Ex Parte Weekamp et al

Patent Trial and Appeal Board

Nov 30, 2016

12518278 (P.T.A.B. Nov. 30, 2016)

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.
12/518,278 06/09/2009 Johannes Wilhelmus Weekamp 2006P02482WOUS 3946
38107 7590 12/02/2016
PTTTT TPS TNTFT T FfTTTAT PROPFRTY fr STANDARDS
EXAMINER
465 Columbus Avenue CARDINAL, ERIN M
Suite 340
Valhalla, NY 10595 ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
12/02/2016 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):
marianne. fox @ philips, com
debbie.henn @philips .com
patti.demichele@philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHANNES WILHELMUS WEEKAMP,
JOHANNES HERMAN SAVENIJE, AALDERT ELEVELT, and
MARCUS JOZEF VAN BOMMEL1
Appeal 2014-009013
Application 12/518,278
Technology Center 3700
Before ERIC B. GRIMES, ULRIKE W. JENKS, and
ROBERT A. POLLOCK, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1—3, 6, 7, 10, 11, 13, 14, and 21. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
The Specification discloses “a feeding tube ... for total parental
nutrition and/or medicine dosing including at least one inner tubing, at least
1 Appellants identify the Real Party in Interest as Koninklijke Philips
Electronics N.V. (App. Br. 1).
Appeal 2014-009013
Application 12/518,278
one lumen, [and] at least one sensor element, in particular an electrode.”
Spec. 1:6—8. The sensing element is “connected to at least one monitoring
device by a wiring for internal monitoring of a patient’s vital functions, the
wiring being at least partially wound in tight contact with a surface of the
inner tubing.” Id. at 1:8—11.
Figure 3b is reproduced below.
u
The embodiment shown in figure 3b provides “a low cost manufactured
feeding tube 11... which may be a single or multi lumen feeding tube 11.
The feeding tube 11 has outer lumens 13 for guiding and protecting a wiring
12.” Id. at 9:27—30. “The outer lumens 13 each provide the continuous
opening 14 in the circumference of the feeding tube 11.” Id. at 10:3—5.
The material of the feeding tube 11 is flexible. Therefore, the
insertion of the wiring 12 into the outer lumens 13 may be easily
conducted by using a method which is schematically shown in
figure 3b. For insertion of the wiring 12, the feeding tube 11 is
pressed at the outside on the top and the bottom of the feeding
tube 11 as indicated in figure 3b by two arrows. By pressing the
outside of the feeding tube 11, the feeding tube 11 is deformed.
This leads to a widening of the openings 14 on the surface of the
feeding tube 11 thus enabling an easy positioning of the wiring
12 in the outer lumens 13.
Id. at 10:12-19.
Claims 1,7, and 13 are illustrative (emphases added):
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Application 12/518,278
1. A feeding tube configured for insertion in an esophageal
opening including:
a flexible inner tubing including at least one lumen configured
for parenteral nutrition and/or medicine dosing;
at least one sensing element disposed along one end of an
outside surface of the inner tubing and configured for internally
sensing a patient’s vital functions;
electrically conductive wire connected to the at least one
sensing element and to at least one monitoring device, and
disposed on the outside surface of the inner tubing;
an outer tubing which covers the inner tubing and the
electrically conductive wire, a surface of the outer tubing having
a spiral shape; and
wherein the inner tubing has recesses pre-formed on the inner
tubing surface that match with the dimensions of and receive the
at least one sensing element and the wire.
7. A feeding tube configured for insertion in an esophageal
opening including:
an inner tubing including at least one inner lumen configured
for parenteral nutrition and/or medicine dosing and at least one
outer lumen disposed adjacent an outside surface of the inner
tubing with an opening extending continuously along the at least
one outer lumen between the outer lumen and an outside surface
of the inner tubing;
at least one sensing element disposed adjacent one end on the
outside surface of the inner tubing and configured for internally
sensing a patient’s vital functions;
wire connected to the at least one sensing element and to at
least one monitoring device, and disposed in the outer lumen of
the inner tubing;
an outer tubing which covers the inner tubing and the wire;
and
wherein the inner tubing is sufficiently flexible that radial
pressure widens the opening to facilitate positioning the wire in
the outer lumen.
13. A feeding tube, comprising:
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Application 12/518,278
an inner tubing including at least one lumen configured for
parenteral nutrition and/or medicine dosing;
at least one sensing element disposed along one end of an
outside surface of the inner tubing and configured for internally
sensing a patient’s vital functions;
electrically conductive wire connected to the at least one
sensing element and to at least one monitoring device, and
disposed on the outside surface of the inner tubing, the wire being
wound around the inner tubing in a spiral; and
an outer tubing which covers the inner tubing and the
electrically conductive wire, the outer tubing being shrunk fit to
the inner tubing such that an outer surface of the outer tubing has
a spiral shape.
