Ex Parte Mittermeyer et al

Patent Trial and Appeal Board

Jan 24, 2018

14164667 (P.T.A.B. Jan. 24, 2018)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/164,667 01/27/2014 Stephan Mittermeyer 013658/000107 4738
108549 7590 01/26/2018 EXAMINER
Tnoker F,11i<; T T P
Brainlab AG CARPENTER, WILLIAM R
950 Main Avenue
Suite 1100 ART UNIT PAPER NUMBER
Cleveland, Uli 44114-/714 3763
NOTIFICATION DATE DELIVERY MODE
01/26/2018 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):
patents @ tuckerellis. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEPHAN MITTERMEYER and
ANDREAS HARTLEP
Appeal 2017-000450
Application 14/164,667
Technology Center 3700
Before LYNNE H. BROWNE, JILL D. HILL, and
JEFFREY A. STEPHENS, Administrative Patent Judges.
BROWNE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Stephan Mittermeyer and Andreas Hartlep (Appellants) appeal under
35 U.S.C. § 134 from the rejection of claims 1-12. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.
Appeal 2017-000450
Application 14/164,667
CLAIMED SUBJECT MATTER
Sole independent claim 1, reproduced below, is illustrative of the
claimed subject matter:
1. A method for administering a substance into a patient’s
tissue, comprising:
providing a catheter having an elongated catheter body
that surrounds a lumen, said catheter body including a plurality
of pressure sensors in the material of the catheter body, detecting
a pressure distribution over a portion of the catheter via the
plurality of pressure sensors, and determining the presence and/
or extent of a backflow along the catheter body based on the
detected pressure distribution.
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Wallace US 4,576,181 Mar. 18, 1986
Olsen US 5,695,473 Dec. 9, 1997
Shlomo US 6,272,371 B1 Aug. 7, 2001
Zdeblick US 2004/0193021 A1 Sept. 30, 2004
Ofek US 2007/0282211 A1 Dec. 6, 2007
Hartlep US 7,740,606 B2 June 22, 2010
Pile-Spellman WO 2007/078463 A1 July 12, 2007
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Application 14/164,667
REJECTIONS
I. Claim 3 stands rejected under 35 U.S.C. § 112(a) as failing to
comply with the written description requirement.1
II. Claim 3 stands rejected under 35 U.S.C. § 112(b) as indefinite.
III. Claims 1, 4, 6, 7, 11, and 12 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Pile-Spellman and Zdeblick.
IV. Claims 2^1 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Pile-Spellman, Zdeblick, and Hartlep.
V. Claim 5 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Pile-Spellman, Zdeblick, and Ofek.
VI. Claim 8 is stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Pile-Spellman, Zdeblick, Shlomo, and Olsen.
VII. Claims 9 and 10 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Pile-Spellman, Zdeblick, and Wallace.
1 The Examiner also objects to the Specification for the same reasons that
claim 3 stands rejected under 35 U.S.C. § 112(a). Final Act. 2. Ordinarily,
an objection is reviewable by petition under 37 C.F.R. § 1.181 and a
rejection is appealable to the Patent Trial and Appeal Board. When the issue
of new matter presented is the subject of both an objection and a rejection,
the issue is appealable. See MPEP § 608.04(c) (providing that “where the
alleged new matter is introduced into or affects the claims, thus necessitating
their rejection on this ground, the question becomes an appealable one, and
should not be considered on petition even though that new matter has been
introduced into the specification also”). To the extent that the objection to
the Specification in the Final Rejection turns on the same issues as the
rejection under 35 U.S.C. § 112, first paragraph, our decision with respect to
the rejection is dispositive as to the corresponding objection.
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Application 14/164,667
DISCUSSION
Rejection of Claim 3 as Failing to Comply
With the Written Description Requirement
The Examiner determines that claim 3 fails to comply with the written
description requirement because, “the originally filed detailed disclosure
fails to provide support for [comparing] pressure distribution with ‘real-time
simulations’ of the dispersion.” Final Act. 3. In support of this
determination, the Examiner notes that paragraphs 16 and 30 of the
Specification “provide support for using (not comparing) [detected pressure
distributions] to develop ‘new simulations’ or adapt ‘existing simulations’,
but makes no mention of ‘real-time’ simulations.” Id. The Examiner
explains “that ‘use’ of data to ‘adapt’ is not the same as ‘comparing’ results
from an ‘already existing simulation’, particularly with no mention of a
‘real-time’ simulation in the specification.” Id.
