Ex Parte Chuter et al

Patent Trial and Appeal Board

Oct 25, 2017

13286407 (P.T.A.B. Oct. 25, 2017)

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.
13/286,407 11/01/2011 Timothy A. Chuter 12730/761 (PA-6723-RFB) 4826
48003 7590 10/26/2017
ROT JCnnk - PTiiraan EXAMINER
PO BOX 10395
CHICAGO, IL 60610
DUKERT, BRIAN AINSLEY
ART UNIT PAPER NUMBER
3738
MAIL DATE DELIVERY MODE
10/26/2017 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 TIMOTHER A. CHUTER, BLAYNE A. ROEDER,
SHARATH GOPALAKRISHNAMURTHY, and ALAN R.
LEEWOOD
Appeal No. 2015-003567
Application No. 13/286,407
Technology Center 3700
Before: PATRICK R. SCANLON, BEVERLY M. BUNTING, and
GORDON D. KINDER, Administrative Patent Judges.
BUNTING, Administrative Patent Judge.
DECISION ON APPEAL
Appeal 2015-003567
Application 13/286,407
STATEMENT OF CASE
Timothy A. Chuter et al. (“Appellants”)1 seek our review under 35
U.S.C. § 134 of the Examiner’s decision, as set forth in the Final Office
Action, dated September 24, 2013 (“Final Act.”), rejecting pending claims 1,
2, and 5—20. We have jurisdiction under 35 U.S.C. § 6(b). An oral hearing
was conducted on June 13, 2017.
We AFFIRM.
CFAIMED SUBJECT MATTER
The claims are directed to an implantable medical device for the
repair of a damaged aortic valve. Spec. 12. Claims 1, 9, and 15 are
independent. Claim 1, reproduced below, is illustrative of the claimed
subject matter:
1. A medical device for implantation in a patient, the
medical device comprising:
a stent comprising:
a proximal region comprising a cylindrical shape having
a first outer diameter when the stent is in an expanded
state;
a distal region comprising a cylindrical shape having a
second outer diameter when the stent is in the
expanded state, where the second outer diameter is
greater than the first outer diameter;
a tapered region disposed between the proximal and
distal regions, where the tapered region transitions the
stent from the first diameter to the second diameter;
a valve coupled to at least a portion of the stent, the valve
having proximal and distal regions, where the proximal
region of the valve is at least partially positioned within
the proximal region of the stent and the distal region of
1 Appellants identity Cook Medical Technologies LLC as the real party in
interest. Appeal Br. 1.
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the valve is at least partially positioned within one of the
tapered and distal regions of the stent;
a plurality of closed cells disposed around the perimeter of
the proximal region of the stent, and another plurality of
closed cells disposed around the perimeter of the distal
region of the stent,
where the tapered region further comprises a plurality of
closed cells, where an overall length of each of the closed
cells of the tapered region is greater than an overall
length of each of the closed cells of the proximal region
of the stent and less than an overall length of each of the
closed cells of the distal region of the stent when the stent
is in the expanded state.
Appeal Br. 29.
REFERENCES
The Examiner relies on the following prior art references in rejecting
the claims on appeal:
Nguyen US 2006/0265056 A1
McGuckin, JR. US 2008/0039891 A1
Tuval US 2010/0094411 A1
Ku US 2012/0053676 A1
REJECTIONS
Appellants seek our review of the following rejections:
Claims 1, 2, 6, 9, 10, 12, and 14 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Nguyen. Final Act. 5.
Claims 5,11, and 15—18 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Nguyen. Id. at 7.
Claim 7 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
Nguyen and Ku. Id. at 8.
Nov. 23, 2006
Feb. 14, 2008
Apr. 15,2010
Mar. 1,2012
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Claims 8 and 20 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Nguyen and Tuval. Id. at 9.
Claims 13 and 19 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Nguyen and McGuckin. Id.
OPINION
Anticipation Based on Nguyen
Claims 1 and 9
As to independent claims 1 and 9, the Examiner finds that Nguyen
discloses each of the limitations of the medical device for implantation in a
patient set forth in claim 1, including, inter alia, a proximal region having a
first outer diameter in an expanded state; a distal region having a second
outer diameter in the expanded state, the second diameter being greater than
the first outer diameter; a tapered region disposed between the proximal and
distal regions; and a valve coupled to a portion of the stent. Final Act. 5—6.
The Examiner annotated Figure 6 of Nguyen, reproduced below, to illustrate
how Nguyen discloses
a plurality of closed cells (fig 6) disposed around the perimeter
of the proximal, tapered, and distal regions of the stent, wherein
each closed cell has an overall length (shown), where an overall
length of each of the closed cells of the tapered region (shown)
is greater than an overall length of each of the closed cells of
the proximal region (shown) of the stent and less than an
overall length of each of the closed cells of the distal region
(shown) of the stent when the stent is in the expanded state.
Id. at 6.
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Figure 6 is a side view of the valve prosthesis of Nguyen,
as annotated by the Examiner. Id. at 5.
Appellants challenge the Examiner’s position that “[t]he lengths of the
cells in the distal region are clearly larger than those of the tapered region,
which are clearly larger than those in the proximal region, in the expanded
state.” Appeal Br. 18 (citing Final Act. 3); See Reply 3—6. According to
Appellants, the Examiner erroneously relies on his own measurements of
Figure 6 because Nguyen does not disclose lengths of the closed cells in any
of the proximal, tapered or distal regions and Nguyen doesn’t state that its
figures are to scale. Id. at 19; Reply 4—6. Appellants support their
arguments with citations to case law, the Manual of Patent Practice and
Procedure (M.P.E.P.), and prior Board decisions.2 Id. at 18—20; Reply 3—6.
2 Appellants’ arguments directed to the MPEP and prior Board decisions are
not controlling. “While the MPEP does not have the force of law, it is
entitled to judicial notice as an official interpretation of statutes or
regulations as long as it is not in conflict therewith.” Molins PLC v. Textron,
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Additionally, Appellants view the statements in Nguyen regarding
“relatively larger cells” as only referring to greater width and not length. Id.
Noting that the length of each contracted closed cell in Nguyen is initially
about the same, Appellants argue that when expanded, “the closed cells at
outflow section 15 may increase in width while becoming smaller in axial
length relative to the other cells. In any event, this text of Nguyen does not
teach or suggest different lengths at three separate regions.'''’ Id. at 20.
Turning to the language of claim 1, we observe that cell length is not
defined absolutely, rather using relative language. We give the claims the
broadest reasonable interpretation consistent with the specification, as we
must. Thus, we interpret “overall length of each of the closed cells of the
tapered region is greater than an overall length of each of the closed cells of
the proximal region . . . and less than an overall length of each of the closed
cells of the distal region” (Appeal Br. 29), as defining the overall length of
the closed cells in the tapered region relative to the overall length of the
closed cells in the proximal region (i.e., greater than) and the distal region
(i.e., less than).
Appellants’ arguments concerning the lack of disclosure in Nguyen
regarding whether Figure 6 is drawn to scale are not convincing. As an
initial matter, we note that “a reference must be considered not only for what
it expressly teaches, but also for what it fairly suggests.” In re Bell, 991 F.
2d 781, 785 (Fed. Cir. 1993) {quoting In reBurckel, 592 F.2d 1175, 1179
(CCPA 1979)). At the same time, our reviewing court also informs us that
when the reference does not disclose that the drawings are to scale and is
silent as to dimensions, arguments based on measurement of the drawing
Inc., 48 F.3d 1172, 1180 n.10 (Fed. Cir. 1995). Moreover, the cited Board
decisions are not precedential.
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features may be of little value. See Hockerson-Halberstadt, Inc. v. Avia
Group Inti, 222 F.3d 951, 956 (Fed. Cir. 2000) (“[I]t is well established that
patent drawings do not define the precise proportions of the elements and
may not be relied on to show particular sizes if the specification is
completely silent on the issue.” (emphases added)).
Contrary to Appellants’ contentions, however, the Examiner is not
relying on Figure 6 for “precise proportions” or “particular sizes.” Instead,
the Examiner has provided “more” (contra Reply Br. 4) by annotating
Figure 6 and explaining how these annotations satisfy the corresponding
claim limitations. Specifically, the Examiner relies on his annotated version
of Figure 6 in identifying the distal, tapered and proximal regions, and the
relative cell length of cells in each of these regions. Ans. 3^4. Appellants’
general argument regarding the use of drawings (Reply Br. 3—6) does not
inform us of error in the Examiner’s assertion that “it would be clear to one
of ordinary skill that the cell lengths (represented by LI, L2 and L3) are
obviously varying in length such that cells of the distal regions (LI) are
longer than the cells of the tapered regions (L2), which are in turn larger
than the cells of the proximal region (L3).” Ans. 3^4.
To support of its contention that Nguyen does not disclose cells
having different lengths at three separate regions, Appellants argue that
Nguyen describes how the closed cells at outflow section 15 increase in
width while becoming smaller in axial length. Appeal Br. 20 (citing Nguyen
11 52, 81, Figure 2). Our review of these passages reveals a disclosure
concerning “the use of relatively larger cells in the outflow section of frame
12” (Nguyen 1 52) and that “outflow section 15 of frame 12 employs
relatively larger cells than the remainder of the frame” {id. at 1 81). As such,
the Examiner reasonably responds that the cell size depends on strut length,
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and “[a]s lengths of the outflow section (annotated as ‘distal region’) stmts
are the only variable accounting for a change in cell size, a ‘relatively larger’
cell size in the outflow section must comprise an increase in the stmt
length.” Ans. 4. Appellants do not challenge this response. {See generally,
Reply Br. 3—6).
Thus, Appellants arguments and evidence do not persuade us that the
Examiner’s findings regarding claim 1 are in error, and we sustain the
Examiner’s rejection of claim 1 under 35 U.S.C. § 102(b).
Claim 9
As to independent claim 9, the Examiner relies on the findings for
claim 1. Final Act. 3. Appellants counter that the Examiner erred by not
addressing claim 9. Appeal Br. 20-21; Reply Br. 6—7. Specifically, because
“claim 1 recites lengths of closed cells in a given region relative to each
other, claim 9 differently recites ‘each closed cell has an overall length,
when the stent is in the expanded state, that is greater than a length of every
other closed cell that is disposed yroximally thereof. ’” Appeal Br. 21.
Notwithstanding this assertion, Appellants rely on the arguments provided
with respect to claim 1. Id.', Reply Br. 6—7.
The Examiner disagrees, arguing that annotated Figure 6 shows that
each individual cell in either the distal and/or tapered region has a length that
is greater than a length of every other cell(s) disposed proximally thereof.”
Ans. 4—5. In turn, Appellants argue that “proportions of features in a
drawing are not evidence of actual proportions when drawings are not to
scale.” Reply Br. 7 (citations omitted).
For the same reasons discussed above with respect to claim 1,
Appellants’ unpersuasive argument regarding the use of drawings does not
inform us of error in the Examiner’s assertion that annotated Figure 6 shows
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how “each individual cell in either the distal and/or tapered region has a
length that is greater than a length of every other cell(s) disposed proximally
thereof.” Ans. 4—5. Nor do Appellants apprise us of error in the Examiner’s
assertion that in annotated Figure 6, “said proximal region is finite with
distinct borders (as drawn). Any additional structure beyond said region is
not considered in the rejection. The examiner notes that the use of the
transitional phrase ‘comprising’ in the preamble is open-ended and allows
for additional structure beyond the annotated proximal region.” Ans. 5.
Because we found no such shortcomings in Nguyen as described
hereinabove, we are not persuaded of Examiner error and we sustain the
Examiner’s rejection of claim 9 under 35 U.S.C. § 102(b).
Dependent Claims 2, 6, 10, 12, and 14
Claims 2 and 6 depend from independent claim 1, and claims 10, 12,
and 14 depend from independent claim 9. App. Br. 29-32. Appellants
present no separate arguments or reasoning for these claims. See Id. at 18—
21. For the foregoing reasons, we also sustain the Examiner’s rejections of
claims 2, 6, 10, 12, and 14 under 35 U.S.C. § 102(b).
Obviousness Based on Nguyen
Claim 15
Independent claim 15 is similar to claim 1, and further recites in
relevant part that “the plurality of closed cells of the proximal region of the
stent comprise a higher radial force relative to the plurality of closed cells of
the distal region of the stent when the stent is in the expanded state.” Appeal
Br. 32—33. Observing that Nguyen does not specifically disclose this
limitation, the Examiner maintains that Nguyen teaches the structural
limitations as shown for claims 1 and 9 and further finds that because “[t]he
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higher radial force is a structurally-dependent property and absent any
additional structural characteristics/limitations, it is reasonably deemed as
inherent to the device.” Final Act. 7—8. The Examiner further reasons that,
alternatively, “it would have been obvious to one having ordinary skill in the
art to provide a higher radial force in the proximal region to enhance the
anchoring and expansion capabilities of the implanted device.” Id. at 8.
Appellants argue that the Examiner has not established inherency.
Appeal Br. 22 (citing In re Robertson, 169 F.3d 743, 745, 49 USPQ2d 1949,
1950-51 (Fed. Cir. 1999)). In the Reply, Appellants convincingly argue that
the Examiner’s reliance on U.S. Patent No. 5,938,697 to Killion in the
Answer is “untimely.” Reply 7—8 (See Ans. 6 “Therefore, the examiner
believes there is sufficient evidence and structure in the Nguyen reference to
support a rejection wherein the radial force in the proximal region is
inherently higher than in the distal region. This argument is predicated on
the well-known fact that in stent construction, a stent portion/segment that
is expanded to fill the cavity of a larger diameter vessel will have less radial
force due to its expanded state. This concept is further evidenced by Killion
et al. (US 5,938,697); force provided would be greater in a smaller
diameter than in the larger diameter'' (Column 2: lines 13—14)).”
