Ex Parte Pearce et al

Patent Trial and Appeal Board

Jul 30, 2018

14070246 (P.T.A.B. Jul. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/070,246 11/01/2013 Jeremy A. Pearce
34284 7590 08/01/2018
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.
102202.0021P2 2444
EXAMINER
DESANTO, MATTHEW F
ART UNIT PAPER NUMBER
3649
NOTIFICATION DATE DELIVERY MODE
08/01/2018 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 JEREMY A. PEARCE,
BRADLEY J. VANDERSTEK, JASON R. STATS, and
WILLIAM R. BARRON1
Appeal2017-010857
Application 14/070,246
Technology Center 3600
Before: STEFAN STAICOVICI, LEE L. STEPINA, and
ARTHUR M. PESLAK, Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Jeremy A. Pearce et al. ("Appellants") appeal under 35 U.S.C.
§ 134(a) from the Examiner's decision rejecting claims 1-13, 15, 16, 18-25,
and 29-32. We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellants' Appeal Brief indicates that C.R. Bard, Inc. is the real party in
interest. Appeal Br. 4.
Appeal2017-010857
Application 14/070,246
CLAIMED SUBJECT MATTER
The claims "are directed to a safety needle assembly of an infusion
set." Spec. ,r 2. Claim 1, reproduced below, is illustrative of the claimed
subject matter:
1. A needle assembly, comprising:
a first needle assembly portion including a groove;
a hollow needle included with the first needle assembly
portion, the needle suitable for passing fluids therethrough;
a second needle assembly portion selectively extensible
from the first needle assembly portion between a first position
and a second position and including a proximally extending
protrusion, wherein (i) a distal tip of the needle extends through
the second needle assembly and the groove of the first needle
assembly portion is configured to receive the proximally-
extending protrusion when the second needle assembly is in the
first position and (ii) the distal tip of the needle is shielded by the
second needle assembly when the second needle assembly is in
the second position;
a self-sealing pad included on the second needle assembly
portion, wherein the distal tip of the needle extends through the
pad when the second needle assembly is in the first position and
wherein the distal tip of the needle retracts from at least a surface
of the pad when the second needle assembly portion is extended
to the second position, the self-sealing pad preventing fluids that
leak from the needle from escaping through the pad after
retraction of the needle from the pad; and
a fluid isolation component disposed proximal to the self-
sealing pad and configured to catch and absorb any fluids or
vapors emanating from the needle.
Appeal Br. 21 (App. A)
REFERENCES RELIED ON BY THE EXAMINER
Fox
Castillo
Butts
US 4,695,274 Sept. 22, 1987
US 5,336,199 Aug. 9, 1994
US 2006/0253076 Al Nov. 9, 2006
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Application 14/070,246
Vaillancourt US 2008/0262434 Al Oct. 23, 2008
THE REJECTIONS
(I) Claims 1-13, 15, 16, 18-25, and 29-32 are rejected under 35
U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
(II) Claims 1-13, 15, 16, 18-25, and 29-32 are rejected under 35
U.S.C. § I03(a) as unpatentable over Vaillancourt, Fox, Butts, and Castillo.
OPINION
Re} ection (I)
Each of independent claims 1, 19, and 2 0 recites, in part, a self-sealing
pad and a fluid isolation component disposed proximal to the self-sealing
pad and configured to catch and absorb any fluids or vapors emanating from
the needle.
The Examiner finds that Appellants' Figures 21-24 and corresponding
disclosure describe a self-sealing pad 500 and fluid isolation component 150
proximal thereto, but the Specification fails to disclose that fluid isolation
component 150 is "configured to catch and absorb any fluid[ s] or vapors
emanating from the needle." Ans. 9. According to the Examiner, although
Figures 9A-I0 show an absorbent fluid isolation component, it is not
proximal to a self-sealing pad. Ans. 10. The Examiner concludes that an
absorbent fluid isolation component and a self-sealing pad are used in
different embodiments, but are not disclosed in combination. Id.
Appellants reply that the Specification contemplates the claimed
combination because the Specification discloses "configurations in
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Application 14/070,246
addition to those shown and discussed herein." Appeal Br. 15 ( citing
Spec. ,r 69); see also Reply Br. 5---6. Appellants assert that for the absorbent
fluid isolation component shown in Figures 9 A and 9B, the Specification
explicitly discloses that the component "can be employed on a variety of
needle-based devices where residual fluid/vapor capture is desired." Reply
Br. 6 ( citing Spec. ,r 45). According to Appellants, the combination is also
implicitly contemplated because absorbent fluid isolation component 200 is
disposed in base portion 136 and the self-sealing pad 500 is disposed on a
bottom external surface of the (same) base portion 136. Id. Appellants thus
conclude that the Specification supports the claimed "limitation either
expressly (by stating that the absorbing component is contemplated to be
used in connection with other needle embodiments), or through implicit or
inherent disclosure (by reference to the written description and figures.)"
Reply Br. 7.
The purpose of the written description requirement in 35 U.S.C.
