Medline Industries, Inc.

Patent Trials and Appeals Board

Jan 19, 2021

2020003579 (P.T.A.B. Jan. 19, 2021)

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.
15/188,656 06/21/2016 Sharbel Maalouf BPMDL0125SM (11637U) 1083
27939 7590 01/19/2021
Philip H. Burrus, IV
Burrus Intellectual Property Law Group LLC
222 12th Street NE
Suite 1803
Atlanta, GA 30309
EXAMINER
ORTIZ, RAFAEL ALFREDO
ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
01/19/2021 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):
kberry@burrusiplaw.com
pburrus@burrusiplaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte SHARBEL MAALOUF and MARY PATRICIA EBLE
__________

Appeal 2020-003579
Application 15/188,656
Technology Center 3700
__________

Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and
ANNETTE R. REIMERS, Administrative Patent Judges.

HOELTER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–11 and 21–25, which constitute all
the claims pending in this application. Final Act. 1 (Office Action
Summary). Claims 12–20 have been canceled. Appeal Br. 5. We have
jurisdiction under 35 U.S.C. § 6(b). For the reasons explained below, we
AFFIRM the Examiner’s rejections.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as “Medline
Industries, Inc.” Appeal Br. 2.
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CLAIMED SUBJECT MATTER
The disclosed subject matter “relates generally to cleaning systems,
and more particularly to cleaning systems in accordance with predefined
methods.” Spec. ¶ 3. Apparatus claim 1 is the sole independent claim on
appeal. See Appeal Br. 7. Claim 1 is representative of the claims on appeal
and is reproduced below.
1. A medical assembly, comprising:
a package comprising an outer surface having a major face
defining an aperture;
an aperture sealing label to selectively attach to the outer
surface to close the aperture and to be selectively peelable from
the outer surface to expose the aperture; and
five sheets arranged in a stacked configuration within the
package; and
printed instructions defining five steps instructing when to
use each sheet disposed within the package, and when to discard
the each sheet disposed within the package, to clean a Foley
catheter insertion site while reducing chances for causing a
catheter associated urinary tract infection.

REFERENCES RELIED ON BY THE EXAMINER
Name Reference Date
Conway et al US 2004/0074794 A1 Apr. 22, 2004
Coonan US 2004/0200751 A1 Oct. 14, 2004
Adler et al US 2013/0341329 A1 Dec. 26, 2013
Lin et al. US 2016/0272925 A1 Sept. 22, 2016
Haaland US 9,483,930 B1 Nov. 1, 2016

