Ex Parte 6554760 et al

Patent Trial and Appeal Board

Jul 21, 2014

95001988 (P.T.A.B. Jul. 21, 2014)

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.
95/001,988 06/08/2012 6554760 JHN-5940-2 2108
23117 7590 07/22/2014
NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON, VA 22203
EXAMINER
FLANAGAN, BEVERLY MEINDL
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
07/22/2014 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
____________________

BEST MEDICAL INTERNATIONAL, INC.
Requester, Respondent

v.

WORLWIDE MEDICAL TECHNOLOGIES, LLC
1

Patent Owner, Appellant
____________________

Appeal 2014-005274
Inter partes Reexamination Control 95/001,988
Patent US 6,554,760 B2
2

Technology Center 3900
____________________

Before JAMES T. MOORE, DANIEL S. SONG and
BRETT C. MARTIN, Administrative Patent Judges.

SONG, Administrative Patent Judge

DECISION ON APPEAL

Each of claims 1-42 subject to reexamination stand rejected, claims
22-42 having been added during the reexamination (App. Br. 4; Right of
Appeal Notice
3
(hereinafter "RAN") 1). The Patent Owner appeals under

1
Worldwide Medial Technologies, LLC is the Patent Owner and the real
party in interest (Appeal Brief of Patent Owner (hereinafter "App. Br.") 3).
2
Patent US 6,554,760 B2 (hereinafter "the '760 patent") issued April 29,
2003 to Lamoureux et al.
3
The Examiner's Answer incorporates the RAN by reference. Hence, we
cite to the RAN herein.
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35 U.S.C. §§ 134(b) and 315 from the Examiner's rejections with respect to
all of the rejected claims (App. Br. 4). We have jurisdiction under 35 U.S.C.
§§ 134(b) and 315.
The Patent Owner relies on its Appeal Brief, Rebuttal Brief
(hereinafter "Reb. Br."), Declaration of Gary Lamoureux (hereinafter "Decl.
of Lamoureux"), and Expert Witness Report of Peter Sanchez (hereinafter
"Expert Report") in support of patentability. The Requester relies on its
Respondent Brief in support of the Examiner's rejections. An oral hearing
with the representative of the Patent Owner was held before the Patent Trial
and Appeal Board on July 9, 2014, a transcript of which will be entered into
the electronic record in due course.
We are informed that the '760 patent is/was involved in seven
different legal actions (App. Br. 3-4). We are also informed that a summary
judgment order entered in the Lamourex, et al. v. Genesis Pharmacy Svc, et
al. (Case 3:03-cv-01382-WIG; D. Mass. 2003) invalidates certain claims of
the '760 patent, but that this case is still pending (App. Br. 4).
We AFFIRM-IN-PART.

The '760 patent is directed to a needle assembly for implanting
therapeutic elements and a method of making such a needle assembly.
Representative independent claims 1 and 17 read as follows (Claims App'x.,
paragraphing and italics added):
1. For implanting therapeutic elements, a needle assembly
comprising
a cannula having a wall and a sharpened distal end,
a line of elements in the cannula extending rearward from
the distal end, yieldable means, including a frictionally held
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plug, for positioning an element more proximate the distal end
a predetermined distance from the distal end, and
a stylet reciprocable in the cannula and having a distal
end engaging an end of the line of elements more remote from
the distal end of the cannula.

17. A method of making a needle assembly for implanting
radiation seeds, comprising the steps of:
a. providing a cannula having a sharpened distal end and
a generally cylindrical plug,
b. forcing the plug into the sharpened distal end of the
cannula to frictionally reside there.

The Examiner rejects the claims as follows:
4

1. Claims 1-18 and 21 under 35 U.S.C. § 103(a) as obvious over
Yoshizumi
5
in view of Miller.
6

2. Claims 1, 2, 4-18 and 21 under 35 U.S.C. § 103(a) 35 U.S.C.
§ 103(a) as obvious over Andrews
7
in view of Miller and Jacobs.
8

