Ex Parte Valaie

Patent Trial and Appeal Board

Nov 26, 2012

11223333 (P.T.A.B. Nov. 26, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/223,333 09/09/2005 Arman H. Valaie 8627/826 (PA-5819-RFB) 9805
48004 7590 11/26/2012
BRINKS HOFER GILSON & LIONE/INDY/COOK
BRINKS HOFER GILSON & LIONE
CAPITAL CENTER, SUITE 1100
201 NORTH ILLINOIS STREET
INDIANAPOLIS, IN 46204-4220
EXAMINER
PATEL, SHEFALI DILIP
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
11/26/2012 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 ARMAN H. VALAIE
____________________

Appeal 2010-010315
Application 11/223,333
Technology Center 3700
____________________

Before: MICHAEL C. ASTORINO, MICHAEL L. HOELTER, and
SCOTT A. DANIELS, Administrative Patent Judges.

DANIELS, Administrative Patent Judge.

DECISION ON APPEAL

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STATEMENT OF CASE
Appellant appeals under 35 U.S.C. § 134 from a rejection of claims 1-
6, 10, 12-17, and 21-24. Claims 7-9 and 11 are canceled and claims 18-20
are withdrawn. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.

THE INVENTION
The claims are directed to a hemostatic valve system, positioned
inside a medical device called an “introducer,” which includes several valve
members allowing for passage of an interventional device, such as a
catheter, through holes which inhibit the leakage or backflow of body fluids
around the catheter. Spec. 1-2, paras. [0001]-[0004]. Claims 1, 12, and 21
are the independent claims on appeal. Claim 12, reproduced below, is
illustrative of the claimed subject matter:
12. A hemostatic valve system for use in a medical
introducer, said valve system comprising:
a plurality of valve members each having a hole
extending therethrough, said valve members axially arranged in
said medical introducer, said holes having a diameter that does
not substantially exceed a diameter of an interventional device
to be passed through said medical introducer and said valve
members, said valve members being aligned in said medical
introducer such that said holes are penetrable by said
interventional device, said valve members being axially
arranged in said medical introducer such that each of said holes
is substantially non-coaxial with reference to other valve
member holes, said holes being offset from a center portion of
said valve, and such that a hole in one valve member is covered
by an adjoining valve member.

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REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Guest
Chin
US 5,000,745
US 6,610,031 B1
Mar. 19, 1991
Aug. 26, 2003
Thompson US 2006/0135977 A1 Jun. 22, 2006

REJECTIONS
The following rejections are before us for review.
Claims 12-14, 21, and 22 stand rejected under 35 U.S.C § 103(a) as
being unpatentable over Chin. Ans. 4.
Claims 1-6, 10, 15-17, and 24 stand rejected under 35 U.S.C § 103(a)
as being unpatentable over Chin and Guest. Ans. 8.
Claim 23 stands rejected under 35 U.S.C § 103(a) as being
unpatentable over Chin, Guest, and Thompson. Ans. 14.