THE REJECTIONS ON APPEAL
Claims 1, 6–10, and 24 are rejected under 35 U.S.C. § 103 as
unpatentable over Coonan. Final Act. 2.
Claims 2, 3, and 11 are rejected under 35 U.S.C. § 103 as
unpatentable over Coonan and Haaland. Final Act. 3.
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Claim 4 is rejected under 35 U.S.C. § 103 as unpatentable over
Coonan and Conway. Final Act. 5.
Claims 5 and 25 are rejected under 35 U.S.C. § 103 as unpatentable
over Coonan, Conway, and Adler. Final Act. 5.
Claims 21–23 are rejected under 35 U.S.C. § 103 as unpatentable over
Coonan and Lin. Final Act. 6.
ANALYSIS
The rejection of claims 1, 6–10, and 24
as unpatentable over Coonan
Claims 1, 6, and 24:
Appellant argues claims 1, 6, and 24 together. Appeal Br. 9–20. We
select claim 1 for review, with claims 6 and 24 standing or falling with claim
1. See 37 C.F.R. § 41.37(c)(1)(iv)(2019).
Independent claim 1 recites a “medical assembly, comprising: a
package,” “five sheets arranged in a stacked configuration within the
package” (hereinafter, the “five sheets limitation”), and “printed instructions
defining five steps instructing when to use each sheet disposed within the
package, and when to discard the each sheet disposed within the package, to
clean a Foley catheter insertion site while reducing chances for causing a
catheter associated urinary tract infection” (hereinafter, “the printed
instructions limitation”). Appeal Br. 27 (Claims App.).
Appellant contends that “[t]he Examiner, without any citation to the
reference or other art of record, simply declares the [five sheets] limitation to
simply be per se obvious.” Appeal Br. 9. Appellant argues that the rejection
is based upon “[i]mpermissible hindsight” because “[t]here is nothing in the
prior art suggesting five sheets be included within a package so as to reduce
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the chance of causing a catheter associated urinary tract infection when
using those sheets in the manner indicated by the packaging.” Appeal Br.
10. As such, according to Appellant, the rejection lacks an articulated
reason that is supported by rational underpinning. Appeal Br. 12.
Appellant’s arguments are unpersuasive in that they do not address the
Examiner’s rejection. The Examiner finds that Coonan discloses a plurality
of sheets (field towels 12) arranged in a stacked configuration within a
package. Final Act. 2 (citing Coonan Fig. 2). The Examiner acknowledges
that “Coonan does not specifically disclose[] the [number] of towels/sheets
within the package.” Final Act. 2. However, the Examiner determines that
it would have been obvious to “modif[y] the package of Coonan [to]
includ[e] any amount of towels/sheets, i.e. five towels/sheets, within the
package depending on the users preference with respect to the amount of
sheets within the package or depending on the interior size space of the
package that fits the desired amount of towels/sheets.” Final Act. 3
(emphases added). “The [E]xaminer points out that the exact amount of
sheets disposed within the package is a matter of design choice.” Final Act.
7 (emphasis added); see also Ans. 9 (“[the] selection of the overall number
is purely a design choice”). Appellant’s contentions do not address why the
Examiner is at fault for assessing that this five sheets limitation is a design
choice, or otherwise explain why five sheets is critical or gives unexpected
results. See In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995).
Moreover, we agree with the Examiner’s assessment that the five
sheets limitation is a design choice. The number of sheets depends on how
much cleaning the user desires. As indicated above, Appellant does not
show the criticality of having five sheets, i.e., whether having five sheets
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produces unexpected results over having more or fewer sheets. See Chu, 66
F.3d at 299 (“design choice” is appropriate where the applicant fails “to set
forth any reasons why the differences between the claimed invention and the
prior art would result in a different function or give unexpected results”).
We thus find that the Examiner’s rejection is based on sound reasoning as
well as evidence disclosed in the cited prior art, rather than being a matter of
improper hindsight reconstruction. Because the Examiner provides a reason
for modifying the number of sheets in Coonan’s package, i.e., as a matter of
design choice, the Examiner does not assert that the five sheets limitation is
per se obvious, but rather, provides an articulated reason that is supported by
rational underpinning.
Further, we note that “[i]t is well settled that patentability of apparatus
claims must depend upon structural limitations . . . .” In re Michlin, 256
F.2d 317, 320 (CCPA 1958). Moreover, “the patentability of apparatus or
composition claims depends on the claimed structure, not on the use or
purpose of that structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com,
Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). “A patent applicant is free to recite
features of an apparatus either structurally or functionally . . . . Yet,
choosing to define an element functionally, i.e., by what it does, carries with
it a risk.” In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997).
“‘Functional’ terminology may render a claim quite broad. By its own
literal terms a claim employing such language covers any and all
embodiments which perform the recited function.” In re Swinehart, 439
F.2d 210, 213 (CCPA 1971). Therefore, “[i]f the prior art structure is
capable of performing the intended use, then it meets the claim” (id.). See In
re Schreiber, 128 F.3d at 1478; In re Swinehart, 439 F.2d at 213.
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In the matter before us, claim 1 is directed to an apparatus rather than
a method. Claim 1 does not positively recite a Foley catheter as being part
of the medical assembly. Consequently, the recitation “to clean a Foley
catheter insertion site while reducing chances for causing a catheter
associated urinary tract infection” is an intended use of the medical
assembly, more particularly, the intended use of the recited “five sheets.”
Coonan’s field towels 12 are capable of being used “to clean a Foley
catheter insertion site while reducing chances for causing a catheter
associated urinary tract infection.” See Coonan ¶ 1 (addressing “[t]he need
to maintain personal hygiene”). Accordingly, in view of the above,
Appellant’s contentions regarding the five sheets limitation is not persuasive
of Examiner error.
Addressing now the printed instructions limitation, Appellant
contends that “[t]he Examiner . . . without any analysis whatsoever, declares
the [printed instructions] limitation to be unrelated to the substrate and
therefore not available to distinguish from the prior art.” Appeal Br. 9; see
also Reply Br. 8. Appellant argues that its printed instructions limitation has
a functional relationship with a substrate in the same manner as the printed
matter and substrate in Gulack2 and in Praxair.3 Appeal Br. 13–20.
According to Appellant,
[Appellant’s] package comprises instructions for using a specific
number of sheets with a corresponding specific number of steps
indicating when to use each sheet and when to discard each sheet

