Ex Parte Tomes et al

Patent Trial and Appeal Board

Jan 18, 2018

12647515 (P.T.A.B. Jan. 18, 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.
12/647,515 12/27/2009 Jennifer E. Tomes BPMDL0005JT.P 1 2088
(10055UC1
27939 7590 01/19/2018
Philip H. Burrus, IV
Burrus Intellectual Property Law Group LLC
222 12th Street NE
Suite 1803
Atlanta, GA 30309
EXAMINER
POON, ROBERT
ART UNIT PAPER NUMBER
3788
MAIL DATE DELIVERY MODE
01/19/2018 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,
KENNETH S. CHUA, JACK E. MAZE, ALBERTO C. SAVAGE,
and ARLENE SIAVELIS
Appeal 2016-003 8731
Application 12/647,5152
Technology Center 3700
Before ANTON W. FETTING, BRADLEY B. BAYAT, and
AMEE A. SHAH, Administrative Patent Judges.
SHAH, Administrative Patent Judge.
1 Throughout this Opinion, we refer to the Appellants’ Appeal Brief (“Br.,”
filed July 7, 2015) and Specification (“Spec.,” filed Dec. 27, 2009), and to
the Examiner’s Answer (“Ans.,” mailed Dec. 2, 2015) and Final Office
Action (“Final Act.,” mailed Apr. 7, 2015).
2 We note related appeals 2014-007096 (App. 13/374,509), 2014-005013
(App. 13/153,265), and 2014-007582 (App. 13/153,300). Br. 2. Related
patents U.S. 8,448,786 B2, U.S. 8,631,935 B2, andU.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)
Appeal 2016-003873
Application 12/647,515
DECISION ON APPEAL
The Appellants3 appeal under 35 U.S.C. § 134(a) from the Examiner’s
final decision rejecting claims 24—37.4 We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
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,
as well as an instruction manual included therewith.” Spec. 12.
Claims 24 and 28 are the independent claims on appeal. Claim 24
(Br. 26 (Claims App.)) is exemplary of the subject matter on appeal and is
reproduced below (with added paragraphing and bracketing):
24. A catheter package assembly with instructions, comprising:
[(a)] a tray having at least a first compartment having at
least one syringe disposed therein and a second compartment
having a catheter assembly disposed therein, wherein the tray is
sealed with a wrap;
[(b)] an instruction manual comprising a health care
services portion and a detachably coupled a patient portion; and
[(c)] a thermally sealed bag disposed about the tray,
wherein the instruction manual is disposed outside the wrap and
within the thermally sealed bag;
3 According to the Appellants, the real party in interest is Medline
Industries, Inc. Br. 2.
4 Claims 38 and 39 have been withdrawn from consideration. Final Act. 1.
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[(d)] wherein the patient portion comprises instructions
printed thereon for reducing a chance of contracting an infection
from using the catheter assembly.
REJECTIONS AT ISSUE ON APPEAL
Claim 24 stands rejected under 35 U.S.C. § 101 on the ground of non-
statutory double patenting as being unpatentable over claim 1 of Tomes (US
8,631,935 B2, iss. Jan. 21, 2014), Morelli (US 2010/0274205 Al, pub. Oct.
28, 2010), and Primer (US 2008/0283426 Al, pub. Nov. 20, 2008). Final
Act. 4.
Claims 24—36 stand rejected under pre-AIA 35 U.S.C. § 103(a) as
being unpatentable over Busch (US 2004/0004019 Al, pub. Jan. 8, 2004),
Morelli, and Primer. Id. at 5.
Claim 37 stands rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Busch, Morelli, Primer, and Hedge (US 5,487,566, iss.
Jan. 30, 1996). Id. at 7.
PRELIMINARY MATTER
The Appellants request clarification on the Restriction Requirement
mailed May 23, 2012. Br. 22—23. The Examiner responds that the
Requirement was not withdrawn. Ans. 9. We note that matters regarding
restriction requirements are to be resolved via petition to the technology
center Director. See 37 C.F.R. § 1.144, MPEP 1002.02(c). We consider
claims 38 and 39 as withdrawn and not pending on appeal.
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ANALYSIS
Double Patenting
The Appellants do not provide any arguments against the Examiner’s
double patenting rejection of claim 24. Thus, we summarily affirm the
rejection.
Obviousness — Claims 24—27
The Appellants contend that the Examiner’s rejection of independent
claims 24 is in error. After careful consideration of the arguments presented
in the Appeal Brief at pages 11—17, we are not persuaded of Examiner error.
