Frank Levy et al.

Patent Trials and Appeals Board

Jul 13, 2020

2020000447 (P.T.A.B. Jul. 13, 2020)

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.
14/944,574 11/18/2015 Frank Levy LEVY-011 3479
21884 7590 07/13/2020
WELSH FLAXMAN & GITLER LLC
2000 DUKE STREET, SUITE 100
ALEXANDRIA, VA 22314
EXAMINER
DARB, HAMZA A.
ART UNIT PAPER NUMBER
3783
MAIL DATE DELIVERY MODE
07/13/2020 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 FRANK LEVY and KIMBERLEY LEVY
____________________

Appeal 2020-000447
Application 14/944,574
Technology Center 3700
____________________

Before JENNIFER D. BAHR, MICHELLE R. OSINSKI, and
SEAN P. O’HANLON, Administrative Patent Judges.

BAHR, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision rejecting claims 1, 3–5, 7, 8, and 12. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

Appeal 2020-000447
Application 14/944,574

2
THE CLAIMED SUBJECT MATTER
Claim 1, reproduced below, is illustrative of the claimed subject
matter.
1. A delivery system for the effective, reliable and foolproof
delivery of controlled amounts of a medical grade gas to a
patient, comprising
a compressed gas unit composed of a vacuum sealed bag
to which is secured at least one compressed gas cartridge
wherein the at least one compressed gas cartridge is an
approximately 16 g to 45 g compressed gas cartridge, and the
vacuum sealed bag includes a central cavity, an outlet port and
an inlet port including a cylinder cartridge puncture valve
adapted to puncture the at least one compressed gas cartridge
when secured to the vacuum sealed bag;
a first Luer fitting is selectively secured to the outlet port
of the sealed bag, and a one-way directional valve with a
second Luer fitting is communicably joined to the first Luer
fitting; and
a multi-part valve delivery system is coupled to the
second Luer fitting via a medical tube extending between the
second Luer fitting and the multi-part valve delivery system.
Appeal 2020-000447
Application 14/944,574

3
EVIDENCE
The prior art relied upon by the Examiner is:
Name Reference Date
Binard US 3,858,572 Jan. 7, 1975
Matsuda US 2007/0282296 A1 Dec. 6, 2007
Levy1 US 2009/0318890 A1 Dec. 24, 2009
Levy2 US 2012/0065502 A1 Mar. 15, 2012
REJECTIONS3
I. Claims 1, 3–5, 7, and 8 stand rejected under 35 U.S.C. § 103 as
unpatentable over Binard, Levy 1, and Levy 2.

1 The Examiner refers to this reference as “Levy1” (see Final Act. 3), and
Appellant refers to it as “Levy 1” (see Appeal Br. 6). For the purposes of
this Decision, we refer to this reference as “Levy 1.”
2 The Examiner refers to this reference as “Levy2” (see Final Act. 3), and
Appellant refers to it as “Levy 2” (see Appeal Br. 6). For the purposes of
this Decision, we refer to this reference as “Levy 2.”
3 Subsequent to the Final Action, Appellant amended claim 8 in an attempt
to overcome the rejection of claim 8 under 35 U.S.C. § 112(b) as indefinite.
See Amdt 6 (Feb. 21, 2019); Final Act. 2 (rejecting claim 8 because “[i]t is
unclear whether [‘the outlet port’ recited in line 3 of claim 8] refers to the
outlet port recited in line 6 of claim 1 or the outlet ports as recited in line 2
of claim 8”). The Examiner entered the Amendment. Advisory Act. 1.
However, the Examiner has not expressly indicated whether this rejection
has been withdrawn. See id. at 2 (addressing only the rejections under
35 U.S.C. § 103); Ans. 3–5 (not identifying any withdrawn rejections, but
only addressing the rejections under 35 U.S.C. § 103). Appellant states that
the rejection under 35 U.S.C. § 112 “has been withdrawn.” Appeal Br. 4.
The Examiner does not indicate in the Answer that this statement is
incorrect. Thus, inasmuch as the amendment to claim 8 specifically alters
the language to which the rejection was directed, we infer the Examiner
intended to withdraw the rejection and decline to address it in our decision,
instead leaving it to the Examiner to clarify whether such a rejection is still
appropriate upon return of jurisdiction of this application to the Examiner.
Appeal 2020-000447
Application 14/944,574

