Ex Parte Moghe et al

Patent Trial and Appeal Board

Sep 28, 2017

13951781 (P.T.A.B. Sep. 28, 2017)

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.
13/951,781 07/26/2013 Ajit K. Moghe H-KN-02723 (1) 4258
149863 7590 10/02/2017
CARDINAL HEALTH INC.
ATTN: DANIEL C. STELTER
300 South Riverside Plaza
Suite 2010
Chicago, IL 60606
EXAMINER
MCCROSKY, DAVID J
ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
10/02/2017 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):
C AH @ cardinal-ip. com
karen.dangelo @ cardinalhealth.com
patent@cardinalhealth.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte COVIDIEN LP1
Appeal 2016-008090
Application 13/951,7812
Technology Center 3700
Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a urine
collection system. The Examiner entered final rejections for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.
STATEMENT OF THE CASE
Background
The Specification discloses:
1 Ajit K. Moghe, Chelsey Elliott and Harish A. Patel are named as inventors.
2 Appellant identifies the Real Party in Interest as Medtronic pic. Appeal Br.
1.
Appeal 2016-008090
Application 13/951,781
Urine collection systems for collecting urine from a
catheterized patient are well known in the art. Such systems
typically include a drain tube having a first end connected to a
urinary catheter of a catheterized patient and a second end
connected to a urine collection bag. The urine collection bag
includes an outlet port for draining fluid from the bag.
Typically an in-line adapter is provided for connecting the
urinary catheter to the drain tube. The adapter may include a
sampling port for providing access to the urine flow upstream
of the urine collection bag to facilitate testing of the urine.
Spec. ^ 3.
The Claims
Claims 1, 2, and 4-25 are on appeal. Final Act. I.3 Claim 1 is
illustrative and reads as follows:
1. A urine collection system comprising:
a collection bag defining a fluid reservoir including a
fluid inlet and a fluid outlet;
an in-line vent positioned upstream of the collection bag
and being fluidly coupled to the collection bag, the in-line vent
including an outlet end;
a sampling port adapter positioned upstream of the in­
line vent and being adapted to be fluidly coupled to a urinary
catheter; and
a compressible tube defining a fluid channel fluidly
connecting the sampling port adapter and the in-line vent, the
compressible tube being clampable to seal the fluid channel
wherein an inside diameter of the fluid channel defined
by the compressible tube is larger at a downstream end of the
fluid channel than the inside diameter at an upstream end of the
fluid channel.
3 Examiner’s Final Action, mailed May 18, 2015.
2
Appeal 2016-008090
Application 13/951,781
Appeal Br. (Claims Appendix) 2. Claims 11 and 21, the only other
independent claims, likewise disclose use of an apparatus with fluid
channels having a downstream or outlet end having a larger diameter than
the upstream or inlet end. Id. at 4, 6.
The following rejections are before us for review:
Claims 1, 2, 4, 8-20, and 25 are rejected under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Propp4 in view of Granger.5 Ans. 2.
Claim 5 is rejected under pre-AIA 35 U.S.C. § 103(a) as obvious over
Propp, Granger, and Sawan.6 Id. at 9.
Claims 6 and 7 are rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious over Propp, Granger and Sibbitt.7 Id.
Claims 21, 22, and 24 are rejected under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Griesel,8 Granger, and Salvadori.9 Id. at 7.
Claim 23 is rejected under pre-AIA 35 U.S.C. § 103(a) as obvious
over Griesel, Granger, Salvadori, and Gewecke.10 Id. at 10.
I
The Examiner has rejected claims 1, 2, 4, 8-20, and 25 as obvious
over Propp and Granger. In making the rejection, the Examiner finds that
4 US 5,919,146, issued July 6, 1999 (“Propp”).
5 Granger, FLUID MECHANICS, Chapter 10 “Laminar Pipe Flow”
481-540 (1989) (“Granger”).
