Ex Parte Tomes et al

Patent Trial and Appeal Board

Jul 31, 2018

14265920 (P.T.A.B. Jul. 31, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/265,920 04/30/2014
27939 7590 08/01/2018
Philip H. Burrus, IV
Burrus Intellectual Property Law Group LLC
222 12th Street NE
Suite 1803
Atlanta, GA 30309
FIRST NAMED INVENTOR
Jennifer E. Tomes
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.
BPMDL0005JT.D1.C2
(10055U
EXAMINER
POON, ROBERT
3668
ART UNIT PAPER NUMBER
3788
MAIL DATE DELIVERY MODE
08/01/2018 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JENNIFER E. TOMES, DEBORAH B. ADLER, JACK E. MAZE,
ALBERTO C. SAVAGE, KENNETH S. CHUA, EARL D. WILSON,
and JOHN HENRY KUTSCH
Appeal2017-004737 1
Application 14/265,9202
Technology Center 3700
Before ANTON W. PETTING, BRADLEY B. BAY AT, and
AMEE A. SHAH, Administrative Patent Judges.
SHAH, Administrative Patent Judge.
1 Throughout this Decision, we refer to the Appellants' Appeal Brief
("Appeal Br.," filed May 3, 2016), Reply Brief ("Reply Br.," filed Jan. 17,
2017), and Specification ("Spec.," filed Apr. 30, 2014), and to the
Examiner's Answer ("Ans.," mailed Nov. 23, 2016) and Final Office Action
("Final Act.," mailed Oct. 2, 2015).
2 The Appellants note related appeals 2016-003873 (App. 12/647,515),
affirmed Jan. 19, 2018; 2014-007096 (App. 13/374,509), affirmed Oct. 24,
2016; 2014-005013 (App. 13/153,265), affirmed Oct. 6, 2016; and 2014-
007582 (App. 13/153,300) (reversed under new ground of rejection, Oct. 12,
2016, rehearing denied Jan. 11, 2018). Appeal Br. 2. Related patents
U.S. 8,448,786 B2, U.S. 8,631,935 B2, and U.S. 8,678,190 B2 have also
been subject to Inter Partes Review (IPR). Review of U.S. 8,448,786 B2
was not granted (IPR2015-00509, Paper 11, July 15, 2015); and reviews of
U.S. 8,631,935 B2 and U.S. 8,678,190 B2 were terminated in response to
cancellation of the contested claims by Patent Owner (IPR2015-00513,
Paper 12, Aug. 11, 2015, IPR2015-00514, Paper 15, July 24, 2015)
Appeal2017-004737
Application 14/265,920
DECISION ON APPEAL
The Appellants3 appeal under 35 U.S.C. § 134(a) from the Examiner's
final decision rejecting claims 1-20, which are all of the pending claims.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
STATEMENT OF THE CASE
The Appellants' invention "relates generally to storage containers for
medical devices, and more particularly to a storage container for a long,
flexible medical implement, such as a catheter, and related medical devices."
Spec. ,r 2.
Claims 1, 12, and 19 are the independent claims on appeal. Claims 1
and 19 (Appeal Br. 28, 31-32 (Claims App.)) are exemplary of the subject
matter on appeal and are reproduced below ( with added paragraphing and
bracketing for reference):
1. A tray configured to accommodate a catheter assembly,
the tray comprising:
[ (a)] a contoured surface defining at least three
compartments separated by barriers and a perimeter wall, the at
least three compartments comprising:
[ ( a 1)] a first compartment comprising a first
compartment base member;
[a2)] second compartment comprising a second
compartment base member;
[ ( a3)] a first barrier separating the first compartment
from the second compartment;
3 According to the Appellants, the real party in interest is Medline
Industries, Inc. Br. 2.
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Application 14/265,920
[(a4)] a third compartment compnsmg a third
compartment base member; and
[ ( a5)] a second barrier separating the second
compartment from the third compartment; and
[ (b)] a first syringe disposed within the first compartment
of the tray;
[ ( c)] a second syringe disposed within the first
compartment of the tray; and
[ ( d)] a catheter assembly comprising a fluid bag disposed
within the second compartment of the tray;
[(e)] wherein:
[ ( e 1)] the first syringe and the second are ordered
within the tray in accordance with their use during a
catheterization procedure;
[ ( e2)] the first compartment supports the first
syringe and the second syringe at different heights;
[ ( e3) the first compartment defines one or more
contours for accommodating flanges of one or more of the
first syringe or the second syringe.
19. A method of manufacturing a packaged catheter
assembly, comprising:
[(a)] providing a tray having at least a first
compartment with a first compartment base member
having a contour and a second compartment, wherein the
first compartment and the second compartment are
separated by a first barrier;
[ (b)] disposing a first syringe and a second syringe
in the first compartment in accordance with their order of
use during a catheterization procedure;
[ ( c)] disposing a catheter assembly in the second
compartment;
[(d)] placing a sterile wrap about the tray;
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Application 14/265,920
[ ( e)] including printed instructions directing a user
to discharge contents of the at least one syringe into the
first compartment; and
[(f)] sealing the tray by placing a sealed bag about
the tray, the sterile wrap, and the printed instructions.
