Ex Parte Crowley et al

Patent Trial and Appeal Board

Dec 11, 2017

13903531 (P.T.A.B. Dec. 11, 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.
13/903,531 05/28/2013 Michael M. Crowley AUM-100US1 1040
23122 7590 12/18/2017
RATNFRPRFSTTA EXAMINER
2200 Renaissance Blvd WOLLSCHLAGER, JEFFREY MICHAEL
Suite 350
King of Prussia, PA 19406 ART UNIT PAPER NUMBER
1742
NOTIFICATION DATE DELIVERY MODE
12/18/2017 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL M. CROWLEY, JUSTIN M. KEEN,
JOHN J. KOLENG, and FENG ZHANG
Appeal 2017-004583
Application 13/903,531
Technology Center 1700
Before TERRY J. OWENS, BRIAN D. RANGE, and JANE E. INGLESE,
Administrative Patent Judges.
OWENS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
The Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’
rejection of claims 1—19. We have jurisdiction under 35 U.S.C. § 6(b).
The Invention
The Appellants claim an extruded laminate. Claim 1 is illustrative:
1. A bioadhesive bi-layered hot-melt extruded laminate
comprising a hydrophilic bioadhesive reservoir layer and a
hydrophobic backing layer, wherein
a) the bioadhesive reservoir layer comprises an active
agent;
b) each of the bioadhesive reservoir layer and the backing
layer comprises poly(ethylene) oxide (PEO); and
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c) the backing layer comprises a hydrophilic polymer in a
sufficiently low amount such that the backing layer is
hydrophobic.
The References
References relied upon by the Examiner
Schiraldi US Re. 33,093 Oct. 17, 1989
US 5,095,619 Mar. 17, 1992
US 5,318,737 June 7, 1994
US 5,766,620 June 16, 1998
US 6,585,997 B2 July 1, 2003
US 2003/0141625 A1 July 31, 2003
US 2005/0100515 A1 May 12, 2005
US 8,465,759 B2 June 18, 2013
Davis
Trabert
Heiber
Moro
Shelby
Sagel
Crowley (Crowley ’759)
Michael McDonald Crowley, Physiochemical and Mechanical
Characterization of Hot-melt Extruded Dosage Forms, Doctor of
Philosophy Dissertation - University of Texas at Austin (2003) (hereinafter
the Crowley dissertation).
Michael M. Crowley et al., Stability of polyethylene oxide in matrix tablets
prepared by hot-melt extrusion, 23 Biomaterials 4241—48 (2002)
(hereinafter the Crowley article).
References relied upon by the Appellants
US 6,375,963 B1 Apr. 23, 2002Repka
A. Apicella. et al., Poly (Ethylene oxide) (PEO) and different molecular
weight PEO blends monolithic devices for drug release, 14 Biomaterials 83—
90 (1993).
The Rejections
The claims stand rejected as follows: claims 1—19 on the ground of
nonstatutory obviousness-type double patenting over claims 1—16 of
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Crowley ’759,1 claims 1—3, 5—9, 11—13, and 19 under 35 U.S.C. § 102(b) or,
in the alternative, under 35 U.S.C. § 103 over Schiraldi, claim 4 over
Schiraldi in view of Shelby or Trabert, claim 10 over Schiraldi in view of
Sagel, claims 14 and 15 over Schiraldi in view of Moro, claim 16 over
Schiraldi in view of Heiber, and claim 17 over Schiraldi in view of Davis,
the Crowley dissertation or the Crowley article.
OPINION
We affirm the obviousness-type double patenting rejection and the
rejections under 35 U.S.C. § 103 and reverse the rejection under
35 U.S.C. § 102(b).
Obviousness-type double patenting rejection
The Appellants do not challenge the obviousness-type double
patenting rejection but, rather, state that “Appellants avoid this rejection by
concurrently filing a terminal disclaimer over U.S. Patent No. 8,465,759
with this Brief’ (App. Br. 4, 10). As pointed out by the Examiner (Ans. 8),
no terminal disclaimer is of record. Accordingly, we summarily affirm the
obviousness-type double patenting rejection.