2 In re Gulack, 703 F.2d 1381 (Fed. Cir. 1983).
3 Praxair Distrib., Inc. v. Mallinckrodt Hosp. Prods. IP Ltd., 890 F.3d 1024
(Fed. Cir. 2018).

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so as to reduce the chances of a catheter associated urinary tract
infection. Thus, just as was the case in Praxair, the claimed
limitations of claim 1 require a “medical provider to take a
specific action,” here, using and discarding the sheets, “as a
result of the recommended limitation” [(i.e., the printed
instructions limitation)] on the package.
Appeal Br. 19; see also Reply Br. 10.
We are unpersuaded by Appellant’s arguments. Contrary to
Appellant’s contention that the Examiner does not provide an analysis
whatsoever, the Examiner reasons that it would have been obvious to
“modif[y] the indicia from the instructions of Coonan to [have] all of the
indicia of the claimed subject matter since it would only depend on the
intended use of the assembly and the desired information to be displayed.”
Final Act. 3. This is consistent with our determination above, that the
recitation “to clean a Foley catheter insertion site while reducing chances for
causing a catheter associated urinary tract infection” is an intended use of
the recited “five sheets” of the “package.” See supra. Further, Coonan’s
corresponding field towels 12 are capable of being used as recited, i.e., “to
clean a Foley catheter insertion site while reducing chances for causing a
catheter associated urinary tract infection.” See Coonan ¶ 1.
The Examiner goes on to explain that “when the claimed printed
matter is not functionally related to the substrate[,] it will not distinguish the
invention from the prior art in terms of patentability.” Final Act. 3. For
example, when “the printed matter and [the substrate] do not depend upon
each other [such that] no functional relationship exists.” Final Act. 3 (citing
In re Gulack, In re Ngai,4 MPEP 2112.01); see also id. at 7 (pointing out that

4 In re Ngai, 367 F.3d 1336 (Fed. Cir. 2004).
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“the instructions printed [o]n applicant’s package are considered [] printed
matter, wherein the information of the printed matter [is] not functionally
related to the substrate”).
In the present situation, there is merit for a lack of functional
relationship between the printed matter and the substrate because the recited
instructions may be printed on the package, on the individual sheets, upon an
insert located within the package, or upon a separate instruction brochure.
See e.g., Spec. ¶¶ 36–41. Regardless of how the instructions are presented,
Appellant’s device would operate the same, i.e., Appellant’s sheets would
still be suitable for cleaning a Foley catheter insertion site. As such, the
Examiner determines that because the printed instructions limitation and the
package of claim 1 do not depend on each other, they thus are not
functionally related such that the printed instructions limitation would not
impart patentable weight. Consequently, contrary to Appellant’s contention,
the Examiner did provide a proper analysis with respect to the printed matter
issue.
We agree with Appellant that decisions pertaining to printed matter in
method claims could also be applicable to apparatus claims. See Reply Br.
7–8. However, we find that the Examiner properly analyzed the functional
relationship determination with respect to claim 1’s printed matter and
substrate, rather than ignoring the requirement for such analysis for the
reasons discussed above. Further, as discussed below, we do not agree with
Appellant’s contention that “when the facts of each case are considered,
those facts confirm that the holding of Praxair is more applicable to the facts
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of the present case than are those of AstraZeneca.”5 Reply Br. 8. In other
words, we find that Praxair is distinguished from the situation at hand.
It has been held that a claim limitation is directed to printed matter “if
it claims the content of information.” Praxair, 890 F.3d 1032 (quoting In re
DiStefano, 808 F.3d 845, 848 (Fed. Cir. 2015)). Further, the Federal Circuit
characterized its decision in Ngai as “foreclos[ing] the argument that simply
adding new instructions to a known product creates the functional
relationship necessary to distinguish the product from the prior art.”
AstraZeneca, 633 F.3d at 1065.
This holding in AstraZeneca is instructive. At issue in that case was a
claim to a kit that included a known drug composition and a label containing
instructions for frequency of administration of the drug. AstraZeneca, 633
F.3d at 1063. The Federal Circuit explained, with regard to the type of
functional relationship necessary to potentially impart patentable weight to
the printed matter, that the instructions in no way functioned with the drug to
create a new, unobvious product, and that removing the instructions from the
claimed kit did not change the ability of the drug to treat respiratory
diseases. Id. at 1065. See also In re Jie Xiao, 462 F. App’x. 947 (Fed. Cir.
2011). Likewise, as we have here, removing claim 1’s printed instructions
limitation does not change the ability of the recited “five sheets” within the
package from being used for cleaning, e.g., a Foley catheter insertion site.
Praxair points out that in order to have a functional relationship, “the
printed matter must be interrelated with the rest of the claim.” Praxair, 890
F.3d 1032 (emphasis added). Praxair explains that in Ngai, “there was no

