Ex Parte Reuter et al

Board of Patent Appeals and Interferences

Sep 19, 2007

10366585 (B.P.A.I. Sep. 19, 2007)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte DAVID G. REUTER and MARK L. MATHIS
____________

Appeal 2009-012555
Application 10/366,585
Technology Center 3700
____________

Decided: January 27, 2010
____________

Before JENNIFER D. BAHR, STEFAN STAICOVICI, and
FRED A. SILVERBERG, Administrative Patent Judges.

STAICOVICI, Administrative Patent Judge.

DECISION ON APPEAL
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STATEMENT OF THE CASE
David G. Reuter et al. (Appellants) appeal under 35 U.S.C. § 134
(2002) from the Examiner’s decision rejecting claims 1-37. We have
jurisdiction over this appeal under 35 U.S.C. § 6 (2002).1

THE INVENTION
Appellants’ invention relates to a method of implanting a mitral valve
therapy device 30 in a patient’s coronary sinus 14 that is adjacent the
patient’s mitral valve annulus 20, to reshape the mitral valve annulus 20 so
as to prevent mitral valve regurgitation when the left ventricle contracts.
Spec. 1, paras. [1], [2] and figs. 1 and 2. The method includes positioning
the mitral valve therapy device, evaluating effectiveness of the device, and
assessing arterial perfusion of the heart. Spec. 6, para. [16].
Claim 1 is representative of the claimed invention and reads as
follows:
1. A method of implanting a mitral valve therapy
device in a patient's coronary sinus adjacent the
patient's mitral valve annulus, the method
comprising the steps of:

1 This is the second appeal in this application. In the Decision in the
first appeal (2006-3319), the panel reversed the rejection of claims 1-3, 11,
12, 14, and 33-37 as anticipated by Cohn, claims 1-11 and 13-37 as
anticipated by Langberg, and claim 13 as unpatentable over Cohn and
Machek and affirmed as to the rejection of claims 15 and 16 as unpatentable
over Cohn and Bardy. Additionally, the panel remanded the application to
the Examiner for consideration of the patentability of the subject matter of
claims 1-14 and 17-37 over Cohn and Bardy, either alone or further in
combination with Langberg or other prior art in light of the panel’s
affirmance of the rejection of claims 15 and 16 as unpatentable over Cohn
and Bardy. See 37 C.F.R. § 41.50(a)(1)(2007).

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positioning the mitral valve therapy device within
the coronary sinus of the patient adjacent to the
mitral valve annulus of the patient;

evaluating effectiveness of the device; and

assessing arterial perfusion of the heart prior to
finalizing deployment of the device in the coronary
sinus.

THE REJECTIONS
The Examiner relies upon the following as evidence of
unpatentability:
Frazin US 5,836,882 Nov. 17, 1998
Langberg US 2002/0016628 A1 Feb. 7, 2002
Bardy US 2002/0143262 A1 Oct. 3, 2002
Cohn US 2002/0183841 A1 Dec. 5, 2002
Santamore US 2002/0188170 A1 Dec. 12, 2002

Appellants rely on the following as evidence of non-obviousness:
Declaration under 37 C.F.R. § 1.132 of Charanjit S. Rihal, MD
(filed April 22, 2008).2
Declaration under 37 C.F.R. § 1.132 of David G. Reuter, MD3
(filed April 22, 2008).,4
The following rejections are before us for review:
The Examiner rejected claims 1-3, 11, 12, 14, and 33-37 under 35
U.S.C. § 103(a) as unpatentable over Cohn, Santamore, and Frazin.

2 Hereafter “Rihal Declaration.”
3 The Declarant, Dr. Reuter, is also a co-inventor in the instant
application.
4 Hereafter “Reuter Declaration.”
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The Examiner rejected claims 1-3, 11, 12, 14-16, and 33-37 under 35
U.S.C. § 103(a) as unpatentable over Cohn, Bardy, and Frazin.
The Examiner rejected claims 4-10, 13, and 17-32 under 35 U.S.C.
§ 103(a) as unpatentable over Cohn, Bardy, Frazin, and Langberg.