REJECTIONS AT ISSUE ON APPEAL 4
I. Claims 1---6, 9-14, and 16 stand rejected under pre-AIA
35 U.S.C. § I03(a) as being unpatentable over Busch (US 2004/0004019 Al,
pub. Jan. 8, 2004) and Nagamatsu (US 2006/0264822 Al, pub. Nov. 23,
2006).
II. Claims 7, 8, and 15 stand rejected under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Busch, Nagamatsu, and Fischer
(US 5,031,768, iss. July 16, 1991).
III. Claims 17 and 18 stand rejected under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Busch, Nagamatsu, and Miller et al.
(US 2007/0084742 Al, pub. Apr. 19, 2007) (hereafter "Miller").
IV. Claims 19 and 20 stand rejected under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Busch, Paikoff et al. (US 4,523,679, iss.
June 18, 1985) (hereafter "Paikoff'), and Miller.
ANALYSIS
Rejection I- Claims 1-6, 9-14, and 16
The Appellants contend that the Examiner's rejection of independent
claims 1 and 12 is in error because "neither Busch nor Nagamatsu, alone or
4 The rejection of claims 19 and 20 under 35 U.S.C. § 112, first paragraph,
has been withdrawn. Ans. 8.
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Application 14/265,920
in combination, teaches ... a first syringe and a second syringe disposed in a
common compartment, where the compartment includes supports the
syringes at different heights," as recited in limitations (al), (b), (c), and (e2)
of claim 1 and similarly recited in claim 12. Appeal Br. 17-18, 20; see also
Reply Br. 7-10. 5 Specifically, the Appellants argue that the Specification is
clear that the first compartment is a single compartment. See Appeal
Br. 18-20; Reply Br. 7-12. After careful consideration of the record before
us, we agree.
The Examiner finds that Busch teaches the catheter packaging system
of claim 1 comprising a tray with a first compartment, as recited in
limitation ( a 1 ), with first and second syringes disposed within, as recited in
limitations (b) and ( c ). See Final Act. 3--4 ( citing Busch Fig. 3). The
Examiner acknowledges that Busch does not teach the compartment
supporting the first and second syringes at different heights, as recited in
limitation (e2), but cites to Nagamatsu to cure this deficiency. See id. at 4.
The Examiner interprets Busch's "single compartments each holding a
syringe [to] both form the combination of a first compartment (A) in which
the syringes are disposed." Ans. 9. Giving the claim its "broadest
reasonable interpretation," the Examiner refers to Figure 3 (reproduced
below) and paragraphs 32, 33, and 36 of the Specification and finds that first
compartment 101 "clearly comprises two compartments ( stepped portions
116, 117) each holding a single syringe, the compartments being separated
5 The Appellants' aspersion on the Examiner's character and motive (Reply
Br. 10) is unnecessary and unhelpful to the issues here. We remind the
Appellants of the necessity of maintaining a professional tone and
professional decorum throughout all proceedings before the USPTO.
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Application 14/265,920
by a boundary since both compartments are inclined with the first stepped
portion (116) shallower than second stepped portion (117)." Id. at 10.
Figure 3 of the Specification, reproduced above, showing a top plan
view of the tray with compartments 101, 102, and 103.
The Specification provides for a tray with, inter alia, first
compartment 101. Spec. ,r 29. First compartment 101 is bounded on the
bottom by first base member 107, on the side by perimeter wall 110, and
separated from second compartment 102 and third compartment 103 by
barriers 105 and 106. Id. ,r,r 29, 32. Base member 107 can include a stair-
stepped contour 115 with portions 116 and 117 at different heights within
the tray to accommodate syringes of different sizes (id. ,r 33), and
protrusions 120 that "help ... prevent the syringes from sliding laterally
within the first compartment 101" (id. ,r 37), as can be seen in Figure 2,
reproduced below. Id. ,r 33.
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Application 14/265,920
FIG. 2
Figure 2, reproduced above, of the Specification showing a left
perspective view of the tray with first compartment 101, barrier 105, and
base member 107, contour 115, step portions 116 and 11 7, and protrusion
120.
As such, we agree with the Appellants that the Specification is clear
that the first compartment is a single compartment. Although the
compartment has various heights and components, we fail to understand how
the Examiner's interpretation that the first compartment can comprise
multiple compartments is within the broadest reasonable interpretation in
light of the Specification. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d
1359, 1364 (Fed. Cir. 2004).
We are persuaded by the Appellants' argument that Busch and
Nagamatsu each teaches multiple compartments for the two syringes, rather
than a single compartment having two syringes. See Appeal Br. 18-19. As
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Application 14/265,920
such, we agree that Busch and Nagamatsu, alone or in combination, do not
teach the first compartment as claimed.
Thus, we do not sustain the Examiner's rejection under 35 U.S.C.
§ 103(a) of independent claims 1 and 12, and dependent claims 2---6, 9--11,
13, 14, and 16.