5 AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed. Cir. 2010).
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functional relationship between claimed instructions and a diagnostic kit, as
the instructions ‘in no way depend[ed] on the kit, and the kit [did] not
depend on the instructions.’” Praxair, 890 F.3d 1032 (quoting Ngai, 367
F.3d at 1339). Praxair confirms the Examiner’s determination that there is
no functional relationship in this case because: (1) the function of
Appellant’s package turns solely on the sheets regardless of what may be
printed in the instructions, and (2) there is no interrelationship between the
printed instructions limitation and the package or sheets. Stated differently,
the instructions have no bearing on the ultimate function of the package,
which is to hold the sheets, or the ultimate function of the sheets themselves,
which is to clean something. As such, the instructions in no way depend on
the sheets or on the package and, conversely, the sheets or the package do
not depend on the instructions.
In the present situation, Appellant simply presumes there is a
functional relationship between the instructions and the sheets/packaging
without explaining why this might be the case. Furthermore, Appellant does
not point out what is considered to be the substrate, and thus, again, fails to
explain how there can be a functional relationship between the substrate and
the printed matter. Yet, Appellant’s attempts to equate claim 1’s printed
instructions limitation with a particular limitation of claim 9 from Praxair.
See Appeal Br. 19.
First, as noted above, Appellant’s claim 1 is directed to an apparatus
whereas, claim 9 in Praxair is directed to a method that requires a medical
provider to take a specific action. Praxair, 890 F.3d 1035. In Praxair, a
step in claim 9 recites “in accordance to” and, in that case, “[b]oth parties
agree that this suffices to create a functional relationship.” Id. Further, in
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Praxair, the result of the recommendation instructions (printed matter) ties
in with the step of the medical provider taking a specific action, i.e., there is
an interrelationship between these two claimed limitations. Thus, in
Praxair, it was undisputed that there is an interrelationship between the
printed matter and the recited method step. Here, however, Appellant’s
reading of Praxair is taken out of context. Appellant argues that claim 1
requires “a result of the recommended limitation,” but claim 1 is directed to
a “medical assembly,” rather than a method. See Appeal Br. 19.
Accordingly, and for the reasons provided above, we sustain the
Examiner’s rejection of claims 1, 6, and 24 as obvious over Coonan.
Claims 7–10:
Regarding claims 7–10, the printed instructions of claim 1 further
comprises: (1) for claim 7, “instructional material comprising . . . a series of
method steps, wherein each step includes an instruction to discard a sheet
after executing the each step on a one-to-one basis with the each step”; (2)
for claim 8, “a command not to flush the each sheet down a toilet”; (3) for
claim 9, “the command [of claim 8] is DO NOT FLUSH”; and (4) for claim
10, “a picture of the package indicating that the printed instructions are to be
used with the medical assembly.” Appeal Br. 28 (Claims App.).
Appellant contends that in rejecting these claims, the Examiner fails
to articulate a reason that is supported by rational underpinning to modify
the disclosure of Coonan to have the above limitations. Appeal Br. 20–22.
Appellant’s contention is unpersuasive for the reasons discussed
above with respect to claim 1. We agree with the Examiner that, even with
the above limitations, there is no functional relationship between the printed
instructions limitation and the sheets or package. See Final Act. 2–3.
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Consequently, the Examiner does not need to articulate a reason to modify
the disclosure of Coonan to have these limitations because even with these
added limitations, the printed instructions limitation does not impart
patentable weight.
Accordingly, we sustain the Examiner’s rejection of claims 7–10 as
obvious over Coonan.
The rejection of claims 2, 3, and 11
as unpatentable over Coonan and Haaland
Claim 2 recites “the printed instructions compris[es] one or more of
pictures or illustrations showing visually how to perform the five steps” and
claim 3 recites “the printed instructions further instructing that the five
sheets disposed within the package are ordered corresponding to use during
a catheter cleaning procedure prescribed by the printed instructions.”
Appeal Br. 28 (Claims App.).
Appellant does not contest the rejection of claim 11. Appeal Br.,
passim. In regard to claims 2 and 3, Appellant contends that “Haaland’s
FIGS. 1 and 2 teach pictures of how to wash your hands. This is not what is
claimed.” Appeal Br. 23–24.
The Examiner correctly responds that “Haaland is only used for the
disclosure that method steps provided as graphics or diagrams were known.”
Ans. 13–14. The Examiner goes on to explain that, however, the
particularities of the pictures or instructions do “not change the functionality
of medical assembly or package.” Id. In other words, the particularities of
the pictures or instructions do not create a functional relationship with the
sheets or package. We agree with the Examiner’s assessment for the reasons
discussed above.
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Accordingly, we sustain the Examiner’s rejection of claims 2, 3, and
11 as obvious over Coonan and Haaland.