§ 112, first paragraph, is to "'clearly allow persons of ordinary skill in the art
to recognize that [the inventor] invented what is claimed."' Ariad Pharm.,
Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010 (citing In re
Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989)). "[T]he test for sufficiency is
whether the disclosure of the application relied upon reasonably conveys to
those skilled in the art that the inventor had possession of the claimed
subject matter as of the filing date." Ariad, 598 F.3d at 1351. This test
"requires an objective inquiry into the four comers of the specification from
the perspective of a person of ordinary skill in the art." Id.
Although there is no in haec verba requirement, nonetheless, newly
added claim limitations must be supported in Appellants' disclosure. In this
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Application 14/070,246
case, Appellants' Figure 10 depicts fluid isolation component 200 having
"absorption disk 202 included with the safety assembly 134 ... disposed
above the needle safety component 140 in the safety assembly base 136 and
is slit to enable the needle 130 to pass therethrough." Spec. ,r 46; Fig. 10.
Appellants' Figures 23A and 23B depict needle 130 withdrawn through self-
sealing pad 500 "affixed to the base portion 13 6" and "shielded by the safety
assembly 134, which occurs when the base portion 136 is selectively
extended from the handle portion 122." Spec. ,r,r 66 and 68; Figs. 23A and
23B. We agree with Appellants that because the same reference numbers
are used in Figures 10 and 23B to depict needle assembly 120, safety
assembly 134, and base portion 136, and because Figure 23B shows and
describes self-sealing pad 500 in conjunction with these other element, one
of ordinary skill in the art would understand that "the needle assembly of Fig
9B or Fig 10 can be and are intended to be used in connection with the self-
sealing pad described in connection with Fig. 23B." Reply Br. 8.
In addition, Appellants' Specification discloses that Figures 9A and
9B "are cross sectional side views of a safety needle assembly including a
fluid isolation component according to one embodiment." Spec. ,r 15.
Figure 9A shows needle 130 extending in a hole through an unnumbered
stippled element at the bottom of base 136. Spec. Fig. 9A. Appellants'
Specification discloses that from the position shown in Figure 9A, "the
safety assembly 134 is axially slid down the needle toward the distal tip
130A" until "the safety assembly 134 has fully shielded the needle distal tip
130A," as seen in Figure 9B, and the isolation component 180 having "plug
182 is positioned about the distal opening of the lumen of the needle 130 so
as to catch and absorb any fluids/vapors emanating therefrom." Spec. ,r 44;
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Application 14/070,246
Fig. 9B. As seen in Appellants' Figure 9B, needle tip 130A is above the
unnumbered element and thus, needle 130 has passed through the
unnumbered element. Spec. Fig. 9B. However, Figure 9B does not depict a
hole in the unnumbered element. That is, the hole in the unnumbered
element through which the needle extends in Figure 9A is not shown in
Figure 9B. Based on this, one of ordinary skill in the art would reasonably
infer that the hole has closed, i.e., the unnumbered element in Appellants'
Figures 9 A and 9B is a self-sealing element. Thus, one of ordinary skill in
the art would understand that absorbent isolation component 180 of Figure
9B is used in connection with a self-sealing element.
For these reasons, Appellants' Figures reasonably convey to those
skilled in the art that an absorbent isolation component and a self-sealing
pad are used together, and thus, reasonably convey to those skilled in the art
that the inventor had possession of the claimed subject matter as of the filing
date. Accordingly, we do not sustain the Examiner's rejection of claims 1-
13, 15, 16, 18-25, and 29-32 under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement.
Re} ection (II)
Appellants make arguments for the patentability of claims 1-13, 15,
16, 18-25, and 29-32 as a group. Appeal Br. 15. We select claim 1 as
representative, and claims 2-13, 15, 16, 18-25, and 29-32 stand or fall with
claim 1. See 37 C.F.R. § 4I.37(c)(l)(iv).
The Examiner finds that Vaillancourt discloses most of the features of
the needle assembly of claim 1, but does not disclose a self-sealing pad and a
fluid isolation component proximal the self-sealing pad that is configured to
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Application 14/070,246
catch and absorb any fluid from the needle. See Final Act. 4. The Examiner
relies on Fox to teach a self-sealing pad and relies on Butts and Castillo to
teach a fluid isolation component as recited. See Final Act. 4--5. The
Examiner reasons that it would have been obvious to modify the device of
Vaillancourt based on the teachings of Fox, Butts, and Castillo in order to
provide "a device to prevent leaks" and "to absorb any material on the
needle or that is expelled by the needle." Final Act. 5-6.
Appellants argue that the references do not show "a self-sealing
member distal to the fluid isolation component," and that the reference
offered for this feature, namely, Castillo "shows that the alleged fluid
isolation component (wiper 24) is actually the distal-most structure on the
Castillo device." Appeal Br. 16. According to Appellants, Castillo teaches
that "there is nothing located more distal than the wiper 24 [fluid isolation
component]" and rather, teaches an arrangement opposite to the claimed
arrangement because Castillo teaches that blocker 26 is proximal to wiper
24. Appeal Br. 17-18. Appellants assert that none of the other references
cited by the Examiner remedy the deficiencies of Castillo because Butts'
septum 48 is not absorbent and neither Vaillancourt nor Fox discloses a fluid
isolation component disposed proximal to the self-sealing pad. Appeal Br.
