Ex Parte Haase

Patent Trial and Appeal Board

Jul 13, 2018

13218007 (P.T.A.B. Jul. 13, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/218,007 08/25/2011
71996 7590 07/17/2018
SHUMAKER & SIEFFERT, P.A
1625 RADIO DRIVE, SUITE 100
WOODBURY, MN 55125
FIRST NAMED INVENTOR
James M. Haase
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.
1023-935US01/P0036889.01 7047
EXAMINER
CARPENTER, WILLIAM R
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
07/17/2018 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):
pairdocketing@ssiplaw.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMES M. HAASE
Appeal2017-010831
Application 13/218,007
Technology Center 3700
Before: STEFAN STAICOVICI, LEE L. STEPINA, and
ARTHUR M. PESLAK, Administrative Patent Judges.
PESLAK, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
James M. Haase ("Appellant") appeals under 35 U.S.C. § 134(a) from
the Examiner's decision rejecting claims 1, 3-5, 7-28, 37, 38, and 41--43. 1
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Medtronic, Inc. and Medtronic plc, the parent of Medtronic, Inc. are
identified as the real parties in interest. Appeal Br. 3.
Appeal2017-010831
Application 13/218,007
THE CLAIMED SUBJECT MATTER
Claim 1, reproduced below, is illustrative of the claimed subject
matter:
1. A therapeutic fluid delivery system comprising:
a first reservoir configured to house a first therapeutic
fluid;
a second reservoir configured to house a second
therapeutic fluid;
an inlet port configured to receive a first fluid delivery
needle having a first diameter and a second fluid delivery needle
having a second diameter less than the first diameter, wherein the
inlet port comprises a first septum and a second septum, and
wherein the inlet port is configured for fluid communication
between the first fluid delivery needle and the first reservoir
when the first fluid delivery needle penetrates the first septum
but not the second septum, and the inlet port is further configured
for fluid communication between the second fluid delivery
needle and the second reservoir when the second fluid delivery
needle penetrates both the first septum and the second septum;
and
wherein the inlet port exhibits a reduced cross-sectional
area between the first septum and the second septum such that
the second needle exhibiting the second diameter less than the
first diameter can access both the first septum and the second
septum, while the first needle exhibiting the first diameter can
access the first septum but not the second septum.
REJECTIONS
1) Claims 1, 3, 4, 5, 7, 9, 37, 41, and 43 are rejected under 35
U.S.C. § 102(b) as being anticipated by Enegren (US 4,955,861, issued Sept.
11, 1990).
2) Claim 8 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Enegren and Fischell (US 4,571,749, issued Feb. 25, 1986).
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Application 13/218,007
3) Claims 10-13 and 38 are rejected under 35 U.S.C. § I03(a) as
unpatentable over Enegren and Kalpin (US 2008/0243093 Al, published
Oct. 2, 2008, hereinafter "Kalpin '093").
4) Claims 14--16 are rejected under 35 U.S.C. § I03(a) as
unpatentable over Enegren, Kalpin '093, and Olsen (US 2007/0255235 Al,
published Nov. 1, 2007).
5) Claims 17-19 are rejected under 35 U.S.C. § I03(a) as
unpatentable over Enegren, Kalpin '093, Olsen, and Sommers (US
2008/0039820 Al, published Feb. 14, 2008).
6) Claims 20 and 21 are rejected under 35 U.S.C. § I03(a) as
unpatentable over Enegren, Kalpin '093, and Kalpin (US 2010/0125246 Al,
published May 20, 2010, hereinafter "Kalp in '246").
7) Claims 22 and 24 are rejected under 35 U.S.C. § I03(a) as
unpatentable over Enegren and Halili (US 2006/0142705 Al, published June
29, 2006).
8) Claims 23 and 25-28 are rejected under 35 U.S.C. § I03(a) as
being unpatentable over Enegren, Halili, and Haase (US 2007 /0255261 Al,
published Nov. 1, 2007, hereinafter "Haase '261").
9) Claim 42 is rejected under 35 U.S.C. § I03(a) as unpatentable
over Enegren and Haase (US 2007 /0255234 Al, published Nov. 1, 2007,
hereinafter "Haase '234").
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Application 13/218,007
DISCUSSION
Rejection 1
The Examiner finds that Enegren discloses each of the limitations of
claim 1 including a reduced cross-sectional area 42 between the first and
second septa. Final Act. 3. According to the Examiner, the device of
Enegren functions as claimed, because "the arrangement of the reduced
cross-sectional area along with the inherent geometry /length of the second
needle creates a configuration wherein the first needle is of insufficient
length to penetrate through the second septum." Id.
