Ex Parte Gencheff

Patent Trials and Appeals Board

Mar 25, 2019

14531482 - (D) (P.T.A.B. Mar. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/531,482 11/03/2014 Nelson E. Gencheff
32116 7590 03/27/2019
WOOD, PHILLIPS, KATZ, CLARK & MORTIMER
500 W. MADISON STREET
SUITE 1130
CHICAGO, IL 60661
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
GEN10708P00112US 3682
EXAMINER
LUONG, PETER
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
03/27/2019 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):
docketing@woodphillips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NELSON E. GENCHEFF 1
Appeal2017-011544
Application 14/531,482
Technology Center 3700
Before ERIC B. GRIMES, TA WEN CHANG, and TIMOTHY G. MAJORS,
Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of controlling intravascular sheaths, which have been rejected as
indefinite, being in improper dependent form, anticipated, and/or obvious.
We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM-IN-PART.
STATEMENT OF THE CASE
"Sheaths ... are commonly directed into different vessels [in] human
bodies to assist the performance of different medical procedures. In certain
portions of the human vessel network, sheaths are required to follow a
1 Appellant identifies the Real Party in Interest as Frontier Medical Devices,
Inc. (Appeal Br. 1.)
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Application 14/531,482
circuitous route to their target location. This may make sheath manipulation
difficult." (Spec. ,r 3.) The invention relates to "a method of controlling the
introduction and withdrawal of such sheaths" by using a guide assembly that
may be directed into the passageway of the sheath. (Id. ,r,r 2, 5.)
Claims 1-26 are on appeal. Claims 1 and 14 are illustrative and
reproduced below:
1. A method of controlling intravascular sheaths, the
method comprising the steps of:
a) obtaining a guide assembly comprising a body with a
tubular wall bounding a passageway, the body having a central
axis and a length between axially spaced ends, the body having
an outer surface that tapers towards each of the spaced ends, the
body flexible at each of the spaced ends to allow the spaced
ends to bend in a direction transversely to the length of the
body;
b) directing the guide assembly into an operative state
within a human body vessel;
c) obtaining a first sheath having a tubular body
extending around a passageway and having a central axis;
d) relatively moving the guide assembly body and first
sheath to thereby direct the guide assembly body into the
passageway on the first sheath; and
e) with the guide assembly body directed into the
passageway on the first sheath and the guide assembly in the
operative state within the human body vessel, guidingly sliding
the first sheath lengthwise against the outer surface of the guide
assembly body to thereby one of: a) advance the first sheath
into the human body vessel; and b) withdraw the first sheath
from the human body vessel.
14. The guide assembly as recited in claim 1 and
configured to be usable to practice the method of claim 1.
(Appeal Br. 15, 18 (Claims App'x).)
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Application 14/531,482
The Examiner rejects claims 14--19 under 35 U.S.C. § 112(b) or
35 U.S.C. § 112 (pre-AIA), second paragraph, as being indefinite. (Ans. 2.)
The Examiner rejects claims 14--16 under 35 U.S.C. § 112(d) or
35 U.S.C. § 112 (pre-AIA), fourth paragraph, as being of improper
dependent form. (Ans. 3.)
The Examiner rejects claims 1, 2, 4--7, 12-19, and 23-26 under pre-
AIA 35 U.S.C. § I02(b) as being anticipated by Baxter. 2 (Ans. 3.)
The Examiner rejects claims 3, 8, 9, and 20 under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Baxter and Wynberg. 3 (Ans. 4.)
The Examiner rejects claims 10 and 11 under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Baxter and Wallace. 4 (Ans. 5.)
The Examiner rejects claims 21 and 22 under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Baxter and Heiman. 5 (Ans. 5.)
I.
Issue
The Examiner has rejected claims 14--19 as indefinite. The Examiner
finds that "[i]t is unclear as to what is included or excluded from" claim 14
because claim 14 fails to set forth any transitional phrases and refers back to
claim 1, a method claim. (Ans. 2.) The Examiner finds that, because
"[c]laim 1 recites a method using a guide assembly and sheath [that] interact
in specific ways" and claim 14 "fails to set forth what structure is included
2 Baxter et al., US 2005/0222558 Al, published Oct. 6, 2005.
3 Wynberg, US 2012/0203064 Al, published Aug. 9, 2012.
4 Wallace et al., US 2007/0197939 Al, published Aug. 23, 2007.
5 Heiman, US 2014/0039264 Al, published Feb. 6, 2014.
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Application 14/531,482
and excluded, it is unclear as to how the guide assembly can perform the
recited steps which require the interaction of the sheath." (Id. at 6.)
