Ex Parte Stepovich et al

Patent Trial and Appeal Board

Aug 24, 2016

12766259 (P.T.A.B. Aug. 24, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
121766,259 04/23/2010
27805 7590
THOMPSON HINE L.L.P.
10050 Innovation Drive
Suite 400
DAYTON, OH 45342-4934
08/26/2016
FIRST NAMED INVENTOR
Matthew J. Stepovich
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
OPHM-03US 1061
EXAMINER
TURK,NEILN
ART UNIT PAPER NUMBER
1798
NOTIFICATION DATE DELIVERY MODE
08/26/2016 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):
ipdocket@thompsonhine.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte MATTHEW J. STEPOVICH, MICHAEL I. FALKEL,
and HARRY NGUYEN
Appeal2015-001722
Application 12/766,259
Technology Center 1700
Before CHUNG K. PAK, JAMES C. HOUSEL, and LILAN REN,
Administrative Patent Judges.
REN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants 1 appeal under 35 U.S.C. § 134 from a rejection of claims
24-26, 28, and 30.2 We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 The real party in interest is identified as OnPharma, Inc. (Appeal Brief,
filed April 24, 2014 ("App. Br."), 3.)
2 Final Rejection dated May 3, 2013 ("FR.").
Appeal2015-001722
Application 12/766,259
CLAIMED SUBJECT MATTER
The claims are directed to "methods and systems for adjusting the pH
of buffers and other medical solutions to achieve uniformity among
pluralities of individual containers." (Spec. ,-i 2.)3 Because "a medical
buffer having an actual pH of 7.0 may perform significantly differently than
a medical buffer having an actual pH of 8.5," it is said to "be desirable to
provide packaged buffers with precisely controlled pH's so that the pH in
each individual package is substantially identical and consistent." (Id. ,-i,-i 6,
7.)
The '259 Specification is said to provide "methods and systems for
preparing container inventories of bicarbonate medical buffer solutions
(buffers) having a precisely controlled pH with minimum variability among
the solutions in any individual container." (Id. ,-i 9.) The buffers are said to
be useful for "control[ing] the pH of other medical solutions, such as local
anesthetics, to a predictable physiologic pH by combining a predetermined
volume of the buffer with the medical solution." (Id.) The '259
Specification provides that "the buffered pH of the combined buffer and
medical solution will also be precisely controlled and predictable, a result
that would not be possible if the pH of the buffer solution were not itself
precisely controlled and predictable." (Id.)
3 Application 12/766,259, Methods and Systems for Adjusting the pH of
Medical Buffering Solutions, filed April 23 2010. We refer to the
'"259 Specification," which we cite as "Spec."
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Application 12/766,259
Figure 1 of the '259 Specification illustrating "a medical solution
container" (id. ii 24) is reproduced below:
16
.- --~ 12
FIG_. 1
Figure 1 shows "buffer container 10" which "comprises a cartridge 12
including a glass cylindrical body having an open bottom 14." (Spec. ii 30.)
"A reduced diameter neck 16 is at the top with an opening 18 which can be
covered and sealed with a cap 20 with a needle-penetrable septum 22." (Id.)
"The bottom of the cartridge 12 is defined by a movable plunger 24 which
can be pushed in an upward direction (indicated by the arrow) to apply
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Application 12/766,259
pressure on the aqueous buffer held within the chamber 12 between the
plunger and the opening 18 in neck 16." (Id.) Buffer container 10 may
contain, for example, a bicarbonate solution which "will be maintained at a
pressure above atmospheric to inhibit the evolution of carbon dioxide during
storage" which "could[] cause the pH to change." (Id. iii! 16, 22.)
Claim 24, reproduced below, is illustrative of the claimed subject
matter:
24. An inventory of buffer containers comprising:
a plurality of containers, wherein each container has:
(a) a sealed interior filled with a volume of an aqueous
sodium bicarbonate buffer solution in the range from 1.0 ml to
50.0 ml; and
(b) structure which applies force to the aqueous buffer
solution in the sealed interior of the container to inhibit the
evolution of carbon dioxide in the sealed container during
transportation and storage to maintain a pH variation below
±0.05 of buffer in each container when compared to the pH of all
other containers in the inventory.
(Claims Appendix; App. Br. 11 (emphases added).)
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Tsals
Lavi
McGinnis
Kennedy
us 5,858,001
US 6,364,865 B 1
US 2003/0065149 Al
US 2005/0282775 Al
4
Jan. 12, 1999
Apr. 2, 2002
Apr. 3, 2003
Dec. 22, 2005
Appeal2015-001722
Application 12/766,259
REJECTIONS4
Claims 24-26, 28, and 30 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Tsals, in view of Kennedy and Lavi. (Ans. 3.)5
Claims 27 and 29 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Tsals in view of Kennedy, Lavi, and McGinnis. (Ans. 4.)
OPINION
Findings of fact throughout this Opinion are supported by a
preponderance of the evidence of record.
Claim 24
Tsals "provides a liquid drug delivery device comprising ... a
columnar cartridge serving as reservoir for the drug . . . and means for
expelling a drug out of the interior of the cartridge[.]" (Tsals, 2, 11. 55-65.)
Figure 1 of Tsals, reproduced below, illustrates "a sectional elevation of a
cartridge-based drug delivery device[:]"
4 Although the Examiner objects to claim 26 because it recites a "glass
bottle" instead of a "glass cartridge" which is recited in claim 25 from which
claim 26 depends (FR. 2), we do not decide the propriety of this objection as
it is a petitionable matter. In re Berger, 279 F.2d 975, 984 (Fed. Cir. 2002)
("There are a host of various kinds of decisions an examiner makes in the
examination proceeding-mostly matters of a discretionary, procedural or
nonsubstantive nature-which have not been and are not now appealable to
the board or to this court when they are not directly connected with the
merits of issues involving rejections of claims, but traditionally have been
settled by petition to the Commissioner.")
5 Examiner's Answer mailed October 3, 2014 ("Ans.").
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Application 12/766,259
26a 18
25
16
I I
(Id. at 7, 11. 44--45.)
12
FIG.1
Figure 1 of Tsals illustrates "a cartridge-based drug delivery device"
10 having "a body 11 comprising a cartridge 12[.]" (Id. at 8, 11. 16-19.) "A
piston 16 is contained in cartridge 12 and defines on one side thereof a drug
compartment 17 and on the other side thereof a driving chamber 18." (Id. at
8, 11. 22-24.) "Compartment 17 is filled with a liquid drug and is sealed at
the end opposite piston 16 by a stopper 19." (Id. at 8, 11. 24-26.)
Figure 1 of Tsals also illustrates that a "spring 23 is held under
compressed tension by a rod 24 having a plate 25 at one end thereof and a
catch projection 26 at the other end thereof." (Id. at 8, 11. 32-34.) "Rod 24
extends through an orifice 26a in a wall section 27 and catch projection 26 is
retained by wall section 27 such that spring 23 is held under tension as long
as catch projection 26 remains in position." (Id. at 8, 11. 34-37.) "A simple
snap mechanism (not shown) causes device 10 to remain in the configuration
illustrated in FIG. 1." (Id. at 8, 11. 40--42.)
The Examiner further finds that Kennedy discloses treating acidemia
"with intravenous sodium bicarbonate" to maintain arterial pH "between
7.35 and 7.45" and concludes that it would have been obvious to use the
drug delivery device of Tsals to apply sodium carbonate. (FR. 4-5 (citing
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Application 12/766,259
Kennedy iJ 88).) The Examiner also finds that "a standard vial" may be "a 2
milliliter volume" as disclosed in Lavi and concludes that it would have
been obvious to "modify Tsals to include 2.0 ml of sodium bicarbonate
solution within the sealed interior" of Lavi. (FR. 5 (citing Lavi, 8, 11. 45-
50).) Additionally finding that "it would have been obvious to provide a
plurality of the above containers so as to allow for multiple users to have
access to such a personal drug delivery device," the Examiner concludes that
claim 24 is unpatentable. (FR. 5.)
Appellants argue that each reference relates to a single container and
none teaches "an 'inventory of buffer containers' comprising 'a plurality of
containers."' (App. Br. 5.) Appellants, however, do not address, much less
dispute the Examiner's finding that a skilled artisan would have had the skill
and knowledge "to provide a plurality of the [] containers [i.e., personal drug
delivery devices] so as to allow for multiple users to have access to such ...
personal drug delivery device" suggested by the collective teachings of
Tsals, Kennedy, and Lavi. (See id.; see, e.g., Reply Br. 2--4; FR. 5; Ans. 5-
6.)6 No reversible error has been identified in the Examiner's factual
findings and reasoning here. See also In re Harza, 274 F.2d 669, 671
(CCPA 1960) ("It is well settled that the mere duplication of parts has not
patentable significance unless a new and unexpected result is produced[.]").
Appellants next argue that none of the references teaches "a 'buffer
container"' that is "sealed and is also filled with 'sodium bicarbonate buffer
solution."' (App. Br. 6.) Appellants acknowledge that "Kennedy discloses
the use of sodium bicarbonate to maintain arterial pH of animals during
studies" but argue that Kennedy "is silent regarding any 'sealed container' of
6 Reply Brief filed December 1, 2014 ("Reply Br.").
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Application 12/766,259
the sodium bicarbonate and does not disclose that the sodium bicarbonate is
present in a buffer solution." (Id.)
Appellants, however, do not address, much less dispute the
Examiner's finding that Tsals discloses "a glass cartridge 12 having a sealed
interior compartment 17 (sealed buffer container, as claimed) filled with a
volume of liquid" and that compartment 17 "is sealed at the end opposite
piston 16 by a stopper 19." (See Tsals, 8, 11. 24-25; see App. Br. 6; see, e.g.,
Reply Br. 2--4; Ans. 6.) Appellants do not dispute the Examiner's finding
that Tsals' compartment 1 7 and the container recited in claim 21 are
"'sealed' in the same manner and [both] include[] a needle penetrable
septum." (See App. Br. 6; see, e.g., Reply Br. 2-4; Ans. 7.) Appellants also
do not dispute the Examiner's finding that the recited "sodium bicarbonate
buffer solution" is chemically indistinguishable from the sodium bicarbonate
solution disclosed in the Kennedy reference. (See App. Br. 6; see, e.g.,
Reply Br. 2--4; Ans. 7.) Nor do Appellants dispute the Examiner's
determination that one of ordinary skill in the art would have been led to
employ the sodium bicarbonate solution, as suggested by Kennedy and Lavi,
in the glass cartridge taught by Tsals. (See App. Br. 6; see, e.g., Reply Br.
2--4; Ans. 6-7.) No reversible error has been identified in the Examiner's
factual findings on this issue.
Appellants lastly argue that none of the references teaches or suggests
a "structure which applies force ... "as recited in claim 24. (App. Br. 7.) In
particular, Appellants argue that although Figure 1 of Tsals shows that
"spring 23 is held under compression in the pre-delivery state of the device,"
"the spring 23 applies no compression or pressure to the drug compartment
17." (Id. at 9.) Appellants argue that "when the catch projection 26 and the
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Application 12/766,259
abutment 26 are dislodged," pressure is "applied to the drug compartment 17
to advance the drug out of the needle 21." (Id.) Appellants argue, without
presenting factual evidence, that such pressure would not perform the
"inhibit[ing]" function of the "structure" recited in claim 24. (Id.)
Appellants concludes that "a person of ordinary skill in the art would
understand that the assembly in Tsals is not capable of providing the
functional claimed subject matter during storage and transportation." (Reply
Br. 4.)
It has long been held that "apparatus claims cover what a device is,
not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909
F.2d 1464, 1468 (Fed. Cir. 1990). An inventor of a structure (machine or
article of manufacture) is entitled to benefit from all of its uses, even those
not described, Roberts v. Ryer, 91 U.S. 150, 157 (1875), and conversely,
patentability of the structure cannot tum on the use or function of the
structure. In re_Michlin, 256 F.2d 317, 320 (CCPA 1958) ("It is well settled
that patentability of apparatus claims must depend upon structural
limitations and not upon statements of function.").
"'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). Where there is reason to believe that the
structure of the prior art is inherently capable of performing the claimed
function, the burden shifts to the applicant to show that the claimed function
patentably distinguishes the claimed structure from the prior art
structure. See In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997); In re
Hallman, 655 F.2d 212, 215 (CCPA 1981).
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Application 12/766,259
Here, the Examiner finds that spring 23 shown in Tsals performs a
compression function which "begets a force to the solution held in
compartment 17." (Ans. 7-8; see also Tsals, 9, 11. 6-8.) Appellants do not
refute that the '259 Specification discloses such recited structure as
including a "spring or other structure that provides enough force to prevent
C02 from evolving out of solution during transportation or storage" (iJ 23)
which the Examiner finds to be disclosed in Tsals. (See App. Br. 7-9; Reply
Br. 2--4.) Appellants in fact acknowledge that when "the rod 24 is released
to free the spring 23 to apply force to plate 25," "[t]he movement of rod 24
causes the plate to push piston 16 so as to 'compress drug compartment
17. "' (Reply Br. 3.)
Appellants' argument that "the end use of the device 10 in Tsals is not
a state in which the device 10 is being stored or transported" and that "the
assembly in Tsals ... is not capable of providing the functional claimed
subject matter" (id. at 3, 4) is not persuasive because there is no reasonable
basis to believe that the device suggested by Tsals, Kennedy, and Lavi is not
capable of transportation for a short distance or storage for a limited time
period. On this record, Appellants have not presented any credible
reasoning or evidence to show that the personal drug delivery device
suggested by the Tsals, Kennedy, and Lavi is not capable of being
transported to different hospitals or not capable of being stored until it is
needed for a drug delivery application. No reversible error has been
identified in the Examiner's factual findings that Tsals discloses the
"structure" recited in claim 24.
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Claims 27 & 29
Appellants argue that the rejections of claims 27 and 29 are in error
based on their respective dependency from claim 24. (App. Br. 10.)
Appellants have not provided arguments separate from those for claim 24,
and we are not persuaded for the reasons discussed with respect to claim 24
from which claims 27 and 29 depend. In re Lovin, 652 F.3d 1349, 1357
(Fed. Cir. 2011) ("[W]e hold that the Board reasonably interpreted Rule
41.37 to require more substantive arguments in an appeal brief than a mere
recitation of the claim elements and a naked assertion that the corresponding
elements were not found in the prior art.").
DECISION
The Examiner's rejection of claims 24-26, 28, and 30 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l.136(a). See 37 C.F.R.
§ l.136(a)(l )(iv).
AFFIRMED
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