Christina D'Arrigo et al.

Patent Trials and Appeals Board

Jun 23, 2021

2020002656 (P.T.A.B. Jun. 23, 2021)

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.
12/376,151 10/12/2009 Christina Joy D'Arrigo P-6889/1 4392
67309 7590 06/23/2021
Servilla Whitney LLC/BDX
33 Wood Ave South, Suite 830
Iselin, NJ 08830
EXAMINER
CARPENTER, WILLIAM R
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
06/23/2021 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):
docket@dsiplaw.com
ip.docket@bd.com
lmurphy@dsiplaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte CHRISTINA JOY D’ARRIGO and
ERIC R. SCHILLER

Appeal 2020-002656
Application 12/376,151
Technology Center 3700
____________

Before MURRIEL E. CRAWFORD, MICHAEL C. ASTORINO, and
TARA L. HUTCHINGS, Administrative Patent Judges.

ASTORINO, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the
Examiner’s decision to reject claims 1 and 4–24. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. The Appellant identifies “[t]he real party in interest [a]s
Becton, Dickinson and Company, the assignee of record.” Appeal Br. 4.
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STATEMENT OF THE CASE
Subject Matter on Appeal
The Appellant’s “invention relates to a syringe and needle assembly
having structure for consistently minimizing dead space in a syringe barrel
while containing an effective seal between the syringe barrel and the needle
assembly.” Spec. ¶ 1. Dead space refers to the “space inside the barrel tip
and between the end of the barrel tip and the end of the cavity in the hub . . .
[that] contain[s] liquid that cannot be delivered by the syringe.” Id. ¶ 2.
Claims 1, 22, and 24 are the independent claims on appeal.2 Claim 1,
reproduced below with some paragraphing added, is illustrative of the
claimed subject matter.
1. A syringe and detachable needle assembly having reduced
dead space features comprising:
an elongate syringe barrel having a longitudinal axis, an
inside surface defining a chamber for retaining fluid, an open
proximal end, an open distal end including a collar and a flat
distally facing annular surface projecting inwardly from said
collar, a portion of said collar having a cylindrically shaped,
axially aligned circular side wall;
a needle assembly including a hub having a body portion
including a proximal end, a distal end, a conduit therethrough, a
flat proximally facing annular surface at the proximal end of
said body portion positioned at an angle in the range of 88° to
92° with respect to the longitudinal axis of the syringe barrel;
wherein said flat proximally facing annular surface on
said body portion contacting said annular surface of said barrel
forming a primary seal between said hub and said barrel, said
hub of the needle assembly further including an outwardly

2 We determine that the Claims Appendix in the Appeal Brief mislabeled
claim 24 as claim 25. See also Appeal Br. 9–10.
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projecting annular sealing ring contained in an annular groove
around the body portion of the hub, the annular groove and
sealing ring positioned proximal of an entirety of a collar-
engaging structure on the hub of the needle assembly for
engaging complementary hub-engaging structure on an inside
surface of the circular side wall of the collar of the syringe
barrel, the annular sealing ring sealingly engaging said inside
surface of the circular side wall of said collar of the syringe
barrel to form a secondary seal between said hub and said
inside surf ace of said circular side wall of said collar wherein
the secondary seal is a backup seal in the event that a user fails
to provide enough rotational torque while connecting the hub to
the barrel to adequately engage the primary seal, said needle
assembly further including a cannula having a distal end, a
proximal end and a lumen therethrough, said proximal end of
said cannula being connected to said distal end of said hub so
that said lumen is in fluid communication with said chamber;
and the collar-engaging structure is positioned distal to
an entirety of the annular groove for releasably engaging said
hub to said collar, wherein a first position where said circular
side wall of said collar and said annular sealing ring of said hub
are engaged with each other is positioned between a second
position and a third position, said second position being a
position where said annular surface of said barrel and said
annular surface of said hub are contacted each other, said third
position being a position where said collar-engaging structure
and said hub-engaging structure are engaged with each other.

