Ex Parte Capelli

Patent Trial and Appeal Board

Mar 26, 2018

13627405 (P.T.A.B. Mar. 26, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/627,405 09/26/2012
108197 7590 03/28/2018
Parker Highlander PLLC
1120 South Capital of Texas Highway
Bldg. 1, Suite 200
Austin, TX 78746
FIRST NAMED INVENTOR
Christopher C. CAPELLI
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
SCCC.P0002US 5085
EXAMINER
RASHID, FAZLE A
ART UNIT PAPER NUMBER
1774
NOTIFICATION DATE DELIVERY MODE
03/28/2018 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):
docket@phiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BOARD OF REGENTS,
THE UNIVERSITY OF TEXAS SYSTEM
Appeal2017-005605
Application 13/627,405
Technology Center 1700
Before ROMULO H. DELMENDO, MONTE T. SQUIRE, and
DEBRA L. DENNETT, Administrative Patent Judges.
DENNETT, Administrative Patent Judge.
DECISION ON APPEAL 1
STATEMENT OF THE CASE
Appellant2 appeals under 35 U.S.C. § 134(a) from a rejection of
claims 1-21. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 In our Opinion, we refer to the Specification filed September 26, 2012
("Spec."); the Final Action mailed May 6, 2016 ("Final Act."); the Appeal
Br. filed October 14, 2016 ("Appeal Br."); and the Examiner's Answer
mailed December 23, 2016 ("Ans."). Appellant did not file a Reply Brief.
2 Appellant is the applicant, Board of Regents, The University of Texas
System. Appellant identifies the inventor, Christopher Capelli, as the real
party in interest. Br. 3.
Appeal2017-005605
Application 13/627,405
The claims are directed to transportable therapeutic cartridges. Claim
1, reproduced below with disputed limitations italicized, is illustrative of the
claimed subject matter:
1. A transportable therapeutic cartridge comprising:
a transport shell; and
a receptacle structure configured to receive one or more
therapeutic agents, and to be coupled to the transport shell such
that one or more therapeutic agents disposed in the receptacle
structure are protected;
wherein the cartridge is configured to be used to
manually mix therapeutic agents and configured to be coupled
to a therapeutic agent robotic mixer such that the robotic mixer
can access therapeutic agents disposed in the cartridge;
wherein the receptacle structure comprises a plurality of
compartments configured to receive therapeutic agent
containers; and
wherein at least one of the plurality of compartments
comprises a recess adjacent the top of the compartment; and
at least one robotic transfer device configured to fit into
the recess.
Br. 13 (Claims App'x).
REFERENCES
The Examiner relies on the following prior art in rejecting the claims
on appeal:
Root et al. ("Root")
Sevigny et al.
(Sevigny")
us 4,895,706
US 2008/0031776 Al
2
Jan.23, 1990
Feb. 7,2008
Appeal2017-005605
Application 13/627,405
REJECTIONS
The Examiner maintains and Appellant seeks review of the following
rejections: (1) claims 1-12, 14, and 17-21under35 U.S.C. § 102(b) over
Sevigny; and (2) claims 13, 15, and 16 under 35 U.S.C § 103(a) over
Sevigny in view of Root. Final Act. 3, 7; Br. 4.
OPINION
Rejection of claims as anticipated by Sevigny
Claim 1 is the sole pending independent claim. Br. 13-15 (Claims
App 'x). Appellant argues that claims 8, 18, and 21 are each patentable for
reasons in addition to those given for patentability of claim 1. See id. at
8-12. We select claim 1 as representative of the group including claims 1-7,
and 9-17 3; these claims will stand or fall with claim 1. 37 C.F.R.
§ 41.37(c)(l)(iv).
The Examiner finds that Sevigny teaches all elements of claim 1.
Final Act. 3. Of significance to our decision, the Examiner finds that
Sevigny discloses:
( 1) a recess formed within chamfered ring 23 and upper portion of
surface 24 of compartment 22, which meets the claim limitation "wherein at
least one of the plurality of compartments comprises a recess adjacent the
top of the compartment;" and
(2) a pipette tip associated with robotic sampling device fits cap 310
disposed inside recess formed by chamfered ring 23 and upper portion of
surface 24 of compartment 22, which meets the claim limitation "at least one
3 Claims 19 and 20 depend directly from claim 18. See Br. 15 (Claims
App 'x). Therefore, claims 19 and 20 will stand or fall with claim 18.