Unsuitable for its intended purpose
The Appellants do not contest the Examiner’s findings, but argue that
the Examiner’s rejection is in error because “one of ordinary skill in the art
would not be motivated to combine Primer with Busch and Morelli, as doing
so would render Primer’s label unsuitable for its intended purpose.” Br. 11;
see also id. at 12—14. We find this argument unpersuasive because the
Examiner’s rejection is not based upon a bodily incorporation of Primer’s
manual into the manual of Busch as modified by Morelli. We also find this
argument unpersuasive because modifying the manual of Busch and Morelli
with the features of Primer would not render Primer’s label unsuitable for its
intended purpose of providing information in an efficient manner. See
Primer 112.
The Examiner finds that Busch teaches the packaged catheter
assembly of claim 24 comprising a tray as recited in limitation (a), and that
Morelli teaches a medical device kit with an instruction manual, as partially
recited in limitation (b) and a thermally sealed bag with the manual disposed
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outside a wrap on the tray as recited in limitation (c). See Final Act. 5— 6.
The Examiner relies on Primer for teaching the instruction manual
comprising a health care services portion and a detachable patient portion, as
partially recited in limitation (b), wherein the patient portion comprises
instructions as recited in limitation (d), determining that one of ordinary skill
in the art would have “replace[d] the single[-]sheet label” (Ans. 7) of Busch
and Morelli to have the portions of Primer to “incorporate additional
information” (Final Act. 6; see also Ans. 7).
Claim 24 recites that the manual comprises instructions and is
“disposed outside the wrap” that seals the individual tray. Br. 26 (Claims
App.). As the Appellants point out (see Br. 12), Primer discloses that its
booklet-type label is attached to an exterior of an individual product. See
Primer, e.g., 45, 56, 60, 64, 68, 72, 76. The booklet-type label provides
instructions as an “efficient means for correlating relevant medical care
information to a respective patient.” Id. ^ 12. A plurality of the individual
products can be packaged together in one container of any material that
includes a label with the same information as provided on the booklet-type
label. Id. H 41, 47. The individual product can be a sterile procedure tray
(“STP”) comprising a “standardized package of a plurality of [] medical
instruments and medical care products used when performing a medical
procedure.” Id. 1 63, Fig. 10. The STP is packaged in a bag-type pouch,
that can be shrink-wrap, and that has a booklet-type label attached to the
exterior surface of the pouch/wrap. Id. ]Hf 63, 64.
The Appellants do not show where, or how, Primer discloses that the
individual item, such as the STP, cannot be further within an enclosure, such
as a sealed bag container, such that the individual item label is still seen, or
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that Primer’s container label cannot be a booklet-type label. In other words,
the Appellants do not show why, or how, having the manual of Busch and
Morelli as modified by Primer would render Primer inoperable for its
intended purpose of providing medical care information on the outside of an
individual item.
Secondary considerations
The Appellants further argue that the Examiner’s rejection is in error
because “secondary evidence demonstrates non-obviousness over the
combination.” Br. 11; see also id. at 14—17. The Appellants present the
Declaration of Jennifer Tomes, dated December 10, 2012 (“Declaration”)
and non-patent literature in the form of articles as evidence of commercial
success and unexpected results. Id. at 15—16. The Appellants also present
the Declaration and non-patent literature in the form of manuals as evidence
of copying. Id. at 16-17.
We have fully considered the Declaration and evidence provided in
support of secondary considerations and, weighing all evidence of
obviousness against all evidence of non-obviousness, we find the secondary
considerations unpersuasive of Examiner error.
Evidence of secondary considerations must be relevant to and
reasonably commensurate with the scope of the claim, and, therefore, we
must determine whether there is a nexus between the merits of the claimed
invention and the evidence of secondary considerations. See In re Huai-
Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011); Ashland Oil, Inc. v. Delta
Resins & Refractories, Inc., 776 F.2d 281, 305 n.42 (Fed. Cir. 1985), cert,
denied, 475 U.S. 1017 (1986).
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Here, inventor Jennifer Tomes’s Declaration is directed to references
that are not the subject of the rejection on appeal. In the Declaration, Tomes
states that claims 11, 18, and 21—27 are rejected as obvious over the prior art
Busch, Roshdy (US 6,793,078 B2), and Paikoff (US 4,523,679) and that
“the information below includes such secondary considerations sufficient to
rebut obviousness in view of the cited references.”