3. Claim 19 under 35 U.S.C. § 103(a) as obvious over Yoshizumi
in view of Miller and Sierocuk.
9

4. Claim 20 under 35 U.S.C. § 103(a) as obvious over Yoshizumi
in view of Miller and Taylor.
10

4
For consistency, we utilize the numbering of "Issues" as used by the Patent
Owner in the Appeal Brief and by the Examiner in the RAN. Rejection
proposed in "Issue 6" was not adopted by the Examiner (RAN 6).
5
U.S. Patent No. 6,572,525 B1 issued June 3, 2003.
6
U.S. Patent No. 6,450,938 B1 issued Sep. 17, 2002.
7
U.S. Patent No. 6,210,315 B1 issued Apr. 3, 2001.
8
U.S. Patent No. 6,402,677 B1 issued June 11, 2002.
9
U.S. Patent No. 6,221,003 B1 issued Apr. 24, 2001.
10
U.S. Patent No. 6,530,875 B1 issued Mar. 11, 2003.
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5. Claims 25, 30, 35 and 40 under 35 U.S.C. § 112, first paragraph
for failing to comply with the written description requirement.
7. Claims 22-25, 28-30, 33-35 and 38-40 are rejected under 35
U.S.C. § 103(a) as obvious over Yoshizumi in view of Miller.
8. Claims 22-25, 28-30, 33-35 and 38-40 under 35 U.S.C. § 103(a)
as obvious over Andrews in view of Miller and Jacobs.
9. Claims 26, 27, 31, 32, 36, 37, 41 and 42 under 35 U.S.C.
§ 103(a) as obvious over Yoshizumi in view of Miller and
Mercereau.
11

ANALYSIS
In rejecting the claims on appeal, the Examiner adopts and
incorporates by reference the rejections set forth in pages 13-55 of the
Requester's Detailed Request for Inter Partes Reexamination filed June 8,
2012 (hereinafter "Request") (RAN 6). We address the various arguments
of the Patent Owner disagreeing with the Examiner's findings and
conclusions infra, but we do so in an order that differs from the order
presented. Only those arguments actually made by the Patent Owner have
been considered and any arguments not made are deemed to be waived. See
37 C.F.R. § 41.67(c)(1)(vii).

Rejection 5
Claims 25, 30, 35 and 40 added during the reexamination stand
rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the

11
U.S. Patent No. 6,450,937 B1 issued Sep. 17, 2002.
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written description requirement (RAN 6). With respect to this rejection, the
Examiner adopts the rejection as proposed in Third Party Requester's
Comments filed April 19, 2013 (hereinafter "Req. Comm.") (RAN 6). These
claims include the limitation that "the wall of the cannula includes an outer
surface configured to abut tissue of a body into which the cannula is to be
inserted." (See, e.g., Claims App'x., Claim 25). Claims 35 and 40 also
recite that "the step of forcing the plug includes positioning the plug in the
cannula at a predetermined distance from the distal end of the cannula."
(See, e.g., Claims App'x., Claim 35).
The Requester argues that "[t]he '760 patent does not use [these] terms
or otherwise provide written description of [] these claim elements," and
lacks description of forcing the plug with a needle without any openings
(Req. Comm. 11-13). The Patent Owner cites to various portions of the '760
patent as providing written description by their disclosure that the needle
assembly is inserted into the tissue of the body, and that the plug is
positioned at a predetermined distance from the distal end (App. Br. 26-27
citing col. 4, ll. 25-33; see also App. Br. 5-8; col. 3, ll. 60-65; col. 4, ll. 34-
41).
We agree with the Patent Owner. The test for sufficiency of written
description is "whether the disclosure of the application relied upon
reasonably conveys to those skilled in the art that the inventor had
possession of the claimed subject matter as of the filing date." Ariad
Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir.
2010). There is no requirement that the specification recite the claimed
invention in haec verba. Id. at 1352.
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The specification of the '760 patent discloses:
The end plug 32 composes a rearward cylindrical end surface
32a (FIG. 2) which is positioned at an exact length back from
the extreme distal end of the tip 20a of the beveled point 20.
This distance is critical and it does not vary from assembly-to-
assembly.
The means by which the end plug 32 is positioned in the
cannula with its end surface 32a at the pre-determined distance
back may be based on one of a variety of structures and
techniques. …
…The end plug 32 may be positioned as a friction fit
pressed into the distal end of the cannula as a cork in a bottle.
(Col. 3, l.-col. 4, l. 9; see also Fig. 2).

The specification of the '760 patent also discloses:
In more detail, in the operation of the needle assembly
shown in FIGS. 1 and 2, as with the other embodiments to
follow, the needle assembly is inserted in the tissue of the body
to be treated, distal end first. …
It will be understood that the exact positioning of the rear
end surface 32a at the pre-established distance back from the tip
20a is a significant advance over the haphazard positioning of
the more proximate end of a bone wax material as used in the
needle assemblies of the prior art. The arrangement of the
present disclosure enables the operator to be 40 assured of the
precise positioning of the front end of the first seed 28 and the
succeeding spaced seeds as they are inserted.
(Col. 4, ll. 25-41; see also Figs. 1 and 2).