Rejections II and III- Claims 7, 8, 15, 17, and 18
The Examiner's rejections of dependent claims 7, 8, 15, 17, and 19
under 35 U.S.C. § 103(a) as unpatentable over Busch and Nagamatsu, and
further in view of Fisher or Miller, rely on the same inadequately supported
findings discussed above, and which are not cured by additional findings
and/or reasoning associated therewith. See Final Act. 7-8.
Thus, for the same reason as discussed above, we do not sustain the
rejections of dependent claims 7, 8, 15, 17, and 18.
Rejection IV- Claims 19 and 20
The Appellants contend that the Examiner's rejection of independent
claim 19 is in error because the printed instructions, as recited in
limitation (e), "are functionally related to their substrate" (Appeal Br. 22),
and "thus distinguishes the claims from the prior art" (id. at 26). See also id.
at 21-25. We disagree.
The Examiner finds that Busch teaches the method of claim 19
comprising providing a tray with first and second compartments, disposing a
syringe in the first compartment, disposing a catheter in the second
compartment, sealing the tray, as recited in limitations (a}-(c) and (f), and
having printed instructions, as partially recited in limitation ( e ). See Final
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Application 14/265,920
Act. 8. The Examiner acknowledges that Busch does not teach placing a
sterile wrap, as recited in limitation ( d), and having the printed instructions
as claimed and inside the tray, as recited in limitation ( e ). See id. The
Examiner cites to Paikoff to cure the deficiency regarding the wrap, i.e.,
limitation ( d), and to Miller for teaching printed instructions in a kit. Id.
at 8-9. The Examiner determines it would have been obvious to put Miller's
instructions in Busch's tray in order to perform procedures and because "the
only difference between a prior art product and a claimed product is printed
matter that is not functionally related to the product, [ such that] the content
of the printed matter will not distinguish the claimed product from the prior
art." Id. at 9 (citing In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)); see
also Ans. 12-15.
Non-functional descriptive material cannot render patentable an
invention that is, otherwise, not patentable over the prior art. See In re
Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983) (when descriptive material is
not functionally related to the substrate, the descriptive material will not
distinguish the invention from the prior art in terms of patentability ).
Claim 19 is directed to a method comprising, in relevant part,
"including printed instructions directing a user to discharge contents of the at
least one syringe into the first compartment," as recited in limitation ( e).
Appeal Br. 31-32. Busch discloses a top-sealing sheet with "visual
indicia 26 printed on it, such as descriptions of how to use the product and
its contents." Busch ,r 25. Miller discloses a kit with "[ w ]ritten instructions
for selecting an insertion site and/ or locating a vein [that] may be provided
in pockets 56 on page one" of a divider in a kit. Miller ,r 67. The only
difference between the claim limitation and the combination of Busch and
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Application 14/265,920
Miller lies in the specific instructions, i.e., that the printed instructions direct
a user to discharge contents of the syringe into the first compartment. Thus,
the relevant question is whether the specific instructions have a "'new and
unobvious functional relationship"' to the method of manufacturing an
assembly. King Pharm., Inc. v. Eon Labs, Inc., 616 F.3d 1267, 1279 (Fed.
Cir. 2010) (quoting Ngai, 367 F.3d at 1338); see Gulack, 703 F.2d at 1386.
The inquiry is not whether the printed matter is functionally related to the
product, but whether it is related to the substrate. In this case, the substrate
is not the packaged assembly or the contents contained therein but, at best, is
the matter (not claimed) on which the instructions are printed, such as a label
(see Spec. ,r 55), that is included in the kit/package. In that sense, the
claimed instructions have no functional relationship to the substrate on
which it is printed, and have no functional relationship to including printed
matter.
We disagree that In re Ngai does not apply here. See Appeal
Br. 21-24. Rather, we agree with the Examiner that AstraZeneca LP v.
Apotex, Inc., 633 F.3d 1042, 1065 (Fed. Cir. 2010) is instructive in applying
In re Ngai to a kit with a label. Ans. 13-14. Like the kit in Ngai and
AstraZeneca, the specific type of instructions of the printed matter does not
change the method of manufacturing the assembly.
The Appellants' reliance on IPR2015-00514 is misplaced. See Appeal
Br. 25. We note that the Decision to Institute ("Dec. Inst.") in that case was
not a final decision as to the patentability of the claims. See Dec. Inst. 2.
Further, the Board held that the steps of accessing an instruction manual,
detaching a portion of the manual, and delivering the portion were functional
features to be given patentable weight. Id. at 12. Here, as the Examiner
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Application 14/265,920
notes (Ans. 14), there are no such limitations. Further, contrary to the
Appellants' insinuation (see Appeal Br. 25), the Board did not find the
written contents of the manual to be functional.
Thus, we are not persuaded the Examiner erred in the rejection of
independent claim 19. We sustain the Examiner's rejection under 35 U.S.C.
§ 103(a) of independent claim 19 and dependent claim 20, which was not
argued separately.
DECISION
The Examiner's rejections of claims 1-18 underpre-AIA 35 U.S.C.
§ 103(a) are REVERSED.
The Examiner's rejection of claims 19 and 20 under pre-AIA
35 U.S.C. § 103(a) is AFFIRMED.
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).
AFFIRMED-IN-PART
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