Ex Parte Ziman et al

Patent Trial and Appeal Board

Feb 20, 2018

11342620 (P.T.A.B. Feb. 20, 2018)

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.
11/342,620 01/31/2006 Lynn A. Ziman 0100/0190 2493
135866 7590 02/21/2018
LAW OFFICE OF LOUIS WOO
717 NORTH FAYETTE STREET
ALEXANDRIA, VA 22314
EXAMINER
BOSWORTH, KAMI A
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
02/21/2018 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 2016-000570
Application 11/342,620
Technology Center 3700
____________________

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

BARRETT, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Lynn A. Ziman and Steven Huu Nguyen (Appellants) seek our review
under 35 U.S.C. § 134(a) of the Examiner’s rejection of claims 24–41. We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

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THE INVENTION
Appellants’ 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 rejected claims, claims 24, 31,
and 37 are independent claims. Claim 24, reproduced below, is illustrative
of the subject matter on appeal.
24. In combination,
a fluid store or a fluid line having a conventional
receptacle end with a conventional configuration adapted to mate
with a needle hub having a conventional complementary
receptacle end;
a one piece needle assembly having a needle hub formed
by an elongate body having a circumferential wall of a given
diameter that extends between a receptacle end and a second end,
the receptacle end having an opening defined by the
circumferential wall, the needle hub including a tapered closed
end that extends integrally away from the second end of the
elongate body, a needle not part of the needle hub extending from
the closed end of the needle hub, the receptacle end of the needle
hub having a given configuration that prevents it from mating
with the conventional receptacle end of the fluid store or fluid
line, the given configuration including two protrusions extending
at opposite sides from an outer surface of the circumferential wall
a particular distance along the elongate body from the opening
and the circumferential wall having a thickness dimensioned to
provide the opening and an internal passage along the elongate
body to the opening with a defined cross section that does not
accept a conventional male receptacle; and
an adapter having a first end with a conventional
complementary receptacle end matable with a conventional
receptacle end of conventional fluid stores or fluid lines and a
second end with a configuration complementary to the given
configuration of the receptacle end of the needle hub so that the
second end of the adapter is matable with the receptacle end of
the needle hub, a particular male receptacle at the second end of
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the adapter configured to be accepted into the opening with the
defined cross section at the needle assembly;
wherein when the fluid store or fluid line is connected to
the first end of the adapter and the needle assembly is connected
to the second end of the adapter, a through passage in the adapter
establishes a fluid path between the fluid store or fluid line and
the needle.
App. Br. 26 (Claims Appendix).

THE REJECTIONS
The following Examiner’s rejections are before us for review:
1. Claims 24–41 are rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the enablement requirement;
2. Claims 24–41 are rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite for failing to particularly point out and
distinctly claim the subject matter which the applicants regard as the
invention;
3. Claims 24–29, 31–35, and 37–41 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Segal (US 2004/0201216 A1, filed Aug.
26, 2003, published Oct. 14, 2004), Sheppard (US 6,500,153 B1, issued Dec.
31, 2002), and Delvigo (US 5,925,028, issued July 20, 1999); and
4. Claims 30 and 36 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Segal, Sheppard, Delvigo, and Sinko
(US 4,453,927, issued June 12, 1984).

