Richard S. Ginn

Patent Trials and Appeals Board

Dec 27, 2019

13673898 - (D) (P.T.A.B. Dec. 27, 2019)

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.
13/673,898 11/09/2012 Richard S. Ginn 0019-000100US 8073
155173 7590 12/27/2019
Acuity IP, LLC
5460 Ward Road
Suite 320
Arvada, CO 80002
EXAMINER
MANNAN, MIKAIL A
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
12/27/2019 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):
ncassell@acuityip.com
ncassell@gmail.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte RICHARD S. GINN
____________

Appeal 2018-003046
Application 13/673,898
Technology Center 3700
____________

Before GEORGE R. HOSKINS, BRADLEY B. BAYAT, and
ARTHUR M. PESLAK, Administrative Patent Judges.

HOSKINS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 2, and 47–55 in this application.2
The Board has jurisdiction over the appeal under 35 U.S.C. § 6(b).
A hearing was held on November 14, 2019. See Transcript (entered
Dec. 9, 2019) (“Tr.”).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies Transaortic Medical, Inc., as the real
party in interest. Appeal Br. 2.
2 Claims 3–46 are canceled. See Appeal Br. (filed July 19, 2017) 2; Claims
App. (filed Aug. 9, 2017) 1.
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CLAIMED SUBJECT MATTER
Claim 1 is the sole independent claim on appeal, and it recites:
1. A system for deploying a device to a distal location across a
diseased vessel, comprising:
a protective sheath defining a lumen therethrough;
said sheath comprising an expandable embolic capture
assembly having a collapsed configuration and an expanded
configuration housed in said sheath and constrained in its
collapsed configuration;
said embolic capture assembly comprising a tubular porous
filter mesh having pores sized to prevent passage of embolic
particles and to permit the flow of blood thereby providing an
outlet for blood;
said embolic capture assembly having an open distal end in
said expanded configuration comprising an inlet;
said embolic capture assembly having a hoop structure
coupled to said tubular porous filter distal end;
said hoop structure being located at the distal portion of said
embolic capture assembly and having a collapsed configuration
and an expanded configuration, said expanded configuration
being dimensioned to engage the walls of a blood vessel; and
a proximal manipulation structure coupled to said hoop
structure which is capable of collapsing said hoop structure and
closing the distal portion of said embolic capture assembly by the
application of hoop tension to capture particles in said tubular
porous filter mesh.
Claims App. 1.
PRIOR ART REFERENCES
The Examiner cites the following prior art references:
Name Reference Date
Kerr US 5,941,896 Aug. 24, 1999
Clubb US 2004/0153117 A1 Aug. 5, 2004
Agnew US 2008/0167705 A1 July 10, 2008
Spenser US 2009/0254169 A1 Oct. 8, 2009
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Name Reference Date
Bortlein US 2010/0100167 A1 Apr. 22, 2010
Angel US 2010/0217304 A1 Aug. 26, 2010
Pah US 2010/0305604 A1 Dec. 2, 2010
REJECTIONS ON APPEAL
Claims 1, 2, and 47–55 are rejected under 35 U.S.C. § 112(a)3 for lack
of written description. Final Act. (dated Apr. 20, 2017) 9–10. In addition,
the Examiner has “objected to” to claim 55. Id. at 9. The reasoning for the
objection is rooted in whether Appellant’s Specification provides written
description support for the challenged subject matter. Id.; Appeal Br. 5 (the
objection is “really . . . that the [claimed] recitation is contrary to the
specification and drawings”). We will therefore review the objection
because, in effect, it is a rejection under 35 U.S.C. § 112(a). Cf. MPEP
§ 1201.
Claim 47 is rejected under 35 U.S.C. § 112(b) for indefiniteness.
Final Act. 10–11; Ans. (dated Dec. 19, 2017) 2 (withdrawing indefiniteness
rejection as to all other claims).
Claims 1, 2, and 51–54 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Pah and Clubb. Final Act. 11–12.
Claims 47 and 55 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Pah, Clubb, and Bortlein. Final Act. 13.
Claims 48–50 are rejected under 35 U.S.C. § 103(a) as unpatentable
over Pah, Clubb, Bortlein, and Spenser. Final Act. 13–14.

3 This application was filed on November 9, 2012, after the AIA
amendments to § 112 took effect on September 16, 2012. See Leahy-Smith
America Invents Act (“the AIA”), Pub. L. No. 112-29, § 4(e), 125 Stat. 284,
297 (2011); MPEP § 2161(I).
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Claims 1, 47–50, and 55 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Agnew and Kerr. Final Act. 14–17.
Claims 2 and 51–54 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Agnew, Kerr, and Angel. Final Act. 17–18.