THE ISSUES
The Examiner and Appellants agree that Cohn does not disclose the
step of assessing arterial perfusion of the heart prior to finalizing deployment
of the device in the coronary sinus, as required by claim 1. App. Br. 5, 16
and Ans. 4, 5. However, the Examiner found that: (1) Santamore discloses
that “arterial and venous vessel[s] lie in close proximity near the heart.”
Ans. 4; (2) Frazin discloses monitoring or assessing arterial perfusion of an
organ (i.e., heart) during or prior to finalizing deployment of a medical
device. Ans. 6.; and (3) Bardy discloses monitoring the heart functions of
patients receiving a medical device, where the monitoring is performed to
determine myocardial ischemia. Ans. 5, 6. Appellants argue that the
Examiner erred in interpreting the disclosure of Santamore and
mischaracterized the teachings of Bardy and Frazin. App. Br. 5-7 and 16.
Specifically, with respect to the teachings of Santamore, Appellants argue
that:
The Examiner erroneously extrapolated from this
disclosure, however, to assert that Santamore
teaches that delivery of a device to the coronary
sinus “can impede or alter to some degree the
blood flow in an adjacent arterial vessel since the
coronary sinus or venous vessel is in close
proximity to an arterial vessel.” (Final Office
Action, p. 5).
App. Br. 16.
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Regarding the teachings of Frazin, Appellants further argue that:
Frazin never describes the need for, or the use of,
monitoring arterial perfusion of the patient's heart
during or after a venous procedure (such as the
recited deployment of a mitral valve annuloplasty
device in the coronary sinus) to look for adverse
effects of such a procedure, and Frazin does not
state or imply that his Doppler velocimeter can or
should be used for that purpose.
App. Br. 5.
Finally, in regards to the teachings of Bardy, Appellants argue that:
Bardy never discloses the step of monitoring
arterial perfusion of the heart during any
procedure, much less during the mitral valve
regurgitation reduction therapies described in
Cohn and the instant application.
App. Br. 7.
As such, according to Appellants, because the Examiner erred in the
interpretation of the disclosure of Santamore, Frazin, and Bardy, the
Examiner’s conclusion of obviousness based on the combined teachings of
Cohn, Bardy and Frazin and Cohn, Santamore, and Frazin, respectively, is
flawed. App. Br. 7 and 17.
Regarding claim 13, Appellants further argue that Langberg does not
disclose fractional flow analysis. App. Br. 13. Pointing to paras. [[0080]
and [0082] of Langberg, the Examiner takes the position that Langberg
discloses that fractional flow reserve analysis is performed via pressure
measurements. Ans. 8.
Finally, with respect to claim 21, Appellants argue that the combined
teachings of Cohn, Bardy, Frazin, and Langberg do not disclose performing
a first arterial perfusion of the heart, deploying the proximal anchor of the
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implant, and then performing a second arterial perfusion of the heart. App.
Br. 14. The Examiner responds that:
It is common sense that a surgeon assess that
delivery is being accomplished appropriately
before proceeding further in a medical procedure
prior to finalizing the deployment. Thus, it would
be obvious that the surgeon first assess arterial
perfusion after the distal anchor is deployed prior
to completing the deployment of the proximal
anchor because the cinching structure of Cohn
becomes locked once the proximal anchor is
deployed. Therefore a surgeon would not continue
in the procedure and cinch the proximal anchor if
they are not sure that the distal anchor is first
appropriately positioned and not causing any
problems within the patient's vasculature.
Ans. 13-14.
Accordingly, the issues presented for our consideration in the instant
appeal are as follows:
1. Have Appellants demonstrated that the Examiner erred in
determining that the combined teachings of Cohn, Santamore, and
Frazin would have prompted a person of ordinary skill in the art to
assess arterial perfusion of a patient’s heart when implanting a
mitral valve therapy device in the coronary sinus of the patient’s
heart?
2. Have Appellants demonstrated that the Examiner erred in
determining that the combined teachings of Cohn, Bardy, and
Frazin would have prompted a person of ordinary skill in the art to
assess arterial perfusion of a patient’s heart when implanting a
mitral valve therapy device in the coronary sinus of the patient’s
heart?
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3. Have Appellants demonstrated that the Examiner erred in
determining that the combined teachings of Cohn, Bardy, Frazin,
and Langberg render obvious the subject matter of claims 4-10, 13,
and 17-32? The issue turns on (a) whether Langberg discloses
fractional flow reserve analysis, as per claim 13, and (b) whether
the combined teachings of Cohn, Bardy, Frazin, and Langberg
disclose first and second steps of performing an arterial perfusion
of the heart, as per claim 21.

SUMMARY OF DECISION
We AFFIRM-IN-PART and ENTER NEW GROUNDS OF
REJECTION PURSUANT TO OUR AUTHORITY UNDER 37 C.F.R.
§ 41.50(b).