Appellant contends that "it is not understood what is indefinite with
respect to the scope of claim 14." (Appeal Br. 4.)
Appellant does not separately argue the claims. We therefore limit
our analysis to claim 14 as representative. The issue with respect to this
rejection is whether the Examiner erred in concluding that claim 14 is
indefinite.
Analysis
We agree with the Examiner that claim 14 is indefinite. Claim 14
claims the guide assembly "as recited" in claim 1 and "configured to be
usable to practice the method of claim 1." (Claims App'x 18.) Claim 1,
however, is a method claim that recites not only the structure of the guide
assembly but also a method of using the guide assembly. It is unclear
whether a guide assembly "as recited" in claim 1 encompasses only the
structural elements of the guide assembly described in step (a) of claim 1, or
whether it also encompasses how the guide assembly is used as recited in
claim 1. See, e.g., 35 U.S.C. § 112 (pre-AIA), ,r 4 (stating that "[a] claim in
dependent form shall be construed to incorporate by reference all the
limitations of the claim to which it refers"). Moreover, to the extent that
claim 14 encompasses both the guide assembly (i.e., a product) and a method
of using the product, the claim is further indefinite because it combines two
separate statutory classes of invention. IPXL Holdings, LLC v. Amazon.com,
Inc., 430 F.3d 1377, 1384 (Fed. Cir. 2005) (holding that a claim that "recites
both a system and the method for using that system ... does not apprise a
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Application 14/531,482
person of ordinary skill in the art of its scope ... and ... is invalid under
section 112, paragraph 2").
Accordingly, we affirm the Examiner's rejection of claim 14. Claims
15-19, which are not separately argued, fall with claim 14. 37 C.F.R.
§ 4I.37(c)(l)(iv).
II.
Issue
The Examiner has rejected claims 14--16 as being improper dependent
form for "failing to further limit the subject matter of the claim upon which
it depends, or for failing to include all the limitations of the claim upon
which it depends," because "[t ]he claims merely recite the same subject
matter as in claim 1 without further adding additional structure." (Ans. 3.)
Appellant contends that "claim 14 is an independent claim that recites
an apparatus used in the method of claim 1 -- not a method per se" and that
"if claim 14 were rewritten to recite each of the limitations of claim 1
relating to the apparatus, the rejection would not apply." (Appeal Br. 4--5.)
Appellant does not separately argue the claims. We therefore limit
our analysis to claim 14 as representative. The issue with respect to this
rejection is whether the Examiner erred in concluding that claim 14 is in
improper dependent form.
Analysis
We agree with the Examiner that claims 14--16 are in improper
dependent form. As the Examiner explained, "a claim in dependent form
shall contain a reference to a claim previously set forth and then specify a
further limitation of the subject matter claimed." Ans. 3 (quoting 35 U.S.C.
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112 (pre-AIA), ,r 4) (emphasis added). As discussed above, claim 14 claims
the guide assembly "as recited" in claim 1 and "configured to be usable to
practice the method of claim 1." (Appeal Br. 18 (Claims App'x).) Whether
claim 14 is construed to include only the structure of the guide assembly
recited in step (a) of claim 1, or to also include how the guide assembly is
used in claim 1, claim 14 does not specify "a further limitation" to the
subject matter claimed in claim 1. That is, if claim 14 includes only the
structure recited in step (a) of claim 1, claim 14 is broader and thus does not
further limit the subject matter of claim 1. If claim 14 includes how the
guide assembly is used in claim 1, it is at most coextensive in scope with
claim 1.
Appellant argues that "claim 14 is an independent claim that recites an
apparatus used in the method of claim 1 -- not a method per se." (Appeal
Br. 4.) We are not persuaded. As an initial matter, claim 14 contains a
reference to claim 1 and is thus at least facially in the form of a dependent
claim. 35 U.S.C. § 112 (pre-AIA) ,r 4 (stating that "a claim in dependent
form shall contain a reference to a claim previously set forth ... ").