Appellants contend that “the application as originally filed provides
support for a simulation related to the dispersion of a substance.” Appeal
Br. 3. In support of this contention, Appellants direct our attention to
originally filed claim 19 of patent U.S. Patent Application No. 12/048,647
(“Parent Application”) which requires “using the detected pressure
distribution in a real-time simulation of the dispersion of a substance from
the catheter” as providing support for the claim language at issue. See id.
However, Appellants do not explain how using the detected pressure
distribution in the manner claimed in claim 19 is the same as comparing
such data to data obtained from a real-time simulation or how such use
shows that Appellants had possession of the claimed comparison at the time
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Application 14/164,667
the instant Application (or the Parent Application) was filed. Thus,
Appellants do not apprise us of error.
Appellants further direct our attention to “the last paragraph on page 2
and the first paragraph on page 3 of the subject application” which
“describe[s] that a physician can rely on real-time feedback from sensors and
choose to adapt an administration plan to accommodate the actual position at
which the catheter is administering the substance, and the administration
plan may be simulated.” Appeal Br. 3—4. Appellants argue that “[sjuch an
adaptation would result from a comparison of the detected pressure to the
simulation.” Id. at 4.
The Specification states:
When a pressure distribution over a portion or length of a
catheter is detected, it is possible to determine a deformation or
change in shape of the catheter. For example, if the catheter is
bent or compressed towards one side, a higher pressure in the
catheter body material can be measured on an inner side of the
catheter (the concave side), and a lower pressure in the catheter
body material can be measured on an outer side of the catheter
(the convex side). Using information obtained from a catheter
equipped with a pressure sensor array, it is possible to ascertain
directional information related to the bending of the catheter.
From this directional information, the user can obtain real-time
feedback related to any deviation from the catheter’s planned
trajectory. Relying on this feedback, the physician may
cho[o]se to remove and replace the catheter or adapt an
administration plan to accommodate the actual position at
which the catheter is administering the substance. The
administration plan may be simulated again (with computer
assistance) using a new administration point or region, and/ or a
new administration plan may be developed or simulated with
adaptations to the original plan. Such adaptations can be
changes to the substance flow rate or changes to the catheter
position, such as repositioning the catheter slightly forward or
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Application 14/164,667
slightly retracted to ensure that the substance is dispersed in the
desired manner.
Spec. 2-3. Thus, in accordance with the Specification real-time feedback
pertains to deviation from the catheter’s planned trajectory. Id. This real­
time feedback is in the form of directional information generated by the
pressure sensor array. Id. Further, one skilled in the art would understand
that a determination that there has been deviation from the catheter’s
planned trajectory would necessarily require a comparison between the
catheter’s planned trajectory and its actual trajectory. However, the claim
language at issue requires comparison of the detected pressure distribution
with a pressure distribution resulting from real-time simulation of the
dispersion of the substance from the catheter. See Appeal Br. 12 (Claims
App.). It is not readily apparent that directional information derived from
the pressure sensor array is the same as the claimed detected pressure
distribution. Moreover, it is not clear from the Specification what
constitutes a real-time simulation as claimed. One possible interpretation is
that the action plan is a real-time simulation. However, it is also not readily
apparent that the administration plan described is generated or modified in
real-time. Rather, as quoted supra, the Specification describes adapting an
existing administration plan or generating a new plan via simulation.
Accordingly, this portion of the Specification does not support Appellants’
position, and does not apprise us of error.
For these reasons, we sustain the Examiner’s decision rejecting claim
3 as failing to comply with the written description requirement.
Rejection of Claim 3 as Indefinite
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The Examiner determines that claim 3 is indefinite because the
phrase “comparing the detected pressure distribution to a pressure
distribution resulting from a real-time simulation of the dispersion” as set
forth in claim 3 is not “found in Applicant’s originally filed specification.”
Final Act. 4. However, the Examiner fails to explain why such a lack of
antecedent basis is sufficient to render this phrase indefinite. The Examiner
further determines that the Specification “lacks suitable disclosure for
determining the confines of ‘comparing’ and the ‘real-time simulation’.” Id.
However, the Examiner does not demonstrate that these claims terms are
used other than in accordance with their ordinary and customary meanings.
Thus, the Examiner fails to show that this claim terminology is indefinite.
In addition, the Examiner determines that claim 3 is indefinite for
essentially the same reasons it lacks written descriptive support. See Final
Act. 4-5. However, the fact that a claim is not supported by the
Specification as originally filed is not grounds for determining that the claim
is indefinite.