The article from Infection Control Today (“Infection Control’)
discusses that the Arkansas Methodist Medical Center “has seen a 21 percent
reduction on catheterizations and catheter-associated urinary tract
infections.” The Infection Control article states that the Foley catheter
management system helped in the reduction with its “one-layer tray design is
labeled in a specific sequence that helps guide . . . [the] nurses during the
catheterization process to adhere to current CDC recommendations,
including aseptic technique,” “checklist to help the nurse make a decision on
whether catheterization is appropriate for the patient and assure that the
education transfers into everyday clinical practice,” “Foley InserTag and
checklist sticker placed on the patient's chart,” and “patient education care
card that looks like an actual get well card . . . [and] is a more effective way
to educate patients about the procedure, including the risks and
complications associated with closed system Foley catheters.” However, the
article also states that, to help reduce catheterizations and, thus, infections,
nursing staff are required “to take the program education on the alternatives
to catheterization,” and it was newly recommend to remove catheters within
24 to 48 hours post-operatively.
The iStockAnalyst article discuses that the “catheter management
system, featuring a revolutionary one-layer tray design, is helping hospitals”
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reduce infections through improved education. Almost duplicative of the
Infection Control article, the iStockAnalyst article discusses the Arkansas
Methodist Medical Center’s reduction in catheterizations resulting from the
catheter management system’s “one-layer tray design [that] is labeled in a
specific sequence that helps guide . . . [the] nurses during the catheterization
process to adhere to current CDC recommendations, including aseptic
technique,” “checklist to help the nurse make a decision on whether
catheterization is appropriate for the patient and assure that the education
transfers into everyday clinical practice,” “Foley InserTag and checklist
sticker placed on the patient's chart,” and “patient education care card that
looks like an actual get well card.” Also similar to the Infection Control
article, the iStockAnalyst article further states that, to help reduce
catheterizations and, thus, infections, nursing staff are required “to take the
program education on the alternatives to catheterization,” and it was newly
recommend to remove catheters within 24 to 48 hours post-operatively.
The Morningstar article discusses Floyd Medical Center’s 83 percent
reduction in catheter associated urinary tract infections (CAUTI) and 23
percent decline in catheterizations due to a comprehensive improvement
initiative featuring the catheter management system that “helps providers by
combining evidence-based principles and training with a revolutionary one-
layer tray design.” The Center utilizes the tray “along with facility-wide
physician and nurse education . . . [of] the appropriate use of catheters and
the importance of avoiding catheters when not medically necessary to reduce
its CAUTI rates.” The Center’s Medical Director cited the “kit’s larger
sterile barrier . . . [flap] and one-layer tray design (versus the industry
standard two-layer tray) as important factors to helping the nursing staff
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maintain aseptic technique,” the “tray’s checklists” that help “document a
valid clinical reason for inserting a catheter and another that reviews the
proper steps to catheter insertion” that are “then adhered to the patient’s
chart for proper documentation of insertion,” and the InserTag yellow sticker
around drain tubing to indicate the date and time of the catheter insertion.
However, all of the evidence for commercial success and unexpected
results make clear that use of the tray in combination with training and
timely removal resulted in reductions in catheterizations and infections. The
Appellants have not adequately shown that the tray itself caused unexpected
results or that “the commercial success was caused by the merits of the
invention as distinct from the prior art.” In re Huai-Hung Kao, 639 F.3d at
1069. Further, the features of the tray that were considered most helpful are
not recited in the claim; the secondary considerations are not reasonably
commensurate with the scope of the claim. Claim 24 does not recite or
require the tray of one-layer labeled in a specific sequence, the instructions
as checklists, an InserTag sticker that goes around drain tubing, a sterile
barrier flap, or a greeting card. As such, the Declaration and articles are not
probative of commercial success and unexpected results because they do not
deal with the specific prior art that was the subject of the rejections (see In re
Beattie, 974 F.2d 1309, 1313 (Fed. Cir. 1992)), and because there is not a
nexus between the merits of the claimed invention and the evidence of
secondary considerations.
The manuals from Bard indicate the differences between an older
label and a newer one that contains more information and in a booklet style.
“Copying requires duplication of features of the . . . [Appellants’] work
based on access to that work, lest all infringement be mistakenly treated as
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copying.” Institut Pasteur & Universite Pierre et Marie Curie v. Focarino,
738 F.3d 1337, 1347-48 (Fed. Cir. 2013). The Appellants have not shown
that the newer label resulted directly from the Appellants’ claim or access
thereto. The Appellants further do not provide adequate evidence that Bard
copied the Appellants’ invention and instructions. Cf. Apple Inc. v. Samsung
Flees. Co., 839 F.3d 1034, 1054 (Fed. Cir. 2016), cert, denied, 138 S. Ct.
