Ex Parte Grunwald et al

Patent Trial and Appeal Board

Mar 26, 2014

11431118 (P.T.A.B. Mar. 26, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________
Ex parte SORIN GRUNWALD and BRADLEY HILL
____________________

Appeal 2011-009119
Application 11/431,118
Technology Center 3700
____________________

Before: JENNIFER D. BAHR, MICHAEL L. HOELTER, and
LYNNE H. BROWNE, Administrative Patent Judges.

BAHR, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF THE CASE
Sorin Grunwald and Bradley Hill (Appellants) appeal under 35 U.S.C.
§ 134 from the Examiner’s decision rejecting claims 1-47. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART and enter a NEW GROUND OF
REJECTION.
The Claimed Subject Matter
Claim 1, reproduced below, is illustrative of the claimed
subject matter.
1. An endovascular access and guidance system,
comprising:
an elongate flexible member adapted and configured to
access the vasculature of a patient;
a sensor at a distal end of the elongate flexible member
and configured to provide in vivo non-image based ultrasound
information of the venous vasculature of the patient;
a convex divergent lens over the sensor;
a processor configured to receive and process in vivo
non-image based ultrasound information of the venous
vasculature of the patient provided by the sensor and to
determine if the sensor is moving in a direction with or a
direction against a flow within the venous vasculature of the
patient; and
an output device adapted to output a first indication if the
processor determines the sensor is moving in a direction against
venous flow and a second indication different from the first
indication if the processor determines the sensor is moving in a
direction with the venous flow.

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Evidence
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Skribiski
Frazin
Christian
Haldeman
US 4,790,831
US 5,038,789
US 5,174,295
US 6,704,590 B2
Dec. 13, 1988
Aug. 13, 1991
Dec. 29, 1992
Mar. 9, 2004
Rejections1
The following rejections are before us for review:
I. Claims 1-12, 15, 17, 18, 20-38, and 40-47 stand rejected under
35 U.S.C. § 103(a) as being unpatentable over Frazin and Christian.
II. Claims 13, 14, and 16 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Frazin, Christian, and Haldeman.
III. Claims 19 and 39 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Frazin, Christian, and Skribiski.

OPINION
Rejection I
A. Claims 1-6, 8-12, 15, 17, 18, and 20-22
In contesting this rejection, Appellants present the same arguments for
claims 1-6, 8-12, 15, 17, 18, and 20-22. We select claim 1 as representative
of this group, with the remaining claims standing or falling with claim 1.
See 37 C.F.R. § 41.37(c)(1)(vii) (2011).

