Ex Parte Jones et al

Patent Trial and Appeal Board

Feb 27, 2018

13922860 (P.T.A.B. Feb. 27, 2018)

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.
13/922,860 06/20/2013 Michael L. Jones 297-PDD-10-157USDIVCIPCON 2943
96000 7590 03/01/2018
C. R. Bard, Inc./BBS
Intellectual Property Department
1415 W. 3rd St.
Tempe, AZ 85281
EXAMINER
MEHL, PATRICK M
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
03/01/2018 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):
raust@ austiplaw.com
B B S IP. Docket @ crbard .com
Charles .Runyan @ crbard. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL L. JONES, PAUL LUBOCK, and JOHN MERRITT
Appeal 2017-001975
Application 13/922,860
Technology Center 3700
Before JEFFREY N. FREDMAN, TIMOTHY G. MAJORS, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants1 submit this appeal under 35 U.S.C. § 134(a) involving
claims to an intracorporeal marker system. The Examiner rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 Appellants identify the Real Party in Interest as SenoRx, Inc. App. Br. 3.
Appeal 2017-001975
Application 13/922,860
STATEMENT OF THE CASE
The “invention is generally directed to devices ... for the delivery of
remotely detectable markers to a desired location within a patient’s body.”
Spec. 1 5. More specifically, “the invention is directed to devices . . .
configured to retain a remotely detectable marker within a delivery device
before delivery to a desired intracorporeal location.” Id. As background, the
Specification explains that detectable markers serve as landmarks to, for
example, remotely and more precisely indicate the site of an internal tissue
(e.g., cancerous lesion) needing treatment, or the site of a prior biopsy of that
tissue. Id. 111.
Claims 1, 21, 22, and 25—31 are on appeal. Claims 1 and 25 are
illustrative:
1. An intracorporeal marker system, comprising:
an elongated intracorporeal marker having an inner core
of bioabsorbable fibers and an outer layer of bioabsorbable fibers
disposed around at least part of the inner core; and
a tissue marker pellet comprised of a polysaccharide
material.
25. A remotely imageable breast tissue marker system
comprising:
a breast tissue marker pellet comprised of a polysaccharide
configured to exhibit hemostatic properties; and
a fibrous breast tissue marker comprising bioabsorbable
fibers.
(App. Br. 44 (Claims App.).)
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Application 13/922,860
The claims stand rejected2 as follows:
I. Claims 1, 21, 22, 25—29, and 31 under 35 U.S.C. § 103(a) over
Moore,3 Vidal,4 Scarborough,5 Klaveness,6 and Thompson.7
II. Claim 30 under 35 U.S.C. § 103(a) over Moore, Vidal,
Scarborough, Klaveness, Thompson, and Ray.8
I
Issue
Has the Examiner established by a preponderance of the evidence that
claims 1, 21, 22, 25—29, and 31 would have been obvious over the cited
references?
2 The Examiner rejected claims 1,21, and 22 for obviousness-type double
patenting over claims 17 and 29 in US Application No. 14/519,531 (issued
as US 9,801,688 B2 on Oct. 31, 2017) in view of Thompson. Final Act. 6.
The Examiner, however, later found applicant had overcome the rejection.
See Adv. Act. (dated Dec. 11, 2015) (“Applicant’s reply has overcome the
following rejection(s): Double patenting.”): see also Adv. Act. 2 (explaining
remaining rejections under § 103 and omitting mention of any double
patenting rejection). We recognize the Answer repeats the double patenting
rejection, but we agree with Appellants (Reply Br. 5) that this appears to
have been inadvertently included. If that is incorrect, and the Examiner
intended to re-introduce the rejection, that would constitute new grounds for
which the Examiner appears to have not complied with the rule and obtained
the necessary approval. 37 C.F.R. § 41.39(a)(2). For these reasons, we do
not consider the double patenting rejection in this appeal.
