Ex Parte Bennett

Patent Trial and Appeal Board

Aug 24, 2016

11257224 (P.T.A.B. Aug. 24, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111257,224
24392 7590
FISH & TSANG LLP
ROBERT D. FISH
2603 Main Street
Suite 1000
10/24/2005
08/26/2016
Irvine, CA 92614-6232
FIRST NAMED INVENTOR
Tionne Allen Bennett
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.
102035.000lUSl 9313
EXAMINER
CARPENTER, WILLIAM R
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
08/26/2016 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):
rfish @fishiplaw.com
patents@fishiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TIONNE ALLEN BENNETT
Appeal2014-008859
Application 11/257 ,224
Technology Center 3700
Before ERIC B. GRIMES, ULRIKE W. JENKS, and ROBERT A.
POLLOCK, Administrative Patent Judges.
PERCURIAM
DECISION ON APPEAL
r-T"I.. • • .. • • .. 1 .. ,..... ,_ T T r'1 I'\ l\ -1 ,..... Al r'" , "1
ims 1s a aec1s10n on appear unaer j) u.~.L. s lj4 rrom me
Examiner's rejection of claims 1-15. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We affirm-in-part.
STATEMENT OF THE CASE
The Specification discloses a catheter cover structure that was
"designed to provide an easy way to secure a catheter to a patient's skin at or
in the vicinity of a catheter puncture site." Spec. i-f 7.
1 Appellant identifies the Real Party in Interest as Tionne Allen Bennett
(App. Br. 1 ).
Appeal2014-008859
Application 11/257 ,224
Claim 1 is representative of the claims on appeal and reads as follows:
1. A protective cover for securing a catheter having a
needle inserted at an insertion site in a patient's skin,
compnsmg:
a single-piece element including (a) a first curved portion
extending about the perimeter of the element and bearing an
adhesive material configured to secure the element to a
patient's skin about an insertion site, (b) a chamber portion
disposed inwardly of the first portion, and ( c) at least one raised
wing having curved upper and lower surfaces extending from
the skin-engaging first portion to the chamber portion;
wherein the at least one raised wing slopes upwardly
with respect to the patient's skin from the skin-engaging first
portion to the chamber portion, such that objects hitting the
element are deflected;
wherein the chamber portion defines a protective housing
for receiving one end of a catheter secured to a needle, the
chamber portion extending substantially diametrically from one
side of a perimeter to an opposing side; and
a slot disposed within the chamber portion and carried by
the element, \'I/herein the slot is configured to prevent
movement of the catheter with respect to the chamber portion.
App. Br. 13 (Claims Appendix) (emphasis added).
The Examiner rejects the claims on appeal as follows:
Claims 1-14 under 35 U.S.C. § 112, first paragraph;
clairns 1-14 under 35 U.S.C. § 112, second paragraph;
claims 1, 2, 9, 10, and 13-15 under 35 U.S.C. § 103(a) in view of
Wagner2 and Cooke;3
2 William H. Wagner, US 3,900,026, issued Aug. 19, 1975.
3 Edith A. Cooke, US 3, 194,235, issued July 13, 1965.
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Application 11/257 ,224
clairns 1, 2, 9, 10, and 13-15 under 35 U.S.C. § 103(a) in view of
Wagner, Cooke, and Proulx;4
claims 3-8 under 35 U.S.C. § 103(a) in view of Wagner, Cooke,
Proulx, and \Vright; 5
claim 11 under 35 U.S.C. § 103(a) in view of \Vagner, Cooke, Proulx,
and Hakky; 6,7 and
claim 12 under 35 U.S.C. § 103(a) in view of vVagner, Cooke, Proulx,
and Bierman.8
I.
Issue
The Examiner has rejected claims 1-14 under 35 U.S.C. § 112, first
paragraph. Ans. 2, Fin. Rej. 3--4.
The issue presented is: Does the evidence of record support the
Examiner's finding that the Specification does not provide adequate written
descriptive support for the language: "the at least one raised wing slopes
upwardly with respect to the patient's skin from the skin-engaging first
portion to the chamber portion," as recited in claim 1 (emphasis added)?
