IP MED, INC. et al.

Patent Trials and Appeals Board

Nov 29, 2021

2021004118 (P.T.A.B. Nov. 29, 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.
16/071,648 07/20/2018 Ari ISAACS INOV25749(100650-00180) 8104
26304 7590 11/29/2021
KATTEN MUCHIN ROSENMAN LLP
575 MADISON AVENUE
NEW YORK, NY 10022-2585
EXAMINER
MOON, MATTHEW RYAN
ART UNIT PAPER NUMBER
3785
NOTIFICATION DATE DELIVERY MODE
11/29/2021 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):
doreen.devito@katten.com
nycuspto@katten.com
samson.helfgott@katten.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ARI ISAACS
____________

Appeal 2021-004118
Application 16/071,648
Technology Center 3700
____________

Before DANIEL S. SONG, STEFAN STAICOVICI, and
BRETT C. MARTIN, Administrative Patent Judges.

STAICOVICI, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE.
Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision in the Final Office Action (dated Sept. 18, 2020, hereinafter “Final
Act.”) rejecting claims 1–6 and 10–16. We have jurisdiction over this
appeal under 35 U.S.C. § 6(b).

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. IP MED, INC. is identified as the real party in interest in
Appellant’s Appeal Brief (filed Mar. 15, 2021, hereinafter “Appeal Br.”).
Appeal Br. 2.
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SUMMARY OF DECISION
We AFFIRM.
INVENTION
Appellant’s invention is directed to a medicament delivery device
including “an oral tubular section for placement in the mouth of a user and a
nasal tubular section for placement in the naris of a user.” Spec. 1, ll. 8–10.
Claim 1, the sole independent claim, is representative of the claimed
invention and reads as follows:
1. A medicament delivery device comprising:
a first tubular section;
a second tubular section;
a bendable section including corrugations
connecting the first tubular section to the second tubular
section;
a one way valve having a widened body in line
with the first tubular section,
wherein the widened body has a greater cross-
sectional diameter than the first tubular section, and
wherein the one way valve allows airflow from the
first tubular section to the second tubular section and
restricts airflow from the second tubular section to the
first tubular section;
a removable cap having a compartment holding a
medicament including a sealable opening,
wherein a proximal end of the second tubular
section is located within the removable cap and abuts the
sealable opening, and
wherein a proximal end of the first tubular section
is located within the cap and does not abut the sealable
opening,
wherein removal of a sealing medium for sealing
the sealable opening causes the medicament to flow
through the second tubular section in a first direction and
into the corrugations of the bendable section, and
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wherein the medicament exits the second tubular
section in a second opposite direction during use of the
medicament delivery device after removal of the
removable cap from the proximal end of the first tubular
section and the proximal end of the second tubular
section.
Appeal Br. 8 (Claims App).

REJECTIONS
I. The Examiner rejects claims 14 and 15 under 35 U.S.C.
§ 112(a) as failing to comply with the written description
requirement.
II. The Examiner rejects claims 1, 10, and 14–16 under 35 U.S.C.
§ 103 as being unpatentable over Keldmann ’482,2 Gray,3
Keldmann ’423,4 and Faram.5
III. The Examiner rejects claim 2 under 35 U.S.C. § 103 as being
unpatentable over Keldmann ’482, Gray, Keldmann ’423,
Faram, and Gengar.6
IV. The Examiner rejects claim 3 under 35 U.S.C. § 103 as being
unpatentable over Keldmann ’482, Gray, Keldmann ’423,
Faram, Gengar, and Denton.7

2 Keldmann et al., US 2002/0165482 Al, published Nov. 7, 2002.
3 Gray et al., US 4,579,114, issued Apr. 1, 1986.
4 Keldmann et al., US 2008/0190423 Al, published Aug. 14, 2008.
5 Faram, US 9,566,397 B2, issued Feb.14, 2017.
6 Gengar et al., US 9,078,989 B2, issued July 14, 2015.
7 Denton et al., US 2013/0298902 A1, published Nov. 14, 2013.
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V. The Examiner rejects claims 4–6 under 35 U.S.C. § 103 as
being unpatentable over Keldmann ’482, Gray, Keldmann ’423,
Faram, Gengar, and Chintakis.8
VI. The Examiner rejects claim 11 under 35 U.S.C. § 103 as being
unpatentable over Keldmann ’482, Gray, Keldmann ’423,
Faram, and Moller.9
VII. The Examiner rejects claims 12 and 13 under 35 U.S.C. § 103
as being unpatentable over Keldmann ’482, Gray, Keldmann
’423, Faram, and Tsutsui.10

ANALYSIS
Rejection I
The Examiner finds that the limitation “the first tubular section is
positioned at 80° relative to the second tubular section” in claim 14 is not
supported by Appellant’s original disclosure. Final Act. 3–4.
As Appellant does not address the rejection, Appellant has waived any
argument of error. See Appeal Br. 3–6. Accordingly, we summarily sustain
the rejection under 35 U.S.C. § 112(a) of claim 14, and its dependent claim
15, as failing to comply with the written description requirement. See In re
Berger, 279 F.3d 975, 984, 985 (Fed. Cir. 2002) (holding that the Board did
not err in sustaining a rejection under 35 U.S.C. § 112, second paragraph,
when the applicant failed to contest the rejection on appeal).

8 Chintakis et al., US 2016/0271352 A1, published Sept. 22, 2016.
9 Moller, US 2011/0066136 A1, published Mar. 17, 2011.
10 Tsutsui et al., US 8,827,946 B2, issued Sept 9, 2014.
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Rejection II
Appellant has not presented arguments for the patentability of claims
10 and 14–16 apart from independent claim 1. See Appeal Br. 4–6.
Therefore, in accordance with 37 C.F.R. § 41.37(c)(1)(iv), we select claim 1
as the representative claim to decide the appeal of the rejection of these
claims, with claims 10 and 14–16 standing or falling with independent claim
1.
The Examiner finds that Keldmann ’482 discloses a medicament
delivery device 10 including, inter alia, first tubular section 11 (oral
section), second tubular section 12 (nasal section), bendable section 13 with
corrugations, medicament dose 14, and one-way valve 28 in line with first
tubular section 11, wherein one-valve 28 allows air to flow from first tubular
section 11 (oral section) to second tubular section 12 (nasal section) and
restricts air flow in the opposite direction. Final Act. 4–5 (citing Keldmann
’482, paras. 46, 56, Figs. 6, 16). However, the Examiner further finds that
Keldmann ’482 “does not disclose a removable cap having a compartment
holding a medicament including a sealable opening,” as called for by
independent claim 1. Id. at 5.
Nonetheless, the Examiner finds that Keldmann ’423 discloses a
medicament delivery device including, inter alia, first and second tubular
sections (right and left tubes) and removable cap 2 having compartment 4,
with sealable opening 7 sealed by film 11, for holding a medicament. Id. at
5–6 (citing Keldmann ’423, Figs. 1, 2). The Examiner further finds that the
proximal end of the first tubular section (right tube) is located within cap 2,
but does not abut sealable opening 7, whereas the proximal end of the
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second tubular section (left tube) is located within cap 2 and abuts sealable
opening 7. Id. at 6 (citing Keldmann ’423, Figs. 2–4).
Thus, in a first instance, the Examiner concludes that because the one-
way valve 28 of Keldmann ’482, associated with the first tubular section
(oral section), prevents airflow from the second tubular section (nasal
section) to the first tubular section (oral section), it would have been obvious
to a person of ordinary skill in the art:
to position the proximal end of the second [nasal] tubular
section [12] of . . . Keldmann ’482 reference within the cap [of
Keldmann ’423] and abut the sealable opening [7] (instead of
the first [oral] tubular section [11]) in order to prevent
inhalation of the medicament (Keldmann ’482 already discloses
that the purpose of including a one-way valve in the first
tubular [oral] section [11] is to prevent inhalation of the
medicament).

Id (citing Keldmann ’482, para. 56). In a second instance, the Examiner
further determines that it would have been obvious to a skilled artisan:
to modify the removable cap and medicament of Keldmann
’482 such that the removable cap has a compartment holding a
medicament including a sealable opening, wherein a proximal
end of the second [nasal] tubular section [12] is located within
the removable cap and abuts the sealable opening, and wherein
a proximal end of the first [oral] tubular section [11] is located
within the cap and does not abut the sealable opening, as taught
by Keldmann ’423, because pre-filling the medicament in a cap
instead of prefilling the medicament in the tube allows for
higher production speed and lower handling costs.

Id (citing Keldmann ’423, para. 67).
Furthermore, the Examiner also relies on Gray to disclose a one-way
valve having a widened body and on Faram to disclose removal of a sealing
medium covering a sealing opening of a tubular section to cause medicament
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to flow in a first direction, and, during use, to flow in a second opposite
direction. Id. at 5, 7 (citing Gray, col. 3, ll. 26–27, Figs. 1–5; Faram, col. 7,
ll. 47–50, Fig. 3). The Examiner determines that modifying the one-way
valve of Keldmann ’482 to have a widened body, as per Gray, would have
been obvious to a skilled artisan “for the purpose of improving control of air
flow due to the inclusion of a biasing spring.” Id. at 5. The Examiner
further determines that it would have been obvious to a person of ordinary
skill in the art to remove the sealing medium covering the sealing opening in
the device of Keldmann ’482, as modified by Keldmann ’423 and Gray, to
cause medicament to flow in a first direction, and, during use, to flow in a
second opposite direction, as per Faram, “for the purpose of reducing risk of
improper dosing events.” Id. at 8. The Examiner explains that:
because the direction of inhalation flow is opposite to that of
the flow of the medicament depositing within the tubular
sections, one of ordinary skill in the art would recognize that
the likelihood of more medicament from the medicament
compartment reaching the patient is increased due to the
medicament being released into the medicament delivery device
closer to the user, therefore having less area to travel when
being inhaled.

Id. at 8–9.
In response, Appellant argues “that the Examiner’s combination of
references relies on conclusory statements and a hindsight construction not
supported by the teachings of the prior art references.” Appeal Br. 4; see
also Reply Brief (filed June 17, 2021, hereinafter “Reply Br.”) 1. Appellant
contends that both Keldmann ’482 and Keldmann ’423 disclose that the
medicament must “pass over all the corrugations,” that is, “flow[] over the
entire length of the corrugations,” whereas in the Examiner’s rejection,
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medicament is released into the second tubular section 12 of Keldmann
’482, as modified by Keldmann ’423, Gray, and Faram, that is, at a location
after (downstream) of the corrugations in the intake direction (the direction
in which medicament flows to exit the device and be delivered to the
patient). See id. at 5–6 (citing Keldmann ’482, para. 11; Keldmann ’423,
paras. 5, 38, 57, Figs. 27a, 27b, 27c) (emphasis omitted). Thus, according to
Appellant, the Examiner’s position that a skilled artisan would recognize
that more medicament would reach the patient in the device of Keldmann
’482, as modified by Keldmann ’423, Gray, and Faram, because the
medicament is released into the medicament delivery device closer to the
user, contradicts the express teachings of both Keldmann ’482 and
Keldmann ’423. Id. at 6 (citing to Final Act. 8).
We are not persuaded by Appellant’s argument that the Examiner’s
determination of obviousness is based on impermissible hindsight
reconstruction. “[I]f a technique has been used to improve one device, and a
person of ordinary skill in the art would recognize that it would improve
similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill.” KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 417 (2007). In this case, the Examiner’s modification is an
improvement to the medicament delivery device of Keldmann ’482 to
include a removable cap having a compartment holding a medicament and a
sealable opening in the same manner as taught by Keldmann ’423 to lead to
the predictable results of “higher production speed and lower handling
costs” and “reduce[d] mechanical agitation of the medicament during
transport of the device.” See Examiner’s Answer (dated Apr. 22, 2021,
hereinafter “Ans.”) 21 (citing Keldmann ’423, paras. 38, 67). Thus, the
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Examiner has provided a sufficient reasoning with rational underpinnings to
combine the teachings of Keldmann ’482 and Keldmann ’423. See In re
Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness
grounds [require] some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness”) (cited with
approval in KSR, 550 U.S. at 418).
Furthermore, we appreciate that Keldmann ’482 discloses medicament
passing over corrugations. See Keldmann ’482, para. 11. However, the
Examiner is correct that Keldmann ’482 does not state “that the medicament
must pass through all the corrugations of the corrugated section.” Ans. 25.
Moreover, claim 1 does not require that the medicament pass over all
corrugations. See Appeal Br. 8 (Claims App.) (“wherein removal of a
sealing medium . . . causes the medicament to flow through the second
tubular section in a first direction and into the corrugations of the bendable
section”). Limitations not appearing in the claims cannot be relied upon for
patentability. In re Self, 671 F.2d 1344, 1348 (CCPA 1982).
We also appreciate that Keldmann ’423 discloses that the medicament
should be located at the beginning of the corrugations before inhalation in
the intake direction (the direction in which medicament flows to exit the
device and be delivered to the patient). See Keldmann ’423, paras. 5, 38, 57.
However, the Examiner is correct that the rejection employs Keldmann ’423
as a secondary reference “to teach that the medicament is housed within a
cap as opposed to being housed within the medicament delivery device prior
to use, and . . . not . . . to teach operation of the medicament delivery
device.” Id (emphasis added). Obviousness does not require that all of the
features of the secondary reference be bodily incorporated into the primary
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reference. In re Keller, 642 F.2d 413, 425 (CCPA 1981). We must attribute
skill to the hypothetical person described in 35 U.S.C. § 103(a). In re
Sovish, 769 F.2d 738, 742 (Fed. Cir. 1985). The fact that some judgment
and mechanical skill may be required for “maneuvering/tilting the
[medicament delivery] device” (see Ans. 26) to allow the medicament to
flow through the second tubular (nasal) section 12 and into the corrugations
of the bendable section 13 of the device of Keldmann ’482, as modified by
Keldmann ’423, Gray, and Faram, does not necessarily mean that such
combination constitutes a nonobvious invention. Graham v. John Deere Co.
of Kansas City, 383 US 1, 10–12 (1966) (discussing Hotchkiss v.
Greenwood, 11 How. 248 (1851)).
Lastly, Appellant argues that neither Keldmann ’482 nor Keldmann
’423 discloses positioning a proximal end of a second (nasal) tubular
section, rather than a proximal end of a first (oral) tubular section, within a
removable cap with a medicament compartment to abut a sealable opening.
See Appeal Br. 4. Appellant’s contention is not persuasive because an
artisan must be presumed to know something about the art apart from what
the references disclose. In re Jacoby, 309 F.2d 513, 516 (CCPA 1962). In
this case, a skilled artisan would have known that positioning the proximal
end of the first (oral) tubular section 11 of Keldmann ’482 to abut the
sealable opening of the removable cap of Keldmann ’423 would have
obviated the purpose of one-way valve 28, namely, to prevent inhalation of
medicament “exiting the opening of the first tubular section [11].” See Final
Act. 6 (citing Keldmann ’482, para. 56); Ans. 26. The Examiner is correct
“that the medicament must be [located] downstream of the valve [28] prior
to user exhalation in the tubular structure in order to prevent user inhalation
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of the medicament, and therefore the sealed opening must be placed on the
second [nasal] tubular section.” Ans. 23 (emphasis added).
In conclusion, for the foregoing reasons, we sustain the rejection
under 35 U.S.C. § 103 of independent claim 1 as unpatentable over
Keldmann ’482, Gray, Keldmann ’423, and Faram. Claims 10 and 14–16
fall with claim 1.

Rejections III–VII
Appellant does not separately argue the rejections under 35 U.S.C.
§ 103 of claims 2–6 and 11–13. See Appeal Br. 3–7. Therefore, for the
same reasons discussed supra, we likewise sustain Rejections III–VII.

CONCLUSION

Claim(s)
Rejected
35
U.S.C.
§
Reference(s)/Basis Affirmed Reversed
14, 15 112(a) Written description 14, 15
1, 10,
14–16
103 Keldmann ’482, Gray,
Keldmann ’423, Faram
1, 10,
14–16

2 103 Keldmann ’482, Gray,
Keldmann ’423,
Faram, Gengar
2
3 103 Keldmann ’482, Gray,
Keldmann ’423,
Faram, Gengar, Denton
3
4–6 103 Keldmann ’482, Gray,
Keldmann ’423,
Faram, Gengar,
Chintakis
4–6
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11 103 Keldmann ’482, Gray,
Keldmann ’423,
Faram, Moller
11
12, 13 103 Keldmann ’482, Gray,
Keldmann ’423,
Faram, Tsutsui
12, 13
Overall
outcome
1–6,
10–16

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