3 Moore, US 4,086,914, issued May 2, 1978.
4 Vidal et al., US 5,334,216, issued Aug. 2, 1994.
5 Scarborough, US 5,676,146, issued Oct. 14, 1997.
6 Klaveness et al., US 5,567,413, issued Oct. 22, 1996.
7 Thompson, US 5,702,682, issued Dec. 30, 1997.
8 Ray, US 5,201,704, issued Apr. 13, 1993.
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Application 13/922,860
Findings of Fact (FF)
The Examiner’s findings of fact and statement of the rejection are
provided at pages 7—15 of the Final Rejection dated Sept. 25, 2015 (“Final
Act.”). See also Adv. Act. 2; Ans. 4—11. The following findings are
provided for emphasis and convenient reference.
FF 1. Moore discloses an implant injector for “depositing implants,
such as the radio-active gold implants for the treatment of cancer, and the
like.” Moore 1:5—6. Moore’s implant injector comprises “an inner and
outer member and a plunger on the outer member traveling within the inner
member, adapted to deposit an implant from the inner member upon each
forward movement of said plunger.” Id. at 1:18—22; see also id. at 2:40-42.
FF 2. Figures 3 and 4 of Moore are reproduced below.
Id. Figs. 3^4. Figure 3 depicts a partial view of Moore’s inner member (1),
including a cartridge receiving chamber (7) and hollow needle (10). Id. at
145—60. Figure 4 is a cross-sectional view of a cut-out portion of cartridge
(7') including a plurality of implants (8) stored in a passageway
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Application 13/922,860
therethrough. Id. at 1:58—61. Activation of a plunger (not shown) causes
contact with the implants in the cartridge and moves them through the
hollow needle. Id. at 2:10—13.
FF 3. Vidal relates to a hemostatic plug for placement at a site where
treatment is indicated, such as a wound cavity. Vidal, Abstract and 1:50-52
(describing a primary object of Vidal’s invention as the making of a
“hemostatic plug which rapidly fills a wound cavity and which provides
advantageous surface area presentment to promote hemostasis.”); see also
id. 2:21—25 (“Because the plugs ... are rolled sheets rather than a solid mass
of hemostatic material, they unfurl when situated in the wound cavity and
subjected to blood and tissue fluid emitting from the wound.”).
FF 4. Figure 2 of Vidal is reproduced below.
Vidal, Fig. 2. Figure 2 is an enlarged, perspective view of a dual-density
hemostatic plug (20) including first (22) and second (24) portions. Id. at
4:16—23. The first portion is made from a rolled, lower-density sheet (26) of
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hemostatic material, and the second portion is made from a rolled, higher-
density sheet (28) of hemostatic material. Id. Vidal teaches that the
respective sheets are secured together as follows: “the innermost comer only
of the first roll of the lower density sheet 26 is positioned to be slightly off
of the wrap line. This creates a wedge 25 of lower density material to be
overlapped by the subsequently rolled higher density sheet 28.” Id. at 5:49—
54; see also id. Figs. 4A-B (showing wedge portion (25)). Vidal teaches that
an opening (16) extends longitudinally through the plug. Id. at 4:41 42.
FF 5. Vidal teaches the hemostatic sheets may be fabricated from
collagen and other hemostatic materials, such as gelatin, polyglycolic acid-
based material and thrombin. See, e.g., id. at 3:66-4:7.
FF 6. Thompson relates to methods for preparing radiopaque medical
devices including, more specifically, incorporating a metal-cation salt of
anionic polymer in the medical device. Thompson, Abstract. Thompson
teaches “[ejxamples of typical medical devices for which the invention is
applicable are: catheters, stents, cannulas, plugs, and constrictors” and
Thompson further teaches “[t]his invention would find utility in any
application where x-ray observation of an implanted device is required.” Id.
at 2:62—3:4; see also id. at 8:4—6 (describing tubular medical implants).