FINDINGS OF FACT

The following enumerated findings of facts (FF) are supported by at
least a preponderance of the evidence. Ethicon, Inc. v. Quigg, 849 F.2d
1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for
proceedings before the Office).
1. Cohn discloses a method for implanting a mitral valve therapy
device (cinching device 106) including first deploying a distal
end 139 and then a proximal end 142 in a patient’s coronary
sinus 30 adjacent the patient’s mitral valve annulus 33 to reduce
mitral regurgitation. Cohn, paras. [0059]-[0063] and figs. 2, 5,
and 10.
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2. Cohn further discloses adjusting or repositioning the cinching
device 106 or even removing it, if necessary. Cohn, paras.
[0038], [0050], and [0066].
3. Cohn further discloses visualization of the implantation
procedure using echocardiography, fluoroscopy, and
intravascular ultrasound. Cohn, para. [0051].
4. Santamore discloses that coronary veins and coronary arteries run
in close proximity to each other. Santamore, para. [0173].
5. Frazin discloses a process and system for determining the
location of the tip of a probe inside the body of a patient, e.g.,
within a blood vessel of a heart patient. Frazin, col. 2, ll. 38-41.
For example, Frazin teaches guiding pressure measurement
probes within the cardiovascular system. Frazin, col. 3, ll. 2-4.
6. The system of Frazin includes a Doppler velocimeter 25, a probe
27 (i.e., catheter), a transceiver 24 attached to the probe 27, an
ultrasonic transducer 23, and an ultrasonic imaging system 20,
21. Frazin, col. 3, ll. 42 and 55-56; col. 4, ll. 8-10; and fig. 1.
7. During operation of Frazin’s system, the probe 27 having the
transceiver 24 is inserted into the cardiovascular system of a
subject 22 (patient) through an artery. Frazin, col. 4, ll. 2-5. The
ultrasonic transducer 23 is used to monitor the progress of
transceiver 24. Frazin, col. 4, ll. 8-11.
8. The ultrasonic transducer 23 of Frazin’s system may be used as a
transesophageal, intravascular, transthoracic, transabdominal,
trangastric, or transcolonic probe. Frazin, col. 4, ll. 10-13.
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9. When a transthoracic probe is used in the method of Frazin, the
ultrasonic transducer 23 is located on an anterior chest wall of the
patient and positionally adjusted to obtain an adequate view of
the Doppler transducer 24. Frazin, col. 4, ll. 29-32.
10. The velocimeter 25 of Frazin monitors the blood flow in the
catherized blood vessel during catherization. The system of
Frazin allows measurement of blood flow during catherization to
determine whether the catheter is moving in the proper direction.
Frazin, col. 3, ll. 34-40.
11. Bardy discloses a method for diagnosing and monitoring the
onset, progression, regression, and status quo of myocardial
ischemia using an automated information collection and analysis
patient care system. Bardy, paras. [0002], [0009] and fig. 1.
12. The system of Bardy collects information such as cardiac injury
chemical tests 66, serum creatinine kinase 67, serum troponin 68,
left ventricular wall motion changes 69, myocardial blood flow
70, and coronary sinus lactate production 71. Bardy, para.[0036].
13. Appellants define “arterial perfusion” as “arterial blood flow to
the heart.” Rihal Declaration, para. 3.
14. A customary and ordinary meaning of the term “ischemia” is
“deficient supply of blood to a body part (as the heart or brain)
that is due to obstruction of the inflow of arterial blood.”
MERRIAM-WEBSTER’S COLLEGIATE DICTIONARY (11th Ed. 2003).
15. Langberg discloses a method for implanting a mitral valve
therapy device (cardiac reinforcement device 44) in a patient’s
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coronary sinus 22 adjacent the patient’s mitral annulus to reduce
mitral regurgitation. Langberg, para. [0044] and fig. 1.
16. The method of implantation of Langberg includes monitoring the
degree of mitral regurgitation by transesophageal echo
cardiography, surface echo cardiography, intracardiac echo
cardiography, fluoroscopy using radiocontrast in the left ventricle
(LVgram), or left atrial or pulmonary capillary wedge pressure
tracings. Langberg, para. [0080].
17. Langberg further discloses that the implant is preferably
combined with drug therapy. After implantation, Lanberg
discloses performing residual regurgitation and other
hemodynamic measurement. Langberg, para. [0082].
18. On the basis of the credentials set forth in the Rihal Declaration,
we find that Dr. Rihal is an expert in the field of cardiology.
Rihal Declaration, Curriculum Vitae and Bibliography of
Charanjit S. Rihal, MD, BSc, BSc(Med), MBA.
19. The Rihal Declaration presents no credentials of Dr. Rihal as an
expert in intellectual property or, in particular, the standard for
obviousness under 35 U.S.C. 103. Accordingly, we do not credit
Dr. Rihal as an expert on the standard of obviousness under 35
U.S.C. § 103.
20. The Rihal Declaration points out that arterial perfusion is
common when cardiac catheter procedures require access into the
arterial vasculature. Rihal Declaration, para. 3. However, Dr.
Rihal opines that because venous procedures do not involve the
coronary arteries, “there is no need to monitor arterial perfusion
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of the heart during or after the venous procedure.” Rihal
Declaration, para. 4.
21. Dr. Rihal further opines that “[b]ecause cardiac arterial perfusion
monitoring adds time, complexity, and potential risk to the
procedure, it simply is not performed when it is not need.” Rihal
Declaration, para. 4.
22. Dr. Rihal further opines that “I would not have expected there to
be any value to monitoring arterial perfusion of the heart during
this venous procedure that would justify the time and expense of
such monitoring.” Rihal Declaration, para. 9.
23. The Rihal Declaration describes an animal study using dogs to
determine the efficacy of Appellants’ mitral valve therapy device
as well as to determine whether the anatomical relationship
between the circumflex artery and the coronary sinus raised any
safety concerns. Rihal Declaration, paras. 9 and 10.
24. In the study, Dr. Rihal explains that heart failure was induced in
the dogs. Transthoracic echocardiography was performed on each
subject to obtain a mitral valve regurgitation baseline. The distal
anchor of Appellant’s mitral valve therapy device was expanded
in the coronary sinus while transthoracic echocardiography was
performed to determine the reduction in mitral valve
regurgitation (efficacy) as proximal tension was applied to the
device. In addition, coronary angiography was performed to
monitor blood flow through the circumflex artery (arterial
perfusion of the heart). If mitral valve regurgitation was reduced
by 50% and blood flow through the circumflex artery was
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preserved, the device’s proximal anchor was deployed and the
device was uncoupled from the delivery system. Rihal
Declaration, para. 10.
25. Dr. Rihal explains that one dog died while preparing to perform
coronary angiography, presumably because of impingement of
the circumflex artery. Rihal Declaration, para. 11.
26. Dr. Rihal further explains that in two other dogs out of eight,
Appellants’ device could not be implanted due to impingement of
the circumflex artery. Rihal Declaration, para. 11.
27. Dr. Rihal concluded that the study showed that “mere
foreknowledge of the circumflex artery/coronary sinus
relationship in a patient does not necessary predict whether
implantation of a percutaneous mitral valve annuloplasty device
would lead to a reduction of arterial perfusion of the heart.”
Rihal Declaration, para. 11. According to Dr. Rihal, “it is
necessary to actually monitor arterial perfusion of the heart
during the procedure-in addition to monitoring efficacy of the
procedure in reducing mitral valve regurgitation.” Id.
28. The Reuter Declaration indicates a human study in which
assessment of arterial perfusion of the heart “required the
recapture of the device in eleven patients due to impingement of
the patients’ circumflex arteries.” Dr. Reuter further states that
“[i]n five of these eleven patients, a second device was
successfully placed proximal to the circumflex.” Reuter
Declaration, para. 3. See also, Rihal Declaration, para. 13.
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29. Pijls discloses that the fractional flow reverse index (FFR)
indicates myocardial ischemia in patients having coronary-artery
stenoses of moderate severity that is difficult to determine using
standard non-invasive tests (i.e., exercise test, thallium scan,
stress echocardiogram). H.J. Pijls, M.D. et al., Measurement of
Fractional FlowRreserve to Assess the Functional Severity of
Coronary-Artery Stenoses, New England Journal of Medicine,
vol. 334, No. 26, p. 1703-1708, Abstract (1996).5
30. According to Pijls, the FFR index is determined from pressure
measurements of the mean distal coronary-artery pressure and the
aortic pressure. Pijls, page 1703.