ANALYSIS
Claims 12-14, 21, and 22 as being unpatentable over Chin.
Claims 12 and 13
Appellant argues claims 12 and 13 as a group. We select claim 12 as
representative of the group, and claim 13 stands or falls with claim 12. See
37 C.F.R. 41.37(c)(1)(vii) (2011).
The Examiner found that all the features of the medical introducer
recited in claim 12 were obvious in view of Chin including a plurality of
valve members each of which have a hole permitting passage of a medical
device through the valve, and that the hole in each adjoining valve member
is covered by the next adjoining valve as shown in Chin’s Figure 5. Ans. 4,
Chin fig. 5 and col. 5, ll. 10-14. The Examiner points to additional
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disclosure in Chin which would make it obvious to one of ordinary skill in
the art to modify Figure 5 so that “the valve members have no common
opening with respect to all valve members (column 7, lines 23-25); hence,
all of the holes are non-coaxial with respect to one another.” Ans. 5. More
specifically, the Examiner cited to Chin column 7, lines 23-25, which states
“additionally, in one embodiment of the invention, the plurality of valve
members 532 include no residual opening portion common to all valve
members 532.”
Appellant argues that the specification language cited by the
Examiner from Chin does not relate to alignment of all the holes and Chin’s
use of the term residual in “residual opening portion” is ambiguous because
“[t]he phraseology may simply mean that adjacent holes are not coaxial, or
that some, unidentified, holes are not coaxial, or perhaps, are partially
coaxial.” Br. 6-7.
The limitation in claim 12 necessitates that the holes in each of the
valve members are “substantially non-coaxial” aligned relative to the other
holes formed in the other valve members. Br. Clms. Appx. Besides
discussing the embodiment shown in Figure 5, Chin discloses at column 7
embodiments relating to partially overlapping and non-overlapping openings
or holes, including “in one embodiment of the invention, the plurality of
valve members 532 include no residual opening portion common to all valve
members 532.” Col. 7, ll. 23-35, emphasis added. We see no ambiguity in
this description where these different embodiments are described in
proximal juxtaposition in the written description as alternatives and
modifications to the embodiment in Figure 5. The subsequent embodiment
in Chin unequivocally includes all the valve members, not merely adjacent
valve members as shown in Chin’s Figure 5. Id. It is evident from Chin’s
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description that the holes formed in each of the plurality of valve members
each lack some commonality with all the other holes in respective valve
members and therefore we agree that the holes must be non-coaxial. Also,
without any evidence or definition in Chin to the contrary, or that an
alternate meaning of the common term “opening” was intended, we agree
with the Examiner that the term “residual opening portion” in Chin’s
disclosure cannot be substantively differentiated from the term “openings”
or “opening portions”. Ans. 16.
Appellant also argues that there is a benefit to the claimed
arrangement of the non-coaxial aligned holes because “the forces exerted on
the interventional device as it passes through the introducer are not
concentrated at one or two points on the surface of the device, as in Chin.”
Id. Appellant provides the Declaration of the inventor, Arman H. Valaie, in
support of this proposition, and asserts additional illustrations of such
benefits from Appellant’s Specification at page 10, line 24 to page 11, line
11, and Figures 9-11. Br. 7-8.
We are not persuaded by Appellant’s argument regarding the benefits
of proportionally distributing the holes circumferentially about the axial
center of the valve system. Br. 7-8. We do not find, nor has Appellant
presented any corresponding feature or limitation, either structural or
functional, in the claim relating to such a benefit aside from the non-coaxial
nature of the holes, which as discussed supra we find to be taught by Chin.
For these reasons we affirm the Examiner’s rejection of both claims
12 and 13 in view of Chin.
Claim 14
We agree with the Examiner that it would have been obvious “to
modify the location of the holes in the valve members, of the illustrated
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embodiment of the valve system (Figure 5) of Chin, to be non-coaxial with
respect to one another, as taught by the unillustrated embodiment of the
valve system of Chin” (Ans. 7). However Appellant’s explanation is
persuasive that in such an arrangement where holes are provided in separate
quadrants of the valve, the forces from the holes are not concentrated at one
or two points on the surface of the device as in Chin, but rather, at four
points distributed about the axial center of the valve. Br. 8, Spec. para.
0048, fig. 5 and Decl. of Arman H. Valaie, paras. 7-9. The Examiner’s
rejection insufficiently explains what in the prior art would have prompted a
person of ordinary skill in the art to align the holes in separate quadrants.
The Examiner has presented no findings in Chin nor other evidence or
articulated reasoning based on rational underpinnings. See In re Kahn, 441
F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds
[require] some articulated reasoning with some rational underpinning to
support the legal conclusion of obviousness”) (cited with approval in KSR
Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007)).
For these reasons we therefore reverse the Examiner’s rejection of
claim 14.
Claims 21 and 22
Appellant argues that Chin fails to teach or disclose the features of
paragraph d) in claim 21, namely “the hole in each valve member is equally
and circumferentially disposed from each adjoining valve member about the
axial center, such that the center of the holes of each said valve members
defines a vertex of a regular polygon about said axial center.” Br., Clms.
Appx. Appellant argues that the benefit of arranging the holes in the manner
of a regular polygon about the axial center of the valve member more evenly
distributes radial forces about the device. Br. Clms. Appx., and Br. 9-11.
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The Examiner reasons that the distribution of force is dependent upon
placement of the holes and because Chin teaches oppositely aligned and
non-coaxial holes it would therefore be obvious for one of ordinary skill in
the art to modify the location of the holes of Chin to define vertices of a
regular polygon. Ans. 22.
Again, as with the separate quadrants recited in claim 14 the Examiner
has not sufficiently articulated reasons and rational underpinnings which
could properly serve as the basis for concluding that it would have been
obvious to a person of ordinary skill in the art to specifically arrange the
holes to form a regular polygon about the axial center of the valve. Chin
discloses that holes may be non-coaxial, and linearly separated as in Fig. 5,
however we fail to see how one of skill in the art would be led to distribute
the holes about the center of the valve members in a regular polygon besides
the Examiner’s mere conclusion using the Appellants own disclosure and
argument that “[w]ith the holes being non-coaxial with respect to each other,
forces on the interventional device would then not be concentrated at only a
few points.” Ans. 21.
Accordingly, the rejection of claims 21 and 22 under 35 U.S.C.
§ 103(a) as unpatentable over Chin cannot be sustained. See In re Fine, 837
F.2d 1071, 1076 (Fed. Cir. 1988) (If an independent claim is nonobvious
under 35 U.S.C. § 103, then any claim dependent therefrom is nonobvious).

