Ex Parte Scalzo et al

Patent Trial and Appeal Board

Aug 4, 2016

13449184 (P.T.A.B. Aug. 4, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/449, 184 04/17/2012
25570 7590 08/08/2016
Roberts Mlotkowski Safran Cole & Calderon, P,C,
7918 Jones Branch Drive
Suite 500
McLean, VA 22102
Howard Scalzo
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.
400055-20010 9623
EXAMINER
HARMON, CHRISTOPHER R
ART UNIT PAPER NUMBER
3649
NOTIFICATION DATE DELIVERY MODE
08/08/2016 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):
lgallaugher@rmsc2.com
docketing@rmsc2.com
dbeltran@rmsc2.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HOWARD SCALZO,
JEROME A. FISCHER, STEPHEN ROTHENBURGER,
ROBERT CERWIN, and JAMES R. McDIVITT
Appeal2014-004710
Application 13/449, 184
Technology Center 3600
Before JAMES P. CAL VE, GEORGE R. HOSKINS,
and FREDERICK C. LANEY, Administrative Patent Judges.
CAL VE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from the final rejection of
claims 1-9. We have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
Appeal2014-004710
Application 13/449,184
CLAIMED SUBJECT MATTER
Claims 1 and 5 are independent. Claim 1 is reproduced below.
1. A method of making a packaged antimicrobial suture
comprising the steps of:
providing a containment compartment that is
substantially free of an antimicrobial agent;
positioning a suture within the containment compartment,
said suture comprising one or more surfaces having an
antimicrobial agent disposed thereon, said antimicrobial agent
being selected from the group consisting of halogenated
hydroxyl ethers, acyloxydiphenyl ethers, and combinations
thereof;
placing the containment compartment having the suture
in an outer package;
placing the outer package, the containment compartment
and the suture in a chamber; and
subjecting the outer package, the containment
compartment and the suture to time, temperature and pressure
conditions sufficient to vapor transfer an effective amount of
the antimicrobial agent from the suture to an inner surface of
the containment compartment, while retaining an effective
amount of said antimicrobial agent on the suture, thereby
substantially inhibiting bacterial colonization on the suture and
the containment compartment.
REJECTIONS
Claims 1, 2, and 5-8 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Kaplan (US 5,366,081, iss. Nov. 22, 1994) and Fan (EP
0761243 Al, pub. Mar. 12, 1997).
Claims 3, 4, and 9 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Kaplan, Fan, and Cerwin (US 6,021,625, iss. Feb. 8,
2000).
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Appeal2014-004710
Application 13/449,184
ANALYSIS
Claims 1, 2, and 5---8 as unpatentable over Kaplan and Fan
The Examiner found that Kaplan discloses the methods of claims 1
and 5, including impregnating the sutures with an antimicrobial agent, but
does not disclose that the antimicrobial agent is selected from the claimed
group of halogenated hydroxyl ethers, acyloxydiphenyl ethers, or other
combinations. Final Act. 2; Ans. 3. The Examiner found that Fan teaches
the use of such halogenated hydroxyl ethers or acyloxydiphenyl ethers for
medical device coatings. Final Act. 2; Ans. 3. The Examiner determined it
would have been obvious to coat the suture of Kaplan with the antimicrobial
agents of Fan to maintain sterility of the device. Final Act. 2; Ans. 3--4.
The Examiner found that Kaplan's disclosure of producing suture
packages for inventory and transporting the packages to dry climates and
humid ones while maintaining integrity and flexibility of the sutures taught
the claimed step of subjecting the package to time, temperature, and pressure
conditions, as claimed. Final Act. 3. The Examiner also found that Kaplan
discusses the migration of a hygroscopic polyhydroxy compound from the
surgical article to the packaging over time and this process and the inherent
chemical reactions in the package, especially areas in direct contact with the
suture would transfer agent, as claimed, especially where Fan discusses the
release rate of the antimicrobial agent over time. Id.; see Ans. 4--5, 6. The
Examiner reasoned that the temperatures to which a package is subjected
affect the internal pressure in the package and these temperature/pressure
ranges cause vapor transfer of an effective amount of agent. Ans. 6-7. The
Examiner also found that the moisture and agents in the package, sutures,
compartment walls and absorbing pad interact via vapor transfer. Id. at 7.
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Appeal2014-004710
Application 13/449,184
Appellants argue that Kaplan impregnates sutures with therapeutic
agents that have antimicrobial properties to be released into tissue at the
surgical site, rather than to internal surfaces of the suture packaging via
vapor transferred, as claimed. Appeal Br. 6-7. Appellants also argue that
Fan discloses triclosan as an antimicrobial agent (as Appellants disclose),
but neither Fan nor Kaplan discloses the vapor transfer of triclosan or any
other antimicrobial agent or coating. Id. at 7-8. Thus, Appellants argue that
a skilled artisan would have had no expectation of vapor transfer occurring if
the antimicrobial agents of Fan such as triclosan were combined with the
sutures and packaging of Kaplan. Id. Appellants also argue that the time,
pressure, and temperature conditions to which Kaplan's suture packages are
subjected during inventory and transportation do not occur in manufacture or
sterilization, as claimed, and do not result in vapor transfer of antimicrobial
