THE SPECTRANETICS CORPORATION

Patent Trials and Appeals Board

May 19, 2021

2020006552 (P.T.A.B. May. 19, 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.
14/700,550 04/30/2015 Blaine Schneider 2014P02047US01 1074
24737 7590 05/19/2021
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
465 Columbus Avenue
Suite 340
Valhalla, NY 10595
EXAMINER
TOWA, RENE T
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
05/19/2021 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):
katelyn.mulroy@philips.com
marianne.fox@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 BLAINE SCHNEIDER
____________

Appeal 2020-006552
Application 14/700,550
Technology Center 3700
____________

Before STEFAN STAICOVICI, JOSIAH C. COCKS, and
CARL M. DeFRANCO, Administrative Patent Judges.

STAICOVICI, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE.
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision in the Final Office Action (dated May 22, 2019, hereinafter “Final
Act.”) rejecting claims 1–7, 9–15, 17–21, 24, 27, and 30.2 We have
jurisdiction over this appeal under 35 U.S.C. § 6(b).

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. THE SPECTRANETICS CORPORATION, which is a
subsidiary of KONINKLUKE PHILIPS N.V., is identified as the real party
in interest in Appellant’s Appeal Brief (filed Oct. 21, 2019, hereinafter
“Appeal Br.”). Appeal Br. 2.
2 Claims 8, 16, 22, 23, 25, 26, 28, and 29 are canceled. See Appeal Br. 15–
17 (Claims App.).
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SUMMARY OF DECISION
We AFFIRM.

INVENTION
Appellant’s invention is directed “to expandable irrigation and
aspiration catheters used in the containment and removal of material
resulting from therapeutic treatment of occlusions within blood vessels.”
Spec., para. 2.
Claims 1, 6, and 15 are independent. Claim 1 is illustrative of the
claimed invention and reads as follows:
1. A catheter system for cutting bodily material of a subject,
the catheter system comprising:
a catheter having a wall, the wall comprising a distal end
carrying a cutting instrument adapted to cut bodily material of
the subject, the distal end being reconfigurable from a collapsed
configuration to an expanded configuration, the wall further
comprising at least two flexible components, wherein the at
least two flexible components have a first flexibility that is
different than a flexibility for another portion of the wall,
wherein the wall comprises two folds in the collapsed
configuration, wherein the at least two flexible components are
within the two folds, respectively, wherein the two folds create
two folded portions, wherein a first of the two folded portions
comprises a first U shape having a concave surface, wherein the
second of the two folded portions comprises a second U shape
having a convex surface, the second U shape coupled to the first
U shape at the two folds, the wall further comprising a U
shaped orifice disposed at the distal end between the first U
shape and the second U shape, the orifice being in fluid
communication with a lumen extending proximally from the
distal end, the lumen being adapted to receive cut bodily
material; and
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a release mechanism coupled to the catheter, the release
mechanism being actuatable to reconfigure the distal end from
the collapsed configuration to the expanded configuration.

Appeal Br. 13 (Claims App.).

REJECTIONS
I. The Examiner rejects claims 1–3 under 35 U.S.C. § 103 as
being unpatentable over Tu, Ziarno, and Hamilton.
II. The Examiner rejects claims 1–7, 9, 10, 13–15, 17, 18,
20, 21, 24, 27, and 30 under 35 U.S.C. § 103 as being
unpatentable over Raybin, Ziarno, and Hamilton.
III. The Examiner rejects claims 11, 12, and 19 under 35
U.S.C. § 103 as being unpatentable over Raybin, Ziarno,
Hamilton, and Tu.