Hence, by disclosing that the needle assembly is inserted into the
tissue of the body to be treated, the '760 patent makes it reasonably clear that
"the wall of the cannula includes an outer surface configured to abut tissue
of a body into which the cannula is to be inserted." Further, by disclosing
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that the plug is "friction fit pressed" into the cannula, and that the rear end
surface 32a of the plug is positioned at a pre-established distance, the '760
patent provides reasonably clear written disclosure for "the step of forcing
the plug includes positioning the plug in the cannula at a predetermined
distance from the distal end of the cannula." While the exact language of the
limitations may not be used in the '760 patent, such use of the exact
language is not required. Finally, the Requester's assertion that the '760
patent lacks description of forcing the plug with "a needle without any
openings" (Req. Comm. 12-13) is misdirected as the claims at issue do not
require such a needle. Therefore, we reverse Rejection 5.

Rejections 1 and 7
Under these rejections, claims 1-18, 21-25, 28-30, 33-35 and 38-40
stand rejected as obvious over Yoshizumi in view of Miller (RAN 5, 7). The
Examiner agrees with the Requester that Yoshizumi discloses "a plug in the
form of stopping mechanism 27 [i.e., spring element] to retain the seeds and
spacers in a first position" and that Yoshizumi alternatively discloses "rather
than using a spring element, the proximal end 29 of the shaft may be
plugged with bone wax or other biologically acceptable surgical paste or
material 31." (RAN 10 citing Req. Comm. 4). The Examiner finds that
"Yoshizumi teaches a plug positioned a predetermined distance from the end
of the cannula, as recited in the claims, either as a spring mechanism or an
actual plug." (RAN 10).
By incorporating by reference the Request, the Examiner also finds
that Miller specifically discloses and solves the problem of not knowing the
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position of the first seed to conclude that it would also have been obvious to
combine Yoshizumi with Miller to modify the plugging of the needle tip
with biologically acceptable plug material that is placed at a predetermined
distance from the needle tip such that the exact location of the first seed is
known (see Request 24-25). We agree with the Examiner's findings and
conclusion.
The Patent Owner argues that "Yoshizumi does not state that the seeds
are positioned a predetermined distance from the end of the cannula," and
fails to recognize the need for precise positioning of the seeds in cannula
because it is directed toward confirming proper sequence of seeds (App. Br.
10-11; Reb. Br. 2). However, Yoshizumi specifically states:
Alternatively, rather than using a spring element as a stopping
mechanism, the proximal end 29 of the shaft may be plugged
with bone wax or other biologically acceptable surgical paste
or material 31 that can be dislodged from the proximal end 29
of the sleeve member upon application of force.
(Yoshizumi, col. 5, ll. 46-51, emphasis added).

Yoshizumi also specifically states:
The radioactive seeds are drawn a predetermined distance into
the catheter to place them into position at the exposed portion
of the catheter 40 proximate to the tumor 38.
(Yoshizumi, col. 6, ll. 22-25; Request 16).

Thus, the disclosed spring element 27 located within the needle
positions the seeds at "a predetermined distance from the distal end" as
recited by the claims and can be considered to be a plug. Alternatively, the
spring element 27 may be replaced by a plug of a biologically acceptable
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material at the same location as suggested in Yoshizumi. The Requester's
argument based on removal of the stopping mechanism in Yoshizumi to
allow sliding of the elements (App. Br. 10-11) is misguided because it is
clear that the removable stopping mechanism 26 pertains to yet another
alternative embodiment therein (Yoshizumi, col. 4, ll. 54-59) that is not
relied upon in the rejection at hand. While Yoshizumi may not explicitly
discuss the importance of predetermined positioning of a plug, this omission
does not detract from the fact that such positioning is disclosed. Cf. In re
Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002) ("Inherency
is not necessarily coterminous with the knowledge of those of ordinary skill
in the art. Artisans of ordinary skill may not recognize the inherent
characteristics or functioning of the prior art.").
Moreover, as also noted by the Examiner, Miller teaches the
importance of such positioning, disclosing that:
Precise placement is enhanced using the present invention
because the first seed is always in a known location within the
passageway unlike prior art devices, which require the use of
bone wax. When wax is forced into the exit aperture of the 60
cannula, the amount of wax that is caught within the aperture is
variable. The physician is never entirely certain how deep the
wax plug extends into the passageway. Of course, the depth of
the wax plug determines the location of the first seed. The
present invention solves this problem because the location of
the first seed is always known and can be easily determined by
examining the outer surface of the cannula to determine the
location of the retention tab.
(Miller, col., 6, ll. 55-67).