6 US 5,849,311, issued December 15, 1998 (“Sawan”).
7 US 2005/0209567 Al, published September 22, 2005 (“Sibbitt”).
8 US 4,265,118, issued May 5, 1981 (“Griesel”).
9 US 2007/0203463 Al, published Aug. 30, 2007 (“Salvadori”).
10 US 2,712,822, issued July 12, 1955 (“Gewecke”).
3
Appeal 2016-008090
Application 13/951,781
Propp discloses a urine collection system comprising all of the elements of
claim 1, except that it does not teach the claim limitation “wherein an inside
diameter of the fluid channel defined by the compressible tube is larger at a
downstream end of the fluid channel than the inside diameter at an upstream
end of the fluid channel.” Ans. 2. However, the Examiner finds that
Granger teaches this limitation. Id.
The Examiner concludes that the skilled artisan would have found it
obvious “to provide the fluid channel of Granger with the tube of Propp to
dissipate, after release of the clamp 54, the energy of the fluid created when
fluid flow is stopped by the clamp 54.” Id.
The issue in this rejection is whether a preponderance of the evidence
supports the Examiner’s conclusion that Propp and Granger suggest the
claimed subject matter. We select claim 1 as representative of the claims
subject to this ground of rejection. 37 C.F.R. § 41.37(c)(l)(iv).
Findings of Fact (FF)
FF1. Propp discloses:
A urine sampling device includes a urine collection vessel
having an open end. A cap member seals the vessel open end.
The cap member includes a vent to allow air displacement
during fluid sampling. A connector element including a hollow
piercing element is in fluid communication with the cap
member. The urine sampling device is useable in combination
with a urine drainage and collection device including a source
tube having inlet and outlet ends for receiving and
communicating urine. The source tube includes a pierceable
connector for receiving the piercing element and is disposed
between the source tube inlet and outlet ends. A fluid metering
device including an inlet and an outlet is connected to the
source tube outlet allowing gravitational fluid flow from the
source tube into the metering device. A valve disposed between
4
Appeal 2016-008090
Application 13/951,781
the pierceable connector and fluid metering device controls the
gravitational fluid flow into the metering device. A receptacle
in serial gravitational fluid communication with the fluid
metering device outlet receives fluid from the metering device.
Propp, Abstract.
FF2. Propp discloses:
The urine sampling device 10 is useable in combination
with urine drainage and collection device 20. Urine drainage
device 20 includes a source tube 40 having inlet and outlet ends
42,44 for receiving and communicating urine from a patient
fluidly connected to the source tube 40. The source tube 40
includes a pierceable connector 46 including a septum 47 for
receiving the piercing means 32 and is disposed between the
source tube inlet and outlet ends 42,44.
A fluid metering device 48 including an inlet and an
outlet 50,52, is connected to the source tube outlet 44 allowing
gravitational fluid flow from the source tube 40 into the
metering device 48. A valve means shown as a flow occluding
clamp 54 is disposed between the pierceable connector 46 and
fluid metering device 48 for controlling fluid flow into the
metering device
A receptacle 56 illustrated as a urological drainage bag is
in serial gravitational fluid communication with the fluid
metering device outlet 52 for receiving fluid from the metering
device 48.
Preferably, metering device 48 includes a hydrophobic vent 60
having a pore size range of 0.22 to 100 microns and a rubber
septum sampling port 62.
Receptacle 56 may include a one-way valve such as an anti-
reflux flap valve or other one-way flow control valve for
preventing back flow of fluid and bacteria into the metering
device 48. Receptacle 56 includes an outlet 68 to permit
5
Appeal 2016-008090
Application 13/951,781
drainage of urine from the receptacle. Outlet 68 has an open and
closed position whereby in the open position the receptacle 56
can be drained, and in a closed position urine is collectable in
receptacle 56.
Id. at 3:12-57.
FF3. Granger discloses:
Valves
Essential in any piping system, valves control the flow of fluid.
They throttle it, they direct it, they prevent back flow - but
mostly they turn the flow on or off. Valves must be selected
carefully for the particular flow requirement. If we want to be
able to turn a flow on or off, then we may wish to use a gate,
plug, or ball valve. If we want to carefully regulate or throttle
the flow, then a globe, needle, or butterfly valve might be our
choice. If we need to guarantee no back flow, then our choice is
a lift or swing check valve.
