Ex Parte Zhang et al

Patent Trial and Appeal Board

Oct 4, 2016

12259352 (P.T.A.B. Oct. 4, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/259,352 10/28/2008
28524 7590 10/06/2016
SIEMENS CORPORATION
INTELLECTUAL PROPERTY DEPARTMENT
3501 Quadrangle Blvd Ste 230
Orlando, FL 32817
FIRST NAMED INVENTOR
Hongxuan Zhang
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.
2007P27099 USOl 1842
EXAMINER
HENSON, MISCHITA L
ART UNIT PAPER NUMBER
2865
NOTIFICATION DATE DELIVERY MODE
10/06/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
ipdadmin.us@siemens.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HONGXUAN ZHANG and RYAN PATRICK MARRY1
Appeal2015-003388
Application 12/259,352
Technology Center 2800
Before JAMES C. HOUSEL, CHRISTOPHER L. OGDEN, and
LILAN REN, Administrative Patent Judges.
OGDEN, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's final
decision2 rejecting claims 1-14 in the above-identified application. We have
jurisdiction pursuant to 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 According to Appellants, the real party in interest is Siemens Medical
Solutions USA Inc. Appeal Brief 2, Nov. 26, 2012 [hereinafter Br.].
2 Office Action, Oct. 4, 2012 [hereinafter Final Action]; Examiner's Answer,
Mar. 7, 2014 [hereinafter Answer].
Appeal2015-003388
Application 12/259,352
BACKGROUND
Appellants' invention relates to "a system for determining electrical
status of patient attached leads in medical patient monitoring by
automatically successively determining whether a lead impedance value is
within a particular impedance value range." Spec. 1. Independent claim 1 is
representative:
1. A system for determining electrical status of patient
attached leads in medical patient monitoring, comprising:
a repository of data indicating a plurality of
predetermined impedance value ranges and corresponding
associated lead status information of at least one electrical lead
attached to a patient for conducting electrical signals for use in
patient monitoring;
an impedance measurement processor using a
substantially passive impedance bridge network operating
exclusive of constant current injection for automatically
successively determining whether an impedance value of a
particular patient attached lead of a plurality of electrical leads
attached to patient skin is within a particular impedance value
range of a plurality of predetermined impedance value ranges
and capturing a cardiac impedance distribution together with
electrophysiological vectors on different leads for together
mapping to localize cardiac tissue conditions and indicating a
potential patient medical condition supporting diagnosis, said
impedance measurement processor predicts a lead signal
voltage conveyed on said particular patient attached lead using
remaining acceptable lead signals in response to a
determination said particular impedance value range of said
particular patient attached lead indicates an unacceptable
connection and comprises a failed lead; and
an output processor for communicating data comprising a
message identifying an electrical status of a particular lead of
said plurality of electrical leads by deriving status information
from said repository in response to a determination said
impedance value of said particular patient attached lead is
within said particular impedance value range.
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Application 12/259,352
Br. 22 (emphasis added). Claims 11 and 14 are also independent. See Br.
25-26.
The Examiner maintains the following grounds of rejection:
I. Claims 1--4 and 7-14 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Blakley3 in view of Morra4 and further in view of
Simske. 5 See Final Action 2-20.
II. Claims 5 and 6 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Blakley in view of Morra and Simske and further in view
ofLahr6 and Becker.7 See Final Action 20-22.
Appellants separately argue claims 1, 3-5, and 7, and argue that
claims 2, 6, and 8-14 are patentable for the same reasons. See Br. 8-21.
Therefore, consistent with the provisions of 37 C.F.R. § 41.37 ( c )(1 )(iv)
(2013), we limit our discussion to claims 1, 3-5, and 7. Claims 2 and 8-14
stand or fall with claim 1, and claim 6 stands or falls with claim 5.
3 U.S. Patent Application Pub. No. US 2006/0015033 Al (published Jan. 19,
2006) [hereinafter Blakley].
4 U.S. Patent No. 5,792,194 (issued Aug. 11, 1998) [hereinafter Morra].
5 U.S. Patent Application Pub. No. US 2006/0235322 Al (published Oct. 19,
2 00 6) [hereinafter S imske].