3
Appeal2017-005605
Application 13/627,405
robotic transfer device configured to fit into the recess." Id. (citing Sevigny
Fig. 1 and ii 57).
Figure 1 of Sevigny is reproduced below:
61
'
60A 40A J,
" I
' 63
50
Sevigny's Figure 1 is an exploded perspective view of a preferred
sample carrier according to Sevigny's invention. Sevigny ii 27. Sevigny
discloses:
Spaced-apart openings 22 are included in the transverse
wall 20 ... which may be of the same or different sizes and are
dimensioned to receive sample tubes 300 into the sample carrier
1 OA. Each opening 22 is positioned above a sample tube
receiving area 60 .... As illustrated in FIGS. 1 and 8, the
transverse wall 20 includes a chamfered ring 23 circumscribing
each opening 22 to facilitate insertion of the sample tubes 300
into the sample carrier 1 OA. An inner surface 24 of each
opening 22 is preferably sized to receive the cap component
310 of the sample tube 300 in touching contact, which may be a
frictional fit, preferably allowing the longitudinal axis of the
cap component to move laterally from the longitudinal axis of
4
Appeal2017-005605
Application 13/627,405
the opening no more than about 0.125 inches (3.12 mm), and
more preferably no more than about 0.1 inches (2.54 mm).
Accordingly, in a preferred application the sample carrier 1 OA
is dimensioned so that at least a portion of each cap 310 is
contained within an opening 22 between top and bottom
surfaces 21, 25 of the transverse wall 20 when the sample tubes
310 are fully inserted into the sample tube receiving areas 60.
Sevigny i-f 57.
Appellant argues that Sevigny does not disclose a "receptacle
structure [that] comprises a plurality of compartments configured to receive
therapeutic agent containers" wherein "at least one of the plurality of
compartments comprises a recess adjacent the top of the compartment" and
"at least one robotic transfer device configured to fit into the recess." Br. 5.
Appellant contends that the "chamfer" disclosed in Sevigny does not meet
the claimed "recess." Id.
As noted by Appellant, the Specification does not define "recess"
explicitly. Id. Appellant provides a dictionary definition of "recess" as "a
hollow cut or built into a surface (as a wall)." Id. (citing hppt://merriam-
webster.com/ dictionary/recess). Appellant distinguishes this definition of
"recess" from that of "chamfer," which Appellant contends is defined as "a
beveled edge." Id. (citing http://merriam-webster.com/dictionary/recess). 4
Appellant argues that a recess is "understood to be formed into a surface,
while a chamfer is formed on an edge." Id. at 6.
We agree with Appellant that "recess" and "chamfer" are not the
same, as a recess is a void, or hollow space defined by three-dimensional
4 Appellant clearly intended to cite https://merriam-
webster/com/dictionary/chamfer, which is where the stated definition can be
found.
5
Appeal2017-005605
Application 13/627,405
structure, 5 while a chamfered ring is, itself, a three-dimensional structure. A
chamfered ring may define at least part of the dimensions of a recess, but the
two terms are not synonymous. However, the rejection does not indicate
that a recess and a chamfered ring are the same, but rather, that the recess
(space) is formed within (i.e., its boundaries are defined by) the chamfered
ring 23 and upper portion of surface 24. Appellant's argument on this issue
is unpersuasive of reversible error in the finding by the Examiner.
Appellant also argues that Sevigny does not disclose "at least one
robotic transfer device configured to fit into the recess." Br. 8. Appellant's
reasoning is that Sevigny teaches that chamfered ring 23 is configured to
facilitate insertion of a sample tube 300 into sample carrier 1 OA, and cap
310 of a sample tube 300 is configured to fit into the chamfered ring 23. Id.
at 7. A robotic pipettor (which the Examiner asserts is the robotic transfer
device of claim 1 (see Final Action 3)) is not configured to fit into the
chamfered ring, according to Appellant. Br. 3.
