John Landy et al.

Patent Trials and Appeals Board

Apr 2, 2021

2020002472 (P.T.A.B. Apr. 2, 2021)

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.
12/228,618 08/14/2008 John Joseph Landy III 2012366-0004 6321
24280 7590 04/02/2021
CHOATE, HALL & STEWART LLP
TWO INTERNATIONAL PLACE
BOSTON, MA 02110
EXAMINER
MCCALISTER, WILLIAM M
ART UNIT PAPER NUMBER
3753
NOTIFICATION DATE DELIVERY MODE
04/02/2021 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):
jnease@choate.com
patentdocket@choate.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN JOSEPH LANDY III and
MICHAEL GILDERSLEEVE
Appeal 2020-002472
Application 12/228,618
Technology Center 3700
Before KEVIN F. TURNER, BRETT C. MARTIN, and
LEE L. STEPINA, Administrative Patent Judges.
MARTIN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 25, 28–30, 32, and 33, which constitute
all the claims pending in this application. See Final Act. 1. Claims 1–24,
26, 27, 31, and 34 have been cancelled. We have jurisdiction under
35 U.S.C. § 6(b).

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 Belmont Instrument,
LLC. Appeal Br. 2.
Appeal 2020-002472
Application 12/228,618

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We REVERSE.
CLAIMED SUBJECT MATTER
The claims are directed “to pressure responsive fluid-flow control
valves particularly adapted for use with intravenous (IV) infusion
applications.” Spec. ¶ 1. Claim 25, reproduced below, is illustrative of the
claimed subject matter:
25. A fluid pressure responsive valve for use in delivery of an
IV infusate to a patient, the valve comprising:
an input port;
an inflow chamber;
a pressure sensor;
an outflow chamber; and
an output port,
wherein the input port receives the IV infusate and directs
the IV infusate to the inflow chamber,
wherein a wall of the inflow chamber comprises a valve
seat,
wherein the pressure sensor reacts to changes of fluid
pressure in the outflow chamber, and comprises a valve operator
and a valve cap,
wherein the valve operator comprises a concave wall from
the perspective of the outflow chamber,
wherein the fluid pressure responsive valve does not
comprise a spring, and wherein the valve operator is connected
to the valve cap such that when fluid pressure in the outflow
chamber is in excess of a critical limit, the concave wall
stretches, thereby displacing the valve cap to seat against the
valve seat so that fluid from the inflow chamber to the outflow
chamber is restricted and/or closed-off without a spring, whereby
flow of the IV infusate from the inflow chamber to the outflow
chamber is only permitted when the fluid pressure in the outflow
chamber is less than the critical limit,
wherein the valve seat is tapered,
wherein a side of the valve cap is tapered,
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Application 12/228,618

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wherein the output port directs the IV infusate from the
outflow chamber to the patient,
wherein the input port and the output port are parallel,
wherein the fluid pressure responsive valve is sterilizable,
and non-pyrogenic, and
wherein the critical limit is in a range from 250 to 350 mm
Hg.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Schmidlin US 3,552,431 Jan. 5, 1971
Murrell US 3,603,214 Sept. 7, 1971
McPhee US 6,273,117 B1 Aug. 14, 2001
Black US 6,892,755 B2 May 17, 2005
Danby US 2003/0159734 A1 Aug. 28, 2003

REJECTIONS
Claims 25, 28–30, 32, and 33 are rejected under 35 U.S.C. § 112(a) or
35 U.S.C. Final Act. 2.
Claims 25, 28–30, and 32 are rejected under pre–AIA 35 U.S.C.
§ 103(a) as unpatentable over Danby, Murrell, and Black. Final Act. 3.
Claims 33 is rejected under pre–AIA 35 U.S.C. § 103(a) as obvious
over Danby, Murrell, and Black. Final Act. 6.
Claims 25, 28–30, and 32 are rejected under pre–AIA 35 U.S.C.
§ 103(a) as obvious over Schmidlin, Danby, Black, and Murrell. Final Act.
6.
Claim 33 is rejected under pre–AIA 35 U.S.C. § 103(a) as obvious
over Schmidlin, Danby, Black, Murrell, and McPhee. Final Act. 9.
Appeal 2020-002472
Application 12/228,618

