Ex Parte Rosenhan

Patent Trial and Appeal Board

Mar 9, 2018

14077202 (P.T.A.B. Mar. 9, 2018)

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.
14/077,202 11/11/2013 Branden D. Rosenhan 6301.33A.1 6255
22913 7590
Workman Nydegger
60 East South Temple
Suite 1000
Salt Lake City, UT 84111
EXAMINER
BOSQUES, EDELMIRA
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
03/13/2018 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BRANDEN D. ROSENHAN
Appeal 2017-002651
Application 14/077,202
Technology Center 3700
Before STEFAN STAICOVICI, LEE L. STEPINA, and
SEAN P. O’HANLON, Administrative Patent Judges.
STAICOVICI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Branden D. Rosenhan (“Appellant”)1 appeals under 35 U.S.C.
§ 134(a) from the Examiner’s decision in the Final Action (dated Dec. 11,
2014, hereinafter “Final Act.”) rejecting claims 1,3,4, 6—11, and 13—20.2
We have jurisdiction over this appeal under 35 U.S.C. § 6(b).
1 University of Utah Research Foundation is identified as the real party in
interest in Appellant’s Appeal Brief (filed Dec. 30, 2015, hereinafter
“Appeal Br.”), at page 4.
2 Claims 2, 5, and 12 are cancelled. Appeal Br. 14, 16 (Claims App’x.).
Appeal 2017-002651
Application 14/077,202
SUMMARY OF DECISION
We REVERSE and enter a NEW GROUND of REJECTION pursuant
to our authority under 37 C.F.R. § 41.50(b).
INVENTION
Appellant’s invention relates to a catheter clamp for a central venous
catheter. Spec., paras. 2, 7.
Claims 1 and 17 are independent, are illustrative of the claimed
invention, and read as follows:
1. A kit comprising:
a central venous catheter having a size in a range from 5
to 9 French; and
a catheter clamp for use in securing the central venous
catheter in a vein, comprising:
a catheter clamp body defining a curved channel
extending between a first end and a second end thereof,
the curved channel configured to accommodate a tubing
of the central venous catheter having a size in a range
from 5 French to 9 French, wherein the catheter clamp
body has a surface that contacts the skin of a patient and
is shaped to orient a free end of the tubing away from a
direction of catheter insertion and to support a bent
profile of the tubing with an angle in a range between 90°
to 210° in a same plane as the surface that contacts the
skin of the patient, thereby reducing the risk of kinking
the tubing; and
an adhesive or one or more eyelets, or both,
coupled to the catheter clamp body for affixing the
catheter clamp to the skin of the patient.
17. A method for securing a catheter to a patient’s skin, the
method comprising:
positioning a central venous catheter in the superior vena
cava of a patient;
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Application 14/077,202
positioning a free end of the central venous catheter in a
catheter clamp the catheter lamp comprising:
a catheter clamp body defining a curved channel
extending between a first end and a second end thereof,
the curved channel configured to accommodate a tubing
of a central venous catheter having a size in a range from
5 French to 9 French, wherein the catheter clamp body
has a surface that contacts the skin of a patient and is
shaped to orient a free end of the tubing away from a
direction of catheter insertion and to support a bent
profile of the tubing with an angle in a range between 90°
to 210° in a same plane as the surface that contacts the
skin of the patient, thereby reducing the risk of kinking
the tubing; and
securing the catheter clamp to the patient’s skin.
REJECTIONS3
I. The Examiner rejected claims 1, 4, 6, 9-11, and 15 under
35 U.S.C. § 102(b) as being anticipated by Collen (US
6,001,081, issued Dec. 14, 1999).
II. The Examiner rejected claims 3 and 13 under 35 U.S.C.
§ 103(a) as being unpatentable Collen.
III. The Examiner rejected claim 7 under 35 U.S.C. § 103(a) as
being unpatentable Collen and Miles (US 5,916,199, issued
June 29, 1999).
IV. The Examiner rejected claim 8 under 35 U.S.C. § 103(a) as
being unpatentable Collen and Matyas (US 5,885,254, issued
Mar. 23, 1999).
3 The rejection of claims 1 and 9 under 35 U.S.C. § 112, second paragraph,
as being indefinite, has been withdrawn by the Examiner. Advisory Action
(dated Apr. 21, 2015, hereinafter “Adv. Act.”); see also Appeal Br. 4.
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Application 14/077,202
V. The Examiner rejected claim 14 under 35 U.S.C. § 103(a) as
being unpatentable Collen and Valley et al. (US 5,766,151,
issued June 16, 1998, hereinafter “Valley”).
VI. The Examiner rejected claim 16 under 35 U.S.C. § 103(a) as
being unpatentable Collen, Weeks (US 4,645,492, issued Feb.
24, 1987), and Lazarus et al. (US 4,128,173, issued Dec. 5,
1978, hereinafter “Lazarus”).
VII. The Examiner rejected claims 17, 19, and 20 under 35 U.S.C.
§ 103(a) as being unpatentable Rozier et al. (US 5,167,240,
issued Dec. 1, 1992, hereinafter “Rozier”) and Collen.
VIII. The Examiner rejected claim 18 under 35 U.S.C. § 103(a) as
being unpatentable Rozier, Collen, and Weeks.
ANALYSIS
Rejection I
Independent claim 1 requires, inter alia, “a central venous catheter
having a size in a range from 5 to 9 French.” Appeal Br. 14 (Claims App’x).
The Examiner finds that Collen discloses “a central venous catheter
(40) having a size in a range from 5 to 9 French (1.5-1.7mm).” Final Act. 3
(citing Collen, col. 2,11. 53—56) (emphasis omitted).
Appellant argues, “Collen fails to teach or suggest a ‘central venous
catheter.’” Appeal Br. 8. According to Appellant, Collen’s IV tubing 40
and cannula 36 do not constitute a central venous catheter (CVC) because
only needle 36 enters a vein, whereas tubing 40 does not, and thus, tubing 40
is not a catheter. Id. at 8—9 (citing, Collen, Fig. 5). Appellant expounds that
in contrast to Collen’s IV tubing, which is not suitable for intubating, a
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Application 14/077,202
central venous catheter “is placed into the central blood supply through the
internal jugular, femoral, or subclavian veins.” Id. at 9—10. Appellant
explains that:
The needle or cannula shown in Collen is clearly not suitable
for placement of a central line in the internal jugular, femoral,
or subclavian veins since the cannula or needle would be too
short to reach the central blood supply and attempting to thread
the needle or cannula through the vein would puncture the walls
of the vein.
Id. at 10 (second emphasis added). Thus, Appellant concludes that “the
structure described in Collen is not suitable for use as a CVC.” Id.
In response, the Examiner interprets the limitation “a central venous
catheter having a size range from 5 to 9 French” “to mean ‘a catheter having
a size range from 5 to 9 French’, since such catheter would be capable of
being placed in a Targe vein’ if desired by a user, or if required by a medical
process.” Examiner’s Answer 11 (dated Oct. 3, 2016, hereinafter “Ans.”).
Hence, according to the Examiner, because Collen’s drip tube 40 has a size
that falls within the claimed range, Collen’s drip tube 40 “can be placed in a
large vein as argued.” Id. Moreover, the Examiner notes that “[Ajppellant
has not further defined structural differences between the claimed catheter
and the catheter ... of Collen.” Id.
Claim language should be read in light of the Specification, as it
would be interpreted by a person of ordinary skill in the art. In re Suitco
Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2010). “Prior art references
may be ‘indicative of what all those skilled in the art generally believe a
certain term means . . . [and] can often help to demonstrate how a disputed
term is used by those skilled in the art.’” In re Cortright, 165 F.3d 1353,
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1358 (Fed. Cir. 1999). In this case, a person of ordinary skill in the art
would understand a “peripheral venous catheter” to be “a small, short plastic
catheter that is placed through the skin into a vein”4 (emphasis added). As
Collen’s needle 36 is located in the patient’s wrist vein, we agree with
Appellant that a skilled artisan would interpret Collen’s drip tube 40 to be a
peripheral venous catheter. See Reply Brief 2 (dated Dec. 5, 2016,
hereinafter “Reply Br.”); see also Collen, col. 3,11. 6—7, Fig. 5. In contrast,
the same person of ordinary skill in the art would understand a “central
venous catheter” to be a ^long, soft, thin, hollow tube that is placed into a
large vein”5 (emphasis added). As such, Appellant is correct in that a skilled
artisan would understand that a “peripheral venous catheter” is different
from a “central venous catheter.” See Reply Br. 2—3.
We appreciate the Examiner’s position that because Cohen’s drip tube
40 has a diameter size that falls within the claimed range from 5 to 9 French,
it “is capable of performing the intended use” of being placed in a “large
vein.” See Ans. 11. However, as noted above, in addition to the diameter
size, a central venous catheter also needs to be longer than a peripheral
venous catheter. As a peripheral venous catheter does not enter central
veins, whereas a central venous catheter enters central veins and terminates
at or close to the heart6, we agree with Appellant that Cohen’s drip tube 40
4 Medline Plus, https://medlineplus.gov/ency/imagepages/19872.htm (last
visited February 27, 2018).
5 American Thoracic Society, Central Venous Catheter, 176 Am. J. Respir.
Crit. Med. (2007) (https://www.thoracic.org/patients/patient-
resources/resources/central-venous-catheter.pdf).
6 See Christine Geffers et al., Use of Central Venous Catheter and
Peripheral Venous Catheter as Rick Factors for Nosocomial Bloodstream
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would be too short to reach the heart. See Appeal Br. 10. Accordingly, we
agree with Appellant that, in light of the understanding of a person having
ordinary skill in the art of catheters, the Examiner’s interpretation of
Collen’s drip tube 40 to be a “central venous catheter” is not reasonable. See
Reply Br. 2.
In conclusion, for the foregoing reasons, Collen’s drip tube 40 does
not constitute a “central venous catheter,” as understood by a person of
ordinary skill in the art. Therefore, we do not sustain the rejection under
35 U.S.C. § 102(b) of claims 1, 4, 6, 9-11, and 15 as anticipated by Collen.
Rejections II—VI
The Examiner’s modification of Cohen and use of the Miles, Matyas,
Valley, Weeks, and Lazarus disclosures does not remedy the deficiency of
Cohen described supra. See Final Act. 5—8.
Accordingly, for the same reasons discussed above, we also do not
sustain the rejections under 35 U.S.C. § 103(a) of claims 3,7, 8, 13, 14, and
16.
Rejection VII
The Examiner finds that Rozier discloses most of the limitations of
independent claim 17, but fails to disclose a catheter clamp, as called for by
claim 17. Final Act. 8—9 (citing Rozier, col. 1,11. 20—26, Fig. 8).
Nonetheless, the Examiner finds that Cohen discloses the claimed catheter
clamp, and concludes that “[i]t would have been obvious to one of ordinary
Infection in Very-Low-Birth-Weight Infants, 31:4 Infection Control and
Hospital Epidemiology 395 (2010).
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Application 14/077,202
skill in the art... to use the catheter [clamp] of Collen to secure a central
venous catheter to the vena cava, to avoid kinking of the catheter and permit
proper transfer [of] fluids within the catheter.” Id. at 9.
Appellant argues that the dome shaped device of Rozier already
“secure[s] the catheter and prevents] kinking near the exit [s]ite.” Appeal
Br. 12. Hence, according to Appellant, “[i]t would not be obvious to remove
the device of Rozier to accommodate the device of Collen because the
purpose of the invention described in Rozier is to provide the dome-shaped
device for securement.” Id.
We agree with Appellant because the reasons proffered by the
Examiner to modify the teachings of Rozier, i.e., to secure a central venous
catheter to the vena cava, to prevent kinking of the central venous catheter,
and to permit proper transfer of fluids within the catheter, appear to already
be adequately performed by the infusion site guard of Rozier. See Rozier,
Fig. 1. The Examiner has not provided any findings that Rozier has a
problem with securing a central venous catheter to the vena cava, preventing
kinking of the catheter, or properly transmitting fluids through the catheter.
Without a persuasive articulated reasoning based on rational underpinnings
for modifying the reference as proposed, the Examiner’s rejection appears to
be the result of improper hindsight analysis. See In re Kahn, 441 F.3d 977,
988 (Fed. Cir. 2006).
Furthermore, we note that in light of Rozier’s objective and purpose—
to guard a catheter infusion site—it would not have been obvious to one of
ordinary skill to modify Rozier to replace its infusion site guard with the
clamp of Collen because such modification would not have maintained
Rozier’s purpose, as the catheter infusion site would be left unprotected.
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Compare Rozier, Fig. 7 with Collen, Fig. 5; see also DePuy Spine, Inc. v.
Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1326 (Fed. Cir. 2009)
(noting that the “predictable result” discussed in KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398 (2007), also means “that the combination would have
worked for its intended purpose”).
Lastly, we agree with Appellant that the Examiner has not adequately
explained how a person of ordinary skill in the art “would modify the device
of Rozier to accommodate the device of Collen.” Appeal Br. 12.
In conclusion, for the foregoing reasons, we likewise, do not sustain
the rejection under 35 U.S.C. § 103(a) of claims 17, 19, and 20 as
unpatentable over Rozier and Collen.
Rejection VIII
The Examiner’s use of the Weeks disclosure does not remedy the
deficiency of the combined teachings of Rozier and Collen described supra.
See Final Act. 10—11.
Accordingly, for the same reasons discussed above, we also do not
sustain the rejection under 35 U.S.C. § 103(a) of claim 18 as unpatentable
over the combined teachings of Rozier, Collen, and Weeks.
NEW GROUND OF REJECTION
We make the following new ground of rejection pursuant to
37 C.F.R. § 41.50(b).
Claims 1 and 17 are rejected under 35 U.S.C. § 103(a) as unpatentable
over Collen and Rozier.
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We adopt the Examiner’s findings regarding the teachings of Collen’s
kit, except for the fact that Collen’s drip tube 40 constitutes a central venous
catheter, as understood by a person of ordinary skill in the art of catheters.
See Final Act. 3^4 (citing Collen, col. 2,11. 53—56, Fig. 2). We further find
that Cohen discloses that its clamp 10 “is not confined to preventing or
reducing kinking in a drip tube, but may be used to prevent kinking in any
flexible tube or hose which is designed to carry a fluid and which normally
undergoes bending.” Cohen, col. 3,11. 16—20. Rozier discloses an infusion
site guard 10 for a needle or catheter 24 inserted into vein 26 of patient 28
through venipuncture site 30, which can be peripheral or central. Rozier,
col. 1,11. 4—5, col. 3,11. 64—67, Fig. 1. As Rozier further discloses that
peripheral sites can be on the upper or lower extremities of the patient and
the central venipuncture site accesses the patient’s vena cava, Rozier
discloses that needle or catheter 24 is a peripheral or a central venous
catheter, respectively.7 Id. at col. 1,11. 14—15.
Hence, in light of Cohen’s disclosure that its clamp 10 can be used
with any flexible tube designed to carry fluids to prevent kinking, it would
have been obvious for a person of ordinary skill in the art to add Rozier’s
central venous catheter to Cohen’s kit in order to provide a potential user a
single kit having both peripheral (i.e., Cohen’s drip tube 40) and central
venous catheters (i.e., Rozier’s catheter 24) and a clamp for preventing
kinking in both types of catheters. Such a modification would improve the
versatility of Cohen’s kit by providing an additional type of catheter.
7 We interpret Rozier’s needle to be similar to Cohen’s needle 36. See
Cohen, Fig. 2.
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With respect to claim 17, when using Collen’s clamp 10 with Rozier’s
central venous catheter 24, the combined teachings of Collen and Rozier
disclose positioning Rozier’s central venous catheter 24 in the superior vena
cava of a patient (see Rozier, Fig. 8), positioning the free end of Rozier’s
catheter into Cohen’s clamp 10 (see Cohen, Fig. 2), and securing Cohen’s
clamp 10 to the patient’s skin using through-apertures 25 and a bandage (see
Cohen, col. 2,11. 19-22).
Although we decline to reject every claim using our discretionary
authority under 37 C.F.R. § 41.50(b), we emphasize that our decision does
not mean the remaining claims are patentable. Rather, we merely leave the
patentability determination of these claims to the Examiner. See MPEP
§ 1213.02.
SUMMARY
The Examiner’s decision to reject claims 1,3,4, 6—11, and 13—20 is
reversed.
We enter a new ground of rejection of claims 1 and 17 under
35 U.S.C. § 103 as unpatentable over Cohen and Rozier.
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shah not be considered final for judicial
review.”
37 C.F.R. § 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
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(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the prosecution
will be remanded to the examiner. The new ground of rejection
is binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the
opinion of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the
claims, appellant may again appeal to the Board pursuant to this
subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
REVERSED
37 C.F.R, $ 41.50(b)
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