Ex Parte Snyder et al

Patent Trial and Appeal Board

Aug 31, 2017

12075470 (P.T.A.B. Aug. 31, 2017)

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.
6298-610 1990
EXAMINER
STUART, COLIN W
ART UNIT PAPER NUMBER
3771
MAIL DATE DELIVERY MODE
12/075,470 03/11/2008
7590757
BGL
P.O. BOX 10395
CHICAGO, IL 60610
Sarah Bruce Snyder
08/31/2017 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 SARAH BRUCE SNYDER and JAMES N. SCHMIDT
Appeal 2015-006192
Application 12/075,470
Technology Center 3700
Before STEVEN D. A. MCCARTHY, LYNNE H. BROWNE, and
THOMAS F. SMEGAL, Administrative Patent Judges.
SMEGAL, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Sarah Bruce Snyder and James N. Schmidt (Appellants)1 seek our
review under 35 U.S.C. § 134 of the Examiner’s rejections2 under 35 U.S.C.
§ 103(a) of claims 67, 68, and 74—83 as unpatentable over (1) Kraemer (US
5,427,089, iss. June 27, 1995), Rupprecht (Medical Device & Diagnostic
Industry Magazine - January 1999), and Appellants’ Admitted Prior Art
(AAPA)(Appellants’ Specification, p. 8—10); and (2) Watt (US 6,578,571
1 According to Appellants, the real party in interest is Trudell Medical
International (TMI). Appeal Br. 1.
2 Appeal is taken from the adverse decision of the Examiner as set forth in
the Final Office Action, dated April 2, 2014 (“Final Act.”).
Appeal 2015-006192
Application 12/075,470
Bl, iss. June 17, 2003), Rupprecht, and AAPA.3 We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
CLAIMED SUBJECT MATTER
Claims 67 and 74 are independent claims. Claim 74 is reproduced
below and illustrates the claimed subject matter, with disputed limitations
emphasized.
74. A method of assembling a medication delivery device
comprising:
providing a see-through holding chamber comprising an
input end and an output end spaced from said input end along a
longitudinal axis, said holding chamber comprising a see-
through, plastic material having a substantially permanent
surface resistivity of between about 10E10 and about 10E12
ohm/sq;
removably securing a metered dose inhaler to said input
end of said holding chamber without first washing said holding
chamber; and
maintaining said substantially permanent surface
resistivity of said plastic material over time regardless of whether
said holding chamber is washed.
ANALYSIS
Obviousness of Claims 67, 68, and 74—83 over Kraemer, Rupprecht,
and AAPA.
Claims 67, 74, 77—79, and 81—83
Appellants argue claims 61, 74, 77—79, and 81—83 together in
contesting the rejection of these claims as obvious over Kraemer, Rupprecht,
3 Claims 1—66, and 69-73 have been cancelled. Appeal Br. 4.
2
Appeal 2015-006192
Application 12/075,470
and AAPA. See Appeal Br. 13—14. We select claim 74 as the representative
claim for this group, and the remaining claims stand or fall with claim 74.
See 37 C.F.R. § 41.37(c)(l)(iv); In re McDaniel, 293 F.3d 1379, 1383 (Fed.
Cir. 2002); see also In re Watts, 354 F.3d 1362, 1368 (Fed. Cir. 2004). .
Appellants also present separate arguments for claims 68, 75, 76, and 80,
which we address infra.
In rejecting claim 74, the Examiner finds Kraemer teaches a method
of assembling a medication delivery device including, inter alia, providing a
plastic holding chamber4 “without first washing, with detergent, the holding
chamber (note that Kraemer does not teach the step of washing the holding
chamber with detergent or any other cleaning substance),” but that “Kraemer
is silent as to whether the holding chamber has “a surface resistivity of
between about 10E10 and about 10E12 ohms/sq,” as recited by claim 74.
Final Act. 8—9. However, the Examiner determines that Rupprecht teaches
“see-through plastics suitable for a wide variety of medical applications,
including . . . bodies for asthma inhalers which have a surface resistivity of
between about 10 E 10 and about 10 E 12 ohm/sq.” Id. at 9 (citation,
including to Rupprecht, page 10, 5th — 6th Table 1, footnote b, omitted).
From the foregoing, the Examiner reasons that it would have been
obvious “to modify the Kraemer device’s holding chamber to be a see-
through plastic material [that has] a surface resistivity of between about 10 E
10 and about 10 E 12 ohm/sq, as taught by Rupprecht, in order to provide an
antistatic surface [to] avoid static capture of medicine [that would]
negatively [affect] the proper dose amount.” Id. at 9.
4 Kraemer teaches that the plastic holding chamber is made of a transparent
plastic material. See Kraemer, col. 2,11. 59-65; see also Final Act. 7.