Moreover, while we acknowledge that Appellant has at various times during
prosecution argued that claim 14 is an independent claim or in the form of
an independent claim (see, e.g., Amendment "A" and Statement of
Substance of Interview ("Amendment") 9 (Aug. 30, 2016); Amendment
under Rule 116 and Request for Reconsideration ("Request for
Reconsideration") 9-10 (Oct. 31, 2016); Pre-Appeal Brief Request for
Review ("Request for Review") 4 (Jan. 25, 2017)), throughout prosecution
Appellant has also treated claim 14 as a dependent claim. (See, e.g., BIB
Data Sheet ( describing the original claim set, which includes claim 14, as
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Application 14/531,482
containing only 1 independent claim (i.e., claim 1)); Amendment 10
( arguing that Baxter does not anticipate claim 14 because claim 14 is "based
directly ... upon claim 1 and recite[ s] further significant limitations to
further distinguish over Baxter"); Request for Reconsideration 10 (stating
with respect to the anticipation rejection that "Applicant will focus herein on
the two independent claims at issue - claims 1 and 23 ") ( emphasis added)).
Appellant also argues that, "if claim 14 were rewritten to recite each
of the limitations of claim 1 relating to the apparatus, the rejection would not
apply," and "the current form of claim 14 is proper to achieve this same
end." (Appeal Br. 4--5.)
We are not persuaded. We have explained above why the current
form of claim 14 is improper. As to Appellant's argument that claim 14
could be rewritten to render the rejection inapplicable, we note that we
review claims as they are drafted, not as how they might be amended. We
further note that a claim in improper dependent form is invalid even if "the
patentee was attempting to claim what might otherwise have been patentable
subject matter." Pfizer, Inc. v Ranbaxy Labs Ltd., 457 F.3d 1284, 1291-
1292 (Fed. Cir. 2006) (finding dependent claim that deals with non-
overlapping subject matter to be invalid even though the claim could have
been properly drafted as an independent claim and stating that courts
"'should not rewrite claims to preserve validity"').
Accordingly, we affirm the Examiner's rejection of claim 14. Claims
15 and 16, which are not separately argued, fall with claim 14. 37 C.F.R.
§ 4I.37(c)(l)(iv).
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Issue
III.
The Examiner has rejected claims 1, 2, 4--7, 12-19, and 23-26 as
being anticipated by Baxter. The Examiner also rejects claims 3, 8, 9, and
20 as obvious over Baxter and Wynberg, claims 10 and 11 as obvious over
Baxter and Wallace, and claims 21 and 22 as obvious over Baxter and
Heiman. The same issues are dispositive for these rejections; we therefore
discuss them together.
The Examiner finds that Baxter discloses a method of using a guide
assembly having the same structure as that cited in claim 1. (Ans. 3--4.)
Appellant contends among other things that Baxter does not teach a
guide assembly comprising a "body with an outer surface that tapers towards
each of its spaced ends" and that "[i]t is not clear what degree of flexibility
is intended" for the structure in Baxter the Examiner appears to identify as
reading on the guide assembly. (Appeal Br. 7 .) Appellant further contends
that "Baxter does not teach a corresponding guide assembly and sheath that
are manipulated to cooperate in [the] specific manners" required by the
claims. (Reply Br. 2; see also Appeal Br. 8.)
The issues with respect to these rejections are whether a
preponderance of evidence of record supports the Examiner's finding that
Baxter teaches each of the limitations of claims 1 and 23 arranged in the
same way as recited in the claims.
Analysis
Claims 14--19 and 22
As discussed above, we find claim 14 to be indefinite. Thus, we do
not reach the merits of the anticipation rejection as to claim 14. Cf In re
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Steele, 305 F .2d 859, 862---63 (CCP A 1962) ( explaining that obviousness
rejection should not be based on "speculations and assumptions" as to the
scope of the claim where "substantial confusion exists ... as to the proper
interpretation to be given to the ... claim[]"). Because claims 15-19 and 22
depend directly or indirectly from claim 14, we likely do not reach the
merits of the anticipation rejection as to claims 15-19 and the obviousness
rejection as to claim 22. 6
Claims 1-13, 20, 21, and 23-26
We agree with Appellant that the Examiner has not established a
prima facie case that Baxter anticipates claims 1 and 23. Claim 1 is a
method claim that requires a step of "guidingly sliding [a] first sheath
lengthwise against the outer surface of the guide assembly body to thereby
... a) advance the first sheath into the human body vessel; [or] b) withdraw
the first sheath from the human body vessel." (Appeal Br. 15 (Claims
App'x).) Likewise, claim 23 is a method claim that requires a step of either
(1) "guidingly sliding [a] first sheath lengthwise against the outer surface of
the guide assembly body ... to thereby withdraw the first sheath from the
human body vessel" or (2) with the guide assembly maintained in a first
position "wherein one of the ... ends of the guide assembly body is adjacent
to a target location," moving the guide assembly into the passageway of a
first sheath and "thereafter guidingly sliding the first sheath lengthwise
against the outer surface of the guide assembly body to thereby situate an
6 The Examiner did not include claim 22 in the indefiniteness rejection.
Nevertheless, because claim 22 depends from claim 14, which we find to be
indefinite, we also do not reach the merits of the obviousness rejection of
claim 22 for the reasons articulated in In re Steele, 305 F .2d at 862.