The factors that govern the selection of a valve are
• Is the fluid a gas or liquid?
• Is the fluid abrasive?
• Is temperature an important factor?
• Is volume rate critical?
• At what pressures will the fluid flow?
• What pressure drop can the system tolerate?
• Must the system be leak proof?
Granger at 505.
FF4. Granger discloses:
10.5.5 Gradual Expansion
The loss of energy per pound of fluid through a gradual
short conical diffuser is given by
25°. For a long conical diffuser, the loss coefficient
must provide for friction losses. For long diffusers,
k
tan
4
„ a / A \
~ .... | 00-51)
•£+ v,r'-^ 7
Id. at 514.
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
7
Appeal 2016-008090
Application 13/951,781
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
Wrigley found a “strong case of obviousness based on the prior art
references of record. [The claim] recites a combination of elements that
were all known in the prior art, and all that was required to obtain that
combination was to substitute one well-known ... agent for another.” Wm.
Wrigley Jr. Co. v. Cadbury Adams USALLC, 683 F.3d 1356, 1364 (Fed.
Cir. 2012).
Analysis
We adopt the Examiner’s findings regarding the scope and content of
the prior art (Final Act. 2-7; FF 1^1) and agree that the claimed device
would have been obvious over the teachings of Propp and Granger. We
address Appellants’ arguments below.
Appellants argue the Examiner erred in rejecting claim 1 “at least
because Granger is non-analogous art.” Appeal Br. 6. Appellants argue that
although
the Technical Field of the application states that the present
disclosure “relates generally to fluid collection systems” ... the
specification makes clear that the field of the invention is
vented fluid collection systems, for example, where the vent is
employed to maintain the collection system at atmospheric
pressure under varying medical circumstances.
Id. at 7-8. Appellants also argue the “field is also specific to gravity-drained
vented systems,” citing language from the Specification and incorporated
art. Id. at 7. Appellants argue “the field of the endeavor is medical
procedures employed with catheterized patients in particular taking samples
8
Appeal 2016-008090
Application 13/951,781
from a urine drain line drained by gravity and vented to atmosphere.” Id. at
9. Appellants further argue that
the Introduction [of] Granger states that Chapter 10 addresses
“problems of transferring energy from one location to another
by means of fluid flow through pipes [because unlike] a battery
[energy stored in fluid] must [be moved] through conduits such
as pipes[]” [and] refers to the “fundamental problem. What
horsepower would a pump require to move a fluid through a
very long pipe? ... Some of the horsepower will be used to
compensate for energy lost in the pressure drop caused by the
friction of the fluid flowing past the pipe’s wetted surface.”
Id. at 10. In view of the above and additional language cited from the
Introduction of Granger, Appellants argue that that the field of endeavor of
Granger is “fluid flow when driven through a pipe under pressure provided
by a pump.” Id. at 10-11. Appellants argue that the teachings and examples
in Granger all regard this field of endeavor and “[are] not in the same field
of endeavor as medical procedures employed with catheterized patients in
particular taking samples from a urine drain line drained by gravity and
vented to atmosphere.” Id. at 12-13. Appellants argue that, in light of the
different fields of endeavor, Granger is not analogous art, and cites the
holding in Stevenson v. Int’l Trade Commission, 612 F.2d 546, 548-550
(CCPA 1973) for its finding that patents directed to a water ski and a
surfboard were found to be non-analogous to an application for a “kicktail
skateboard.” Id. at 15. Finally, Appellants argue that Granger “is also not
reasonably pertinent to the problem faced by the inventor because the
9
Appeal 2016-008090
Application 13/951,781
pressure surge caused by releasing the clamp results in turbulent flow rather
than in a laminar flow (the subject matter of Granger).” Id. at 16.
