John Connors et al.

Patent Trials and Appeals Board

Jan 6, 2021

2020001754 (P.T.A.B. Jan. 6, 2021)

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.
10/831,813 04/26/2004 John J. Connors III 8627/211 (PA-5406-RFB) 1646
48004 7590 01/06/2021
BGL/Cook - Indianapolis
BRINKS GILSON & LIONE
P.O. BOX 10395
Chicago, IL 60610
EXAMINER
WEISBERG, AMY REGINA
ART UNIT PAPER NUMBER
3649
MAIL DATE DELIVERY MODE
01/06/2021 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 JOHN J. CONNORS III,
CHRISTOPHER G. DIXON, and
RAY LEONARD II

Appeal 2020-001754
Application 10/831,813
Technology Center 3600
Before BRETT C. MARTIN, ANNETTE R. REIMERS, and
MICHAEL L. WOODS, Administrative Patent Judges.
WOODS, Administrative Patent Judge.
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Application 10/831,813

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DECISION ON APPEAL
STATEMENT OF THE CASE1
Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the
Examiner’s decision to reject claims 1–10, 14, 16, 18, 20–26, 30, and 33–36.
See Appeal Br. 1. Claims 11–13, 15, 17, 19, 27–29, 31, and 32 are
cancelled. Id. at 56–60 (Claims App.). An oral hearing was held on
December 15, 2020. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
CLAIMED SUBJECT MATTER
The application is titled “Flexible Sheath with Varying Durometer.”
Spec. 1. Claims 1, 22, and 34 are independent. Appeal Br. 54–60 (Claims
App.). Claim 1, reproduced below with emphasis added to a limitation
central to our analysis, is illustrative of the claimed subject matter:
1. A flexible, kink-resistant introducer sheath, said sheath
having a proximal end and a distal end, comprising:
an inner tube having a passageway extending
longitudinally therethrough, said passageway having a
substantially uniform diameter;
a coil comprising a plurality of turns positioned
longitudinally around said inner tube, said turns having a
predetermined spacing therebetween; and

1 The subject application was previously before the Patent Trial and Appeal
Board in Appeal No. 2013-003068. See Decision dated September 29, 2015.
In that Decision, the adverse decision of the Examiner was AFFIRMED.
Following that Decision, Appellant reopened prosecution and further
amended the claims.
2 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as Cook Medical
Technologies, LLC. Appeal Br. 4.
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an outer tube positioned longitudinally around said coil
and said inner tube and connected to said inner tube through the
spaces between said turns, said outer tube having a diameter of
greater than 5 French, and said outer tube comprising a plurality
of tube segments aligned in order of decreasing durometer from
said proximal end to said distal end, said plurality of segments
comprising a major segment of higher durometer comprising at
least 75% of the length of the outer tube, and three minor
segments of lower durometer; and
wherein the three minor segments are sized to access the
common carotid, a most-distal minor segment of the three minor
segments having a length of 3.2 cm and a durometer of between
20-30 on the Shore D Scale, a second-most-distal minor segment
being the longest of the three minor segments, the second-most-
distal minor segment having a length of 5 cm and a durometer of
between 35-45 on the Shore D Scale, wherein the second-most-
distal minor segment is immediately proximal from a most-distal
minor segment of the three minor segments, and a third-most-
distal minor segment of the three minor segments having a length
of 3 cm and a durometer of between 53-63 on the Shore D Scale,
wherein the third-most-distal minor segment is immediately
proximal from the second-most-distal minor segment.
Id. at 54 (Claims App.) (emphasis added).
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Pinchuk US 4,960,410 Oct. 2, 1990
Nita US 5,951,539 Sept. 14, 1999
Chow US 6,171,296 B1 Jan. 9, 2001
Parker US 2002/0032408 A1 Mar. 14, 2002
Hewitt US 2004/0153049 A1 Aug. 5, 2004

REJECTIONS
The following rejections are before us on appeal:
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(1) Claims 1–10, 14, 16, 18, 20, and 34–36 stand rejected under 35
U.S.C. § 103(a) as unpatentable over Parker, Nita, and Hewitt.
(2) Claim 21 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Parker, Nita, Hewitt, and Chow.
(3) Claims 22, 23, 26, 30, and 33 stand rejected under 35 U.S.C. §
103(a) as unpatentable over Parker, Nita, Hewitt, and Pinchuk.
(4) Claims 24 and 25 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Parker, Nita, Hewitt, Pinchuk, and Chow.