The claims stand rejected as follows:
claims 3, 7, 10, and 11 under 35 U.S.C. § 102(b) in view of Levin2;
claim 7 under 35 U.S.C. § 102(b) in view of Van Erp3;
claims 1, 2, 6, 10, and 13 under 35 U.S.C. § 103(a) in view of Van
Erp and Donlon4;
claims 1, 2, 6, 7, 10, 11, 13, and 14 under 35 U.S.C. § 103(a) in view
of Hadani5 and Wessman6;
claim 21 under 35 U.S.C. § 103(a) in view of Sinderby7 and Hadani;
claim 21 under 35 U.S.C. § 103(a) in view of Sinderby and Colson.8
2 Levin et al., US 6,078,830, issued June 20, 2000.
3 Van Erp, US 5,591,142, issued Jan.7, 1997.
4 Donlon, US 5,755,687, issued May 26, 1998.
5 Hadani, WO 2006/060458 Al, published June 8, 2006.
6 Wessman et al., US 2002/0143377 Al, published Oct. 3, 2002.
7 Sinderby et al., US 2008/0125638 Al, published May 29, 2008.
8 Colson et al., GB 2254253 A, published Oct. 7, 1992 (“Colson”).
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Application 12/518,278
I.
Issue
The Examiner rejects claims 3, 7, 10, and 11 under 35 U.S.C. § 102(b)
as anticipated by Levin. Final Rej. 3^4; Ans. 2.
Findings of Fact
FF1 Levin discloses “a catheter having a molded distal end assembly , . .
[that] includes a plurality of electrodes and lead wires that are all molded
into the walls of the assembly.” Levin, Abstract. “[L]ead wires . . . are
preferably spiral wound within the molded walls of the assembly to
reduce the possibility that lead wires may become disconnected during
manufacturing and use of the catheter.” Levin, Abstract.
FF2 Figure 3 of Levin is shown below:
Figure 3 shows a “side cross-sectional view of a . . . multi-electrode
assembly 12” with electrodes 50, 52 and 54. Levin, col. 5,11. 29—31.
“[W]ai! 24 generally defines a central lumen 44.” Levin, col. 5,1. 8.
“[CJentrai lumen 44 includes a distal lumen section 72 defined by the distal
wadi section 26 ... . The inner sidewall of the distal lumen section 72 is
formed by a thin wall tubular section 84.” Levin, col. 5,11. 34-41.
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Application 12/518,278
Analysis
The Examiner finds that Levin discloses “a hollow tube (capable of
being used for feeding) with a polymer inner tubing (84), wire (112...)
connected to a distal sensor ... a polymer outer tubing (26),” and a spirally
would lead wire. Final Rej. 3—4, citing Levin, col. 5,11. 23—29, col. 5,1. 49-
col. 6,1. 11, and Fig. 3. The Examiner finds that Levin’s “outer tubing has
an opening to access the sensor (the wires cross the tubing wall through an
opening . . .).” Final Rej. 4, citing Levin, Fig. 4. The Examiner finds that
Levin’s “device is made of polymers that are sufficiently elastic to bend and
stretch during insertion, and the outer tubing is fit tightly over the inner
tubing.” Final Rej. 4.
Appellants argue that claim 7 requires an “inner tubing including at
least one inner lumen . . . and at least one outer lumen disposed adjacent an
outside surface of the inner tubing with an opening extending continuously
along the . . . outer lumen.” App. Br. 15. Appellants argue that Levin does
not disclose or suggest an “outer lumen disposed adjacent an outside surface
of the inner tubing.” App. Br. 15. Appellants argue that Levin discloses “a
molded distal portion of a catheter with the components molded within.”
App. Br. 15, citing Levin, Abstract.
The Examiner responds that “Levin teaches an inner tubing (84
between the center lumen and the wire) and an outer tubing (26 between the
wire and the outer catheter surface . . .).” Ans. 8, citing Levin, Figs. 4 and 6.
We agree with Appellants that the Examiner has not adequately
explained how Levin discloses the feeding tube of claim 7 that comprises an
“outer lumen disposed adjacent an outside surface of the inner tubing with
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Application 12/518,278
an opening extending continuously along the at least one outer lumen
between the outer lumen and an outside surface of the inner tubing,” wherein
wire is disposed in the outer lumen. Although Levin discloses an inner
tubing 84, the wire is spirally wound around the outside of the inner tubing
rather than being located within an outer lumen of the inner tubing. FF2.
Thus, we reverse the rejection of independent claim 7 and dependent
claims 3, 10, and 11 under 35 U.S.C. § 102(b) as being anticipated by Levin.
II.
Issue
The Examiner rejects claim 7 under 35 U.S.C. § 102(b) as anticipated
by Van Erp. Final Rej. 3; Ans. 2.