FF 7. Thompson teaches “polysaccharides that contain carboxylate or
sulfate functionality are particularly preferred” as the anionic polymers and
lists, among others, alginic acid, carboxymethyl cellulose, and chitosan. Id.
at 3:10—23. Thompson teaches “[preferred metal-cations for use in the
invention are barium, strontium, iron, copper, lead, tin, iron, gold and silver
cations.” Id. at 3:61—63.
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Analysis
Claim 1
The Examiner finds that Moore teaches an implant injector capable of
performing as a component of an intracorporeal marker system. Final Act.
7. The Examiner finds, however, that Moore does not teach the two types of
markers in claim 1: (i) an elongated marker having an inner core of
bioabsorbable fibers with an outer layer of bioabsorbable fibers disposed
around at least part of the inner core and (ii) a tissue marker pellet comprised
of a polysaccharide material. Id. So, the Examiner turns to Vidal,
Scarborough, and Klaveness as teaching or suggesting the first marker type,
and to Thompson as teaching or suggesting the second. Id. at 8—11.
The Examiner finds Vidal teaches, inter alia, the making and use of a
hemostatic plug, formed with partially-overlapping sheets of hemostatic
materials (such as gelatin or denatured collagen) having different densities.
Id. at 8. According to the Examiner, Vidal’s plug includes materials that
expand at different rates, “with the inner core being filled with sub layers of
the outer core.” Id. The Examiner concludes it would have been obvious to
use Vidal’s hemostatic plug and to deliver such plugs with Moore’s implant
injector “to insure the dryness of the site of implantation with the hemostatic
plug/sponge expanding in a predictable fashion due to the arrangement of
the different layers of gelatin/collagen or cellulose.” Id. Because the
Examiner finds Vidal does “not explicitly disclose an inner core of
bioabsorbable fibers,” the Examiner turns to Scarborough. Id. at 8—9.9
9 The Examiner asserts, without adequate support, that “Vidal implicitly
disclose[s] the inner core of the hemostatic plug as being filled with
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Application 13/922,860
The Examiner finds Scarborough discloses surgical implants that
include a resorbable marker, such as partially demineralized bone. Id. at 9;
see also Scarborough 2:12—14 (“The radiopaque marker which is to be
incorporated into the resorbable implant of this invention is advantageously
provided as native bone.”). The Examiner states that Vidal and Scarborough
are similar and that, in Scarborough, “an outer core made of collagen or
collagen derivatives . . . [is] preformed as a sheet with the marker
incorporated within the sheet.” Final Act. 9. The Examiner concludes it
would have been obvious to combine Scarborough with Vidal’s hemostatic
plug, “with the placement of the demineralized bone fiber marker at the core
of the hemostatic plug ... to be used as a marker of the biopsy or medical
intervention location.” Id. Then, turning to Klaveness, which the Examiner
finds teaches polymer structures with microbubbles may be used as
ultrasound contrast agents, the Examiner concludes it would have been
obvious “to have substituted the demineralized bone inner core of the
hemostatic plug with a bioabsorbable polymeric fiber filled with
microbubbles.” Id. at 10. According to the Examiner, this modification is
obvious “to obtain a very echogenic marker using the presence of the
microbubbles at the inner core of the hemostatic plug/sponge.” Id.
bioabsorbable fibers after implantation.” Final Act. 8. Once implanted,
however, Vidal’s plug quickly “unfurl[s] or unroll[s] to the boundaries of the
wound cavity and thereby fill[s] the wound cavity.” Vidal 7:12—15. The
Examiner has not clearly established how this unfurled structure (sheets of
hemostatic material) would satisfy the requirement of claim 1 of an
“elongated intracorporeal marker” having an “inner core” and “outer layer”
with the claimed characteristics.
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Application 13/922,860
The Examiner finds Thompson teaches methods of preparing medical
imaging devices providing radiopacity. Final Act. 10. According to the
Examiner, the methods include mixing polymers with heavy metals, which
may be extruded or molded into tubular shapes for a pellet form. Id. at 11.
