Ex Parte Peters

Patent Trial and Appeal Board

Jul 25, 2018

13320381 (P.T.A.B. Jul. 25, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/320,381 02/27/2012 Gary Peters
34284 7590 07/27/2018
RUTAN & TUCKER, LLP
611 ANTON BL VD
SUITE 1400
COST A MESA, CA 92626
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.
101900.0103P 2414
EXAMINER
ZAM ORY, JUSTIN L
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
07/27/2018 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
patents@rutan.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GARY PETERS 1
Appeal2017-010492
Application 13/320,381
Technology Center 3700
Before JAMES P. CALVE, BENJAMIN D. M. WOOD, and
ARTHUR M. PESLAK, Administrative Patent Judges.
CAL VE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the Non-Final
Office Action finally rejecting claims 1-12, 19, and 20. Appeal Br. 3.
Claims 13-18 are withdrawn. Id. We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM.
1 C. R. Bard, Inc. is identified as the real party in interest. Appeal Br. 3.
Appeal2017-010492
Application 13/320,381
CLAIMED SUBJECT MATTER
Claims 1 and 19 are independent. Claim 1 is reproduced below.
1. A catheter stabilization device comprising:
at least one anchor pad having a lower surface at least
partially covered by an adhesive for contacting a
patient's skin;
at least one mounting wing disposed on the at least one
anchor pad;
an adapter member having a longitudinal axis, a proximal
portion, and a distal portion, the adapter member
comprising a first connector forming at least part of
the proximal portion, a second connector forming at
least part of the distal portion, and a lumen extending
from the first connector to the second connector, the
first connector being configured to connect to a hub of
a catheter near an insertion site; and
at least one support member supporting the adapter
member away from the at least one mounting wing,
the adapter member permanently attached to the at
least one support member.
Appeal Br. 21 (Claims App'x).
REJECTIONS
Claims 1-3 and 8-12 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Bierman (US 7,014,627 B2, iss. Mar. 21, 2006) and Fuchs
(US 4,161,177, iss. July 17, 1979).
Claims 4, 5, and 7 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Bierman, Fuchs, and Brimhall (US 2007 /0250021 A 1,
pub. Oct. 25, 2007).
Claims 6, 19, and 20 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Bierman, Fuchs, and D' Alo (US 4,326,519, iss. Apr. 27,
1982).
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Appeal2017-010492
Application 13/320,381
ANALYSIS
Claims 1-3 and 8-12
Rejected Over Bierman and Fuchs
Appellant argues claims 1-3 and 8-12 as a group. Appeal Br. 8-16.
We select claim 1 as representative, with claims 2, 3, and 8-12 standing or
falling with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
The Examiner finds that Bierman discloses a catheter stabilization
device as recited in claim 1, except for the adapter member ( connector fitting
300) being "permanently attached to the at least one support member." Non-
Final Act. 2-3. The Examiner finds that Fuchs teaches a catheter attachment
device comprising an adapter member (front and rear sections 1, 2) attached
permanently with support members (integral crosspieces 6 and fixing plates
7, 7'). Id. at 3. The Examiner also finds that Fuchs teaches that this integral
attachment of an adapter to support members prevents any movements of the
catheter caused by tension, pressure, or lateral deflections, and determines it
would have been obvious to modify Bierman' s catheter adapter member to
be integral with a support member for similar benefits. Id.
Appellant argues that Bierman is configured to retain a variety of
catheter hubs or connector fittings ( adapter members) so making a single
catheter adapter integral with the support member would prevent the retainer
from retaining different hubs or medical articles and would restrict rotation
of a medical retainer. Appeal Br. 9-12. Appellant also argues that Bierman
thus teaches away from the modification. Id. at 12-13. Appellant further
argues that Bierman discloses a device that prevents or restricts movements
of the catheter so there is no motivation to modify Bierman with teachings of
Fuchs absent impermissible hindsight. Id. at 14--15.
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Appeal2017-010492
Application 13/320,381
Bierman' s mere disclosure of alternative designs does not teach away
from a particular design or from a permanent attachment of medical articles
300, such as connector fittings with a support member (body member 130),
as claimed. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). A
"teaching away" requires the "clear discouragement" from implementing a
technical feature. In re Ethicon, Inc., 844 F.3d 1344, 1351 (Fed. Cir. 2017).
Bierman does not disparage or clearly discourage the permanent
attachment of medical articles to body member 130 as claimed. Bierman
teaches to connect medical article 300 (an adapter member) to body member
130 (a support member) to restrict, and prevent, any lateral and transverse
movement, and any longitudinal and rotational movement, of the retained
section of the medical article. Bierman, 7:25-30, 13:28-50, 21:15-34.
Fuchs teaches to achieve this objective via the permanent attachment
of front and rear sections 1, 2 to fixing plates 7, 7' via integral crosspieces 6
in order to prevent dislocation or disruption of a catheter in a patient and any
resulting injury to the patient. Fuchs, 1:39-59, 2: 15-20, 3:27--41.
The fact that the motivating benefit [ of Fuchs] comes at the
expense of another benefit, however, should not nullify its use
as a basis to modify the disclosure of one reference with the
teachings of another. Instead, the benefits, both lost and
gained, should be weighed against one another.
Winner Int'! Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir.
2000). Therefore, the issue is whether a skilled artisan would have been
motivated to modify Bierman to provide a permanent attachment of medical
article 300 to body member 130, as claimed, even if this change comes at the
expense of having the ability to attach different medical articles 3 00 to body
member 130.
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Appeal2017-010492
Application 13/320,381
The Examiner reasonably determined that a skilled artisan would have