Analysis
FF3 Van Erp discloses a catheter that comprises a
tubular, thin walled body having a metal wire reinforcing layer
defined by metal wires which are woven or wound into a
generally cylindrical weave of metal wire reinforcement
incorporated into the tubular body[;] .... at least one lumen
within the tubular body[;].... [and a]t least one electrical
operating element, such as an electrically conductive sensor, []
mounted on the distal end portion and [] electrically connected
to at least one of the wires.
Van Erp, Abstract.
FF4 Figure 3 of Van Erp is shown below:
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Application 12/518,278
FIG. 3
Figure 3 shows “a partly broken away view” of the catheter. Van Erp,
col. 2,11. 61-62. “The construction of the basic body of the catheter 3
. . . comprises a base tubular layer 14, a woven metal wire reinforcing
layer 15 forming a generally cylindrical weave of reinforcing wires 11
and a coating layer 16 arranged thereover.” Van Erp, col. 3,11. 37-41.
FF5 Figures 4 and 4A of Van Erp are shown below:
Figure 4 shows “a partial section” along lines 4-4 in Figure 3. Van
Erp, col. 2,1. 64. Figure 4A shows a sectional view similar to Figure
4 “but shows a metal layer around the insulated wires of the metal
wire reinforcement.” Van Erp, col. 2,11. 65—67.
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Application 12/518,278
Analysis
The Examiner find that Van Erp discloses “a hollow tube (capable of
being used for feeding) with an inner tubing (14), helically wound wire (11
. . .) connected to a distal sensor (5 . . .) and a connector (5 A), and an outer
tubing (16).” Final Rej. 3, citing Van Erp, Figs. 2A, 2B, 4, and 5. The
Examiner finds that Van Erp’s “inner tubing has recesses for the wires and
sensor . . . and the outer tubing has an opening to access the sensor.” Final
Rej. 3, citing Van Erp, Figs. 4 and 4A. The Examiner finds that Van Erp’s
“device is made of polymers that are sufficiently elastic to bend and stretch
during insertion, and the outer tubing is fit tightly over the inner tubing.”
Final Rej. 3.
Appellants argue that that Van Erp does not disclose or suggest “at
least one outer lumen disposed adjacent an outside surface of the inner
tubing with an opening extending continuously along the at least one outer
lumen between the outer lumen and an outside surface of the inner tubing,”
as required by claim 7. App. Br. 4, 15. Rather, Appellants argue, that Van
Erp “only discloses an inner lumen 22 of the catheter.” App. Br. 15, citing
Van Erp, col. 4,11. 26—30.
We agree with Appellants that the Examiner has not adequately
explained how Van Erp discloses the feeding tube of claim 7 with “at least
one outer lumen disposed adjacent an outside surface of the inner tubing.”
Van Erp discloses that the basic body of the catheter comprises a base
tubular layer 14 and woven metal wire reinforcing layer 15. FF4. Thus,
Van Erp discloses that the wires form a separate layer from the tubular layer.
The Examiner points to Figures 4 and 4 A of Van Erp as showing that the
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Application 12/518,278
inner tubing has recesses for wires, but such recesses are not described in
Van Erp, and Van Erp’s Figures 4 and 4A appear to show the wires
embedded in the outer tubing 16. See FF5.
Accordingly, we reverse the rejection of independent claim 7 under
35 U.S.C. § 102(b) as being anticipated by Van Erp.
III.
Issue
The Examiner rejects claims 1, 2, 6, 10, and 13 under 35 U.S.C.
§ 103(a) as obvious in view of Van Erp and Donlon. Final Rej. 4—5; Ans. 2.
Findings of Fact
FF6 Donlon discloses an “aortic occlusion catheter [having] a blood return
lumen for returning oxygenated blood to a patient and an occluding
member for occluding the patient’s ascending aorta.” Donlon,
Abstract.
FF7 Figures 7 through 10 of Donlon are shown below:
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Application 12/518,278
FIG. 7
,?& .•&$ rS§ ,-s?
FiQ, 8
S3' l
FIG. 9
_.-ss ,-*ss
52
£ r&rs^ rares*g^c*.
V
FIG. 10
Figures 7 and 9 show longitudinal cross-sectional views that illustrate
methods of forming a wire-reinforced blood flow lumen. Id. at 2:64—3:3.
Figures 8 and 10 show longitudinal cross-sectional views of the structure
of Figure 7 and 9, respectively, after heating. Id. at 2:66—67, 3:4—5. In
constructing the catheter, “[a] first tube 54 is mounted on a mandrel. . .
and the wire 39 is wrapped in a helical fashion around the first tube 54”
as shown in Figures 7 and 9. Id. at 6:9-16. “A second tube 56 is then
positioned over the wire 39 and the first and second tubes 54, 56 are
encased in a heat shrink tube (not shown) and heated so that the first and
second tubes 54, 56 and wire 39 form the reinforced tube 52” shown in
Figures 8 and 10. Id. at 6:17—21.