Appellant argues that the Examiner's rejection is not supported by the
disclosure of Enegren because "Enegren provides no description that the
cross-sectional area of outer compartment 42" would enable a needle to
"pass through inlet portion (32), but be too large to pass through the reduced
cross-sectional area portion (42)." Appeal Br. 12.
The Examiner responds that the first and second needles are not
positively recited and that the relationship between the needles and
compartment 42 is met because the compartment has the claimed structure,
namely, a reduced cross-sectional area. Ans. 4--7. According to the
Examiner, "the geometry of the inlet port, including the location of the
reduced cross-sectional area between the two septums [] creates the spatial
separation necessary to ensure that the second needle can access both
septums while the first needle can access only the first septum." Ans. 8.
The Examiner states, "the claim does not explicitly address how the reduced
cross-sectional area restricts needle access and more particularly fails to link
the diameter of the reduced cross-sectional area with the diameters of the
first and second needles for controlling access." Id. The Examiner notes
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Application 13/218,007
that because the needles are not recited, "Enegren can be used with a long,
slender needle with sufficient length to penetrate both septums as well as a
second short, thick needle which has insufficient length to penetrate the
second septum, only being able to penetrate the first septum." Ans. 11
( emphasis added).
Appellant replies that "claim 1 [] expressly defines a relationship
between the reduced cross-sectional area and the elements directed toward
access and the needle size." Reply Br. 5. Appellant argues that
Id.
One of ordinary skill in the art would have understood that it is
the reduced cross-sectional area of the inlet port that permits the
second diameter less than the first diameter to access both the
first septum and the second septum, and permits the first needle
exhibiting the first diameter to access the first septum but not to
access the second septum.
Further, Appellant contends that "spatial separation between the two
septums" is not a reasonable interpretation of the claims. Id. Appellant
argues that the Examiner mischaracterizes Enegren because Enegren's
needle stop 34 stops needle 98 and the reduced cross-section of compartment
42 does not prevent penetration of the second septum by the first needle. Id.
Appellant asserts that the Examiner's selection of a long slender needle and
short thick needle does not meet the limitations of claim 1 because claim 1
requires the inlet port diameter to prevent access not the needle length.
Reply Br. 6. For the following reasons, we do not sustain the rejection of
claim 1.
We give claim terms their broadest reasonable interpretation
consistent with the Specification as it would be interpreted by one of
ordinary skill in the art. See In re Suitco Surface, Inc., 603 F.3d 1255, 1259-
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60 (Fed. Cir. 2010); In re Morris, 127 F.3d 1048, 1054--55 (Fed. Cir. 1997).
Although the claims are interpreted in light of the Specification, limitations
from the Specification are not read into the claims. In re Van Geuns, 988
F.2d 1181, 1184 (Fed. Cir. 1993). Although we appreciate the Examiner's
position that the first and second needles are not positively recited, the inlet
port is recited to have a specific configuration, namely, "configured to
receive a first fluid delivery needle having a first diameter and a second fluid
delivery needle having a second diameter less than the first diameter." The
term "configured to" is generally used to mean that the inlet port is "made
to" or "constructed to" perform the claimed function. See In re Giannelli,
739 F.3d 1375, 1379 (Fed. Cir. 2014). Here, the inlet port, as recited in
claim 1, includes additional structure, namely, a reduced cross-sectional area
that performs the function of controlling access to the septa. See Reply Br.
5. Appellant's Specification discloses that "reducing the cross-sectional area
of inlet port 154 ... limits the size of fluid delivery needle 200 that can
access second fluid reservoir 160," and further discloses that needle size
refers to "outer diameter (OD)." Spec. ,r 69.
In addition to the configuration of the inlet port recited in claim 1, the
second wherein clause of claim 1 contains a recitation referring back to the
inlet port and including the further limitation that "the inlet port exhibits a
reduced cross-sectional area between the first septum and the second
septum." Appeal Br. 22 (Claims App.). We agree with Appellant that the
term "such that" after this limitation defines a relationship between the
reduced cross-sectional area and the function performed thereby (see Reply
Br. 4), namely, "the second needle exhibiting the second diameter less than
the first diameter can access both the first septum and the second septum,
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while the first needle exhibiting the first diameter can access the first septum
but not the second septum." Thus, contrary to the Examiner's assertion,
claim 1, in light of the Specification, establishes that the relationship
between the reduced cross-sectional area of the inlet port and the needles is
based on the diameter of the needles. Accordingly, the Examiner's position
that "the arrangement of the reduced cross-sectional area [ of Enegren] along
with the inherent geometry/length of the second needle creates a
configuration wherein the first needle is of insufficient length to penetrate
through the second septum," (Final Act. 3) is based on an unreasonably
broad interpretation of an inlet port configured as recited in claim 1 because
it is not controlling access based on diameter. See In re Skvorecz, 580 F.3d
1262, 1267 (Fed. Cir. 2009)("[t]he protocol of giving claims their broadest
reasonable interpretation ... does not include giving claims a legally
incorrect interpretation.").