References
The prior art relied upon by the Examiner is:
Name Reference Date
Bell et al. (“Bell”) US 5,273,543 Dec. 28, 1993
Botich et al. (“Botich”) US 5,788,677 Aug. 4, 1998
Nguyen et al. (“Nguyen”) US 5,827,218 Oct. 27, 1998
Wiklund US 6,629,957 B1 Oct. 7, 2003
Sharp US 6,699,223 B2 Mar. 2, 2004
Caizza et al. (“Caizza”) US 6,840,291 B2 Jan. 11, 2005
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Donnan et al. (“Donnan”) US 2004/0006312 A1 Jan. 8, 2004
Fangrow US 2006/0161115 A1 July 20, 2006
Watts et al. (“Watts”) US 2006/0200085 A1 Sept. 7, 2006

Rejections
Claims 1, 4, 5, 7, 10, 12–18, 20, 22, and 23 are rejected under
35 U.S.C. § 103(a) as unpatentable over Caizza in view of Watts, Sharp, and
Nguyen.
Claim 6 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Caizza in view of Watts, Sharp, Nguyen, and Bell.
Claims 8, 9, 11, and 24 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Caizza in view of Watts, Sharp, Nguyen, and Wiklund.3
Claims 9, 11, and 24 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Caizza in view of Watts, Sharp, Nguyen, and Botich.4
Claim 19 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Caizza in view of Watts, Sharp, Nguyen, and Fangrow.
Claim 21 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Caizza in view of Watts, Sharp, Nguyen, and Donnan.

3 Although the Examiner sets forth separate statements for the rejection of
claims 8, 9, and 11 (Final Act. 13) and claim 24 (id. at 17), we consolidate
the statements into a single ground of rejection because they are each based
upon same the combination of references.
4 Although the Examiner sets forth separate statements for the rejection of
claims 9 and 11 (Final Act. 14) and claim 24 (id. at 25), we consolidate the
statements into a single ground of rejection because they are each based
upon same the combination of references.
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ANALYSIS
The Appellant argues claims 1, 4, 5, 7, 10, 12–18, 20, 22, and 23 as a
group. See Appeal Br. 11–25. We select claim 1 as representative.
Claims 4, 5, 7, 10, 12–18, 20, 22, and 23 stand or fall with claim 1. See 37
C.F.R. § 41.37(c)(1)(iv).
The Appellant argues that the Examiner’s rejection of claim 1 is
improper because “(a) prima facie obviousness has not been established, and
(b) the cited primary reference teaches away from the [c]laimed
[i]nvention.” Appeal Br. 11. For the foregoing reasons we determine that
the Appellant’s arguments are not persuasive of Examiner error.