FF8 Donlon Figures 8 and 10 “illustrate slight depressions between
adjacent portions of the wire 39 which are eventually filled when the
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Application 12/518,278
pressure lumens 34, 36 and inflation lumen 38 are added.” Id. at 6:41—
45; see id. at 3:6—17, Figs 11—13.
Analysis
The Examiner relies on Van Erp as disclosing “the features of the
claimed invention . . . including recesses in the inner tubing.” Final Rej. 4.
The Examiner finds that Van Erp “states that similar catheter construction is
per se known.” Final Rej. 4, citing Van Erp, 5:37-41. The Examiner finds
that Donlon discloses a catheter device having “a hollow catheter body
having an inner tubing (54), spiral windings (39), and an outer tubing of
shrink fit (56).” Final Rej. 4. The Examiner finds that Donlon also discloses
that “a sufficiently thin outer tubing of the design produces a spiral outer
layer.” Final Rej. 4, citing Donlon, Figs. 7—10. The Examiner concludes
that, in view of Van Erp’s suggestion to reference devices known in the art
“for the tubing construction, it would have been obvious to one having
ordinary skill in the art. . . [to consult] Donlon for the layer materials and
manufacturing techniques for how to include a wound wire layer between
two polymeric layers while leaving an open lumen.” Final Rej. 4—5. The
Examiner reasons that the “[u]se of the Donlon process would result in the
device[]” recited in the claims. Final Rej. 5.
Claims E 6, and 10
Appellants argue that claim 1 requires “recesses pre-formed on the
inner tubing surface that match with the dimensions of and receive the at
least one sensing element and the wire.” App. Br. 10. Appellants argue that
although the Examiner points to Van Erp’s Figures 4 and 4A as disclosing
“recesses in the inner tubing,” the reference does not disclose this feature.
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Application 12/518,278
Id. at 10-11. Appellants argue that Donlon also does not disclose or suggest
such recesses and, therefore, “none of the references show the ‘structural’
feature of recesses on an inner tubing surface that match with the dimensions
of and receive the at least one sensing element and the wire.” App. Br. 11.
We agree with Appellants that the Examiner has not adequately
explained how the combination of Van Erp and Donlon would have made
obvious the feeding tube of claim 1, which requires that “the inner tubing
has recesses pre-formed on the inner tubing surface that match with the
dimensions of and receive the at least one sensing element and the wire”
(emphasis added). As discussed above, the Examiner has not adequately
shown that Van Erp discloses recesses on the inner tubing surface that
contain the wires, nor has the Examiner explained how this limitation is
satisfied by Donlon.
Thus, we reverse the rejection of independent claim 1 and dependent
claim 6 under 35 U.S.C. § 103(a) as being obvious in view of Van Erp and
Donlon.
Claim 10 depends from claim 7. As discussed above, claim 7 requires
an inner tubing that includes “at least one inner lumen . . . and at least one
outer lumen disposed adjacent an outside surface of the inner tubing'1'’
(emphasis added). The Examiner relies on Van Erp as disclosing recesses or
an outer lumen adjacent an outside surface of the inner tubing. Because the
Examiner has not adequately shown that either Van Erp or Donlon discloses
an outer lumen, as recited in claim 7, and we also reverse the rejection of
claim 10 as it depends from claim 7.
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Application 12/518,278
Claims 2 and 13
Claim 13 requires “an outer tubing which covers the inner tubing and
the electrically conductive wire, the outer tubing being shrunk fit to the inner
tubing such that an outer surface of the outer tubing has a spiral shape.”
Appellants argue that Van Erp “discloses a coating layer 16 arranged over a
base tubular layer and a woven metal wire reinforcing layer 15... [but]
does not disclose properties of the outer surface of the coating layer or
surface properties of the catheter.” App. Br. 17. Appellants argue that the
combination of Van Erp and Donlon do not teach or suggest a spiral shape.
App. Br. 17—18 (arguing that “Donlon does not disclose, suggest, or imply a
spiral shape of the outer surface”).
We do not find Appellants’ argument persuasive in light of the
Examiner’s reasoned findings that the combination of Donlon and Van Erp
results in an “inherent spiral outer structure” because:
Van Erp discloses winding the wire in a spiral and covering it
with a thin layer (16). Donlon teaches that winding a wire (39)
in a spiral over an inner tubing (54) and covering the wire with
another thin layer of tubing (56; see Figs. 7 and 9). This covering
layer is then shrink fit (Figs. 8 and 10), and results in a spiral
outer shape (these figures illustrate that with a thin layer of shrink
fit tubing over the spiral wound wire, the helical shape of the
windings is preserved rather than “smoothed out” by a thicker
tubing layer). Donlon explains that this layering technique results
in depressions between the raised wire that is wound in a helix
(i.e., a spiral outer surface; see col. 6, lines 41-43).