6 U.S. Patent No. 3,774,592 (issued Nov. 27, 1973) [hereinafter Lahr].
7 U.S. Patent No. 6, 136,008 (issued Oct. 24, 2000) [hereinafter Becker].
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Application 12/259,352
DISCUSSION
Claim 1
The Examiner finds that Blakley teaches a system for determining the
electrical status of patient leads in medical patient monitoring according to
claim 1, except that
Blakley is not explicit that the impedance measurement proces-
sor uses a substantially passive impedance bridge network or that
the impedance measurement processor automatically determines
whether an impedance value of a particular patient attached
lead/electrode indicates a potential patient medical condition
based on a comparison to a plurality of stored predetermined im-
pedance value ranges indicative of potential patient medical con-
ditions supporting diagnosis.
Final Action 3--4. However, the Examiner finds that Morra discloses an
automatic system for measuring transvalvular impedance that teaches
comparing lead impedance values with stored ranges "indicative of potential
patient medical conditions supporting diagnosis" to determine whether the
impedance values indicate a potential medical condition. Id. at 4 (citing
Morra 8:47-9:22). The Examiner also finds that Morra teaches that the
system "uses a substantially passive impedance bridge network operating
exclusive of a constant current injection." Id. (citing Morra 5:20-38). The
Examiner determines that
[i]t would have been obvious to one having ordinary skill in the
art to modify the invention of Blakley to explicitly indicate that
the impedance measurement processor uses a substantially pas-
sive impedance bridge network and automatically determin[]es
whether an impedance value of a particular patient attached
lead/electrode indicates a potential patient medical condition
based on a comparison to a plurality of stored predetermined im-
pedance value ranges indicative of potential patient medical con-
ditions, as taught by Morra, because, as suggested by Morra, the
combination would have improved the system of Blakley by
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Appeal2015-003388
Application 12/259,352
providing a simplified means for measuring impedance through
an accurate, established, relationship between the measured volt-
ages and a known resistance while providing the ability to deter-
mine, and indicate, potentially harmful, or noteworthy, medical
conditions to perform more thorough and desirable medical mon-
itoring.
Id. at 4--5 (citations to Morra 5:20-38 and 8:47-9:22 omitted).
The Examiner also finds that the combination of Blakley and Morra
"is not explicit in capturing electrophysiological vectors on different leads
for together mapping to localize cardiac tissue conditions and automatically
initiating prediction of a lead signal." Id. at 5. However, the Examiner cites
Simske as teaching a "method of generating a virtual lead associated with a
physiological recording wherein a plurality of leads capture
electrophysiological vectors on different leads for together mapping to
localize cardiac tissue conditions." Id. (citing Simske i-fi-12, 5, 51). The
Examiner also finds that Simske teaches, "in response to a determination
that a particular patient lead indicates an unacceptable connection and
comprises a failed lead, automatically initiating prediction of a lead signal
voltage conveyed on said particular patient lead using remaining acceptable
lead signals." Id. (citing Simske i-fi-123, 48--49). The Examiner determines
that
[i]t would have been obvious to one having ordinary skill in the
art to modify the invention of Blakley and Morra to explicitly
include capturing electrophysiological vectors on different leads
for together mapping to localize cardiac tissue conditions and au-
tomatically initiating prediction of a lead signal, as taught by
Simske, because, as suggested by Simske, the combination
would have improved the system of Blakley and Morra by main-
taining consistency in the observed lead signals regardless of the
position of the recording electrodes as well as in the situation
when a lead is lost, failed, or in any way generates an unaccepta-
ble condition.
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Appeal2015-003388
Application 12/259,352
Id. at 6 (citing Simske i-fi-123, 48--49).
Appellants argue that Blakley, Morra, and Simske do not teach all the
limitations of claim 1 in the combinations required by claim 1. See Br. 8-13.
In particular, Appellants argue that the references fail to teach "[t]he use of
BOTH 'a cardiac impedance distribution' and 'electrophysiological vectors'
(ECG data)," which "advantageously facilitates early and accurate detection
of a cardiac condition." Id. at 10. Appellants also argue that the references
do not suggest using this combination "for 'together mapping' to 'localize
cardiac tissue conditions and indicating a potential patient medical
condition supporting diagnosis."' Id. In addition, Appellants argue that
"[t]he combination of reference features as suggested in the Rejection
merely provides a measurement of a valve impedance performed at a
different time and with different equipment (internal heart electrodes) than
the equipment used by Simske and Blakley (e.g. comprising skin surface
electrodes) for ECG virtual lead signal generation." Id. at 10-11.