4
OPINION
Written Description
The Examiner rejects the claims due to Appellant’s inclusion of a
negative limitation regarding the absence of a spring that the Examiner
asserts is unsupported. Final Act. 2. As Appellant points out, however, “the
present Specification properly describes the alternative feature, namely a
valve embodiment that comprises a spring.” Reply Br. 5. Given that
Appellant’s Specification compares the present invention without a spring to
prior art having a spring, it is clear that Appellant properly possessed the
invention at issue and support for the claimed absence of a spring is
supported. Accordingly, we do not sustain this rejection.
Obviousness
Regarding the combination of Danby and Murrell, Appellant argues,
and we agree, that Danby is not properly usable in the context of IV infusion
because Danby’s “valve” is actually “a seal for a drinks container” that “is
closed when it is idle,” whereas “the claimed valve is designed as a flow
regulator, not a seal” and “is open when the IV fluid delivery system is not
in operation.” Reply Br. 7. We further agree that the valve of the present
invention “closes only when (A) the IV fluid delivery system is operating
(e.g., fluid is flowing through the valve) and (B) the fluid pressure in the
outflow chamber is greater than the critical limit.” App. Br. 10. Danby’s
valve is only opened when actuated by a vacuum and therefore operates in
the opposite manner of Appellant’s claimed invention. As Appellant further
points out, “[t]he valve in Danby operates as a seal for a drinks container,
and thus creates or maintains a seal at atmospheric pressure corresponding to
approximately 750 mm Hg,” which “is more than twice the upper limit of
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Application 12/228,618

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the claimed range.” App. Br. 12. Accordingly, other than being a valve/seal
without a spring, Danby does not operate as claimed.
In responding to Appellant, the Examiner states that “Danby is
capable of handling IV infusate just as it handles the disclosed liquids.”
Ans. 12. The mere fact that a container may handle liquids, however, does
not make it suitable for use in all applications. Although not directly
identified by the Examiner, Danby’s Figure 36b shows a drink bag
according to Danby’s invention hanging next to a patient with the tube going
toward the patient. The tube is not connected intravenously, but is depicted
as being held by the patient for use in the same manner as other
embodiments disclosed therein, namely to drink from the tube end. As
Appellant correctly argues, Danby’s “valve of Danby is closed, and only
open when a user applies a pressure lower than atmospheric pressure.”
Reply Br. 7. An IV is not operable by the user’s body applying a vacuum to
the IV, but requires the valve be open at ambient pressure to allow fluid to
flow. The claimed invention includes a valve that stays open, but closes
when a user applies pressure higher than a certain limit. This is essentially
the opposite of Danby’s system, which requires a user to supply a vacuum to
open the valve and is closed at ambient pressure. As such, we do not sustain
the Examiner’s rejection over Danby and Murrell.2
As to Schmidlin, Appellant is correct that “the valve in Schmidlin
relies on the interplay between the forces exerted by a diaphragm, a spring,

2 We acknowledge that this rejection is made “if necessary, further in view
of Black,” but the Examiner relies on Black only with respect to the last
limitation of claim 25, which is not pertinent to the deficiency we identify.
See Final Act. 5.
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and an inlet pressure for calibration and operation.” Reply Br. 9. Appellant
backs this up with the Landy Declaration which states that “the removal of
the spring will make the valve inoperable, thereby destroying the purpose
of the valve (e.g., providing a constant pressure.)” Reply Br. 19, citing
Landy Dec. ¶ 10. The Examiner does not address the Landy Declaration.
Given that a prior art combination may not destroy the intended purpose of
the prior art, we agree that the Examiner’s combination is in error.
Accordingly, we do not sustain the rejections over Schmidlin, Danby, and
Black. 3
The additional rejections of claim 33 rely on the same base references
discussed above and we reverse those rejections on the same basis.
CONCLUSION
The Examiner’s rejections are REVERSED.
More specifically,

3 We acknowledge that this rejection is made “if necessary, further in view
of Murrell,” but the Examiner relies on Murrell only with respect to a
tapered side of the valve cap in claim 25, which is not pertinent to the
deficiency we identify. See Final Act. 8.
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Application 12/228,618

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DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
25, 28–30,
32, 33
112(a) Written
Description
25, 28–30,
32, 33
25, 28–30,
32, 33
103(a) Danby, Murrell,
Black
25, 28–30,
32, 33
25, 28–30,
32, 33
103(a) Schmidlin, Danby,
Black, Murrell
25, 28–30,
32, 33
33 103(a) Danby, Murrell,
Black, McPhee
33
33 103(a) Schmidlin, Danby,
Black, Murrell,
McPhee
33
Overall
Outcome
25, 28–30,
32, 33

REVERSED