Ex Parte Wu et al

Patent Trial and Appeal Board

Jan 27, 2017

11855437 (P.T.A.B. Jan. 27, 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.
11/855,437 09/14/2007 Shang-Ren Wu 4684-073347 (P-6975) 6857
32182 7590 01/31/2017
David W. Highet, VP & Chief IP Counsel
Becton, Dickinson and Company
(The Webb Firm)
1 Becton Drive, MC 110
Franklin Lakes, NJ 07414-1880
EXAMINER
YAGER, JAMES C
ART UNIT PAPER NUMBER
1782
NOTIFICATION DATE DELIVERY MODE
01/31/2017 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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
lorraine_kow alchuk @ bd .com
ip_docket @bd.com
patents @ webblaw. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SHANG-REN WU,
ANGEL ALVAREZ, and STEPHEN SIMMONS, JR.
Appeal 2016-000019
Application 11/855,437
Technology Center 1700
Before KAREN M. HASTINGS, GEORGE C. BEST, and
N. WHITNEY WILSON, Administrative Patent Judges.
HASTINGS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants1 appeal the Examiner’s
decision finally rejecting claims 1—4, 6—9, 11, 12, 14—19, 21—24, and 26—29
under 35 U.S.C. § 103(a). We have jurisdiction over the appeal under 35
U.S.C. § 6(b).
We AFFIRM.
1 The real party in interest is stated to be Becton, Dickinson & Co. (Appeal
Br. 1).
Appeal 2016-000019
Application 11/855,437
Claims 1 and 14 are illustrative of the appealed subject matter
(paragraphing and emphasis added to highlight key disputed limitations)
1. A chamber for a medical article,
the chamber having an inner surface adapted to sealingly
engage an outer surface of a sealing member for a medical article,
wherein the inner surface of the chamber has a coating
thereon prepared from a composition comprising an
organopolysiloxane, the organopolysiloxane having a viscosity
of about 100 to about 100,000 centistokes, the coating being
adhered to the inner surface by crosslinking induced by
(1) oxidative treatment for a time period of about 1 second
to about 10 minutes; and subsequent
(2) irradiation of about 5 to about 50 kilo Greys with an
isotope or electron beam,
wherein the chamber is prepared from cyclic polyolefin.
14. A sealing member for a medical article,
the sealing member having an exterior surface in sliding
engagement with an interior surface of a chamber of a medical
article and adapted to sealingly engage the interior surface of the
chamber,
wherein the exterior surface of the sealing member has a
coating thereon prepared from a composition comprising an
organopolysiloxane, the organopolysiloxane having a viscosity
of about 1,000 to about 500,000 centistokes, the coating being
adhered to the exterior surface by crosslinking induced by
(1) oxidative treatment for a time period of about 1 second
to about 10 minutes; and subsequently
(2) irradiation of about 5 to about 50 kilo Greys with an
isotope or electron beam,
wherein the chamber is prepared from cyclic polyolefin.
(Appeal Br. 37, 39; Claims App.).
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Application 11/855,437
The Examiner maintains the following rejections:
(a) claims 14—19, 21, 22, 24, and 28 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Lubrecht (US 6,746,430 B2, issued June 8,
2004) (hereinafter “Lubrecht”) in view of Williams et al. (US 4,767,414,
issued Aug. 30, 1988) (hereinafter “Williams”);
(b) claim 29 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Lubrecht in view of Williams, and further in view of Reinhard et al. (US
6,065,270, issued May 23, 2000) (hereinafter “Reinhard”); and
(c) claims 1—4, 6—9, 11, 12, 23, 26, and 27 are rejected under 35
U.S.C. § 103(a) as unpatentable over Lubrecht in view of Berg (WO
2004/064901 A2, published Aug. 5, 2004) (hereinafter “Berg”), and further
in view of Williams and Reinhard.
Appellants’ arguments urging reversal of the obviousness rejections of
claims 2—4, 6—9, 11, 12, 15—19, 21—24, 26, and 28 focus on limitations
common to independent claims 1 and 14 (Appeal Br. 14, 20). Thus, in the
absence of specific arguments for their patentability, dependent claims 2—4,
6—9, 11, 12, 23, and 26 stand or fall with claim 1; and dependent claims 15—
19, 21, 22, 24, and 28 stand or fall with claim 14. 37 C.L.R.
§ 41.37(c)(l)(iv).
