Chad Amborn et al.

Patent Trials and Appeals Board

Mar 25, 2020

13860770 - (D) (P.T.A.B. Mar. 25, 2020)

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.
13/860,770 04/11/2013 Chad Amborn 0109/0043 6707
135866 7590 03/25/2020
LAW OFFICE OF LOUIS WOO
717 NORTH FAYETTE STREET
ALEXANDRIA, VA 22314
EXAMINER
DRAGICEVICH, ZACHARY T
ART UNIT PAPER NUMBER
3679
MAIL DATE DELIVERY MODE
03/25/2020 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 CHAD AMBORN, GEOFF CLARK, and
RENEE ROBERT

Appeal 2018-003752
Application 13/860,770
Technology Center 3600
____________

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, 3–11, 13–20, 22, and 24. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM IN PART.

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. CLAIMED SUBJECT MATTER
The claims are directed to “connector fittings and more particularly to
a filling fitting adapted to be used with medicament infusion systems.”
Spec. ¶ 2. According to the Specification, the disclosed filling fitting
“prevents mis-connection among connectors to ensure that the correct
medicament is input to the cassette [to be used with a medicament infusion
system].” Id. ¶ 4. Of the claims on appeal, claims 1, 11, and 22 are
independent claims. Claim 1, reproduced below, is illustrative of the
claimed subject matter:
1. A fitting, comprising:
a body having a longitudinal portion and a first end and a
second end, one through passage in the body connecting the
first and second ends, the first end having a conventional luer
connector, the second end having an opening to the one through
passage;
a non-conventional connector including an extension
adapted to fit into the opening of the body, an other through
passage extending along the non-conventional connector and
the extension in longitudinal alignment with the one through
passage, the non-conventional connector having a given
configuration that prevents it from mating with a counterpart
conventional luer connector but matable with a counterpart
non-conventional connector having a configuration
complementary to the given configuration;
at least one wing extending from and longitudinally
along at least a part of a main portion of the body, the wing
having a longitudinal top edge; and
a partition having a surface away from the first end
extending circumferentially about the body, the end of the wing
facing the first end merging with the surface of the partition
with the top edge of the wing align [sic] with an outer
circumferential edge of the partition.
Appeal Br. 22 (Claims Appendix).
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Independent claim 22 recites, rather than a “non-conventional
connector,” “the connector having a given configuration that prevents it
from mating with any luer connector but matable with a counterpart
connector having a configuration complementary to the given
configuration.” Id. at 26.
II. REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Guala US 5,855,230 Jan. 5, 1999
Segal US 6,402,207 B1 June 11, 2002
Kennard US 2008/0065023 A1 Mar. 13, 2008
Kyle US 2011/0230856 A1 Sept. 22, 2011
III. REJECTIONS2
1. Claims 1, 3–11, and 13–20 are rejected under 35 U.S.C.
§ 112(b) as being indefinite for failing to particularly point out and distinctly
claim the subject matter which the inventor or a joint inventor regards as the
invention;
2. Claims 1, 3–5, 9, 11, 13, 15, 17, 22, and 24 are rejected under
35 U.S.C. § 102(a)(l) as anticipated by Guala;
3. Claims 6, 7, 18, and 19 are rejected under 35 U.S.C. § 103 as
being unpatentable over Guala and Segal;
4. Claims 10 and 16 are rejected under 35 U.S.C. § 103 as being
unpatentable over Guala and Kennard; and