Appellants further argue that "Blak[le ]y, iviorra and Simske teach
incompatible systems." Id. at 13.
Having considered the above arguments and Appellants' supporting
citations and reasoning, we do not find the arguments persuasive of
reversible error in the rejection. The test for obviousness does not require
that the specific combination of features set forth in claim 1 be found bodily
in the prior art, or that the systems disclosed by Morra and Simske may be
directly incorporated into the system disclosed by Blakley. Rather, the test
for obviousness is based on "what the combined teachings of those
references would have suggested to those of ordinary skill in the art." In re
Keller, 642 F.2d 413, 425 (CCPA 1981). The Examiner has provided a
persuasive rationale for why it would have been obvious to combine the
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Application 12/259,352
relevant teachings of Morra and Simske with the disclosure of Blakley, and
Appellants have not specifically disputed the Examiner's stated reasons for
combining the references. Moreover, the Examiner determines that "both
Morra and Simske et al. teach techniques for improving the signals of
Blakley et al.," and that "[c]apturing BOTH 'a cardiac distribution' (as
taught by Morra) together with 'electrophysiological vectors' (as taught by
Simske et al.)for together mapping would flow naturally as a result of
following the suggestions of the prior art." Answer 5. Appellants have not
contested this determination. 8
Appellants also argue that the combined references do not teach that a
measured impedance value falls within "a plurality of predetermined
impedance value ranges and indicates a potential patient medical condition
supporting diagnosis." Id. at 12. According to Appellants, "Processing an
impaired lead signal to improve it, alerting a user a lead is bad or detecting
valve position does NOT support 'diagnosis' of a medical condition." Id.
We do not find Appellants' argument persuasive. As the Examiner correctly
notes,
Morra discloses determining maximum and minimum imped-
ance values while leads are connected to a patient to establish
reference values (i.e. a plurality of predetermined impedance
value ranges) and later re-measuring the impedance values to de-
termine if the ranges have changed (i.e. determining if the im-
pedance is within a particular val[ u ]e range). These measure-
ments are used to determine whether an atrial systole flag is set
based upon whether the ventricular filling phase and atrial con-
tractions are occurring (i.e. indication of a potential patient med-
ical condition supporting diagnosis).
8 Appellants did not submit a reply brief contesting the findings and
conclusions set forth in the Examiner's Answer.
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Application 12/259,352
Answer 9. Thus, the Examiner has provided a persuasive rationale as to why
Morra teaches comparing a measured impedance from a lead with a plurality
of predetermined impedance value ranges, and that the impedance indicates
a potential patient medical condition supporting diagnosis. Appellants have
not directed our attention to contrary factual evidence on this record, or
otherwise provided persuasive technical reasoning pointing to any reversible
error in the Examiner's rationale.
Appellants also argue that Blakley teaches away from "an impedance
measurement processor using a substantially passive impedance bridge
network operating exclusive of constant current injection." Br. 13.
According to Appellants, Blakley teaches "active signal stimulation and
current injection," and thus "teaches precisely the type of reduced safety
system recognized and avoided by the claimed arrangement." Id. Moreover,
Appellants argue that "Blak[le ]y fails to mention an impedance bridge
network at all." Id.
We do not find these arguments to be persuasive of reversible error in
the rejection. The Examiner cites Morra, not Blakley, for the teaching of an
impedance bridge network. See Final Action 4. Blakley's teaching of an
alternative to the impedance bridge network required by claim 1 does not
constitute teaching away unless Blakely is shown to "criticize, discredit, or
otherwise discourage the solution claimed." In re Fulton, 391 F.3d 1195,
1201 (Fed. Cir. 2004). While Blakley teaches the use of sweeping or
chirping characterizing signals, see Blakley 24, Appellants have not shown
that Blakley's teachings would have dissuaded a person of ordinary skill in
the art from using an impedance bridge network as taught by Morra.
Moreover, the Examiner correctly notes that the limitation of claim 1 "is
only exclusive of constant current injection," and "does not exclude the use
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Appeal2015-003388
Application 12/259,352
of any or all current injection with the bridge network." Answer 10.