420 (2017) (record containing “multiple internal Samsung presentations
given by different Samsung groups at different times stating that the
iPhone’s slide to unlock feature is better than the various Samsung
alternatives” was substantial evidence of copying).
Thus, we are not persuaded the Examiner erred in the rejection of
claim 24. We sustain the Examiner’s rejection of independent claim 24 and
dependent claims 25—27, which were not argued separately (Br. 11).
Obviousness — Claims 28—37
The Appellants contend that the Examiner’s rejection of independent
claims 28 is in error. After careful consideration of the arguments presented
in the Appeal Brief at pages 17—21, we are not persuaded of Examiner error.
The Examiner finds that, similar to claim 24, Busch, Morelli, and
Primer teach the manual configured for inclusion with a tray, the manual
comprising a health care services portion with information and a detachably
coupled patient portion with information. See Final Act. 6, Ans. 8—9. The
Examiner finds that the prior art does not teach the information comprises
instruction for using the catheter assembly and devices, i.e., the contents of
the information. See Final Act. 7, Ans. 9. But the Examiner determines that
the type of information provided, i.e., the instructions, is non-functional
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descriptive material that would not distinguish the invention from the prior
art in terms of patentability. Final Act. 7, Ans. 8—9. We agree.
The Appellants do not contest the Examiner’s findings, but argue that
the specific type of information is functional and should be given patentable
weight. See Br. 17—21. We note that 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). Although we will not disregard any claim limitations
and will assess the claimed invention as a whole, we will follow the Federal
Circuit’s guidance as in the Gulack decision and will “not give patentable
weight to printed matter absent a new and unobvious functional relationship
between the printed matter and the substrate.” In re Lowry, 32 F.3d 1579,
1582-83 (Fed. Cir. 1994).
Claim 28 is directed to a manual comprising a portion with
instructions for using the assembly and devices and a detachably coupled
patient portion. Primer discloses a label with usage instructions for a
product to treat a medical condition. Primer 114. The only difference
between the claim limitations and Primer lies in the instructions, i.e., that the
usage instructions are for using a catheter assembly and devices on a patient.
Thus, the relevant question is whether the specific instructions have a “new
and unobvious functional relationship” with the aid. We disagree that In re
Ngai, 367 F.3d 1336 (Fed. Cir. 2004) does not apply here. Br. 17—19. There
is no objective evidence of record that there is such a functional distinction
between the instructions. Although the specific instructions may change
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based on the devices or items in the assembly, the function of usage
instructions for a product and instructions for using the catheter assembly
and devices would be same. As such, the specific type of instructions
constitutes non-functional descriptive that may not be relied upon for
patentability. See In re Ngai, 367 F.3d at 1339; see also Ans. 8—9.
Concluding otherwise would result not only in the Appellants’
descriptive appearance distinguishing over the prior art, but equally would
distinguish every other type of appearance of matter printed on a card or
label. To give effect to the Appellants’ arguments, we would need to ignore
our reviewing court’s concerns with repeated patenting. See, e.g.,
AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1064—65 (Fed. Cir. 2010)
(“As explained in Ngai, if this court concluded otherwise ‘anyone could
continue patenting a product indefinitely provided that ‘they add a new
instruction sheet to the product.’ 367 F.3d at 1339. Neither the Patent Act
nor our precedent countenances such an outcome”); King Pharm., Inc. v.
Eon Labs, Inc., 616 F.3d 1267, 1279 (Fed. Cir. 2010) (“The rationale behind
this line of cases is preventing the indefinite patenting of known products by
the simple inclusion of novel, yet functionally unrelated limitations”).
Contrary to the Appellants’ assertion, the Board did not hold in related
IPR2015-00514 that the instructions were functional. Rather, the Board
held, as the Appellants cite, that the detachability of the two portions appears
to be a functional feature. Br. 21.
Thus, we are not persuaded the Examiner erred in the rejection of
claim 28. We sustain the Examiner’s rejections of independent claim 28 and
dependent claims 29—37, which were not argued separately (Br. 11).
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DECISION
The Examiner’s rejection of claim 24 under 35 U.S.C. § 101 on the
ground of non-statutory double patenting is AFFIRMED.
The Examiner’s rejections of claims 24—37 under pre-AIA 35 U.S.C.
§ 103(a) are 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
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