3
Appeal 2015-006192
Application 12/075,470
The Examiner also explains that
the choice of material, for example PermaStat 600 series as
evidenced by [Appellants’] specification [at] page 9, would have
been an obvious matter of design choice to one of ordinary skill
in the art. . . to obtain expected results (anti—static properties)
and modify the modified Kraemer to use this well-known
material which would provide the permanent surface resistivity
property regardless of whether the holding chamber is washed.
Note that the use of the permanent anti-static material, such as
PermaStat 600, would also make pretreating/washing the device
unnecessary due to the material’s anti-static properties.
Id. at 9—10.
Additionally, the Examiner points out that Appellants’ disclosure
“was only relied upon for the teaching of a particular material, PermaStat
600, which had a permanent surface resistivity property,” explaining that
“[t]he Rupprecht reference not only identifies the same problem applicant is
concerned with, inaccurate dosing due to static capture of the drug to be
inhaled. . . but also provides the substantially similar solution as the
applicant, providing an antistatic material having particular surface
resistivity.” Id. at 11. (emphasis added). The Examiner then concludes that
“[c]hoosing an already well-known material which explicitly exhibited these
properties permanently, such as PermaStat 600, would have been obvious to
one of ordinary skill in the art.” Id.
Without responding to the Examiner’s findings and conclusions
regarding the teachings of Kraemer and Rupprecht, and without providing
any evidence to support the contention, Appellants contend that the
“teachings in the Specification, including the identification of particular
materials, is not admitted prior art.”5 Appeal Br. 6. Regardless of whether
5 We agree with the Examiner that “it does not appear that the
4
Appeal 2015-006192
Application 12/075,470
this material is admitted prior art, the Specification indicates that Appellants
did not invent this material, as it is a commercially available product. Spec.
8. Appellants do not contest the Examiner’s finding that PermaStat 600 is a
well-known material. Final Act. 4. Thus, Appellants do not apprise us of
error.
Appellants continue by contending that “even if the PermaSlat 600
reference in [Appellants’] specification is considered as ‘admitted prior art,’
then the Examiner has not fully or properly considered the substantial
evidence of secondary considerations, linked to the claimed invention, which
further negate a finding of obviousness.” Appeal Br. 8. Appellants rely on
evidence of secondary considerations of nonobviousness in the form of a
declaration by co—inventor James N. Schmidt (hereafter “Declaration”).
Appeal Br. 20-23, Evidence App. Appellants contend that “there is
substantial documentary evidence that a commercial device embodying the
invention of Watt, namely the Funhaler® Spacer, expressly discloses that
the spacer chamber ‘should be washed each week in clean water with dish­
washing detergent and allowed to drain and dry without rinsing.’” Appeal
Br. 9 (citing Deck 12, Ex. B).
However, we disagree that the Declaration evidences any secondary
consideration (i.e. unexpected results, long felt need, commercial success).
Rather, the Declaration, at best, appears to provide evidence that a
commercial embodiment of the invention disclosed in Watt—not Kraemer—
[Appellants have] invented such a material, but rather selected an already
well-known material to form the holding chamber of the instant claims,”
noting that Rupprecht “solves the same problem as addressed in the instant
application.” Ans. 12 (citing the Specification, p. 1,1. 28—p. 2,1. 3).
5
Appeal 2015-006192
Application 12/075,470
requires washing before using. However, Watt is not relied upon in this
rejection. Thus, Appellants provide no evidence or persuasive argument in
support of their contention that facts asserted in the Declaration apply to
Kraemer.
More generally, Appellants’ arguments focus on whether the claimed
subject matter would have been obvious to the authors of the cited prior art.
See Appeal Br. 10-11 (e.g., Appeal Br. 10: “Watt and Rupprecht had not
identified such a material, and indeed, RTP was still working on a solution
years later after Applicants solved the problem.”). Although the failure of
Watt and Rupprecht to recognize the advantages of the Appellants’ claimed
subject matter until after the Appellants applied for a patent is some
evidence of the level of ordinary skill in the art, such evidence is anecdotal
in nature. The teachings of Rupprecht are more persuasive. Furthermore,
the continued marketing of the Funhaler® device with instructions to wash
the device weekly with detergent to maintain performance is not a “teaching
against the purported combination advanced by the Examiner” (see Appeal
Br. 9), in the sense of criticizing or disparaging such a combination. Exhibit
A to the Declaration is not persuasive evidence of a long felt need as of 1999
to eliminate a requirement for washing and air drying to reduce static prior
to inhaler use. See Appeal Br. 10. The Exhibit teaches washing and air
drying as a solution to the problems arising from electrostatic charges in
inhalers, and does not suggest that washing and air drying was itself a
problem.
We agree with the Examiner that it would have been obvious to use
acrylonitrile butadiene styrene (ABS) resins, known to eliminate
accumulated static charges that can clog the flow of materials in medical
6
Appeal 2015-006192
Application 12/075,470
applications such as asthma inhalers, as taught by Rupprecht, in delivering
medication, as taught by Kraemer. See Final Act. 3^4. Appellants do not
provide any evidence or argument sufficient to show that the proposed
modification of Kraemer would have been beyond the level of ordinary skill
in the art and yields more than one would expect from such an arrangement,
the combination is obvious.” KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398,
416 (2007), quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976).
The Examiner’s finding that the combination yields predictable results has
not been rebutted by Appellants with either evidence or technical reasoning
Because the Examiner has articulated adequate reasoning having
rational underpinnings as pointed out supra, that the choice of materials
“would have been an obvious design choice to one of ordinary skill in the
art,” we are not persuaded that the combination impermissibly uses the
disclosure of the present patent application as a guide as argued by
Appellants. See Appeal Br. 6—8. Furthermore, Appellants have not
identified any knowledge that the Examiner relied upon 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); see also Radix Corp.
v. Samuels, 13 USPQ2d 1689, 1693 (D.D.C. 1989) (“[A]ny obviousness
inquiry necessarily involves some hindsight.”).
After reviewing all of the evidence before us, including the totality of
Appellant’s evidence, it is our conclusion that, on balance, the evidence of
obviousness discussed above outweighs the evidence of nonobviousness
submitted by Appellants and, accordingly, the subject matter of claims 67,
74, 77—79, and 81—83 would have been obvious to one of ordinary skill in
7
Appeal 2015-006192
Application 12/075,470
the art within the meaning of 35 U.S.C. § 103(a) at the time Appellants’
invention was made.
Based on the foregoing, we sustain the Examiner’s unpatentability
rejection of claims 67, 74, 77—79, and 81—83 over Kraemer, Rupprecht, and
AAPA.
Claims 68 and 75
Appellants contend that the Examiner’s reliance on AAPA in rejecting
dependent claim 75, which further limits the recitation in claim 74 of
“without first washing said holding chamber” by reciting “with a detergent,”
is impermissible.6 Appeal Br. 14. However, Appellants misread the
rejection. The Examiner relies on Kraemer, not AAPA, for teaching without
first washing with a detergent, in rejecting claims 67, 68, 74 and 75. See
Final Act. 9. Thus, we sustain the rejection of claims 68 and 75 over
Kraemer, Rupprecht, and AAPA.
Claims 76 and 80.
Appellants contend that the Examiner’s reliance on AAPA in rejecting
dependent claim 80, which further limits the recitation in claim 74 of
“maintaining said substantially permanent surface resistivity of said plastic
material over time regardless of whether said holding chamber is washed,”
by further reciting “for at least a year,” is impermissible.7 However, merely
reciting the language of a claim and asserting that the cited prior art
6 Dependent claim 68 contains a similar limitation of the corresponding
recitation in independent claim 67, from which it depends. See Appeal Br.
16, Claims App.
7 Dependent claim 76 contains a similar limitation of the corresponding
recitation in independent claim 67, from which it depends. See Appeal Br.
17, Claims App.
8
Appeal 2015-006192
Application 12/075,470
references do not disclose that limitation is insufficient. Appeal Br. 15; See
In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011). Arguments of this nature
do not satisfy the requirements of 37 C.F.R. § 41.37(c)(l)(iv). In re Lovin,
652 F.3d at 1357.
Obviousness of Claims 67, 68, and 74—83 over Watt, Rupprecht, and
AAPA.
We affirm the rejection of claims 67, 68, and 74—83 under 35 U.S.C.
§ 103(a) as being unpatentable over Kraemer, Rupprecht, and AAPA. This
affirmance disposes of all claims before us on appeal. Consequently, we
find it unnecessary to reach a decision about the cumulative rejection of
claims 67, 68, and 74—83 under 35 U.S.C. § 103(a) as being unpatentable
over Watt, Rupprecht, and AAPA. See 37 C.F.R. § 41.50(a)(1) (“The
affirmance of the rejection of a claim on any of the grounds specified
constitutes a general affirmance of the decision of the examiner on that
claim, except as to any ground specifically reversed.”).
DECISION
We AFFIRM the Examiner’s rejection of claims 67, 68, and 74—83
over Kraemer, Rupprecht, and AAPA. We do not reach the additional issues
raised by Appellants regarding the cumulative rejection of claims 67, 68, and
74—83 over Watt, Rupprecht, and AAPA.
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)(l)(iv).
AFFIRMED
9