18-19.
The Examiner responds that it is Vaillancourt not Castillo that is the
primary reference being modified, first to include a self-sealing pad based on
the teachings of Fox and further modified to include a fluid isolation
component based on the teachings of Castillo and Butts. Ans. 12. The
Examiner notes that because Appellants point out shortcomings of Castillo
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whereas the rejection is based on the combination of references, Appellants
are improperly attacking the references individually. Ans. 14.
In reply, Appellants take issue with how the Examiner has combined
the references and assert that the basis for the rejection in the Answer is
different than the original basis and thus is a new ground of rejection. Reply
Br. 8-10. Appellants argue that, nonetheless, the Examiner's rejection is
conclusory and that the Examiner "has not shown that Castillo provides the
missing elements relating to the absorption component, nor the element
relating to where the absorption element should be placed within the
device." Reply Br. 11-12.
With respect to Appellants' contention that the Answer includes a new
ground of rejection, any request to seek review of the Primary Examiner's
failure to designate a rejection as a new ground of rejection in an Examiner's
Answer must be by way of a petition to the Director under 3 7 C.F .R. § 1.181
filed within two months from the entry of the Examiner's Answer and before
the filing of any Reply Brief. See 37 C.F.R. § 4I.40(a).
As to Appellants' other arguments regarding the rejection, we do not
find these arguments to be persuasive because they are not commensurate
with the Examiner's rejection. See Ans. 12-13. The Examiner initially
proposes to modify Vaillancourt to make the foam pad at the distal most end
of Vaillancourt a self-sealing pad based on the teachings of Fox and states
that the rationale for the proposed modification is "to reseal the aperture
created by the needle (see Fox, col. 3, 11. 5-12), thus providing a device to
prevent leaks." Final Act. 5. Appellants do not assert persuasively that this
rationale is improper.
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Application 14/070,246
The Examiner then proposes to further modify the device of
Vaillancourt to include an absorbent material at a more proximal location
than the seal-sealing pad, based on the teachings of Castillo and Butts. Final
Act. 6. The Examiner is correct in pointing out that 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). The fact that a "fluid isolation
component disposed proximal to the self-sealing pad" is not specifically
mentioned in either Castillo or Butts does not, without more, establish that
the Examiner erred. What a reference teaches or suggests must be examined
in the context of the knowledge, skill, and reasoning ability of a skilled
artisan and is not limited to what a reference specifically "talks about" or
what is specifically "mentioned" or "written" in the reference. Syntex
(US.A.) LLC v. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005). "A
person of ordinary skill is also a person of ordinary creativity, not an
automaton." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,421 (2007).
Here, Castillo discloses a needle assembly portion (sheath assembly
16) "that contains in its hollow interior a wiper element (24) made of an
absorbent material." Castillo, 3:59---62; Fig. 2. Although we appreciate that
Castillo also teaches blocker element 26 that might be considered a sealing
pad and that is more proximal than wiper 24 (see Appeal Br. 18), the
Examiner does not rely on blocker element 26 of Castillo in the rejection of
claim 1. See Ans. 13-14. Rather, as discussed above, the Examiner finds
that the combined teachings of Vaillancourt and Fox disclose a sealing pad
(see Final Act. 5---6) and relies on Castillo to teach an absorbent wiper and
relies on Butts for the location of a wiper. Ans. 14. Specifically, as the
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wiper/septum 48 of Butts is located proximal to the distal end of the
housing, in the Examiner's rejection, Castillo's wiper would be positioned
inside Vaillancourt's sheath assembly 16. In other words, it is this location
of Butts' wiper/septum 48 that the Examiner is using, i.e., Butts teaches "the
location of the wiper/septum with respect to the housing." Ans. 14; see also
Butts, Fig. 4C. Thus, because Vaillancourt, as modified by Fox, already has
a self-sealing pad exterior to the housing, we agree with the Examiner that
adding Castillo's wiper to the interior of the housing, as taught by Butts,
would result in the "fluid isolation component [wiper] proximal the self-
sealing pad." Ans. 14. We also agree with the Examiner's conclusion that
"it would be obvious to place the wiper material proximal the self-sealing
pad because it provides the benefit of absorbing anything that might leak out
of the needle." Final Act. 6. Appellants have not shown error in the
Examiner's findings and reasoning.
We have considered all of Appellants' arguments regarding claim 1,
but determine the Examiner has the better position. Accordingly, we affirm
the rejection of claim 1. Claims 2-13, 15, 16, 18-25, and 29-32 fall with
claim 1.
DECISION
The Examiner's decision to reject claims 1-13, 15, 16, 18-25, and
29-32 under 35 U.S.C. § 112, first paragraph as failing to comply with the
written description requirement is reversed.
The Examiner's decision to reject claims 1-13, 15, 16, 18-25, and
29-32 under 35 U.S.C. § 103(a) as unpatentable over Vaillancourt, Fox,
Butts, and Castillo is affirmed.
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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)(l )(iv).
AFFIRMED
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