Ans. 10-11 ; see FF 7, 8. The Examiner further explains that “Donlon is
used to replace the Van Erp outer layer of insulation with a thinner layer of
shrink-fit insulation . . . not the entire Donlon structure of multiple pressure
lumens.” Id. at 10—11.
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In light of the above, we affirm the rejection of independent claim 13
under 35 U.S.C. § 103(a) as being obvious in view of Van Erp and Donlon.
Claim 2 falls with claim 13. See 37 C.F.R. § 41.37(c)(l)(iv).
The Examiner rejects claims 1, 2, 6, 7, 10, 11, 13, and 14 under
35 U.S.C. § 103(a) as obvious in view of Hadani and Wessman. Final Rej.
5—6; Ans. 2.
Findings of Fact
FF9 Hadani discloses a “feeding tube, such as a gastric tube or nasogastric
tube . . . with at least one electrode suitable for electrical stimulation of a
body organ (e.g., heart) and/or suitable for signal sensing from the body
organ.” Hadani 3:7—10.
FF10 Hadani discloses that “[ejlectrodes 108 are optionally positioned
along the length of tube 100 .... In some embodiments of the invention,
wires 110 connect electrodes 108 to a proximal electrical port.” Hadani
7:26-29.
FF11 Figure 3 of Hadani is shown below:
IV,
Issue
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Application 12/518,278
Figure 3 shows a cross-sectional view of a nasogastric tube. Hadani
7:5. “[T]ube 100 includes an internal channel 124 defined by a wall
122 .. . [and] a bundle 116 of wires 110, which connect electrodes
108 to electrical port 120, run along wall 122.” Hadani 8:31—33.
“Wires 110 of the electrodes 108 optionally pass along tube 100 in a
single bundle 116 embedded in one side of the perimeter of a wall 122
of tube 100. Alternatively, wires 110 are distributed around wall 122,
allowing wall 122 to be thinner than if the wires are concentrated.”
Hadani 9:30-32. “[Alternatively . . . wires 110 pass within channel
124” or can “extend outside of tube 100.” Hadani 10:6—10.
FF12 Wessman discloses a “lead body and method for lead body
manufacture . . . [wherein] at least one conductor [is] positioned between
an inner insulator and an outer insulator . . , [and] the outer insulator is
fused to the inner insulator by heating.” Wessman, Abstract.
M-13 Wessman discloses that a “variety of medical electrode catheters are
available today . . . [which] can be used to sense electrical activity within
the body.” Wessman f 4. “[A] reduced diameter lead is desired to limit
the negative steric effects of lead implantation.” Wessman f 4,
FF14 Figure IB of Wessman is shown below:
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Figure IB shows “a transverse cross-section of. . . a lead body.”
Wessman f 13. “Lead body 10 includes a lumen 12. an inner
insulator 14, at least one conductor 16 and an outer insulator 18.”
Wessman f 21. Conductors 16 can be wires. Wessman f 21.
“Conductors 16 are typically wound about the lumen and are insulated
from the external environment by outer insulator 18 and from the
lumen by inner insulator 14.” Wessman f 21. “Inner insulator 14 and
outer insulator 18 are fused together during manufacture.” Wessman
121.
FF15 Figure 4C of Wessman is shown below:
Figure 4C shows a partial cross-section of a lead embodiment “prior
to fusing the outer insulator to the inner insulator.” Wessman f 18.
“[A] desired number of conductors 16 are wound over inner insulator
14.” Wessman If 24. “In addition to conductors 16, an insulating
spacer . . . [may be] wound between conductors. Insulating spacer 21
can function to maintain the spacing of the wires during manufacture
and to further insulate the individual conductors.” Wessman f 24.
“Outer insulator 18 is then applied over conductors 16” and “fused to
inner insulator 14 by heating the lead body.” Wessman f 24. “To
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fuse the materials, a shrink-wrap, a vacuum or other method may be
utilized.” Wessroan If 24.
Analysis
The Examiner finds that Hadani discloses “a feeding tube connected
to a monitoring device” Final Rej. 5, citing Hadani, Abstract. “A tubing
(100) with a lumen (124) has electrodes (108) with wires (110) in the wall
(the wires are in wall 122, forming an inner tube and a tight outer tube with
the wires between).” Final Rej. 5. “Openings in the outer tubing (between
the wire and outside surface) allow access to the electrode (the wires connect
to the electrode outside the outer tubing . . .).” Final Rej. 5. “The
construction also results in the wiring [being] located in an outer lumen near
the surface.” Final Rej. 5.