The Examiner responds that
there is pressure in the tube of Appellant’s disclosure as well as
tube of the prior art. A gravity drained and vented system has at
least atmospheric pressure in the line and quite possibly more,
depending on the effect of gravity on the tube which will
depend on the position of the tube. Indeed, the point of a vented
system is to provide access to at least atmospheric pressure so
as to avoid a negative pressure (vacuum) in the tube which can
cause severe pain and injury to the catheterized patient.
Ans. 11. The Examiner provides significant additional reasoning why
Granger’s teachings apply to the problem at issue in Propp, based on the
principle that because there is at least atmospheric pressure in the tube of the
urine collection system of Propp, this pressured flow would lead the skilled
artisan to consider Granger’s teachings on dissipating energy using the fluid
channel design taught in Granger. See Ans. 12-16. The Examiner further
responds that Appellants’ reference to the introduction of Granger is
improper because “[[wjhen considering the introduction as a whole, as well
as the entire chapter 10 as a whole, Granger is from the same field of
endeavor as the claimed invention.”11
In reply, Appellants argue that the Examiner’s reasoning that the
Granger is analogous art is based on an incorrect understanding of
11 The Examiner additionally references Holland, a reference cited earlier in
prosecution, for support; however, because the Holland reference is not
before us on appeal, we do not address the Examiner’s reliance on it,
Appellants’ arguments related to Holland, or rely on Holland in our findings.
10
Appeal 2016-008090
Application 13/951,781
“pressurized.” Reply Br. 2. According to Appellants, the claims are
directed to “systems, apparatus and methods employed with urine collection
systems operating at atmospheric pressure” and not under pressure higher
than that of the surroundings. Id. at 2-3. Appellants argue that because
Granger involves “industrial and high pressure . . . piping systems,” its
teachings are not pertinent to the problem of the invention. Id. at 3—4.
We are not persuaded that the Examiner erred in rejecting claim 1 as
obvious over the cited art.
“Two criteria have evolved for determining whether prior art is
analogous: (1) whether the art is from the same field of endeavor, regardless
of the problem addressed, and (2) if the reference is not within the field of
the inventor’s endeavor, whether the reference still is reasonably pertinent to
the particular problem with which the inventor is involved.” In re Clay, 966
F.2d 656, 658-59 (Fed. Cir. 1992). Granger discloses that valves control the
flow of fluid and are “essential in any piping system.” FF3. Granger
discloses that valves must be carefully selected for the particular flow
requirement, and can be optimized to control the flow using provided factors
governing valve selection. Id. Granger further discloses that using a larger
diameter at the downstream end of a fluid channel than the upstream end
will dissipate energy of the fluid created when the fluid flow is stopped by
the clamp, thereby promoting fluid flow in the system. FF4.
Appellants provide no evidence, only attorney argument in support of
their contentions that Granger’s teachings apply only to industrial and high
pressure piping systems. Granger itself contains no such limiting language.
Because, as Granger teaches, valves are “essential in any piping system,” we
11
Appeal 2016-008090
Application 13/951,781
find Granger’s teachings on valve selection, design, and flow optimization to
be useful to ordinarily skilled artisans working with valves in fluid systems
regardless of whether they are drained by gravity and vented to the
atmosphere or driven through a pipe under pressure provided by a pump.
We find Granger’s teachings on optimizing flow through valve selection are
reasonably pertinent to Propp’s stated purpose in designing “a urine
sampling device usable in combination with [a] urine drainage device” to
avoid prior devices that previously required changing devices in a
complicated manner that potentially resulted in urine spillage. See Propp
1:42—2:6. We find the skilled artisan would have found Granger’s teaching
in optimizing control of the flow of a gravity-drained device through
analysis of the factors provided (FF3) particularly helpful in maximizing the
ability of the device for use in collecting a sample to drain quickly and
thereby limit the time needed to take a urine sample for collection. In
addition, because both Propp and Granger teach methods for controlling
flow, it would have been prima facie obvious to substitute Granger’s larger
downstream diameter design for Propp’s design. See In re Font, 675 F.2d
297, 301 (CCPA 1982) (“Because both [references] teach a method for
separating caffeine from oil, it would have been prima facie obvious to
substitute one method for the other. Express suggestion to substitute one
12
Appeal 2016-008090
Application 13/951,781
equivalent for another need not be present to render such substitution
obvious.”). We affirm the rejection of claim 1.