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ANALYSIS
A. The Enablement Rejection
Independent claim 24 recites a needle hub having an elongate body
with a receptacle end and a second end where “a tapered closed end . . .
extends integrally away from the second end of the elongate body” and with
“a needle . . . extending from the closed end of the needle hub.” App. Br. 26
(Claims Appendix, emphasis added). Independent claims 31 and 37 contain
similar recitations.
The Examiner maintains that “the end of Applicant’s hub is not
actually closed” and “[b]ecause the distal end of the hub obviously has an
opening for fluid to flow through (because it is attached to hollow needle
which receives fluid from the hub), the recitation that this end is ‘closed’
fails to comply with the enablement requirement.” Non-Final Act. 3.
We agree with Appellants that one of ordinary skill, considering the
claimed invention in light of the Specification, would not read the claim
term “closed” as referring literally to a completely closed end. See App.
Br. 11–12 (citing Spec. ¶ 18, Fig. 1). This understanding is consistent with
the extrinsic evidence indicating that “closed end” has been used in the art to
refer to the needle end of a syringe. App. Br., Evidence Appendix A (US
5,651,774, issued July 29, 1997), col. 5, ll. 55–57, Fig. 4; Evidence
Appendix B (US 6,436,075 B1, issued Aug. 20, 2002), col. 2, ll. 13–18,
Fig. 2.
We do not conclude that one would have to engage in undue
experimentation in order to practice the claimed invention having a “closed
end.” Accordingly, we do not sustain the enablement rejection.
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B. The Indefiniteness Rejection
The independent claims recite certain components as having a
“conventional” structure or configuration, and other components as being
configured other than “conventional.” For example, claim 24, with
emphasis added, recites “a conventional receptacle end with a conventional
configuration adapted to mate with a needle hub having a conventional
complementary receptacle end,” which is contrasted with “the receptacle end
of the needle hub having a given configuration that prevents it from mating
with the conventional receptacle end.” The Examiner rejected claims 24–41
as being indefinite, maintaining that the term “conventional” is a relative and
subjective term that is not defined adequately in the Specification. Non-
Final Act. 4–5; Ans. 4–5.
Appellants argue that an applicant may be his or her own
lexicographer and that claims are properly construed in light of the
Specification, and points to particular paragraphs in the Specification. App.
Br. 13 (citing Spec. ¶¶ 18, 20, 23, Figs. 1, 4a–4f); see also Reply Br. 3
(Appellants asserting that “the terms ‘conventional’ and ‘nonconventional’
are described in the specification.”). However, the cited paragraphs merely
use, without elaboration, the term “conventional” in modifying the words
“needle,” “luer end,” and “luer connection,” respectively, and do not provide
a lexicographical definition of the term “conventional” as used in the claims
to modify “receptacle” and “fluid stores or fluid lines.”
Appellants also provide a proposed construction, arguing
“conventional” and “non-conventional” “simply mean that they are not the
same and that one is a ‘non’ of the other.” Reply Br. 4. We cannot accept as
correct that proposed construction as it is an unjustified deviation from the
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normal usage of the terms. It would, for example, encompass the use of two
components that both are deemed to be “conventional” but yet are different
from one another.
Although not dispositive, we also note that Sheppard’s specification
defines with specificity the terms “typical syringe” and “typical needle.”
Sheppard, col. 3, l. 60–col. 4, l. 10. This suggests that, in the pertinent art,
there is a need to attach more clarity to the term “typical,” a term similar in
connotation to that of “conventional.”
The meaning of the term “conventional” is sufficiently unclear to
render indefinite the rejected claims. In re Packard, 751 F.3d 1307, 1311
(Fed. Cir. 2014). Accordingly, we affirm the Examiner’s indefiniteness
rejection under § 112, second paragraph.
C. The Obviousness Rejection–Segal, Sheppard, and Delvigo
Independent claim 24 recites a needle hub formed by “an elongate
body having a circumferential wall of a given diameter that extends between
a receptacle end and a second end.” Independent claims 31 and 37 recite the
same or similar language.
Appellants argue that the Examiner’s finding that Segal discloses this
feature is erroneous. See App. Br. 16–17. The Examiner finds that Segal’s
entire body 3, as shown in Figure 8D, is the elongate body of the needle hub.
Non-Final Act. 5–6; Ans. 6–7. The Examiner provides an annotated figure,
shown below, to explain the findings.
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Ans. 7. Figure A above is a portion of Segal’s Figure 8D depicting second
female medical connector portion 3, with the Examiner’s annotations
indicating the components deemed to correspond to recited features. The
Examiner finds that the portion identified above as the “circumferential
wall” satisfies the claim language “a given diameter that extends between a
receptacle end and a second end.” Id. at 6–7. The Examiner reasons that the
claim language does not require the “given diameter” to extend the full
length of the elongate member, but “the claims only require the wall to
extend between the two ends.” Id. According to the Examiner, “[t]he
portion of the elongate body indicated as the ‘circumferential wall’ meets the
limitations of the claim because it is of a given diameter and it lies between
the receptacle end and the second end.” Id. at 6.
The Examiner applies an unreasonably broad construction to the
pertinent claim phrase. While we will not read unrecited features from the
Specification into the claim, we determine that one of ordinary skill reading
the pertinent limitation in light of the Specification, and particularly the
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figures, would understand that the subject phrase refers to a section having a
constant diameter from the receptacle end to the second end (where the
tapered section begins). Although the Specification provides little or no
verbal description that sheds light on the meaning of the phrase, the figures
consistently depict needle hub 4 as having a constant diameter from the
receptacle end to the beginning of the taper. See Spec., Figs. 1, 2, 3, 6; see
also id. ¶ 19 (“Receptacle end of needle hub 4 comprises an elongate
cylindrical portion . . . .”). Thus, we determine that it is not enough, as the
Examiner impliedly concludes, that a circumferential wall exist between two
ends or extend from one towards the other, it must extend between the two
ends for the full distance.
The Examiner identifies a wall extending from the receptacle end to a
point well shy of that identified by the Examiner as the second end. This
finding does not meet the recited limitation. As such, we cannot sustain the
rejection of the independent claims, or of the dependent claims which
necessarily contain the same limitation.
D. The Obviousness Rejection–Segal, Sheppard, Delvigo, and Sinko
In the rejection of claims 30 and 36, the Examiner relies on Sinko for
the disclosure of a filter, but does not rely on Sinko in any manner that cures
the defect of the underlying combination of Segal, Sheppard, and Delvigo.
See Non-Final Act. 17–18. Accordingly, we cannot sustain the rejection of
claims 30 and 36 as being obvious.

CONCLUSIONS
We conclude that the Appellants have shown that the Examiner erred
in rejecting claims 24–41 under the enablement requirement and claims 24–
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41 as being obvious. We further conclude that the Examiner did not err in
rejecting claims 24–41 as being indefinite.

DECISION
The decision of the Examiner to reject claims 24–41 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