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The Patent Owner also argues that Miller teaches away from using a
plug by disparaging its use and because use of a plug would not provide
advantages of the retaining tab disclosed therein, such as providing tactile
indication or visible indication (App. Br. 13-14). The Patent Owner asserts
that "[r]egardless of the material used to form the plug, the amount of
material in the plug and the depth of the plug may be uncertain." (App. Br.
15). Hence, the Patent Owner asserts that a person of ordinary skill in the art
would not combine the teachings of Yoshizumi with Miller, which teaches
away from the use of plugs (App. Br. 15).
However, we agree with the Examiner that these arguments are
misplaced because "Miller does not teach away from the use of plugs, but
instead discusses difficulties with using bone wax specifically." (RAN 10-
11). Indeed, like the excerpt of Miller reproduced above, various other
portions of Miller relied upon by the Patent Owner in asserting that Miller
disparages use of plugs are all directed to the use of bone wax (App. Br. 14-
15; Miller col. 1, ll. 60-67; col. 4, ll. 8-16). Hence, we agree with the
Requester that the Patent Owner's "efforts to extrapolate from bone wax to
'all types of plugs' are misplaced, and mischaracterize the teachings of
Miller." (Resp. Br. 5). Miller disparages use of bone wax for its numerous
disadvantages disclosed therein, but does not disparage use of plugs in
general, and thus, the evidence of record supports a finding that Miller does
not teach away from using all types of plugs, including those not made of
bone wax.
Moreover, while the use of a plug may not result in certain advantages
of the retaining tab disclosed in Miller, this does not establish that Miller
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teaches away from combining the teachings of Yoshizumi and Miller as
asserted by the Patent Owner. While lack of such indicators may be less
desirable in certain applications, "case law does not require that a particular
combination must be the preferred, or the most desirable, combination
described in the prior art in order to provide the motivation for the current
invention." In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004).