Appellants have not contested the Examiner's finding that "Blakely does not
indicate that any current injection must be 'constant' or that a 'substantially
passive impedance bridge network' must operate with 'constant current
injection."' Id. at 11.
For the above reasons, Appellants have not persuaded us of reversible
error in the Examiner's determination that claim 1 is obvious based on the
combination of Blakley, Morra, and Simske. For the same reasons, we find
no reversible error in the Examiner's rejection of claims 2 and 8-14.
Claim 3
Claim 3 reads as follows:
3. A system according to claim 1, wherein
said repository of data comprises data stored in an
arrangement of electrical components,
said plurality of predetermined impedance value ranges
indicate potential patient medical conditions and
said impedance measurement processor automatically
selects between a potential patient medical condition and an
unacceptable connection based on an impedance value of a
particular patient attached lead.
Br. 23. The Examiner finds that "Blakley teaches identifying an
unacceptable connection" of a lead. Final Action 9 (citing Blakley i-fi-125,
59). The Examiner also finds that "Morra teaches determining whether an
impedance value of a particular patient attached lead/electrode indicates a
potential patient medical condition." Id. (citing Morra 8:47-9:22). Based
on these teachings, the Examiner concludes that "one having ordinary skill
in the art would recognize that the combination of Blakley and Morra selects
between the determination of a potential patient medical condition and an
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Appeal2015-003388
Application 12/259,352
unacceptable connection based on a comparison of a lead impedance value
and a corresponding range." Id. at 9-10.
Appellants argue that the prior art combination "nowhere suggests an
'impedance measurement processor' that 'automatically selects between a
potential patient medical condition and an unacceptable connection based
on an impedance value of a particular patient attached lead."' Br. 12. In
response, the Examiner determines that
one having ordinary skill in the art would recognize that the com-
bination of Blakley and Morra selects between the determination
of a potential patient medical condition and an unacceptable con-
nection based on a comparison of a lead impedance value and a
corresponding range. That is, the limitations would flow natu-
rally as a result of following the suggestions of the prior art.
Answer 15. We find the Examiner's rationale for combining the teachings of
Blakley and Morra to be persuasive, and Appellants have not directed our
attention to evidence to the contrary. Therefore, we are not persuaded of
reversible error in the Examiner's rejection of claim 3.
Claim 4
Claim 4 reads as follows:
4. A system according to claim 1, wherein
said plurality of predetermined impedance value ranges
include, (a) a first value range indicating a particular patient
attached lead has an acceptable connection, (b) a second value
range indicating a particular patient attached lead has a poor or
intermediate connection and ( c) a third value range indicating a
particular patient attached lead has negligible connection.
Br. 23. The Examiner finds that Blakley teaches three distinct impedance
ranges:
an acceptable connection (i.e. attached and in desired range)
(0025, lines 4--13 and 0059, lines 5-7)[,] a second value range
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Application 12/259,352
indicating a particular patient attached lead has a poor or inter-
mediate connection (i.e. attached but outside the desired range)
(0059, lines 7-10)[,] and a third value range indicating a partic-
ular patient attached lead has negligible connection (i.e. unat-
tached) (0019, lines 4--14 and 0059, lines 10-16).
Final Action 10.
Appellants argue that "Blak[le ]y para. 0059 relied on discusses
electrode transfer function tolerance being within a particular range. The
transfer function is NOT impedance but an amplitude or phase response."
Br. 14 (citing Blakley i-f 20). We do not find Appellants' argument to be
persuasive of reversible error in the rejection. We interpret claims according
to "their broadest reasonable interpretation consistent with the
specification." In re Translogic Tech. Inc., 504 F.3d 1249, 1256 (Fed. Cir.
2007) (quoting In re Hyatt, 211F.3d1367, 1372 (Fed. Cir. 2000)). The
Specification defines impedance as "a measure of the degree to which a
component resists the flow of electrical current if a given voltage is applied
and if a real quantity is measured in ohms." Spec. 5. While the
Specification refers to real impedance, it does not exclude a broader
definition of impedance as discussed in Blakley, which may include phase
and amplitude. See Blakley i-f 17-18. The preponderance of the evidence on
this record supports the Examiner's conclusion that "the impedance transfer
function disclosed in Blakley et al. is impedance." Answer 16. Thus, we are
not persuaded of reversible error in the Examiner's rejection of claim 4.