The Examiner finds that Wessman discloses “a large hollow sensing
device . . . [and] catheters capable of being used for a feeding tube.” Final
Rej. 5, citing Wessman 14. The Examiner finds that Wessman discloses an
“inner tube (14) ha[ving] a lumen (12), a sensing element. . . wiring (16)
wound in tight contact with the inner tubing . . . and an outer tubing (18)
over the wiring.” Final Rej. 5, citing Wessman, Figs. 1—4. The Examiner
finds that the “outer tubing can be made by shrink-wrapping the inner tube
. . . which would give the surface of the outer tubing a spiral shape (the leads
are spiral wound . . . [and] that shape would be maintained by a thin shrink
wrap layer 18).” Final Rej. 5, citing Wessman
124 and Figs. 1 A, 4B, and 4C.
The Examiner concludes that, in view of Hadani’s suggestion “to
locate the wires in the tube wall, it would have been obvious to one having
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ordinary skill in the art... to look to devices such as that of Wessman for
the necessary details of construction, and predictable results would ensue.”
Final Rej. 6. The Examiner finds that Wessman discloses “recesses in the
outer tube for the wires . . . but does not disclose recesses on the surface of
the inner tubing for the wires.” Final Rej. 6, citing Wessman, Figs. 1 A—B.
The Examiner finds that it is known in the art that, “when a wire is between
two tubes . . . equivalent recesses at the interface include (a) in the inner
surface of the outer tube; (b) in the outer surface of the inner tube; and (c)
matched partial recesses in the mating surfaces of both tubes.” Final Rej. 6.
The Examiner concludes that it would have been obvious to one of ordinary
skill in the art to modify Wessman’s device “by moving the recess from the
inner surface of the outer tubing at least partially to the outer surface of the
inner tubing for the predictable result of a tight hold for the wire.” Id.
Claim 1
Claim 1 requires that “the inner tubing has recesses pre-formed on the
inner tubing surface that match with the dimensions of and receive the at
least one sensing element and the wire.” Appellants argue that Wessman
“does not disclose, teach, suggest, or imply recesses.” App. Br. 12. With
respect to Wessman’s Figs. 1A and IB, cited by the Examiner as showing
recesses, Appellants argue that Wessman teaches that “an insulating spacer
may be provided between the conductors” and the use of “a spacer between
conductors is contrary to any suggestion of pre-formed recesses.” App. Br.
12.
We agree with Appellants that the Examiner has not adequately
explained how the combination of Hadani and Wessman would have made
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obvious the feeding tube of claim 1 that comprises an inner tubing having
“recesses pre-formed on the inner tubing surface that match with the
dimensions of and receive the at least one sensing element and the wire”
(emphasis added). Hadani discloses a tubing with wires that run along the
inside or outside of the tubing, or that are embedded within the tubing wall.
FF11. Wessman discloses that the wires are wrapped around an inner
tubing, wherein an outer tubing is then fused to the inner tubing. FF14 and
FF15. We do not discern, nor does the Examiner explain, where Wessman
discloses that either the inner or outer insulators that form the tubing wall
has recesses that hold the wires. The Examiner also fails to persuasively
explain why, or how, one of skill in the art would have modified Wessman’s
procedure of wrapping the wire around the outer tubing to arrive at a
procedure that generates recesses in the inner tubing. Accordingly, we
reverse the rejection of independent claim 1 and dependent claim 6 under 35
U.S.C. § 103(a) in view of Hadani and Wessman.
Claim 7
Claim 7 requires an inner tubing that includes both an inner lumen and
“at least one outer lumen disposed adjacent an outside surface of the inner
tubing with an opening extending continuously along the at least one outer
lumen between the outer lumen and an outside surface of the inner tubing.”
Appellants argue that Hadani does not teach or suggest the claimed “outer
lumen disposed adjacent an outside surface of the inner tubing,” because
[t]he channels of Hadani are all internal to the tubing and not adjacent an
outside surface.” App. Br. 16. Appellants further argue that Wessman does
not cure the defect in Hadani because Wessman discloses “an outer and an
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inner insulator and fusing the outer and inner insulators to one another” to
form a single lumen, such that Wessman fails to disclose an outer lumen as
required by claim 7. App. Br. 16, citing Wessman 111.
We agree with Appellants that that the Examiner has not adequately
explained how the combination of Hadani and Wessman would have made
obvious the feeding tube of claim 7 comprising an outer lumen. As
discussed above for claim 1, the Examiner has not explained why one of
skill in the art would have modified Wessman’s process of wrapping the
wires around the inner tubing to arrive at an inner tubing that has a recess or
an outer lumen adjacent the outer surface of the inner tubing. As this
limitation is not found in Hadani, we reverse the rejection of independent 7
and dependent claims 10, 11, and 14 under 35 U.S.C. § 103(a) in view of
Hadani and Wessman.
