RUHOF CORPORATION

Patent Trials and Appeals Board

Nov 19, 2021

2021001244 (P.T.A.B. Nov. 19, 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.
14/772,437 09/03/2015 Douglas MACKAY 09363.0017-00000 6941
22852 7590 11/19/2021
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER
LLP
901 NEW YORK AVENUE, NW
WASHINGTON, DC 20001-4413
EXAMINER
BOWERS, ERIN M
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
11/19/2021 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):
regional-desk@finnegan.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DOUGLAS MACKAY, MARC B. ESQUENET,
BERNARD E. ESQUENET, and LEE A. RUVINSKY
____________

Appeal 2021-001244
Application 14/772,437
Technology Center 1600
____________

Before DONALD E. ADAMS, ERIC B. GRIMES, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 8 and 11–17 (Appeal Br. 5). We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.

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 “Ruhof
Corporation” (Appellant’s July 21, 2020, Appeal Brief (Appeal Br.) 3).
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STATEMENT OF THE CASE
Appellant’s disclosure relates to “devices and methods for testing the
cleanliness of medical instruments” (Spec.2 ¶ 1). Appellant’s claim 8 is
reproduced below:
8. A method of testing a cleanliness of a cannula of a medical
instrument using a testing device, wherein the testing device
comprises a guiding member having a rounded first end and a
second end releasably coupled to a sponge element containing a
dry extractant, the steps comprising:
activating the dry extractant by wetting the sponge
element in at least one of sterile water and ATP-free water;
inserting the first end of the guiding member into a
proximal end of the cannula;
pushing the guiding member into the cannula to pass the
first end of the guiding member through the cannula until the
first end of the guiding member exits a distal end of the
cannula;
pulling at least part of the guiding member out of the
distal end of the cannula;
lysing a cell located on the inner surface of the cannula
by contacting an inner surface of the cannula with the activated
extractant;
pulling the second end of the guiding member and the
sponge element out of the distal end of the cannula;
detaching the sponge element from the guiding member;
introducing the sponge element into a test swab tube; and
exposing the sponge element to a reagent in the test swab
tube.
(Appeal Br. 20–21.)

2 Appellant’s September 3, 2015, Specification.
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Claims 8 and 11–17 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Basile,3 Skiffington,4 Gonzalez,5 and
Richter.6
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Basile
relates to system of testing a lumen of a cannula of an
endoscopic medical device. The system may include an
elongated, flexible, semi-rigid prod configured to fit with[in]
the lumen and comprising a material suitable for non-
destructive movement within the lumen. The system may
include a swab at one end of the prod which may be sufficiently
sized to contact sides of the lumen in such a[] manner as to
collect particles included therein. The system may include an
activating vial for storing an activating agent and a testing vial
for storing an indicating agent. The testing vial may be
sufficiently sized to receive the swab and the activating agent
may be added to the indicating agent within the testing vial,
prior to receipt of the swab, so that the agents react with the
collected particles to indicate whether the collected particles are
contaminates, and thereby, indicate whether the tubular member
is contaminated.
(Basile ¶ 5; see Ans. 4.)
FF 2. Basile’s
method may include inserting a testing prod having a collection
unit at one end into the tubular member, moving the collection
unit within the tubular member to collect particles included

3 Basile et al., US 2006/0269445 A1, published Nov. 30, 2006.
4 Skiffington et al., US 5,827,675, issued Oct. 27, 1998.
5 Gonzalez et al., US 2005/0250168 A1, published Nov. 10, 2005.
6 Richter et al., US 3,619,843, issued Nov. 16, 1971.
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therein, and exposing the collection unit to a testing agent
which indicates whether the collected particle[s] are
contaminates, and thereby, indicate whether the tubular member
is contaminated.
(Basile ¶ 9; see id. ¶ 22 (Basile discloses that its “collection unit . . . may be
a swab”); see also Ans. 4–5.)
FF 3. Basile’s
method may include removing the collection unit from the end
of the testing prod and inserting the removed collection unit
within a testing vial having the testing agent, and shaking the
testing vial having the testing agent and the collection unit so as
to cause the testing agent to react with the collected particles,
whereby the reaction of the testing agent with the collected
particles indicating whether the collected particle are
contaminates, and thereby, indicate whether the tubular member
is contaminated.
(Basile ¶ 10; see Ans. 4.)
FF 4. Basile’s Figure 1 is reproduced below:

Basile’s “FIG. 1 illustrates a testing prod” (Basile ¶ 14 (emphasis omitted)).
As shown in FIG. 1, the collection unit 14 may be removed or
otherwise detached from the testing prod, such as with scissors
32 or other cutting utensil. The flexible portion 16 may be
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suitabl[y] configured to support detaching the collection unit 14
in this manner. Of course, however, the present invention fully
contemplates other configurations for supporting detachment of
the collection unit 14, such as by modifying the flexible portion
16 to include a clip, fastener, or other feature.
(id. ¶ 26 (emphasis omitted); see Ans. 4–5.)
FF 5. Basile discloses that “[o]nce removed, the collection unit 14 may be
received within [a] . . . testing vial,” which “may include a
cover . . . sufficient to retain the testing fluid and the swab so that the testing
vial may be shaken without leaking the testing fluid” (Basile ¶ 27; see Ans.
4–5).
FF 6. Examiner finds that Basile does not disclose a collection unit, i.e., a
sponge that “contains a dry extractant that is activated by wetting” or “the
particular steps of pulling the sponge through the cannula” (Ans. 5; see also
id. at 8 and 10).
FF 7. Skiffington discloses a test apparatus, method and test system “for
the detection of test samples from a material or material surface, by
employing known test techniques” (Skiffington 2:64–3:2).
FF 8. Skiffington’s test apparatus comprises “an elongated semi-rigid
probe” that
contains a test sample collection material secured at the one
end, such as for example, a fibrous type material such as a
cotton swab, which may, if desired, be premoistened, such as
by [] water or an aqueous wetting solution, or with other
compositions such as . . . reagents, . . . or merely may contain
chemicals which physically or chemically bind to the material
to which the test is directed.
(Skiffington 4:33–61; see also id. at 12:34–36 (Skiffington’s swab may
“contain[] water or cleaning solution (e.g. detergent, such as an anionic-like
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sodium lauryl sulfate[)]”); see Ans. 6 (Examiner finds that sodium lauryl
sulfate is a detergent that will lyse cells).)
FF 9. Richter discloses “sponges impregnated with dry compositions,”
such as detergents, including sodium lauryl sulfate (Richter 1:25–26, 8:61–
66, and 11:6–20).
FF 10. Examiner finds that the combination of Basile, Skiffington, and
Richter does not “teach the steps of passing the guiding member and sponge
element through [a] . . . cannula” and relies on Gonzalez to make up for this
deficiency (Ans. 9).
FF 11. Gonzalez discloses a device comprising a solid support member, an
indicator immobilized on the solid support member, and a retaining member
holding the solid support thereon, wherein the retaining member and solid
support are configured to facilitate contact between the solid support and a
surface (Gonzalez ¶¶ 9–12; see id. ¶ 63 (Gonzalez’s “solid support member
can be made to comprise materials that include: films, nonwoven materials
such as cellulosic materials and . . . sponges.”).
FF 12. Gonzalez discloses that when its device is
inserted within a channel of a medical device (e.g., an
endoscope), the solid support member comprises conformable,
flexible, high integrity materials that are able to conform to and
fit within the inner channels of a medical device while
maintaining contact with the inner surfaces of the channel
without experiencing structural failure (e.g., tearing or leaving
remnants within the channel) when the solid support member is
pushed and/or pulled through the length of the channel.
(Gonzalez ¶ 63.)
ANALYSIS
Basile relates to system of testing a lumen of a cannula of a medical
device (FF 1). Basile discloses that its system includes a device comprising
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a prod comprising a material suitable for non-destructive movement within
the lumen and configured to fit within the lumen of the medical device (FF
1–4). Basile’s system may include a swab releasably coupled to one end,
i.e., the second end, of the prod that is sufficiently sized to contact sides of
the lumen in such a manner as to collect particles included therein (id.).
Gonzalez, like Basile, discloses a device comprising, inter alia, a nonwoven
cellulosic material or a sponge for collecting a sample from within the lumen
of a medical device, i.e., an endoscope (FF 11–12). Thus, the evidence on
this record supports a conclusion that a swab and sponge are equivalent
structures for the purpose of collecting a sample from within the lumen of a
medical device. Therefore, we find no error in Examiner’s conclusion that it
would have been prima facie obvious to a person of ordinary skill in this art,
at the time Appellant’s invention was made, to substitute Gonzalez’s sponge
with the swab component of Basile’s device (see Ans. 10; see also FF 11; cf.
FF 1–4).
Skiffington discloses a collection device comprising a swab that is
“premoistened, such as by [] water or an aqueous wetting solution, or with
other compositions such as . . . reagents, . . . or merely may contain
chemicals which physically or chemically bind to the material to which the
test is directed” (FF 7–8). Skiffington discloses that the reagent may be
sodium lauryl sulfate, which Examiner finds is a detergent that will lyse cells
(FF 8). Richter discloses that sodium lauryl sulfate may be added to a
sponge in dry form (FF 9). Thus, we find no error in Examiner’s conclusion
that it would have been prima facie obvious to a person of ordinary skill in