OPINION
A. Written Description (Claims 1, 2, and 47–55)
Claim 1 (and Claims 2 and 47–55 Via Dependencies)
The Examiner determines claim 1 fails to have written description
support in Appellant’s Specification, in reciting an expandable embolic
capture assembly being “housed in said sheath.” Claims App. 1 (emphasis
added); Final Act. 2–3, 9–10. The Examiner finds Appellant’s Specification
describes the capture assembly as comprised of rail members 32, which “are
part of the ‘sheath’ and not a separate structure as” required by the “housed
in” term in claim 1. Id. at 3, 9–10 (citing Spec. 30:4–5). Dependent
claims 2 and 47–55 are rejected on the same basis. Id. at 9–10.
Appellant contends “it is plain from Fig. 18G [of Appellant’s
Specification] that the embolic capture assembly 26 is housed in sheath 16.”
Appeal Br. 6.
The Examiner answers that Appellant’s Figure 18G “does not clearly
show” the capture assembly within the sheath. Ans. 3. The Examiner finds
Appellant’s Specification describes reference number 26 as an “expanded
configuration” of sheath 16. Id. (citing Spec. 29:22–23). The Examiner
concludes reference number 26 is “a portion of the sheath,” so it is not
housed in the sheath as required by claim 1. Id.
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Appellant replies that Appellant’s Figure 18B “shows that the
obturator-jacket assembly 168 comprises the distal portion of the sheath 16,”
and the capture assembly is housed within assembly 168. Reply Br. 2 (citing
Spec. 29:8–13)4.
We conclude the Examiner has the better position. As described in
Appellant’s Specification, Figures 18B–18E illustrate “a railed sheath in a
collapsed configuration (16),” and “the distal portion of the railed sheath
may be allowed to become fully expanded (26).” Spec. 27:22–29:29
(emphases added). These Figures additionally show how the “collapsed
railed sheath portion (16) [is] removably coupled to a distal obturator-jacket
assembly (168),” such that removal of assembly 168 exposes portion 26 of
sheath 16 so it may fully expand. Id. at 28:13–15 (emphasis added),
28:31–29:6. These disclosures fail to demonstrate possession of an
expandable capture assembly (i.e., sheath portion 26) being “housed in” a
sheath (i.e., sheath portions 16 and 26) as claimed, because sheath portion 26
is part of the sheath. Appellant’s counsel conceded this point during the
hearing. See Tr. 5:24–6:7. Although sheath portion 26 is housed in
assembly 168 (Figs. 18B–18C), assembly 168 is not part of the sheath, as
demonstrated by the description of assembly 168 being removably coupled
to sheath portion 16 (Figs. 18B–18E, Spec. 28:3–15). Thus, we sustain the
rejection of claim 1, and of claims 2 and 47–55 by virtue of depending from
claim 1, as lacking written description.

4 We have modified Appellant’s citations here, and elsewhere in our
decision, to refer to the pertinent disclosures in the Specification filed on
November 9, 2012, rather than the corresponding disclosures in the
publication of the application on May 30, 2013.
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Claim 47 (and Claims 48–50 and 55 Via Dependencies)
The Examiner determines claim 47 fails to have written description
support in Appellant’s Specification, in reciting an “obturator having an
exterior transverse dimension smaller than that of said sheath” and
“surrounding said embolic capture assembly” of the sheath. Claims App. 1;
Final Act. 2, 10. “Rather, the ‘obturator jacket assembly’ is collapsed and
then pulled proximally through said ‘sheath.’” Id. (citing Spec. 29:27–29).
“There is no support for the obturator jacket assembly (168, 152)
surrounding the expandable capture assembly (26) and having a smaller
transverse dimension, there is only support for the obturator jacket having a
smaller transverse dimension when it is pulled through the lumen.” Id. at 2.
Dependent claims 48–50 and 55 are rejected on the same basis. Id. at 9–10.
Appellant contends it “would not be possible” for the obturator jacket
assembly to be collapsed and pulled proximally through the sheath as
described in Appellant’s Specification, “unless . . . the exterior cross-section
of the obturator was smaller than that of the sheath.” Appeal Br. 6–7.
The Examiner answers that, while Appellant’s Specification states
“the ‘obturator assembly may be pulled proximally through the lumen of the
sheath’” (Spec. 29:27–29), “there is no disclosure of the dimension of the
‘obturator’ in relation to the ‘sheath.’” Adv. Act. (dated July 31, 2017), 2.
According to the Examiner, “[t]he ‘obturator’ does not necessarily need to
have a smaller dimension than the ‘sheath’ to be pulled through, since the
obturator jacket is configured to be deformed.” Id.; Ans. 4. The Examiner
also cites Appellant’s Figures 18B and 18D as “show[ing] the obturator
jacket [168] having the same dimension at the proximal end as the sheath
16.” Adv. Act. 2; Ans. 4.
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We conclude Appellant has the better position. It is undisputed that
obturator-jacket assembly 168 is collapsed, and then pulled proximally
through sheath portion 16. See Spec. 29:27–29. In order for that to occur,
assembly 168 must have an exterior transverse dimension smaller than that
of sheath 16 as recited in claim 47, even if assembly 168 must be torn or
fractured to achieve such a configuration as contemplated in the
Specification. See id. at 29:6–24. Claim 47 does not specify that the
dimension must be achieved in a pre-collapsed configuration as the
Examiner appears to conclude; the claim is open to assembly 168 being
collapsed to have the recited transverse dimension. Thus, we do not sustain
the rejection of claim 47, and of claims 48–50 and 55 by virtue of depending
from claim 47, as lacking written description.