(A) Prima Facie Obviousness Has Been Established
The Appellant points out that the Examiner’s rejection includes a
finding that “Caizza does not disclose sealing engagement provided by an
annular sealing ring.” Id. at 18. The Appellant argues:
None of Watts, Sharp or Nguyen teach or suggest a device in
which the annular groove and the sealing ring it contains are
positioned on the hub of the needle assembly proximal to the
entirety of a collar-engaging structure which is also on the
needle hub to form a secondary seal between the needle hub
and the inside surface of the circular side wall of the collar of
the syringe barrel.
Id. at 19–20. The Appellant’s argument is not persuasive of Examiner error.
The Examiner’s rejection includes a modification of Caizza’s syringe
and detachable needle assembly with teachings from Watts, Sharp, and
Nguyen to result in,
said hub of the needle assembly further including an outwardly
projecting annular sealing ring contained in an annular groove
around the body portion of the hub, the annular groove and
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sealing ring positioned proximal of an entirety of a collar-
engaging structure on the hub of the needle assembly for
engaging complementary hub-engaging structure on an inside
surface of the circular side wall of the collar of the syringe
barrel,
as recited claim 1. See Final Act. 5–11; Ans. 20–27.
More specifically, the Examiner finds that Caizza’s syringe and
detachable needle assembly includes a sealing engagement between “a
collar-engaging structure (i.e. threads 358) for engaging a complementary
hub-engaging structure (331) on the circular side wall of the collar.” Final
Act. 5 (citing Caizza Fig. 20); see Caizza Figs. 21–24. The Examiner also
finds that Caizza fails to teach “the hub of the needle assembly further
include[s] an outwardly projecting annular sealing ring.” Final Act. 5.
Similar to Caizza, the Examiner finds that Watts teaches a sealing
engagement between the cooperative geometry of a hub and syringe alone.
Id. (citing Watts Fig. 2). Different from Caizza, the Examiner finds that
Watts teaches an alternative sealing engagement that further includes a
projecting annular sealing ring at various locations on the hub to form a
cooperative seal with the syringe. See id. (citing Watts ¶¶ 44–46, Figs. 2);
see also Watts Figs. 3A, 3B, 3C. The Examiner determines that it would
have been obvious for one having ordinary skill in the art to modify Caizza’s
sealing engagement with Watts’ teaching of an alternative sealing
engagement having a projecting annular sealing ring (i.e., a secondary seal)
for the purposes of redundancy to ensure there is no contamination or
leakage of the retained contents of the syringe. See Final Act. 5–6; Ans. 21.
As for the particular location of the seal, the Examiner relies on
Sharp’s teachings as well as Nguyen’s teachings. See Final Act. 6–8; see
also id. at 8–11. Specifically, the Examiner finds that Sharp teaches:
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a syringe having a collar (16) engageable with a hub (20) via a
collar-engaging structures (54)[,] which corresponds to
complimentary hub engaging structures (56)[,] wherein the hub
further includes an outwardly projecting annular sealing ring
(60) contained in an annular groove (65) around the body
portion of the hub ([s]ee Fig. 2), the annular groove and sealing
ring being positioned proximal of an entirety of the collar-
engaging structure (see Fig. 2 on the hub of the needle
assembly) the annular sealing ring sealingly engaging an inside
surface of the circular side wall of said collar (see Fig[.] 2) to
form a seal between the hub and the collar[,] and the collar
engaging structure is positioned distal to an entirety of the
annular groove for releasably engaging the hub to the collar
(Fig. 2). As such, Sharp establishes a known suitable location
for a sealing ring in a threaded needle hub which is received
within and engages corresponding threads of a circumferential
syringe collar (a mounting structure shared with the Caizza
syringe construction).
See id. at 6–7. The Examiner makes additional findings based on Nguyen
(id. at 7), but clarifies in the Answer that “Nguyen is only purported to
demonstrate the effectiveness of a secondary seal (53) retained within an
annular groove between two threaded cooperating geometries of a medical
device structure” (Ans. 26 (italics added)). The Examiner determines:
It would have been obvious for one having ordinary skill
in the art . . . to configure the device of Caizza to include an
annular sealing ring provided within an annular groove in the
hub to form a secondary seal between the hub and the collar, as
disclosed by Sharp and Nguyen[,] thereby only providing a
well-known means of affixing a[n] o-ring seal to a hub as is
known in the medical environment. Furthermore, it would have
been obvious for one having ordinary skill in the art . . . to
provide the annular groove proximal to collar engaging threads,
as disclosed by Sharp, thereby only achieving the expected
results of utilizing a well-known location for such a[n] annular
o-ring seal to provide for known, suitable and predictable
results of provide a sealing function between a cannula hub and