ANALYSIS
Rejection I
Appellant does not present arguments for the patentability of claims 2
and 3 apart from claim 1. See Appeal Br. 6, 11. Therefore, in accordance
with 37 C.F.R. § 41.37(c)(1)(iv), we select claim 1 as the representative
claim to decide the appeal of the rejection of these claims, with claims 2 and
3 standing or falling with claim 1.
The Examiner finds Tu discloses a catheter assembly for cutting
bodily material including, inter alia, catheter 77 having a distal wall
configurable from a collapsed configuration to an expanded configuration
and a lumen for receiving bodily material, release mechanism 17, and
cutting instrument 22, 24. See Final Act. 3–4 (citing Tu, paras. 3, 36, 37,
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40–44, 49, Figs. 4A, 4B, 4C). The Examiner further finds that Tu fails to
disclose that catheter 77 includes U-shaped folds in its collapsed
configuration and flexible components, as called for by independent claim 1.
Id. at 4. Nonetheless, the Examiner finds that Ziarno discloses an instrument
having U-shaped folds in its collapsed configuration and Hamilton discloses
the use of at least two flexible components 44 mounted within wall 34 to
obtain wall portions with different flexibilities. Id. at 4–6 (citing Ziarno,
para. 103, Fig. 14; Hamilton, paras. 10, 11, 15, 19, 22–24, 28, 35, 35, Figs.
1–3).
Thus, the Examiner concludes that it would have been obvious for a
skilled artisan to modify Tu’s catheter system in its collapsed state to have
Ziarno’s U-shaped folds in order to “selectively collaps[e] the funnel in the
manner taught by Ziarno.” Id. at 5. The Examiner also determines that it
would have been obvious to a person of ordinary skill in the art to further
modify the catheter assembly of Tu, as modified by Ziarno, to include
Hamilton’s flexible components in order to “forc[e] the funnel and/or fold(s)
into the expanded configuration once it’s no longer constrained within the
working channel.” Id. at 6–7 (citing Hamilton, para. 24). According to the
Examiner, the modifications of Tu’s catheter system, according to Ziarno
and Hamilton, constitute applying a known technique to a known device
ready for improvement to achieve a predictable result. Id. at 5, 6 (citing KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, (2007); MANUAL OF PATENT
EXAMINING PROCEDURE §§ 2143, 2144–2144.09).
Furthermore, the Examiner determines that locating Hamilton’s
flexible elements within the folds of Tu’s catheter, as modified by Ziarno,
“would be an obvious expedient of merely rearranging known parts . . . to
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achieve the same function of forcing the flexible cup of Ziarno into the
expanded configuration.” Id. at 31. Thus, the Examiner takes the position
that such a modification “is a mere design choice that would have produced
the same improvement of forcing the funnel and/or fold(s) into an expanded
configuration once it’s no longer constrained within the working channel.”
Advisory Action (mailed Aug. 1, 2019, hereinafter “Adv. Act.”) 2.
Appellant argues that “the Examiner has not explained why one of
skill in the art would rearrange the parts to ultimately provide the device
with the same function.” Appeal Br. 8 (emphasis added). According to
Appellant, “the Examiner has essentially ignored the language [of the
claims], stating that the positioning of the flexible members is a mere design
choice.” Reply Brief (filed Sept. 21, 2020, hereinafter “Reply Br.”) 2.
We are not persuaded because in appropriate circumstances, a
modification of prior art teachings may be a matter of design choice. E.g.,
ACCO Brands Corp. v. Fellowes, Inc., 813 F.3d 1361, 1367 (Fed. Cir. 2016)
(where the prior art consistently located two sensors in shredder’s feed,
skilled artisan faced two design choices of placing the thickness sensor
above or below the presence sensor and each design choice was an obvious
combination of prior art elements). Design choice may apply when
alternative elements or configurations in the prior art perform the same
function as the claimed structures with no unexpected results. See In re
Kuhle, 526 F.2d 553, 555 (CCPA 1975) (explaining that the use of the
claimed feature “would be an obvious matter of design choice” when it
“solves no stated problem” and “presents no novel or unexpected result”
over the disclosed alternatives).
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Here, in the context of a rejection based on design choice, the relevant
issue is whether the alleged differences between the claimed invention and
the prior art “result in a difference in function or give unexpected results.”
See In re Rice, 341 F.2d 309, 314 (CCPA 1965). In this case, we agree with
the Examiner that “Appellant has not disclosed that locating the flexible
components within the two folds provides an advantage, is used for a
particular purpose, or solves a stated problem.” Examiner’s Answer (dated
July 21, 2020, hereinafter “Ans.”) 7. The Specification explicitly states that
“flexible components 120 may be disposed at multiple locations about the
distal end 106,” but does not specify any preference or advantage for
locating the flexible elements at a specific location, namely, within the two
folds of the wall, as required by claim 1. Spec., para. 45 (emphasis added).
In particular, we note that Appellant’s reliance on paragraphs 9–12 of the
Specification as evidence of the benefits provided by positioning “the at
least two flexible components . . . within the two folds,” as called for by