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end of the first sheath adjacent to the target location." (Id. at 19-20 (Claims
App'x).) As further discussed below, the Examiner has not established that
Baxter teaches such relative movements of the guide assembly and sheath to
advance or withdraw the sheath from a human body vessel.
Baxter teaches "deflectable sheath catheters includ[ing] a deflectable
tip section at a distal end and having a varying stiffness along at least a
portion of the distal tip section which allows the deflectable tip to deflect
along a compound curve." (Baxter ,r 16.) Baxter further teaches that the
catheter may be used to "provide access and delivery of ablation
instruments, medications, or fluids into the heart" for purposes of treating
atrial fibrillation, and that the catheter "can further include a stiffening
element ( e.g., a dilator) which is initially deployed within the catheter body
to assist in passing the catheter to the target region." (Id. ,r,r 4, 18; see also
id. ,I,I 131-132, Fig. 10.)
In response to the Appeal Brief, the Examiner appears to point to the
dilator as the guide assembly and to the deflectable sheath catheter as the
first sheath recited in claims 1 and 23. (Ans. 6-7.) The Examiner asserts
that paragraph 131 of Baxter teaches "the guide assembly being passed into
the catheter ... wherein the guide assembly is slid along [a] catheter and a
guidewire." (Id. at 7.)
Paragraph 131 of Baxter is reproduced below:
A variety of devices can be used with the catheter described
herein such as a dilator or an ablation instrument. FIG. 10 shows
one embodiment of the catheter including a dilator 150. The
dilator 150 can have any configuration that allows it to be passed
through the catheter and over a guide wire and into the heart,
however, as shown the dilator 150 has proximal and distal ends
149, 151, and can include a central lumen 152 formed therein.
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Application 14/531,482
The central lumen 152 can have any shape and size, such as
circular, ovular or oblong, however here the central lumen 152
corresponds in shape to the shape of the catheter (e.g., is ovular),
and is adapted to fit snugly within the central lumen of the
deflectable sheath catheter, allowing easy insertion of an atrial
septum puncture instrument through the vasculature. One skilled
in the art will appreciate that the close fitting nature of the dilator
150 within the deflectable catheter can prevent the tip 30 of the
deflectable catheter from prolapsing if axial forces are
encountered crossing the atrial septal puncture site.
(Baxter ,r 13 1.)
While paragraph 131 of Baxter does describe passing the dilator (i.e.,
the "guide assembly") "through the catheter and over a guide wire and into
the heart," it does not teach advancing or withdrawing the catheter (i.e., the
"first sheath") into or from a human body vessel, or situating an end of the
catheter adjacent to a target location, via the passage of the dilator through
the catheter, as required by claims 1 and 23. 7
Citing paragraphs 12 and 18 of Baxter, the Examiner asserts that
"advancing/withdrawing the sheath are normal operation procedures (i.e.,
performed by using the instrument in a procedure)" and that "removing
sheaths and replacing with another is common practice in the art." (Ans. 7.)
The Examiner also relies on paragraph 18 to argue that Baxter "discloses
moving the guide assembly body and the sheath relative to each other and
guidingly sliding the sheath lengthwise against the guide assembly to situate
7 Although "whereby" or "thereby" clauses "that merely states[ s] the result
of the limitations in the claim add[] nothing to the patentability or substance
of the claim," Texas Instruments Inc. v. U.S. Int'! Trade Comm 'n, 988 F.2d
1165, 1172 (Fed. Cir. 1993), the Examiner has not made any findings or
provided any analysis that the thereby clauses in claims 1 and 23 merely
state the result of the other limitations in the claims.
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the sheath adjacent to the target location." (Id. at 8.) In particular, the
Examiner argues that paragraph 18 teaches that the dilator (i.e., the guide
assembly) can "subsequently be removed and partially retracted" from the
catheter (i.e., the first sheath), and "removing or partial retraction [is
interpreted to mean] moving/sliding the guide assembly and the sheath
relative to/against each other." (Id.)