The Examiner further finds Thompson teaches the preferred polymers are
polysaccharides10 such as alginic acid and cellulose, and that the preferred
metals include gold cations. Id. The Examiner reasons it would have been
obvious to have designed and applied with Moore’s implant injector:
pelleted markers such made with gold and made of hemostatic
polysaccharide as taught by Thompson in order to mark and
locate highly vascularized tissue sites for regular image
monitoring ... and [to] use the hemostatic properties of the pellet
polysaccharide material to make the pellet sticking to the tissue
by activating the hemostasis pathway ....
Id. The Examiner, thus, finds that Thompson teaches a “tissue marker pellet
comprised of polysaccharide material” as in claim 1, and that, in view of the
other cited references, the claim would have been obvious. Id. at 7—11.
The preponderance of the evidence on this record does not support the
Examiner’s conclusion that claim 1 would have been obvious. As
Appellants argue, Vidal does not disclose “an elongated intracorporeal
marker having an inner core of bioabsorbable fibers” as recited in claim 1.
App. Br. 44 (emphasis added); see also id. 18. To the contrary, Vidal’s plug
has no structure at its “inner core” and instead provides an opening or lumen
extending throughout the plug’s length. FF 4. We are unpersuaded that
10 The Examiner finds that polysaccharides disclosed in Thompson “are
known to present hemostatic properties.” Final Act. 11.
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Application 13/922,860
Vidal’s rolled sheets — even to the extent they overlap somewhat — satisfy
the requirement of an “inner core of bioabsorbable fibers.” Id. On this
point, the Specification provides support: Figure 3 depicts a marker
comprising a rolled sheet and is described as being “without a core
member”; and Figure 2 depicts a marker “with a core member” and shows a
rolled sheet surrounding a distinct bioabsorable structure disposed at and
along the innermost longitudinal axis of the elongated marker — the
marker’s “inner core.” Spec. Figs. 2—3; Tflf 36—37; see also id. Figs. 4A—D,
^Hf 3 8, 51. To the extent the Examiner posits that the claimed “inner core” is
“implicitly” (i.e., inherently) disclosed in Vidal, we are unpersuaded as
explained above. See supra n. 9; Final Act. 8.
Scarborough and Klaveness do not make up for Vidal’s deficiencies
related to the marker’s “inner core.” Scarborough relates to an implant for
repairing skeletal defects and, more specifically, to structures that provide
scaffolding to enable new bone growth (e.g., bone grafts). Scarborough
1:30—34, 3:2—30. Yes, Scarborough teaches shaped pieces of native bone or
partially demineralized bone as detectable markers that may be used in such
support or scaffolding. Id. at 2:12—30. But it is unclear (absent hindsight)
why the skilled artisan would have turned to or employed Scarborough’s
teachings in the manner proposed by the Examiner. App. Br. 19; Final
Act. 9. No apparent and persuasive evidence-based reason is given for
adding an inner core of partially demineralized bone fibers in Vidal’s plug.
Confusing matters, the Examiner then suggests it would have been obvious
to substitute the proposed inner core of bone with an inner core comprising a
polymer fiber filled with microbubbles based on Klaveness. Final Act. 10.
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This is hindsight. Once again, there is no sufficient reason given for
modifying Vidal’s plug to include an “inner core” — whether made of bone
or echogenic polymers with microbubbles.
For these reasons, we reverse the Examiner’s rejection of claim 1 (and
dependent claims 21 and 22).
Claim 25
We reach a different conclusion on claim 25. Importantly, claim 25
recites “a fibrous breast tissue marker comprising bioabsorbable fibers,” and
no “inner core” like claim 1 is required. App. Br. 44. The teachings of
Scarborough and Klaveness are, thus, unnecessary and we do not rely upon
them here. In re Bush, 296 F.2d 491, 496 (CCPA 1961) (the Board may rely
on fewer than all of the references relied upon by Examiner).
