Ex Parte Mythen

Patent Trial and Appeal Board

Aug 8, 2014

11885472 (P.T.A.B. Aug. 8, 2014)

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.
11/885,472 08/31/2007 Michael Mythen 0119/0072 5000
21395 7590 08/08/2014
LOUIS WOO
LAW OFFICE OF LOUIS WOO
717 NORTH FAYETTE STREET
ALEXANDRIA, VA 22314
EXAMINER
STUART, COLIN W
ART UNIT PAPER NUMBER
3771
MAIL DATE DELIVERY MODE
08/08/2014 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MICHAEL MYTHEN

__________

Appeal 2012-001297
Application 11/885,472
Technology Center 3700
__________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to an
apparatus including a tube and an elongate penetration instrument. The
Examiner rejected the claims as indefinite and as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

1 Appellant identifies the Real Party in Interest as Smiths Group
PLC (see App. Br. 3).
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Application 11/885,472

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Statement of the Case
Background
“In various surgical situations it is necessary to make a passage into a
body cavity so that a tube can have one end inserted in the cavity” (Spec. 1).
The Specification teaches that “where the patient is obese and has an
excessive thickness of tissue overlying the trachea, it can be difficult to
estimate the thickness of the tissue and conventional tubes with fixed flanges
may not be suitable” (Spec. 1). The Specification teaches that often “it is
preferable to use a tube with a flange that can be moved . . . . A problem
with such tubes is that the flange has to be manipulated and positioned after
the tube has been inserted, which can cause trauma to the patient” (Spec. 1).
The Claims
Claims 1–11 are on appeal. Claims 1, 3, and 10 are representative and
read as follows:
1. Apparatus including a tube and an elongate
penetration instrument, the instrument being adapted to
penetrate a body cavity in which the tube is to be placed,
characterized in that the instrument is provided with visible
markings along its length by which the extent of insertion of
the instrument can be readily ascertained, that the tube is
correspondingly provided with visible markings of the same
character as those on the instrument, and that the tube has a
flange movable and lockable along the length of the tube
against the markings so that the flange can be positioned
appropriately by observation of the markings on the
instrument indicative of extent of penetration.

3. Apparatus according to Claim 1, characterized in that
the visible markings are colored differently from one
another.
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10. A method of placing a tube in a body cavity
comprising the steps of:
penetrating body tissue with an instrument, detecting
when the instrument has penetrated the body cavity,
observing markings along the instrument to determine which
marking is aligned with the skin surface, displacing a flange
along a tube until the flange is aligned with a marking on the
tube corresponding to the marking on the instrument,
retaining the flange in position on the tube and subsequently
inserting the tube along the passage established by the
instrument until the flange on the tube comes into contact
with the skin surface.

The issues
A. The Examiner rejected claim 3 under 35 U.S.C. § 112, second
paragraph as indefinite (Ans. 4).
B. The Examiner rejected claims 1 and 4–11 under 35 U.S.C. § 103(a) as
obvious over Toye,2 McNeirney,3 and Christopher4 (Ans. 5–7).
C. The Examiner rejected claims 2 and 3 under 35 U.S.C. § 103(a) as
obvious over Toye, McNeirney, Christopher, and Clark5 (Ans. 7–8).
A. 35 U.S.C. § 112, second paragraph
The Examiner finds that, in claim 3, “it is unclear as to what is meant
by the limitation ‘the visible markings are colored differently from one
another’ (line 2). Is the claim referring to the visible markings on the tube or
the instrument?” (Ans. 4).

2 Toye, F., US 4,364,391, issued Dec. 21, 1982.
3 McNeirney, J., US 6,200,274 B1, issued Mar. 13, 2001.
4 Christopher, K., US 5,515,844, issued May 14, 1996.
5 Clark et al., US 6,613,002 B1, issued Sept. 2, 2003.
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The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that claim 3 is indefinite?
Findings of Fact
1. The Specification teaches that the “needle 10 has visible
markings 13 along its length in the form of four, differently coloured bands
extending around the circumference of the needle and arranged one after the
other” (Spec. 3).
2. The Specification teaches that:
The rear, machine end of the tube has a straight portion 25,
along which the flange 24 can be positioned, and a part of
the length of this portion has visible markings of the same
character as those on the needle, in the form of a series of
four differently coloured bands 26 located one after the other
to provide a pattern of bands of the same colour and
arranged in the same order as the bands 13 on the needle 10.