Claim 55 (and Claims 48–50 Via Dependencies)
As discussed above, we will review the Examiner’s objection to
claim 55, because in substance it is properly characterized as a rejection
under 35 U.S.C. § 112(a). According to the Examiner, Appellant’s
Specification indicates the term “obturator jacket-like wrapper portion” in
claim 55 “is meant to read ‘expandable embolic capture assembly’,” because
“the obturator jacket-like wrapper portion is clearly not uncovered.” Final
Act. 9.
Appellant contends “the Examiner is wrong,” because “it is the
jacket-like wrapper portion 26 of the device that is uncovered when the
obturator 168 is advanced distally.” Appeal Br. 5–6 (emphasis added)
(citing Spec. 27:22–29, and Figs. 18B, 18C and 18D).
We conclude the Examiner has the better position. As described in
Appellant’s Specification, Figures 18B–18E illustrate how distal
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displacement of obturator-jacket assembly 168 removes assembly 168 from
sheath portion 26, thereby permitting sheath portion 26 to expand fully.
Spec. 28:13–15, 28:31–29:6. Assembly 168 is uncovered both before and
after that removal (Figs. 18B–18E). These disclosures fail to demonstrate
possession of assembly 168 being uncovered when assembly 168 is
advanced distally to be released from sheath 16, 26, as is required by
claim 55. Although sheath portion 26 is uncovered when assembly 168 is
advanced distally, sheath portion 26 is part of the sheath, not assembly 168.
Thus, we sustain the rejection of claim 55, and of claims 48–50 by virtue of
depending from claim 55, as lacking written description.
B. Indefiniteness (Claim 47)
The Examiner determines claim 47, in reciting “said obturator,” is
unclear and therefore indefinite. Final Act. 10–11; Ans. 2 (withdrawing
portion of rejection focusing on “jacket-like wrapper portion” in claim 47).
The Examiner determines there is no antecedent basis for the “said
obturator” term, and “[i]t is unclear if [the term] is referring to the ‘elongate
obturator-jacket assembly’ or a portion of the assembly.” Final Act. 11.
Appellant contends there is antecedent basis for the “said obturator”
term in claim 47, because claim 47 previously recites an “obturator-jacket
assembly.” Appeal Br. 8. The “obturator” portion of the previous term,
according to Appellant, provides antecedent basis for the later-recited “said
obturator.” Id.
The Examiner answers that “the ‘obturator’ could be a different
structure from the ‘obturator-jacket assembly.’” Ans. 4.
We conclude Appellant has the better position. A person of ordinary
skill in the art would understand that, where claim 47 recites “an elongate
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obturator-jacket assembly,” the assembly includes an obturator portion. The
person further would understand that, where claim 47 later recites “said
obturator,” the claim is referring back to the obturator portion of the
obturator-jacket assembly. Thus, we do not sustain the rejection of claim 47
as indefinite.
C. Obviousness over Pah and Clubb (Claims 1, 2, and 51–54)
Appellant argues for the patentability of claims 1, 2, and 51–54 over
Pah and Clubb as a group, without arguing for any of the claims separately
from the other claims. See Appeal Br. 8–10. We therefore select claim 1 to
decide the appeal of the rejection based on obviousness over Pah and Clubb.
See 37 C.F.R. § 41.37(c)(1)(iv) (2017).
In rejecting claim 1, the Examiner finds Pah discloses each and every
claim limitation, including an expandable embolic capture assembly (i.e.,
filter 2 of catheter 1 as shown in Figure 5), except Pah’s filter element 8 is a
film filter rather than a mesh filter as claimed. Final Act. 11–12. The
Examiner finds Clubb discloses a mesh filter that, like Pah’s film filter
element 8, is designed to capture emboli from a bloodstream. Id. at 12
(citing Clubb ¶ 4). The Examiner determines it would have been obvious to
modify Pah’s filter element 8 to be a mesh filter rather than a film filter,
“because the substituted elements and their functions were known in the art
and the results of the substitution would have the same predictable result of
capturing emboli.” Id.
Appellant firstly argues Pah’s filter 2 is not an “embolic capture
assembly” as required by claim 1 (emphasis added). Appeal Br. 8–10.
According to Appellant, Pah’s filter 2 instead is an emboli “flow-through
device” because filter 2 merely inhibits emboli from entering tributary
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arteries, such that the emboli continue flowing through the main artery in
which filter 2 is placed. Id. at 8–9. In support, Appellant asserts Pah’s
filter 2 comprises distal portion 6 having small openings that prevent
passage of emboli into the tributary arteries, and proximal portion 7 having
large openings that minimize the impedance of blood flow through the main
artery and therefore do not impede the passage of emboli. Id. (citing Pah
¶¶ 21, 22, 25, 66, 88).