PRINCIPLES OF LAW
Obviousness
"Section 103 forbids issuance of a patent when 'the differences
between the subject matter sought to be patented and the prior art are such
that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains.'" KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406
(2007). The question of obviousness is resolved on the basis of underlying
factual determinations including (1) the scope and content of the prior art,
(2) any differences between the claimed subject matter and the prior art, (3)
the level of skill in the art, and (4) where in evidence, so-called secondary
considerations. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). See
also KSR, 550 U.S. at 407 ("While the sequence of these questions might be

5 Hereafter referred to as “Pijls.”
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reordered in any particular case, the [Graham] factors continue to define the
inquiry that controls.")
While there must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness, “the analysis
need not seek out precise teachings directed to the specific subject matter
of the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” KSR,
550 U.S. at 418 (2007).
When a work is available in one field of endeavor,
design incentives and other market forces can
prompt variations of it, either in the same field or a
different one. If a person of ordinary skill can
implement a predictable variation, § 103 likely
bars its patentability. For the same reason, if a
technique has been used to improve one device,
and a person of ordinary skill in the art would
recognize that it would improve similar devices in
the same way, using the technique is obvious
unless its actual application is beyond his or her
skill.
Id. at 417. We “must ask whether the improvement is more than the
predictable use of prior art elements according to their established
functions.” Id.
Secondary considerations
Whenever obviousness is found with respect to the subject matter on
appeal, and Appellants furnish evidence of secondary considerations, it is
our duty to reconsider the issue of obviousness anew, carefully weighing the
evidence for obviousness with respect to the evidence against obviousness.
See, for example, In re Eli Lily & Co., 902 F.2d, 943, 945 (Fed. Cir. 1990).
We are also mindful that the objective evidence of nonobviousness in any
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given case may be entitled to more or less weight depending on its nature
and its relationship with the merits of the invention. See Stratoflex Inc. v.
Aeroquip Corp., 713 F.2d 1530, 1538 (Fed. Cir. 1983).

OPINION
Issue (1)
The obviousness rejection over Cohn, Santamore, and Frazin
Appellants argue the rejection under 35 U.S.C. §103(a) of claims 1,
11, 12, 14, and 34-37 together as a group. App. Br. 15-19. Therefore, we
have selected claim 1 as the representative claim to decide the appeal, with
claims 11, 12, 14, and 34-37 standing or falling with claim 1. See 37 C.F.R.
§ 41.37(c)(1)(vii)(2007). In view of Appellants’ arguments, we will address
the rejection of claims 2, 3, and 33 separately. See App. Br. 11-12.
At the outset, we note that the Appellants’ arguments appear to attack
the teachings of Cohn, Santamore, and Frazin individually, rather than the
combination of Cohn, Santamore, and Frazin. See App. Br. 6-7.
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).
As shown above, Cohn discloses a method of implanting a mitral
valve therapy device (cinching device 106) in a patient’s coronary sinus 30
adjacent the patient’s mitral valve annulus 33 to reduce mitral regurgitation.
FF 1. However, as the Examiner notes, Cohn does not disclose the step of
assessing arterial perfusion of the heart prior to finalizing deployment of the
device in the coronary sinus, as required by claim 1. Ans. 4. Santamore
discloses that coronary veins and coronary arteries run in close proximity to
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each other. FF 4. Frazin discloses a process that measures blood flow
through a blood vessel during a catherization procedure. FF 6-8 and 10.
Hence, Appellants’ claimed method is nothing more than Cohn’s
implantation procedure including the step of assessing blood flow through
an artery (blood vessel) to the heart (arterial perfusion, FF 13), which can be
performed using Frazin’s method. Such a combination strikes us as nothing
more than the predictable use of prior elements according to their established
functions. We agree with the Examiner that the level of ordinary skill in the
art in this case is high and that the person of ordinary skill in the art is a
cardiac surgeon. See Ans. 6. Furthermore, we find that a person of ordinary
skill in the art, namely, a cardiac surgeon, is familiar with the risks and
complications involved with any cardiac procedure and with the techniques
for monitoring such risks. An artisan must be presumed to know something
about the art apart from what the references disclose. See In re Jacoby, 309
F.2d 513, 516 (CCPA 1962). As noted above, Santamore discloses that
coronary veins and coronary arteries run in close proximity to each other.
FF 4. A person of ordinary skill in the art of cardiac surgery exercising only
ordinary creativity and an abundance of caution would have readily
understood that if the coronary sinus is expanded so as to implant a therapy
device it may impinge on a nearby coronary artery and hence, occlude blood
flow to the heart. After all, “[a] person of ordinary skill is also a person of
ordinary creativity, not an automaton.” KSR Int’l. Co. v. Teleflex Inc., 550
U.S. 398, 421 (2007). Although Cohn may not provide an express teaching
that the patient undergoing the mitral cinching device implantation
procedure in the cardiac sinus should be monitored for arterial perfusion of
the heart, a cardiac surgeon, knowing that coronary veins and arteries run in
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close proximity to each other (as taught by Santamore) would have readily
appreciated that such a patient should be monitored for arterial perfusion to
the heart. Hence, modifying the procedure of Cohn to include a step of
assessing arterial perfusion to the heart using the process of Frazin would
not have been uniquely challenging to a person of ordinary skill in the art,
because it is no more than “the mere application of a known technique to a
piece of prior art ready for the improvement.” Id. at 417. Therefore, the
modification appears to be the product not of innovation but of ordinary skill
and common sense. An improvement that is nothing more than the
predictable use of prior art elements according to their established functions
is likely to be obvious. Id. Moreover, Appellants have not alleged, much
less shown, that the modification of Cohn to include a step of assessing
arterial perfusion using the process of Frazin would have been beyond the
skill of a person of ordinary skill in the art. Lastly, we note that both Cohn
and Frazin disclose using echocardiography, to either visualize the
implantation procedure of cinching device 106 in Cohn (FF 3) or to measure
blood flow through a blood vessel in Frazin (FF 8 and 9). As such, a person
of ordinary skill in the art exercising only ordinary creativity would have
appreciated that when implanting the therapeutic device in the process of
Cohn, the same echocardiography technique can both visualize the
procedure and monitor arterial perfusion of the heart by simple manipulation
of the ultrasonic probe.
In conclusion, we agree with the Examiner that in view of the
teachings of Santamore that coronary veins and coronary arteries run in
close proximity to each other, it would have been obvious for a person of
ordinary skill in the art to modify the procedure of Cohn to include a step of
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assessing arterial perfusion of the heart, according to the process of Frazin,
because the person of ordinary skill in the art would have recognized that
blood flow to the heart would be altered in a coronary artery that is adjacent
the coronary sinus in which a therapeutic device is implanted according to
the procedure of Cohn. See Ans. 4, 5.
For the foregoing reasons, we conclude that the Examiner’s
combination of the teachings of Cohn, Santamore, and Frazin establishes a
prima facie case of obviousness of the subject matter of claims 1, 11, 12, 14,
and 34-37.
Claims 2 and 3 require the additional steps of “adjusting the position
of the device” and “removing the device after the assessing step,”
respectively. Appellants argue that because the Examiner has failed to show
that the combined teachings of Cohn, Santamore, and Frazin disclose a step
of assessing arterial perfusion of the heart, Cohn, Santamore, and Frazin
cannot disclose the limitations of claims 2 and 3. App. Br. 18. However, as
shown above, we find that the combined teachings of Cohn, Santamore, and
Frazin disclose a step of assessing arterial perfusion of the heart.
Furthermore, we agree with the Examiner that Cohn specifically teaches
adjusting or repositioning the device (as per claim 2) and removing the
device (as per claim 3). Ans. 3-4. See also FF 2. Accordingly, we likewise
conclude that the Examiner’s combination of the teachings of Cohn,
Santamore, and Frazin establishes a prima facie case of obviousness of the
subject matter of claims 2 and 3.
Finally, regarding claim 33, Appellants rely on the same arguments as
presented with respect to claim 1. App. Br. 18-19. Thus, Appellants’
arguments with respect to the rejection of claim 33 are likewise
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unpersuasive. Accordingly, we find that the Examiner’s combination of the
teachings of Cohn, Santamore, and Frazin establishes a prima facie case of
obviousness of the subject matter of claim 33.