Rejection under 35 U.S.C. § 102(b)
“Anticipation requires that every limitation of the claim in issue be
disclosed, either expressly or under principles of inherency, in a single prior
art reference.” Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868
F.2d 1251, 1255—56 (Fed. Cir. 1989). We need address only the sole
1 The Examiner states that the rejection is “on the ground of nonstatutory
double patenting” (Final Act. 3). As indicated by the Examiner’s
acknowledgement that the claims on appeal and the claims in Crowley ’759
are not identical {id.), the rejection is on the ground of nonstatutory
obviousness-type double patenting. See MPEP § 804.
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independent claim, i.e., claim 1. That claim requires that each of a
bioadhesive reservoir layer and a backing layer comprises PEO.
Schiraldi discloses an extruded single- or multi-layered film which
must have a hydroxypropyl cellulose and ethylene oxide homopolymer-
containing water-soluble or water-swellable polymer matrix bioadhesive
layer and may have an outer protective barrier membrane layer (col. 2,
11. 15—48, 57—60; col. 4,11. 2—7). The hydroxypropyl cellulose and ethylene
oxide homopolymer are among the film-forming polymers which “are most
useful in the bioadhesive layer of the film” (col. 3,11. 16—26). “Various
non-soluble polymers may also be incorporated for modification of the
film’s permeability properties, such as ethyl cellulose, propyl cellulose,
polyethylene, polypropylene and carboxymethylcellulose (free acid)” (col. 3,
11. 26—30). The outer protective barrier membrane layer can consist
essentially of “a polymer matrix of a major proportion of a non-water-
soluble polymer selected from the group consisting of ethyl cellulose, propyl
cellulose, polyethylene and polypropylene, and a minor portion of
hydroxypropyl cellulose” (col. 10,11. 25—32). By varying the ratios of the
polymers, “both the solubility and the adhesive properties of each layer of
film may be controlled” (col. 3,11. 30-32).
The Examiner finds that Schiraldi’s bioadhesive and outer protective
membrane layers “share a common polymer (Example 5), including PEO
(col. 3, lines 1-37)” (Final Act. 4).
Example 5’s outer protective membrane layer does not include PEO,
and the Examiner does not point to where Schiraldi discloses in relied-upon
column 3, lines 1—37 an outer protective membrane layer including PEO.
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Thus, the Examiner has not established a prima facie case of
anticipation of the Appellants’ claimed laminate.
Rejections under 35 U.S.C. § 103
The Appellants argue the claims as a group (App. Br. 5—10).
Although additional references are applied in some dependent claim
rejections the Appellants do not separately argue those claims (App. Br. 10).
We therefore limit our discussion to one claim, i.e., claim 1. Claims 2—17
and 19 stand or fall with that claim. See 37 C.F.R. § 41.37(c)(l)(iv) (2012).
The Appellants assert that “Schiraldi does not teach, suggest, or
disclose that the PEO is present in any other layer than the bioadhesive
layer” (App. Br. 5) and that Schiraldi “distinguishes water-soluble and/or
water-swellable materials, such as PEO, from non-soluble polymers. In fact,
Schiraldi places the water-soluble or swellable materials into a completely
separate grouping, those that are ‘useful in the bioadhesive layer of the film, ’
from the non-soluble polymers” (App. Br. 7).
Schiraldi’s disclosure that the hydroxypropyl cellulose and PEO are
most useful in the bioadhesive layer indicates that they have some usefulness
in other layers such as the outer protective membrane layer (col. 3,11. 16—
26). That usefulness is indicated further by Schiraldi’s disclosures that the
outer protective membrane layer can contain a minor proportion of
hydroxypropylcellulose (col. 10,11. 25—32) and that “[by] varying the ratios
of the above polymers [including hydroxypropylcellulose, PEO and
non-soluble polymers] both the solubility and the adhesive properties of
each layer of film may be controlled” (col. 3,11. 30-32).
The Appellants assert that Schiraldi’s Examples 1 and 5 and claims 8
and 9 expressly disclose that hydroxypropyl cellulose can be present in both
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the adhesive layer and the outer protective membrane layer whereas PEO is
limited to the bioadhesive layer (App. Br. 8).2 3
Schiraldi is not limited to its examples, see In re Fracalossi, 681 F.2d
792, 794 n.l (CCPA 1982); In re Mills, 470 F.2d 649, 651 (CCPA 1972), or
to its claims 8 and 9. Instead, all disclosures therein must be evaluated for
what they would have fairly suggested to one of ordinary skill in the art. See
In re Boe, 355 F.2d 961, 965 (CCPA 1966). As set forth above, Schiraldi
would have suggested to one of ordinary skill in the art that the outer
protective membrane layer can contain a minor proportion of PEO.