4
II. Claim 12 stands rejected under 35 U.S.C. § 103 as unpatentable
over Binard, Levy 1, Levy 2, and Matsuda.
OPINION
Rejection I – Obviousness based on Binard, Levy 1, and Levy 2
Appellant presents arguments for independent claim 1 (Appeal
Br. 7–10) and does not assert any separate arguments for dependent claims
3–5, 7, and 8 (see id. at 10). We select claim 1 as representative, and claims
3–5, 7, and 8 stand or fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(iv).
The Examiner finds that
Binard discloses a delivery system for the effective, reliable and
foolproof delivery of controlled amounts of a medical grade gas
to a patient (Fig. 1, Fig. 5), comprising a compressed gas unit
(12 and 10) composed of a vacuum sealed bag (10) to which is
secured at least one compressed gas cartridge (12); and the
vacuum sealed bag (10) includes a central cavity (34), an outlet
port (42) and an inlet port (26) including a cylinder cartridge
puncture valve (26); and a multi-part valve delivery system (46,
56, 58, 36 and include 70, 20 and 78), and moreover it discloses
that the outlet (42) is coupled to a medical tube extending (70)
between the outlet (42) and the multi-part valve delivery system
(Fig. 1).
Final Act. 3. The Examiner finds that Binard does not disclose that
the at least one compressed gas cartridges are approximately 16
g to 45 g compressed gas cartridges, the cylinder cartridge
puncture valve adapted to puncture the at least one compressed
gas cartridges when secured to the vacuum sealed bag and a
first Luer fitting is selectively secured to the outlet port of the
sealed bag, and a one-way directional vale with a second Luer
fitting is communicably joined to the first Luer fitting; the
multi-part valve delivery system is coupled to the second Luer
fitting via a medical tube extending between the second Luer
fitting and the multi-part valve delivery system.
Appeal 2020-000447
Application 14/944,574

5
Id. However, the Examiner finds that Levy 1 “discloses a medical apparatus
(Fig. 2) wherein the compressed gas cartridge (28) [is an] approximately
16 g to 45 g compressed gas cartridge (¶0054) and the device has a cylinder
cartridge puncture valve (26) adapted to puncture the at least one
compressed gas cartridge as it secured (¶0052).” Id. at 3–4. The Examiner
determines that it would have been obvious to modify Binard according to
the teachings of Levy 1 “for the purpose of choosing a standard size
cartridge and using a well-known valve to secure the gas cylinder.” Id. at 4
(citing Levy 1 ¶¶ 43, 52, 54).
The Examiner also finds that Levy 2 discloses a
delivery system (Fig. 1, abstract) wherein the system has a first
Luer fitting (20) [that] is selectively secured to the outlet port of
the source (¶0033), and a one-way directional valve (24) with a
second Luer fitting (26) is communicably joined to the first
Luer fitting (Fig. l); the multi-part valve delivery system is
coupled to the second Luer fitting via a medical tube (12)
extending between the second Luer fitting and the multipart
valve delivery system (16, Fig. 1).
Final Act. 4. The Examiner determines that it would have been obvious to
further modify Binard according to the teachings of Levy 2 “for the purpose
of controlling the precise dosage of CO2 and preventing a deadly dose.” Id.
at 5 (formatting added) (citing Levy 2 ¶ 48).
Appellant argues that the Examiner failed to provide adequate
reasoning for the proposed modifications of Binard. See Appeal Br. 8–10.
In particular, Appellant asserts that “Binard provides a mechanism for
insufflating a patient’s body with a pressurized gas. Levy 1 and Levy 2 are
concerned with the provision of small quantities of CO2 for vascular
procedures. As those skilled in the art will appreciate, these are vastly
different medical procedures requiring vastly different considerations.” Id.
Appeal 2020-000447
Application 14/944,574

6
at 8. According to Appellant, “[t]he medical concerns associated with these
two vastly different procedures are distinct and one of ordinary skill in the
art of insufflation would not look to vascular procedures for teachings.” Id.
at 9; see also Reply Br. 3 (asserting that “one looking for teachings
regarding the insufflation of body cavities would not be[] looking to a
system that applies CO2 to the vascular system of a patient”). We are
unpersuaded by this argument.
Binard discloses:
Pneumography is the use of a gas as a contrast medium
for radiographic visualization of the body interstices. When
insufflated into a patient’s body, gases separate tissues and
organs in the body, and since they have lower densities than the
surrounding body tissues and organs, they are delineated on
X-rays and outline body organs, cavities, and intestines, to
facilitate radiography.
Binard, col. 1, ll. 9–16; see also id., col. 1, ll. 40–42 (disclosing “that
insufflation of the patient is best carried out through the use of carbon
dioxide, due to the possible danger of gas embolism when a different gas is
used”). Levy 1 discloses that CO2 “is used for imaging by infiltrating the
tissues, body cavities, and abdomen for better visualization.” Levy 1 ¶ 30;
see also id., ¶ 35 (describing “use[s] requiring CO2 for its performance, such
as[] imaging, tissue separation, and vascular/vessel compartmentalization”
(formatting added)). Levy 2 discloses a system “for delivering controlled
dosages of a medical contrast fluid such as carbon dioxide (CO2) for use in
the radiological imaging of arteries and veins of a patient’s vascular
system.” Levy 2 ¶ 31; see also id. (disclosing that “the system may be used
for the controlled delivery of various other types of liquids and gases
administered as part of assorted surgical and medical procedures”). In other
Appeal 2020-000447
Application 14/944,574