Issue (2)
The obviousness rejection over Cohn, Bardy, and Frazin
Appellants argue the rejection under 35 U.S.C. §103(a) of claims 1,
11, 12, 14-16, and 34-37 together as a group. App. Br. 15-19. Therefore,
we have selected claim 1 as the representative claim to decide the appeal,
with claims 11, 12, 14-16, and 34-37 standing or falling with claim 1. In
view of Appellants’ arguments, we will address the rejection of claims 2, 3,
and 33 separately.
At the outset, we note once more that the Appellant’s arguments
appear to attack the teachings of Cohn, Bardy, and Frazin individually,
rather than the combination of Cohn, Bardy, and Frazin. See App. Br. 6-7.
As shown above, Cohn discloses a method of implanting a mitral
valve therapy device (cinching device 106) in a patient’s coronary sinus 30
adjacent the patient’s mitral valve annulus 33 to reduce mitral regurgitation.
FF 1. As noted by the Examiner, Cohn does not disclose the step of
assessing arterial perfusion of the heart prior to finalizing deployment of the
device in the coronary sinus, as required by claim 1. Ans. 4. Bardy
discloses a method for diagnosing and monitoring the onset, progression,
regression, and status quo of myocardial ischemia using an automated
information collection and analysis patient care system. FF 12. Appellants
argue that, “Bardy never discloses the step of monitoring arterial perfusion
during any procedure, much less during the mitral valve regurgitation.”
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App. Br. 7. However, this argument evidences what we believe to be an
unreasonably narrow reading or interpretation of the Bardy disclosure. A
reference may be relied upon for all that it would have reasonably suggested
to one having ordinary skill the art, including nonpreferred embodiments.
Merck & Co. v. Biocraft Laboratories, 874 F.2d 804 (Fed. Cir. 1989). In
this case, a customary and ordinary meaning of the term “ischemia” is
“deficient supply of blood to a body part (as the heart or brain) that is due to
obstruction of the inflow of arterial blood.” FF 14. Hence, “myocardial
ischemia” represents a deficient supply of blood to the heart caused by
obstruction of the inflow of arterial blood to the myocardium, i.e., the heart.
“Arterial perfusion” means “arterial blood flow to the heart.” FF 13. Since
“myocardial ischemia” is the result of arterial blood flow obstruction,
monitoring “arterial perfusion” of the heart is a way of preventing
myocardial ischemia. Moreover, Bardy specifically discloses collecting
information regarding myocardial blood flow. FF 12. As such, we find that
Bardy as a whole would have conveyed to a person of ordinary skill in the
art the importance of monitoring arterial perfusion of the heart of a patient,
especially one having a condition requiring an implantable medical device
(see Bardy, para. 31). As noted above, Frazin discloses a process that
measures blood flow through a blood vessel during a catherization
procedure. FF 6-8 and 10. As previously stated, the level of ordinary skill
in the art in this case is high and the person of ordinary skill in the art is a
cardiac surgeon who is familiar with the risks and complications involved
with any cardiac procedure and with the techniques for monitoring such
risks. Although Cohn does not provide an express teaching that a patient
undergoing a mitral valve cinching device implantation procedure should be
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monitored for arterial perfusion of the heart, we find that a cardiac surgeon,
having ordinary skill in the art and exercising ordinary common sense and
an abundance of caution, in view of the teachings of Bardy, would have
readily appreciated that a patient receiving a mitral valve therapy device
should be monitored for any common indications of cardiac distress, such as
myocardial ischemia, by monitoring arterial perfusion (myocardial blood
flow) of the heart of the patient.
Hence, Appellants’ claimed method is nothing more than Cohn’s
implantation procedure including Bardy’s step of assessing arterial blood to
the heart of a patient (arterial perfusion) according to the method of Frazin.
Modifying the procedure of Cohn to include a step of assessing arterial
perfusion of the heart using the process of Frazin would not have been
uniquely challenging to a person of ordinary skill in the art, because it is no
more than “the mere application of a known technique to a piece of prior art
ready for the improvement.” KSR at 417. Therefore, the modification
appears to be the product not of innovation but of ordinary skill and common
sense. An improvement that is nothing more than the predictable use of
prior art elements according to their established functions is likely to be
obvious. Id. Moreover, Appellants have not alleged, much less shown, that
the modification of Cohn to including Bardy’s step of assessing arterial
perfusion of the heart of a patient using the process of Frazin would have
been beyond the skill of a person of ordinary skill in the art. Furthermore,
both Cohn and Frazin disclose using echocardiography, to either visualize
the implantation procedure of cinching device 106 in Cohn (FF 3) or to
measure blood flow through a blood vessel in Frazin (FF 8 and 9). As such,
a person of ordinary skill in the art exercising only ordinary creativity would
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have appreciated that when implanting the therapeutic device in the process
of Cohn, the same echocardiography technique can both visualize the
procedure and monitor arterial perfusion to the heart by simple manipulation
of the ultrasonic probe.
In conclusion, we agree with the Examiner that in view of Bardy’s
disclosure of monitoring arterial perfusion of the heart (myocardial blood
flow) of a patient, it would have been obvious for a person of ordinary skill
in the art to modify the procedure of Cohn to include the step of assessing
arterial perfusion of the heart, using the process of Frazin, because the
person of ordinary skill in the art would have readily recognized that a
patient receiving a mitral valve therapy device as that of Cohn should be
monitored for any common indications of cardiac distress, such as
myocardial ischemia, by monitoring arterial perfusion (myocardial blood
flow) of the heart of the patient. See Ans. 6.
For the foregoing reasons, we conclude that the Examiner’s
combination of the teachings of Cohn, Bardy, and Frazin establishes a prima
facie case of obviousness of the subject matter of claims 1, 11, 12, 14-16,
and 34-37.
Claims 2 and 3 require the additional steps of “adjusting the position
of the device” and “removing the device after the assessing step,”
respectively. Appellants argue that because the Examiner has failed to show
that the combined teachings of Cohn, Bardy, and Frazin show a step of
assessing arterial perfusion of the heart, Cohn, Bardy, and Frazin cannot
disclose the limitations of claims 2 and 3. App. Br. 11. However, as shown
above, we find that the combined teachings of Cohn, Bardy, and Frazin
disclose a step of assessing arterial perfusion of the heart. Further, we agree
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with the Examiner that Cohn specifically teaches adjusting or repositioning
the device (as per claim 2) and removing the device (as per claim 3). Ans.
3-4. See also FF 2. Accordingly, we likewise conclude that the Examiner’s
combination of the teachings of Cohn, Bardy, and Frazin establishes a prima
facie case of obviousness of the subject matter of claims 2 and 3.
Finally, regarding claim 33, Appellants rely on the same arguments as
presented with respect to claim 1. App. Br. 11-12. Thus, Appellants’
arguments with respect to the rejection of claim 33 are likewise
unpersuasive. Accordingly, we find that the Examiner’s combination of the
teachings of Cohn, Bardy, and Frazin establishes a prima facie case of
obviousness of the subject matter of claim 33.