4 Raymond E. Proulx et al., US 4,679,553, issued July 14, 1987.
5 Clifford A. Wright, US 2004/0158209 Al, published Aug. 12, 2004.
6 Said Ismail Hakky et al., US 6, 113,577, issued Sept. 5, 2000.
7 The Examiner's Answer incorrectly references the Hakky reference as US
6,113,557.
8 Steven F. Bierman, US 2002/0133121 Al, published Sep. 19, 2002.
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Application 11/257 ,224
Analysis
We have reviewed Appellant's contentions that the Examiner erred in
rejecting claims 1-14 under 35 U.S.C. § 112, first paragraph for lack of as
adequate written descriptive support in the Specification. App. Br. 3-5,
Reply Br. 2---6. We agree with Appellant that the Examiner's rejection was
in error. For emphasis, we highlight and address the following:
FF 1. Figure 1 of the Specification is shown below:
Fig. 1
Figure 1 shows a top perspective view of a shield or cover 10. Spec. i-f 14.
The shield or cover "includes a body 12 having a central chamber 14, an
edge portion 16 extending about the perimeter of the body, and side portions
18, 18' disposed on opposite sides of the chamber 14." Spec. i-f 22. Edge
portion 16 is "a relatively narrow-width peripheral region arranged about the
perimeter of the body, and preferably carries on its underside a layer of
adhesive 26." Spec. i-f 22. "Each side portion slopes from its skin engaging
perimeter to the dome portion to permit objects hitting the cover to be
deflected and [prevent] the cover from being dislodged" (emphasis added).
Spec. i-f 9.
FF2. Figure 4 of the Specification is shown, in part, below:
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Application 11/257 ,224
Figure 4 "illustrates the combined catheter and cover secured to a patient's
arm." Spec. i-f 17.
FF3. Figure 5 of the Specification is shown below:
Figure 5 shows "a cross-sectional view, taken along section line 5-5 in
Figure 4." Spec. i-f 18.
The Examiner finds that the Specification discloses a raised wing that
slopes from the skin engaging perimeter to the dome portion, but that the
Specification does not disclose a raised wing that "slopes upwardly with
respect to the patient's skin," as recited in claim 1. Fin. Rej. 3, citing the
Spec., i-f 22. The Examiner finds that although the Specification provides
"support for the [ w ]ings to be sloped, if such a slope follows the curvature of
the patient's skin" the wing would not slope upward with respect to the
patient's skin. Fin. Rej. 4. The Examiner finds that there "is no indication
in the originally filed detailed disclosure that the slope of the wing differs
from the slope of the skin." Fin. Rej. 4.
Appellant argues that sufficient disclosure "exists in at least Figure 5
and in the written description to reasonably convey to one of ordinary skill
in the art that Appellant had possession of this limitation at the time of
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Application 11/257 ,224
filing." App. Br. 3. Appellant argues that Figure 5 "shows separation
indicating that where the wing meets the chamber portion, the wing is
distanced from the patient's skin (i.e., sloped upwardly with respect to the
skin)." App. Br. 4. Appellant argues that, if the Specification "lacked
support for the limitation that the wings slope upwardly toward the chamber
portion relative to a patient's skin ... then no separation should exist
between the wings and the skin as shown in Figure 5." App. Br. 4.
Appellant provides the following annotated version of a portion of Figure 5:
App. Br. 4.
Additionally, as shown in the Specification at Figures 1, 4 and 5,
among others, both the skin engaging first portion and the chamber are
configured to rest on top of the skin. FFs FF1-FF3. The Specification also
discloses that each side portion or wing portion slopes from its skin-
engaging perimeter to the dome portion of the chamber. FF 1. One of
ordinary skill in the art would recognize that because the disclosure that each
side portion or wing slopes from its skin engaging first portion to the dome
portion of the chamber, Appellant was in possession of a raised wing or side
portion that "slopes upwardly with respect to the patient's skin," as required
by claim 1.
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Application 11/257 ,224
Thus, we reverse the rejection of independent claims 1 and dependent
claims 2-14 under 35 U.S.C. § 112, first paragraph.