Claim 13
Appellants argue that claim 13 requires that the outer tubing is
“shrunk fit to the inner tubing such that an outer surface of the outer tubing
has a spiral shape.” App. Br. 18. Appellants argue that Hadani “does not
disclose an inner and . . . outer tube,” or disclose a surface property of the
tube. App. Br. 18. Appellants argue that Wessman does not disclose or
suggest “a property of the outer surface or the lead.” App. Br. 18.
Appellants argue that, therefore, “claim 13 is distinguished from Hadani and
Wessman.” App. Br. 18.
Appellants’ arguments are not persuasive. Wessman discloses heat
fusing an outer tubing or outer insulator to an inner tubing or inner insulator,
wherein the inner insulator is wrapped with wire in a spiral configuration.
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FF14 and FF15. Wessman also discloses that the heat fusion takes place
under pressure, e.g., shrink-wrapping. FF13andFF15. In view of
Wessman’s disclosure, we agree with the Examiner that it would have been
obvious to one of skill in the art to use a layer of outer tubing that is
sufficiently thin such that heat fusion of the inner and outer layers would
result in the spiral pattern of the wire being visible in the outer layer. See
Ans. 9 (referencing discussion of Donlon). Thus, we affirm the rejection of
claim 13 under 35 U.S.C. § 103(a) in view of Hadani and Wessman.
Claim 2
Claim 2 depends from claim 13 and further requires that “at least one
opening is provided in the outer tubing at the location of the at least one
sensing element to allow an access to the at least one sensing element.”
Appellants argue that Hadani “does not disclose an outer tubing.” App. Br.
13. Appellants argue that Wessman discloses “an outer insulator layer but
does not disclose an outer tubing . . . [or] disclose, suggest, or imply any
opening.” App. Br. 13.
Appellants’ arguments are not persuasive. Although Wessman does
not disclose the location of electrode placement in the lead, Hadani discloses
a tubing with electrodes disposed on the outer surface of the tubing that are
connected to wires that run within the tubing. FF10, FF11. Thus, it would
have been obvious to one of ordinary skill in the art to connect wires that run
between the inner and outer insulating layers, as disclosed in Wessman, to
electrodes on the surface of the lead through openings in the outer insulating
layer. See Ans. 9-10. Thus, we affirm the rejection of claim 2 under 35
U.S.C. § 103(a) in view of Hadani and Wessman.
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V.
Issue
The Examiner rejects claim 21 under 35 U.S.C. 103(a) as obvious in
view of Sinderby, and further in view of either Hadani or Colson. Final Rej.
6—7; Ans. 2. Claim 21 recites:
21. A feeding tube for total parenteral nutrition and/or
medicine dosing including at least one inner tubing, at least one
lumen, at least one sensing element which includes an
electrode, the sensing element being connected to at least one
monitoring device by a wiring for internal monitoring of a
patient’s vital functions, the wiring being at least partially
wound in tight contact with a surface of the inner tubing, the
inner tubing being at least partially surrounded by an outer
tubing in order to cover the inner tubing and the wiring,
wherein the outer tubing and the inner tubing are made
from one-piece wherein at least one inner lumen is formed in
the center of the feeding tube and at least one outer lumen is
formed near the surface of the tubing for guiding and protecting
the wiring to be inserted into the at least one outer lumen,
wherein at least one groove is located in the at least one
outer lumen which provides a continuous opening in the least
one outer lumen to enable a positioning of the wiring in the
outer lumen from outside,
wherein the material of the feeding tube is flexible to
enable a widening of the groove and an easy positioning of the
wiring in the outer lumen by pressing at the outside of the
feeding tube.
Findings of Fact
FF16 Sinderby discloses an “electrode catheter using thin metallic threads
or wires.” Sinderby, Abstract. “[Ejmbodiments allow for the efficient
mounting of at least one electrode on a catheter, resulting in the creation
of a flexible ring-microelectrode.” Sinderby, Abstract.
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FF17 Figure 9 of Sinderby is shown below:
Figure 9 shows “a cross-sectional view of a wire carrier and a host
tube.” Sinderby 137. “Wire carrier 400 is formed with a series of
transversal indents . . . through which the loop portions 10 can be
mounted onto the wire carrier 400.” Sinderby | 81. “The wire carrier
400 also has a longitudinal, inner groove 420 in which the wire
portions 20 can be placed.” Sinderby 181. “After the bared wire loop
portions 10 have been mounted on the wire carrier 400 and after the
insulated wire portions 20 have been placed inside the wire carrier
400, the wire earner 400 can he mounted onto a host tube 440.”
Sinderby f 82. Sinderby discloses that the tube may be, “for example
a nasogastric tube[] with a lumen 460 and a groove 450 adapted to
receive the wire carrier 400.” Sinderby f 82, “The wire carrier 400 is
secured in the groove 450 using mechanical means such as clipping,
glue or any other method known to those of ordinary skill in the art.”
Sinderby 1 82.