We are persuaded the subject matter of claim 25 would have been
obvious over Moore, Vidal, and Thompson. As described above, Moore
teaches an injector assembly usable to inject therapeutic implants (e.g.,
radioactive gold) into body tissues and/or cavities. FF 1—2. Vidal teaches a
plug comprising bioabsorbable fibers, such as collagen and polyglycolic acid
that unfurls when contacted by fluids in a body cavity, and helps to promote
hemostasis. FF 3—5; see also Vidal 2:25—28 (“The plugs thereby provide
increased surface area and correspondingly more rapid efficacy within the
wound cavity to promote blood flow cessation and healing.”). As VidaFs
plugs are made of the same types of bioabsorbable-marker materials and
unfurl or unfold like the markers described in Appellants’ Specification,
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Vidal’s plugs are capable of acting as a “fibrous breast tissue marker.”
FF 3—5; see, e.g., Spec. Tflf 22, 27, 30.
As to the “marker pellet comprised of a polysaccharide configured to
exhibit hemostatic properties,” that element of claim 25 is suggested in
Thompson. Thompson teaches making radiopaque indwelling medical
devices (tubes, plugs, etc.) by including anionic polymers (preferably
polysaccharides) and metal cations (preferably barium, gold, etc.). FF 6—7.
Appellants’ Specification indicates that polysaccharides (e.g., cellulose) are
hemostatic agents (Spec. 122), so we agree with the Examiner that
Thompson identifies polysaccharides that would exhibit hemostatic
properties absent evidence to the contrary. Final Act. 11.
It would have been obvious, on this record, to design an intracorporeal
marker system including Moore’s injector along with the hemostatic plug of
Vidal and a radiopaque-polysaccharide plug as suggested in Thompson. The
skilled person would have had reason to include Vidal’s plug to mitigate
blood or fluid leakage at the relevant surgical or treatment site. Final Act. 8;
Ans. 18. Also, it would have been obvious to include a radiopaque marker
(e.g., a plug) at the site so that the site/marker is readily and more accurately
located in the future with, for example, x-ray examination.11 Final Act. 11
(reasoning it would have been obvious to use Thompson’s markers “in order
to mark and locate specific highly vascularized tissue sites for regular image
11 The Specification discloses that gold (and several other metals) are
suitable markers for x-ray and MRI examinations. Spec. ]Hf 19, 56; Ans. 17
(“Appellant agrees with the MRI marker intrinsic properties for Gold
marker.”) (citing App. Br. 23 (“MRI requires the use of a non-magnetic
marker (including gold).”).
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monitoring”); Ans. 20 (explaining that Thompson is related to “markers for
radiation imaging to a desired intracorporeal location”).12 For the above
reasons, we affirm the Examiner’s rejection of claim 25.
We address below Appellants’ arguments.
Appellants emphasize that the markers in claim 25 are described as
being “breast tissue markerrs].” App. Br. 31. This recitation, however, does
not impart a specific structural requirement. It is, instead, an intended use
of the markers.13 Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289
F.3d 801, 809 (Fed. Cir. 2002) (“[T]he patentability of apparatus or
composition claims depends on the claimed structure, not on the use or
purpose of that structure.”). Appellants’ contentions about claim 25’s
recitation of “breast tissue” are, thus, unpersuasive.
Appellants argue claim 25 “does not recite a delivery device as does
Moore, and . . . Moore is not relevant.” App. Br. 31; see also id. 17 (“Moore
is disclosing an implant injector for injecting radio-active gold implants for
treating cancer.”). We disagree. Moore teaches a means of implanting in a
body tissue or cavity Vidal’s plug and a radiopaque marker plug of
Thompson. FF 1—2. As such, it is relevant to the Examiner’s proposed
combination and the reasoning in support. We also disagree that Moore is
limited to injecting radio-active gold implants for treating cancer. That use
12 The Specification confirms, as background, that it was known to place
biopsy-site markers in biopsied breast tissues. Spec. 111 (“current
radiographic type markers may persist at the biopsy site”).