The Examiner has also objected to the Specification and asserted that,
for the reasons discussed above, no antecedent basis exists in the
Specification for the claim 1 recitation wherein "at least one raised wing
slopes upwardly with respect to the patient's skin." Fin. Rej. 2. Appellant
argues that the objection was not proper and requests that "this issue be
decided on appeal because the same limitation is additionally rejected
according to§ 112, First Paragraph." App. Br. 3.
We agree with Appellant. The Examiner's objection to the
Specification should be withdrawn as moot in view of our decision to
reverse the Examiner's rejection of claims 1-14 under 35 U.S.C. § 112, first
paragraph. See In re Hengehold, 440 F.2d 1395, 1404 (CCPA 1971) ("[T]he
kind of adverse decisions of examiners which are reviewable by the board
must be those which relate, at least indirectly, to matters involving the
rejection of claims.").
Conclusion of Law
The evidence of record does not support the Examiner's finding that
the Specification lacks adequate written descriptive support for the limitation
that at least one "raised wing slopes upwardly with respect to the patient's
skin from the skin-engaging first portion to the chamber portion, as recited in
claim 1" (emphasis added).
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Application 11/257 ,224
Issue
II.
The Examiner has rejected claims 1-14 under 35 U.S.C. § 112,
second paragraph. Ans. 2, Fin. Rej. 3--4.
The issues presented are: Does the evidence of record support the
Examiner's conclusions
(i) that the recitation in claim 1 of "wherein the at least one raised
wing slopes upwardly with respect to the patient's skin" renders claim 1
indefinite?
and
(ii) that the recitation in claim 14 of "non-flexible" renders claim
14 indefinite?
Analysis
We have reviewed Appellant's contentions that the Examiner erred in
rejecting claims 1-14 under 35 U.S.C. § 112, second paragraph as indefinite.
App. Br. 5-8, Reply Br. 6-7. With respect to issue (i), we agree with
Appellant that the Examiner erred in rejecting independent 1 and dependent
claims 2-14 under 35 U.S.C. § 112, second paragraph. However, with
respect to issue (ii), we affirm the Examiner's rejection of claim 14 under 35
U.S.C. § 112, second paragraph. For emphasis, we highlight and address the
following:
Claim 1
The Examiner finds that, for the reasons discussed above, the
Specification does not provide adequate written descriptive support for the
limitation that "the at least one raised wing slopes upwardly with respect to
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Application 11/257 ,224
the skin" and therefore, it is unclear how "the wing 'slopes upwardly with
respect to the patient's skin'." Fin. Rej. 4--5.
Appellant argues that the "claim language inherently makes use of
reference frames through the use of relative language (i.e., 'with respect to')
to describe the tendency of the wings to slope upwardly toward the chamber
portion." App. Br. 6.
We agree with Appellant that one of ordinary skill in the art would
understand the metes and bounds of claim 1. That is, one of skill in the art
would understand that the skin-engaging first curved portion, the chamber,
and the at least one raised wing are configured such that, when the skin-
engaging first curved portion and the chamber are resting on a surface, such
as the skin surface, the at least one raised wing slopes upward with respect
of the surface or skin.
Accordingly, we reverse the rejection of independent claim 1 and
dependent claims 2-13 under 35 U.S.C. § 112, second paragraph.
Claim 14
Claim 14 reads as follows:
14. The protective cover of claim 1, wherein the first curved portion,
the chamber portion and the at least one raised wing are each made of non-
jlexible material.
FF4. The Specification discloses that the "shield or cover 10 of the
present invention is made of non-flexible material and includes a body 12
having a central chamber 14, an edge portion 16 extending about the
perimeter of the body, and side portions 18, 18' disposed on opposite sides
of the chamber 14." Spec. i-f 22.
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Application 11/257 ,224
The Examiner finds that the limitation non-flexible material renders
claim 14 indefinite because the "phrases 'flexible' and 'non- flexible' are
relative terms that require some sort of quantification in order to be
limiting." Fin. Rej. 5. The Examiner finds that the Specification "does not
provide a standard for ascertaining the requisite degree, and one of ordinary
skill in the art would not be reasonably apprised of the scope of the
invention." Fin. Rej. 5. The Examiner finds that the Specification does not
disclose "what material the element is to be made of, so it is unclear what
types of materials" are considered non-flexible. Fin. Rej. 5.