We agree with the Examiner’s finding that filter 2 of Pah’s Figure 5
captures emboli, and does not simply prevent emboli from passing through
the filter. Pah does disclose, as Appellant contends, that in some
embodiments filter 2 has smaller pores in a distal filter section 6 and larger
pores in a proximal filter section 7. Pah ¶¶ 18, 21, 22, 25, 53, 58, 65, 66, 88,
and Figs. 2–4. However, filter 2 of Figure 5, which is cited by the
Examiner, is not such a filter. See id. at Fig. 5. Instead, filter 2 of Figure 5
has pores with “a roughly constant size over the entire length of the filter,”
which will work in the context of Figure 5 because “the filter . . . tapers
gradually from distal to proximal” thereby providing “a very large filter
surface.” Id. ¶¶ 26, 82, 88, 104. Thus, in Figure 5, filter 2 “reliably
retain[s]” embolism-causing material such as plaque and debris, so that
“[w]hen the filter 2 is pulled in, the embolic material, plaque and debris
filtered from the blood remain completely in the filter 2 and are pulled back
with it into the catheter tube 3.” Id. ¶¶ 15, 30, 88, 117 (emphases added).
Appellant next asserts “the removal of Pah’s filter 2 by withdrawing it
into catheter tube 3 would flush emboli out of the distal end of filter 2 rather
than capturing it,” “as a matter of fundamental fluid dynamics.” Appeal
Br. 9 (emphasis added). Appellant acknowledges the Pah disclosure quoted
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above reflecting that the embolic material and debris filtered from the blood
remain completely in the filter 2 (Pah ¶ 117), but asserts this disclosure “is
implacably at odds with the flow-through nature of [Pah’s] device which
will necessarily wash the emboli which are filtered out through the ‘larger
openings’ in the proximal section 7 and has to be considered a mis-statement
by [Pah’s] attorney.” Id. at 9–10 (citing Pah ¶ 87).
The Examiner answers that the purpose of Pah’s filter 4 is to capture
emboli, plaque, and debris found in the blood. Ans. 4–6 (citing Pah ¶¶ 15,
30, 104, 117).
Appellant replies that, in disclosing embolic material “remain[s]
completely in the filter 2” (Pah ¶ 117 (emphasis added)), the phrase “‘in the
filter’ does not mean captured by the filter,” but rather “must mean in the
bloodstream which flows through the filter,” because Pah discloses
“substantially unimpeded flow of blood through filter 2 and . . . this
unimpeded flow will carry embolic particles to the feet and legs.” Reply
Br. 3–4 (emphasis by Appellant) (citing Pah ¶¶ 22, 25, 60, 66, 92); id. at 4
(further citing Pah ¶¶ 7, 15, 18, 24, 88, 104).
We agree with the Examiner. Appellant’s assertion that Pah’s filter
cannot operate as described in Pah relies solely on attorney argument, which
“cannot take the place of evidence in the record.” See In re Geisler,
116 F.3d 1465, 1470 (Fed. Cir. 1997). Appellant does not cite, and we are
not aware, of any evidence in the record tending to suggest Pah’s description
of how filter 2 in Figure 5 operates is somehow incorrect. Thus, the
evidence establishes filter 2 in Figure 5 captures embolic particles, and does
not merely prevent embolic particles from entering a tributary artery as they
continue to flow past the filter through a main artery. See, e.g., Pah ¶¶ 15,
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30, 104, 117. For example, as already discussed above, filter 2 in Figure 5
has pores of roughly constant size, not proximal and distal sections of
differently sized pores.
Appellant finally asserts, in a new argument raised in the Reply Brief,
that the Examiner errs in finding Pah discloses the limitation in claim 1
reciting “a proximal manipulation structure coupled to said hoop structure
which is capable of collapsing said hoop structure and closing the distal
portion of said embolic capture assembly by the application of hoop tension
to capture particles in said tubular porous filter mesh.” Claims App. 1;
Reply Br. 5. Here, the Examiner finds Pah’s filter wire 10 is a proximal
manipulation structure, coupled to distal ring section 11 which is a hoop
structure, such that pulling on wire 10 collapses ring section 11 to close
filter 2. Final Act. 11–12 (citing Pah ¶¶ 69, 114, 117).
Appellant objects that Pah “constricts the proximal, not the distal
portion of his filter when he removes it by pulling the filter 2, proximal
section 7 first, proximally into catheter 3.” Reply Br. 5 (emphasis by
Appellant) (citing Pah ¶ 117). According to Appellant, “[t]here is absolutely
no structure in Pah which permits constriction or closure of the distal portion
of filter 6 [sic ‘2’].” Id.