Issue (3)
The obviousness rejection over Cohn, Bardy, Frazin, and Langberg
Regarding claims 4-10, 17-20, and 22-32, Appellants do not present
any arguments separate from the arguments presented with respect to
independent claim 1. App. Br. 12-13. Accordingly, we conclude that the
Examiner’s combination of the teachings of Cohn, Bardy, Frazin, and
Langberg establishes a prima facie case of obviousness of the subject matter
of claims 4-10, 17-20, and 22-32.
In regard to claim 13, paragraph [0080] of Langberg discusses
monitoring the degree of mitral regurgitation by transesophageal echo
cardiography, surface echo cardiography, intracardiac echo cardiography,
fluoroscopy using radiocontrast in the left ventricle (LVgram), or left atrial
or pulmonary capillary wedge pressure tracings. FF 16. Paragraph [0082]
of Langberg states that the implant is preferrably combined with drug
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therapy and after implantation residual regurgitation and other hemodynamic
functions are measured. FF 17. Hence, we could not find any disclosure in
Langberg to sustain the Examiner’s position that fractional flow reserve
analysis is performed via pressure measurements. Therefore, in light of the
above, we agree with Appellants that Langberg does not disclose fractional
flow reserve analysis, as required by claim 13. App. Br. 13. Accordingly,
the rejection of claim 13 over the combined teachings of Cohn, Bardy,
Frazin, and Langberg cannot be sustained.
With respect to claim 21, Cohn specifically discloses implanting a
mitral valve therapy device (cinching device 106) including first deploying a
distal end 139 and then a proximal end 142 in a patient’s coronary sinus 30
adjacent the patient’s mitral valve annulus 33 to reduce mitral regurgitation.
FF 1. As detailed above, we find that the combined teachings of Cohn,
Bardy, Frazin, and Langberg would have prompted a person of ordinary skill
in the art, namely, a cardiac surgeon, to assess arterial perfusion of a
patient’s heart when implanting a mitral valve therapy device in the coronary
sinus of the patient’s heart. Cohn further discloses visualization of the
implantation procedure. FF 3. Since the implantation procedure of Cohn,
Bardy, Frazin, and Langberg includes the deployment of both distal and
proximal anchors, we find that the disclosure of Cohn would have
reasonably suggested to a person of ordinary skill in the art visualization of
the procedure after deployment of the distal anchor and after deployment of
the proximal anchor. As such, we find that the same person of ordinary skill
in the art exercising ordinary common sense would have readily assessed
arterial perfusion of the patient’s heart throughout the procedure of Cohn,
Bardy, Frazin, and Langberg, that is, after deployment of the distal anchor
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and after deployment of the proximal anchor. We agree with the Examiner
that a person of ordinary skill in the art would have first assessed the arterial
perfusion to the heart after deployment of the distal anchor to determine
whether to proceed with deployment of the proximal anchor. See Ans. 13-
14. We find that the same person of ordinary skill in the art would have
assessed the arterial perfusion to the heart after deployment of the proximal
anchor to determine whether the implantation device of Cohn, Bardy, Frazin,
and Langberg had been positioned correctly in the patient’s coronary sinus.
Like the Examiner, we find the claimed sequence of steps to be based on
mere common sense. After all, “[a] person of ordinary skill is also a person
of ordinary creativity, not an automaton.” KSR Int’l. Co. v. Teleflex Inc.,
550 U.S. 398, 421 (2007). In conclusion, we find that the Examiner’s
combination of the teachings of Cohn, Bardy, Frazin, and Langberg
establishes a prima facie case of obviousness of the subject matter of claim
21.
NEW GROUNDS OF REJECTION
We make the following additional new ground of rejection pursuant to
37 C.F.R. § 41.50(b)(2007).
Claim 13 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Cohn, Bardy, Frazin, and Pijls.
As shown above, the combined teachings of Cohn, Bardy, and Frazin
disclose a step of assessing arterial perfusion of the heart. However, Cohn,
Bardy, and Frazin do not disclose using fractional reserve flow analysis to
assess arterial perfusion of the heart. Neither the Examiner nor Appellants
have explained what constitutes fractional flow reserve analysis. Pijls
discloses that the fractional flow reverse index (FFR) indicates myocardial
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ischemia (a deficient supply of blood to the heart caused by obstruction of
the inflow of arterial blood to the myocardium, i.e., the heart) in patients
having coronary-artery stenoses of moderate severity that is difficult to
determine using standard non-invasive tests. FF 29. According to Pijls, the
FFR index is determined from pressure measurements of the mean distal
coronary-artery pressure and the aortic pressure. FF 30. Frazin discloses a
process that measures blood flow through a blood vessel during a
catherization procedure. FF 6-8 and 10. Frazin further teaches guiding
pressure measurement probes within the cardiovascular system. FF 5. We
find that a person of ordinary skill in the art would have readily recognized
that the FFR index of Pijls could easily be derived from the pressure
measurements obtained by Frazin. As such, we find that it would have been
obvious for a person of ordinary skill in the art to use the pressure
measurements of Frazin to determine the FFR index of Pijls to asses arterial
perfusion of the heart when implanting the mitral valve therapy device of
Cohn and Bardy, because Pijls specifically discloses that the FFR index
provides superior results in determining myocardial ischemia in patients
having coronary-artery stenoses of moderate severity.
In light of the above, we conclude that the combined teachings of
Cohn, Bardy, Frazin, and Pijls establishes a prima facie case of obviousness
of the subject matter of claim 13.