agents from the sutures to the packaging, as recited in claim 1. Id. at 10-12.
Appellants further argue that Fan's teaching of migration of antimicrobials
from one location to another does not teach or suggest the vapor transfer of
those antimicrobials, as claimed. Id. at 12. Appellants also assert that the
Examiner has not shown that Kaplan's stabilizing agents are antimicrobials,
or that they vapor transfer from sutures to packages. Reply Br. 6.
The Examiner has not established by a preponderance of evidence that
the combined teachings of Kaplan and Fan render obvious the methods of
making packaged medical devices by subjecting the package and medical
device positioned therein to time, temperature, and pressure conditions that
are sufficient to vapor transfer an effective amount of antimicrobial agent
from the suture or medical device to the inner surface of the containment
compartment or package, as recited in independent claims 1 and 5.
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Appeal2014-004710
Application 13/449,184
The Examiner's finding that such vapor transfer takes place inherently
at temperatures and conditions recognized by the prior art is not supported
by a preponderance of evidence. See In re Robertson, 169 F.3d 743, 745
(Fed. Cir. 1999) ("Inherency ... may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from a given set
of circumstances is not sufficient.").
Kaplan's disclosure of water vapor transfer from and to sutures in a
package such that the moisture content of the sutures can vary in different
environments over time does not teach vapor transfer of antimicrobial agents
from the sutures to an inner surface of a package in which the sutures are
contained. Kaplan teaches that sutures shipped to a desert environment may
lose moisture through the seal line of the package while moisture may enter
the pouch in a very humid environment resulting in undesirable moisture
levels of the sutures. Kaplan, 16:21-26. Kaplan teaches the placement of a
packaging stabilizing element 58 in the pouch to maintain the moisture level
of sutures or surgical items at a desired level. Id. at 16:27-36. Kaplan thus
teaches that water vapor transfer may occur between packaged sutures and
the environment but such vapor transfer is undesirable and is controlled by
adding packaging stabilizing element 58 to a package. Id. at Figs. 14--16.
Kaplan also teaches that sutures can be maintained at higher moisture
levels without undergoing hydrolysis or other adverse degradation in storage
by filling the suture or other polymeric article with a stabilizing agent, e.g.,
by submerging articles in the agent, or by spraying, brushing, or wiping the
agent on surfaces of the sutures and polymeric articles. Id. at 14:25-15:29.
Kaplan uses stabilizing agents to allow sutures to be stored at high moisture
levels and avoid adverse drying out of sutures. See id. at 3 :52--4:40, 6: 1---6.
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Appeal2014-004710
Application 13/449,184
The Examiner has not explained how water vapor transfer teaches or
suggests vapor transfer of an antimicrobial agent, as claimed. Kaplan wants
to maintain the moisture level of packaged sutures and inhibit vapor transfer
of moisture from and to packaged sutures by adding a stabilizing agent to the
sutures and packaging the sutures with a package stabilizing agent 58.
Kaplan impregnates sutures with antimicrobial agents that then are
deposited at a suture site and slowly released into tissue to combat infection.
Id. at 17:5-32. This does not teach the vapor transfer of the antimicrobials.
Kaplan uses thickeners with the stabilizing agent to prevent migration
of the stabilizing agent from the sutures or polymeric article to surrounding
packaging. Id. at 12:67-13:32. Kaplan does not teach that migration of the
hygroscopic polyhydroxy compound from sutures to packaging occurs via
vapor transfer, or that this compound has antimicrobial properties. Kaplan
adds a thickener to the stabilizing agent to prevent migration of stabilizing
agent away from the polymeric sutures to the inner packaging. See Ans. 4.
Fan addresses the problem of infections resulting from catheter use.
Fan, 2:10-19. Fan teaches biostatic coatings on catheters and other medical
devices to control infections. Id. at 2:41--49. The coatings are hydrophilic
and include antimicrobial agents such as halogenated 2-hydroxy diphenyl
ether and halogenated 2-acyloxy-diphenyl ether that appear to correspond to
the claimed antimicrobial halogenated hydroxyl ethers and acyloxydiphenyl
ethers. However, the Examiner has not established that Fan teaches vapor
transfer of these antimicrobial agents from a medical device to a package.
Instead, the release of these antimicrobial agents occurs at an implant site to
prevent infections in surrounding tissue. See id. at 5: 15-30.
Accordingly, we do not sustain the rejection of claims 1, 2, and 5-8.
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Appeal2014-004710
Application 13/449,184
Claims 3, 4, and 9 as unpatentable over Kaplan, Fan, and Cerwin
The Examiner relied on Cerwin to teach the sterilization process of
claims 3, 4, and 9, and not to overcome the deficiencies of Kaplan and Fan
regarding the vapor transfer of antimicrobial agents discussed above. Final
Act. 4; Ans. 5; see Appeal Br. 13. Thus, we do not sustain the rejection of
claims 3, 4, and 9.
DECISION
We REVERSE the rejections of claims 1-9.
REVERSED
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