been motivated to modify Bierman to provide a permanent attachment of the
medical article 300 to body member 130 to achieve the benefits taught by
Fuchs and desired by Bierman, i.e., preventing movement of medical article
300 relative to body member 130 and a patient. The benefits to be gained by
a permanent attachment outweigh the loss of the ability to change medical
articles 300 in body member 130. This motivation is particularly compelling
for embodiments of Bierman where rotation or movement of medical article
300 relative to body member 130 is not desired. Bierman, 13: 16-18 (some
embodiments of retainer 120 inhibit rotational movement). Permanent
attachment also avoids problems associated with inserting medical article
300 into body member 130, e.g., a risk of the squeezing sides of body 130
and constricting channel 140 in which medical article 300 is positioned, and
a need for a healthcare provider to grip movable tab 310 when disconnecting
a connector fitting 300 from a catheter hub. Id. at 14:8-17, 17:33--46.
Thus, the proposed modification improves the stability of Bierman' s
device at the cost of being able to use a single support 130 with different
medical articles. A skilled artisan could reasonably determine that the
advantages of reduced cost, simplicity of design, ease of use, and improved
stability for reduced risk of patient injury outweigh any loss of versatility.
Ans. 7-8. See KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416-17 (2007)
(the mere substitution of one element for another known in the field must do
more than yield a predictable result; if a technique has been used to improve
one device and a person of ordinary skill 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 ability).
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Appeal2017-010492
Application 13/320,381
We also agree with the Examiner that Bierman teaches an adapter
member as medical article 300 that includes a second connector as radially
extending elements 370a, 370b. Ans. 8. These elements connect medical
article 300 to body member 130 and are positioned on a distal portion of
medical article 300 opposite to a proximal portion with first connector 350.
Non-Final Act. 2; Ans. 8; Bierman, 17:5-22. Claim 1 does not recite any
other features of the claimed second connector, and Appellant's Figure 1
illustrates luer connector 116 with a bayonet-like connection. The recitation
in dependent claims 4--6 of the second connector comprising a female luer
connection, a mechanical valve, and an extension set, means that the second
connector recited in claim 1 is not limited to such dependent claim features.
Thus, we sustain the rejection of claims 1-3 and 8-12. 2
Claims 4, 5, and 7
Rejected Over Bierman, Fuchs, and Brimhall
The Examiner relies on Brimhall to teach a second connector on a
catheter device that comprises a female luer connector, a mechanical valve,
and a split septum as recited, respectively, in dependent claims 4, 5, and 7.
Non-Final Act. 4. The Examiner determines it would have been obvious to
include such a second connector of Brimhall on the modified device of
Bierman to prevent fluid from leaking out of the adapter during use thereby
maintaining the sterility of the device and protecting the user and patient
during an infusion. Non-Final Act. 4--5; Ans. 8-9.
2 Appellants' hindsight argument is not persuasive where the Examiner has
provided a rationale for the combination that is supported adequately by
sufficient facts and a rational underpinning. In re Cree, 818 F .3d 694, 702,
n.3 (Fed. Cir. 2016) (hindsight argument is ofno moment where a sufficient,
non-hindsight reason to combine the references is provided).
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Appeal2017-010492
Application 13/320,381
Appellant argues that "the Examiner erroneously relies on the
Brimhall septum 420 for a teaching of both the claimed septum of claim 7
and the mechanical valve of claim 5." Appeal Br. 17 ("it is improper to rely
on the same structure as disclosing two separate claim elements.").
This argument is not persuasive because it is not commensurate with
the scope of claims 4, 5, and 7. Each of these claims depends from claim 1
and recites that the second connector of claim 1 comprises "a female luer
connector" ( claim 4), "a mechanical valve" ( claim 5), or "a split septum"
( claim 7). Appeal Br. 21-22 (Claims App 'x). The Examiner correctly finds
that Brimhall teaches a second connector that comprises a female luer that
also is a split septum that functions as a mechanical valve as recited in these
dependent claims. Appellants do not explain why Brimhall' s connector is
not a female luer, split septum, or mechanical valve as claimed. The claims
require structure that is one of these three connectors. Brimhall discloses a
structure that satisfies all three limitations.
Thus, we sustain the rejection of claims 4, 5, and 7.
Claims 6, 19, and 20
Rejected Over Bierman, Fuchs, and D 'Alo
Appellant's argument that Bierman and Fuchs do not render obvious
the claimed permanent attachment of a support member and adapter in
independent claim 19 for similar reasons as claim 1 ( Appeal Br. 17-18) is
not persuasive for the reasons discussed above for the rejection of claim 1.
We also agree with the Examiner that D' Alo teaches a catheter with a
second connector in the form of an extension set of flexible tubing 7 4 and
cap 76 of tubing port 72 as recited in claims 6 and 19. Non-Final Act. 6.
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Appeal2017-010492
Application 13/320,381
The Examiner proposes to substitute the extension set of D 'Alo for
the second connector of Bierman/Fuchs as a means of attaching the device to
a needle or other device for introducing medicaments or withdrawing blood
as D' Alo teaches are the advantages of such an extension on a catheter
device such as that of Bierman/Fuchs. Id. at 6; see KSR, 550 U.S. at 416-17.
We are not persuaded by Appellant's arguments that Bierman/Fuchs
lack a second connector for combining with the teachings of D 'Alo ( Appeal
Br. 19) for the reasons discussed above for claim 1. Thus, we sustain the
rejection of claims 6, 19, and 20.
DECISION
We affirm the rejections of claims 1-12, 19, and 20.
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
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