OPINION
A. Issue
The issue before us is whether the Examiner committed reversible
error in failing to consider Appellant’s secondary consideration evidence.

B. Law Pertaining to Secondary Consideration Evidence
Whenever obviousness is found with respect to the subject matter on
appeal, and Appellant furnishes evidence of secondary considerations, it is
our duty to reconsider the issue of obviousness anew, carefully weighing the
evidence for obviousness with respect to the evidence against obviousness.
See, e.g., In re Eli Lily & Co., 902 F.2d. 943, 945 (Fed. Cir. 1990). To be
given substantial weight in the determination of obviousness or
nonobviousness, evidence of secondary considerations must be relevant to
the subject matter as claimed, and therefore we must determine whether
there is a nexus between the merits of the claimed invention and the
evidence of secondary considerations. Ashland Oil, Inc. v. Delta Resins &
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Refractories, Inc., 776 F.2d 281, 305 n.42 (Fed. Cir. 1985), cert. denied, 475
U.S. 1017 (1986).

C. Examiner’s Rejection
In rejecting all of the claims, the Examiner relies primarily on
Parker’s teaching of a sheath, but acknowledges that Parker doesn’t teach
the claimed “three minor segments,” each having various lengths and
material hardness, as measured by a durometer. See Final Act. 15 (rejecting
independent claim 1); see also id. at 21–22 (rejecting similar independent
claim 34); see also id. at 25 (rejecting similar independent claim 22). To
address the claimed “three minor segments,” the Examiner relies on Nita for
teaching “a known medical device wherein there are three minor segments”
with various lengths and hardness. See id. at 16 (claim 1); see also id. at 21–
22 (claim 34); see also id. at 26 (claim 22). In combining Parker with Nita,
the Examiner reasons that a skilled artisan would have modified Parker’s
sheath “to include three segments as taught by Nita . . . [for] kink resistance
and flexibility.” Id. at 16 (claim 1); see also id. at 22 (claim 34); see also id.
at 26 (claim 22).

D. Appellant’s Argument
Appellant’s primary argument is that “evidence of secondary
considerations outweighs the rejection for obviousness over Parker in view
of Nita and Hewitt.” Appeal Br. 11. In particular, Appellant relies on
evidence of commercial success and long felt, but unresolved, need. See id.
Appellant enters as evidence the following appendices along with its
Appeal Brief:
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(A) Appendix A (the “Brumleve Declaration” or “Brumleve Dec.”) –
The declaration testimony of John Anthony Brumleve, the
“Director of Business Development & Physician Societies
Corporate Liaison.” Brumleve Dec. ¶ 1.
(B) Appendix B (the “Bersin Declaration” or “Bersin Dec.”) – The
declaration testimony of Dr. Robert M. Bersin, a “physician with
33 years of experience in the field of medical procedures utilizing
endoluminal catheters and sheaths” who has “performed
endovascular procedures since 1986.” Bersin Dec. ¶¶ 1, 2.
(C) Appendix C (the “Connors Declaration” or “Connors Dec.”) – The
declaration testimony of Dr. John Joseph Connors, co-inventor of
the subject application and a “retired physician with 40 years of
experience in the field of medical procedures utilizing
endoluminal catheters and sheaths.” Connors Dec. ¶¶ 1, 3.
(D) Appendix D (“App. D”) – Comparative sales for the Flexor Shuttle
Guiding Sheath and the Flexor Shuttle Select Guiding Sheath.
(E) Appendix E (“App. E”) – “Shuttle Select™ System for Carotid
Artery Access” includes an image from the data sheet sold with
the Flexor Shuttle Select Guiding Sheath in 2004 demonstrating
certain specifications of the guiding sheath. Brumleve Dec. ¶ 8.
(F) Appendix F (“App. F”) – “Shuttle Select™ System Enhances
Access and Minimizes Device Exchanges” includes an image sole
with the Flexor Shuttle Select™ Guiding Sheath in 2004
demonstrating the method of operation for the sheath. Brumleve
Dec. ¶ 8.
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(G) Appendix G (“App. G”) – “Market Forecast Data” that projects
various stent procedures, by indication, including carotid, from
2016 to 2026, as prepared by the Millennium Research Group, Inc.
(H) Appendix H (“App. H”) – “U.S. Sales and Market Share of Flexor
Shuttle Select® Guiding Sheath for Carotid Access Stent
Procedures, 2006-2016.”