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Analysis
The Examiner finds that Hadani discloses “including wires (110) in
the tube wall (the wires are in wall 122, forming an inner tube and a tight
outer tube with the wires between).” Final Rej. 7. The Examiner finds that
Sinderby discloses “a similar device including a feeding tube (440 . . .) with
a central lumen (460) and a peripheral outer lumen (450) having a groove
(the lumen 450 is open to the outside of the tube at a groove . . .).” Final
Rej. 7, citing Sinderby 1 82 and Fig. 9. The Examiner finds that Sinderby’s
“wires (20) are placed through the groove into the outer lumen . . . [wherein
the] grooved outer lumen would also expand or open if the tube were
compressed.” Final Rej. 7, citing Sinderby ^fl[ 81—82. The Examiner
concludes that it would have been obvious to one of ordinary skill in the art
to use Sinderby’s “design of a grooved lumen to place the electrodes in the
. . . Hadani device, as predictable results would ensue.” Final Rej. 7.
Appellants argue that claim 21 requires that “the material of the
feeding tube is flexible to enable a widening of the groove and an easy
positioning of the wiring in the outer lumen by pressing at the outside of the
feeding tube,” but Sinderby does not disclose “widening of the groove and
positioning of the wiring by pressing at the outside of the feeding tube.”
App. Br. 19.
Appellants’ argument is not persuasive. With respect to “widening of
the groove and an easy positioning of the wiring in the outer lumen by
pressing at the outside of the feeding tube,” we agree with the Examiner that
this phrase comprises a product by process limitation. See Ans. 11—12.
“The patentability of a product does not depend on its method of production.
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If the product in a product-by-process claim is the same as or obvious from a
product of the prior art, the claim is unpatentable even though the prior
product was made by a different process.” In re Thorpe, 111 F.2d 695, 697
(Fed. Cir. 1985) (citation omitted).
Sinderby discloses the desirability of generally flexible micro­
electrode catheters and that the “wire carrier 400 is secured in the groove
450 using mechanical means such as clipping, glue or any other method
known to those of ordinary skill in the art.” Sinderby, Abstract and f 82; see
FT 1.7. Accordingly, we agree with the Examiner that the material of
Sinderby’s catheter “is sufficiently flexible to be assembled as recited,” and
that it would have been obvious to one of ordinary' skill in the art to provide
a groove in an outer lumen of a tubing that is sufficiently flexible to enable
positioning of the wiring in the outer lumen by widening of the groove of the
outer lumen. See Ans. 11—12.
Appellants further argue that Sinderby “positions the wiring in a wire
carrier, not the groove as called for by the claim . . . [and] secures the wire
carrier” in the groove. App. Br. 19. Thus, Appellants argue, “Sinderby
teaches away from the claim by positioning wire in a wire carrier and not
directly in the groove.” App. Br. 19. Appellants’ argument is not
persuasive.
We do not read claim 21 as requiring “positioning wire . . . directly in
the groove,” as Appellants contend. See SuperGuide Corp. v. DirecTV
Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (“Though understanding
the claim language may be aided by the explanations contained in the
written description, it is important not to import into a claim limitations that
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are not a part of the claim.”). Sinderby discloses positioning both the wire
carrier and the associated wire in a groove in tubing. FF17. Hadani
discloses securing wire within the wall of tubing. FF11. In view of the
combination of the cited references, it would have been obvious to one of
ordinary skill in the art to place the wire of Hadani inside a groove in the
tubing to facilitate manufacturing of the feeding tube. Thus, we affirm the
rejection of claim 21 under 35 U.S.C. § 103(a) in view of Hadani and
Sinderby.
The rejection of claim 21 under 35 U.S.C. § 103(a) in view of Colson
and Sinderby is cumulative, and affirmed for the same reasons.
SUMMARY
We reverse the rejection of claims 3,7, 10, and 11 under 35 U.S.C.
§ 102(b) in view of Levin.
We reverse the rejection of claim 7 under 35 U.S.C. § 102(b) in view
of Van Erp.
We reverse the rejection of claims 1, 6, and 10 under 35 U.S.C.
§ 103(a) in view of Van Erp and Donlon.
We affirm the rejection of claims 2 and 13 under 35 U.S.C. § 103(a)
in view of Van Erp and Donlon.
We reverse the rejection of claims 1, 6, 7, 10, 11, and 14 under
35 U.S.C. § 103(a) in view of Hadani and Wessman.
We affirm the rejection of claims 2 and 13 under 35 U.S.C. § 103(a)
in view of Hadani and Wessman.
We affirm the rejection of claim 21 under 35 U.S.C. § 103(a) in view
of Sinderby and Hadani.
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We affirm the rejection of claim 21 under 35 U.S.C. § 103(a) in view
of Sinderby and Colson.
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).
AFFIRMED-IN-PART
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