1 The Examiner withdrew the provisional obviousness-type double patenting
rejection of claims 1-47 in view of the filing of a Terminal Disclaimer. Ans.
2.
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Claim 1 is directed to an endovascular access and guidance system
comprised of an elongate flexible member having a sensor at the distal end
to provide non-image based ultrasound information for use in guiding the
elongated flexible member through the venous vasculature of a patient.
Claim 1 requires that the endovascular access and guidance system have “a
processor configured to receive and process in vivo non-image based
ultrasound information . . . and to determine if the sensor is moving in a
direction with or a direction against a flow within the venous vasculature.”
Claim 1 additionally requires that the endovascular access and guidance
system have “an output device adapted to output a first indication if the
processor determines the sensor is moving in a direction against venous flow
and a second indication different from the first indication if the processor
determines the sensor is moving in a direction with the venous flow.”
Appellants argue that the Examiner fails to show how Frazin teaches
either a processor or an output device, stating that the transceiver and
monitor of Frazin are not comparable to the claimed processor and output
device. App. Br. 11. Appellants argue that the passages of Frazin cited by
the Examiner, i.e., column 2, lines 58-68 and column 3, line 41 to column 4,
line 3, are silent as to the processor called for in claim 1. Id. Appellants
also argue that the Examiner failed to give patentable weight to the
limitation “venous vasculature” and states that the entire design of the Frazin
system is directed to receiving information from the arterial vasculature. Id.
at 12. Appellants also argue that the transceiver and oscilloscope-type
monitor of Frazin additionally do not meet the processor and output
limitations because they do not make a determination of sensor movement in
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relation to venous flow direction and do not output a first or second
indication based on the determination. Id.
The Examiner finds that at column 3, lines 29-35, Frazin discloses a
processor (control apparatus) that processes signals produced by the sensor
18 (transceiver) which in turn generates ultrasound signals. Ans. 8. The
Examiner then finds that at column 3, lines 46-56, Frazin discloses that the
non-image based ultrasound information provided by the sensor 18 is
utilized by the processor to determine if the sensor 18 is moving in a
direction with the vascular flow or against the vascular flow. Id. The
Examiner also finds that the output device (the oscilloscope-type monitor) is
connected to the processor (control apparatus and, as shown by Figure 5,
outputs a first indication (upwardly-directed peaks) if the processor
determines that the sensor 18 is moving in a direction against blood flow,
and also outputs a second indication (downwardly-directed peaks 38),
different from the first indication, if the processor determines that the sensor
18 is moving in a direction with the blood flow. Id. at 8-9 (referring to
Frazin, col. 3, ll. 32-35 and 56-64). The Examiner also states that “an
indication is merely considered to be a visual representation of the direction
of the blood flow.” Id. at 9. Finally, the Examiner finds that Frazin also
teaches use of the device within the venous vasculature. Id. (referring to col.
5, ll. 6-10 of Frazin).
The Examiner’s determination that Frazin discloses the claimed
processor and output device is correct. As noted by the Examiner, at column
3, lines 29-35, Frazin plainly discloses an ultrasound control apparatus
connected to the transceiver 18 by leads 20 that processes signals produced
by the transceiver and displays those signals as a tracing on an oscilloscope-
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type monitor. As also noted by the Examiner, at column 3, lines 44-56, and
Figure 5, Frazin also clearly describes and depicts a first indication in
upwardly-directed peaks 36 on the oscilloscope-type monitor (Figure 5B),
which represents blood flow towards the transceiver 18 and a second
indication in downwardly-directed peaks 38 on the oscilloscope-type
monitor (Figure 5C), which represents blood flow away from the transceiver
18. It is further apparent from Figure 5 of Frazin that the first indication and
the second indication are different. We additionally agree with the
Examiner’s statement that “an indication is merely considered to be a visual
representation of the direction of the blood flow.” Accordingly, we consider
the tracings displayed in Figures 5B and 5C of Frazin to be first and second
indications. Furthermore, as noted by the Examiner, at column 5, lines 6-10,
Frazin clearly discloses use of the device within venous vasculature.
For the above reasons, Appellants’ arguments do not apprise us of
error in the Examiner’s rejection of claim 1. We thus sustain the rejection of
claim 1 under 35 U.S.C. § 103(a) as unpatentable over Frazin and Christian.
We also sustain the rejection of claims 2-6, 8-12, 15, 17, 18, and 20-22,
which fall with claim 1, as unpatentable over Frazin and Christian.