E. Examiner’s Answer
In response to Appellant’s commercial success evidence, the
Examiner states, “Regarding commercial success, the success must be linked
to the claimed invention and not some extraneous factor such as advertising,
brand name recognition, or market share. Appellant has provided no
evidence to address these factors.” Ans. 5–6.
In response to Appellant’s long-felt need evidence, the Examiner
states,
Regarding long felt need, Appellant has not provided any
evidence. A proper showing of long-felt need should include
evidence of three factors: the need recognized by those of
ordinary skill in the art and not have been satisfied by another
before the invention by Appellant, the invention must in fact
satisfy the long-felt need, and evidence must show unsuccessful
efforts to solve the problem. Appellant has not provided anything
more than the opinion of the inventors.
Id. at 6–7 (emphases added).

F. Analysis
The Examiner committed reversible error in failing to properly
consider Appellant’s secondary consideration evidence of nonobviousness.
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As to the Examiner’s position that Appellant failed to establish the
required nexus, we disagree. See Ans. 6 (“Appellant has failed to show the
requisite ‘nexus’ between the claimed features and any commercial success
attributable to specific claimed features.”).
Appellant establishes that the commercial success of its Flexor Shuttle
Select Guiding Sheath product was due to the features recited in the claims,
namely, the claimed “three minor segments.” See Appeal Br. 11–17. Mr.
Brumleve testifies that
[T]he Flexor Shuttle Select® Guiding Sheath shares the features
of the “three minor segments” associated with the sheath
described in claims 1, 22, and 34 of the present application.
Specifically, the Flexor Shuttle Select® Guiding Sheath includes
a most distal minor segment having a length of 3.2 cm and a
durometer of 25 D, a second-most-distal minor segment having
a length of 5 cm and a durometer of 40 D, and a third-most-distal
minor segment having a length of 3 cm and a durometer of 58 D.
Brumleve Dec. ¶ 4. Additionally, Dr. Bersin and Dr. Connors provide
similar testimony tying the specific features recited in the independent
claims with the Flexor Shuttle Select Guiding Sheath. See Bersin Dec. ¶ 6;
see also Connors Dec. ¶¶ 4, 12–14.
In addition to declaration testimony, Appellant submits evidence in
the form of a data sheet that describes the “Shuttle Select™ System for
Carotid Artery Access” as having the claimed lengths. See App. E.
Having established a nexus between the claimed features and the
Shuttle Select System, Appellant submits further evidence to show that the
Shuttle Select System was commercially successful. Mr. Brumleve testifies,
The Flexor Shuttle Select® Guiding Sheath was and
continues to be an immense commercial success. The Flexor
Shuttle Select® Guiding Sheath was introduced in 2004, shortly
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after the filing of the present application. Sales have continued
to increase since that date, with more than 232,000 Flexor Shuttle
Select® Guiding Sheaths being sold up to the present date as
shown in Appendix D. Appendix E includes an image from the
data sheet sold with the Flexor Shuttle Select® Guiding Sheath
in 2004 demonstrating the specifications of the guiding sheath.
Brumleve Dec. ¶ 8. Indeed, Appellant’s sales figures further support a
finding that the Flexor Shuttle Select Guiding Sheath experienced
commercial success since its introduction in 2004. Appendix D shows that
the quantity of Flexor Shuttle Select Guiding Sheaths sold annually
increased from 3,237 (in 2004) to 23,151 (in 2016). Furthermore, Appendix
H is evidence that the Flexor Shuttle Select Guiding Sheath was used in
37.40% of carotid access stent procedures in 2006 and increased steadily to
51.50% in 2016.
Dr. Bersin further testifies, “I am confident that the commercial
success and market dominance of the Flexor Shuttle Select® Guiding Sheath
and the Shuttle Select Carotid Access System is primarily due to the
combination lengths and durometers of the three minor segments at the
distal end of the guiding sheath, as described in claims 1, 22, and 34.”
Bersin ¶ 9 (emphasis added). Dr. Bersin’s testimony that the commercial