We are not persuaded of Examiner error. It is undisputed that Pah
indicates filter 2 is retracted into catheter 3 by pulling on filter wire 10,
which is connected to distal ring section 11 via end ring 9 and struts 13. See
Pah, Fig. 5, ¶¶ 31, 67, 69, 78, 84–86, 117. Pah, therefore, discloses a
proximal manipulation structure coupled to a distal hoop structure to
collapse the hoop structure. Appellant’s argument relies on an implicit
claim construction whereby the term “coupled to” in claim 1 requires some
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sort of direct connection between filter wire 10 and distal ring section 11,
precluding intermediate elements such as end ring 9 and struts 13. Appellant
does not cite, and we cannot find, any disclosure in Appellant’s
Specification that would support this narrow claim construction. See, e.g.,
Spec. 28:27–31, 29:30–30:7, 31:1–10, Figs. 18F–18G; In re Am. Acad. of
Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004) (during examination of
a patent application, pending claims are given their broadest reasonable
construction consistent with the Specification).
For the foregoing reasons, we sustain the rejection of claims 1, 2, and
51–54 as having been obvious over Pah and Clubb.
D. Obviousness over Pah, Clubb, and Bortlein (Claims 47 and 55)
In rejecting claim 47 as having been obvious over Pah, Clubb, and
Bortlein, the Examiner relies solely on Bortlein as disclosing the subject
matter added by claim 47 to its parent claim 1. Final Act. 13. The Examiner
finds Bortlein’s Figures 3A and 3B disclose catheter 114 having an
obturator-jacket assembly (i.e., distal sheath portion 132) removably coupled
to a distal end of a sheath (i.e., proximal sheath portion 134) and having a
distal tip (i.e., tapered section 138) and a jacket-like wrapper portion (i.e.,
the portion of distal sheath portion 132 surrounding medical device 112).
Id.; see Bortlein ¶¶ 27–28. According to the Examiner, Bortlein’s obturator
“has a dimension relative to said sheath to allow the obturator to be
withdrawn proximally through the lumen of sheath,” as required by
claim 47. Final Act. 13 (citing Bortlein, Figs. 3D–3G).
Appellant argues, in part, that Bortlein fails to disclose an obturator
“being capable of being withdrawn proximally through the lumen in said
sheath,” as recited in claim 47. Appeal Br. 12–13. Appellant asserts
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Bortlein’s distal sheath portion 132 is not such an obturator, because it
“cannot be removed through” Bortlein’s proximal sheath portion 134. Id.
The Examiner answers that “the features upon which Appellant relies
(i.e., the obturator being removed through the sheath) are not recited in”
claim 47. Ans. 7–8.
We conclude Appellant has the better position. Claim 47 pertinently
recites “said obturator having an exterior transverse dimension smaller than
that of said sheath and being capable of being withdrawn proximally through
the lumen in said sheath.” Claims App. 1 (emphases added). Thus, in order
to sustain the Examiner’s rejection, Bortlein’s distal sheath portion 132 must
at least be capable of being withdrawn proximally through the lumen of
proximal sheath portion 134.
The evidence of record does not support such a finding. Bortlein
indicates proximal section 148 of distal sheath portion 132 collapses
inwardly toward inner tube 122. Bortlein ¶ 30, Figs. 3A & 3D. Then
Bortlein’s assembly is repositioned so that distal sheath portion 132 encloses
hub 126 of central tube 124. Id. ¶ 31, Figs. 3A & 3D–3F. “With this
arrangement, a smoother and lower profile is created for withdrawing the
catheter through the medical device 112 in the proximal direction 170, as
shown in” Figures 3F and 3G. Id. ¶ 31 (emphasis added). At best, this
disclosure establishes that a small part of distal sheath portion 132 may be
received within the lumen of proximal sheath portion 134. Id. at Fig. 3G.
This disclosure does not establish that distal sheath portion 132 is capable of
“being withdrawn proximally through” the lumen of proximal sheath
portion 134, as is required by claim 47 (emphases added).
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For the foregoing reasons, we do not sustain the rejection of claim 47
and claim 55 depending therefrom, as having been obvious over Pah, Clubb,
and Bortlein.
E. Obviousness over Pah, Clubb, Bortlein, and Spenser (Claims 48–50)
In rejecting claims 48–50 as having been obvious over Pah, Clubb,
Bortlein, and Spenser, the Examiner relies solely on Bortlein as disclosing
the subject matter recited in claim 47, from which each of claims 48–50
depend. Final Act. 13–14; Claims App. 1–2 (claims 49 and 50 each depend
from claim 48, which depends from claim 55, which depends from
claim 47). As discussed above, a preponderance of the evidence does not
support the Examiner’s finding that Bortlein discloses the subject matter
recited in claim 47. Therefore, we do not sustain the rejection of
claims 48–50 as having been obvious over Pah, Clubb, Bortlein, and
Spenser.
F. Obviousness over Agnew and Kerr (Claims 1, 47–50, and 55)
Claim 1
In rejecting claim 1, the Examiner finds Agnew’s Figure 1 discloses
each and every claim limitation, including a sheath (i.e., outer member 12)
comprising an expandable embolic capture assembly with a filter (i.e.,
prosthesis 24), except Agnew does not disclose a mesh filter, or a collapsible
hoop structure located at the distal end of the filter, as claimed. Final
Act. 14–15 (citing Agnew ¶¶ 8, 26).
