Ex Parte Wilkinson et al

Patent Trial and Appeal Board

Jul 10, 2017

12257057 (P.T.A.B. Jul. 10, 2017)

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.
12/257,057 10/23/2008 Bradley M. Wilkinson 3896-083182 (P-7917/1) 6357
32182 7590 07/12/2017
David W. Highet, VP & Chief IP Counsel
Becton, Dickinson and Company
(The Webb Firm)
1 Becton Drive, MC 110
Franklin Lakes, NJ 07414-1880
EXAMINER
MUI, CHRISTINE T
ART UNIT PAPER NUMBER
1797
NOTIFICATION DATE DELIVERY MODE
07/12/2017 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):
lorraine_kow alchuk @ bd .com
ip_docket @bd.com
patents @ webblaw. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BRADLEY M. WILKINSON and
C. MARK NEWBY1
Appeal 2016-006122
Application 12/257,057
Technology Center 1700
Before: JAMES C. HOUSEL, AVELYN M. ROSS, and
MERRELL C. CASHION, JR., Administrative Patent Judges.
ROSS, Administrative Patent Judge.
DECISION ON APPEAL2
Appellants appeal under 35 U.S.C. § 134(a) from a rejection of claims
1—4 and 6—21. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the real party in interest as Becton, Dickinson and
Company, the assignee of the instant application. Appeal Br. 3.
2 In our Decision we refer to the Specification (“Spec.”) initially filed
October 23, 2008 and as later amended, the Final Office Action (“Final
Act.”) dated April 29, 2015, the Appeal Brief (Appeal Br.) filed December
1, 2015, the Examiner’s Answer (“Ans.”) dated April 12, 2016, and the
Reply Brief (“Reply Br.”) filed May 25, 2016.
Appeal 2016-006122
Application 12/257,057
STATEMENT OF THE CASE
The subject matter on appeal relates to closed kit for tissue
containment and stabilization for molecular and histopathology diagnostics.
Claim 1, reproduced below, is illustrative of the claimed subject matter:
1. A system for storing a biological sample, comprising:
a container having a closed end, an open end, and a
sidewall extending therebetween, defining a container interior;
a removable closure for enclosing the open end of the
container;
a sample holder for housing a biological sample, insertable
within the container interior;
a port disposed within at least one of the container and the
removable closure; and
an injection device engageable with the port to allow a
fluid to pass from within the injection device into the container
interior, wherein the sample holder is matable with the closure,
and wherein when the sample holder is mated with the closure
and the closure is engaged with the container, the sample holder
is located directly adjacent to and beneath the port along a
longitudinal axis of the port.
Appeal Br. 22 (Claims App’x).
REJECTIONS
The Examiner maintains the following rejections:
A. Claims 1—4, 6—10, 12—14, and 16—21 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Duymelinck.3
Final Act. 4.
3 Duymelinck et al., WO 2007/014741 A2, published February 8, 2007
(“Duymelinck”).
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Application 12/257,057
B. Claims 11 and 15 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Duymelinck in view of Ryan4 or
Smith.5 Id. at 9.
C. Claims 1—4, 6—10, 12—14, and 16—21 stand rejected under
35 U.S.C. § 102(b) as anticipated by Duymelinck. Ans. 9.
Appellants request reversal of Rejections A-C. Appellants argue
rejections A and C together, and argue the independent claims 1,16, and 21
together as a group. See generally Appeal Br. Appellants also do not
present separate arguments for the remaining claims. Id. Therefore,
consistent with the provisions of 37 C.F.R. § 41.37(c)(l)(iv) (2013), we limit
our discussion to claim 1, and all other claims stand or fall together with
claim 1.
OPINION
Rejection A — Obviousness (claims 1—4, 6 10, 12—14, and 16—21)
The Examiner rejects claim 1 as obvious over Duymelinck. Final Act.
4. The Examiner finds that Duymelinck teaches a system for storing a
biological sample having each of the claimed elements, including a
container, a removable closure, a sample holder, a port, and an injection
device. Final Act. 4—5. The Examiner acknowledges that Duymelinck does
not disclose a sample container that is “located directly adjacent and beneath
the port along a longitudinal axis of the port.” Final Act. 5. The Examiner
finds Duymelinck discloses “the elongated member (103) of [the
Duymelinck] device can change lengths so that it [is] able to be at different
4 Dana Wm. Ryan, US 5,833,213, issued November 10, 1998 (“Ryan”).
5 James C. Smith, US 6,375,028 Bl, issued April 23, 2002 (“Smith”).
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Application 12/257,057
depth[s] within the inner space of the vial.” Id. The Examiner additionally
finds Duymelinck discloses that in “an embodiment of the holder there is
particular length and depth of the holder seen in Figure 21a and b so that it
does not directly abut the bottom of the closure preventing any flow form
[sic] an access port to the holder.” Id. The Examiner concludes that the
broadest reasonable interpretation of “directly adjacent to and beneath the
port” means “directly beneath the port.” Id. Therefore, the Examiner
reasons that it would have been obvious to modify the length of the
elongated member so that the sample holder is “directly adjacent to and
beneath the port” for three alternative reasons: (1) “to directly exchange
sample fluid from the injection to the holder minimizing any sort of risk of
contamination or spillage;” (2) to rearrange the parts to adjust the sample
holder location as a matter of design choice; or (3) as “a matter of design
choice and wherein there is a finite number of placements, orientations and
lengths of the elongated member relative to the holder to optimize the
reaction time between components and flow from one part of the system to
the other.” Id. at 6.