Commercial Success
The Patent Owner also argues that the Examiner erred in finding that
the submitted evidence of secondary considerations fails to establish nexus
to the claimed invention, and erred in dismissing the declarations as
conclusory (App. Br. 23, 25). The Patent Owner argues that "commercial
success is the creation of a market for needle assemblies pre-loaded with
therapeutic elements," which reduces time and cost (App. Br. 24).
According to the Patent Owner, the "nexus between the commercial success
and the claimed invention is the positioning of the plug in the needle
assembly a predetermined distance from the distal end of a cannula of the
needle assembly," which enhances accuracy of seed placement (App. Br.
25).
In his declaration, Mr. Lamoureux declares, inter alia, that "it is my
opinion that Seed[-] Lock, Readi[-]Load and Readi[-] Strand have changed
the direction of prostate cancer treatment industry, and represent an
improvement over the prior method of Brachytherapy needle assemblies" in
that they provide pre-plugged, pre-loaded, pre-sterilized needles so as to
lower risk of infection and improved accuracy to help improve treatment
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outcomes (Decl. of Lamourex ¶¶ 3, 4, 7). In his Expert Report, Mr. Sanchez
states, inter alia, that World Wide's pre-plugged, pre-loaded needles
overcame various drawbacks of bone wax, saved time in the operating room,
and enhanced "consistency and accuracy of the seed delivery to the desired
locations." (Expert Report, pg. 5).
In reviewing the proffered evidence, we find no error in the
Examiner's conclusions because there is inadequate evidence to establish
commercial success, much less nexus between the alleged commercial
success and the claimed invention. Firstly, while "commercial success" is
alleged, the proffered evidence lacks supporting objective evidence such as
sales figures, market share information, etc., that actually establish
commercial success. Kansas Jack, Inc. v. Kuhn, 719 F.2d 1144, 1150-51
(Fed. Cir. 1983) ("There was no evidence of market share, of growth in
market share, of replacing earlier units sold by others or of dollar amounts,
and no evidence of a nexus between sales and the merits of the invention.
Under such circumstances, consideration of the totality of the evidence,
including that relating to commercial success, does not require a holding that
the invention would have been nonobvious at the time it was made to one
skilled in the art.").
While the Patent Owner asserts "commercial success is the creation of
a market for needle assemblies pre-loaded with therapeutic elements," there
is minimal evidence as to the size of this market, or comparative information
demonstrating its acceptance, such as its impact on the original market. In
addition, we also observe that pre-loading of a needle assembly is not recited
in the claims, and even if it were implicitly required, when a needle
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assembly is provided to the physician during surgery, it is typically pre-
loaded for the physician by a Certified Medical Dosimetrist prior to the
surgery (see generally, Expert Report). Ormco Corp. v. Align Technology,
Inc., 463 F.3d 1299, 1311-12 (CAFC 2006) ("if the commercial success is
due to an unclaimed feature of the device, the commercial success is
irrelevant. So too if the feature that creates the commercial success was
known in the prior art, the success is not pertinent.").
As noted, we are not provided with any objective evidence that
establishes the size of the market, the increasing size of the market, its
impact on non-pre-loaded needle assembly market, etc. The Patent Owner
argues that such detailed sales numbers or the like is not required (App. Br.
25). However, presence of such detailed sales and market information
would aid in factually establishing commercial success, whereas the lack
thereof limits the probative value of the evidence submitted to that of an
unsubstantiated assertion of commercial success.
The Patent Owner explains that "such numbers could reveal
confidential business trade secrets that are not to be publically disclosed"
and that the Requester has not shown a lack of commercial success (App. Br.
25). However, the Patent Owner does not state that submission of such
evidence would in fact reveal trade secrets, and regardless, it is the Patent
Owner's burden to support its allegations of commercial success through
objective evidence in support of its contentions of nonobviousness. In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992); see also In re Piasecki, 745
F.2d 1468, 1472 (Fed. Cir. 1984). The burden does not lie with the Patent
Office or the Requester to demonstrate a lack of commercial success.
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Furthermore, even if there were commercial success, the Patent
Owner fails to establish the requisite nexus between the asserted commercial
success and the claimed invention persuasively. Whereas the Patent Owner
asserts that nexus has been established because the claimed invention is
directed to positioning of the plug at a predetermined distance, the Patent
Owner has not submitted persuasive objective evidence linking the asserted
commercial success to the asserted benefit. See In re Huang, 100 F.3d 135,
140 (Fed. Cir. 1996) (If evidence of commercial success is relied upon, the
Appellant must offer proof "that the sales were a direct result of the unique
characteristics of the claimed invention-as opposed to other economic and
commercial factors unrelated to the quality of the patented subject matter.").
We also disagree with the Patent Owner's assertion that the Examiner
dismissed the declarations (App. Br. 25). Instead, the Examiner correctly
found the evidence inadequate and unpersuasive (RAN 11). The mere fact
that the Examiner's conclusion with respect to the proffered evidence differs
from that of the Patent Owner does not mean that the Examiner dismissed
them. Correspondingly, in view of the above, we are not persuaded that the
Examiner erred in considering the proffered evidence of record.

Claims 17 and 18
The Patent Owner also argues that Yoshizumi and Miller references
fail to disclose forcing or placing a cylindrical plug into the distal end of the
cannula as recited in independent claims 17 and 18, or modifying the
diameter of the plug to enhance its frictional engagement as recited in claim
18 (App. Br. 9, 12). The Patent Owner asserts that "[t]he rejection does not
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provide a prima facie rejection for claims 17 and 18 because it does not
explain clearly why the Examiner found that Yoshizumi or Miller teach or
suggest a cylindrical plug that is forced or placed in a cannula." (App. Br.
12).
In rejecting claim 17, the Examiner relies on the disclosure in
Yoshizumi of plugging the needle "with bone wax or other biologically
acceptable surgical paste or material 31 that can be dislodged from the
proximal end 29 of the sleeve member upon application of force."
(Yoshizumi, col. 5, ll. 46-51; RAN 5; Request 34). In this regard, there is no
dispute that the use of bone wax as plugs for needles was well known in the
art (see '760 patent, col. 1, ll. 29-32, 43-47; Yoshizumi, col. 4, ll. 40-44, col.
5, ll. 46-51). In mentioning the conventional use of bone wax, Miller also
states that "wax is forced into the exit aperture of the 60 cannula" (Miller,
col. 6, ll. 59-61) thereby demonstrating that forcing of plugs of wax was well
known in the art. As also explained by the Patent Owner's representative
during the oral hearing, plugging of needles is conventionally attained by
forcing the bone wax into the opening at the distal end of the needle. Hence,
a person of ordinary skill, in reviewing the prior art, would have known that
the disclosed bone wax would be forced into the opening at the distal end of
the needle. See Hybritech v. Monoclonal Antibodies, Inc., 802 F.2d 1367,
1384 (Fed. Cir. 1986) ("[A] patent need not teach, and preferably omits,
what is well known in the art[.]").
As also noted supra, Yoshizumi discloses use of "other biologically
acceptable surgical paste or material 31 that can be dislodged from the
proximal end 29 of the sleeve member upon application of force."
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(Yoshizumi, col. 5, ll. 46-51). Hence, a person of ordinary skill would have
understood that such alternative plugs are also forced into the distal end of
the cannula, or otherwise would have found such installation of the plug
obvious. Moreover, to the extent that other biologically acceptable surgical
material is used, it would have been obvious to provide the plug in a
"generally cylindrical" shape as recited in the claim in view of the fact that
the needle/cannula is cylindrical/tubular in shape.
As to claim 18 which requires modifying the diameter of the plug to
enhance its frictional engagement, the Examiner relies on various portions of
Miller (RAN 5; Request 35-36). In this regard, Miller discloses that it is
known to use needles with a constricted portion so that the contents thereof
are slightly larger than the constricted portion (Miller, col. 2, ll. 1-15).
Miller also discloses the fact that objects received in the cannula can vary in
size, that the retaining tab can be adjusted according to the size, and that the
dimensions of the cannula and the retaining tab can also be selected based on
a particular application (Miller, col. 5, ll. 19-22, 37-54).
In view of these teachings, we agree with the Examiner that
"modifying the diameter of the plug to enhance its frictional engagement
with the wall of the cannula" would have been obvious to a person of
ordinary skill in the art. The retaining tab of Miller performs the same
function as the claimed plug, that is, to retain the seeds and spacers within
the cannula. Whereas Miller discloses adjustment or modification of the
passageway through the cannula via provision of a retaining tab or a
constricted portion, it would have been obvious to one of ordinary skill in
the art that similar retention can be attained by modifying the diameter of the
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plug. In other words, in view of the teachings in Miller to decrease the size
of the passageway, it would have been obvious to practice the reverse by
increasing the size of the plug. See In re Gazda, 219 F.2d 449, 452 (CCPA
1955) (reversal of parts would be an obvious expedient); see also In re
Einstein, 46 F.2d 373, 374 (CCPA 1931).

Claims 5-8 and 12-14
These dependent claims require an "irregularity" or an "inward tab" in
the wall of the needle that cooperates with the plug. The Patent Owner
argues that "it would not have been obvious to use both a plug and a
retaining tab or other irregularity in the wall of the cannula as recited
dependent claims 5 to 8 and 12 to 14." (App. Br. 17). However, the
evidence of record establishes that an irregularity or an inward tab in the
wall was well known in the art and that such tabs retain the desired contents
within the cannula (Miller, col. 2, ll. 1-5; col. 4, ll. 60-67; Figs. 2-5). Thus,
we agree with the Examiner that providing such a feature on a needle
assembly that cooperates with the plug, would have been obvious to one of
ordinary skill, the plug also being received within the cannula. An inward
tab would allow for adjusting the degree to which the contents of the
cannula, including the plug, are retained (Miller, col. 5, ll. 19-22, 51-54).

Claim 15
Claim 15 depends from independent claim 9 and recites "wherein the
stylet is formed with an axial vent." (Claims App'x.). The position of the
Examiner is that this limitation is satisfied by an axial recess of Miller that is
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"used to insert the seeds and spacer" and "allows the stylet to be inserted" for
pushing the seeds into the patient (RAN 5; Request 33 citing Miller, col. 5,
ll. 1-20; col 7, ll. 1-20).
The Patent Owner argues that this limitation is not disclosed and that
Yoshizumi and Miller disclose what appear to be solid shafts (App. Br. 17).
We agree with the Patent Owner. The portions of Miller relied upon and the
Examiner's rejection as set forth in the Request appear to pertain to the
cannula instead of the stylet received therein. In this regard, independent
claim 9 recites both a cannula, and a stylet that is reciprocable in the
cannula. Stylet 45 is not described in Miller as having an axial vent (see
Miller, col. 6, ll. 7-11) and it is not apparent where or how Miller discloses
this limitation. Thus, we are persuaded that the Examiner has not set forth
an adequate prima facie case of obviousness in Rejection 1 as to claim 15.

Claims 22-42
As to dependent claims 22-42, the Patent Owner argues that "the
combination of Yoshizumi and Miller would not have rendered obvious
using a plug to position a therapeutic element a predetermined distance from
the end of a cannula." (App. Br. 17). However, this line of argument is
unpersuasive for the reasons already discussed supra.