Claims 1-6, 10, 15-17 and 24 as being unpatentable over Chin and Guest.
Appellant argues claims 1, 4- 6, and 10 as a group, where claim
1 is the only independent claim. We select claim 1 as representative of the
group where claims 4-6, and 10 stand or fall with claim 1, and address in
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turn Appellant’s separate arguments as to the remaining claims. See 37
C.F.R. 41.37(c)(1)(vii) (2011).
Claims 1, 4-6, and 10
The Examiner found that Chin teaches all the features of claim 1, with
the exception of the claimed notch on the circumferential edge of each valve
member designed to engage with a tab on the inside of the valve housing in
order to appropriately align each valve member. Ans. 9. The Examiner
found that Guest teaches valve members which each include a notch 152,
154, and 156 on the outer edge for engaging with tab 150 formed on an
inside surface of the valve housing cap 16 and reasoned that “notches on
each valve member and respective tabs in the housing, as taught by Guest et
al, in an introducer of Chin, . . . will create a means for aligning the valve
members within the medical introducer (column 5, lines 23-32) in an
organized fashion.” Ans. 9-10. In addition, the Examiner found that Guest
discloses further unillustrated embodiments of notches and protrusions for
aligning the membranes in the cap such as forming recesses in the
membranes and molding protrusions in the cap or forming notches. Guest
col. 5, ll. 23-26 and fig. 1.
Appellant argues with respect to the claimed notches and tabs that
“[t]he respective notches and tabs act as a key of sorts, wherein a tab is
receivable in a notch when a valve member is arranged in the chamber” and
such structure is useful because the valve members may be maintained in a
desired orientation with respect to one another. Br. 12. Appellant also
argues that because of the plurality of axially and circumferentially spaced
tabs in the end cap, each valve member can be otherwise identical and the
assembly process simplified “[w]hen assembling the valve system, a
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plurality of otherwise-identical disks may be taken from a previously
manufactured stack of such disks.” Br. 13.
We are not persuaded by Appellant’s position because Guest
specifically describes that aligning of the valve members can occur by the
use of a plurality protrusions and notches. See Guest col. 5, ll. 23-26. The
teachings of Guest and Chin in this case reasonably support the Examiner’s
reliance on In re Japikse, 181 F.2d 1019 (CCPA 1950) and a well-articulated
determination that the claimed notches and tabs are an obvious
rearrangement of parts involving only routine skill available to one of
ordinary skill in the art and therefore, the rejection of claims 1, 4-6, and 10
for obviousness over Chin in view of Guest is sustained.
Claim 2
The Examiner found dependent claim 2 to be obvious where Chin
teaches holes offset from the valve member center axis, and that based on
Chin’s embodiment described at column 7, lines 23-25, it would be obvious
to one of ordinary skill in the art to align all of the holes in a non-coaxial
arrangement in the modified introducer of Chin and Guest for the same
reasoning with regards to claim 12 discussed supra. Ans. 27.
Appellant argues that the claimed arrangements are not taught or
suggested by the combination. Br. 15. We find this inadequate to overturn
the Examiner’s findings that Chin discloses offset holes and an embodiment
“in which the valve members have no common opening with respect to all
valve members (column 7, lines 23-25); hence, the holes are non-coaxial.”
Ans. 27. Therefore we sustain the Examiner’s rejection of claim 2.
Claim 3
Similar to claim 14 discussed supra the Examiner uses Chin’s
embodiment at column 7, lines 23-25 to support the finding that Chin
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teaches providing holes in each of the valve members which have no
common openings, and therefore it is a matter of design choice for one of
ordinary skill in the art to position the holes in different quadrants. Ans. 27.
We agree that this finding is in error noting Appellant’s argument,
supporting declaration and Specification describing that by proportionally
distributing the four holes about the axial center in distinct and separate
quadrants the forces from each hole are not concentrated at one or two points
on the surface of the device as in Chin, but rather, at four points distributed
about the axial center of the valve. Br. 14, Spec. para. [0048], fig. 5 and
Decl. of Arman H. Valaie paras. 7-9. Because the prior art does not disclose
four holes distributed about the center in four distinct quadrants we reverse
the rejection of claim 3.
Claims 15-17
The Examiner found that where Chin is silent in regards to a key
portion, Guest teaches notches (recesses) in the valve members and engaging
tabs (protrusions) formed in the end cap of the introducer housing and “that
each of said generally circular holes (holes [38][40]) is positioned at a
portion of the valve member (membranes [32][34]) directly opposite of a
notch (indentations [152][154]). Ans. 29-30. The Examiner reasons that by
forming the notches in the same (identical) location on each valve member
Appellant is merely undertaking an obvious rearrangement of parts
involving only routine skill in the art. Ans. 30. Appellant contends, that
“[n]either Chin nor Guest teaches or suggests a valve system comprising
identical ‘keyed’ valve members as claimed.” Br. 15. Emphasis added.
We are not persuaded of error in the Examiner’s findings because
Chin discloses “identical valve members”, and Guest teaches various
embodiments of engaging notches and tabs, i.e., key portion(s) and
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corresponding key portion(s). Chin fig. 5 and Guest fig. 1. Moreover,
Appellant’s own Specification raises various alternatives to the claimed
notch and tab structure. Spec. paras. [0044]-[0045]. Furthermore, without
objective evidence to the contrary, the asserted benefit towards an improved
assembly process as argued by Appellant is insufficient to convince us that
the Examiner’s findings and interpretations of the prior art are incorrect, and
thus we sustain the obviousness rejection of claims 15-17.1
Claim 24
Appellant argues with respect to claim 24 that the claimed
arrangement of the holes in the valve members being positioned directly
opposite from the notch in the circumferential edge is not found in Chin and
Guest, and also that such relative positioning of these features is a benefit
because it facilitates “the very specific assembly of the valve member.” Br.
15. The Examiner found that “Guest et al teaches that each of said generally
circular holes (holes [38][40]) is positioned at a portion of the valve member
(membranes [32][34]) directly opposite of a notch (indentations
[152][154]).” Ans. 28-29. The Examiner also found unpersuasive
Appellant’s position regarding such an arrangement as beneficial beyond the
teachings of Chin and Guest because positioning the notches opposite from
the holes would be an obvious design choice. Ans. 29.
Observing Guest’s Figure 1 which illustrates the holes 38, 40 and
relative notches 152, 154 formed diametrically opposed on the valve
member, we see no error in the Examiner’s findings that the claimed