B. Claims 23-28, 30-32, and 34-38
In contesting this rejection, Appellants present the same arguments for
claims 23-28, 30-32, and 34-38. We select claim 23 as representative of this
group, with the remaining claims standing or falling with claim 23. See 37
C.F.R. § 41.37(c)(1)(vii) (2011).
Claim 23 is directed to an endovascular access and guidance system
comprised of an elongate flexible member having a sensor at the distal end
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to provide non-image based ultrasound information for use in guiding the
elongated flexible member through the venous vasculature of a patient.
Claim 23 requires that the endovascular access and guidance system have “a
processor configured to receive and process in vivo non-image based
ultrasound information . . . and to determine if the sensor is moving in a
direction towards a heart . . . or in a direction away from the heart.” Claim
23 additionally requires that the endovascular access and guidance system
have “an output device adapted to output a first indication if the processor
determines the sensor is moving in a direction towards the heart and a
second indication different from the first indication if the processor
determines the sensor is moving away from the heart.”
Appellants argue that the Examiner fails to articulate how Frazin
discloses the processor and the output device. App. Br. 13. Appellants
argue that the Examiner’s comments all relate to the language of
independent claim 1 and do not make any reference to the limitations of
independent claim 23. Id.
The Examiner finds that in the abstract and at column 3, lines 57-66,
Frazin discloses “generating from signals produced by the [transceiver 18] a
continuous indication of the direction of blood flow relative to the catheter
tip to advance the catheter towards the heart . . . and steering the catheter in
response to the first and second indication if the catheter is not being
advanced towards the heart.” Ans. 10. The Examiner also finds that the
output device (the oscilloscope-type monitor) is connected to the processor
(control apparatus) and, as shown by Figure 5, outputs a first indication
(upwardly-directed peaks) if the processor determines that the sensor 18 is
moving in a direction against blood flow, and also outputs a second
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indication (downwardly-directed peaks 38), different from the first
indication, if the processor determines that the sensor 18 is moving in a
direction with the blood flow. Ans. 10 (referring to col. 3, ll. 32-35 and 56-
64 of Frazin).
We note that Appellants have commented regarding the purported
inadequacy of the Examiner’s rejection of claim 23. However, those
statements do not point out any errors in the Examiner’s findings or
reasoning nor do they explain with any specificity why the Examiner’s
findings and reasoning is insufficient to establish that the subject matter of
claim 23 would not have been obvious, and thus do not constitute separate
arguments for the patentability of claims 23-32 and 34-38. See In re Lovin,
652 F.3d 1349, 1357 (Fed. Cir. 2011) (holding that the Board had reasonable
interpreted 37 C.F.R § 41.37(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 reasons stated above with respect to claim 1, Appellants’
arguments do not apprise us of error in the Examiner’s rejection of claim 23.
We thus sustain the rejection of claim 23 under 35 U.S.C. § 103(a) as
unpatentable over Frazin and Christian. We also sustain the rejection of
claims 24-28, 30-32, and 34-38, which fall with claim 23, as unpatentable
over Frazin and Christian.
C. Claims 7 and 29
Claims 7 and 29 recite “a sensor attachment mechanism” and do not
use the term “means.” Typically, when a claim recitation does not include
the term “means,” the recitation is presumed not to be in means-plus-
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function format. However, in this case, the claim term “mechanism” is a
generic term that fails to recite sufficiently definite structure. Moreover, the
remainder of claims 7 and 29 recite functional language without sufficient
structure for performing the recited functions. Because the term
“mechanism” and the functional language that follows are “essentially . . .
devoid of anything that can be construed as structure,” the presumption is
overcome. See Flo Healthcare Solutions, LLC v. Kappos, 697 F.3d 1367,
1374 (Fed. Cir. 2012). We thus conclude that claims 7 and 29 are drafted in
means-plus-function format.
The sixth paragraph of 35 U.S.C. § 112 states:
An element in a claim for a combination may be expressed as a
means or step for performing a specified function without the
recital of structure, material, or acts in support thereof, and such
claim shall be construed to cover the corresponding structure,
material, or acts described in the specification and equivalents
thereof.
Therefore, in accordance with the sixth paragraph of 35 U.S.C. § 112,
the claimed “sensor attachment mechanism” shall be construed to cover the
corresponding structure described in Appellants' Specification and
equivalents thereof. We note that the Specification at paragraph [00196]
only nominally discloses a “sensor attachment mechanism adapted to
removably detach the sensor from the guided endovascular access device,”
without providing any disclosure of the structure of such a mechanism. In
order to satisfy the requirement of the second paragraph of 35 U.S.C. § 112
to “particularly point out and distinctly claim,” the Specification must
disclose “[s]ufficient structure [to] ‘permit one of ordinary skill in the art to
know and understand what structure corresponds to the means limitation’ so
that he may ‘perceive the bounds of the invention.’” In re Aoyama, 656 F.3d
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1293, 1298 (Fed. Cir. 2011) (quoting Finisar Corp. v. DirecTV Grp., Inc.,
523 F.3d 1323, 1340-41 (Fed. Cir. 2008). In failing to disclose any structure
for a “sensor attachment mechanism . . . ,” Appellants have made it
impossible for one of ordinary skill in the art to ascertain the metes and
bounds of that claim limitation (the corresponding structure described in the
Specification and its equivalents) and, thus, in effect have failed to
particularly point out and distinctly claim the invention.
For the reasons discussed above, claims 7 and 29 are indefinite. Thus,
pursuant to 37 C.F.R. § 41.50(b) (2011), we enter a new ground of rejection
of claims 7 and 29 under 35 U.S.C. § 112, second paragraph, as being
indefinite.
Having determined that claims 7 and 29 are indefinite, for the reasons
discussed above, we cannot sustain the rejection of these claims under
35 U.S.C. § 103(a), because the rejection necessarily is based on speculative
assumption as to the scope of the claims. See In re Steele, 305 F.2d 859,
862-63 (CCPA 1962) (holding that the Board erred in affirming a rejection
of indefinite claims under 35 U.S.C. § 103(a), because the rejection was
based on speculative assumptions as to the meaning of the claims).