claim 1, is misplaced. Reply Br. 4. These paragraphs discuss the benefits
provided in general by the claimed invention, but do not describe any
benefits resulting from specifically locating flexible components 120 in the
claimed location, i.e., “within the two folds.”
Thus, Appellant does not adequately explain why a skilled artisan
would not have reasonably expected Hamilton’s flexible elements 44 to
perform in the same manner, whether located along the perimeter of flexible
cup 34 or within the folds of Tu’s catheter wall, as modified by Ziarno. See
Hamilton, para. 24, Fig. 3; Final Act. 5–6. The Examiner is correct that both
“arrangements would perform the same function of forcing the funnel and/or
fold(s) into the expanded configuration once it’s no longer constrained
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within the working channel.” Ans. 7. Simply selecting one of a plurality of
a finite number of identified locations to position Hamilton’s flexible
elements 44 within Tu’s catheter wall, as modified by Ziarno, is not the
product of innovation but something that occurs in the ordinary course of
using a known device. See, e.g., In re Kubin, 561 F.3d 1351, 1358–61 (Fed.
Cir. 2009).
Appellant further argues that, absent hindsight, a skilled artisan would
not have modified the catheter assembly of Tu, as modified by Ziarno, to
include Hamilton’s flexible components to “forc[e] the funnel and/or fold(s)
into the expanded configuration once it’s no longer constrained within the
working channel.” Appeal Br. 10. According to Appellant, the catheter of
Tu, as modified by Ziarno, “is already selectively collapsible.” Id.
We are not persuaded that the Examiner’s determination of
obviousness is based on impermissible hindsight reconstruction. See Appeal
Br. 10. We appreciate that the distal end of Tu’s catheter 77 is disclosed as
“self-expandable” when released from the constraint of catheter shaft 19.
See Tu, Figs. 2, 4B, 4C, para. 43. However, Tu does not disclose the
mechanism that allows the distal end of catheter 77 to expand. Therefore, as
Tu does not disclose the expansion mechanism of the distal end of catheter
77, Hamilton’s disclosure of using flexible elements 44 for automatically
expanding flexible cup 34 is merely providing details that are missing from
Tu. In other words, as Tu does not disclose the expansion mechanism of the
distal end of catheter 77, providing Hamilton’s flexible elements 44 to the
catheter of Tu, as modified by Ziarno, is merely the application of a known
technique (i.e., a known expansion mechanism) to a piece of prior art ready
for the improvement. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417
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(2007) (“[I]f a technique has been used to improve one device, and a person
of ordinary skill in the art would recognize that it would improve similar
devices in the same way, using the technique is obvious unless its actual
application is beyond his or her skill.”). We, thus, agree with the Examiner
that the modification is an improvement to the catheter of Tu, as modified by
Ziarno, to have at least two flexible elements in the same way as taught by
Hamilton to lead to a predictable result, namely, “to force the funnel to the
deployed configuration once it’s no longer constrained within a working
channel.” See Ans. 9. Accordingly, the Examiner’s determination of
obviousness does not amount to impermissible hindsight.
Lastly, Appellant argues that “there is no evidence showing there is a
reasonable expectation of success of combining the teachings of these
references.” Appeal Br. 10. According to Appellant, “the Examiner has not
demonstrated how one of skill in the art would combine the funnel of
Hamilton with the modified funnel of Tu and Ziarno.” Id.
“The reasonable expectation of success requirement refers to the
likelihood of success in combining references to meet the limitations of the
claimed invention.” Intelligent Bio-Systems, Inc. v. Illumina Cambridge
Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). “For obviousness under § 103,
all that is required is a reasonable expectation of success.” In re O’Farrell,
853 F.2d 894, 904 (Fed. Cir. 1988); see also Pfizer, Inc. v. Apotex, Inc., 480
F.3d 1348, 1364 (Fed. Cir. 2007) (“the expectation of success need only be
reasonable, not absolute”). In the instant case, the Examiner provides an
adequate reasoning to modify Tu’s catheter, as modified by Ziarno, namely,
“to force the funnel to the deployed configuration once it’s no longer
constrained within a working channel.” See Final Act. 6–7 (citing Hamilton,
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para. 24). Further, the Examiner provides an informed explanation and
analysis as to how Hamilton’s flexible elements 44 provide for different
flexibilities to expand flexible cup 34. Id. at 5–6. Furthermore, in the
Examiner’s combination, Hamilton’s flexible elements 44 are being used in
accordance with their typical expansion function. As such, a person of
ordinary skill in the art would have had a reasonable expectation of success
in using Hamilton’s flexible elements 44 to expand the distal end of Tu’s
catheter 77, as modified by Ziarno. Appellant presents neither evidence nor
persuasive technical reasoning that making the Examiner’s combination
requires more than the ordinary skill or produces unexpected results.
In conclusion, for the foregoing reasons, we sustain the rejection
under 35 U.S.C. § 103 of independent claim 1 as unpatentable over Tu,
Ziarno, and Hamilton. Claims 2 and 3 fall with claim 1.