ANALYSIS
Upon consideration of the evidence on this record and each of
Appellants’ contentions, we find that the preponderance of evidence
supports the Examiner’s conclusion that independent claims 1 and 14; all of
their respective dependent claims; and independent claims 27 and 29, are
unpatentable over the applied prior art and that Appellants have failed to
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Application 11/855,437
show that the Examiner erred reversibly. We sustain the Examiner’s § 103
rejections, listed in (a)-(c) above, of all the appealed claims for essentially
the reasons set out by the Examiner in the Answer.
We add the following primarily for emphasis.
Rejections (a) and (b)
Appellants’ main argument is that “one of ordinary skill in the art
would have no motivation, reason, or suggestion to treat the sealing member
of Lubrecht with ionizing plasma as disclosed by Williams” (Appeal Br. 13).
Appellants argue that because Lubrecht teaches that radiation treatment
provides crosslinking between silicone molecules and a syringe stopper, the
ordinary skilled artisan would infer that Williams’ “subsequent ionizing [i.e.,
oxidation] treatment would not be effective to induce appreciable further
crosslinking” {id. at 13 (citing Lubrecht 3:9-12; 1:66—2:4)). According to
Appellants, “it would be counterintuitive to duplicate [Lubrecht’s]
crosslinking effect and adherence to the sealing member already achieved by
[Williams’] first process” (Reply Br. 3).
Appellants’ arguments are not persuasive because they do not fully
address the inferences of the references that are presented on this record for
our review. As set forth in the Answer, the Examiner supports the prima
facie case of obviousness based on the combined teachings of Lubrecht and
Williams, either with or without Reinhard (Ans. 3—11; 16—19). Appellants’
arguments, however, fail to consider this prior art as a whole, and do not
directly address the Examiner’s position (e.g., id.). See, e.g., In re Preda,
401 F.2d 825, 826 (CCPA 1968) (it is well established that in evaluating
references it is proper to take into account not only the specific teachings of
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Application 11/855,437
the references but also the inferences which one skilled in the art would
reasonably be expected to draw therefrom).
Appellants have not sufficiently refuted and, thus, have not shown
reversible error in the Examiner’s determination that it would have been
prima facie obvious to combine the known method of crosslinking
lubricating silicone on a sealing member’s exterior surface by irradiation, as
suggested by Lubrecht, after initially crosslinking the same substance onto
the same surface using an oxidative plasma treatment, as suggested by
Williams, to enhance lubricant stability and its resistance to migration (e.g.,
Ans. 17).
Appellants have also not provided persuasive technical reasons or
evidence that demonstrate reversible error in the Examiner’s determination
that it would have been prima facie obvious to combine Lubrecht’s and
Williams’ teachings (e.g., id. at 3—11; 16—19), to achieve, with the use of no
more than ordinary creativity, the known desirable results of increased
lubricant stability and migration resistance, while reducing the known
problem of sudden separation of stationary surfaces in contact (see generally
id.; Appeal Br.; Reply Br.). See KSR Int 7 Co. v. Teleflex Inc., 550 U.S. 398,
421 (2007) (“A person of ordinary skill is also a person of ordinary
creativity, not an automaton.”). Therefore, Appellants’ arguments that it
would be counterintuitive to duplicate Lubrecht’s crosslinking effect and
adherence to the sealing member already achieved by Williams are
unpersuasive. The record evidence provides that it was known to the
ordinary skilled artisan that crosslinking silicone lubricant to sealing
member surfaces may be induced by irradiation and oxidative plasma
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Application 11/855,437
treatment, and that such plasma treatment would enhance lubricant stability
and migration resistance (see Final Act. 4; Ans. 3).
Appellants argue that the Examiner’s position is erroneous because
“there is no guidance to suggest whether one would subject the object to
irradiation first, or plasma first” (Appeal Br. 14). Appellants further argue
that the ordinary skilled artisan “could apply a plasma treatment after
radiation; however, the resulting product would need to be sterilized
subsequently, adding another processing step; and increased cost” (id.).
Thus, Appellants conclude that the applied prior art “provide[s] no guidance
to subject the sealing member to oxidative treatment first, then subsequently
to irradiation” (id.).
It is, however, well established that when claimed and prior art
products are produced by identical or substantially identical processes, the
PTO can require an applicant to prove that the prior art products do not
necessarily or inherently possess the characteristics of his claimed product.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977). This is true whether the
rejection is under 35 U.S.C. § 102 (anticipation) or 35 U.S.C. § 103
(obviousness), and is based on the fact that the PTO is not in a position to
manufacture products or to obtain and compare prior art products. Id.
