Ex Parte Pederson

Patent Trial and Appeal Board

May 5, 2017

11402463 (P.T.A.B. May. 5, 2017)

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.
11/402,463 04/12/2006 Brian D. Pederson P39759.00 US 6406
28390 7590 05/09/2017
MEDTRONIC VASCULAR, INC.
IP LEGAL DEPARTMENT
3576 UNOCAL PLACE
SANTA ROSA, CA 95403
EXAMINER
DINGA, ROLAND
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
05/09/2017 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):
rs. vasciplegal @ medtronic .com
medtronic_c v_docketing @ cardinal-ip. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BRIAN D. PEDERSON
Appeal 2015-0018461
Application 11/402,4632
Technology Center 3700
Before MICHAEL C. ASTORINO, KENNETH G. SCHOPFER, and
MATTHEW S. MEYERS, Administrative Patent Judges.
SCHOPFER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the rejection of claims
1—33. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 Our decision references the Appeal Brief (“Appeal Br.,” filed Jan. 27,
2014) and Reply Brief (“Reply Br.,” filed Nov. 10, 2014), and the
Examiner’s Answer (“Ans.,” mailed Sept. 25, 2014) and Non-Final Office
Action (“Non-Final Act.,” mailed Aug. 1, 2013).
2 According to Appellant, the real party in interest is Medtronic ATS
Medical Inc. Appeal Br. 3.
Appeal 2015-001846
Application 11/402,463
BACKGROUND
According to Appellant, “[t]he present invention relates to systems
and methods for conditioning various surfaces in vivo generally, and more
particularly to systems and methods for inhibiting blood platelet adhesion on
such surfaces, and specifically blood platelet adhesion to surfaces of
implanted medical devices.” Spec. 1,11. 6—10.
CLAIMS
Claims 1—33 are on appeal. Claim 1 is illustrative of the appealed
claims and recites:
1. A method for inhibiting thrombogenesis on a surface of a
body in vivo, said method comprising:
(a) providing an electrical energy source;
(b) coupling said electrical energy source to said surface;
and
(c) delivering between about 0.1 and about 10 mA
electropositive current from said electrical energy source to said
surface to create an electropositive current density of between
about 0.001 and about 1.0 mA/cm2 on said surface.
Appeal Br. 19.
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Application 11/402,463
REJECTIONS
1. The Examiner rejects claims 1, 2, 4, 6, 7, 10, 12—15, 17, 19-23, 25, 27,3
and 29-33 under 35 U.S.C. § 103(a) as unpatentable over Opie.4
2. The Examiner rejects claims 3,5, 11, 16, 18, 26, and 28 under 35 U.S.C.
§ 103(a) as unpatentable over Opie in view of Whitney.5
3. The Examiner rejects claims 8, 9, 23, and 24 under 35 U.S.C. § 103(a) as
unpatentable over Opie in view of Hauk.6
DISCUSSION
With respect to all of the independent claims on appeal, the Examiner
finds that Opie discloses a method as claimed except that Opie discloses a
current of 100 to 300 mA and does not disclose using a current of 0.1 to 10
mA or a current density of 0.001 to 1.0 mA/cm2. Non-final Act. 2. The
Examiner finds that Opie discloses the use of trial and error to find the
necessary charge to inhibit thrombosis, and the Examiner concludes
It would have been obvious to one having ordinary skill in the art
at the time the invention was made to have a current of 0.1 to 10
mA to create a current density of 0.001 to 1.0 mA/cm2 on the
surface, since it has been held that where the general conditions
of a claim are disclosed in the prior art, discovering the optimum
3 Although claims 4, 17, and 27 are rejected by the Examiner over Opie
alone, we note that those claims depend from claims 3,16, and 26,
respectively, which have been rejected over the combination of Opie and
Whitney. We also note that although the Examiner lists claim 23 in the
heading for this rejection, claim 23 is only discussed in the rejection over
Opie in view of Hauk. Because we do not sustain the rejections of the
independent claims from which each of claims 4, 17, 23, and 27 depend, we
consider these inconsistencies to be harmless error.
4 Opie, US 2005/0021134 Al, pub. Jan. 27, 2005.
5 Whitney, US 5,603,731, iss. Feb. 18, 1997.
6 Hauk, US 6,560,489 B2, iss. May 6, 2003.
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Application 11/402,463
or workable ranges involves only routine skill in the art. In re
Aller, 105 USPQ 233.
Id. at 2—3.
As discussed below, we are persuaded of reversible error in the
rejections of claims 1—11, 13, and 15—33. However, we are not persuaded of
reversible error in the rejection of claims 12 and 14.
Claims 1—11 and 15—33
Appellant relies on the March 25, 2010 Declaration of Brian Pederson
(“Pederson Declaration”) to argue that the rejections are in error. Appeal Br.
10-13. With respect to claim 1, we are persuaded by Appellant’s argument
that the use of the claimed range of electropositive current was not obvious
in view of Opie because the range is “dramatically less than what is
disclosed in Opie” and the results of using the claimed range were
unexpected and surprising. Appeal Br. 11—12 (citing Pederson Declaration |
7). In support, Appellant asserts that the general understanding in the field
was that increasing current levels would correspond to increasing
antithrombogenic effects and that Opie discloses that the current necessary
may need to be higher than the disclosed range of 100 to 300 mA. Appeal
Br. 11—12 (citing Pederson Declaration | 7).
In response, the Examiner maintains that Opie teaches that the amount
of current applied is a result effective variable that the claims here are
merely optimizing. Ans. 6. Thus, the Examiner finds that Appellant’s
results are expected and Appellant only varies “known parameters to achieve
those results.” Id. In further support, the Examiner finds that Opie suggests
that the current applied may vary depending on the degree of
thrombogenesis reduction desired, and that the Specification indicates that
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Application 11/402,463
the amount of current density required may be somewhat greater than the
upper limit of the claim range. Id.
We conclude that a preponderance of the evidence supports
Appellant’s position. Although we find that Opie provides that the amount
of current applied to achieve the desired anti-thrombogenic effect is a result-
effective variable, the evidence provided by Appellant, which is supported
by the art, shows that one of ordinary skill in the art would not have found it
obvious to reduce the current applied to the levels claimed to inhibit
