Ex Parte MORALES

Patent Trials and Appeals Board

Feb 26, 2019

14453493 - (D) (P.T.A.B. Feb. 26, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/453,493 08/06/2014
77218 7590 02/28/2019
Medtronic Vascular - APV Division
c/o IP Legal Department
3576 Unocal Place
Santa Rosa, CA 95403
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
CARLOS R. MORALES
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.
355844US02/1216-025US01 6241
EXAMINER
SPAMER, DONALD R
ART UNIT PAPER NUMBER
1799
NOTIFICATION DATE DELIVERY MODE
02/28/2019 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):
rs. docketingapv@medtronic.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE
THE PATENT TRIAL AND APPEAL BOARD
Exparte CARLOS R. MORALES 1
Appeal2018-000442
Application 14/453,493
Technology Center 1700
Before MARK NAGUMO, GEORGIANNA W. BRADEN, and
WESLEY B. DERRICK, Administrative Patent Judges.
NAGUMO, Administrative Patent Judge.
DECISION ON APPEAL
Medtronic ("Morales") timely appeals under 35 U.S.C. § 134(a) from
the Final Rejection2 of claims 1-14.3 We have jurisdiction. 35 U.S.C. § 6.
We affirm.
1 The applicant under 3 7 C.F .R. § 1.46, and hence the appellant under
35 U.S.C. § 134, is the real party in interest, identified as Medtronic plc
("Medtronic"), the ultimate parent entity of Covidien LP, the assignee of
record. (Appeal Brief, filed 8 May 2017 ("Br."), 3.)
2 Office Action mailed 4 November 2016 ("Final Rejection"; cited as
"FR").
3 Remaining co-pending claims 15-20 have been withdrawn from
consideration by the Examiner (FR 1, § 5a), and are not before us.
Appeal2018-000442
Application 14/453,493
A. Introduction4
OPINION
The subject matter on appeal relates to methods of sterilizing
cyanoacrylate compositions using microwave irradiation.
According to the '493 Specification, "[ c ]yanoacrylate esters
compositions are well known for their fast and strong bonding properties.
They have been used in ... the medical and veterinary fields for wound
management, tissue/organ repair, embolization and treatment of venous
malformations, and venous reflux disease." (Spec. 1 [0002].) The
Specification reveals that for use in the medical and veterinary fields, "the
bacterial bioburden count or sterility assurance level [ should] not exceed, for
example, 10-6." (Id. at 7 [0014].) For these uses, a number of additives are
commonly added. (Id.) Such additives are said to include thickeners (to
raise the viscosity of the liquid cyanoacrylates) (id. at [0015]), plasticizers
(to lessen the brittleness of cured compositions based on lower homologues)
(id. at 8 [0016]), radiopaque agents and dyes (id.), and anionic- and radical-
polymerization inhibitors (id. at [0017]). These additives may be thermally
labile (id. at [0015]), and thus care must be taken not to degrade them in the
sterilizing process. In the words of the Specification, however, "[ c ]urrently,
the methods of sterilizing cyanoacrylate compositions contribute to
degradation of the additives and reduce the shelf life stability of
4 Application 14/453,493, Microwave sterilization of pharmaceutical
cyanoacrylate esters compositions, filed 6 August 2014, claiming the benefit
of 61/862,901, filed 6 August 2013. We refer to the "'493 Specification,"
which we cite as "Spec."
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Application 14/453,493
cyanoacrylate compositions." (Id.) Current methods are said to include
gamma ray- and electron-beam irradiation, visible light pulses, and dry heat
sterilization. (Id. at [0018].)
Morales seeks patent protection for processes of sterilizing
cyanoacrylate compositions by using microwave radiation, which is said to
"shorten[] the sterilization times dramatically, minimizing potential
damaging effects that may be caused by long conventional dry heat cycles
and ionizing sterilizers." (Id. at 9 [0019].)
Claim 1 is representative and reads:
A method of sterilizing cyanoacrylate, the method
compnsmg:
moving a first container comprising a first cyanoacrylate
composition along a first pathway into a microwave chamber;
exposing the first cyanoacrylate composition within the
microwave chamber to microwave energy with
a power of between about O .1 kW to about 12 kW and
at a temperature of less than about 190° C
for no more than about 30 seconds,
such that a Bacillus subtilis count in the composition
does not exceed 10-6; and
moving the first container along a second pathway out of
the microwave chamber.
(Claims App., Br. 22; some formatting, and emphasis added.)
Claim 2 is particularly relevant to the question of the scope of the
claims, and reads:
The method of claim 1, wherein moving the first container
along the second pathway out of the microwave chamber
compnses
moving the first container into an oven, and wherein the
method further comprises:
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Application 14/453,493
post-heating the composition in the oven for
about 1 second to about 30 seconds; and
substantially immediately after post-heating the
composition, cooling the composition.
(Id., certain formatting and emphasis added)
The Examiner maintains the following grounds of rejection: 5, 6
A. Claims 1-8, 10, 11, and 13 stand rejected under 35 U.S.C.
§ 103(a) in view of the combined teachings of Sasaki7 and
Hickey. 8
Al. Claims 5-7, 9, and 12 stand rejected under 35 U.S.C.