Specifically, in Enegren, although needle 92 and tubing 98 have
different diameters, and the walls defining compartment 42 may have a
smaller cross-sectional area than septum 36 and septum 38, the configuration
of the walls defining compartment 42 (inlet port) does not function in the
manner required by claim 1 such that needle 92 exhibiting the second
diameter less than tubing 98 (the first diameter) can access both the first
septum and the second septum, while the first needle (tubing 98) exhibiting
the first diameter can access the first septum but not the second septum.
Rather, Enegren discloses that
when needle unit 14 is inserted into passage 3 2 so that its
needle tip 92a engages or bottoms on needle stop 34, the lower
end of the needle lumen 93 will automatically be located in
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passage compartment 44, while the tubing hole 105 will be
located in passage compartment 42.
Enegren, 7:20-25. Absent needle stop 34, nothing in Enegren would
prevent tube 98 from penetrating Enegren's second septum 38, and the
Examiner does not point to any portion of Enegren that discloses that the
reduced diameter of compartment 42 performs this function. Thus,
Enegren's needle stop 34 controls access to the reservoirs, not the reduced
cross-sectional area of the inlet port. See Reply Br. 5. Accordingly,
disclosure of the intended operation of the system taught by Enegren does
not support a finding that this system has the specific configuration required
by claim 1.
The Examiner's position that the device of Enegren could be used
with "any suitably proportioned pair of hypothetical needles" to perform the
recited function of the inlet port is also not persuasive. See Ans. 15. In
support of this position, the Examiner provides a drawing showing two
hypothetical needles in which one of the needles is prevented from accessing
a lower compartment (apparently corresponding to compartment 44 in
Energren), solely based on its length not its diameter as required by claim 1.
Id. 2
Further, the Examiner's discussion of Haase '234 with respect to the
rejection of claim 42 based on Enegren and Haase '234, as relating to claim
1, is not persuasive. 3 See Ans. 12-13. Notwithstanding that the Examiner
2 To the extent that structure above compartment 44 would prevent an object
with a diameter much greater than the needles in the hypothetical example
set forth in the Answer from entering compartment 44, the Examiner has not
established that such an object would qualify as a needle.
3 We note that the Examiner does not reject claim 1 under 35 U.S.C.
§ 103(a) based on Enegen and Haase '234. See Final Act. passim.
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states that Haase '234 "is not contemplated for its ability to restrict access of
the needle(s) of Enegren, but rather the benefit recognized by Haase, that a
conical shape serves to funnel a provided needle toward the center of the
septum," ( Ans.13-14 ), as Appellant correctly notes, the disclosure of Haase
'234 relates to placing a conical element at the opening to the inlet port. See
Reply Br. 13. Thus, one of ordinary skill in the art reading Haase '234
would be led to use a conical element to protect Enegren's (first) septum 36,
and would place a conical needle guide above septum 36 with no additional
guide being necessary between Enegren's septum 36 and septum 38. See Id.
For the reasons discussed above and in light of our construction of
claim 1, we determine that the Examiner's finding that Enegren anticipates
claim 1 is not supported by a preponderance of the evidence. We, therefore,
do not sustain the rejection of claim 1 as anticipated by Enegren. We also
do not sustain the rejection of claims 3-5, 7, 9, 41, and 4 3, which depend
from claim 1 for the same reason. The Examiner rejects claim 3 7 based on
the same findings as for claim 1. Final Act. 2-3. We do not sustain the
rejection of independent claim 37 as anticipated by Enegren for the same
reasons as stated above for claim 1.
Rejections 2-9
Claims 8, 10-28, and 42 depend directly or indirectly from claim 1
and claim 38 depends from claim 37. Appeal. Br. 23-30 (Claims App.).
The Examiner rejects these claims as unpatentable over Enegren and various
additional disclosures from Fischell, Kalpin '093, Olsen, Sommers, Kalpin
'246, Halili, Haase '261, and Haase '234. Final Act. 5-14. The Examiner
does not rely on the additional disclosures from Fischell, Kalpin '093, Olsen,
Sommers, Kalpin '246, Halili, Haase '261, and Haase '234 to cure the
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deficiencies in Enegren discussed above for claim 1. Id. Therefore, we do
not sustain the rejection of claims 8, 10-28, and 42 under 35 U.S.C. § 103(a)
for the same reasons stated in connection with claim 1.
DECISION
The Examiner's decision rejecting claims 1, 3-5, 7-28, 37, 38, and
41--43 is reversed.
REVERSED
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