success of the Flexor Shuttle Select Guiding Sheath was due to the claimed
“three minor segments” (id.) further supports a finding of nonobviousness.
Accordingly, Appellant submits evidence to establish that a nexus
exists between the claimed invention and the commercially successful
Flexor Shuttle Select System. Ashland Oil, 776 F.2d at 305. The Examiner
committed reversible error in failing to consider fully this evidence of
nonobviousness. See Eli Lily, 902 F.2d at 945.
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Moreover, and as to the Examiner’s position that Appellant has failed
to establish evidence of long-felt need and only submitted evidence of the
inventors, we also disagree. See Ans. 6–7 (“Regarding long felt need,
Appellant has not provided any evidence . . . . Appellant has not provided
anything more than the opinion of the inventors.”).
Although Dr. Connors is a named inventor (Connors Dec. ¶ 3), Dr.
Bersin and Mr. Brumleve are not named inventors, and even if they were
named inventors, we do not discount their testimony entirely, as the
Examiner has done.
Dr. Bersin testifies,
Before the introduction of the Flexor Shuttle Select®
Guiding Sheath and the Shuttle Select Carotid Access System,
placing a large diameter sheath into the common carotid artery
was exceedingly difficult or impossible due to the tortuous
geometry of the aorta and the turbulent forces of blood flow
within the aorta. Large diameters sheaths were necessary in
being able to deliver large diameter devices, such as stents, to
areas accessible via the common carotid artery, such as the brain.
This problem and long-felt need was met by the
introduction of the Flexor Shuttle Select Guiding Sheath. The
combination of lengths and durometers at the distal end of the
Flexor Shuttle Select® Guiding Sheath is critical to being able to
place a large diameter guiding sheath into the common carotid
artery.
As a result of this capability, the Flexor Shuttle Select®
Guiding Sheath has become a preferred device in the cardiology
field for accessing the common carotid artery. I have used the
Flexor Shuttle Select® Guiding Sheath in accessing the common
carotid artery and am confident that the combination lengths and
durometers of the three minor segments at the distal end are the
primary feature that sets the Flexor Shuttle Select® Guiding
Sheath and the Shuttle Select Carotid Access System apart from
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other large diameter guiding sheaths incapable accessing the
common carotid artery.
Bersin Dec. ¶¶ 7–9 (emphasis added).
In addition to Dr. Bersin’s testimony, Dr. Connor testifies about the
difficulty of accessing the common carotid artery with preexisting large
guide catheters. Connors Dec. ¶ 9. Dr. Connors explains in detail the steps
that were undertaken to develop the claimed invention and how it fulfilled
the need that prior catheters struggled to fulfill. See id. ¶¶ 10–15.
Finally, we disagree with the Examiner’s position that long-felt need
evidence “must show unsuccessful efforts to solve the problem.” Ans. 7.
Rather, long-felt need and failure of others are separate considerations. See
Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966) (“secondary
considerations as commercial success, long felt but unresolved needs, failure
of others, etc., might be utilized to give light to the circumstances
surrounding the origin of the subject matter sought to be patented”).
In addition to the commercial success evidence, we find Dr. Bersin’s
and Dr. Connor’s testimony of long-felt need to be persuasive, and the
Examiner committed reversible error by failing to give their testimony
appropriate weight. See Ans. 7.
For the foregoing reasons, we do not sustain the Examiner’s
rejections.

CONCLUSION
The Examiner’s rejections are reversed.
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DECISION SUMMARY
In summary:
Claims
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
1–10, 14, 16,
18, 20, 34–36
103 Parker, Nita,
Hewitt
1–10, 14, 16,
18, 20, 34–36
21 103 Parker, Nita,
Hewitt, Chow
21
22, 23, 26,
30, 33
103 Parker, Nita,
Hewitt, Pinchuk
22, 23, 26,
30, 33
24, 25 103 Nita, Hewitt,
Pinchuk, Chow
24, 25
Overall
Outcome
1–10, 14, 16,
18, 20–26,
30, 33–36

REVERSED