The Declarations under 37 C.F.R. § 1.132 of
Charanjit S. Rihal, MD and David G. Reuter, MD
We recognize that evidence of secondary considerations, such as that
presented by Appellants, must be considered in route to a determination of
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obviousness/nonobviousness under 35 U.S.C. § 103. App. Br. 8-10.
Accordingly, we consider anew the issue of obviousness under 35 U.S.C.
§ 103, carefully evaluating and weighing both the evidence relied upon by
the Examiner and the objective evidence of nonobviousness provided by
Appellants.
As pointed out in our findings above, the credentials set forth in the
Rihal Declaration amply establish that Dr. Rihal is an expert in the field of
cardiology, but do not establish that Dr. Rihal is an expert in the field of
intellectual property, or obviousness under 35 U.S.C. § 103, in particular.
FF 18 and 19. An expert's opinion on the legal conclusion of obviousness is
neither necessary nor controlling. Avia Group Intern., Inc. v. L.A. Gear
Calif., Inc., 853 F.2d 1557, 1564 (Fed. Cir. 1988). Furthermore,
obviousness is an objective standard based on a hypothetical person of
ordinary skill in the art. Dr. Rihal’s subjective impression of obviousness or
whether he would have expected there to be any value to monitoring arterial
perfusion of the heart during a venous procedure (FF 22) is immaterial to the
obviousness determination. See, e.g., Standard Oil Co. v. American
Cyanamid Co., 774 F.2d 448, 454 (Fed. Cir. 1985).
Dr. Rihal’s opinion that cardiac arterial perfusion would not have
been obvious because “there is no need to monitor arterial perfusion of the
heart during or after the venous procedure” (FF 20) and because it adds time,
complexity, and potential risk” (FF 21) is entitled to little, if any, weight for
the reasons discussed below. Simply that benefits may come at the expense
of another benefit does not obviate the clear teachings in the art. While
Cohn does not disclose monitoring arterial perfusion when implanting a
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mitral valve therapy device, Bardy specifically discloses the importance of
monitoring arterial perfusion of the heart of a patient. See also, FF 12-14.
Furthermore, as we have noted on multiple occasions throughout this
opinion, a person of ordinary skill in the art, i.e. a cardiac surgeon, knowing
that coronary veins and arteries run in close proximity to each other, (as
taught by Santamore), would have readily understood that if the coronary
sinus is expanded so as to implant a therapy device, a nearby coronary artery
may be impinged so as to occlude blood flow to the heart. The same person
of ordinary skill in the art exercising only ordinary creativity and an
abundance of caution would have appreciated that such a patient should be
monitored for arterial perfusion of the heart. It appears that Dr. Rihal is not
taking into account the fact that a person of ordinary skill is also a person of
ordinary creativity, not an automaton. There is no evidence in this record
that monitoring arterial perfusion of a patient’s heart when implanting a
mitral valve therapy device in the patient’s coronary sinus was beyond the
technical grasp of a person of ordinary skill in the art.
Moreover, Dr. Rihal has not provided any objective evidence to show
that monitoring arterial perfusion of the heart “adds time, complexity, and
potential risk.” The fact that a combination would not be made by
businessmen for economic reasons does not mean that a person of ordinary
skill in the art would not make the combination because of some
technological incompatibility. In re Farrenkopf, 713 F.2d 714 (Fed. Cir.
1983). Furthermore, both Cohn and Frazin disclose using echocardiography,
to either visualize the implantation procedure of cinching device 106 in
Cohn (FF 3) or to measure blood flow through a blood vessel in Frazin (FF 8
and 9). Hence, a person of ordinary skill in the art exercising only ordinary
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creativity would have recognized that when implanting the therapeutic
device in the process of Cohn, the same echocardiography technique can
both visualize the procedure and monitor arterial perfusion of the heart by
simple manipulation of the ultrasonic probe.
Appellants further allege that the Rihal Declaration shows unexpected
results when monitoring arterial perfusion of the heart while performing a
percutaneous mitral valve annuloplasty procedure. See App. Br. 8-10. To be
given substantial weight in the determination of obviousness or non-
obviousness, evidence of secondary considerations must be relevant to the
subject matter as claimed, and therefore, there needs to be a nexus between
the merits of the claimed invention and the evidence of secondary
considerations. Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776
F.2d 281, 306 n.42 (Fed. Cir. 1985).
At the outset, we note that the scope of the study in the Rihal
Declaration was to determine whether the anatomical relationship between
the circumflex artery and the coronary sinus of a dog poses a safety concern
when implanting a percutaneous mitral valve annuloplasty device in the
coronary sinus of a dog. FF 23. First, while the study in the Rihal
Declaration is limited to monitoring blood flow through the circumflex
artery of dogs, Appellants’ claimed method is not so limiting. Each of
independent claims 1, 21, and 33 requires a step of assessing “arterial
perfusion of the heart,” without limiting the claimed method to the
circumflex artery (merely one of the coronary arteries) of dogs. Similarly,
the Reuter Declaration is also limited to monitoring blood flow through the
circumflex artery. FF 28. Second, the Rihal Declaration indicates that three
out of eight dogs died because of impingement of the circumflex artery.
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FF 25-26. However, this does not constitute objective evidence that
assessing arterial perfusion of the heart provides an unexpected result. For
example, the Rihal Declaration does not provide any objective evidence to
show that the other five dogs survived the implantation procedure because
assessment of arterial perfusion of the heart was performed. As such, Dr.
Rihal’s statement that “it is necessary to actually monitor arterial perfusion
of the heart during the procedure” is merely conclusory. See FF 27.
Moreover, as discussed above, given the known proximity of coronary veins
and coronary arteries to each other (see FF 4), a person of ordinary skill in
the art of cardiac surgery exercising only ordinary creativity and an
abundance of caution would have readily understood that if the coronary
sinus is expanded so as to implant a therapy device it may impinge on a
nearby coronary artery and hence, occlude blood flow to the heart.
Accordingly, any benefits resulting from the assessment of arterial perfusion
of the heart during the procedure would appear to be expected, rather than
unexpected. Expected beneficial results are evidence of obviousness just as
unexpected beneficial results are evidence of unobviousness. See Ex parte
Novak, 16 USPQ2d 2041, 2043 (BPAI 1989), aff'd mem., 899 F.2d 1228
(Fed. Cir. 1990); In re Skoner, 517 F.2d 947, 950 (CCPA 1975).
Lastly, with respect to the Reuter Declaration, although the study was
performed on humans, the Reuter Declaration fails to indicate how many
patients were tested. FF 28. Without knowing the total number of patients
in the study it is not clear whether the eleven instances in which assessment
of arterial perfusion of the heart was needed actually represents an
unexpected result. Moreover, the Reuter Declaration does not provide any
description of the study, i.e., the number of patients tested, the test
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procedures, the cardiac health of the patients, the size and configuration of
the devices implanted, etc.
After reviewing all of the evidence, as well as the respective
arguments of the Examiner and Appellants with respect thereto, we conclude
that, on balance, the evidence of nonobviousness of the subject matter of
claims 1-37 fails to outweigh the evidence of obviousness. See Richardson-
Vicks Inc. v. Upjohn Co., 122 F.3d 1476, 1483 (Fed. Cir. 1997).