The Appellants assert that Schiraldi’s “outer layer is described as
‘consisting of’ non-adhesive and non-soluble polymers. See Id. at Col. 3,
lines 12-15. PEO is both soluble and adhesive, having characteristics that
would render it unsuitable for the durability and protection characteristics
necessary in the outer layer” (App. Br. 6-1)?
That assertion pertains to Schiraldi’s exemplification of an aphthous
lesion-treating laminated two-layer film wherein benzocaine is incorporated
into the adhesive layer and “[t]he outer layer would consist of non-soluble/-
non-adhesive polymers that provide durability, protection and directs the
delivery of benzocaine toward the lesion” (col. 3,11. 8—15). The Appellants
2 Repka’s Example 12’s film relied upon by the Appellants (App. Br. 9)
includes hydroxypropyl cellulose in inner matrix and outer backing layers,
but does not contain PEO in either layer. The inner matrix layer, however,
contains polyethylene, which indicates that both a water-swellable or
water-soluble polymer (hydroxypropylcellulose) and a non-soluble polymer
(polyethylene) can be present in the same layer.
3 We do not consider the Appellants’ reliance upon Apicella in support of
that assertion (App. Br. 7) because the record does not include a copy of that
reference.
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do not provide justification for interpreting Schiraldi’s term “consist of’ as
though it is a claim transition term excluding non-recited components.
Regardless, that term appears in an example, and Schiraldi is not limited to
its examples. See Fracalossi, 681 F.2d at 794 n.l; Mills, 470 F.2d at 651.
Furthermore, the Appellants do not provide evidence that PEO is unsuitable
in an outer layer. The Appellants provide mere unsupported attorney
argument, and arguments of counsel cannot take the place of evidence. See
In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984).
The Appellants assert that Schiraldi’s hydroxypropylcellulose and
PEO are not functionally equivalent (Reply Br. 2).
Schiraldi’s hydroxypropylcellulose and PEO both function as a
water-swellable or water-soluble polymer in Schiraldi’s layers (col. 3,11. 16—
32). Therefore, one of ordinary skill in the art, through no more than
ordinary creativity, would have used not only hydroxypropylcellulose in the
outer protective layer (col. 10,11. 25—32), but also would have used PEO in
that layer. See KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (in
making an obviousness determination one “can take account of the
inferences and creative steps that a person of ordinary skill in the art would
employ”).
The Appellants argue (Reply Br. 3):
In contrast to the functional and chemical characteristics
of PEO, which is freely soluble in water, a person of ordinary
skill in the art would recognize that the solubility of
hydroxypropylcellulose decreases with increasing temperature,
such that at the body temperatures in which Schiraldi’s devices
would be used, hydroxypropylcellulose would not be expected
to dissolve in a manner similar to PEO. Thus, a person of
ordinary skill in the art would recognize that the chemical and
functional characteristics of hydroxypropylcellulose render
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hydroxypropylcellulose suitable for use in a layer designed for
protection or durability, unlike the characteristics of PEO.
That argument is not well taken because it is merely unsupported
attorney argument, and arguments of counsel cannot take the place of
evidence. See De Blauwe, 736 F.2d at 705.
For the above reasons we are not persuaded of reversible error in the
rejections under 35 U.S.C. § 103.
DECISION/ORDER
The rejection of claims 1—19 on the ground of nonstatutory
obviousness-type double patenting over claims 1—16 of Crowley ’759 and
the rejections under 35 U.S.C. § 103 of claims 1—3, 5—9, 11—13, and 19 over
Schiraldi, claim 4 over Schiraldi in view of Shelby or Trabert, claim 10 over
Schiraldi in view of Sagel, claims 14 and 15 over Schiraldi in view of Moro,
claim 16 over Schiraldi in view of Heiber, and claim 17 over Schiraldi in
view of Davis, the Crowley dissertation or the Crowley article are affirmed.
The rejection of claims 1—3, 5—9, 11—13, and 19 under 35 U.S.C. § 102(b) is
reversed.
It is ordered that the Examiner’s decision 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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