As the Examiner fails to adequately explain why claim 3 fails to
particularly point out and distinctly claim the subject matter which the
inventors regard as their invention, the Examiner fails to set forth a prima
facie case of indefmiteness. For these reasons, we do not sustain the
Examiner’s decision rejecting claim 3 as indefinite.
Rejection of Claims 1, 4, 6, 7, 11, and 12 as Unpatentable
Over Pile-Spellman and Zdeblick
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Claims 1,4,6, 7, and 11
Appellants argue claims 1, 4, 6, 7, and 11 together. Appeal Br. 4-8.
We select claim 1 as the representative claim, and claims 4, 6, 7, and 11
stand or fall with claim 1. See 37 C.F.R. § 41.37(c)(l)(iv).
The Examiner finds that Pile-Spellman and Zdeblick disclose or
suggest each and every limitation of claim 1. In particular, the Examiner
finds that Pile-Spellman discloses a plurality of pressure sensors lOa-lOd in
a system “configured to determine the presence and/or extent of fluid
backflow along an exterior of the wall using the parameters detected by the
sensors.” Final Act 6 (citations omitted). The Examiner determines that
Pile-Spellman fails to disclose “the pressure sensors [that] are ‘in the
material of the catheter body’.” Id. The Examiner further finds that in a
similar catheter 100 having a plurality of pressure sensors 106a-106e,
“Zdeblick illustrates that these pressure sensors may be deposited on the
surface of the catheter (106a and 106b) in the interior lumen of the catheter
(106d and 106e) or embedded within the catheter wall material itself
(106c).” Id. at 6-7. The Examiner notes that “Zdeblick discusses that the
location and position of the pressure sensors may be provided in any suitable
configuration (Par. 47).” Id. at 7. Based on these findings, the Examiner
reasons that it would have been obvious
to provide the pressure sensors of the invention of Pile-
Spellman to be embedded within the material forming the
catheter wall such that the pressure sensors will be configured
to measure a pressure profile IN THE MATERIAL, as disclosed
by Zdeblick, since Zdeblick explicitly discloses that such a
configuration is a suitable alternative to those positions used by
Pile-Spellman.
Id.
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Appellants argue that “Zdeblick nowhere discloses determining a
length of backflow along the catheter body.” Appeal Br. 6, 7; see also Reply
Br. 1, 2. Although Appellants are correct, this is not indicative of error, as
the rejection relies upon Pile-Spellman, not Zdeblick to meet the limitations
pertaining to determining backflow. See Final Act. 6.
Appellants further argue that “there is no teaching in either Pile-
Spellman or Zdeblick that a sensor in the material of a catheter body detects
a pressure distribution over a portion of the catheter body such that the
presence and/ or extent of backflow along the catheter body can be
determined.” Appeal Br. 6; see also Reply Br. 2-3. Again, Appellants are
correct, but this is not indicative of error. As discussed supra, the rejection
relies upon the combined teachings of Pile-Spellman and Zdeblick to meet
this limitation. Specifically, the rejection relies upon Pile-Spellman’s
disclosure of the use of pressure sensors to detect backflow and Zdeblick’s
teaching of the equivalence of pressure sensors placed on and in catheter
body material. See Final Act. 6-7. Appellants do not address the combined
teachings of Pile-Spellman and Zdeblick. Rather, Appellants attack the
references separately. Nonobviousness cannot be established by attacking
the references individually when the rejection is predicated upon a
combination of prior art disclosures. See In re Merck & Co., 800 F.2d 1091,
1097 (Fed. Cir. 1986). Moreover, Appellants do not explain why Pile-
Spellman’s pressure sensors, like Zdeblick’s pressure sensors, would not
work equally well if located in the material instead of on it. Accordingly,
Appellants do not apprise us of error.
In addition, Appellants argue that the Examiner’s reliance on In re
Japikse (181 F. 2d 1019 (CCPA 1950)) is misplaced. See Appeal Br. 7; see
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Application 14/164,667
also Reply Br. 4. However, we need not consider the relevance, if any, of
Japikse to the facts of this case, because the rejection as articulated by the
Examiner sets forth articulated reasoning in support of the proposed
modification separate from any reliance on Japikse. As Appellants have not
apprised us of error in this reason, as discussed supra, if the Examiner’s
reliance on Japikse is in error, we hold such error to be harmless error.