Nonetheless, as discussed above, we determine that Nguyen discloses
that the lengths of cells in the distal region are larger than those of the
tapered region, which are larger than those in the proximal region, in the
expanded state. Appellants’ argument — “the mere fact that a different
radial force at the proximal region versus the distal region may result from
the given set of circumstances” (Appeal Br. 22) is not sufficient reasoning or
evidence explaining why this additional finding of the Examiner is in error.
Specifically, Appellants have not explained the error in the Examiner’s
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finding that Nguyen’s stent inherently possesses a higher radial force in the
proximal region relative to the distal region because radial force is a
structurally-dependent property. Final Act. 7—8; Ans. 6—7. Indeed, once a
prima facie case of unpatentability has been established, the burden shifts to
the Appellant to prove that the prior art product does not necessarily or
inherently possess the characteristics of the claimed product. In re Best, 562
F.2d 1252, 1255 (CCPA 1977) (“Where, as here, the claimed and prior art
products are identical or substantially identical, or are produced by identical
or substantially identical processes, the PTO can require an applicant to
prove that the prior art products do not necessarily or inherently possess the
characteristics of his claimed product.”). See also In re Spada, 911 F.2d
705, 708-09 (Fed. Cir. 1990).
Next, Appellants challenge the articulated reasoning provided by the
Examiner, i.e., that one of skill in the art would provide a higher radial force
in the proximal region to enhance the anchoring and expansion capabilities
of the implanted device. Appeal Br. 22—24; Reply 7—9. Appellants argue
that the Examiner’s articulated reasoning is speculative because “the
Examiner does not cite to any portion of Nguyen, or any other reference
whatsoever, to support this broad assertion.” Id. at 22—23.
We are not persuaded by Appellants’ arguments.3 Our reviewing
courts inform us that it is not sufficient to demonstrate that each of the
components is known. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418
(2007) (“a patent composed of several elements is not proved obvious
3 Appellants’ arguments directed to the MPEP are likewise unavailing.
“While the MPEP does not have the force of law, it is entitled to judicial
notice as an official interpretation of statutes or regulations as long as it is
not in conflict therewith.” Molins PLC v. Textron, Inc., 48 F.3d 1172, 1180
n. 10 (Fed. Cir. 1995).
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merely by demonstrating that each of its elements was, independently,
known in the prior art”). The Examiner must also explain how a person of
ordinary skill in the art would combine those embodiments, and why such a
person would be motivated to do so. See, e.g., In re Chaganti, 554 F. App’x
917, 922 (Fed. Cir. 2014) (“It is not enough to say that... to do so would
‘have been obvious to one of ordinary skill. ’ Such circular reasoning is not
sufficient—more is needed to sustain an obviousness rejection.”). Indeed,
this articulated reasoning must include some rational underpinning to
support the legal conclusion of obviousness. See KSR, 550 U.S. at 418
(citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)).
Appellants’ assertion that the Examiner’s proffered reasoning lacks
rational underpinnings, i.e., because the Examiner does not cite Nguyen or
another reference for support, is unavailing. It is well settled that “[a]
suggestion, teaching, or motivation to combine the relevant prior art
teachings does not have to be found explicitly in the prior art, as the
teaching, motivation, or suggestion may be implicit from the prior art as a
whole, rather than expressly stated in the references.” Kahn, 441 F.3d at
987. Here, the Examiner’s stated rationale for providing a higher radial
force in the proximal region (i.e., to enhance the anchoring and expansion
capabilities of the implanted device) is supported by technical reasoning as
to why one of ordinary skill in the art would be led to make the proposed
modification. Final Act. 4. Appellants’ arguments do not convince us that
this rationale is not implicit from the prior art as a whole.
For the foregoing reasons, we are not persuaded that the Examiner
erred in concluding that the Nguyen renders obvious the subject matter of
independent claim 15, and we sustain the rejection of independent claim 15.
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Dependent Claims
Claims 5,11, and 16—18 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Nguyen. Final Act. 7. Claim 7 stands rejected under 35
U.S.C. § 103(a) as unpatentable over Nguyen and Ku. Id. at 8. Claims 8
and 20 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Nguyen
and Tuval. Id. at 9. Claims 13 and 19 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Nguyen and McGuckin. Id.
Appellants rely on the same arguments relating to the alleged
shortcomings of Nguyen alone, as well as in combination with one of Ku,
Tuval or McGuckin, respectively. See Appeal Br. 24—27; Reply Br. 8—9.
Because we found no such shortcomings in Nguyen as described
hereinabove, we are not persuaded of Examiner error and we sustain the
Examiner’s rejections of claims 5, 7, 8, 11, 13, 16—20 under 35 U.S.C.
§ 103(a).
DECISION
For the above reasons, the Examiner’s rejection of claims 1,2, and 5—
20 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv) (2009).
AFFIRMED
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