Appellant argues that the "mere fact that the limitation is broad ...
does not render the term indefinite," and that a "person of ordinary skill in
the art would readily understand what is meant by the use of the term 'non-
flexible' with respect to the claimed invention." App. Br. 7, citing In re
Miller, 441F.2d689 (CCPA 1971)). Appellant asserts that "countless
patents have been issued having claims that include the term 'flexible'
without providing express definitions of the term,"9 and the "Office should
use a consistent interpretation of a term unless there is good reason to
interpret terms differently from one patent to another." App. Br. 7, citing In
re Cortright, 165 F.3d 1353, 1358 (Fed. Cir. 1999).
Appellant further argues that, "[i]n the context of medical devices and
the uses claimed in the application, it would be perfectly clear to a person of
ordinary skill in the art that the term non-flexible as it relates to this device
does not refer to materials that cannot bend when unassisted human force is
9 Appellants cite US Patent Nos. 8,484,855, 8,456,861, 8,435,605, and
8,393,340.
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Application 11/257 ,224
applied." Id. at 8. In particular, one of ordinary skill in the art in this field
would understand that in the present case, "non-flexible material is simply
one that provides adequate protection from external forces that would
otherwise strike a needle in a patient's arm." Id. Moreover, a "person of
ordinary skill in the art would make use of materials having desired
compliance properties (e.g., plastics) so that the wings can conform to a
person's arm while still providing protection in the center area." Id. Thus,
"[i]n the context of medical devices, and in particular, catheter covers, a
person of ordinary skill in the art who reads the term 'non-flexible' would be
sufficiently informed as to the nature of the material to be used with the
device." Reply Br. 6.
Although no range of Young's moduli is included in the
specification, it is sufficient to describe the material as non-
flexible because it would be obvious to one of ordinary skill in
the art that the material need only be stiff enough to deflect
incoming kinetic energy such as a person bumping the cover, an
article of clothing brushing against it, or even small objects
hitting it.
Reply Br. 6-7; see also id. at 7 ("[A] non-flexible material is one that does
not easily collapse or bend when it encounters such external forces.").
vVe apply the broadest reasonable interpretation of claim terms,
consistent with the specification, as would be understood by one of ordinary
skill in the art. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed.
Cir. 2004) (citations omitted). \Vhere, as here, the Specification does not
define a term; the term should be given its ordinary rneaning and broadest
reasonable interpretation. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d
1364, 1368 (Fed. Cir. 2003). The dictionary defines the term flexible as
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Application 11/257 ,224
meaning "capable of bending or being bent." 10 Thus, the ordinary meaning
of non-flexible would be not capable of bending or being bent, and this
meaning is consistent \Vi th the use of the term non-flexible in the ._,
Specification. See FF FF4. Appellant argues that one of ordinary skill in the
art would understand the tenn non-flexible in claim 14 to mean that the
material of the first curved portion, the chamber, and the at least one raised
wing need are, e.g., "stiff enough to deflect incoming kinetic energy such as
a person or small objects hitting or bumping the cover and to deflect an
article of clothing brushing against it." See Reply Br. 6-7. But Appellant
has not provided evidence to support this asserted meaning for the claim
term non-flexible. Thus, we agree with the Examiner that, on this record,
the metes and bounds claim 14 cannot be determined, and we affirm the
rejection of claim 14 under 35 U.S.C. § 112, second paragraph.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that the recitation in claim 1 of "wherein the at least one raised wing slopes
upwardly with respect to the patient's skin" renders claim 1 indefinite.
However, the evidence of record supports the Examiner's conclusion
that the recitation of "non-flexible" in claim 14 renders this claim indefinite.
10 I\1erriam-\1Vebster Online Dictionary, http://www.merriam-
webster.com/dictionary/flexible (last accessed August 13, 2016).
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Issue
III.
The Examiner has rejected claims 1, 2, 9, 10, and 13-15 under 35
U.S.C. § 103(a) as obvious in view of Wagner and Cooke. Ans. 6-12.