Rejection 3
Claim 19 depends from claim 18 and recites "wherein the diameter [of
the plug] is modified by heating" and stands rejected as obvious over
Yoshizumi in view of Miller and Sierocuk (RAN 5; Request 52-54). The
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position of the Examiner is that Sierocuk discloses "modifying the diameter
of the plugs by heating and forcing melted polymer through a die" to make
"a single line of spacers or plugs by a heating process." (Request 53, citing
Sierocuk col, 10, ll. 37-67). The Patent Owner disagrees and argues that
disclosure of Sierocuk pertains to formation of spacers, which are distinct
from an end plug and are not placed into the distal end of the cannula, but
rather, are loaded into a seed cartridge (App. Br. 22).
We generally agree with the Patent Owner. The relevance of Sierocuk
as to disclosing modifying the diameter of the plug using heat is unclear,
Sierocuk's disclosure being directed to the manufacture of spacers. The
Requester asserts that "Sierocuk teaches plugs (spacers 18) which are
manufactured by a heat processes (col. 10, ll. 37-40)" (Resp. Br. 8) thereby
equating plugs with spacers. However, we have not been presented with any
objective evidence that spacers are plugs, or that spacers are used as plugs,
plugs being closest to the opening at the distal end of the cannula. Instead,
the evidence of record tends to support the contrary, the prior art references
distinguishing between seeds, spacers, and plugs, such spacers being
positioned subsequent to a plug and a seed. Correspondingly, we are
persuaded that the Examiner has not set forth an adequate prima facie case
of obviousness as to claim 19.

Rejection 4
Claim 20 depends from claim 18 and recites "wherein the diameter of
the plug is modified by treating the plug with a solvent" and stands rejected
as obvious over Yoshizumi in view of Miller and Taylor, the Examiner
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relying on Taylor for the recited solvent and stating that "the needle
assembly can be treated with a solvent (e.g., solvent bonding); it should be
interpreted that the spacers and plugs are inserting [sic, inserted] into the
needle and therefore, the solvent is reacting with the spacers and plugs to
deform them within the needle." (RAN 5; Request 54, citing Taylor, col. 11,
ll. 29-40). The Patent Owner argues that Taylor does not disclose a plug for
a sharpened distal end of a cannula but instead, discloses a sleeve for seeds
and spacers that is inserted into the cannula (App. Br. 23). The Patent
Owner further observes that a sleeve is not a cannula and does not have a
sharpened end (App. Br. 23).
We agree with the Patent Owner. The portion of Taylor relied upon
pertains to adhesively affixing sleeve hub 40 and sleeve 32 together, sleeve
32 being advanced into lumen 104 of sleeve hub 40. We fail to see the
relevance of affixing components of the sleeve hub/sleeve together to the
recited claim limitation regarding modifying the diameter of the plug by
treating the plug with a solvent. Hence, we are persuaded that the Examiner
has not set forth an adequate prima facie case of obviousness as to claim 20.