D. Claim 33
Appellants argue that the Examiner has not shown that Frazin
discloses a third indication that is different from the first and second
indications. App. Br. 15. Appellants argue that, at most, Frazin teaches a
tracing on an oscilloscope monitor of ultrasound information and, even if the
tracing were considered to be an indication, the tracing cannot constitute a
first indication, second indication, and third indication. Id. at 15-16.
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Appellants argue that the passage in Frazin cited by the Examiner relates to
real-time changes in the signal from the transceiver. Id. at 16.
The Examiner finds that the third indication is where the processor
outputs information indicating zero blood flow, shown as a flat line in Figure
5A. Ans. 6, 11 (referring also to Frazin, col. 3, ll. 42-56). The Examiner
also finds that “an indication is merely a visual representation of the
direction of blood flow.” Id. at 11.
We find that the Examiner’s determination that Frazin discloses a
third indication different from the first and second indications is correct.
Frazin clearly discloses a third indication, as shown in Figure 5A by the flat
line portions, and this indication is different than the first indication
(upwardly-directed peaks) and the second indication (downwardly-directed
peaks). Furthermore, as called for in the claims, Frazin discloses that these
three indications depict the direction of the blood flow and are utilized
specifically in guiding the elongated device through the vasculature. See
Frazin, col. 3, ll. 42-56. We further agree with the Examiner’s statement
that “an indication is merely a visual representation of the direction of blood
flow.”
For the above reasons, Appellants’ arguments do not apprise us of
error in the Examiner’s rejection of claim 33. We thus sustain the rejection
of claim 33 under 35 U.S.C. § 103(a) as unpatentable over Frazin and
Christian.
E. Claims 40-47
Appellants group claims 40-47 together in contesting this rejection.
App. Br. 16. Thus, we select claim 40 as representative of this group, with
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the remaining claims standing or falling with claim 40. See 37 C.F.R.
§ 41.37(c)(1)(vii) (2011).
Appellants argue that the Examiner fails to articulate how Frazin and
Christian disclose each and every limitation of the claims and assert that
there is no requirement under the patent laws to disclose an advantage,
particular purpose or solution to a stated problem. App. Br. 16. Appellants
also argue that Frazin is silent as to any green light indication related to a
movement of a sensor in the venous vasculature and, at most, discloses a
tracing on an oscilloscope that does not include a green light. Id. at 17.
The Examiner finds that Appellants have “not disclosed that a colored
light, as well as an arrow and circular shape provides an advantage, is used
for a particular purpose, or solves a stated problem.” Ans. 7. The Examiner
then finds that one of ordinary skill in the art “would have expected
[Appellants’] invention to perform equally well with an upwardly-directed
peak first indicator, a downwardly-directed peak second indicator and a zero
peak third indicator.” Id. The Examiner further states that “an indication is
merely a visual representation” and that “[t]he upwardly-directed peaks,
downwardly-directed peaks and flat line (fig.5a-c) of Frazin provide the
same function of providing the user with a direction of blood flow, and are
all different types of visual representations and are therefore indicators.” Id.
at 11.
The Examiner determines that the particular indicators set forth in
claims 40-47 do not patentably distinguish the claimed invention over
Frazin. We agree with the Examiner. The particular content of the indicator
is not functionally related to the substrate (in this case the “output device”)
and thus will not distinguish the claimed invention from the prior art in
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terms of patentability. “[W]here the printed matter is not functionally
related to the substrate, the printed matter will not distinguish the invention
from the prior art in terms of patentability.” See In re Ngai, 367 F.3d 1336,
1339 (Fed. Cir. 2004)) (quoting In re Gulack, 703 F.2d 1381, 1385 (Fed.
Cir. 1983)). As pointed out by the Examiner, the particular content of the
indication does not alter its function or performance. The substance of the
indicator cannot impart patentability, as it is “‘useful and intelligible only to
the human mind.’” See In re Lowry, 32 F.3d 1579, 1583 (Fed. Cir. 1994)
(quoting In re Bernhart, 417 F.2d 1395, 1399 (CCPA 1969)).
For the reasons stated above, Appellants’ arguments do not apprise us
of error in the Examiner’s rejection of claim 40. We thus sustain the
rejection of claim 40 and of claims 41-47, which fall with claim 40, under
35 U.S.C. § 103(a) as unpatentable over Frazin and Christian.