Appellants conclude their arguments in the Appeal Brief by noting
that:
there has been no showing that the pressure profiles outside the
catheter wall in Pile-Spellman will “necessarily” be distributed
to sensors in the wall to allow backflow along the catheter body
to be determined because no analysis of the sensitivity of the
sensors, thickness of the catheter wall relative to sensor
placement, etc. has been made by the Examiner.
Appeal Br. 7-8. Appellants’ argument demonstrates a misapprehension of
what it means to combine the teachings of the prior art references. The
relevant inquiry is whether the claimed subject matter would have been
obvious to those of ordinary skill in the art in light of the combined
teachings of those references. See In re Keller, 642 F.2d 413, 425 (CCPA
1981). “Combining the teachings of references does not involve an ability
to combine their specific structures.” In re Nievelt, 482 F.2d 965, 968
(CCPA 1973). Moreover, Appellants’ argument presumes that one skilled in
the art can only follow explicit guidance in the references. However, “a
person of ordinary skill is also a person of ordinary creativity, not an
automaton.” KSRInt’l. Co. v. Teleflex, Inc., 550 U.S. 398, 421 (2007).
Absent evidence to the contrary, in this case where it is shown by Zdeblick’s
teachings that pressure sensors in the catheter wall material perform equally
well as pressure sensors located on the material, one skilled in the art would
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Application 14/164,667
be able to apply those teachings to Pile-Spellman’s pressure sensors such
that they would continue performing their task of detecting backflow once
incorporated in Pile-Spellman’s catheter material. As noted supra,
Appellants provide no evidence or persuasive argument that Pile-Spellman’s
pressure sensors would not be capable of such modification. Thus,
Appellants do not apprise of us error.
For these reasons, we sustain the Examiner’s decision rejecting claim
1, and claims 4, 6, 7, and 11, which fall therewith as unpatentable over Pile-
Spellman and Zdeblick.
Claim 12
Regarding claim 12, Appellants similarly argue that “Pile-Spellman
does not disclose sensors in the wall of the catheter body, and Zdeblick does
not disclose that its sensors within the carrier body are capable of detecting
parameters to allow backflow to be determined.” Appeal Br. 8. Appellants’
argument is not persuasive for the reasons discussed supra.
Accordingly, we do not sustain the Examiner’s decision rejecting
claim 12 as unpatentable over Pile-Spellman and Zdeblick.
Rejection of Claims 2—4 as unpatentable over
Pile-Spellman, Zdeblick, and Hartlep
Claims 2 and 4
Regarding claims 2 and 4, Appellants contend that “[t]he rejections
advanced by the Examiner are improper and should be reversed.” Appeal
Br. 8. Appellants provide no further argument in support of this contention.
Appellants’ bald allegation does not apprise us of error.
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We sustain the Examiner’s decision rejecting claims 2 and 4 as
unpatentable over Pile-Spellman, Zdeblick, and Hartlep.
Claim 3
The Examiner finds that “Hartlep discloses [a] method [that] can
include providing real-time simulation analysis comparing the actual
infusion with the infusion plan/simulation (225).” Final Act. 8. Noting that
“Hartlep discloses that ‘[a]t step 225, a comparison can be made between the
infusion actually performed and the infusion plan and, in the event of
deviations, the corresponding parameters can be modified at step 230,
preferably by utilizing known active mechanisms,’” Appellants contend that
“Hartlep compares infusion actually performed to an infusion plan.” Appeal
Br. 9 (citing Hartlep 7:67-8:4). Based on this contention, Appellants argue
that “[t]he Examiner has not provided any support for the conclusion that
Hartlep discloses comparing a detected pressure distribution to a pressure
distribution resulting from a real-time simulation.” Id.
Appellants’ argument is not responsive to the rejection as articulated
by the Examiner. As noted by the Examiner and as we discuss supra,
nonobviousness cannot be established by attacking the references separately.
Ans. 13-14. Furthermore, as the Examiner explains, the rejection relies upon
Pile-Spellman for monitoring actual dispersion and Hartlep for its teachings
of computer modeling to simulate dispersion and comparison of such
simulation to real-word data. See Ans. 13-14. Appellants do not explain
why Hartlep does not suggest comparison of real-world to simulated data.
Thus, Appellants do not apprise us of error.
For these reasons, we sustain the Examiner’s decision rejecting claim
3 as unpatentable over Pile-Spellman, Zdeblick, and Hartlep.