7
words, as the Examiner correctly observes, each of the references concerns
delivering CO2 to the body in the context of radiology or imaging
procedures. See Ans. 3–4 (finding that “Binard [is] used for radiological
imaging for delivering a specific amount of CO2 to body cavities such as the
brain, abdomen cavity, intestine” (citing Binard, col. 1, ll. 10–15, 30–40),
and Levy 1 and Levy 2 “require delivering CO2 for imaging procedure[s]”
(citing Levy 1 ¶ 35; Levy 2 ¶¶ 3, 6)). Thus, Appellant’s contention that the
references have different considerations (see Appeal Br. 8–9) does not
apprise us of error.
Appellant argues that “Binard is concerned with the application of
relatively large quantities of CO2 for use in performing insufflation.” Reply
Br. 3 (citing Binard, col. 1, l. 9–col. 2, l. 12). Appellant points to Binard’s
disclosure that “two liters of carbon dioxide is adequate for a perirenal
insufflation procedure” (Appeal Br. 9 (quoting Binard, col. 1, ll. 50–51)) and
asserts that “the sizes being taught by Levy 1, and as suggested by the
Examiner for modifying Binard, would not provide the quantity of gas
required for the procedures contemplated by Binard” (id.). According to
Appellant, Levy 1 and Levy 2 are only “concerned with dispensing a small
amount of carbon dioxide gas to the vascular system of the patient in order
to displace the patient’s blood.” Reply Br. 3. This line of argument is
unpersuasive.
In the portion of Binard cited by Appellant, Binard discloses using
two liters of CO2 for perineal insufflation only as an example. See Binard,
col. 1, ll. 49–50 (“For example, two liters of carbon dioxide is adequate for a
prerienal insufflation procedure.”). Appellant does not contest the
Examiner’s position that “other organ[] insufflation procedures need [a]
Appeal 2020-000447
Application 14/944,574

8
different . . . quantity of CO2 than the quantity in the given example such as
insufflation in the small intestine or in the brain.” Ans. 5; see Reply Br. 3
(“The Examiner is correct in stating that the amount of gas needed for
specific medical procedures is dictated by the specific medical procedure
being performed.”). Although Appellant correctly observes that the Levy
references describe using CO2 for vascular procedures (see Appeal Br. 8–9;
see also Levy 1 ¶ 29; Levy 2 ¶ 31), Levy 1 also discloses that CO2 can be
used to “expand internal body cavities and tissues” (Levy 1 ¶ 30), and
Levy 2 discloses using “a desired volume of gas to be administered to the
patient during the radiological imaging or other medical/surgical procedure”
(Levy 2 ¶ 42). In other words, the teachings of the Levy references are not
limited to vascular procedures involving small CO2 volumes.
Appellant argues that the Examiner’s reasoning for the proposed
modification of Binard based on the teachings of Levy 2 is insufficient
because Binard already addresses the issues of providing a standardized
cartridge size and controlling the precise dosage of CO2 to prevent a deadly
dose. Reply Br. 2. In particular, Appellant asserts that “Binard provides a
means for indicating a preselected volume of gas in the reservoir in the form
of the balloon 45.” Id. (citing Binard, col. 5, ll. 3–19). According to
Appellant, “[a]s such, it must be questioned why Binard would replace the
balloon 45 with a cartridge as disclosed by Levy 1 and Levy 2.” Id. This
argument is unpersuasive because it is not responsive to the modification of
Binard proposed by the Examiner in the rejection presented. Here, the
Examiner proposes modifying “the compressed gas cartridges of Binard so
that the at least one compressed gas cartridge is [an] approximately 16 g to
45 g compressed gas cartridge, [and] the cylinder cartridge puncture valve
Appeal 2020-000447
Application 14/944,574