Rejection 9
Dependent claims 26, 27, 31, 32, 36, 37, 41 and 42 require a uniform
and uninterrupted outer surface, and stand rejected as obvious over
Yoshizumi in view of Miller and Mercereau (RAN 8). The Examiner finds
Mercereau as demonstrating that a cannula having a uniform and
uninterrupted outer surface that is devoid of openings is "well known in the
art as an alternative to cannulas having openings," and thus, concludes that it
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would have been obvious for one of ordinary skill in the art to make the
cannula of Yoshizumi "with a uniform and uninterrupted outer surface
devoid of openings, in the manner described by Mercereau et al." (Id.). The
Patent Owner disagrees and argues that because Yoshizumi includes a slot
for viewing seeds, it would not have been obvious to form cannula without
this slot (App. Br. 17, 23).
We agree with the Examiner. While lack of an opening on the
cannula of Yoshizumi would not allow for visual inspection of the seeds and
spacers, we do not consider such disadvantage to be determinative as to
obviousness. See In re Fulton, 391 F.3d at 1200; see also Medichem, S.A. v.
Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) ("a given course of
action often has simultaneous advantages and disadvantages, and this does
not necessarily obviate motivation to combine."). Indeed, the evidence
indicates that cannulas without openings were well known in the art as
demonstrated Mercereau. See EWP Corp. v. Reliance Universal Inc., 755
F.2d 898, 907 (Fed. Cir. 1985) ("A reference must be considered for
everything it teaches by way of technology and is not limited to the
particular invention it is describing and attempting to protect."); see also In
re Heck, 699 F.2d 1331, 1332-33 (Fed. Cir. 1983). Correspondingly, we
agree with the Examiner's conclusion that it would have been obvious to use
such a cannula without openings as an alternative to the cannula with an
opening in Yoshizumi, the claimed invention merely substituting one known
cannula (having an opening on the outer surface) with another (not having
any opening on the outer surface). KSR Int'l Co. v. Teleflex Inc., 550 U.S.
398, 416 (2007).
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Rejections 2 and 8
Under these rejections, claims 1, 2, 4-18 and 21-25, 28-30, 33-35 and
38-40 stand rejected as obvious over Andrews in view of Miller and Jacobs
(RAN 5, 7). In rejecting the claims, the Examiner relies on Andrews as
disclosing the limitation requiring positioning an element a "predetermined
distance from the distal end." (RAN 5, 7; Request 38-39). The Examiner
also relies on Jacobs, which discloses a plug of "bone wax or other suitable
biocompatible (and preferably bioabsorbable) material" (Jacobs, col. 4, ll.
59-64; RAN 5, 7; Request 38-39). By incorporating by reference the
Request, the Examiner also finds that Miller specifically discloses and solves
the problem of not knowing the position of the first seed to conclude that it
would also have been obvious to combine Andrews with Miller and Jacobs
to modify the plugging of the needle tip with biologically acceptable plug
material that is placed at a predetermined distance from the needle tip such
that the exact location of the first seed is known (see Request 38-39).
The Patent Owner asserts that Andrews does not recognize the need
for precise positioning of the elements and "does not suggest that a plug is
positioned at a pre-determined location in the cannula," but merely states
that the plug is "closely adjacent" which does not require a predetermined
distance (App. Br. 18). The Patent Owner argues that Jacobs also does not
teach positioning a therapeutic element a predetermined distance from the
end of a needle, and further relies on its argument that "Miller disparages the
use of plugs in a needle assembly." (App. Br. 19-20). The Patent Owner
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further asserts that the rejection improperly discounts an advantage of the
invention (App. Br. 20).
We agree with the Examiner and find the Patent Owner's arguments
unpersuasive. Firstly, as pointed out by the Requester, Andrews discloses
that the device "facilitates engagement of the distal end 24 of the stylet 14
with the seeds 26 and spacers 28 to allow their proper and complete
positioning in, and proper advancement through, the bore defined by the
bore surface 78 and the interior of the needle." (Andrews, col. 9, ll. 1-8,
emphasis added; Resp. Br. 7). While Andrews does not explicitly set forth
the advantages associated with proper positioning of the seeds, this omission
does not detract from the fact that such positioning is disclosed. Cf. In re
Cruciferous Sprout Litig., 301 F.3d at 1349. Moreover, Miller explicitly
discloses the desirability and advantages of precisely positioning the first
seed (see Miller, col., 6, ll. 55-67; Resp. Br. 7). The Patent Owner's
assertion that Miller disparages the use of plugs is unpersuasive because it
merely disparages the use of bone wax as discussed supra.

Claim 17, 18, 21
The Patent Owner's arguments in support of patentability of these
claims are substantively similar to those already discussed (App. Br. 21-22).
Hence, they are unpersuasive for substantially the same reasons.

CONCLUSIONS
The appeal from the Examiner's rejections of claims is decided as
follows:
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1. A. Rejection 1 of claims 1-14, 16-18 and 21 is AFFIRMED.
B. Rejection 1 of claim 15 is REVERSED.
2. Rejections 2, 7-9 are AFFIRMED.
3. Rejections 3-5 are REVERSED.
Thus, the rejection of claims 1-18 and 21-42 is affirmed, but the
rejection of claims 19 and 20 is reversed.
Requests for extensions of time in this inter partes reexamination
proceeding are governed by 37 C.F.R. § 1.956. In the event neither party
files a request for rehearing within the time provided in 37 C.F.R. § 41.79,
and this decision becomes final and appealable under 37 C.F.R. § 41.81, a
party seeking judicial review must timely serve notice on the Director of the
United States Patent and Trademark Office. See 37 C.F.R. §§ 90.1 and
1.983.

AFFIRMED-IN-PART

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Patent Owner:

NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11 TH FLOOR
ARLINGTON, VA 22203

Third Party Requester:

BEST MEDICAL INTERNATIONAL, INC.
7643 FULLERTON ROAD
SPRINGFIELD, VA 22153