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Rejection of Claim 5 as Unpatentable Over
Pile-Spellman, Zdeblick, and Ofek
The Examiner determines that Pile-Spellman fails to disclose sensors
that are “circumferentially disposed about the catheter” in the same cross-
sectional plane. Final Act. 9. The Examiner finds that “Ofek discloses a
catheter having pressure sensors (120') which are arranged in a cross-
sectional plane of the catheter and are distributed circumferentially on or in
the catheter body (Fig. 3B, 4B, or 4C).” Id. Based on these findings, the
Examiner reasons that it would have been obvious
to provide a plurality of pressure sensors circumferentially
within a plane in the system of Pile-Spellman, as disclosed by
Ofek, in contrast to the single circumferential sensor disposed
within a plane, in order to increase the sensitivity of the sensors
in measuring annular pressure profiles by preventing distortion
of the sensing elements.
Id.
Appellants argue that the Examiner’s reasoning is conclusory and
lacks support in Ofek. See Appeal Br. 10. Responding to this argument, the
Examiner explains that both Pile-Spellman and Zdeblick teach that a
plurality of circumferentially disposed sensors is more sensitive than a single
sensor. See Am,. 14-15. The Examiner further explains that “[t]he Ofek
reference merely provides one specific implementation for such
circumferentially disposed sensors.” Id. at 15.
Appellants do not contest the Examiner’s findings or further
explanation. See, generally, Reply Brief. Furthermore, the Examiner’s
findings are supported by Pile-Spellman, Zdeblick, and Ofek.
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In addition, Appellants contend that the rejection uses Appellants’
disclosure as a roadmap for piecing together the references. Appeal Br. 10.
In other words, Appellants allege that the rejection relies upon improper
hindsight. Appellants do not identify any knowledge relied upon by the
Examiner that was gleaned only from Appellants’ disclosure and that was
not otherwise within the level of ordinary skill at the time of the invention,
thereby obviating Appellants’ assertion of hindsight. See In re McLaughlin,
443 F.2d 1392 (CCPA 1971).
Then, Appellants argue that
a review of the figures of Ofek show that the sensors are larger
than the tip and thus could not be in the material of the tip, and
that the wires connecting the sensors take up a large amount of
space in the tip which would interfere with use of the catheter
of Pile-Spellman.
Appeal Br. 10. In other words, Appellants argue that Ofek’s sensors cannot
be bodily incorporated into Pile-Spellman’s catheter.
This argument is not responsive to the rejection as articulated by the
Examiner, which does not propose the use of Ofek’s sensor’s in Pile-
Spellman’s catheter. Moreover, “it is not necessary that the inventions of
the references be physically combinable to render obvious the invention
under review.” In re Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983) (citation
omitted). The relevant inquiry is whether the claimed subject matter would
have been obvious to those of ordinary skill in the art in light of the
combined teachings of those references. See In re Keller, 642 F.2d 413, 425
(CCPA 1981). “Combining the teachings of references does not involve an
ability to combine their specific structures.” In re Nievelt, 482 F.2d 965, 968
(CCPA 1973).
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For these reasons, we sustain the Examiner’s decision rejecting claim
5 as unpatentable over Pile-Spellman, Zdeblick, and Ofek.
Rejection of Claim 8 as Unpatentable Over
Pile-Spellman, Zdeblick, Shlomo, and Olsen
Appellants argue that the rejection of claim 8 should be reversed
“[f]or at least the same reasons discussed above regarding claim 1.” Appeal
Br. 10. As Appellants’ arguments pertaining to claim 1 do not apprise us of
error for the reasons discussed supra, Appellants’ argument is unconvincing.
We sustain the Examiner’s decision rejecting claim 8 as unpatentable
over Pile-Spellman, Zdeblick, Shlomo, and Olsen.
Rejection of Claims 9 and 10 as Unpatentable Over
Pile-Spellman, Zdeblick, and Wallace
Appellants argue that the rejection of claims 9 and 10 should be
reversed “[f]or at least the same reasons discussed above regarding claim 1.”
Appeal Br. 11. As Appellants’ arguments pertaining to claim 1 do not
apprise us of error for the reasons discussed supra, Appellants’ argument is
unconvincing.
We sustain the Examiner’s decision rejecting claims 9 and 10 as
unpatentable over Pile-Spellman, Zdeblick, and Wallace.
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DECISION
With the exception of the Examiner’s rejection of claim 3 under 35
U.S.C. § 112(b), which is REVERSED, the Examiner’s rejections of claims
1-12 are 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). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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