9
[is] adapted to puncture the at least one compressed gas cartridges when
secured to the vacuum sealed bag.” Final Act. 4. The Examiner does not
propose replacing Binard’s balloon 45 with the cartridge of Levy 1, as
asserted by Appellant. Reply Br. 2. Moreover, although Binard discloses
that balloon 45 indicates a preselected volume of gas (Binard, col. 3, ll. 43–
45), Appellant does not set forth persuasive technical reasoning as to why
this would undermine the Examiner’s stated reason for the proposed
modification based on Levy 1.
Appellant argues that the proposed combination of reference teachings
would not have a reasonable expectation of success. See Appeal Br. 8;
Reply Br. 1–2. This argument is unpersuasive because Appellant does not
proffer factual evidence or persuasive technical reasoning to explain how
combining the teachings of Binard, Levy 1, and Levy 2 in an operable
manner would be beyond the level of ordinary skill in the art. See KSR Int’l
Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (“A person of ordinary skill is
also a person of ordinary creativity, not an automaton.”). In other words, we
are not persuaded that successfully combining the teachings of Binard,
Levy 1, and Levy 2 would be beyond the skill and creativity of an ordinary
artisan.
Appellant argues that “there is nothing in the art itself that suggests
the modification being suggested by the Examiner, and it must be concluded
that the Examiner has simply relied upon impermissible hindsight to arrive
at the conclusion of obviousness.” Appeal Br. 10; see also id. at 8 (quoting
Final Act. 5 and asserting that “Binard has no concern with providing a
precise dosage of CO2 and preventing a deadly dose”). This argument is
unpersuasive.
Appeal 2020-000447
Application 14/944,574

10
Appellant’s argument appears to insist on an explicit teaching,
suggestion, or motivation in the cited art to establish obviousness, but such a
requirement has been foreclosed by the Supreme Court. KSR, 550 U.S. at
419 (stating that a rigid insistence on teaching, suggestion, or motivation is
incompatible with its precedent concerning obviousness). The Court noted
that an obviousness analysis “need not seek out precise teachings directed to
the specific subject matter of the challenged claim, for [an examiner] can
take account of the inferences and creative steps that a person of ordinary
skill in the art would employ.” Id. at 418. Instead, the relevant inquiry is
whether the Examiner has set forth “some articulated reasoning with some
rational underpinning to support the legal conclusion of obviousness.” In re
Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), cited with approval in KSR, 550
U.S. at 418. Here, as discussed above, the Examiner articulates adequate
reasoning based on rational underpinnings as to why the combined teachings
of Binard, Levy 1, and Levy 2 renders obvious the claimed subject
matter. See Final Act. 4–5. Appellant’s arguments do not persuasively
refute the Examiner’s articulated reasoning.
Moreover, Appellant does not identify, nor do we discern, any
knowledge relied upon by the Examiner that was gleaned only from
Appellant’s disclosure and that was not otherwise within the level of
ordinary skill at the time of the invention. See In re McLaughlin, 443 F.2d
1392, 1395 (CCPA 1971) (“Any judgment on obviousness is in a sense
necessarily a reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level of ordinary
skill at the time the claimed invention was made and does not include
knowledge gleaned only from [Appellant’s] disclosure, such a reconstruction
Appeal 2020-000447
Application 14/944,574

11
is proper.”). As such, we are unpersuaded by Appellant’s contention that the
Examiner relied on impermissible hindsight in reaching the determination of
obviousness of the claimed subject matter. See Appeal Br. 10; Reply Br. 2.
For the foregoing reasons, Appellant does not apprise us of error in
the Examiner’s conclusion of obviousness with respect to claim 1.
Accordingly, we sustain the rejection of claim 1, and claims 3–5, 7, and 8
falling therewith, under 35 U.S.C. § 103 as unpatentable over Binard,
Levy 1, and Levy 2.

Rejection II – Obviousness based on Binard, Levy 1, Levy 2, and Matsuda
In contesting the rejection of dependent claim 12, Appellant relies on
the same arguments and reasoning we found unpersuasive in connection
with independent claim 1. See Appeal Br. 10 (relying on the alleged
deficiencies in the combination of Binard, Levy 1, and Levy 2, and asserting
that Matsuda fails to remedy such deficiencies). Accordingly, for the same
reasons discussed above with respect to Rejection I, we also sustain the
rejection of claim 12 under 35 U.S.C. § 103 as unpatentable over Binard,
Levy 1, Levy 2, and Matsuda.
CONCLUSION
In summary:
Claim(s)
Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3–5, 7, 8 103 Binard, Levy 1,
Levy 2
1, 3–5, 7, 8
12 103 Binard, Levy 1,
Levy 2, Matsuda
12
Overall Outcome 1, 3–5, 7,
8, 12

Appeal 2020-000447
Application 14/944,574

12
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED