Ex Parte Burgess et al

Patent Trial and Appeal Board

Feb 26, 2019

14283449 (P.T.A.B. Feb. 26, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/283,449 05/21/2014
27939 7590 02/26/2019
Philip H. Burrus, IV
Burrus Intellectual Property Law Group LLC
222 12th Street NE
Suite 1803
Atlanta, GA 30309
FIRST NAMED INVENTOR
James E. Burgess
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.
BPMDL0007JB.D1
10076U Dl
6467
EXAMINER
WILLETT, TARYN T
ART UNIT PAPER NUMBER
1743
MAIL DATE DELIVERY MODE
02/26/2019 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 JAMES E. BURGESS and JOHN H. KUTSCH
Appeal2018-003385
Application 14/283,449
Technology Center 1700
Before CATHERINE Q. TIMM, JAMES C. HOUSEL, and
N. WHITNEY WILSON, Administrative Patent Judges.
HOUSEL, Administrative Patent Judge.
DECISION ON APPEAL 1
Appellant2 appeals under 35 U.S.C. § 134(a) from the Examiner's
decision rejecting claims 1-11. We have jurisdiction over the appeal under
35 U.S.C. § 6(b).
We AFFIRM.
1 Our decision refers to the Specification ("Spec.") filed May 21, 2014, the
Examiner's Final Office Action ("Final") dated May 10, 2017, Appellant's
Appeal Brief ("Appeal Br.") filed October 6, 2017, the Examiner's Answer
("Ans.") dated December 13, 2017, and Appellant's Reply Brief ("Reply
Br.") filed February 8, 2018.
2 Appellant is the Applicant, Medline Industries, Inc., which is identified in
the Appeal Brief as the real party in interest (Appeal Br. 2).
Appeal2018-003385
Application 14/283,449
STATEMENT OF THE CASE
The invention relates to a method of producing a luer access port
comprising two parts formed in a single mold using an insert molding
process (Spec. ,r 24). Appellant discloses a connector for a fluid conduit
including a luer access port, to which a luer connector or a needle-less
syringe may couple (id. ,r 21). Appellant's connector is depicted in Figure 9,
reproduced below.
907
80<1\ I '3G5
909 ~
\ : 904
FIG. 9
Appellant's Figure 9, depicting a luer connector
The luer connector 9003 includes a luer access port 800 inserted in a
luer access opening of the connector. Appellant discloses that luer access
port 800 is made of two parts, a first elastomer part 500 and a second
thermoplastic part 600 (id. ,r,r 47--48). Appellant's luer access port 800 is
shown in more detail in Figure 8, reproduced below.
3 Throughout this Opinion, for clarity, we present labels to elements in
figures in bold font, regardless of their presentation in the original document.
2
Appeal2018-003385
Application 14/283,449
FIG. 8
Appellant's Figure 8, depicting a two part luer access port
Appellant discloses that the luer access port can be formed in a single
mold using one of two insert molding processes (id. ,r 53). Appellant
discloses that the method includes the steps of forming a first portion of the
luer access port in a mold by injecting first material into a cavity of the
mold, removing at least one tooling component from the cavity, thereby
creating additional space, and forming a second portion of the luer access
port by injecting a second material into the cavity (id. ,r 54). The first
process forms the cylindrical body of the luer access port, opens the mold
with the body still inside, rotates the mold 180 degrees to form new cavities,
and then forms stair-stepped elastomer integrally with the cylindrical body
over one end thereof (id. ,r 56). The second process forms a stair-stepped
elastomer in a mold, removes cavity blocks to provide a body forming
cavity, and then forms a cylindrical body integrally about the elastomer (id.
,r,r 58-59). In both processes, the resulting luer access port is attached to a
luer connector in alignment with the luer connector access opening and a slit
is cut in the elastomer (id. ,r 57).
3
Appeal2018-003385
Application 14/283,449
Claim 1, reproduced below from the Claims Appendix to the Appeal
Brief, is illustrative of the subject matter on appeal. The limitations at issue
are italicized.
1. A method of manufacturing a luer access port with an insert
molding process, comprising:
forming a first portion of the luer access port in a mold
by injecting a first material into a cavity of the mold;
the first portion comprising one of a stair-stepped
elastomer membrane or a luer access port body;
removing at least one tooling component from the cavity,
thereby creating additional space in the cavity; and
forming a second portion of the luer access port by
injecting a second material into the cavity about the one of the
stair-stepped elastomer membrane or the luer access port body
to form the luer access port;
the second portion comprising another of the stair-
stepped elastomer membrane or the luer access port body; and
the first material comprising one of an elastomer or a
thermoplastic, and the second material comprising another of
the elastomer or the thermoplastic.
REFERENCES
The Examiner relies on the following references, the prior art status of
which is not in dispute:
Mortensen us 5,641,184 June 24, 1997
Gahl et al. ("Gahl") US 2004/0082370 Al April 29, 2004
Jepson et al. ("Jepson") US 6,605,076 Bl August 12, 2003
Peppel US 2006/0217671 Al September 28, 2006
Beasley et al. ("Beasley") US 2006/0264898 Al November 23, 2006
4
Appeal2018-003385
Application 14/283,449
REJECTIONS
The Examiner maintains, and Appellant requests our review of, the
following grounds of rejection:
1. Claims 1, 2, and 4 under 35 U.S.C. § 102(b) as anticipated by
Mortensen;
2. Claims 5, 7, and 10 under 35 U.S.C. § 103(a) as unpatentable
over Mortensen;
3. Claims 1, 2, 4, 5, 7, and 10 under 35 U.S.C. § 103(a) as
unpatentable over Mortensen in view of Gahl;
4. Claim 3 under 35 U.S.C. § 103(a) as unpatentable over
Mortensen in view of Jepson, or alternatively, Mortensen in view of
Gahl and Jepson;
5. Claims 6 and 11 under 35 U.S.C. § 103(a) as unpatentable over
Mortensen in view of Peppel, or alternatively, Mortensen in view of
Gahl and Peppel;
6. Claim 8 under 35 U.S.C. § 103(a) as unpatentable over
Mortensen in view of Peppel and Beasley, or alternatively, Mortensen
in view of Gahl, Peppel, and Beasley; and
7. Claim 9 under 35 U.S.C. § 103(a) as unpatentable over
Mortensen in view of Peppel, Beasley, and Jepson, or alternatively,
Mortensen in view of Gahl, Peppel, Beasley, and Jepson.
ANALYSIS
Appellant argues rejections 1 and 3 separately, but does not argue
rejections 2 and 4--7, separately (Appeal Br. 9-10; Reply Br. 6-7). In
addition, for each of rejections 1 and 3, Appellant argues the claims as a
group, focusing on the limitations of claim 1 only. Accordingly, we select
claim 1 for our discussion of the issues presented regarding each of
5
Appeal2018-003385
Application 14/283,449
rejections 1 and 3. Claims 2-11 stand or fall with claim 1. 37 C.F.R.
§ 4I.37(c)(l)(iv) (2017). Thus, the two issues presented on appeal are:
1) Whether the Examiner erred in finding that Mortensen
anticipates claim 1; and
2) Whether the Examiner erred in concluding that claim 1
would have been obvious over the combined teachings of
Mortensen and Gahl.
See Reply Br. 6.
After review of the opposing positions Appellant and the Examiner
articulate, the applied prior art, and Appellant's claims and Specification
disclosures, we determine that Appellant's arguments are insufficient to
identify reversible error in either of the Examiner's anticipation and
obviousness rejections. In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011).
Accordingly, we affirm the stated anticipation and obviousness rejections for
substantially the reasons set forth by the Examiner in the Examiner's
Answer. We offer the following for emphasis only.
Rejection 1: Anticipation of claim 1 by Mortensen
The Examiner finds that Mortensen teaches a method of
manufacturing a luer access port with an insert molding process as recited in
claim 1 (Ans. 11-13). Specifically, the Examiner finds that Mortensen's
method comprises forming a first portion (body 6) of the luer access port in
mold 21a by injecting a first elastomer material into a cavity 24, wherein the
first portion is a stair-stepped membrane (id. at 11, referring to Mortensen,
Figs. 6 and 8A). The Examiner further finds that Mortensen teaches
removing at least one tooling component (projecting negative component
28) from the cavity, thereby creating additional space in the cavity (id. at
6
Appeal2018-003385
Application 14/283,449
11 ). The Examiner finds that Mortensen thereafter rotates mold 21a 180
degrees relative to a lower mold portion, such that the mold 21a forms a
cavity suitable for molding a tube or luer connector, and injecting a second
thermoplastic material into the cavity about the stair-stepped elastomer to
form a second portion of the luer access port (id. at 11-12). Also, because
the Examiner finds that Mortensen's cavity includes the cavity defined by
mold 21a, although also including lower mold part 21b, core 26, and slide
37, Mortensen's cavity is the same cavity in which the first portion is formed
(id. at 12).
Appellant asserts that claim 1 requires the first material and the
second material be injected into the same cavity (Reply Br. 8). Appellant
notes that claim 1 recites that the first material is injected into "a cavity,"
that a tooling component is removed from "the cavity," and that the second
material is injected into "the cavity" (id.). Appellant argues that, unlike
claim 1, Mortensen teaches forming a tube in two different cavities and fails
to teach the injection of two different materials into a single cavity (Appeal
Br. 11; Reply Br. 8). Appellant contends that Mortensen teaches the
creation of a hollow tube, wherein body 6, having one or more flanges to
keep fluids from passing between the body and the walls of the hollow, is
then inserted into the hollow (Appeal Br. 11; Reply Br. 9). However,
Appellant contends that Mortensen teaches that insertion of a body with
flanges into the hollow is extraordinarily difficult (Appeal Br. 11; Reply Br.
9). Appellant, therefore, solves this problem by forming the tube in two
different cavities within a mold, where a first mold part 21a with body 6 is
displaced or rotated to a second mold part 21b (Appeal Br. 11-12; Reply Br.
9). Thus, in Appellant's view, Mortensen, Figure 8A, teaches that the first
7
Appeal2018-003385
Application 14/283,449
material is injected into a first cavity in the left side of the mold tool and the
second material is injected into a second, different cavity in the rights side of
the mold tool (Appeal Br. 13; Reply Br. 10).
Appellant argues, in contrast, that claim 1 recites forming both a first
and a second portion of a luer access port in one cavity (Appeal Br. 13;
Reply Br. 11 ). Appellant urges that this occurs at the same location (Reply
Br. 12). Appellant also urges that after the first elastomer portion is formed
in the cavity of the mold, a tooling component is removed from the mold,
thereby increasing the size of the cavity, and the thermoplastic material is
injected into the cavity (id.).
We begin with the claim's words. See Oakley, Inc. v. Sunglass Hut
Int'!, 316 F.3d 1331, 1339 (Fed. Cir. 2003) (explaining that anticipation and
obviousness require comparison of the properly construed claims to the
available prior art); Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239
F.3d 1343, 1351 (Fed. Cir. 2001) ("Only when a claim is properly
understood can a determination be made ... whether the prior art anticipates
and/or renders obvious the claimed invention."). "During examination,
'claims ... are to be given their broadest reasonable interpretation consistent
with the specification, and ... claim language should be read in light of the
specification as it would be interpreted by one of ordinary skill in the art."'
In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004)
( quoting In re Bond, 910 F .2d 831, 833 (Fed. Cir. 1990)).
The term, "cavity," is defined to be "an unfilled space within a
mass. "4 Claim 1 recites that the first portion of the luer access port is
4 https://www.merriam-webster.com/dictionary/cavity, last visited February
13, 2019.
8
Appeal2018-003385
Application 14/283,449
formed by injecting a first material into a cavity of a mold, that at least one
tooling component is removed from the cavity, "thereby creating additional
space in the cavity," and that the second portion is formed by injecting a
second material into the cavity about the first portion, where the first portion
can be either the stair-stepped elastomer membrane or the luer access port
body. We note the Specification generally describes the insert molding
process as including the steps of forming a first portion of the luer access
port in a mold by injecting first material into a cavity of the mold, removing
at least one tooling component from the cavity, thereby creating additional
space, and forming a second portion of the luer access port by injecting a
second material into the cavity (Spec. ,r 54). The Specification then
describes two insert molding processes as flow 1201 and flow 1202, wherein
the general description refers to the steps of both flows (id. ,r,r 54, 56-59).
In particular, the Specification states that the step of removing at least one
tooling component from the cavity to thereby create additional cavity space
is shown by steps 1204 and 1207, wherein step 1204 is described as opening
the mold after the luer access body is formed, rotating 180 degrees, and new
cavities formed (id. ,r,r 54 and 56; see also Fig. 12).
Moreover, the Specification describes, in flow 1202, that at step 1206,
"[t ]he first cavity, which is for the stair-stepped elastomer membrane, is
blocked from a second cavity for the body cores within the mold" (Spec.
,r 58). At step 1207, after the at least one tooling component is removed
from the mold, the Specification further describes that the cavity size is
increased, exposing the first portion to "the second cavity for the body" (id.
,r 59). At step 1208, the Specification describes injecting the second
material "into the second cavity that has been exposed about" the first
9
Appeal2018-003385
Application 14/283,449
portion (id.). There is no requirement that the cavity in which the first
portion is formed and the cavity in which the second portion is formed be
exactly the same cavity or be at exactly the same location. These
descriptions contradict Appellant's more limiting claim construction, and are
consistent with the Examiner's broader construction. The ordinary artisan
would understand this description to indicate that the cavity recited in claim
1 may refer only to the cavity in which the first portion is formed or may
refer to a portion of the cavity that encompasses the space in which both the
first and second portions of the luer access body is formed.
Thus, the Specification supports the Examiner's broader construction
of claim 1, permitting the cavity of claim 1 to be defined by Mortensen' s
upper mold cavity 21a, because Mortensen similarly opens the mold after
forming a first portion in a cavity of the mold, rotates the cavity relative to a
lower mold, and forms a second portion in the cavity. Mortensen's tooling
components 28, 29 are removed from cavity 21 a to provide additional space
about the elastomer part and the cavity also includes additional space within
the lower mold (Mortensen 5: 1-10, 7:4--48). Therefore, even under
Appellant's narrower construction, Mortensen uses cavity 21a to form the
elastomer part, removes tooling components 28, 29 from this cavity and
forms the thermoplastic part of the luer access port about the elastomer part
in this same cavity. In addition, Mortensen teaches that the rotation to align
cavities 21a, 21b may involve rotation of either the upper or the lower molds
such that cavity 21a may remain in the same location during the formation
of both the first and second portions of the luer access port.
Accordingly, we sustain the Examiner's anticipation rejection of
claims 1, 2, and 4 by Mortensen.
10
Appeal2018-003385
Application 14/283,449
Rejection 2: Obviousness over Mortensen in view of Gahl
Although we sustain the Examiner's finding that Mortensen
anticipates the process of claim 1, we address the Examiner's conclusion
that claim 1 would have been obvious over the combined teachings of
Mortensen and Gahl to the extent Appellant argues this rejection separately.
In relevant part, the Examiner determines that it would have been obvious to
modify Mortensen's process to include a removable tooling component for
forming a second cavity corresponding to the luer connector with a luer
access port after the elastomer part of the luer access port is formed as Gahl
teaches in order to provide high molding accuracy and to eliminate the need
for mold rotation for faster manufacturing (Ans. 4--5).
Appellant argues that neither Mortensen nor Gahl teaches injection of
two different materials into one cavity of a mold (Appeal Br. 10-11 ).
Specifically, Appellant contends that Mortensen teaches forming a tube (i.e.,
the luer connector) in two different cavities (id. at 11-15). Appellant also
contends Gahl discloses forming rectangular depressions in a housing blank
by injection molding, but fills these depressions by either simply pouring, or
by electrodepositing, material into them (id. at 16). Appellant asserts that
Gahl teaches to remove the housing entirely from the mold cavity prior to
filling the depressions (id.).
We note Appellant's arguments regarding Mortensen are substantially
the same as raised against the Examiner's anticipation rejection which were
not found persuasive as discussed above. Further, Appellant's arguments
regarding Gahl mischaracterize Gahl' s teachings and are also not persuasive
of reversible error. Gahl clearly discloses an insert molding process in
which a first portion is injection molding in a cavity of a mold, a removable
11
Appeal2018-003385
Application 14/283,449
core is removed from the mold in such a way that a cavity corresponding to
a second portion is formed, and then a second material is injected into this
cavity (see Gahl ,r 13). Gahl teaches, consistent with the Examiner's
findings, that "[a] major advantage of this method lies in the high
reproducing accuracy with regard to the housing[, i.e., first portion,] and
antenna[, i.e., second portion,] geometry" (id.). Gahl's disclosure of
pouring or electrodeposition are alternatives to this two-component injection
molding process and, for the purposes of the Examiner's obviousness
rejection, are not relevant. Appellant otherwise fails to address the
Examiner's specific findings of the Examiner regarding Gahl.
Accordingly, we also sustain the Examiner's obviousness rejection of
claims 1, 2, 4, 5, 7, and 10 over the combined teachings of Mortensen and
Gahl.
CONCLUSION
The rejection of claims 1, 2, and 4 under 35 U.S.C. § 102(b) as
anticipated by Mortensen is affirmed.
The rejection of claims 5, 7, and 10 under 35 U.S.C. § 103(a) as
unpatentable over Mortensen is affirmed.
The rejection of claims 1, 2, 4, 5, 7, and 10 under 35 U.S.C. § 103(a)
as unpatentable over Mortensen in view of Gahl is affirmed.
The rejections of claim 3 under 35 U.S.C. § 103(a) as unpatentable
over Mortensen in view of Jepson, or alternatively, Mortensen in view of
Gahl and Jepson, are affirmed.
12
Appeal2018-003385
Application 14/283,449
The rejections of claims 6 and 11 under 35 U.S.C. § 103(a) as
unpatentable over Mortensen in view of Peppel, or alternatively, Mortensen
in view of Gahl and Peppel, are affirmed.
The rejections of claim 8 under 35 U.S.C. § 103(a) as unpatentable
over Mortensen in view of Peppel and Beasley, or alternatively, Mortensen
in view of Gahl, Peppel, and Beasley, are affirmed.
The rejection of claim 9 under 35 U.S.C. § 103(a) as unpatentable
over Mortensen in view of Peppel, Beasley, and Jepson, or alternatively,
Mortensen in view of Gahl, Peppel, Beasley, and Jepson, are affirmed.
DECISION
Upon consideration of the record, and for the reasons given above and
in the Examiner's Answer, the decision of the Examiner rejecting claims
1-11 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)(l).
AFFIRMED
13