The Examiner finds Kerr discloses a mesh filter that, like Agnew’s
filter, is designed to capture emboli from a bloodstream. Id. at 15 (citing
Kerr, 5:61–62, 7:22–25). The Examiner determines it would have been
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obvious to modify Agnew’s filter to be a mesh filter as in Kerr, “because the
substituted elements and their functions were known in the art and the
results of the substitution would have the same predictable result of
capturing emboli.” Id.
The Examiner finds Kerr also discloses an “embolic capture assembly
having a hoop structure (hoop of guidewire 220 . . . ) coupled to the porous
filter distal end and having a collapsed configuration and an expanded
configuration being dimensioned to engage the walls of a blood vessel.” Id.
at 15 (citing Kerr, Figs. 11–12, 9:1–2, 9:10–15). The Examiner finds Kerr
discloses “a proximal manipulation structure (guidewire 212) coupled to”
the hoop structure, and capable of collapsing the hoop structure by
application of hoop tension. Id. at 15–16 (citing Kerr, 9:26–27, 9:33–37).
The Examiner determines it would have been obvious to modify Agnew’s
filter to include Kerr’s hoop structure coupled to a proximal manipulation
structure, “to more effectively trap and remove emboli.” Id. at 16.
Appellant firstly argues Agnew “has no meaningful disclosure of an
embolic capture assembly or of any kind of embolic protection device.”
Appeal Br. 14. According to Appellant, Agnew’s “passing reference . . . to
an ‘embolic protection device’” is “so brief and ephemeral as to be
meaningless,” and “provides no evidence of which, if any, of the many types
of embolic protection devices [Agnew] has in mind.” Id. at 14–15.
Appellant also asserts Agnew’s embolic protection device “would include
flow-through devices such as that of Pah and would not be embolic capture
devices as explained with regard to Pah.” Id. at 14.
The Examiner answers that a person of ordinary skill in the art “would
know what an ‘embolic protection device’ is [in Agnew] without further
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description.” Ans. 9 (citing Agnew ¶ 26). Further according to the
Examiner, the evidence does not support Appellant’s contention that
Agnew’s embolic protection device is a flow-through device, and “it is
known that an ‘embolic protection device’ is for capturing emboli.” Final
Act. 2; Ans. 9. The Examiner also finds Kerr’s filter mesh “would have the
result of the capturing emboli, since the particles would be prevented from
flowing through the mesh openings.” Id.
We determine the Examiner does not err in finding that the
combination of Agnew and Kerr discloses an embolic capture assembly. It
is undisputed that Agnew discloses deploying “self-expanding
prosthesis 24” which may be a “filter” or an “embolic protection device,”
among other options. Agnew ¶ 26. The only concrete issue raised by
Appellant is whether such a device would “capture” embolic materials, as
recited in claim 1. Here, the Examiner relies on the “fine-mesh net” filter
structure that the Examiner proposes to adapt from Kerr’s disclosure into
Agnew’s structure, which we agree would operate to “capture” embolic
particles. See Final Act. 15; Ans. 9; Kerr, Fig. 12, 5:61–62, 7:22–25,
8:52–55. A person of ordinary skill in the art, when desiring to implement
Agnew’s prosthesis 24 as an embolic protection device as expressly
contemplated by Agnew, would naturally consider using Kerr’s fine
nesh-met filter structure that is disclosed as capturing embolic particles, even
if Agnew does not provide any details on specific filter structures that are
useful in protecting against embolic particles. See, e.g., In re Merck & Co.,
800 F.2d 1091 (Fed. Cir. 1986) (nonobviousness is not established by
attacking references individually when unpatentability is predicated upon a
combination of prior art disclosures).
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Appellant next argues “[t]here is no way” Kerr’s structure “could be
incorporated into the dual sheath delivery structure of Agnew without major
reconstruction of Agnew,” so there is no motivation to attempt the
Examiner’s proposed combination. Appeal Br. 15. Appellant particularly
contends Kerr’s embolic capture device “is complex and requires a
specialized guide wire structure which also serves as a support for a filter.”
Id. Appellant also points out that Agnew’s prosthesis 24 “is housed inside
sheath 12,” whereas Kerr’s filter 200 is “mounted on the outside of
catheter 206.” Reply Br. 6 (emphases by Appellant).
The Examiner answers that the proposed modification to Agnew
would include only Kerr’s mesh filter, and hoop structure with a pull wire.
Final Act. 7 (citing Agnew, Fig. 3); Ans. 9. The Examiner determines a
person of ordinary skill in the art “would understand how to combine the
references for a predictable result, considering it would only require adding
the [cited] features of Kerr to Agnew,” and not the bodily incorporation of
Kerr’s structure into Agnew’s device. Ans. 9–10.
We determine a preponderance of the evidence supports the
Examiner’s determination of obviousness here. Appellant’s opposition rests
largely on the premise that the bodily incorporation of Kerr’s entire filter
structure within Agnew’s prosthesis 24 would be difficult. However, the test
for obviousness is not whether the features of one reference (such as Kerr)
may be bodily incorporated into the structure of the other reference (such as
Agnew), but rather 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)). “A person of ordinary skill is also a person of
ordinary creativity, not an automaton.” KSR Int’l Co. v. Teleflex Inc.,
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550 U.S. 398, 421 (2007). In this case, we agree with the Examiner that a
person of ordinary skill in the art would have been capable of adapting
Kerr’s mesh filter, and hoop structure with a pull wire for removal, within
Agnew’s prosthesis 24, which is deployed from the inside of a delivery
sheath, not the outside of a delivery sheath as in Kerr. See, e.g., Agnew,
Figs. 1–4, ¶¶ 42–44.
Appellant finally argues Kerr’s Figures 11–12 “show that filter 200 is
mounted on the surface of catheter 202,” not “housed in” the catheter sheath
as recited in claim 1, so the combination does not lead to the claimed
invention. Appeal Br. 15 (emphasis by Appellant) (citing Kerr, 8:42–9:37).
Instead, according to Appellant, the combination “would result in the filter
of Kerr being mounted on the exterior of the device of Agnew.” Id.; Reply
Br. 7. This argument is not persuasive because, as discussed above,
Agnew’s prosthesis 24 is deployed from the inside of a delivery sheath. See,
e.g., Merck, supra.
For the foregoing reasons, we sustain the rejection of claim 1 as
having been obvious over Agnew and Kerr.
Claim 47
In rejecting claim 47 as having been obvious over Agnew and Kerr,
the Examiner cites Agnew as disclosing an obturator-jacket assembly (i.e.,
cap 30) having a jacket-like wrapper portion (i.e., the portion of outer
member 12 with tear line 48 that covers prosthesis 24) removably coupled to
the distal end of a sheath. Final Act. 8, 16 (citing Agnew, Figs. 1–2, ¶ 8).
Appellant argues the Examiner errs in relying on “element 40” in
Agnew as being the “obturator” of claim 47, because “element 40 is a
‘channel’ and not a closure device.” Appeal Br. 15. This argument is not
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persuasive, because the Examiner relies on Agnew’s cap 30 as being an
obturator, not Agnew’s channel 40. See Final Act. 8, 16; Ans. 10. Thus, we
sustain the rejection of claim 47 as having been obvious over Agnew and
Kerr.
Claims 48–50 and 55
The Appeal Brief does not present additional argument against the
rejection of claims 48–50 and 55 as having been obvious over Agnew and
Kerr. See Appeal Br. 14–15. Appellant’s counsel presented new arguments
concerning claims 48 and 55 at the oral hearing, which we refuse to consider
as untimely presented. See Tr. 2:19–4:2, 10:1–11:16; 37 C.F.R. § 41.47(e)
(2017). We therefore sustain this rejection, for the reasons provided above
in connection with parent claims 1 and 47. See 37 C.F.R. § 41.37(c)(1)(iv)
(2017).
G. Obviousness over Agnew, Kerr, and Angel (Claims 2 and 51–54)
Claims 2 and 53
Claim 2 recites: “The system of claim 1, wherein said embolic capture
assembly comprises rail members coupled to said hoop structure and which
are configured to expand when said hoop expands.” Claims App. 1.
The Examiner determines “Agnew as modified by Kerr . . . is silent
regarding the embolic capture assembly comprising rail members coupled to
the hoop structure and which are configured to expand when the hoop
expands.” Final Act. 17 (emphasis added), 8. The Examiner then cites
Angel as “teach[ing] a filter element having a wire circumference distal end
for the purpose of capturing and retaining embolic material.” Id. (emphasis
added) (citing Angel ¶ 73, Fig. 20). The Examiner concludes it would have
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been obvious “to have modified the filter of Agnew as modified by Kerr to
include the structure of the filter of Angel in order to facilitate additional
apposition between the filter member and the vascular wall.” Id. (emphasis
added) (citing Angel ¶ 79).
Appellant opposes the Examiner’s rejection of claim 2. See Appeal
Br. 16–17.
We conclude that we cannot sustain the foregoing rejection of claim 2.
The Examiner expressly determines that Agnew and Kerr do not disclose the
claimed “rail members,” but then does not establish such a disclosure to be
present in Angel, or anywhere else in the prior art. See Final Act. 8–9, 17.
Instead, the rejection cites Angel as disclosing “a wire circumference distal
end,” which appears to relate to the hoop structure of claim 1, not the rail
members of claim 2. Id.; Ans. 10–11. This is confusing, because the
Examiner has already relied on Kerr as disclosing the hoop structure of
claim 1. Final Act. 15–16 (analysis of claim 1), 17 (“Agnew as modified by
Kerr discloses the claimed invention as set forth in claim 1”). Thus, it is not
clear exactly what structure(s) are being added to Kerr from Angel to result
in the invention of claim 2, especially the “rail members.” In that regard,
both Kerr and Angel disclose structures which might be considered “rail
members” coupled to a hoop structure. See Kerr, Fig. 12; Angel, Fig. 20.
