Lynn A. Ziman et al.

Patent Trials and Appeals Board

Sep 23, 2019

13714501 - (D) (P.T.A.B. Sep. 23, 2019)

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.
13/714,501 12/14/2012 Lynn A. Ziman 0100/0231 9400
135866 7590 09/23/2019
LAW OFFICE OF LOUIS WOO
717 NORTH FAYETTE STREET
ALEXANDRIA, VA 22314
EXAMINER
BOSWORTH, KAMI A
ART UNIT PAPER NUMBER
3783
MAIL DATE DELIVERY MODE
09/23/2019 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte LYNN A. ZIMAN and STEVEN HUU NGUYEN

Appeal 2018-002180
Application 13/714,501
Technology Center 3700
____________

Before KEN B. BARRETT, BRANDON J. WARNER, and
ARTHUR M. PESLAK, Administrative Patent Judges.

BARRETT, Administrative Patent Judge.

DECISION ON APPEAL

Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1 and 3–20. 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. Appellant identifies the real party in interest as Smiths
Medical ASD, Inc. Appeal Br. 3.
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I. THE INVENTION
Appellant’s claimed invention pertains to “a needle assembly that is
designed to mate with an adapter for correct connection to a particular
medication store or line.” Spec. ¶ 1. Of the claims on appeal, claims 1, 8,
and 14 are independent. Claim 1, reproduced below with paragraphing
added, is illustrative of the subject matter on appeal.
1. A one piece needle assembly comprising
a needle hub having
an elongate cylindrical portion formed by a
circumferential wall that extends from a hub receptacle
end to an opposite end,
the opposite end of the elongate cylindrical portion
tapers to a closed end from which a needle extends,
the circumferential wall of the cylindrical portion
having a thickness that defines an opening at the
receptacle end and a through passage along the elongate
cylindrical portion of the needle hub to have a given
cross section,
the hub receptacle end having a particular
formation that prevents the hub receptacle end from
mating with a luer of a medical device,
the particular formation including two
protrusions formed at the outer surface of the
circumferential wall at opposite sides of the
elongate cylindrical portion a particular distance
along the elongate cylindrical portion from the
opening of the hub receptacle end so that the
protrusions are passable through corresponding
channels at a shroud and threadedly matable with
an internal thread formed at an inner
circumferential wall of the shroud having a
complementary configuration to the particular
formation,
the hub receptacle end with the protrusions not
matable with a luer, the particular formation further
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defined by the circumferential wall of the elongate
cylindrical portion being dimensioned to have the
thickness that effects the given cross section for the
opening to prevent a male luer receptacle from being
fittingly accepted into the opening.
Appeal Br. 29 (Claims Appendix) (with paragraphing added).
II. THE REJECTIONS
The following Examiner’s rejections are before us for review:
1. Claims 1 and 3–20 are rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the enablement requirement;
2. Claims 1, 3–5, 7–11, 13–18, and 20 are rejected under 35
U.S.C. § 103(a) as being unpatentable over Segal (US 2004/0201216 A1,
published Oct. 14, 2004), Gettig (US 5,718,690, issued Feb. 17, 1998), and
Delvigo (US 5,925,028, issued July 20, 1999); and
3. Claims 6, 12, and 19 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Segal, Gettig, Delvigo, and Sheppard
(US 6,500,153 B1, issued Dec. 31, 2002).
III. ANALYSIS
A. The Enablement Rejection of Claims 1 and 3–20
The Examiner rejected all of the claims on appeal as failing to satisfy
the enablement requirement based on the recited taper. Non-Final Act. 3–4.
Claim 1, for example, recites a needle hub having “an elongate
cylindrical portion formed by a circumferential wall that extends from a hub
receptacle end to an opposite end” and where “the opposite end of the
elongate cylindrical portion tapers to a closed end from which a needle
extends.” Appeal Br. 29; see id. at 30 (independent claim 8 reciting the
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same or similar language), 31 (independent claim 14 reciting an elongate
cylindrical portion having “an opposite end that tapers to a closed end”).
The Examiner construes the language of the latter phrase as requiring
that the opposite end be tapered and also be cylindrical. Non-Final Act. 3;
see also Ans. 5 (“the language of the claims require[s] that the ‘opposite
end’ itself tapers”). The Examiner maintains that the same component
cannot be both cylindrical (i.e. with straight, parallel sides and constant
diameter along its entire length) and tapered. Non-Final Act. 3–4 (citing the
online Oxford Dictionary). Thus, according to the Examiner, the limitation
is not enabled. Id. at 4.
Appellant argues that the Examiner has misconstrued the claim
language; however, Appellant’s interpretation, at least in part, appears to be
consistent with that of the Examiner. See Appeal Br. 9–10. In particular,
Appellant asserts that “the ‘opposite end’ form[s] one end of the elongate
cylindrical portion.” Id. at 9. Appellant’s position is explained, in part, via
annotated Figures 3A and 3B, cropped views of which are shown below.