thrombogenesis. The Pederson Declaration states that the general
understanding in the field was “that a relatively linear relationship exists
between the extension of clotting time at a surface with increasing current
values. Consequently, conventional thought is that increased current levels
correspondingly increase antithrombogenic effect, and, conversely,
decreased current levels correspondingly decrease antithrombogenic effect.”
Pederson Decl. 17. Based on this conventional understanding in the field,
Pederson concludes that “it is a surprising discovery that an electropositive
current of between about 0.1 and about 10 mA to provide an electropositive
current density of between about 0.001 and about 1.0 mA/cm2 is effective in
establishing an antithrombogenic surface.” Id.
We find that Opie supports Appellant’s position that one of ordinary
skill in the art would have found it surprising and unexpected that using the
current claimed would provide a sufficient anti-thrombogenic response.
Opie discloses that “[standard trial and error” may be used to find “the
necessary charge to repel platelets and passing red blood cells.” Opie 131.
However, Opie goes on to disclose that the necessary charge is “expected to
lie somewhere between +/- 100 to 300 milliamps” and that the current
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Application 11/402,463
necessary “might need to be higher than that charge depending upon the
indexed mass of the individual.” Id. Further, Opie discloses that “a high
positive surface charge . . . induces a progressive decrease in contact
efficiency” between erythrocytes and the charged surface. Id. at | 5. Thus,
although Opie discloses that trial and error may be used to find the current
necessary to inhibit thrombosis, Opie suggests the use of higher current and
indicates that as the current increases the anti-thrombogenic effect increases.
See id. at 131. For these reasons and because of the large disparity between
the claimed current range and current density range and that disclosed in
Opie, we find that one of ordinary skill in the art would not have found it
obvious to pursue a current in the range claimed.
Based on the foregoing, we find that the evidence before us shows
that one of ordinary skill in the art would not have found it obvious to reduce
the current used in Opie to the values claimed. Therefore, we do not sustain
the rejection of claim 1 as obvious over Opie. For the same reasons, we do
not sustain the rejections of claims 2—11 or 15—33.
Claims 12—14
Independent claim 12 differs from the other independent claims on
appeal in that it does not require a specific current or current density range.
Claim 12 recites a method comprising: “electrically coupling said medical
device to an electrical energy source such that said electrical energy source
delivers electropositive current to said medical device to generate a sub­
threshold current density on said medical device.” Appeal Br. 21. The only
limit on the current applied is that it creates a “sub-threshold current
density” on the implant.
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As discussed below, we are not persuaded of reversible error by
Appellant’s arguments with respect to this claim.
First, to the extent Appellant relies on the arguments discussed above
with respect to claim 1, we are not persuaded of error because those
arguments are not commensurate with the scope of claim 12, which, as
noted, does not require a specific current range or current density range.
Second, Appellant argues that the use of solely electropositive current
differentiates the claimed method from Opie. Appeal Br. 10—11.
Specifically, Appellant asserts that the general understanding in the art is
that negatively charged surfaces assist in inhibiting coagulation while the
claims require electropositive current; that Opie does not utilize solely
electropositive current; and that the claimed method was not expected in
view of Opie because the superior effect of electropositive surface charge on
inhibiting coagulation was surprising. Id. (citing Pederson Declaration at
17).
We are not persuaded because Opie discloses that the device 10 “is
electrically charged, either positively or negatively,” and thus, the device has
either a positive or negative current density. Opie 121. Appellant does not
sufficiently explain why Opie’s use of positive current is somehow different
than the electropositive current required by the claim. Further, to the extent
that Appellant argues that the method or device must deliver only
electropositive charge, the claim is not so limited. The claim requires
delivering electropositive current, but does not exclude also delivering
negative current.
Finally, Appellant argues that the current required by the claim is
below the excitation threshold level for adjacent tissue, in contrast to Opie,
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which uses “current magnitudes . . . within the range that could cause
excitation.” Appeal Br. 12. We disagree. Opie discloses that current should
be used that is “insufficient to interfere with the heart’s normal beating.”
Opie 116. Further, Appellant’s Specification indicates that threshold
current density for cardiac tissue is about 75mA/cm2 (Spec. 6) and
Appellant calculates that the current density range for Opie based on Opie’s
use of 100—300mA on a heart valve would be 8.1—24.2 mA/cm2 (Reply
Br. 3); i.e., below the threshold cited in the Specification.
Based on the foregoing, we are not persuaded of error with respect to
the rejection of claim 12, and accordingly, we sustain the rejection of claim
12. We also sustain the rejection of claim 14 which is dependent therefrom,
for which Appellant does not provide separate arguments.
However, we will not sustain the rejection of claim 13, which requires
that the “sub-threshold current density is between about 0.0001 and about
1.0 mA/cm2.” Appeal Br. 13. For the reasons set forth above with respect
to claim 1, we are persuaded that a person of ordinary skill in the art would
not have found it obvious to use the claimed current density range in view of
Opie.
CONCLUSION
For the reasons set forth above, we AFFIRM the rejection of claims
12 and 14 and we REVERSE the rejections of claims 1—11, 13, and 15—33
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED-IN-PART
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