Ex Parte Stepovich et al

Patent Trial and Appeal Board

Jun 20, 2017

13428283 (P.T.A.B. Jun. 20, 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.
13/428,283 03/23/2012 Matthew J. Stepovich OPHM-02US3 7951
27805 7590 06/22/2017
THOMPSON HTNF T T P
EXAMINER
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3761
NOTIFICATION DATE DELIVERY MODE
06/22/2017 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.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MATTHEW J. STEPOVICH and MICHAEL I. FALKEL
Appeal 2015-007870
Application 13/428,283
Technology Center 3700
Before JOHN C. KERINS, JAMES P. CALVE, and
ARTHUR M. PESLAK, Administrative Patent Judges.
CALVE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the final rejection of
claims 1—3 and 5—15. Claim 4 has been cancelled. Appeal Br. 10 (Claims
Appendix). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
Appeal 2015-007870
Application 13/428,283
CLAIMED SUBJECT MATTER
Claims 1 and 8 are independent. Claim 1 is reproduced below.
1. A method for storing a bicarbonate buffer solution, the
method comprising:
receiving a cartridge having an open interior, a needle
penetrable septum, and a plunger that can be advanced into the
open interior to pressurize contents thereof;
filling the cartridge with a solution of bicarbonate buffer
that will evolve carbon dioxide at room temperature and
pressure;
storing the cartridge; and
exerting a force on the plunger with a compression
member that causes the plunger to apply a pressure to the
solution,
wherein the pressure is sufficient to inhibit the evolution
of carbon dioxide during storage.
REJECTION
Claims 1—3 and 5—15 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Skinkle (US 2001/0056259 Al, pub. Dec. 27, 2001) and
Segers (US 5,383,324, iss. Jan. 24, 1995).
ANALYSIS
Appellants argue claims 1,3, and 5—15 as a group. Appeal Br. 2—8.
We select claim 1 as the representative claim, with claims 3 and 5—15
standing or falling with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
The Examiner found that Skinkle discloses storing a medicament as
recited in claim 1 by providing cartridge 20 with an open interior, penetrable
septum 35, and plunger 40 that can be advanced into the interior to provide
pressure to a medical solution therein. Final Act. 2. The Examiner also
found that Skinkle retains the medical solution under pressure until the
septum (one-way valve 35) is forced open. Id.
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Appeal 2015-007870
Application 13/428,283
The Examiner found that Skinkle does not disclose that a bicarbonate
solution is retained under pressure. Id. The Examiner found that Segers
discloses that it is known in the medical storage arts to store a bicarbonate
solution under pressure to maintain the solution in a stable condition, i.e., by
avoiding CO2 gas egress. Id. at 2—3. The Examiner determined that it would
have been obvious to use Skinkle’s method and substitute the bicarbonate
solution of Segers into Skinkle to maintain the bicarbonate solution in a
stable condition as Segers teaches. Id. at 3; Ans. 6.
Appellants argue that Segers discloses the use of carbon dioxide to
stabilize bicarbonate solutions, but does not disclose that the carbon dioxide
gas, which has a partial pressure of at least 80 mm Hg (0.105 atm), prevents
carbon dioxide from evolving, or inhibits the evolution of CO2, as claimed.
Appeal Br. 4—5. Appellants argue that Segers merely applies a small partial
pressure of CO2 to the container to replace any evolved CO2 but does not
exert a pressure on the bicarbonate solution to prevent the evolution of the
CO2 in the first instance. Id. at 5. Appellants also argue that Segers teaches
stabilization of a bicarbonate solution by the partial pressure and presence of
excess free carbon dioxide gas originating from a chemically-reacted solid
material, but this arrangement does not prevent the evolution of the CO2. Id.
Appellants thus asserts that Segers does not teach storing a bicarbonate
solution under pressure to maintain the solution in a stable condition, and
pressurization is not a factor that stabilizes the bicarbonate solution in Segers
or inhibits the evolution of CO2 gas through the application of pressure to a
container. Id. at 6—7. Thus, Appellants argue that neither reference teaches
that a bicarbonate solution can be stabilized by exerting mechanical pressure
on a solution to minimize CO2 evolution. Id. at 7.
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Appeal 2015-007870
Application 13/428,283
The Examiner’s determination that it would have been obvious to
store the bicarbonate solutions of Segers under pressure in the device of
Skinkle to maintain the solutions in a stable condition is supported by a
rational underpinning. As Appellants recognize, Segers teaches to store
bicarbonate solutions under pressure to “stabilize” the solutions. Appeal Br.
5—6. Segers discloses that CO2 gas is generated by device 20 and creates
CO2 pressure in bicarbonate container 24 to stabilize bicarbonate solution 26
stored therein. Segers, 6:18—36, Fig. 2. Other embodiments also generate
pressurized CO2 in containers 32a, 32b, 32c where bicarbonate solution is
stored, to stabilize the solutions. Id. at 3:33—68, 6:47—51, 7:14—65, 7:66—8:9,
Figs. 3—5. Each embodiment generates pressurized CO2 gas to stabilize a
bicarbonate solution and inhibit the loss of CO2 gas from the bicarbonate
solution so the solution retains a desired pH value and medical efficacy. Id.
at 3:55-59, 4:1-7, 6:18-36 and 47-51.
Segers also seals a bicarbonate solution under “high” carbon dioxide
pressures without using a separate device to generate pressurized C02 gas.
Segers, 8:23—28; Reply Br. 3. Segers teaches that other means can be used
to generate C02 gas at the high pressures needed to stabilize a bicarbonate
solution and maintain a desired pH. Segers, 8:32—39; see Final Act. 3.
We agree with the Examiner that these teachings would have
motivated a skilled artisan to use Skinkle’s device to store a bicarbonate
solution under pressure. Skinkle teaches a device that retains a fluid under
pressure with a spring. Skinkle 127. Skinkle teaches that pressure created
in the fluid in the infusion pump is proportional to the force generated by
spring 60. Id. 1 56; see Ans. 6—7. Skinkle’s device would apply high
pressures to a bicarbonate solution and any CO2 gas contained therein.
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Appeal 2015-007870
Application 13/428,283
Segers’s teaching to store a bicarbonate solution under pressure to
preserve its stability by inhibiting the loss of CO2 gas from the solution
would have motivated a skilled artisan to store the solution in Skinkle’s
device as an alternate means of applying pressure to the fluid, as Skinkle
teaches. Ans. 6. Like Segers, Skinkle teaches to adjust the pressure applied
to the fluid to a desired level. Skinkle 57—60; see Spec. 13, 23.
Thus, we sustain the rejection of claims 1,3, and 5—15.
Claim 2
Claim 2 depends from claim 1 and recites that the buffer comprises a
sodium bicarbonate with a pH in the range from 7.5 to 7.8, and that the
applied pressure is greater than 1.2 atm. The Examiner determined that
because the general conditions were known in the art, it would have been
obvious to discover optimum or workable ranges for storing a solution with
a desired pH at a pressure sufficient to ensure a stable product, where
Skinkle already teaches the claimed pressure. Final Act. 3; Ans. 8—9.
Appellants repeat their arguments that Segers does not teach a partial
pressure of the C02 that inhibits the evolution of carbon dioxide gas during
storage or the application of pressure by mechanical means. Appeal Br. 7—8.
These arguments are not persuasive for the same reasons as were noted with
respect to the rejection of claim 1, and also do not address the Examiner’s
determination of obviousness for claim 2, as set forth above. Therefore,
Appellants’ arguments do not apprise us of error. Moreover, Skinkle and
Segers both teach that the level of pressure applied to a fluid can be varied,
as desired, by increasing the pressure of the CO2 gas in Segers, or by
increasing the force of spring 60 in Skinkle. Segers 4:60—68, 5:63—68, 8:23—
39; Skinkle 1 59. Thus, we sustain the rejection of claim 2.
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Appeal 2015-007870
Application 13/428,283
DECISION
We affirm the rejection of claims 1—3 and 5—15.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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