2 The application is being examined under the First Inventor to File
provisions of the Leahy-Smith America Invents Act (“AIA”), Pub. L.
No. 112-29, which was enacted on September 16, 2011. Final Act. 2.
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5. Claim 14 is rejected under 35 U.S.C. § 103 as being
unpatentable over Guala and Kyle.
IV. OPINION
A. The Indefiniteness Rejection
Independent claims 1 and 11 recite “a conventional luer connector”
and “a non-conventional connector . . . , the non-conventional connector
having a given configuration that prevents it from mating with a
counterpart conventional luer connector but matable with a counterpart
non-conventional connector having a configuration complementary to the
given configuration.” The Examiner rejected claims 1, 3–11, and 13–20 as
being indefinite, maintaining that the terms “conventional” and
“non-conventional” fail to impart particular structure to the connectors. See
Final Act. 2, 10; Ans. 3–5.
Appellant argues that “a person skilled in the art could readily see
that, with more than reasonable certainty, ¶¶ 005 and 0021–0023 [of the
Specification] amply describe the differences between a ‘conventional’
connector and a ‘non-conventional’ connector.” App. Br. 8. Appellant
further argues that the meaning of the disputed terms is made clear through
references in the Specification to certain International Standard Organization
(ISO) standards and a provisional application incorporated by reference. Id.
(citing Spec. ¶¶ 21, 23 (as amended by preliminary amendment)); see id.
(citing but not discussing paragraph 25 of the Specification). Appellant’s
proposed construction is that “conventional” luer connectors are “the luer
connectors that are defined by ISO 594-1 and 594-2” and, “[b]y extension, a
‘non–conventional’ connector is a connector that is not based on the ISO
584-1 and 594-2 standards.” App. Br. 8.
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For the reasons that follow, we affirm the Examiner’s indefiniteness
rejection.
As mentioned, Appellant directs our attention to, inter alia,
paragraphs 5 and 25 of the Specification. See App. Br. 8. Paragraph 5, in
discussing “[t]he inventive filling fitting,” states that “[t]he non-conventional
connectors are disclosed in the [then co-pending provisional application
No. 61/457,879] and may be referred to as CorrectInject® (CI) connectors.”
Spec. ¶ 5. Similarly, paragraph 25 along with paragraph 27 describe
Figure 6 as “a cross-sectional view of the fitting 100 of the instant invention
showing the non-conventional male connector . . . [where] filling fitting 100
has . . . a non-conventional connector 112 in the form of a male CI connector
at its other or second end.” Spec. ¶¶ 25, 27 (emphasis added). From this, a
person of ordinary skill in the art might understand that the non-conventional
connectors of the claimed invention are limited to the specific CI connectors
disclosed in the cited provisional application or to that shown in Figure 6 of
the instant Specification,3 and are not, as Appellant urges, merely anything
other than the particular luer connector of the ISO standards. Cf. Reply Br. 4
n.2 (Appellant, in attempting to distinguish the prior art, arguing that, “[i]n
the claims, the recited ‘non-conventional connector’ is clearly shown in the
drawings and explained in the specification.”).
The preliminary amendment to paragraph 21 inserted the following
language: “As disclosed in the aforenoted incorporated by reference
[provisional] application 61/457,879 (now 13/517,782), standard or

3 It is not clear whether the CorrectInject® (CI) connectors of the cited
provisional application and as shown in the figures of the instant
Specification are the same.
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conventional luer connectors are manufactured in accordance with the
current ISO (International Standard Organization) Standards 594-1 and
594-2.” Prelim. Amend. (6/30/14) ¶ 21 (underlining omitted). In response
to the Examiner’s concern regarding the practice of defining claim
limitations using standards that can change over time, Appellant represented
that the cited ISO Standards issued in 1986 and 1998, respectively, and that
those two standards do not change, and further asserts that those “have been
replaced by ISO standard 80369-7 published in 2016.” Reply Br. 2.4
After the Preliminary Amendment, paragraph 23 provides, with
underlining showing inserted language:
The non-conventional male connector, as a standalone
component 112, is shown in Fig. 4. The particulars of the
non-conventional male connector, which may be referred to as a
male CorrectInject® (CI) connector as noted above, is described
in greater detail in the aforenoted ’879 (now ’782) application,
where non-conventional connectors are defined to be designed
such that they are incompatible with the luer connectors that are
manufactured in accordance with the current ISO (International
Standard Organization) Standards 594-1 and 594-2.[5] As

4 The Examiner requested that Appellant submit copies of the cited
standards. Final Act. 10. Appellant responded as follows: “Appellant
submits that the examiner is wrong in requiring that copies of the ISO
standard be submitted. As pointed out above, the ISO standard 594-1 was
published in 1986 and the ISO 594-2 in 1998. Therefore, each of those
standards is publicly available and well known to persons who practice in
the medical field.” Reply Br. 3.
5 To be precise, paragraph 5 of the provisional application refers not to a
definition of “non-conventional connectors” generally, as the language of
the Preliminary Amendment might suggest, but rather characterizes the
design of the particular connector disclosed in that provisional application.
Appl. No. 61/457,879, Spec. ¶ 5 (“The connectors for the various conduits
of the drug delivery system of the instant invention are designed such that
they are incompatible with the standard or conventional connectors such as
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shown, non-conventional male connector 112 has a connector
end represented by male CI connector 113 and a neck
extension 114. . . . .
Prelim. Amend. (6/30/14) ¶ 23 (underlining in original). Thus, a
“non-conventional connector” could be understood to be: 1) that shown in
Figure 4 of the instant Specification, 2) the CI connector described in the
provisional application, or 3) any connector that is incompatible with a luer
connector manufactured in accordance with one of two older ISO Standards.
As to the latter and Appellant’s proposed construction—where a
non-conventional connection is anything not based on the referenced ISO
standards (App. Br. 8)—the incorporated provisional application suggests
that luer connectors were, at that time, not the only type of known “standard
or conventional connectors.” Appl. No. 61/457,879, Spec. ¶ 5 (referring to
“the standard or conventional connectors such as luer connectors that are
manufactured in accordance with the ISO (International Standard
Organization) Standards 594-1 and 594-2.”) (emphasis added). If that is a
correct proposition, Appellant’s term “non-conventional” confusingly would
encompass a non-luer fitting that was regarded in the art as conventional at
the time of the invention.
Additionally, the Examiner notes that “essential material,” which
includes material necessary for claim definiteness, only may be incorporated
by reference to a U.S. patent or U.S. patent application publication which
does not itself incorporate by reference essential material. Ans. 4–5 (quoting

luer connectors that are manufactured in accordance with the ISO
(International Standard Organization) Standards 594-1 and 594-2, but are
compatible only with specially designed counterpart complementary
connectors.”).
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37 C.F.R. § 1.57(d)). Appellant responds, inter alia, with the assertion that,
“to allege that the terms ‘conventional’ and ‘non-conventional’ are ‘essential
material’ and therefore the claim is indefinite is non sequitur.” Reply Br. 3.
The Examiner has the better position. The cited ISO standards are “essential
material” because Appellant relies on them to define the claim terms
“conventional” and “non-conventional.” Therefore, we agree with the
Examiner that the incorporation by reference of the standards is improper,
whether they are incorporated directly in the instant Specification or through
a patent application publication that is incorporated in the instant
Specification.
On the record of this appeal, the meaning of the terms “conventional”
and “non-conventional” are 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(b) of claims 1, 3–5, 9, 11, 13, 15, 17, 22, and 24.
B. The Anticipation Rejection—Guala
Claims 1, 3–5, 9, 11, 13, 15, 17, 22, and 24 are rejected as anticipated
by Guala. As discussed above, independent claims 1 and 11 recite “a
non-conventional connector.” App. Br. 22, 23–24 (claims appendix).
Independent claim 22 recites “a connector . . . having a given configuration
that prevents it from mating with any luer connector but matable with a
counterpart connector having a configuration complementary to the given
configuration.” Id. at 26.
The Examiner found that Guala’s cap 8 is the recited
non-conventional connector of claims 1 and 11 and the non-luer connector
of claim 22. Final Act. 3, 5, 10; Ans. 5. Appellant disagrees, arguing that
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component 8 is a protection cap, not a non-conventional connector. App.
Br. 9.
Figure 1 of Guala is reproduced below:

Figure 1 depicts “a diagrammatic axially sectioned view of a Luer-Lock
fitting for medical infusion/transfusion lines.” Guala, 1:50–51. Shown is “a
Luer-Lock fitting [element number 1] . . . comprising . . . a first outer Luer
cone connector 3, intended to be coupled within the terminal end of a
flexible hose . . . and defining at the other end a second outer Luer cone
connector 4.” Guala, 1:54–60. “Reference numeral 8 indicates a protection
cap sealingly fitted axially over the Luer cone connector 4.” Id., 2:1–2.
In making the finding that Guala’s cap 8 is a non-conventional,
non-luer connector, the Examiner reiterates the position that
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“non-conventional connector” is indefinite and therefore “all that can be
used to define” it are the remaining structural limitations recited in the claim.
Ans. 5; see also Final Act. 10 (“In response to applicant’s argument that the
connector 8 of Guala is not ‘non-conventional’, there is nothing in claim 1
that prevents this connector from being considered a ‘non-conventional
connector’. If applicant wishes to further structurally define what constitutes
a ‘non-conventional’ connector, then the claim should be amended
accordingly.”). According to the Examiner,
Under broadest reasonable interpretation, the connector 8 can
be considered a “non-conventional connector” since it contains
an extension (11) and a through passage in longitudinal
alignment with a through passage of the body as required by
claim 1. Further, since cap 8 has an inner diameter too large to
successfully mate with the outer diameter of a counterpart
conventional connector “3”, the cap 8 of Guala is a
“non-conventional connector” as defined by claim 1.
Ans. 5; see also id. at 7–8 (similarly addressing independent claim 11), 9
(addressing independent claim 22).
Although we recognize that Guala’s cap connects to the luer cone
connector, we fail to see how the cap itself is a connector. See Guala, 1:43–
47 (“According to a variant of the invention, said outer surface of the Luer
cone connector is formed with an outer annular enlarged portion for the
forced coupling into the inner end of the cap.”). Guala’s description of the
various components of the overall fitting repeatedly refers to a “cap” and a
“connector” in the same sentence and as two different types of components
and impliedly distinguishes their respective functions of protecting and
connecting. See, e.g., id., 1:43–47, 2:1–2 (“Reference numeral 8 indicates a
protection cap sealingly fitted axially over the Luer cone connector 4.”).
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Regardless as to the meaning of “non-conventional,” the Examiner
has not explained adequately why a person of ordinary skill would have
considered the cap to be a “connector” within the meaning of the rejected
claims. Accordingly, we determine that the Examiner has attributed an
unreasonably broad construction to the term “connector.” We cannot find
that a person of ordinary skill in the art would have understood Guala’s
cap 8 to be the recited “connector.”
In light of the above, we cannot sustain the anticipation rejection of
the independent claims, or of the rejected dependent claims which
necessarily contain the same limitation.
C. The Obviousness Rejections—Guala and Segal, Guala and Kennard, and
Guala and Kyle
The Examiner determined that several dependent claims would have
been obvious in light of Guala in combination with one of three secondary
references. Final Act. 6–9. The Examiner relies on Segal for, among other
things, the relationship between the fluid source, the fluid store, and the
fitting interposed therebetween as recited in dependent claim 6. Id. at 6.
The Examiner relies on Kennard for the orange color of dependent claims 10
and 16, and relies on Kyle for providing indicia on a member as recited in
dependent claim 14. Id. at 7–8, 9. The three obviousness rejections all are
based on the anticipation rejection of the independent claims as discussed
above and, specifically, are premised on the Examiner’s finding that Guala’s
cap is the claimed non-conventional connector. See id. at 6, 7, 9. In light of
our disposition of the underlying anticipation rejection, we cannot sustain
the obviousness rejections of claims 6, 7, 18, and 19 over Guala and Segal,
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claims 10 and 16 over Guala and Kennard, and claim 14 over Guala and
Kyle.
V. CONCLUSION
The Examiner’s indefiniteness rejection is affirmed. The Examiner’s
anticipation and obviousness rejections are reversed.
VI. DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3–11,
13–20
112(b) Indefiniteness 1, 3–11,
13–20

1, 3–5, 9,
11, 13, 15,
17, 22, 24
102(a)(l) Guala 1, 3–5, 9,
11, 13, 15,
17, 22, 24
6, 7, 18, 19 103 Guala, Segal 6, 7, 18, 19
10, 16 103 Guala, Kennard 10, 16
Overall
Outcome
1, 3–11,
13–20
22, 24

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED IN PART