Claim 5
Claim 5 reads as follows:
5. A system according to claim 4, wherein
said first value range is below a threshold of
approximately 4--7 kOhms,
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Application 12/259,352
said second value range exceeds said first value range but
is below approximately 18-22 kOhms and
said third value range exceeds said second value range.
Br. 23. The Examiner finds that Lahr teaches numerical values for the
impedance ranges within the ranges set forth in claim 5, and that Becker
teaches that a value above approximately 100 kOhms is undetectable. See
Final Action 21 (citing Lahr 1:31-35, 2:28-29, Becker 1:26-28). The
Examiner determines that
[i]t would have been obvious to one having ordinary skill in the
art to modify the invention of Blakely, Morra, and Simske to ex-
plicitly generating four distinct impedance ranges as taught by
the combination of Lahr and Becker, because it is considered to
be conventional in the art to provide a plurality of distinct ranges
for indication to a user a plurality of different statuses and, as
suggested by Lahr and Becker, the combination would have im-
proved the system of Blakely, Morra, and Simske by providing
means for more thorough analysis of the electrode/lead connec-
tion and providing a better indication to the user as to the specific
electrode/lead connection.
Id. The Examiner also finds that it \vould have been \vell \vithin the skill of
one having ordinary skill in the art to determine a plurality of specific ranges
to indicat[ e] a plurality of specific conditions." Id. at 21-22.
In addition to arguments that are substantially the same as those
presented in response to the rejection of claim 1, Appellants argue that "Lahr
column 1 lines 31-35 relied on merely states a good electrical connection to
a scalp is less than 10 kOhms and nowhere suggests of the multiple different
ranges claimed contrary to the Rejection statement on page 14." Br. 15. We
do not find Appellants' arguments persuasive of reversible error in the
rejection of claim 5. In addition to the range of less than 10,000 ohms
representing "good conduction," see Lahr 1 :31-35, Lahr also refers to a
range of 5,000-7000 ohms representing a lead with "excellent conduction."
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Application 12/259,352
See Lahr 2:25-29. Thus, the Examiner has shown that Lahr establishes
ranges reflecting an acceptable connection (5,000-7,000 ohms) and an
intermediate connection (less than 10,000 ohms). The Examiner also cites
Becker to establish a range (above about 100 kOhms), higher than the
intermediate range, representing a negligible connection. See Final Action
21. Moreover, Appellants have not pointed to evidence contesting the
Examiner's determination that the impedance value ranges specified by
claim 5 may be obtained by routine experimentation. See In re Aller, 220
F.2d 454, 456 (Fed. Cir. 1955) ("[W]here the general conditions of a claim
are disclosed in the prior art, it is not inventive to discover the optimum or
workable ranges by routine experimentation.") Thus, we find no reversible
error in the Examiner's rejection of claim 5. For the same reasons, we find
no reversible error in the Examiner's rejection of claim 6.
Claim 7
Claim 7 depends from claim 1, and requires that "said impedance
measurement processor automatically initiates said prediction of said lead
signal conveyed on said particular patient attached lead in response to a
weighted lead signal combination using remaining acceptable ECG lead
signals." Br. 23. The Examiner finds that Simske teaches prediction "in
response to a weighted lead signal combination." Final Action 11 (citing
Simske i-fi-123, 30, 48--49). The Examiner further explains that "Simske et al.
measures signals from the electrode leads and uses all of these signals to
predict (i.e. via mathematical manipulation e.g. extrapolation, weighted
signal combinations) that signal that is lost or altered." Answer 18.
We agree with Appellants that Simske does not teach the use of a
weighted lead signal combination. Br. 14--15. The Examiner does not direct
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Application 12/259,352
our attention to any specific teaching in Simske of the use of a weighted lead
signal combination as required by claim 7. Although Simske teaches
mathematical manipulation to arrive at the prediction of the missing lead
signal, the Examiner does not explain how Simske's manipulations
demonstrate a weighted lead signal combination. Because the Examiner has
not established that the combination of all the limitations of claim 7 would
have been obvious in view of the cited prior art, we reverse the Examiner's
decision to reject claim 7.
DECISION
The Examiner's decision to reject claims 1-6 and 8-14 is affirmed.
The Examiner's decision to reject claim 7 is reversed.
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).
AFFIRl'viED-IN-PART
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