The rejection of claim 4
as unpatentable over Coonan and Conway
The rejection of claims 21–23
as unpatentable over Coonan and Lin
Appellant does not provide substantive arguments for these rejections
and thus, appears to rely on arguments made for independent claim 1.
Appeal Br. 9–26. As we find no deficiencies in the Examiner’s rejection of
independent claim 1 as being obvious over Coonan for the reasons discussed
above, we likewise sustain the Examiner’s rejections of claims 4 and 21–23
over the variously indicated combinations of cited art.
The rejection of claims 5 and 25
as unpatentable over Coonan, Conway, and Adler
Claim 5 recites
all information corresponding to properly cleaning the Foley
catheter insertion site of a female is disposed along a front major
face of the substantially flat substrate, and all information
corresponding to properly cleaning the Foley catheter insertion
site of a male is disposed along a rear major face of the
substantially flat substrate.
Appeal Br. 27–28 (Claims App.). Claim 25 recites
a first side of the printed instructions discloses a method of
cleaning the Foley catheter insertion site when a Foley catheter
is inserted into a female patient, and a second side of the printed
instructions discloses a method of cleaning the Foley catheter
insertion site when the Foley catheter is inserted into a male
patient.
Id. at 29–30.
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Appellant contends that “Adler’s FIG. 7C teaches an instructional
label for taking pills. This is not what is claimed.” Appeal Br. 25.
The Examiner correctly responds that “[t]he [E]xaminer uses the
teachings of Adler for simply showing that instructions could be provided on
both sides of a flat substrate which provide the benefit of more or additional
information to the user.” Ans. 15. Further, the Examiner again states that
“the content of the printed matter will not distinguish the claimed product
from the prior art.” Id. at 14–15. In other words, the particularities of the
printed instructions do not create a functional relationship with the sheets or
package. We agree the Examiner’s assessment for the reasons discussed
above.
Consequently, we sustain the Examiner’s rejection of claims 5 and 25
as obvious over Coonan, Conway, and Adler.
DECISION SUMMARY
In summary:
Claims
Rejected
35
U.S.C. § 
Reference(s)/Basis Affirmed Reversed
1, 6–10, 24 103   Coonan 1, 6–10, 24
2, 3, 11 103 Coonan, Haaland 2, 3, 11
4 103 Coonan, Conway 4
5, 25 103 Coonan, Conway,
Adler
5, 25
21–23 103 Coonan, Lin 21–23
Overall
Outcome
1–11, 21–
25

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