Appellants’ arguments are not persuasive because the Examiner has
explained why both Lubrecht’s process of irradiating a lubricated sealing
member with cobalt radiation at a target dose of 2.5 to 4.0 Mrads and
Williams’ method of treating a syringe coated with polydialkylsiloxane with
ionizing plasma is substantially similar to the process described in
Appellants’ claims (Ans. 4—5 (citing Lubrecht || 3:3—10; Williams 2:34—65;
4:20-36)). Placing the burden on Appellants is appropriate under these
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circumstances. See Best, 562 F.2d at 1255. Appellants have not met this
burden for the reasons set forth in the Examiner’s Answer.
Appellants filed four Rule 132 Declarations of named inventor Dr.
Shang-Ren Wu to rebut the Examiner’s prima facie case of obviousness.
Appellants filed the First Declaration to “demonstrate the criticality of
treating syringes or stoppers for medical articles with oxidative treatment
followed by irradiation” (Appeal Br. 21). Appellants filed the Second
Declaration and Third Declaration to provide additional evidence of
nonobviousness and to refute the Examiner’s findings that data submitted to
demonstrate criticality of the claimed invention did not support the scope of
the claims (id. at 24, 26). Appellants filed the Fourth Declaration to refute
the Examiner’s position that the results of Dr. Wu’s experiments do not
prove that irradiation crosslinks siloxane to the sealing member (id. at 30).
Appellants’ assertion that the four Declarations of Dr. Wu and the test
data disclosed in the originally filed application provide both:
(i) unexpected results demonstrating the criticality of using irradiation after
oxidative plasma treatment (e.g., Appeal Br. 26, 28; Reply Br. 5), and
(ii) sufficient evidence to rebut the Examiner’s prima facie case of
obviousness (e.g., id. at21, 35), is unpersuasive.
It is well settled that the burden of establishing unexpected results
rests on the party asserting them. In re Klosak, 455 F.2d 1077, 1080 (CCPA
1972). In this instance, Appellants have not provided the required side-by-
side comparison of the claimed invention with the closest prior art which is
commensurate in scope with the claims, and explained why the results
would have been unexpected by one of ordinary skill in the art. See In re
Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991); In re De Blauwe,
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Application 11/855,437
736 F.2d 699, 705 (Fed. Cir. 1984); In re Grasselli, 713 F.2d 731, 743 (Fed.
Cir. 1983). As the Examiner notes, Dr. Wu’s submitted data is not
commensurate in scope with the scope of the claims:
No data is provided for organopolysiloxane having any
viscosity other than 12.5k cst (barrel) and 100k cst (stopper),
while claims 1 and 14 broadly recite a viscosity of about 100 to
about 100,000 cst for the barrel and about 1,000 to about
500,000 cst for the stopper.
No data is provided for any amount of plasma treatment other
than 3—10 seconds, while claims 1 and 14 broadly [recite] 1
second to 10 minutes.
No data is provided for any type of oxidative treatment other
than Ar plasma, He: Ar, AnCE, He:02 and He: Ar, while claims
1 and 14 broadly recite any type of oxidative treatment.
No data is provided for any type of plasma treatment other than
Ar plasma, He:Ar, Ar: O2, He:02 and He:Ar, while claim 21
broadly recites any type of plasma treatment.
Additionally, it is noted that for some of the data, for example
the viscosity of the organopolysiloxane on the barrel and on the
stopper, only one data point is provided (12.5k cst (barrel) and
100k cst (stopper)).
(Ans. 36—37).
Appellants argue that: (i) “the Third Declaration of Dr. Wu clearly
explains why one of ordinary skill in the art would be able to determine the
trend in the submitted data to support the assertion of unexpected results”
(Reply Br. 8) and (ii) the Examiner objects to Dr. Wu’s evidence without
providing evidence to the contrary (Appeal Br. 35).
Appellants’ arguments, however, are not convincing. As the
Examiner found, Dr. Wu’s explanation “is merely a conclusory statement
and no evidence (i.e. data) is provided to support this assertion” (Ans. 24).
Furthermore, the ordinary skilled artisan would not be able to reasonably
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discern a trend from data that provides a single data point for viscosity of the
organopolysiloxane on the barrel and on the stopper. Appellants’ second
assertion, moreover, impermissibly places a burden on the Examiner to
prove that the prior art products necessarily or inherently possess the
characteristics of Appellants’ claimed product. See Best, 562 F.2d at 1255.