Rejection II
In contesting the rejection of claims 13, 14, and 16 under 35 U.S.C.
§ 103(a) as unpatentable over Frazin, Christian, and Haldeman, Appellants
merely rely on the arguments asserted against the rejection of claim 1, from
which claims 13, 14, and 16 depend. See App. Br. 17. This argument is not
convincing, for the reasons discussed above in regard to claim 1. We thus
also sustain the rejection of claims 13, 14, and 16.

Rejection III
In contesting the rejection of claims 19 and 39 under 35 U.S.C.
§ 103(a) as unpatentable over Frazin, Christian, and Skribiski, Appellants
merely rely on the arguments asserted against the rejection of claims 1 and
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23, from which claims 19 and 39 depend, respectively. See App. Br. 17-18.
This argument is not convincing, for the reasons discussed above in regard
to claims 1 and 23. We thus also sustain the rejection of claims 19 and 39.

DECISION
The Examiner’s decision rejecting claims 1-6, 8-28, and 30-47 under
35 U.S.C. § 103(a) is affirmed. The Examiner’s decision rejecting claims 7
and 29 under 35 U.S.C. § 103(a) is reversed. We enter a new ground of
rejection of claims 7 and 29 under 35 U.S.C. § 112, second paragraph.

FINALITY OF DECISION
Regarding the affirmed rejection(s), 37 C.F.R. § 41.52(a)(1) provides
“Appellant[s] may file a single request for rehearing within two months from
the date of the original decision of the Board.”
In addition to affirming the Examiner's rejection(s) of one or more
claims, this decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.”
37 C.F.R. § 41.50(b) also provides that Appellants, 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:
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(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 proceeding will be remanded to
the examiner. . . .

(2) Request rehearing. Request that the proceeding be reheard
under § 41.52 by the Board upon the same record. . . .
Should Appellants elect to prosecute further before the Examiner
pursuant to 37 C.F.R. § 41.50(b)(1), in order to preserve the right to seek
review under 35 U.S.C. § 141 or 145 with respect to the affirmed rejection,
the effective date of the affirmance is deferred until conclusion of the
prosecution before the Examiner unless, as a mere incident to the limited
prosecution, the affirmed rejection is overcome.
If Appellants elect prosecution before the Examiner and this does not
result in allowance of the application, abandonment or a second appeal, this
case should be returned to the Patent Trial and Appeal Board for final action
on the affirmed rejection, including any timely request for rehearing thereof.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED-IN-PART; 37 C.F.R. § 41.50(b)

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