1 Claim 17 is not substantively argued by Appellant and therefore because it
is directly dependent upon claim 15 and where we find no error in the
Examiner’s findings for claim 15, we also sustain the rejection of claim 17.
Only issues and findings of fact contested by the Appellant will be
addressed. See Ex Parte Frye, 94 USPQ2d 1072, 1075-76 (BPAI 2010).
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relative arrangement between the notches and holes is merely a
rearrangement of parts which involves only routine skill in the art. Ans. 29.
The Examiner reasoned that such an arrangement would facilitate the
specific assembly and alignment of the valve members with respect to one
another. Id. Furthermore, Appellant’s assertions that the opposite
positioning of the holes and notches in the valve facilitates the assembly
process of the device is unsupported by evidence from the Specification and
is insufficient to convince us that the Examiner’s findings with respect to the
alignment of the holes and the notches are wrong and we therefore sustain
the Examiner’s rejection of claim 24.

Claim 23 as unpatentable over Chin and Guest, and further in view of
Thompson.

The Examiner introduced the tertiary reference of Thompson for the
teaching that tabs which engage and align the valve members inside the
introducer can be “evenly spaced”, as recited in Appellant’s claim 23. Ans.
31. Appellant argues that Thompson’s disclosed “key” structure is different
from the claimed structure because “[u]nlike the claimed structure, the ‘tabs’
of Thompson are provided on a common retaining ring, aligned to be
received in corresponding openings in a common female sealing ring 46.”
Id. The Examiner answers by explaining that where Chin and Guest disclose
the specific “keyed” structural arrangement as recited in the claims, “[e]ven
though Thompson may not teach an interior housing surface, since
Thompson teaches a retaining ring, Thompson is still applicable art since
Thompson teaches securely positioning two components together by a
keyed-type arrangement (Thompson, paragraph [0041]).” Ans. 32.
Thompson’s use of a retaining ring with evenly spaced prongs 45 as seen in
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Thompson’s Figure 2, using tabs or protrusions on the interior housing wall,
even with circumferential displacement of the tabs the evenly spaced tabs
could be used to appropriately align the valve members and securely
position the valve members with respect to the housing. Ans. 32.
Appellant’s argument that Thompson is not persuasive because of its
different structure does not persuade us of error in the Examiner’s findings
here because it is well settled that “[c]ombining the teachings of references
does not involve an ability to combine their specific structures.” In re
Nievelt, 482 F.2d 965, 968 (CCPA 1973). For these reasons we therefore
also sustain the Examiner’s rejection of claim 23.

DECISION
For the above reasons, we AFFIRM the rejections of claims 12 and 13
as being unpatentable over Chin; claims 1-6, 10, 15-17, and 24 as being
unpatentable over Chin and Guest; and claim 23 as being unpatentable over
Chin, Guest, and Thompson.
We REVERSE the rejections of claims 14, 21, and 22 as being
unpatentable over Chin; and claim 3 as being unpatentable over Chin and
Guest.
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) (2011).

AFFIRMED-IN-PART
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