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syringe collar. . . . Only the expected and predictable results of
selecting a known location, to provide a known sealing device,
to provide a secondary seal between a syringe and cannula hub
as is known in the art would be achieved.
Final Act. 7–8.
We determine that the foregoing findings and determinations from the
Examiner’s rejection are adequately supported and result in
said hub of the needle assembly further including an outwardly
projecting annular sealing ring contained in an annular groove
around the body portion of the hub, the annular groove and
sealing ring positioned proximal of an entirety of a collar-
engaging structure on the hub of the needle assembly for
engaging complementary hub-engaging structure on an inside
surface of the circular side wall of the collar of the syringe
barrel,
as recited claim 1. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)
(“[R]ejections on obviousness grounds . . . [require] some articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness.”) (cited with approval in KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 418 (2007)).
The Appellant argues that each of the embodiments in Watts’
Figures 3A–3C individually do not include the claimed configuration in
which the annular sealing ring sealingly engages the inside surface/interior
threaded surface of the circular side wall of the collar of the syringe barrel to
form a secondary seal. Appeal Br. 19–21. The Appellant’s argument,
however, is not consistent with the Examiner’s rejection. As we explain
above, the Examiner does not rely on Watts for the location of the sealing
ring. Rather, the Examiner relies on Watts to teach a secondary seal for the
purposes of redundancy and Sharp to teach the location of the secondary
seal.
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The Appellant argues that Sharp’s “seal is formed between the adapter
and the reduced diameter section of the syringe barrel, not between the
needle hub and the inside surface of the circular side wall of the syringe
barrel collar as claimed.” Id. at 22. The Appellant’s argument is not
persuasive of Examiner error. We agree and adopt as our own the
Examiner’s response at pages 22–25 of the Answer, which explains how one
of ordinary skill in the art would understand that Sharp’s adapter is part of a
hub and that Sharp’s seal is positioned between the hub and syringe barrel
collar.
The Appellant submits that “Nguyen is also cited as evidence of the
claimed configuration of the annular sealing ring on a needle hub” and
argues that Nguyen fails to teach a seal “between a needle hub and an inside
surface of a syringe barrel collar.” Id. at 23. The Appellant’s argument is
not persuasive of Examiner error. As we explained above, the Examiner
clarifies in the Answer that “Nguyen is only purported to demonstrate the
effectiveness of a secondary seal (53) retained within an annular groove
between two threaded cooperating geometries of a medical device
structure.” Ans. 26 (italics added).
The Appellant also argues that the Examiner’s “rejection is merely an
assertion that the claimed configuration could have been made, likely with
aid of impermissible hindsight.” Appeal Br. 24. Similarly, the Appellant
argues “that one of skill in the art would not have a reason to look to the
secondary references for the inclusion of a gasket in the device.” Id. at 19.
The Appellant’s arguments are not persuasive of Examiner error. As we
discussed above, we determine that the Examiner’s findings and
determinations are adequately supported.
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(B) Caizza Does Not Teach Away from the Claimed Invention
The Appellant argues that “Caizza teaches away from the use of
gaskets, including a projecting annular sealing ring.” Id. at 17; see generally
id. at 13–18; Reply Br. 2–5, 10–16.5 The Appellant’s argument primarily
relies on two assertions: (1) Caizza’s “invention provides a clear departure
and improvement over the prior art by offering features such as leakage
protection without the use of gaskets” (Appeal Br. 13 (emphasis omitted);
see also Reply Br. 3–16); and (2) Caizza’s non-retractable needle
embodiment, which is relied upon by the Examiner, lacks “a clear location
of a gasket, nor is there a clear need in Caizza to include an annular sealing
ring” (id. at 14). The Appellant’s argument is not persuasive of Examiner
error.
The Appellant bases the first assertion on the following description
regarding Caizza’s retracting needle embodiment:
One of the issues not well addressed by the prior art is
leakage. During use, the contents of the syringe are subject to
high pressures, both positive and negative, when trying to draw
in and deliver medications, especially with viscous medications.
To help prevent leakage, preferably without having to use a
gasket, the preferred embodiment includes tapered cylindrical
surface 69 on inner hub 61 and tapered cylindrical surface 35
on the inside of cylindrical collar 31 of the barrel. When the
retracting needle assembly engages the collar of the barrel, the
tapered cylindrical surface 35 on the collar engages tapered
cylindrical surface 69 on the inner hub to seal the interface