Appellants, thus, have not shown reversible error in the Examiner’s
finding that the experimental data set forth in the Specification (see, e.g.,
Ans. 23) and the four Rule 132 Declarations of Dr. Wu are not
commensurate in scope with the scope of the claims (see, id. at 21—32; 36—
37). For these reasons, Appellants have not adequately demonstrated
criticality regarding the order of steps. Therefore, Appellants’ evidence is
not persuasive evidence of the nonobviousness of independent claims 14 and
29.
Thus, we affirm the rejections of claims 14—19, 21, 22, 24, 28, and 29.
Rejection (c)
The Examiner determines that it would have been obvious to apply
silicone lubricant to Berg’s chamber surface constructed of Reinhard’s
cyclic polyolefin, then subject it to Williams’ oxidative treatment, followed
by treatment with Lubrecht’s irradiation, in order to induce crosslinking
within the chamber surface (Ans. 12—16). The Examiner further determines
that one of ordinary skill in the art would have found it obvious to apply
such oxidative treatment, followed by irradiation, to prevent migration of the
lubricant into the medicament (id. at 14).
Appellants’ main argument is that Lubrecht teaches away from the
present invention because “Lubrecht specifically states that the
‘prelubrication of the plastic material during the plastic compounding
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procedure effectively eliminates the possibility for the lubricant to become
deposited in the medicament’” (Reply Br. 4 (citing Lubrecht 3:27—33
(emphasis added); see also Appeal Br. 19—20). Appellants further argue that
“because the prelubricated plastic material effectively eliminates migration
of the lubricant into the medicament as well as the need to apply additional
lubricant to the inside of the chamber, Lubrecht teaches away from post­
treatment of the chamber” (Reply Br. 4).
Whether a reference teaches away from a claimed invention is a
question of fact. In re Harris, 409 F.3d 1339, 1341 (Fed. Cir. 2005). For a
reference to “teach away,” it must criticize, discredit, or otherwise
discourage the claimed solution. See In re Fulton, 391 F.3d 1195, 1201
(Fed. Cir. 2004).
Appellants’ arguments are not persuasive because they fail to identify
any teaching in the applied prior art that criticizes, discredits, or discourages
oxidative treatment, followed by irradiation treatment, of a chamber’s
silicone lubricated inner surface as claimed. Therefore, we are not
persuaded by Appellants’ arguments that Lubrecht teaches away from
independent claims 1 and 27.2
2 We note that Appellants’ claims are directed to an apparatus defined by
processing steps. In other words, the instant claims are written in a product-
by-process format. In such circumstances, we gauge “the patentability of the
products defined by the claims, rather than the processes for making them,
. . . in light of the prior art.” In re Wertheim, 541 F.2d 257, 271 (CCPA
1976); see also In re Thorpe, 111 F.2d 695, 697 (Fed. Cir. 1985) (“[E]ven
though product-by-process claims are limited by and defined by the process,
determination of patentability is based on the product itself’). As the
Examiner finds, the chamber and/or sealing member surfaces disclosed in
the applied prior art of Lubrecht, Williams and Berg each adhere silicone
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Furthermore, for the reasons set forth above, Appellants have not
shown reversible error in the Examiner’s finding that the experimental data
set forth in the Specification (see, e.g., Ans. 23) and the four Rule 132
Declarations of Dr. Wu are not commensurate in scope with the scope of the
claims (see, id. at 21—32; 36—37). In other words, Appellants have not
sufficiently demonstrated the criticality of the order of steps. Therefore,
Appellants have not submitted persuasive evidence of the nonobviousness of
independent claims 1 and 27.
We, therefore, affirm the rejection of claims 1—4, 6—9, 11, 12, 23, 26,
and 27.
DECISION
The Examiner’s § 103 rejections are affirmed.
lubricant (see generally Ans. 3—16). Appellants do not contest these
findings (see, e.g., Appeal Br. 13; Reply Br. 3, 12, 16). Indeed, Williams
discloses that, in a preferred embodiment, “the [silicone] lubricant is . . .
applied to the surfaces of a syringe barrel and associated syringe stopper
prior to the plasma treatment” (Williams 2:47—50 (emphasis added)). In the
absence of persuasive evidence or arguments that Williams’ apparatus could
not adhere silicone lubricant without modification, the teachings of Lubrecht
and Berg are cumulative. See, e.g., Wertheim, 541 F.2d at 271; see
also Thorpe, 111 F.2d at 697. Appellants have not identified any structural
differences in the claimed sealing member or chamber compared to
Williams’ sealing member and chamber. Rather, they have merely argued
that the combined teachings of the applied prior art do not teach the claimed
processing steps.
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TIME PERIOD
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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