CONCLUSIONS
1. Appellants have failed to show that the Examiner erred in determining
that the combined teachings of Cohn, Santamore, and Frazin would
have prompted a person of ordinary skill in the art to assess arterial
perfusion of a patient’s heart when implanting a mitral valve therapy
device in the coronary sinus of the patient’s heart.
2. Appellants have failed to show that the Examiner erred in determining
that the combined teachings of Cohn, Bardy, and Frazin would have
prompted a person of ordinary skill in the art to assess arterial
perfusion of a patient’s heart when implanting a mitral valve therapy
device in the coronary sinus of the patient’s heart.
3. Appellants have failed to show that the Examiner erred in determining
that the combined teachings of Cohn, Bardy, Frazin, and Langberg
render obvious the subject matter of claims 4-10, and 17-32.
Appellants have shown that the Examiner erred in determining that
the combined teachings of Cohn, Bardy, Frazin, and Langberg render
obvious the subject matter of claim 13.

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DECISION
The Examiner’s decision to reject claims 1-37 is affirmed as to claims
1-12 and 14-37 and reversed as to claim 13.
We enter a new ground of rejection of claim 13 under 35 U.S.C. §
103(a) as unpatentable over Cohn, Bardy, Frazin, and Pijls.
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 grounds of rejection to
avoid termination of the appeal as to the rejected claims:
(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 . . .

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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) (2007).

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

Klh

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