5 The Reply Brief lacks page numbers. We designate page 1 as the page that
includes the heading “REPLY BRIEF” and number the remaining pages in
the Reply Brief consecutively therefrom.

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between the hub and the collar to prevent leakage during
normal use.
The present invention provides a clear departure and
improvement over the prior art by offering features such as
leakage protection without the use of gaskets, and low dead-
space in combination with a removable retracting needle
assembly.
Caizza col. 8, ll. 45–62 (italics added); see id. at Figs. 6–10. According to
the Appellant:
The [Examiner’s] assertion that Caizza acknowledges the
usefulness of gaskets in preventing leakage is not explicitly
supported by the specification of Caizza. Even if Caizza’s
disclosure of “[to] help prevent leakage, preferably without the
use of a gasket” may imply the usefulness of gaskets in
preventing leakage, Caizza read as a whole “provides a clear
departure and improvement over the prior art by offering
features such as . . . leakage protection without the use of
gaskets, and low dead-space in combination with a removable
retracting needle assembly.”
Reply Br. 4 (footnotes omitted). The Examiner responds that Caizza’s use
of the word “‘preferably’ is not a blanket prohibition against the usage of
gaskets.” Ans. 8 (“The term ‘preferably’ is ordinarily defined as ‘ideally; if
possible.’” (citing Oxford University Press Online Dictionary)). The
Examiner explains:
an ordinary artisan would reasonably recognize and appreciate
that Caizza implicitly acknowledges (by usage of “preferably”
versus a clear and unambiguous prohibition upon the usage of
gaskets) that in some instances the usage of gaskets may be
necessary to prevent leakage, e.g. medicaments which are
required to be sealed against air infiltration, viscous
medicaments which require substantial forces to expel, thin
hydrophobic medicaments that tend to leak past non-
elastomeric seals ... etc.
Id. The Examiner has the better position.
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First, we agree with the Examiner that Caizza does not exclude the
possibility of using a gasket for leakage protection. This is why Caizza also
describes, “[t]o help prevent leakage, preferably without having to use a
gasket, the preferred embodiment includes tapered cylindrical surface 69 on
inner hub 61 and tapered cylindrical surface 35 on the inside of cylindrical
collar 31 of the barrel” (Caizza col. 8, ll. 48–52 (italics added)), which
implies that a gasket may be included. We determine that one of ordinary
skill in the art would understand Caizza to allow the use of a gasket for
further leakage protection when there would be a benefit to its inclusion; for
example, redundant protection by way of a secondary seal. See Final
Act. 5–6.
Second, as the Appellant acknowledges in the Reply Brief (see Reply
Br. 3), Caizza attributes the improved leakage protection without the use of
gaskets to the tapered surfaces of the retracting needle embodiment. See
Caizza col. 8, ll. 48–62. Specifically, when the retracting needle assembly
engages the collar of the barrel, tapered cylindrical surface 35 on the collar
engages tapered cylindrical surface 69 on the inner hub to seal the interface
between the hub and the collar to prevent leakage. Id. at col. 8, ll. 53–57;
see also id. at Figs. 6–10. We agree with the Appellant that one of ordinary
skill in the art would understand that, in terms of leakage protection,
Caizza’s retracting needle assembly with tapered cylindrical surfaces 35, 69
is a clear departure and improvement over a prior art retracting needle
assembly that lacks these tapered cylindrical surfaces.
However, as the Appellant also acknowledges (see Reply Br. 4), the
Examiner relies on the non-retractable needle embodiment, which does not
include tapered surfaces, to reject the claims. See, e.g., Final Act. 3 (citing
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Caizza Figs. 20, 22); Ans. 7 (citing Caizza Fig. 20). Nonetheless, the
Appellant contends that Caizza’s “superior leak protection” without the use
of gaskets, which is afforded by tapered surfaces, applies equally to the non-
retractable needle embodiment. See Reply Br. 3; see also id. at 4 (asserting
that “Caizza read as a whole ‘provides a clear departure and improvement
over the prior art by offering features such as . . . leakage protection without
the use of gaskets”). Specifically, the Appellant argues that in Caizza’s non-
retractable needle embodiment, a “tight fitment between a distal surface 335
of the barrel and a ‘proximally-facing frustoconically shaped surface 359 [is]
positioned to contact distal surface 335 on the barrel to prevent liquid flow
. . .’ without the use of a gasket.” Id. According to the Appellant:
Caizza distinguishes between retractable and non-
retractable needle assemblies only with regard to low dead
space. The reason why Caizza discloses a retractable needle
assembly (of the “preferred embodiment” of Figures 6-10) and
a non-retractable needle assembly (of Figure 20) is because the
retractable needle assembly is directed to the second aim of
Caizza. The second aim of Caizza is disclosed as “[another]
important feature of the present invention is providing a
retracting needle syringe with low dead space”. Caizza directs
the feature of low dead space only with the embodiments
having a retractable needle assembly.
As such, a fair reading of Caizza is “[the] present
invention provides a clear departure and improvement over the
prior art by offering features such as leakage protection without
the use of gaskets,” (of the invention as a whole) “and low
dead-space in combination with a removable retracting needle
assembly.” The comma which separates these two clauses is
clearly in line with the previously disclosed “important
feature”; namely “[another] important feature of the present
invention is providing a retracting needle syringe with low dead
space”.
Reply Br. 12 (footnotes omitted); see id. at 8–9.
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Yet, the structure of the two embodiments differ substantially. For
example, unlike tapered cylindrical surfaces 31 and 69 in the retracting
needle embodiment, the corresponding proximally-facing frustoconically
shaped surface 359 and distal surface 335 on the barrel/collar in the non-
retracting needle embodiment are not located on cylindrical surfaces that
extend away from the terminal end surfaces of the hub and collar. Compare
id. at Figs. 6, 8 with Figs. 22, 24. Additionally, tapered cylindrical surfaces
31 and 69 in the retracting needle assembly are not threaded (see, e.g., id. at
Figs. 6, 8–10), whereas the corresponding cylindrical surfaces in the non-
retracting needle assembly are threaded (see, e.g., id. at Figs. 20, 22, 24).
When comparing the “tight fitment” between the hub and the collar for each
embodiment, one of ordinary skill in the art would understand that the
corresponding surfaces are at different locations and have different structural
characteristics. Accordingly, the Appellant does not persuade us that
Caizza’s non-retractable needle embodiment, which forms the basis of the
Examiner’s rejection, provides similar leakage protection to the superior
leakage protection provided without gaskets by the retracting needle
embodiment. As such, we understand the features of Caizza’s present
invention that provide a “clear departure and improvement over the prior
art,” as described in column 8, lines 58–62, to be directed solely to the
retracting needle assembly embodiment.
However, even if we were to agree with the Appellant that Caizza’s
non-retractable needle embodiment also provides a clear departure and
improvement over the prior art by offering leakage protection without the
use of gaskets, we do not understand Caizza to discourage the use of a
gasket for further leakage protection if there is a benefit to its inclusion, as
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we describe above.
In view of the foregoing, we are not persuaded that a person of
ordinary skill, upon reading Caizza, would be discouraged from using a
gasket for further leakage protection or would be led in a direction divergent
from using projecting annular sealing ring. See Galderma Labs., L.P. v.
Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013). Therefore, we disagree
with the Appellant that Caizza teaches away from the use of gaskets,
including a projecting annular sealing ring.
The Appellant’s second assertion — i.e., Caizza’s non-retractable
needle embodiment, which is relied upon by the Examiner, lacks “a clear
location of a gasket, nor is there a clear need in Caizza to include an annular
sealing ring” (Appeal Br. 14) — is also not persuasive. First, the
Examiner’s rejection adequately supports the modification of Caizza’s
assembly to include a secondary seal (i.e., gasket/annular sealing ring) and
the location thereof by articulating reasoning with rational underpinning.
Second, the Appellant’s argument confuses silence as to the inclusion of a
gasket in Caizza’s non-retractable needle embodiment with a teaching that
discourages and/or diverges from the inclusion of a gasket. See Galderma
Labs., 737 F.3d at 738.
The Appellant submits additional arguments that are similar to those
addressed above. See Appeal Br. 18; Reply Br. 5–9. One such argument is
that the Examiner’s proposed combination “would frustrate the principle of
operation of the needle assembly of Caizza.” Appeal Br. 18. Each of these
additional arguments is not persuasive of Examiner error as they are each
premised on the same or similar points and assertions discussed above. We
have considered the Appellant’s remaining points and assertions in the
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Appeal and the Reply Briefs as to why the Examiner erred and determine
that they are not persuasive.
Thus, we sustain the Examiner’s rejection of claim 1 as well as
claims 4, 5, 7, 10, 12–18, 20, 22, and 23. See 37 C.F.R. § 41.37(c)(1)(iv).
The Appellant includes further headings, but lacks further arguments for the
rejections of claims 6, 8, 9, 11, 19, 21, and 24. Id. at 25–30. We likewise
sustain the Examiner’s rejections of these claims as well.

CONCLUSION
In summary:
Claim(s)
Rejected
35 U.S.C. § References/Basis Affirmed Reversed
1, 4, 5, 7,
10, 12–18,
20, 22, 23
103(a) Caizza, Watts, Sharp,
Nguyen
1, 4, 5, 7,
10, 12–18,
20, 22, 23

6 103(a) Caizza, Watts, Sharp,
Nguyen, Bell
6
8, 9, 11, 24 103(a) Caizza, Watts, Sharp,
Nguyen, Wiklund
8, 9, 11, 24
9, 11, 24 103(a) Caizza, Watts, Sharp,
Nguyen, Botich
9, 11, 24
19 103(a) Caizza, Watts, Sharp,
Nguyen, Fangrow
19
21 103(a) Caizza, Watts, Sharp,
Nguyen, Donnan
21
Overall
Outcome
1, 4–24

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED