Ex Parte Smaldone et al

Patent Trial and Appeal Board

May 30, 2013

11062519 (P.T.A.B. May. 30, 2013)

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.
11/062,519 02/22/2005 Gerald C. Smaldone STONYB-09331 8157
23535 7590 05/31/2013
MEDLEN & CARROLL, LLP
703 Market Street
SUITE 340
SAN FRANCISCO, CA 94103
EXAMINER
DIXON, ANNETTE FREDRICKA
ART UNIT PAPER NUMBER
3778
MAIL DATE DELIVERY MODE
05/31/2013 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 GERALD C. SMALDONE and LUCY B. PALMER
____________

Appeal 2011-005397
Application 11/062,519
Technology Center 3700
____________

Before STEFAN STAICOVICI, WILLIAM V. SAINDON, and
MICHAEL C. ASTORINO, Administrative Patent Judges.

STAICOVICI, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING
Appeal 2011-005397
Application 11/062,519

2
Gerald C. Smaldone and Lucy B. Palmer (Appellants) filed a Request
for Rehearing (“Request”) under 37 C.F.R. § 41.52 requesting that we
reconsider our decision of February 27, 2013 (“Decision”) affirming the
rejections under 35 U.S.C. § 103(a) of claims 22-24, 26, 27, and 31-33 as
unpatentable over Piper (US 5,287,849, iss. Feb. 22, 1994), Robertson (US
5,487,378, iss. Jan. 30, 1996), and Appellants’ Admitted Prior Art (hereafter
“AAPA”) (Spec. 20, l. 28 through Spec. 21, l. 4); of claims 29, 30, 38, and
39 as unpatentable over Piper, Robertson, AAPA, and Burns (US 5,284,133,
iss. Feb. 8, 1994); of claim 40 as unpatentable over Piper, Robertson,
AAPA, Burns and Mason (US 3,642,987, iss. Feb. 15, 1972); and of claims
34 and 37 as unpatentable over Piper, Robertson, AAPA, and Isaza (US
5,881,717, iss. Mar. 16, 1999).
In the Request, Appellants contend that: (1) the Board overlooked or
misapprehended the technical incompatibility of Piper and Robertson and
that we made a new argument1 for supporting the Examiner’s obviousness
rejection of Piper and Robertson (Request 3-5); (2) we made a new
argument for supporting the Examiner’s obviousness rejection of Piper,
Robertson, and AAPA (Request 6-7); (3) we made two new grounds of

1 The Board does not argue, but rather reviews the Examiner’s decision in
view of Appellant’s arguments. 35 U.S.C. § 6. We consider Appellant’s
allegations of a “new argument” to mean Appellant is alleging we made a
new ground of rejection. However, we note that a discussion and/or
elaboration of the Examiner’s rejection does not constitute an “argument” or
a new ground of rejection. Hyatt v. Doll, 576 F.3d 1246, 1276 (Fed. Cir.
2009) (“While the Board's explanations were often, though not always, more
detailed, the ‘thrust’ of these rejections was identical to that of the
examiner’s corresponding rejections. The Board cannot be said to have
presented a new ground of rejection simply by elaborating on the examiner’s
rejection or by using different words”).
Appeal 2011-005397
Application 11/062,519

3
rejection for supporting the Examiner’s obviousness rejection of Piper,
Robertson, and AAPA (Request 7-9); (4) we misapplied In re Merck & Co.,
Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986) in our response to Appellants’
arguments with respect to the obviousness rejection based upon Burns and
based upon Mason (Request 9-10); (5) we made a new argument for
supporting the obviousness rejection based upon Isaza; and (6) our
construction of claim 27 constitutes a new argument (Request 11).

Issue (1)
Pointing to pages 8 and 9 of the Appeal Brief Appellants argue that
not only did we not take into consideration Appellants’ arguments as to why
the diverse technologies of Piper and Robertson would not and could not be
combined, but we also made new arguments for supporting the obviousness
rejection. Request 3-5.
According to Appellants, because “Piper boasted of a 900% increase
in efficiency over conventional [delivery] systems,” the combination with
Robertson would be a “further improvement” that is not supported by the
record. Request 4; see also App. Br. 8. Appellants further point out that
Robertson’s design for a handheld inhaler does not take into account the
design parameters of Piper’s ventilator system, such as, “a) the dynamics of
the large volume ‘charging system’ of Piper, b) the continuous flow design
of Piper, or c) the impact of the inhalation and exhalation phases on the
ventilator.” Request 5; see also App. Br. 8.
At the outset, we note that Appellants’ arguments were acknowledged
on page 5 of our Decision. However, after reviewing Appellants’ iteration
of the technological differences of Piper and Robertson, we concluded that
Appeal 2011-005397
Application 11/062,519

4
although there are differences between the technologies of Piper and
Robertson, Appellants have not shown that the differences “are of such a
nature as to have dissuaded a person of ordinary skill in the art . . . from
[combining the teachings of Piper and Robertson].” Decision at 6 (emphasis
added). We do not agree that our conclusion constitutes a new ground of
rejection (see Request 3) because it merely represents our response to
Appellants’ position that the diverse technologies of Piper and Robertson
would not and could not be combined.
We also stated in our Decision that, “the modification of Piper to
include the aerosol generator of Robertson, as proposed by the Examiner, is
nothing more than the substitution of one element, i.e., Robertson’s aerosol
generator, for another known in the field, i.e., Piper’s generic nebulizer 102,
to yield a predictable result.” Decision 6. Appellants, on rehearing, argue
that “re-characterizing the combination of Piper with Robertson as merely
the substitution of one element for another” “is a new argument.” Request
5-6.
We do not agree that this is a new basis for supporting the
obviousness rejection. In our view, this is merely an example explaining
why we agreed with the Examiner’s position that modifying the nebulizer of
Piper to include the vibrating aerosol generator of Robertson to control the
dispensing of medicament during therapy would have been obvious to a
person of ordinary skill in the art. See Ans. 7. We noted in our Decision
that Piper’s system includes a nebulizer (aerosol generator) 102 for
dispensing a medicinal aerosol, but fails to disclose “the particulars of the
nebulizer,” and that the aerosol generator of Robertson dispenses medicinal
aerosol. Decision 4-5. Hence, our example did not intend to provide all of
Appeal 2011-005397
Application 11/062,519

5
the features of Robertson’s aerosol generator be bodily incorporated into the
system of Piper, as Appellant argues (Request 6), but merely to modify the
nebulizer of Piper to include a vibrating aerosol generator as taught by
Robertson. Decision 5.
Finally, with respect to the Declaration of Michael Klimowicz
(hereafter “Klimowicz Declaration”), because we do not agree that we have
made a new ground of rejection, the Klimowicz Declaration, filed with the
instant Request on April 24, 2013 (see Request 6) is not entitled to
consideration. See 37 C.F.R. § 41.63(c) (“Affidavits or other evidence filed
after the date of filing an appeal pursuant to § 41.61 will not be admitted
except as permitted by reopening prosecution under § 41.77(b)(1).”). Even
in the event of a new ground of rejection, the plain language of 37 C.F.R. §
41.50(b) states that Appellant cannot add new evidence for consideration in
a rehearing, and Appellant cannot simultaneously seek to reopen prosecution
and request rehearing.

Issue (2)
Appellants consider our statement that, “. . . it follows that the
advantages of a dome-shaped aperture plate, as presented in the Declaration
of Yehuda Ivri, filed June 30, 2008, paras. 6 and 7 (hereafter ‘Ivri
Declaration’), were also known” to be a new argument. Request 6,
Decision 7. According to Appellants, after looking at the Ivri Declaration,
“one finds NOTHING that suggests the advantages were known.”
Request 7. Moreover, Appellants argue that we overlooked “key language
in the Ivri Declaration.” Request 7; see also Declaration of Yehuda Ivri,
filed Jun. 30, 2008, para. 6.
Appeal 2011-005397
Application 11/062,519

6
We do not agree that our statement is a new basis for supporting the
obviousness rejection. In our view, this statement merely explains why we
agreed with the Examiner that it would have been obvious for a person of
ordinary skill in the art to modify the ventilator system of Piper and
Robertson to include the dome-shaped aperture plate of AAPA. Decision 7;
see also Ans. 7-8. Namely, because we agreed with the Examiner that
Appellants’ Specification shows that the use of a dome shaped aperture plate
was known at the time of the invention. Decision 7; see also Spec. 20, l. 28-
Spec. 21, l. 4. Moreover, an artisan must be presumed to know something
about the art apart from what the references discloses. See In re Jacoby, 309
F.2d 513, 516 (CCPA 1962). The fact that the specific advantages described
in the Ivri Declaration are not specifically mentioned in any of the applied
references does not, without more, establish that the advantages of using a
dome shaped aperture plate were not known to a skilled artisan when the use
of a dome shaped aperture plate was known.
Furthermore, even assuming arguendo that a skilled artisan may not
have recognized the specific advantage of using a dome shaped aperture
plate for administering viscous antibiotic formulas, as Appellants argues, a
“‘dome or non-planar shape is advantageous for any vibrating mesh plate,’
which would include aperture plate 50 (nozzle array) of Robertson’s
device.” Decision 7; see also Ivri Declaration, para. 6. In determining
whether the subject matter of a claim is obvious, “neither the particular
motivation nor the avowed purpose of the [applicant] controls.” KSR Int'l
Co. v. Teleflex, Inc., 550 U.S. 398, 419 (2007).

Appeal 2011-005397
Application 11/062,519

7
Issue (3)
Appellants contend that:
The Board, without any support in the record,
dismissed the technical argument on two new
grounds. First, the Board argued that Applicants
technical argument was mere attorney argument.
Second, the Board argued that “both Robertson's
nozzle array 50 and the dome-shaped aperture
plate . . . rely on ultrasonic vibrations . . . [.]”
(Board's decision, p. 8).
. . . .
Applicants respond to these two new arguments of
the Board with a showing of facts pursuant to 37
CFR 1.196(b)(1). More specifically, Applicants
submit the Declaration of Michael Klimowicz, an
engineer with over 25 years of relevant experience.
Request 8-9.
At the outset, we note that we agreed with Appellants in our Decision
“that the reservoir of Robertson’s device requires a negative differential
pressure.” Decision 8. However, we do not agree that our statements
constitute new grounds of rejection, as Appellants suggest. Our statements
merely explain why we did not find Appellants’ arguments persuasive.
Namely, because Appellants did not provide any persuasive evidence,
besides attorney argument, to show that the Examiner’s proposed
modification of Piper’s system according to Robertson and AAPA (1) would
not dispense a medicinal aerosol because of leakage and (2) would render
Piper’s ventilator system unsatisfactory for its intended purpose. Id. Our
statement comparing the similar functioning principle of Robertson’s nozzle
array 50 and a dome-shaped aperture plate (see Decision 8), namely, the use
ultrasonic vibrations, was further explanation that without more, one of
ordinary skill in the art would expect them to function in a similar manner.
Appeal 2011-005397
Application 11/062,519

8
Finally, with respect to the Klimowicz Declaration, because we do not
agree that we have made any new grounds of rejection, the Klimowicz
Declaration, filed with the instant Request on April 24, 2013 (see Request 8-
9) is not entitled to consideration. See C.F.R. § 41.63(c).

Issue (4)
Appellants’ argument “that neither Mason nor Burns teach
ANYTHING about ventilators,” evinces that Appellants are not taking into
consideration the combined teachings of Piper, Robertson, and AAPA. See
Request 10. Appellants’ argument merely points out differences between
the claimed subject matter, i.e., ventilators, and an embodiment disclosed in
one reference, i.e., either Burns or Mason.
However, as stated in our Decision, “the combined teachings of Piper,
Robertson, and AAPA discloses . . . ‘ventilator circuits.’” Decision 13; see
also Ans. 7 (“Piper discloses . . .a ventilator (100).” We thus do not agree
that In re Merck has been misapplied.

Issue (5)
Appellants argue that:
[The] Board concedes that the art cited (Isaza
patent) teaches replacing things that are occluded
but makes the new argument that "even if the
tubing system is occluded, air still flows through
the system . . ." (citing to Isaza, col. 4, lines 22-
26). However, when looking at this portion of
Isaza, it is evident that little if any air is still
flowing[.]
Request 10.
Appeal 2011-005397
Application 11/062,519

9
We do not agree with Appellants because Isaza specifically discloses
in column 4, lines 22-26, that due to breathing circuit disconnections and/or
occlusions “either no breathing gas or very little gas from the ventilator”
reaches the patient (emphasis added). Thus, as stated in our Decision, “even
if the tubing system is occluded [in Isaza], air still flows through the system,
albeit at a level lower than a threshold level.” Decision 16. Furthermore, we
do not agree that our statement is a new argument because the cited portion
is merely a clearer expression of the disclosure in column 1, lines 43-60 of
Isaza, which was originally cited by the Examiner. See Ans. 10.
Lastly, with respect to Appellants’ amendment to claim 37 (see
Request 10), because we do not agree that we have made a new ground of
rejection, Appellants’ Amendment, filed with the instant Request on April
24, 2013 is not entitled to consideration. See 37 C.F.R. § 41.63(b) (“All
other amendments filed after the date of filing an appeal pursuant to § 41.61
will not be admitted except as permitted by § 41.77 (b)(1).”); see also id. at
§ 41.50(b).

Issue (6)
Appellants argue that our statement “. . . use of the term ‘comprising’
allows stem 20 to include other elements besides a lumen and an aerosol
generator . . .” constitutes a new argument (Request 11).
The Examiner found that Figure 2 of Piper discloses a Y-piece having
a connection to an inspiratory line 18, an expiratory line 18, and a stem
having an “aerosol generator . . . located on the stem (via line 32).” Ans. 14.
We thus do not agree that our statement is a new ground of rejection, but
merely an explanation of why the Examiner correctly construed the term
Appeal 2011-005397
Application 11/062,519

10
“stem” of claim 27 “to include other elements besides a lumen and an
aerosol generator.” See Decision 12.
Finally, with respect to Appellants’ amendment to claim 27, because
we do not agree that we have made a new ground of rejection, Appellants’
Amendment, filed with the instant Request on April 24, 2013 (see Request
11) is not entitled to consideration. See C.F.R. § 41.63(b).
In conclusion, for the foregoing reasons, Appellants’ Request does not
persuade us that this panel’s Decision misapprehended or overlooked any
matter or that we erred in affirming the Examiner’s rejection of claims 22-
24, 27, 29-34, and 37-40.
CONCLUSION
We have granted Appellant’s request to the extent that we have
considered our Decision in light of the points raised therein, but have denied
the request with respect to any modification to the Decision.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

DENIED

hh