(Spec. 4.)
Principles of Law
A “patent is invalid for indefiniteness if its claims, read in light of the
specification delineating the patent, and the prosecution history, fail to
inform, with reasonable certainty, those skilled in the art about the scope of
the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 134 S.Ct. 2120,
2124 (2014).
Analysis
In interpreting the phrase “the visible markings are colored differently
from one another” in claim 3, several different interpretations are consistent
with the claim language. First, each marking may be differently colored on
a single device so claim 3 may be interpreted as a set of visible markings
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composed of different colored bands on the instrument and the same visible
markings and color bands on the tube, as taught by the Specification (FF 1–
2) and argued by Appellant (App. Br. 10). Second, the visible markings on
the instrument may be composed of one set of colors which are differently
colored than a second set of colors employed as visible markings on the
tube. A third interpretation is that the same set of colors is used for both the
instrument and tube, but the order of colors is different, such that the “visible
markings are colored differently from one another.”
Appellant contends that this limitation “is made clear in the
specification, with reference to page 3, lines 5-7 (for the visible markings on
the instrument), and page 4, lines 9-14 (for the visible markings on the
tube)” (App. Br. 10).
We are not persuaded. Appellant argues limitations found in the
Specification, but we do not read limitations from the Specification into the
claims. 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 are not a part of the claim. For example,
a particular embodiment appearing in the written description may not be
read into a claim when the claim language is broader than the embodiment.”)
The instant situation is one where “the patent drafter is in the best
position to resolve the ambiguity in the patent claims, and it is highly
desirable that patent examiners demand that applicants do so in appropriate
circumstances so that the patent can be amended during prosecution rather
than attempting to resolve the ambiguity in litigation.” Halliburton Energy
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Servs., Inc. v. M–I LLC, 514 F.3d 1244, 1255 (Fed. Cir. 2008). Appellant
has not chosen to amend and clarify the claim, but rather simply argue. We
therefore affirm the rejection.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that claim
3 is indefinite.
B. 35 U.S.C. § 103(a) over Toye, McNeirney, and Christopher
The Examiner finds that “Toye teaches an elongate penetration
instrument (syringe 24, upper body 22, and needle 20) for penetrating a body
cavity (e.g. a trachea as shown in Fig. 1) in which a tracheostomy tube
(reference 42 in Figs. 4 and 7-10) with a flange (i.e. tube cap portion 44) is
to be placed” (Ans. 5). The Examiner acknowledges that “Toye fails to
teach that the instrument has visible markings” (Ans. 5).
The Examiner finds that “McNeirney teaches that spaced markings
along the surface of a surgical insertion needle to indicate the depth of
penetration of the tip of the needle is old and well-known” (Ans. 5). The
Examiner acknowledges that “Toye in view of McNeirney does not teach
that the tube has visible markings and a movable flange” (Ans. 5).
The Examiner finds that “Fig. 9 of Christopher teaches a
tracheostomy tube (10) with visible markings (shown in Fig. 9) and a flange
(neck flange 11) [that is] movable (i.e. adjustable; see column 10, lines 20-
22) and lockable” (Ans. 5).
The Examiner finds it obvious to “provide the penetration needle of
Toye with spaced markings along its surface as taught by McNeirney in
order to allow a physician to keep track of the depth of penetration of the
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needle through a patient’s neck” (Ans. 5). The Examiner further finds it
obvious to “substitute the tracheostomy tube of Toye with the tracheostomy
tube comprising visible markings and a movable and lockable neck flange as
taught by Christopher in order allow [sic] a physician greater control over
the insertion and placement of a tracheostomy tube” (Ans. 6). The Examiner
also finds it obvious
[T]o modify the tube and instrument of Toye in view of
McNeirney further in view of Christopher to have
corresponding markings in order to facilitate proper fitting
of the tracheostomy tube into a patient’s trachea based on
the observed length of the patient’s tracheotomy stoma and
to prevent the need for making marking length conversions.