The relevant portion of paragraph 12 of Baxter explains that
"[ c ]urrently methods to address th[ e] issue [ of catheters being unable to
make tight turns to reach a target region without causing trauma to a patient]
include using a set of sheath catheters with different curves and removing
one catheter and replacing it with another, several times." (Baxter ,r 12.)
The relevant portion of paragraph 18 of Baxter states:
Another aspect of the present invention can include a
deflectable sheath catheter having an elongate catheter body with
proximal and distal ends such that the catheter body has at least
two segments along its length, with at least one segment having
a different stiffness. . . . The catheter can further include a
stiffening element (e.g., a dilator) which is initially deployed
within the catheter body to assist in passing the catheter to the
target region. The stiffening element or dilator can subsequently
be removed or partially retracted.
(Id. ,I 18.)
While these paragraphs teach that sheaths may be advanced and
withdrawn during medical procedures, neither teaches advancing and
withdrawing the sheaths by "sliding the ... sheath ... against the outer
surface of the guide assembly [(i.e., dilator)] body." Neither do we agree
that a teaching that the dilator/guide assembly may be removed or partially
retracted after the catheter/sheath has reached the target region constitutes a
teaching of "sliding the sheath lengthwise against the guide assembly to
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situate the sheath adjacent to the target location," as the Examiner appears to
assert. (Ans. 8.)
[U]nless a [prior art] reference discloses within the four comers
of the document not only all of the limitations claimed but also
all of the limitations arranged or combined in the same way as
recited in the claim, it cannot be said to prove prior invention of
the thing claimed and, thus, cannot anticipate under 35 U.S.C.
§ 102.
Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).
For the reasons discussed above, the Examiner has not established that
Baxter discloses all of the limitations claimed arranged or combined in the
same way as recited in claims 1 and 23. Thus, we reverse the Examiner's
rejection of claims 1 and 23 as anticipated by Baxter.
For the same reasons, we also reverse the Examiner's rejection of
claims 2, 4--7, 12, 13, and 24--26, which depend directly or indirectly from
claims 1 and 23. Finally, the Examiner relies on Wynberg, 8 Wallace, and
8 The Examiner does assert in the Answer that "Wynberg discloses
interchanging different sheaths while leaving a guiding apparatus in place"
and thus meets the limitation in claim 3 of "withdraw[ing] the first sheath
from the human body vessel while leaving the guide assembly in its
operative state and further ... obtaining a second sheath ... and ...
guidingly sliding the second sheath lengthwise against the outer surface of
the guide assembly body ... to thereby advance the second sheath into the
human body vessel." (Ans. 8.) While such teaching may also disclose
advancing or withdrawing a first sheath from the human body vessel, as
recited in claims 1 and 23, the Examiner provides no sufficient reason why a
skilled artisan would use the dilator (the asserted guide assembly) in Baxter
in the same manner that "the guiding apparatus" (i.e., puncture wire) is used
in Wynberg, stating only that "it would have been obvious to one of ordinary
skill in the art to have provided Baxter et al. with a second sheath as taught
by Wynberg as it is well known to use a second sheath in order to exchange
devices." (Id. at 4.) "[R]ejections on obviousness grounds cannot be
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Heiman only for disclosure of certain dependent claim limitations. (Ans. 4--
5, 8-9.) Thus, the citation to these references in the obviousness rejection
does not remedy the deficiencies with respect to Baxter in the Examiner's
prima facie case. According, we also reverse the Examiner's rejection of
claims 3, 8, 9, and 20 as obvious over Baxter and Wynberg, claims 10 and
11 as obvious over Baxter and Wallace, and claim 21 as obvious over Baxter
and Heiman.
SUMMARY
For the reasons above, we affirm the Examiner's rejection of claims
14--19 as indefinite. We also affirm the Examiner's rejection of claims 14--
16 as being in improper dependent form. We reverse the Examiner's
rejection of claims 1, 2, 4--7, 12, 13, and 23-26 as anticipated by Baxter.
We also reverse the Examiner's rejection of claims 3, 8, 9, and 20 as obvious
over Baxter and Wynberg, claims 10 and 11 as obvious over Baxter and
Wallace, and claim 21 as obvious over Baxter and Heiman. We do not reach
the merits of the Examiner's rejection of claims 14--19 as anticipated by
Baxter or the Examiner's rejection of claim 22 as obvious over Baxter and
Heiman.
sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007) (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)).
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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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