Appellants contend that the Examiner’s claim construction is too
broad and impermissibly broadens the plain meaning of independent claims
1,16, and 21. Appeal Br. 12. According to Appellants, the Examiner’s
definition does not give full effect to “directly adjacent and beneath.” Id. at
13; see also Reply Br. 2 (“this interpretation fails to give any weight to the
word ‘adjacent’”). Appellants assert that “adjacent” should be interpreted as
“close or near, or sharing a border, wall, or point.” App. Br. 13. ppellants
offer the following comparison figures, Figure 4 and Modified Figure 4 to
illustrate their position.
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Application 12/257,057
Modified FIG. 4
Id. Appellants explain that Figure 4 shows a holder directly adjacent to and
beneath the port 76 while Modified Figure 4 simply shows a sample holder
50 directly beneath the port—not adjacent. Id. at 13—14. According to
Appellants, the Examiner acknowledges that placement directly adjacent and
beneath the port is not taught. Id. at 14.
The Examiner finds that even using Appellants’ “shared border”
definition, the modification results in the claimed invention and provides a
“motivation to adjust the elongated member so that it does satisfy the
embodiment of sharing a boarder [sic].” Ans. 16.
Appellants contend that the claimed placement is not a matter of
design choice and such a modification requires a reason to make the changes
proposed. Appeal Br. 14. Appellants direct attention to the teachings of
Duymelinck that suggest the sample holder is positioned in the inner space
of the vial. Id. at 15. In particular, Appellants note Duymelinck teaches that
the sample holder is advantageously placed “in the lower half, lower third,
lower fourth of the body of the vial, or otherwise adjacent or closely
proximal to the base of the vial.” Id. at 15—16. In light of these teachings,
Appellants urge that Duymelinck teaches away from the Examiner’s
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Application 12/257,057
modification to move the sample holder adjacent the port as claimed. Id. at
16.
This argument is not persuasive, however, because “[a] reference does
not teach away ... if it merely expresses a general preference for an
alternative invention but does not ‘criticize, discredit, or otherwise
discourage’ investigation into the invention claimed.” DePuy Spine, Inc. v.
Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)
(quoting In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)). Appellants
have not identified any passage in Duymelinck that actually criticizes,
discredits, or discourages placement of the sample holder directly adjacent to
and beneath the port.
Moreover, we agree with the Examiner (Ans. 17) that Duymelinck
suggests modification in the length of the elongated member because the
elongated member is taught to be placed a different depths within the vial
according to the solution level and a desire to immerse the sample. Ans. 17.
Specifically, Duymelinck explains that
[sjuch elongated member 103 may serve to suitably position the
sample holding means within the inner space 241 of the vial 84,
such that this would become immersed in solutions introduced
thereto, advantageously by being placed, e.g., in the lower half,
lower third, lower fourth of the body of the vial, or otherwise
adjacent or closely proximal to the base of the vial.
Duymelinck 39. Thus, there is a suggestion that the length of the elongated
member is a design choice.
Appellants also contend that the proposed modification would render
Duymelinck unsatisfactory for its intended purpose. Appeal Br. 15. In
particular, Appellants insist that
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Application 12/257,057
[positioning the sample holder of Duymelinck as suggested by
the Examiner would render Duymelinck inoperative for its
intended purpose; not because the rearrangement would prevent
the fluid access means (88, 89) from expelling solutions over the
sample and into the interior of the vial as the Examiner has
attempted to rebut, but because without the ability to insert the
fluid transfer means (88, 89) at least into the lower half of the
vial and advantageously “adjacent or closely proximal to the base
of the vial” as taught by Duymelinck, the device would be unable
to clear each fluid solution in between steps.
Id. at 18. Asa result, “upon penetrating breakable seals (92, 93) the fluid
access means (88, 89) would immediately contact a surface of the sample
holder (104), thereby preventing the tip of the fluid access means (88, 89)
from breaking the surface of the solution” and thereby requiring manual
manipulation, as opposed to an automated process, for producing paraffin
sections of biological tissue. Id. at 19; see also Reply Br. 6.
Appellants’ arguments are not persuasive of reversible error by the
Examiner. We agree with the Examiner that the intended purpose of
Duymelinck is not frustrated by the proposed modification because “[i]n the
case where the cassette 201, Figure 21a and b . . . the cassette still includes
a particular depth where the sample is enclosed within the cassette and there
would still be fluid access means.” Ans. 17. According to Duymelinck,
in most cassettes at least the bottom plate of the receptacle
member and/or the top plate of the cover member, and preferably
both, are conducive to liquids so as to enable the exposure of the
tissue sample enclosed in the cassette to liquid agents when the
cassette is submerged in the latter. Typically, this may be
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Application 12/257,057
achieved by provision of suitably sized and shaped perforations
in the said plates.