The issue presented is: Does the evidence of record support the
Examiner's conclusion that the combination of Wagner and Cooke would
have made obvious a protective cover that comprises a raised wing that
extends "from the skin-engaging first portion to the chamber portion" and
"slopes upwardly with respect to the patient's skin from the skin-engaging
first portion to the chamber portion," as recited by claim 1?
Analysis
We have reviewed Appellant's contentions that the Examiner erred in
rejecting claims 1, 2, 9, 10, and 13-15 as obvious over the cited art. App.
Br. 8-10, Reply Br. 7-11. We agree with Appellant that the Examiner's
rejection was in error. For emphasis, we highlight and address the
following:
FF5. Wagner discloses a "guard for intravenous needles and their
connections [that] comprises a transparent cap or cover, formed of fairly
rigid but somewhat conformable plastic material, having peripheral skin-
contacting flanges. The latter can be attached or secured to the patient's arm
or other body part to cover and protect the inserted needle." Wagner,
Abstract.
FF6. Figure 1 of Wagner is shown below:
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Figure 1 shows a perspective view of a guard or protective device for
intravenous needles and their connections. Wagner, col. 2, 11. 13-14 and 26-
29. The protective device "comprises a box-like cap or enclosure 15 ...
[that is] thin enough to be somewhat flexible and conformable to the arm 11
or other body member but strong and rigid enough to give adequate
protection to the needle and its connections." Wagner, col. 2, 11. 13-14 and
26-29. "[T]he box or cap member 15 has a slightly curved top 16 and more
or less vertical side wall elements 16a, 16b, 16c, and 16d." Wagner, col. 2,
11. 40-43. "Each of these side walls is turned out at its bottom to form a
more or less flat flange or support element which rests on the surface of the
patient's arm 11 or other body part." Wagner, col. 2, 11. 43--46. "The
flanges 28, 29, 30 and 31 are thin and reasonably flexible so they conform
suitably to the surface on which they rest." Wagner, col. 2, 11. 46--48.
FF7. Figure 2 of Wagner is shown below:
Fig. 2
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Application 11/257 ,224
Figure 2 shows "a transverse vertical sectional view, taken substantially
along the line 2-2" of the guard shown in Figure 1. Wagner, col. 2, 11. 15-
16.
FF8. Figure 3 of Wagner is shown below:
Fig. 3
Figure 3 shows a "vertical sectional view, taken substantially along the line
3-3" of Figures 1 and 2. Wagner, col. 2, 11. 17-18.
FF9. Cooke discloses "a shielding device for protecting infusion
needles during intravenous feeding operations and ... more particularly to
such a shielding device which effectively protects the needle from
dislocation after initial placement." Cooke, col. 1, 11. 8-12.
According to the Examiner, the Wagner's device comprises "a single-
piece element (13) including chamber portion (15) disposed in the center of
the device and at least one raised wing (28 and 29) extending from an outer
edge to the chamber ... and having curved upper and lower surfaces." Fin.
Rej. 6. The Examiner provides the following annotated version of Wagner's
Figure 3:
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Application 11/257 ,224
Annotated Wagner Figure 3 indicates that the flange element 30 has curved
upper and lower surfaces. Fin. Rej. 7. The Examiner finds that Cooke
discloses "a similar protective cover ( 10) ... [that] includes a first curved
portion/flange (20) extending about the perimeter of the element and bearing
an adhesive material." Fin. Rej. 7, citing Cooke, Fig. 2. The Examiner
concludes that it would have been obvious to one of ordinary skill in the art,
in view of Cooke, "to include a first curved portion/flange about the
perimeter of the outer edge of the device of Wagner ... in order to eliminate
any sharp edges that might cause discomfort to the patient's skin." Fin. Rej.
7.
The Examiner finds that Wagner discloses that the "raised wing slopes
upwardly from the skin-engaging first portion of the edge to the chamber
portion ... with respect to the patient's skin." Fin. Rej. 8, citing Wagner,
Fig. 3. The Examiner provides the following second annotated version of
Wagner's Figure 3:
The second annotated version of Wagner Figure 3 indicates that the flange
element slopes upward. Fin. Rej. 8.