Conclusion of Law
Claims 2, 4-20, and 25 have not been argued separately12 and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
II
Appellants raise no independent arguments regarding the teachings of
the art with regard to the rejection of claim 5 under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Propp, Granger, and Sawan; the rejection of claims
6 and 7 under pre-AIA 35 U.S.C. § 103(a) as obvious over Propp, Granger
and Sibbit; the rejection of claims 21, 22, and 24 under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Griesel, Granger, and Salvadori; or the rejection of
claim 23 under pre-AIA 35 U.S.C. § 103(a) as obvious over Griesel,
Granger, Salvadori, and Gewecke. Instead, Appellants rely on their
12 Appellants assert that “Independent claims 1,11 and 25 are allowable for
at least the preceding reasons. Each of claims 2, 4-10 and 12-20 depend from
an allowable independent claim. Secondary references [Sawan and Sibbitt]
applied in rejecting claims 5, and 6 (and 7), respectively, do not cure the
deficiencies in the rejection of the independent claims. Thus, each of claims
2, 4-10 and 12-20 are patentable for at least the same reason as the
independent claim from which it depends, respectively.” Appeal Br. 16.
Such an argument is not sufficient as a separate argument for patentability of
these claims. In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (noting that
separately arguing a claim requires “more substantive arguments in an
appeal brief than a mere recitation of the claim elements and a naked
assertion that the corresponding elements were not found in the prior art.”)
13
Appeal 2016-008090
Application 13/951,781
arguments made in regard to the respective independent claims. Appeal Br.
20. For the reasons discussed above in Section I, those arguments are
unpersuasive. We summarily affirm the rejections of claim 5-7. See 37
C.F.R. § 41.37(c)(l)(iv) (requiring that “arguments shall explain why the
examiner erred as to each ground of rejection . . . [and that] any arguments
or authorities not included in the appeal brief will be refused consideration
by the Board”); see also Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI
2010) (precedential) (“If an appellant fails to present arguments on a
particular issue—or, more broadly, on a particular rejection—the Board will
not, as a general matter, unilaterally review those uncontested aspects of the
rejection”).
Appellants argue with respect to the rejection of claims 21-24 that the
rejection is improper because it is based on hindsight analysis. Appeal Br.
18. Appellants argue the Examiner’s rationale for combination is not
apparent in view of the cited art. Id. Rather, Appellants argue, the cited
section of Granger “teaches a conical diffuser for the purpose of determining
the losses that the diffuser creates” and would not motivate the skilled
artisan to make the claimed subject matter. Id. at 18-19.
We are unpersuaded by Appellants’ argument. Appellants point to no
evidence that any of the Examiner’s findings were beyond the level of
ordinary skill at the time of the invention or could have been taken only
from Appellants’ Specification. See In re McLaughlin, 443 F.2d 1392, 1395
(CCPA 1971). Moreover, we agree with the Examiner that Granger’s
teachings support the rejection and rationale as stated. FF3, FF4. We affirm
the rejection of claims 21-24.
14
Appeal 2016-008090
Application 13/951,781
SUMMARY
We affirm the rejection of claims 1, 2, 4, 8-20, and 25 under
pre-AIA 35 U.S.C. § 103(a) as obvious over Propp in view of
Granger.
We affirm the rejection of claim 5 under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Propp, Granger, and Sawan.
We affirm the rejection of claims 6 and 7 under pre-AIA 35
U.S.C. § 103(a) as obvious over Propp, Granger and Sibbitt.
We affirm the rejection of claims 21, 22, and 24 under pre-AIA
35 U.S.C. § 103(a) as obvious over Griesel, Granger, and Salvadori.
We affirm the rejection of claim23 under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Griesel, Granger, Salvadori, and Gewecke.
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)(l)(iv).
AFFIRMED
15