the claimed functional imitations inherently).
For similar reasons, Appellants' arguments that Schulte' s fins 20, 21
are not a static mixer as claimed does not rebut the Examiner's findings that
Schulte' s fins 20, 21 have structure that is almost identical to the structure of
the claimed static mixer and is capable of performing the claimed function
of mixing blood across the radial extent of a blood vessel as claimed. Ans.
22-23. The Examiner correctly finds that Appellants disclose a static mixer
as a mixer that achieves mixing by staying still. Id. at 22 (citing Spec. 14:5-
6). The Examiner correctly finds that Schulte's fins 20, 21 are deployable to
a position similar to Appellants' mixers 18 in Figure 1. Id. at 23.
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Application 12/355,486
Appellants disclose that their mixers are deployable from a stowed,
inactive state in which they are close to the outer surface of catheter 10 to
allow for insertion "into the blood vessel 2 more easily." Spec. 14:20-25.
Once catheter 10 has been inserted into a desired region of blood vessel 2,
mixers 18 are moved to a deployed, active state toward the outer regions of
blood vessel 2. Id. at 14:25-28; Fig. 1. The Examiner correctly finds that
Schulte discloses a closed, inactive state in Figures 2 and 5. See Ans. 22.
Additionally, figures 1 and 3 of Schulte disclose catheter 10 and fins 20, 21
in a deployed, active state in which they would be capable of mixing blood
across the radial extent of a blood vessel in which they would be positioned.
Appellants' conclusory attorney arguments that Schulte's fins 20, 21
are not structured to mix anything (Appeal Br. 12) does not identify what
structure of the claimed static mixer is lacking in Schulte' s fins 20, 21. Nor
do Appellants explain persuasively why Schulte' s fins 20, 21 are not capable
of mixing blood across the radial cross section of a blood vessel when
Schulte's fins 20, 21 have a structure that is very similar to the structure of
Appellants' mixers 10 shown in Appellants' Figure 1. See id. at 11-12.
Appellants' attorney argument that using Schulte's catheter in a blood
vessel would cause platelets to block holes in Schulte's catheter and clot is
not evidence and is speculative and therefore not persuasive. Reply Br. 7-8.
Essentially, Appellants disclose their mixers as extending from a catheter
across a cross section of a blood vessel to disrupt the flow of blood and thus
to cause the blood flow to move around the mixers and mix. The Examiner
relies on Schulte' s fins 20, 21 for similar structure and function. Appellants
have not persuaded us that Schulte' s deployable, flexible fins 20, 21 are not
capable of mixing blood or fluid that flows around them after they deploy.
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Application 12/355,486
Appellants' arguments that Schulte' s ports/ drainage means 14 does
not keep fluid within each chamber 24 separate from fluid in other chambers
24 (Appeal Br. 12-13) is not persuasive because it is not commensurate with
the scope of claim 43. Claim 43 requires a flexible catheter body to have "a
plurality of longitudinally spaced blood collection ports for simultaneously
capturing discrete blood samples taken along a length of the blood vessel."
Claim 43 does not recite any other structure or feature of the catheter body
that maintains the discrete blood samples as discrete samples after they are
captured by the blood collection ports. For example, claim 43 does not
recite individual chambers or collection areas that receive the discrete blood
samples that are captured by the blood collection ports.
The Examiner correctly finds that Schulte discloses ports 14/25 that
capture discrete fluid/blood samples along the length of the catheter and also
along the length of a blood vessel into which Schulte' s catheter is inserted.
Claim 43 requires no more in this regard. See Ans. 24.
Accordingly, for all the foregoing reasons, we sustain the rejection of
claim 43 as anticipated by Schulte.
Claims 1, 3, 6-8, 10-20, 28, 30-34, 36--42, 44, and 45
Unpatentable over Schulte and Gruhl
Claim 1 recites a vascular catheter with similar features as claim 43
but also including static mixer elements that extend at successive angles and
are in non-contiguous contact with a blood vessel wall to maintain an open
region between the plurality of mixing elements. Appeal Br. A-1 (Claims
App.). The Examiner relies on Gruhl to teach mixing elements with such
features. Final Act. 6-7.
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Application 12/355,486
The Examiner determines it would have been obvious to include
Gruhl' s mixing elements with Schulte' s device for the benefit of pushing the
catheter to one side of the cavity/vessel "so that the catheter may have a
sufficient contact force against the wall of the cavity/vessel and be rotated to
collect fluid/samples from an entire space within the cavity/vessel (see para
[0023] of Gruhl)." Id. at 7.
Appellants argue persuasively that adding this feature to Schulte
would render Schulte inoperable for its intended purpose of capturing fluid
because Schulte's fins 20, 21 would be unable to collect fluid if they are
collapsed against an inside surface of a blood vessel as Gruhl teaches to do.
See Appeal Br. 14--15. In this regard, Gruhl uses fins 20 on catheter 10 that
includes a window 18 for imaging an inner wall of a lumen to steer window
18 very close to the lumen wall to minimize the amount of blood between
window 18 and the lumen wall. Gruhl ,r,r 23-26, Figs. 1, 6. Any blood that
is between imaging window 18 and an inner wall of a lumen may appear
opaque to the near-IR radiation emitted from window 18 denigrating the
quality of images of the lumen wall. See id. ff 23, 25.
Unlike Gruhl, Schulte is not concerned with placing catheter 10
against an inner wall of a lumen or blood vessel. To the contrary, Schulte
teaches that catheter fins 20, 21 spring open to their annular shape to drain
fluid. Schulte, 2:39-42, Fig. 3. When fins 20, 21 are opened, their holes 25
are exposed to fluid flow to remove the fluid into chambers 24 and then to
catheter 10 for further removal to a blood vessel. Id. at 2:5-15, 2:34--54.
Thus, we are not persuaded that a skilled artisan would have been
motivated to angle Schulte' s fins as taught by Gruhl to improve Schulte' s
ability to collect fluid. See Ans. 26; Final Act. 7.
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The benefits that this configuration may provide to Gruhl have not
been shown to benefit Schulte similarly. Instead, Gruhl's teachings and fin
design would destroy or at least impair the ability of Schulte's fins 20, 21 to
open to collect fluid as Schulte desires. Therefore, the Examiner's reasoning
lacks a rational underpinning. Accordingly, we do not sustain the rejection
of claims 1, 3, 6-8, 10-20, 28, 30-34, 36-42, 44, and 45.
Claim 21 Unpatentable over Schulte, Gruhl, and Fogarty
The Examiner's reliance on Fogarty to teach a sleeve as recited in
claim 21 does not remedy the deficiencies of Schulte and Gruhl as to claim 1
from which claim 21 depends. See Appeal Br. 16. Thus, we do not sustain
the rejection of claim 21.
DECISION
We affirm the rejection of claims 14--17 as being indefinite.
We affirm the rejection of claim 43 as anticipated by Schulte.
We reverse the prior art rejections of claims 1, 3, 6-8, 10-21, 28, 30-
34, 36-42, 44, and 45.
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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