Appellant argues that Wagner does not teach or suggest "a raised
wing that slopes upwardly with respect to the patient's skin ... [but] teaches
a guard for IV needles having peripheral skin-contacting flanges that are
'more or less .flJI1."' and are flexible so that they conform to the surface of the
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Application 11/257 ,224
skin. App. Br. 8-9, citing Wagner, col. 2, 11. 45--48. Appellant argues that
the "curved flange shown in Figure 3 ... does not slope upwardly with
respect to the patient's skin, but rather clearly parallels the contours of the
patient's skin." App. Br. 9. Appellant argues that Cooke also discloses "a
shielding device similar to that of Wagner, namely having a cup from which
extends a substantially flat flange." App. Br. 9, citing Cooke, col. 1, 11. 60-
72 and Fig. 1.
We agree with Appellant that the Examiner has not adequately
explained how the combination of Wagner and Cooke would have made
obvious the protective cover of claim 1 that comprises a raised wing that
extends "from the skin-engaging first portion to the chamber portion" and
"slopes upwardly with respect to the patient's skin from the skin-engaging
first portion to the chamber portion." The Examiner points to elements 28
and 29 of Wagner's device as corresponding to the raised wing elements of
claim 1, but Wagner discloses that elements 28 and 29, along with elements
30 and 31, are flanges that are thin and flexible so that they conform to the
surface on which they rest. See FF 6. Thus, the Examiner has not
adequately explained how the combination of Wagner and Cooke would
have made obvious the protective cover of claim 1.
Thus, we reverse the rejection of independent claim 1 and dependent
claims 2, 9, 10, 13 and 14 under 35 U.S.C. § 103(a) in view of Wagner and
Cooke. Claim 15 includes the same relevant limitations and, for the reasons
discussed above, we also reverse the rejection of independent claim 15 under
35 U.S.C. § 103(a) in view of Wagner and Cooke.
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Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that the combination of Wagner and Cooke would have made obvious the
protective cover of claim 1 that comprises a raised wing that "slopes
upwardly with respect to the patient's skin from the skin-engaging first
portion to the chamber portion."
IV.
Issue
The Examiner has rejected claims 1, 2, 9, 10, and 13-15 under 35
U.S.C. § 103(a) as obvious in view of Wagner, Cooke, and Proulx. Ans. 2;
Fin. Rej. 12-17. The Examiner has also rejected claims 3-8, 11, and 12
under 35 U.S.C. § 103(a) as obvious in view of Wagner, Cooke, and Proulx,
and further in view of one of Wright (claims 3-8), Hakky (claim 11 ), or
Bierman (claim 12). Ans. 2-3; Fin. Rej. 18-22.
The issue presented is: Does the evidence of record support the
Examiner's conclusion that the combination of Wagner, Cooke, and Proulx
would have made obvious a protective cover that comprises a raised wing
that extends "from the skin-engaging first portion to the chamber portion"
and "slopes upwardly with respect to the patient's skin from the skin-
engaging first portion to the chamber portion," as recited by claim 1?
Analysis
We have reviewed Appellant's contentions that the Examiner erred in
rejecting claims 1, 2, 9, 10, and 13-15 as obvious over the cited art. App.
Br. 10; Reply Br. 7-12. We agree with Appellant that the Examiner's
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rejection was in error. For emphasis, we highlight and address the
following:
FFlO. Proulx discloses a "venipuncture site protector." Proulx, col. 1,
11. 12-13.
FF 11. Figure 1 of Proulx is shown below:
Figure 1 shows "a perspective view of a venipuncture site protector ... fixed
to a patient's arm ... and illustrating in phantom lines" the needle position.
Proulx, col. 2, 11. 23-28. "The protector body 10 is shaped to form a
relatively rigid cup-like shield 11 ... and mounting tabs 12 extend[] from
the shield." Proulx, col. 2, 11. 23-28.
FF12. Figure 2 of Proulx is shown below:
FIG-7
Figure 2 shows an "enlarged section taken on line 2-2" of Figure 1. Proulx,
col. 2, 11. 29-30. Figure 7 illustrates "how the modified site protector may
be bent to conform to a wide range of body parts and body surface
contours." Proulx, col. 2, 11. 42--44. Proulx discloses that the mounting tabs
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"are taped to the patient's body with the shield positioned over the
venipuncture site." Proulx, Abstract.