(Ans. 6.)
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Toye, McNeirney, and Christopher
render the claims obvious?
Findings of Fact
3. Toye teaches that a “hollow inner needle 20, similarly wedge-
shaped at its distal end, is coaxially slidably received within the outer needle
bore 18 and is characterized by an upper body 22 which is engageable upon
the outer needle upper body 12” (Toye, col. 4, ll. 1–5).
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4. Figures 1 and 4 of Toye are reproduced below:

“FIG. 1 is an elevational view of the inner and outer needles of the present
tracheostomy apparatus, a syringe being utilized to facilitate initial insertion
of the needles into the tracheal lumen . . . . FIG. 4 is a view . . . illustrating
threading of the dilator leader into the outer needle slot” (Toye, col. 2, ll.
29–42).
5. Toye teaches that a “complementally [sic, complementarily]
curved metal trachea tube 42 is coaxially slidably fitted over the curved
intermediate portion 34 of the dilator 30 . . . . The upper or proximal end of
the trachea tube 42 includes a flat cap portion 44 which engages the
shoulder” (Toye, col. 4, ll. 50–63).
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6. McNeirney teaches that:
Needles are commonly employed to obtain biopsy
specimens for laboratory evaluation. This entails a surgical
procedure which requires that the surgeon know precisely
the depth to which the needle is inserted in the patient’s
tissue to be sure that a proper specimen is obtained.
Typically, spaced markings are provided along the surface
of the needle to indicate the depth of penetration of its tip.
A depth stop may be employed to limit penetration of the
needle to the desired depth.

(McNeirney, col. 1, ll. 19–26.)
7. Figure 9 of Christopher is reproduced below:

Figure 9 shows that “an adjustable neck flange 11 slides relative to the
tracheostomy tube 10 and can be manually positioned at any desired location
along its length” (Christopher, col. 10, ll. 40–42).
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8. Christopher teaches that
[A] series of radio-opaque markings extend along the length
of the tracheostomy tube 10. These markings permit the
health care provider to visually check whether the neck
flange 11 has moved from its desired position on the
tracheostomy tube. The markings also permit the health
care provider to clearly observe the position of the distal end
15 of the tracheostomy tube 10 within the patient’s trachea
by means of x-ray imaging.

(Christopher, col. 10, ll. 46–53.)
Analysis
Claim 1
Toye teaches an apparatus which comprises a tracheostomy tube
(“curved metal trachea tube” (FF 5)) and an elongate penetration instrument
(“inner and outer needles” (FF 4)). Toye teaches that the device is for
insertion into the trachea, a body cavity (FF 3–5). Toye does not teach
visible markings or flanges on the tube (see Ans. 5).
McNeirney teaches the use of visible markings on needles where
“spaced markings are provided along the surface of the needle to indicate the
depth of penetration of its tip” (McNeirney, col. 1, ll. 24–25; FF 6).
Christopher teaches flanges on tracheostomy tubes, specifically
teaching that “an adjustable neck flange 11 slides relative to the
tracheostomy tube 10 and can be manually positioned at any desired location
along its length” (Christopher, col. 10, ll. 40–42; FF 7). Christopher also
teaches visible markings on tracheostomy tubes, teaching that “markings
permit the health care provider to visually check whether the neck flange 11
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has moved from its desired position on the tracheostomy tube” (Christopher,
col. 10, ll. 48–50; FF 8).
Applying the KSR standard of obviousness to the findings of fact, we
conclude that the person of ordinary skill would have reasonably marked
Toye’s needles since McNeirney teaches that spaced markings allow
indications on the depth penetration of the needle (FF 6). Further, we
conclude that the person of ordinary skill would have incorporated a
movable flange into Toye’s tracheostomy tube to permit manual positioning
of the flange along the tube as taught by Christopher (FF 7). The ordinary
artisan would also have put markings on Toye’s tracheostomy tube to ensure
that the tube is placed in the desired position (FF 8). Adding visible
markings and a flange as expressly suggested by the prior art (FF 6–8) is
merely a “predictable use of prior art elements according to their established
functions.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
Appellant contends that “[n]one of Toye, McNeirney and Christopher
discloses visible markings at an instrument used to penetrate the patient and
corresponding visible markings at a tube that guide the positioning of a
movable flange along the tube by referencing the visible markings at the
instrument” (App. Br. 11). Appellant contends that “there is no teaching or
suggestion in any of those references that the flange of the tube is to be
moved against the markings on the tube by observing the markings on the
penetrating instrument” (App. Br. 13).
We do not find this argument persuasive for the apparatus claims,
whose structural limitations only require visible markings on both the
penetration instrument and tube. The requirement that “the tube is
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correspondingly provided with visible markings of the same character as
those on the instrument” (claim 1) merely requires markings that allow “the
flange [to] be positioned appropriately by observation of the markings”
(Claim 1). This limitation requires only that the markings allow the position
of a flange on the instrument to be observed, a function that is allowed by
the markings on the devices of McNeirney and Christopher (see FF 6, FF 7).
Claim 10
Appellant contends that “claim 10 requires the step of ‘observing
markings along the instrument to determine which marking is aligned with
the skin surface’, and the step of ‘displacing a flange along a tube until the
flange is aligned with a marking on the tube corresponding to the marking
on the instrument’” (App. Br. 14).
The Examiner finds that:
While the references may not explicitly describe
aligning markings with the skin surface, the visible markings
along the instrument of the modified Toye reference are
used to determine depth of the instrument and one of
ordinary skill in the art would recognize to observe the
marking aligned with the skin surface when determining the
depth of the instrument to correspondingly adjust the flange
position on the tube and therefore the depth of the tube.