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Shown above is a cropped version of Appellant’s Figures 3A and 3B (side
views of the needle assembly) annotated by Appellant to explain Appellant’s
identification of certain features. Id. at 10; Spec. 4 (describing the figures).
Based on Appellant’s annotated figures, we understand Appellant to
contend that the recited “opposite end” of the claims refers to a point or
plane at one end of the “cylindrical portion.” Appeal Br. 10; cf. Reply Br. 2
(“the other end of the circumferential wall [that forms the elongate
cylindrical portion] ends at the opposite end”). Thus, we further understand
the Examiner and Appellant to agree that the cylindrical portion is that
portion that extends from a point labeled the “hub receptacle end” to a point
labeled the “opposite end” and having straight, parallel sides and a constant
diameter for its full length.
Appellant argues that “shown in Figs. 3A and 3B is that ‘taper’ that
extends from the opposite end of the elongate cylindrical portion 14 to the
closed end 8.” Appeal Br. 9 (emphasis added). Appellant also argues that
“it is clear that it is at the opposite end of the elongate cylindrical portion (d)
that the taper begins towards the closed end.” Reply Br. 3 (emphasis
added). Appellant identifies, as the “taper,” a portion of the hub between the
cylindrical portion and a portion labeled the “closed end.” See Appeal
Br. 9–10. Appellant additionally argues that an artisan would be able to
mold a needle hub as shown in Figures 3A and 3B and states that “appellants
fail to see how there could be a non-enablement issue.” Id. at 9.
Appellant’s arguments are not consistent with the claim language,
which, in claim 1 is “the opposite end of the elongate cylindrical portion
tapers to a closed end.” Appeal Br. 29. The claim does not, as Appellant
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implies, recite a “taper” portion that extends from the opposite end or that
begins at the opposite end. In the recited claim phrase, the term “tapers” is a
verb,2 not the noun “taper,” and refers to the “opposite end of the elongate
cylindrical portion.” We agree with the Examiner that the claim calls for the
cylindrical portion to taper. Appellant’s argument that the needle hub shown
in the Figures is enabled is not on point as it is the claimed apparatus that
must be enabled, not just that depicted in a figure. The Examiner’s rejection
is that the invention defined by the appealed claims is not enabled.
Non-Final Act. 3–4; see also Ans. 3–5. By focusing on the alleged
enablement of the disclosure, rather than of the claimed subject matter, and
by applying an incorrect construction, Appellant has not identified an error
in the rejection. Cf. Ex parte Frye, Appeal No. 2009–006013, at 9–10
(BPAI Feb. 26, 2010) (precedential) (The Board, as a general matter,
reviews the appealed rejections for error based upon the issues identified by
Appellant and in light of the arguments and evidence produced thereon.)
(cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011)
(“[I]t has long been the Board’s practice to require an applicant to identify
the alleged error in the examiner’s rejections.”)). Accordingly, we affirm
the Examiner’s rejection of claims 1 and 3–20 for lack of enablement.

2 Appellant, in the Reply Brief, appears to concede that “tapers” is a verb.
See Reply Br. 3 (quoting a dictionary definition for the verb form of
“taper”).
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B. The Enablement Rejection of Claims 7, 13, and 20
The Examiner additionally rejected dependent claims 7, 13, and 20 as
failing to comply with the enablement requirement due to the flange feature.
Non-Final Act. 5–6.
Claim 7, which depends directly from claim 1, is exemplary and
recites “a flange between the opposite end of the elongate cylindrical portion
and the closed end separating the needle from the rest of the needle hub.”
Appeal Br. 30.
The Examiner concludes that the opposite end and the closed end are
both part of the needle hub, and maintains that a flange located between
these ends would not separate the needle from the rest of the needle hub
“because the flange does not separate the closed end from the needle.”
Non-Final Act. 5. The Examiner also asserts that the claim has not defined
what constitutes the “rest” of the needle hub.3 Ans. 6.
Appellant notes that claim 1, from which claim 7 depends, recites that
the closed end is part of the needle hub and that it is “a closed end from
which a needle extends.” Appeal Br. 12. Appellant refers to the
Specification’s description that, “[a]s shown [in Figure 1], the closed end 8
is separated from the rest of needle hub 4 by a flange 12.” Id. (quoting Spec.
¶ 18). Appellant argues that, because the needle extends from the closed
end, which is part of the needle hub, one would understand that Figure 1

3 To the extent that the Examiner implies that a lack of definition of “the rest
of the needle hub” renders the claim unclear, we do not reach such an issue
because an indefiniteness rejection is not before us.
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depicts the needle also as separated from the rest of the needle hub by the
flange, and therefore contends that there is no non-enablement issue. Id.
We do not read the “rest of the needle hub” as meaning that the needle
is part of the needle hub, as the Examiner asserts and upon which the
rejection is based. Ans. 6. Also, we do not agree with the implied assertion
that the claim requires that the flange separate the needle from the entirety of
the needle hub, as that would read the phrase “the rest of” out of the claim.
Ans. 5–6. We are not persuaded by the Examiner’s articulation of the
rejection that one of ordinary skill in the art would have to engage in undue
experimentation in order to make and use the flange feature of the claimed
invention. Accordingly, we do not sustain the Examiner’s enablement
rejection of claims 7, 13, and 20.
C. The Rejection of Claims 1, 3–5, 7–11, 13–18, and 20 as Obvious Over
Segal, Gettig, and Delvigo
A dispositive issue raised by Appellant’s arguments is whether the
Examiner has provided an adequate reason why a person of ordinary skill in
the art would have modified Segal’s device to have a one piece needle
assembly with a hub component that tapers. See Appeal Br. 18, 22.
Claim 1, for example, recites:
A one piece needle assembly comprising a needle hub
having an elongate cylindrical portion formed by a
circumferential wall that extends from a hub receptacle end to
an opposite end, the opposite end of the elongate cylindrical
portion tapers to a closed end from which a needle extends.
Id. at 29. Appellant and the Examiner both appear to construe the recited
“needle assembly” as comprising a needle hub and a needle, and appear to
agree that the recitation of a “one piece” assembly limits the claimed
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apparatus to one having the needle and hub as a single component. See
Appeal Br. 12; Non-Final Act. 8.
The Examiner finds that Segal discloses an assembly that can connect
to a needle but “does not disclose how the distal end of assembly 3 exactly
connects to the needle.” Non-Final Act. 8 (citing Segal ¶ 30). Thus,
according to the Examiner, Segal does not disclose a one piece assembly
having a closed end from which a needle extends. Id. The Examiner also
finds that Segal lacks a portion that tapers. Id. For those features, the
Examiner relies on Gettig. Id. (citing Gettig, Fig. 19). The Examiner’s
proposed modification includes the “replacement of Segal et al.’s needle
with Gettig’s needle.” Id. at 9.
The Examiner also finds, in pertinent part, that Gettig teaches that “a
needle 334 extends (as seen in Fig 19) for the purpose of injection of
medicinal drugs into a patient.” Id. (citing Gettig, 1:14–16, 8:53–55). The
Examiner relies on this latter finding as an explicit teaching to modify Segal.
Id. at 8–9. Specifically, the Examiner reasons that:
Therefore, it would have been obvious to one of ordinary
skill in the art at the time the invention was made to modify
Segal et al. to replace the components of needle hub 3 that lie
distal to the elongate cylindrical portion of Segal et al. as well
as Segal et al.’s needle with a tapered portion and a closed end
directly attached to a needle, as taught by Gettig, for the
purpose of injection of medicinal drugs into a patient.
Id. (emphasis added) (citing Gettig, 1:14–16, 8:53–55). The Examiner
additionally reasons that it would have obvious to replace Segal’s two piece
needle and hub with the combined hub and needle of Gettig “since it has
been held that forming in one piece an article which has formerly been
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formed in two pieces and put together involves only routine skill in the art.”
Id. (citing Howard v. Detroit Stove Works, 150 U.S. 164 (1893)).
Appellant argues that the Examiner has failed to set forth an adequate
reason why one of ordinary skill in the art would have combined the
identified features of Segal and Gettig. Appeal Br. 18. Appellant asserts
that the Examiner is selectively picking and choosing parts of the references
in order to reach the claimed combination and, in so doing, the Examiner has
engaged in improper hindsight. See Appeal Br. 13, 17–18; Reply Br. 7.
Appellant also argues that the Detroit Stove Works case does not support the
Examiner’s position. Appeal Br. 18.
We agree with Appellant that the Examiner has not set forth adequate
reasoning as to why one of ordinary skill in the art would have modified
Segal’s connector to have the hub-needle assembly and taper of Gettig. As
mentioned, the Examiner maintains that Gettig provides an explicit teaching
to modify Segal in stating that the configuration, including the needle-hub
assembly, is “for the purpose of injection of medicinal drugs into a patient.”
Non-Final Act. 9 (citing Gettig, 1:14–16, 8:53–55); cf. Ans. 13 (The
Examiner confirming that the rejection’s reasoning to combine references is
an explicit teaching from a reference: “[A]s can be seen in the last Office
Action, each modification has been provided with a motivation taken from
the references and a citation for each of the motivations has been
provided.”). The Examiner, however, acknowledges that Segal’s apparatus
also has a needle, even if not shown in the figures. See, e.g., Non-Final
Act. 9 (proposing to replace Segal’s needle with Gettig’s needle). Also as
the Examiner acknowledges, Segal’s needle is a “fluid conduit[] used to
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transfer fluid from the proximal end of the device to a patient.” Ans. 10
(citing Segal ¶¶ 30, 48). Thus, Segal’s apparatus—in an unmodified form—
already serves the purpose of injecting medications into a patient.
Accordingly, we fail to see, and the Examiner has not adequately explained,
why the relied-upon teaching of Gettig would have provided a reason to
modify Segal’s device. Additionally, even if we were to find that Gettig’s
teaching prompted a modification regarding the needle, we still would fail to
see adequate reasoning by the Examiner as to why Segal would be modified
to have the recited portion that tapers.
As to Detroit Stove Works, the Examiner does not elaborate on the
application of that case to the facts before us. See Non-Final Act. 9.4 We
find the Examiner’s conclusory reliance on the Detroit Stove Works decision
to be inadequate to sustain a rejection. See In re Ochiai, 71 F.3d 1565, 1572
(Fed. Cir. 1995) (It is incorrect to rely on the use of per se rules.). And,
again, even if any holding of Detroit Stove Works supported a determination
that it would have been obvious to form Segal’s hub and needle as a
single-piece structure, we still are left without an adequate reason to modify
Segal to have a portion that tapers.

4 Detroit Stove Works involved a grate for a fire box of a heating stove.
Howard v. Detroit Stove Works, 150 U.S. at 165, 169. We understand the
Examiner to rely on the Court’s statement: “As to the third patent, it is void
because the claims in it were clearly anticipated, and because it involves no
invention to cast in one piece an article which has formerly been cast in two
pieces, and put together,” id. at 169.
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In the Answer, the Examiner asserts that Segal discloses the hub as
“being connectable to a ‘fluid receiving device’ . . . [,] which can be a
needle.” Ans. 10. The Examiner then reasons that:
[B]oth the “fluid receiving device” of Segal et al. and the
needle 334 of Gettig are fluid conduits used to transfer fluid
from the proximal end of the device to a patient; because both
are fluid conduits used for similar purposes, one of ordinary
skill in the art would recognize that it would be obvious to
replace the fluid conduit of Segal et al. with that of Gettig and
that it would also be obvious to modify the shape of the distal
end of the hub (connector 3) of Segal et al. so as to have the
shape of the distal end of the hub 330 of Gettig since the distal
ends of both of these hubs are simply acting to hold the fluid
conduits.
Id. at 11. The first part of this reasoning appears to be that it would be
obvious to replace a needle with a needle, which, even if true, fails to
explain adequately why one would replace Segal’s “connectable” needle
with a needle and hub combination formed as a one-piece assembly. We
further determine that the second part of this reasoning, presumably
addressing the claimed portion that tapers, is an inadequate explanation as to
why one of ordinary skill would modify a hub shape based on the asserted
fact that both references teach a structure to hold a fluid conduit.
The three independent claims on appeal, claims 1, 8, and 14, all
contain the same or similar recitation of a one-piece needle assembly and an
opposite end of a hub that tapers to a closed end from which a needle
extends. Because the Examiner has not adequately explained why the
references would have been combined in a manner to arrive at claimed
subject matter having these features, we do not sustain the Examiner’s
obviousness rejection of claims 1, 3–5, 7–11, 13–18, and 20.
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D. The Rejection of Claims 6, 12, and 19 as Obvious Over Segal, Gettig,
Delvigo, and Sheppard
Claims 6, 12, and 19 each depend directly from an independent claim,
and each further limits the needle to a specific type, such an epidural or
spinal needle. Appeal Br. 29–31. The Examiner finds that Sheppard
discloses a spinal/epidural needle, but does not rely on Sheppard in any
manner that cures the deficiency of the underlying rejection of the
independent claims based on Segal, Gettig, and Delvigo. Non-Final Act. 24.
As such, we also reverse the rejection of claims 6, 12, and 19.
IV. CONCLUSION
In summary:
Claims
Rejected
Basis Affirmed Reversed
1 and 3–20 § 112, first
paragraph
(enablement)
1 and 3–20
7, 13, and 20 § 112, first
paragraph
(enablement)
7, 13, and 20
1, 3–5, 7–11, 13–
18, and 20
§ 103(a) Segal,
Gettig, and
Delvigo
1, 3–5, 7–11,
13–18, and 20
6, 12, and 19 § 103(a) Segal,
Gettig, Delvigo,
and Sheppard
6, 12, and 19
Overall Outcome 1 and 3–20
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V. DECISION
The decision of the Examiner to reject claims 1 and 3–20 is affirmed.
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)(1)(iv).

AFFIRMED