§ 103(a) in view of the combined teachings of Sasaki,
Hickey, and Rutala. 9
A2. Claim 14 stands rejected under 35 U.S.C. § 103(a) in view of
the combined teachings of Sasaki, Hickey, and Iijima. 10
5 Examiner's Answer mailed 13 September 2016 ("Ans.").
6 Because this application was filed before the 16 March 2013, effective
date of the America Invents Act, we refer to the pre-AIA version of the
statute.
7 Koichi Sasaki et al., Validation of a microwave sterilizer for injection
ampules, 53 PDA J. Pharm. Sci. and Tech., 60-69 (1999) ["PDA":
Parenteral Drug Association].
8 Timothy Hickey and Ubonwan A. Stewart, Sterilized cyanoacrylate
solutions containing thickeners, U.S. Patent No. 6,310,166 B 1 (2001 ).
9 William A. Rutala et al., Guidelines for Disinfection and Sterilization in
Healthcare Facilities, 2008 (Healthcare Infection Control Practices
Advisory Committee (HICP AC).
1° Kenichi Iijima, Method and apparatus for sterilizing sealed containers
utilizing microwave, U.S. Patent No. 5,132,594 (1992).
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Application 14/453,493
B. Discussion
The Board's findings of fact throughout this Opinion are supported by
a preponderance of the evidence of record.
Morales urges that the Examiner erred harmfully by failing to show
that the combined teachings of Sasaki and Hickey disclose the claimed
subject matter of claim 1, and further, the Examiner failed to demonstrate
any reason to modify those teachings to arrive at that subject matter. (Br. 4,
11. 16-20.) More particularly, Morales argues that Sasaki teaches that the
required sterilization level (10-6) are obtained, not at the end of the
microwave exposure, but only after additional heat treatment with external
heaters. (Id. at 5, 11. 13-16.) Furthermore, Morales urges, Sasaki teaches
microwave sterilization of two particular drugs, not cyanoacrylates, and the
Examiner has failed to establish an equivalence between those drugs and
cyanoacrylates that would have suggested that sterilizing cyanoacrylate
compositions would have been a predictable result. (Id. at 7, 1. 11-9, 1. 18.)
The Examiner's conclusion (Adv. 11 2, 2d para., last sentence) that those
teachings would have led the routineer to adapt microwave sterilization to
any thermally labile drug products, Morales argues, is flawed for the
Examiner same reasons. (Br. 7-9.) The two sets of compounds are, in
Morales's view, "structurally unrelated." (Id. at 9, 1. 24). "In addition,"
Morales adds, "Sasaki does not describe or suggest that its sterilization
parameters for mecobalamin or diprophylline provide guidance for
sterilization of dissimilar chemical compounds, for example, cyanoacrylate
compositions." (Id. at 11. 16-18.) In light of the chemical and structural
11 Advisory Action entered 20 January 2017 ("Adv.").
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Application 14/453,493
differences, Morales urges, "[ m ]icrowave parameters that may be effective
for sterilization of a first composition may or may not be effective for
sterilization of a second composition, depending on the respective physical,
chemical, and biological properties of the compositions." (Id. at 10, 11. 13-
16.) Finally, Morales argues that the optimization of the three parameters
(microwave energy, duration, and temperature) would have been too
unpredictable to provide a reasonable expectation of success. (Id. at 15.)
Morales's arguments are not persuasive of harmful error in the
appealed rejections. As the Examiner recognizes (e.g., FR 5, 1st full para.;
Ans. 6, 2d and 3d paras.), Sasaki teaches that sterilization by way of
exposure to microwave radiation occurs due to heating. (Sasaki 60, col. 1,
2d para., "microwave sterilization has the advantage that it takes only short
periods of time to heat objects for the purpose of sterilization"; id.,
paragraph bridging cols. 1-2, penultimate sentence, "[ w ]e have shown in
these studies that during microwave sterilization, objects exposed to
microwaves generate heat which kills microorganisms in the objects"
( emphasis added).) For that reason, Sasaki explains, "the basic principle of
validation of microwave sterilization should be similar to that of validation
of high-pressure steam sterilization, which sterilizes objects by the same
mechanism." (Id., last sentence ( emphasis added.)) Sasaki reports, inter
alia, that injectable solutions of mecobalamin 12 were dosed with spores of
Bacillus subtilis. (Id. at 66.) According to Sasaki, based on extensive
testing (id. at 62---65, 68) with a 5 kW microwave sterilizer (id. at 61, ,r 2),
about 30 seconds were required to elevate the temperature of the drug
12 Mecobalamin is a water soluble form of vitamin B 12.
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Application 14/453,493
solution to the "predesignated level" (id.), and that "[ s ]terilization is assured
with the 12-seconds period while the ampule is passing through the
sterilization temperature maintaining zone" (id. at ,r 11.) The sterilization
temperature maintaining zone with external heaters was found to be
necessary because "[t]he sterilizing temperature is difficult to maintain with
microwaves." (Id. at 64, col. 1, 2d para.) In the words of Sasaki,
"[i]rrespective of the method used for sterilization, it is required that sterility
is assured at the level of 10-6 by terminal sterilization." (Id. at 62, col. 2, 4th
full para.)
Hickey discloses that cyanoacrylate compositions further comprising
thickeners, which are used as adhesives of choice for biological tissues
(Hickey, col. 1, 11. 19--22), may be "steriliz[ ed] by heat ( dry or moist) ...
and [by] microwave irradiation" (id. at col. 5, 11. 41--44). According to
Hickey, a suitable temperature for sterilizing cyanoacrylate compositions is
"typically at least I60°C." (Id. at col. 5, 11. 28-29.)
Given the teaching by Sasaki that microwave irradiation kills bacterial
spores due to the heat generated in the materials exposed to the microwaves,
and the teaching by Hickey that cyanoacrylate ester compositions suitable
for treating biological tissues can be sterilized by heat or by irradiation with
microwaves, and the cautions by both against undesirable side-reactions, we
are persuaded that, as the Examiner determined (FR 5, 1st and 2d paras.), the
ordinary worker would have been adequately guided to optimize the
procedures taught by Sasaki for cyanoacrylate ester compositions. 13
13 Users of microwave ovens for home cooking are familiar with instructions
that the cooking time depends on the power of the microwave oven.
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Application 14/453,493
Morales's focus on the differences in chemical structure between
mecobalamin and cyanoacrylate esters is not well-taken. The injectable
solutions tested by Sasaki are not the pure drugs. The primary ingredient in
the injectable solutions is the polar solvent-most likely water, in the case of
mecobalamin. In any event, the cyanoacrylates are relatively small, polar
molecules that persons having ordinary skill in the art would have expected
to get hot similarly to water or other small polar molecules in response to
exposure to microwaves. The known approximate sterilization temperature
for a standard bacteria such as B. subtilis, and the ordinary power (5 kW) of
the sterilizer would have provided a reasonable expectation that similar
times would be required to achieve similar temperatures at that irradiation
power. The alleged complexities arising from the "three-parameter
optimization" asserted by Morales to result in no reasonable expectation of
success, are not supported by a preponderance of the evidence of record.
Similarly, Morales's arguments about the necessity of an external
heater oven in Sasaki's sterilization apparatus are not persuasive of harmful
error. Sasaki teaches that it is necessary to maintain the temperature at a
certain "predetermined value" for a 12-second period. In a "boundaries" -
based claiming system, as long as all of the conditions recited in the claim
are met, the claim is met. If Morales wanted to require that only the
microwave irradiation, as a source of heat, was sufficient to produce the
sterilization, then a more limiting transitional phrase than "comprising"
A person having ordinary skill the arts of sterilization, seeking to apply
similar technology to sterilize compositions for medical uses, would have
been expected to be well aware of the necessity to vary conditions to
optimize heating times for different samples.
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Application 14/453,493
would be required, or, perhaps, further express language excluding the
presence of other heating elements. No such further limitations are present
in the appealed claims. Moreover, the claims at issue are not patented
claims, and thus they must be read as broadly as permitted by the plain
language of the claims, consistent with the supporting disclosure. In re
ICON Health & Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007) (during
prosecution of patent applications, "the PTO must give claims their broadest
reasonable construction consistent with the specification.") The broad
reading in which the overall transitional phrase "comprising" permits
additional heating elements that perform sterilization to bring the
composition to 10-6 in B. subtilis is also supported by dependent claim 2,
which specifies further heating in another oven, and which does not exclude
a bacteriocidal function at any level. In this regard, Morales has not directed
our attention to any disclosure in the Specification that so limits the function
of the post-heating step.
Still further in this regard, Sasaki's teaching that a certain temperature
must be achieved for a certain period of time in order to kill B. subtilis in
samples might call into question the scope of enablement of claim 1, as
interpreted by Morales. For example, claim 1 permits microwave powers as
low as 0.1 kW-a factor of 50 less than the 5 kW microwave used by
Sasaki-but permits microwave irradiation times of no more
than 30 seconds. Morales, however, has not directed our attention to
evidence of record that irradiation by microwaves having a power of O .1 kW
for less than 30 seconds would raise the temperature of a cyanoacrylate
composition to a level sufficient to provide a B. subtilis count of 10-6• We
emphasize that we do not make or imply any judgments on these matters.
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Application 14/453,493
These issues have not been fleshed out with evidence in discussions on the
record between the Examiner and Morales. But such speculations illustrate
the absence of harmful error on the present record in the Examiner's
rejection of claim 1.
Morales's nominally separate arguments regarding claims 4--7, 10, 11,
and 13 (Br. 16-17), and regarding claim 8 (id. at 17-18), are substantially
cumulative with the arguments regarding claims 1-3, and we find them
unpersuasive for the same reasons. Similarly, we find insufficient merits in
Morales's arguments against Rejections Al and A2, as those arguments are
directed to the alleged failure of the additional references to cure the defects
of Sasaki and Hickey.
C. Order
It is ORDERED that the rejection of claims 1-14 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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