Appellant acknowledges that Sevigny discloses a robotic pipettor. Br.
7; see also Sevigny i-fi-157, 70, 76. A robotic pipettor is an automated (or
robotic) device for transferring discrete amounts of fluids from one location
to another, thus, falls within the broadest reasonable interpretation of a
"robotic transfer device" in claim 1. See In re Am. Acad. of Sci. Tech. Ctr.,
367 F.3d 1359, 1364 (Fed. Cir. 2004) (During prosecution, an application's
claims are given their broadest reasonable scope consistent with the
specification.). The issue is whether a robotic pipettor, as disclosed in
5 See, e.g., https://www.merriam-webster.com/dictionary/recess (defining
"recess" as "an indentation cleft·"
' '
https:en.oxforddictionaires.com/ definition/recess (defining "recess" as "a
hollow space inside something").
6
Appeal2017-005605
Application 13/627,405
Sevigny, would have been "configured to fit into the recess" adjacent the top
of a compartment. We find that it would have been so configured.
Figure 15 of Sevigny is reproduced below:
10C
\
150
Figure 15 is an exploded perspective view of another sample carrier
according to Sevigny's invention with two sample tubes inserted into the
sample tube receiving areas. Sevigny i-f 41. Caps 310 are shown on sample
tubes 300.
One of ordinary skill in the art at the time of the invention would have
understood from the disclosures of Sevigny that a pipette tip of a robotic
pipettor would penetrate the center of the top of cap 310 in order to
withdraw fluid from or inject fluid into sample tube 300. See Sevigny i-f 57.
Because the sample tube would have been configured to fit into the recess,
7
Appeal2017-005605
Application 13/627,405
as illustrated in Fig. 15, supra, and disclosed in paragraph 57, the pipette of
the robotic pipettor would have been configured to fit into the recess as well.
The pipette would have been configured to pass through a centrally located
passage in the cap, which would have required the pipette to then pass
through the middle of the recess.
For the reasons above, we find that no reversible error in the
Examiner's rejection, and sustain the rejection of claim 1 as anticipated by
Sevigny. We, likewise, sustain the rejection of claims 2-7, and 9-17 as
anticipated by Sevigny.
Rejection of claim 8 as anticipated by Sevigny
Claim 8 depends from claim 1 and further recites that the robotic
transfer device comprises a latching element configured to be secured on the
cap of the therapeutic agent container. Br. 14 (Claims App'x).
The Examiner finds that a pipette tip capable of being snapped to cap
310 meets the latching element of claim 8. Final Act. 5 (citing Sevigny
ii 78).
Appellant argues that one of ordinary skill in the art would not have
considered a pipette tip to be a "latching element." Br. 8-9.
We agree with Appellant that, even if a pipette tip is capable of
snagging on the cap, it does not meet the "latching element" limitation of
claim 8. See id. at 9. A pipette tip is not configured to snag on the cap as
the pipette tip is withdrawn from the sample tube. If the pipette tip snags, it
indicates a potential problem with the continuing function of the device.
Sevigny explains, "Vertical movement of the sample carrier 10 [to which the
capped sample tube is physically attached] is of particular concern when a
robotic pipettor is used to withdraw a test sample from sample tubes 300
8
Appeal2017-005605
Application 13/627,405
having penetrable caps 310." Sevigny i-f 78. Sevigny guards against this
unwanted occurrence by restricting the vertical movement of the sample
carrier with an inner runner and a blocking wall. Id.
We do not sustain the Examiner's rejection of claim 8 as anticipated
by Sevigny.
Rejection of claim 18 as anticipated by Sevigny6
Claim 18 depends from claim 1 and further requires that the
transportable therapeutic cartridge comprises a temperature regulator or
pressure modulator. Br. 15 (Claims App'x).
The Examiner finds that spring 50 meets the "pressure modulator"
limitation. Final Act. 6.
Appellant contends that Sevigny does not disclose a pressure
modulator. Br. 10. Appellant points to the description of pressure
modulation in the Specification:
As used herein, pressure modulation[ s] means that the one
compartment or a plurality of compartments internal pressure
can be made to be lower, higher or equal pressure to the
external environment so the therapeutic drug container can have
the desired pressure during the mixing of the therapeutic drug.
Id. (quoting Spec. 26, 11. 16-19)7. Appellant contends that the springs in
Sevigny are designed to provide tension on the sample tubes to hold then in
place while samples are removed. Id.
The springs in Sevigny arguably exert mechanical pressure on sample
tubes to hold them in place. However, here Appellant elected to be its own
lexicographer, and provided a specific definition of pressure modulator,
6 Claims 19 and 20, depending from claim 18, stand or fall with claim 18.
7 See ,-r 86 in the published Application.
9
Appeal2017-005605
Application 13/627,405
which it is free to do. Cf Vitronics Corp. v. Conceptronic, Inc., 90 F .3d
1576, 1582 (Fed. Cir. 1996) ("[W]ords in a claim are generally given their
ordinary and customary meaning, [but] a patentee may choose to be his own
lexicographer and use terms in a manner other than their ordinary meaning,
as long as the special definition of the term is clearly stated in the patent
specification or file history."). Sevigny does not teach that the springs exert
any internal pressure in a compartment relative to the external environment.
See Sevigny Fig. 1. We, therefore, do not sustain the rejection of claim 18
as anticipated by Sevigny. For the same reasons, we do not sustain the
rejection of claims 19 and 20, which depend from claim 18.
Rejection of claim 21 as anticipated by Sevigny
Claim 21 depends from claim 1 and recites the additional limitation
that the cartridge is a closed-system drug-transfer device having the means
to modulate pressure between the therapeutic drug container and the external
environment. Br. 15 (Claims App'x).
The Examiner finds that Sevigny meets the additional claim
limitations because Sevigny' s ( 1) cartridge provides protection against
cross-contamination of contents within and (2) caps have weakened centers,
filters, central passages, or slits to modulate pressure between the therapeutic
container and the external environment. Final Act. 6 (citing Sevigny i-fi-155
and 57).
Appellant argues that Sevigny' s disclosure that caps "must be
penetrated by a pipette tip or other fluid transfer device" would not be
considered a means to modulate pressure between the therapeutic container
and the external environment. Br. 12.
10
Appeal2017-005605
Application 13/627,405
The Examiner's finding indicates that Sevigny's caps can modulate
pressure between the internal environment of the therapeutic drug container
and the external environment. However, Appellant's definition of a "closed-
system drug-transfer device" as "a drug transfer device that mechanically
prohibits the transfer of environmental contaminants into a system and the
escape of hazardous drug or vapor concentrations outside the system"
conflicts with the requirement of equalization of pressure between the
external environment and the contents of the sample tubes. A cap that
permits passage of air into the inside of the sample tube would not meet the
requirement of claim 21 for a closed-system drug-transfer device.
For the reasons above, we do not sustain the rejection of claim 21 as
anticipated by Sevigny.
Rejection of claims as obvious over Sevigny in view of Root
Claim 13, 15, and 16 each depend indirectly from claim 1 and each
require a seal between the receptacle and the transport shell, claim 16 further
requiring that the seal is airtight. Br. 14--15 (Claims App'x).
The Examiner finds that Root teaches an airtight seal for a cartridge
wherein a transport shell is coupled to a receptacle. Final Act. 8. The
Examiner relies on Sevigny for teaching the limitations of claim 1, from
which claims 13, 15, and 16 depend.
Appellant did not address the Examiner's rejection of claims 13, 15,
and 16 over Sevigny in view of Root. See generally Br. Thus, Appellant
does not identify reversible error in the rejection, and we sustain the
rejection proforma.
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Appeal2017-005605
Application 13/627,405
DECISION
The rejection of claims 1-7 and 9-17 as anticipated by Sevigny is
affirmed. The rejection of claims 13, 15, and 16 as obvious over Sevigny in
view of Root is affirmed.
The rejection of claims 8 and 18-21 as anticipated by Sevigny is
reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv) (2015).
AFFIRMED-IN-PART
12