The Examiner finds that Wagner discloses that the "wings should
curve in order to better conform to the curvature of the patient's skin." Fin.
Rej. 12. The Examiner finds that Proulx discloses "a similar protective
cover for securing a catheter ... [which] comprises wings extending from
the chamber." Fin. Rej. 12, citing Proulx, Fig. 2. The Examiner finds that
Proulx discloses that the "wings may be formed [of] 'relatively rigid'
material which is 'non-resilient or non-elastic' and can be shaped to exhibit
upward curvature ... [with] the device holding this curvature absent an
applied force by virtue of its non-resilient or non-elastic character." Fin.
Rej. 12-13, citing Proulx, Fig. 7.
The Examiner reasons that the materials of Proulx' s device allow "the
device to be worked to conform to one surface of the patient's skin (e.g. a
patient's head, see Fig. 15) and then moved to another portion of the
patient's anatomy (e.g. the forearm, see Fig. 1)." Ans. 18. The Examiner
reasons that assuming Proulx' s device "is not reshaped upon the change of
location[,] the disparate curvatures of the patient's body part will create a
clear 'separation' between the wings (12) and the patient's skin." Ans. 18.
The Examiner concludes that it would have been obvious to a person having
ordinary skill in the art to form Wagner's device with "a plastically
deformable material, as disclosed by Proulx, in order to allow the device to
conform to a patient's anatomy and retain its shape at various insertion sight
[sic] locations." Ans. 18. The Examiner asserts that supplying a "modified
device of Wagner with the curvature required for the head [and] then
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Application 11/257 ,224
moving it to the forearm is within the metes and bounds of the context of the
claim." Ans. 18-19.
We agree with Appellant (App. Br. 10) that the Examiner has not
adequately explained how the combination of Wagner, Cooke, and Proulx
would have made obvious the protective cover of claim 1. The Examiner
relies on the mounting tabs 12 of Proulx as corresponding to the raised wing
recited in claim 1. However, Proulx discloses bending the tabs to conform
to the patient's body and then taping the tabs to the patient's body. See
FF 12. Thus, Proulx suggests that the tabs lie adjacent to the skin surface,
and the Examiner has not explained how the combination of Proulx with
either Wagner or Cooke would result in a protective cover that comprises a
raised wing that "slopes upwardly with respect to the patient's skin from the
skin-engaging first portion to the chamber portion," as recited in claim 1.
Accordingly, we reverse the rejection of independent claim 1 and
dependent claims 2, 9, 10, 13, and 14 under 35 U.S.C. § 103(a) in view of
Wagner, Cooke, and Proulx.
Claim 15 includes the same relevant limitations as claim 1 and thus
we reverse the rejection of independent claim 15 under 35 U.S.C. § 103(a) in
view of Wagner, Cooke, and Proulx.
The Examiner has also rejected dependent claims 3-8, 11, and 12
under 35 U.S.C. § 103(a) as obvious in view of Wagner, Cooke, and Proulx,
and further in view of one of Wright (claims 3-8), Hakky (claim 11 ), or
Bien11an (claim 12). For these rejections, the Examiner relies on Wagner,
Cooke, and Proulx, as discussed above, and the Examiner cites Wright,
Hakky, and Bierman only to supply dependent claim limitations. Thus, we
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Appeal2014-008859
Application 11/257 ,224
also reverse the rejection of claims 3-8, 11, and 12 under 35 U.S.C. § 103(a)
for the reasons discussed above.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that the combination of Wagner, Cooke, and Proulx would have made
obvious a protective cover that comprises a raised wing that extends "from
the skin-engaging first portion to the chamber portion" and "slopes upwardly
with respect to the patient's skin from the skin-engaging first portion to the
chamber portion," as recited by claim 1.
SUMMARY
We affirm the rejection of claim 14 under 35 U.S.C. § 112, second
paragraph.
We reverse the rejection of claims 1-13 under 35 U.S.C. § 112,
second paragraph.
We reverse the rejection of claims 1-14 under 35 U.S.C. § 112, first
paragraph.
We reverse the rejection of claims 1-15 under 35 U.S.C. § 103(a).
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART
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