This begs the question: what structure(s) in Angel correspond to the “rail
members” that the Examiner expressly finds to be absent in Kerr, and
exactly how does the combination lead to claim 2? Those questions are not
answered by the rejection.
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Due to this lack of clarity, we cannot sustain the rejection of claim 2,
and of claim 53 which depends from claim 2, as having been obvious over
Agnew, Kerr, and Angel.
Claims 51, 52, and 54
Claims 51, 52, and 54 each specify particular characteristics of the
“hoop structure” initially recited in their parent claim 1. Claims App. 2.
The Examiner cites Angel’s Figure 20 as disclosing a hoop structure having
the specified characteristics. Final Act. 17–18 (citing Angel ¶¶ 17, 73, 90).
We reproduce Angel’s Figure 20 here:

Figure 20 is a perspective view of a filter in an expanded state. Angel ¶¶ 39,
75, 79. As described in Angel, the filter “is formed of plural interconnected
structural elements.” Id. ¶ 76. First structural members 217 extend along
the longitudinal axis of the filter. Id. Second structural members 219 extend
from first structural members 217 to “form at least two successive zigzag
structures . . . about the circumference of the filter,” defining a “lattice-like
pattern.” Id. Circumferential ring member 252 extends from apices 227 of
second members 219. Id. ¶ 79.
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Claim 51 specifies “a plurality of hoops.” Claims App. 2. The
Examiner finds Angel’s filter has “a plurality of hoops (struts at distal end of
filter 250 and the circumferential ring 252, see Fig. 20 of Angel).” Final
Act. 17; id. at 8–9; Ans. 10–11. Appellant objects that “there are no ‘hoop
structures’ in the filter of Angel,” in part because second structural
members 219 “form a ‘lattice-like pattern’ which pattern is not and cannot
be considered to be a hoop.” Appeal Br. 16. We agree with Appellant. At
best, Angel’s circumferential ring 252 forms one hoop, not a plurality of
hoops as required by claim 51. Angel’s second structural members 219,
meanwhile, form a complicated lattice structure that the Examiner does not
adequately explain, and we do not see, how this structure can reasonably be
construed as a hoop. Thus, we do not sustain the rejection of claim 51 as
having been obvious over Agnew, Kerr, and Angel.
Claim 52 depends from claim 51, and specifies that the “plurality of
hoops are inter-coupled by struts having a zig-zag configuration.” Claims
App. 2. The Examiner finds that, in Angel’s filter, “the plurality of hoops
are inter-coupled by struts having a zig-zag configuration (see Fig. 20 of
Angel).” Final Act. 18; id. at 8–9; Ans. 10–11. For the reasons provided
above in connection with claim 51, we do not sustain the Examiner’s finding
that Angel discloses a plurality of hoops. In addition, it is not clear, and the
Examiner does not explain, how Angel’s Figure 20 discloses both a plurality
of hoop structures and inter-coupling struts having a zig-zag configuration.
Thus, we do not sustain the rejection of claim 52 as having been obvious
over Agnew, Kerr, and Angel.
Claim 54 specifies that the “hoop structure comprises nitinol.”
Claims App. 2. The Examiner finds “Angel further teaches the rail members
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and hoop structure comprise nitinol.” Final Act. 18 (emphasis added)
(citing Angel ¶ 8). We disagree with this finding. The cited disclosure
indicates only that “[r]ecovery nitinol filters” were known in the prior art.
Angel ¶ 8. It does not indicate that nitinol is an appropriate material for
forming Angel’s filters, such as the filter illustrated in Figure 20. Id.
Further, the Examiner does not provide any reasoning to bridge this gap in
the Angel disclosure, by establishing a rational basis for why it would have
been obvious to make the filter of Angel’s Figure 20 out of nitinol. See
Final Act. 18. Thus, we do not sustain the rejection of claim 54 as having
been obvious over Agnew, Kerr, and Angel.
CONCLUSION
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Basis / References Affirmed Reversed
1, 2, 47–55 112(a) Written Description 1, 2, 47–55
47–50, 55 112(a) Written Description 47–50, 55
48–50, 55 112(a) Written Description 48–50, 55
47 112(b) Indefiniteness 47
1, 2, 51–54 103(a) Pah, Clubb 1, 2, 51–54
47, 55 103(a) Pah, Clubb, Bortlein 47, 55
48–50 103(a) Pah, Clubb, Bortlein, Spenser 48–50
1, 47–50, 55 103(a) Agnew, Kerr 1, 47–50, 55
2, 51–54 103(a) Agnew, Kerr, Angel 2, 51–54
Overall
Outcome
1, 2, 47–55
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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)(1)(iv).
AFFIRMED