13 See Spec. 17 (“The biopsy and treatment site described will generally be
the human breast, although the invention is suitable for marking biopsy sites
in other parts of the human and other mammalian body as well.”).
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is mentioned briefly, and is illustrative only — “depositing implants, such as
the radio-active gold implants for the treatment of cancer, and the like[.]”
Moore 1:5—6 (emphasis added). The skilled artisan would have interpreted
Moore’s device as usable for depositing other implants that would fit within
and through the device’s chamber and needle. FF 1—2.
Appellants contend “Thompson does not recognize polysaccharides as
adding an imaging characteristic (radiopacity).” App. Br. 31. Here again,
Appellants fail to structurally distinguish the subject matter of claim 25 from
the prior art. Ans. 21; see also Ans. 17 (“Appellant appears to argue that the
examiner is suggesting that the radiopacity is provided only by the
polymer/polysaccharide”). Thompson teaches radiopaque tubular structures
and plugs comprising polysaccharides and metal cations, thus providing a
marker structure encompassed by the relevant limitation of claim 25. FF 6—
7.14 Relatedly, Appellants contend Thompson “only addresses x-ray
imaging, and does not so much as even mention ultrasound or MRI
imaging.” App. Br. 23. Claim 5, however, does not exclude a “marker”
detectable by x-ray, which is undisputedly shown in Thompson. FF 6—7.
For these reasons, Appellants’ contentions are unpersuasive.
14 Claim 25 recites “a breast tissue marker pellet comprised of a
polysaccharide configured to exhibit hemostatic properties.” App. Br. 44
(emphasis added). The claim is open-ended and thus the pellet does not
exclude other radiopaque compounds (e.g., metals). Indeed, claim 29, which
depends indirectly from claim 25 indicates “a radiopaque element [may be]
coupled with ... the polysaccharide breast tissue marker,” {id. at 46), and
the Specification indicates that the markers may include radiopaque
elements like gold. Spec., Fig. 6, ^fl[ 47, 56.
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Appellants further argue Thompson does not disclose a marker
“pellet” as claimed. App. Br. 31; see also id. at 22 (“Thompson refers to
‘pellet’ in the context of the form of the polymeric material before being
‘molded or extruded into device form.’”). We remain unpersuaded.
Appellants’ Specification does not define “pellet.” Indeed, the only use of
the term is in an amendment to the Abstract. Without a special definition,
Moore teaches implants that are reasonably understood as “pellets.” FF 1—2.
And Thompson teaches implantable medical devices — particularly
radiopaque tubular structures and plugs — that we interpret as at least
suggesting a pellet-shaped structure. FF 6—7.
Finally, Appellants argue Scarborough and Thompson are non-
analogous art. App. Br. 32. According to Appellants, “Applicant’s field is
primarily that of delivering ultrasonically detectable markers to a desired
intracorporeal location.” Id. at 30. Appellants contend “Thompson is
directed to an enhancement of the radiopacity of medical devices” and “the
problem Thompson solves is how to better carry out x-ray diagnostic
procedures.” Id. at 29.
Appellants’ arguments are unpersuasive. Appellants parse the “field”
of the invention too narrowly as limited to delivering ultrasonically
detectable markers to locations within a body. The Specification discloses
that a variety of imaging techniques, including x-ray and MRI, may also be
used to detect the markers of the invention. See, e.g., Spec. 129. And the
Specification discloses that the markers may include a variety of radiopaque
marker elements (e.g., gold, barium, etc.) to aid their visualization. Id. Fig.
4E, Fig. 6,H26, 46-47, 50, 54, 56. The field of the invention, therefore,
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includes detecting implanted markers having radiopaque, x-ray and MRI-
detectable features. Thompson, which relates to implantable medical
devices with improved radiopacity and x-ray detectability is within the same
field or, at minimum, is reasonably pertinent to the inventors’ field and the
problem they were trying to solve. FF 6—7. As we do not rely on
Scarborough, we need not decide whether it is analogous art.