Rejection II
In contrast to Rejection I, Rejection II is based on a different
combination of references, namely, Raybin, Ziarno, and Hamilton. See Final
Act. 8–28. Appellant relies on the same arguments discussed supra in
Rejection I, which for the reasons stated above, we did not find persuasive.
See Appeal Br. 11 (“Applicant respectfully disagrees with the rejection of
claim 1 for similar reasons to those described above in view of the rejection
based on the combination of Tu, Ziarno, and Hamilton.”). In particular, we
do not agree with Appellant’s position that a skilled artisan would not
combine the teachings of Raybin, Ziarno, and Hamilton because “the funnels
from the corresponding references are already selectively collapsible” for the
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same reasons discussed above in Rejection I with respect to the combination
of Tu, Ziarno, and Hamilton.
Accordingly, for the foregoing reasons, we also sustain the rejection
under 35 U.S.C. § 103 of claims 1–7, 9, 10, 13–15, 17, 18, 20, 21, 24, 27,
and 30 as unpatentable over Raybin, Ziarno, and Hamilton.

Rejection III
Appellant relies on the same arguments discussed supra in Rejection
II. See Appeal Br. 12. Therefore, for the same reasons discussed above, we
also sustain the rejection of claims 11, 12, and 19 over the combined
teachings of Raybin, Ziarno, Hamilton, and Tu.

CONCLUSION

Claim(s)
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
1–3 103 Tu, Ziarno,
Hamilton
1–3
1–7, 9, 10,
13–15, 17,
18, 20, 21,
24, 27, 30
103 Raybin, Ziarno,
Hamilton
1–7, 9, 10,
13–15, 17,
18, 20, 21,
24, 27, 30

11, 12, 19 103 Raybin, Ziarno,
Hamilton, Tu
11, 12, 19
Overall
outcome
1–7, 9–15,
17–21, 24,
27, 30

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
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AFFIRMED