(Ans. 12.)
We find that Appellant has the better position. Unlike apparatus claim
1, claim 10 is a method claim. As Appellant correctly notes, claim 10
requires that the “flange is aligned with a marking on the tube corresponding
to the marking on the instrument.” Thus, it is not sufficient for a rejection of
claim 10 to simply demonstrate the obviousness of an apparatus with
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markings on both the instrument and the tube, as for claim 1. Instead, there
must also be a reason, supported by evidence, to align the markings on the
instrument and the marking on the tube as required by claim 10. The
Examiner may provide a reason to align the flange with the tracheostomy
tube (see Ans. 6, 12), but the Examiner has not explained why it would have
been necessary to further align these elements with the penetration device or
needle.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that Toye,
McNeirney, and Christopher renders claim 1 obvious.
The evidence of record does not support the Examiner’s conclusion
that Toye, McNeirney, and Christopher renders claims 10 and 11 obvious.
C. 35 U.S.C. § 103(a) over Toye, McNeirney, Christopher, and Clark
Appellant contends, regarding Clark, that
[E]ven ignoring for the moment that the marks are
radiopaque marks that are visible under imaging, not
visually as required in the claims, such regular interval
marks would not provide an accurate determination of the
extent of insertion of the instrument into the patient as the
instrument may well be inserted into the patient between
markings.

(App. Br. 15.)
The Examiner finds that the “Clark reference was used for the
teaching of medical instruments with visible markings in the form of bands
of different colors (see Clark col. 1 ln. 19-20) to provide better visibility to
the visible markings” (Ans. 12–13).
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We find that the Examiner has the better position. Clark teaches that
“the placement of a series of markings on a surgical instrument such as a . . .
catheter, needle, etc., can aid the physician in proper placement of the device
in the body of a patient during a medical procedure. These markings can
include . . . colors . . . to indicate position or movement of the device within
the body” (Clark, col. 1, ll. 15–22). We agree with the Examiner that Clark
reasonably suggests the use of color as a type of visible marking on a needle
or catheter (i.e., tube for insertion into patient), where incorporation of
Clark’s color as a marking into the apparatus of Toye, McNeirney, and
Christopher is merely a “predictable use of prior art elements according to
their established functions.” KSR, 550 U.S. at 417. To the extent that
Appellant is pointing to the specific embodiment taught by Clark, the “test
for obviousness is not whether the features of a secondary reference may be
bodily incorporated into the structure of the primary reference . . . . Rather,
the test is what the combined teachings of the references would have
suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d 413,
425 (CCPA 1981).
SUMMARY
In summary, we affirm the rejection of claim 3 under 35 U.S.C. § 112,
second paragraph as indefinite.
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as
obvious over Toye, McNeirney, and Christopher. Pursuant to 37 C.F.R.
§ 41.37(c)(1)(iv), we also affirm the rejection of claims 4–9, as these claims
were not argued separately.
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We reverse the rejection of claims 10 and 11 under 35 U.S.C. § 103(a)
as obvious over Toye, McNeirney, and Christopher.
We affirm the rejection of claims 2 and 3 under 35 U.S.C. § 103(a) as
obvious over Toye, McNeirney, Christopher, and Clark.

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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