this art, at the time Appellant’s invention was made, to modify the sponge
portion of the device made obvious by the combination of Basile and
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Gonzalez to include dry sodium lauryl sulfate, as suggested by Richter, and
subsequently wet, i.e., pre-moisten, the sponge portion of the device prior to
use as suggested by Skiffington (see Ans. 10; see also FF 7–9).
Gonzalez discloses a method of passing a collection device through
the lumen of a medical device by pushing and/or pulling the device through
the length of the lumen (see FF 12). Thus, we find no error in Examiner’s
conclusion that it would have been prima facie obvious, at the time of
Appellant’s claimed invention was made, to insert the pre-moisten device
made obvious by the combination of Basile, Skiffington, Gonzalez, and
Richter through the inner channel of a medical device by inserting the non-
sponge end of the guiding member through the inner channel and then
pulling the sponge end of the guiding member through the inner channel,
thereby allowing the pre-moistened extractant, i.e., sodium lauryl sulfate, to
lyse a cell located on the inner surface of the cannula (see Ans. 9–10; see
also FF 1–12).
Basile discloses that the collecting unit of its device may be detached
from the remainder of its device, placed into a container, i.e., tube, and
exposed to a testing reagent (see FF 1–4). Thus, we find no error in
Examiner’s conclusion that it would have been prima facie obvious to a
person of ordinary skill in this art, at the time Appellant’s invention was
made, to detach the sponge element from the guiding member of the device
made obvious by the combination of Basile, Skiffington, Gonzalez, and
Richter, place the detached sponge element into a container and expose the
sponge element to a reagent in the container as suggested by Basile (see
generally Ans. 10–11).
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Basile discloses releasably coupling its collection unit to the
remainder of its device, i.e., by “clip, fastener, or other feature” (FF 4).
Therefore, we are not persuaded by Appellant’s contention that “the Office
makes no showing of why one of ordinary skill in the art would have had
any reason to make Basile’s flexible portion releasably coupled to a sponge
element” (Appeal Br. 10).
Richter discloses the application of a dry extractant, i.e., sodium lauryl
sulfate, to a sponge (FF 9). Therefore, we are not persuaded by Appellant’s
contention that Skiffington does not teach a device comprising a dry
extractant, which fails to account for Richter’s contribution to the
combination of Basile, Skiffington, Gonzalez, and Richter (see Ans. 11).
Skiffington discloses pre-moistening the collection member, i.e.,
sponge, with water prior to use (FF 8). Pre-moistening a collection member
comprising a dry extractant, as made obvious by the combination of Basile,
Skiffington, Gonzalez, and Richter, with water will necessarily activate the
dry extractant on the sponge. Therefore, we are not persuaded by
Appellant’s contention to the contrary (see Appeal Br. 11).
Appellant failed to establish that the modification of Basile with the
combination of Skiffington, Gonzalez, and Richter, as discussed above,
renders Basile unsatisfactory for its intended purpose. Thus, we are not
persuaded by Appellant’s contention that the combination of Basile,
Skiffington, Gonzalez, and Richter “would render Skiffington unsatisfactory
for its intended purpose” (Appeal Br. 11; see id. at 11–14).
Skiffington discloses that the swab, or sponge, portion of a collection
device may be premoistened with water or a reagent, such as sodium lauryl
sulfate (FF 8). As discussed above, Richter suggests to those of ordinary
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skill in this art that sodium lauryl sulfate may be included on a sponge in dry
form (see FF 9). In combination, Skiffington and Richter teach those of
ordinary skill in this art that sodium lauryl sulfate may be added to a swab,
i.e., sponge, in either liquid form or in dry form. Those of ordinary skill in
this art would understand if a reagent is added to a collection device, i.e.,
sponge, in dry form then it would have been prima facie obvious to
premoisten the sponge comprising the dry reagent prior to use. It is proper
to “take account of the inferences and creative steps that a person of ordinary
skill in the art would employ.” KSR Int’l v. Teleflex Inc., 550 U.S. 398, 418
(2007); see also id. at 421 (“A person of ordinary skill is also a person of
ordinary creativity, not an automaton.”); In re Sovish, 769 F.2d 738, 743
(Fed. Cir. 1985) (Skill in the art is presumed.). Therefore, we are not
persuaded by Appellant’s contention that “one of ordinary skill would not
find it obvious or be motivated to modify the premoistened swab of
Skiffington based on the teaching of Richter, which was addressing a
problem due to limitations in the materials available at least 25 years earlier”
(Appeal Br. 15–16).
For the foregoing reasons, we are not persuaded by Appellant’s
contention that Examiner relied upon improper hindsight (Appeal Br. 17).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claim 8 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Basile, Skiffington,
Gonzalez, and Richter is affirmed. Claims 11–17 are not separately argued
and fall with claim 8.

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
8, 11–17 103(a) Basile, Skiffington,
Gonzalez, Richter
8, 11–17

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) (2019).

AFFIRMED