For the above reasons, we affirm the Examiner’s conclusion that
claim 25 would have been obvious.
Claim 26
Claim 26 is reproduced at page 45 of Appellants’ Appeal Brief. In
general, it recites an elongated tubular shaft with an inner lumen, and in the
lumen an arrangement wherein, upon sliding of a plunger element, the
fibrous breast tissue marker is first discharged, followed by the breast tissue
marker comprised of polysaccharide. App. Br. 45.
The Examiner has not met the burden to show that this arrangement
would have been obvious. The Examiner acknowledges the cited art does
not teach “the order of placement in the lumen of the injector and therefore
implicitly the discharge sequence of the different imaging pellets.” Final
Act. 12. The Examiner concludes, however, the sequence would have been
obvious based on “the sequence of discharge order of the pellet as implicitly
taught by Vidal.” Id. at 13. But Vidal teaches no particular sequence, as it
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simply relates to the design and placement of a hemostatic plug.15 The
Examiner asserts it would have been obvious to place the fibrous marker
plug first, followed by placement of the polysaccharide tissue marker in
order to maintain dryness during implantation. Id. The Examiner later
contradicts this position concerning claim 28, which requires the fibrous
breast tissue marker be interposed in the lumen between two polysaccharide
breast tissue marker pellets. App. Br. 45. The Examiner concludes this
latter arrangement, with the fibrous tissue marker being dispensed after a
polysaccharide marker pellet, would have been obvious for the same reason
— to maintain dryness. Final Act. 14. The Examiner may be suggesting
that any order of implantation of the various markers would be obvious. Yet
the Examiner has not made that case clearly and persuasively on this record.
The rejection of claim 26 (and dependent claims 27 and 31) is thus reversed.
Claim 28
Claim 28 depends from claim 25 and, as noted above, recites an inner
lumen “wherein the fibrous breast tissue marker is interposed in the inner
lumen between two polysaccharide breast tissue marker pellets.” App. Br.
45. We are not persuaded the Examiner met the prima facie burden of
showing claim 28 would have been obvious for the same reasons explained
above related to claim 26. Accordingly, the rejection of claim 28 (and claim
29, which depends from claim 28) is reversed.
15 If anything, Vidal would seem to suggest placing the hemostatic plug last
in a treatment regime to fill the operative cavity and prevent fluid/blood
leakage and help close and heal the wound site. See Vidal 7:5—12; FF 2—5.
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II
The Examiner rejects claim 30 based on the combination of Moore,
Vidal, Scarborough, Klaveness, Thompson, and Ray. Final Act. 15—17.
Claim 30 depends from claim 25 and recites, inter alia, “the fibrous
breast tissue marker comprises a multi-layered breast tissue marker having
an inner core of bioabsorbable fibers and an outer layer of bioabsorbable
fibers disposed around the inner core.” App. Br. 46 (emphasis added).
Claim 30 includes an “inner core” limitation similar to claim 1.
The Examiner relies on the additional reference of Ray as purportedly
disclosing claim 30’s limitation of “a radiopaque marker element disposed
around the multi-layered breast marker that is configured to constrict the
multi-layered breast tissue marker.” App. Br. 46; Final Act. 16. The
Examiner has not, however, asserted or shown that Ray makes up for the
deficiencies of Moore, Vidal, Scarborough, Klaveness, and Thompson as
explained above regarding claim 1 and the particular “inner core”
limitations, which similarly appear in claim 30. See supra Section I. For
this reason, we reverse the rejection of claim 30.
SUMMARY
The rejections of claims 1, 21, 22, and 26—31 as obvious are reversed.
The rejection of claim 25 as obvious is affirmed.
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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).
AFFIRMED-IN-PART
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