Duymelinck 4 (emphasis added).
Moreover, we note that Duymelinck is not limited to the cassette
design of Figures 21a and b, but instead teaches plural embodiments of
sample holders. See e.g., Duymelinck 4 (“tissue sample holders or tissue
sample cassettes can adopt variable forms), 24 (“sample supporting means
can be any suitable structure such as a gridded platform provided with a clip
to hold the sample on the platform”), and 28 (sample holder “refer[s] to any
receptacle employed in the art. . . for the storage and processing of
samples.”); see also id. Figure 8 (element 87) and Figure 11 (item 104). In
the embodiments depicted in Figures 8 and 11, the fluid access means (88,
89) is positioned next to the sample holder (87) and does not preclude access
to the surface of the solution. Id. Figures 8, 11.
Lastly, and for the first time in reply, Appellants urge that there is no
reason to modify the teachings of Duymelinck because the Examiner’s
purported reason, i.e., to minimize any sort of risk of contamination or
spillage, is already addressed by Duymelinck. Reply Br. 4. Appellants
contend that the “Examiner has not provided any reasoning why a distance
of the sample holding means (104) relative to the port (92, 93) has any effect
on contamination or spillage when the lid (101) is connected to the vial.” Id.
Appellants have not explained, nor is it apparent, that these arguments
were necessitated by the Examiner’s Answer or could not have been
presented in the principal brief. Therefore, these arguments are untimely
and we will not reach arguments presented for the first time in a reply brief
in the absence of good cause. 37 C.F.R. §41.41(b)(2).
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Rejection C — Anticipation (claims 1 4, 6—10, 12—14, and 16—21)
The Examiner also rejects claims 1—4, 6—10, 12—14, and 16—21 as
anticipated by Duymelinck. Ans. 9. The Examiner finds that Duymelinck
teaches a system for storing a biological sample having each of the claimed
elements, including a container, a removable closure, a sample holder, a port,
and an injection device. Id. at 9—10. With respect to the rejection under 35
U.S.C. § 102(b), the Examiner concludes that the broadest reasonable
interpretation of “directly beneath the port” means “close or near” and
adjacent similarly means “close or near.” Id. at 10. Asa result, the
Examiner finds the claim limitation requiring that “the sample holder [to be]
located directly adjacent to and beneath the port along a longitudinal axis of
the port” is met by Duymelinck’s disclosure that “the elongated member
(103) of its device can change lengths so that it able to be at different
depth[s] within the inner space of the vial. . . and is placed in a location
close or near and beneath the port and within a defined space of the
container interior.” Id.
Appellants contend that the Examiner’s interpretation of “directly
adjacent to and beneath”—as applied to the rejection under 35 U.S.C.
§ 102(b)—fails to give weight to the word “beneath.” Reply Br. 3.
Appellants additionally argue that the sample holder of Duymelinck,
depicted in Figure 10, is not close or near. Id.
We agree with Appellants. “A prior art reference anticipates a patent
claim under 35 U.S.C. § 102(b) if it discloses every claim limitation.” In re
Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012) (citing Verizon Servs.
Corp. v. CoxFibernet Va., Inc., 602 F.3d 1325, 1336—37 (Fed. Cir. 2010)).
In this instance, Duymelinck teaches embodiments where the sample holder
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Application 12/257,057
is positioned within the vial and at a distance away from the port. See e.g.,
Duymelinck 39 and Figures 8, 10A, 10B, 11, 12, 24a, 24b, 25, and 26a—g.
We agree that the Examiner’s construction of “directly adjacent to and
beneath the port” as meaning “close or near” does not give full effect to the
words of the claim. Reply Br. 3. Moreover, a sample holder, like that of
Duymelinck, placed “in the lower half, lower third, lower fourth of the body
of the vial, or otherwise adjacent or closely proximal to the base of the vial”
is not “close or near” a port located at the top of the vial. Duymelinck 39.
Therefore, on this record, we cannot sustain the Examiner’s rejection of
claims 1^1, 6-10, 12-14, and 16-21 under 35 U.S.C. § 102(b).
CONCLUSION
The Examiner did not reversibly err in rejecting claims 1—4, 6—10, 12—
14, and 16—21 under 35 U.S.C. § 103(a) as being unpatentable over
Duymelinck.
The Examiner did not reversibly err in rejecting claims 11 and 15
under 35 U.S.C. § 103(a) as being unpatentable over Duymelinck in view of
Ryan or Smith.
The Examiner did reversibly err in rejecting claims 1—4, 6—10, 12—14,
and 16—21 under 35 U.S.C. § 102(b) as being unpatentable over
Duymelinck.
DECISION
For the above reasons, the Examiner’s rejection of claims 1—4 and 6—
21 is affirmed.
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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).
AFFIRMED
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