Ex Parte Katayama et al

Patent Trial and Appeal Board

Feb 27, 2017

13516094 (P.T.A.B. Feb. 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.
13/516,094 08/20/2012 Akiko Katayama 037209.64595US 5579
23911 7590
CROWELL & MORING LLP
INTELLECTUAL PROPERTY GROUP
P.O. BOX 14300
WASHINGTON, DC 20044-4300
EXAMINER
PEEBLES, KATHERINE
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
03/01/2017 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):
edocket @ crowell. com
tche @ crowell. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte AKIKO KATAYAMA and KATSUYUKIINOO
Appeal 2014-009387
Application 13/516,094
Technology Center 1600
Before ULRIKE W. JENKS, KIMBERLY McGRAW, and
KRISTI L. R. SAWERT, Administrative Patent Judges.
McGRAW, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from a final rejection of
claims 1, 3, 4, 13, and 14. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
Appeal 2014-009387
Application 13/516,094
STATEMENT OF THE CASE
In general, the independent claims on appeal are directed to an
adhesive patch having an active ingredient adhesive layer consisting
essentially of (1) an anti-inflammatory analgesic, such as valdecoxib or
acetaminophen, and (2) a local anesthetic as an absorption promoter for the
analgesic, such as lidocaine or oxybuprocaine. The Specification admits that
prior art teaches adhesive patches that use a local anesthetic as an absorption
promoter for anti-inflammatory analgesics. Spec, at || 4, 6. However, the
Specification states that the drug permeation profile of the present invention
shows excellent drug release of the analgesic without inhibiting the drug
release of the anesthetic. Id. at^ffl 13, 19, 57—67; Figs. 1—6.
Claims 1,13, and 14 are the only independent claims on appeal and
are reproduced below:
1. A transdermal adhesive patch, comprising an active
ingredient adhesive layer consisting essentially of both an anti­
inflammatory analgesic and a local anesthetic as an absorption
promoter for the anti-inflammatory analgesic,
wherein the anti-inflammatory analgesic is acetaminophen
or valdecoxib, and wherein the local anesthetic is lidocaine or
oxybuprocaine.
13. A transdermal adhesive patch comprising an adhesive
layer consisting essentially of acetaminophen as an anti­
inflammatory analgesic and lidocaine or oxybuprocaine as an
absorption promoter.
14. A transdermal adhesive patch comprising an adhesive
layer consisting essentially of valdecoxib as an anti­
inflammatory analgesic and oxybuprocaine as an absorption
promoter.
App. Br. 14 (Claims App’x).
2
Appeal 2014-009387
Application 13/516,094
REJECTIONS
Claims 1,3, and 4 stand rejected under 35 U.S.C. § 102(b) as being
anticipated by Richlin (US 2004/0208914 Al, pub. October 21, 2004). Final
Act. 4; Examiner’s Answer mailed July 11, 20141 (“Ans.”) at 2.
Claims 1,3,4, and 13 stand rejected under 35 U.S.C. § 103(a) over
Richlin and Griswold (US 2008/0114098 Al, pub. May 15, 2008), as
evidenced by Swann (US 2008/0103206 Al, pub. May 1, 2006). Final
Act. 6; Ans. 2.
Claims 1,3,4, and 14 stand rejected under 35 U.S.C. § 103(a) over
Richlin and Bookbinder (US 2005/0260186 Al; pub. Nov. 24, 2005). Final
Act. 7; Ans. 2.
ANALYSIS
Only those arguments actually made by Appellants in the Briefs have
been considered in this Decision. Arguments that Appellants could have
made but declined to make are considered waived. See 37 C.F.R.
§ 41.37(c)(l)(iv).
Anticipation Rejection of Claims 1, 3, and 4
Appellants assert the Examiner erred in finding claims 1,3, and 4
anticipated by Richlin. Appellants argue, inter alia, the Examiner erred by
“picking and choosing” lidocaine from the laundry list of possible
anesthetics and valdecoxib from the laundry list of possible analgesics
recited in Richlin, “with no indication of which ingredients of the various
1 Two Examiner’s Answers were mailed, one on July 3, 2014 and another on
July 11, 2014. Appellants note that the Examiner’s “Response to
Arguments” appears to be identical in both documents and refers to the July
11, 2014 version in its Reply. Reply 1, n.l. For consistency, we will also
refer to the Examiner’s Answer mailed July 11, 2014.
3
Appeal 2014-009387
Application 13/516,094
lists should be combined.” App. Br. 6; Final Act. 4 (citing || 17, 18, 27, 34,
54); see also Richlin || 19—36.
We agree with Appellants. For a § 102 rejection to be proper, the
prior art must clearly and unequivocally disclose the claimed invention or
direct those skilled in the art to the claimed invention without any need for
picking, choosing, and combining various disclosures not directly related to
each other by the teachings of the cited reference. In re Arkley, 455 F.2d
586, 587—88 (CCPA 1972); see Net Money IN, Inc. v. Verisign, Inc., 545
F.3d 1359, 1369 (Fed. Cir. 2008); see also Impax Labs., Inc. v. Aventis
Pharms. Inc., 468 F.3d 1366, 1383 (Fed. Cir. 2006) (stating that in order to
anticipate the prior art must be such that a person of ordinary skill would “at
once envisage” the specific claimed composition).
The Examiner finds that Richlin discloses lidocaine in claim 28 and
valdecoxib in claim 38 “as ingredients for their transdermal delivery system”
and “therefore Richlin et al. anticipates these limitations.” Ans. 2—3.
However, both claim 28 and 38 recite a number of other ingredients besides
lidocaine and valdecoxib. See claim 28 (listing 10 anesthetics), claim 38
(listing 8 long-acting analgesics). The Examiner has not adequately
explained why one of ordinary skill in the art would immediately envisage
the specific combination of lidocaine and valdecoxib from lists that recite
anesthetics, long-acting analgesics, or other ingredients, for inclusion in
Richlin’s transdermic patch. See Impax Labs., 468 F.3d at 1383 (the specific
combination must be at once envisaged). Therefore, we reverse the
4
Appeal 2014-009387
Application 13/516,094
Examiner’s anticipation rejection of claims 1,3, and 4 as anticipated by
Richlin.
Obviousness Rejections of Claims 1, 3, 4, and 13 over Richlin, Griswold,
and Swann and of Claims 1, 3, 4, and 14 over Richlin and Bookbinder
The Examiner rejected claims 1,3,4, and 13 over Richlin and
Griswold as evidenced by Swann (Final Act. 6—7) and rejected claims 1,3,
4, and 14 over Richlin and Bookbinder {id. at 7—9). In both sets of
rejections, the Examiner found Richlin teaches, inter alia, a transdermal
patch with an active ingredient layer containing the anti-inflammatory
analgesic valdecoxib and the local anesthetic lidocaine. Final Act. 6, 8.
The Examiner stated the “consisting essentially of’ language of
Appellants’ claims limits the scope of the claims to the specified materials
and to “those that do not materially affect the basic and novel
characteristic(s)’ of the claimed invention.” Id. at 9. The Examiner noted
that although Appellants had argued that the additional components included
in the Richlin patch “would interfere with the surprising release profiles of
the instant invention,” Appellants did not provide any evidence or reasoning
to support this argument. Id. Specifically, the Examiner found that
Appellants had not provided any evidence as to how the inclusion of the
three additional ingredients of Richlin’s patch would alter the drug
permeation profiles of the claimed patch. Id. at 8; see also id. at 9 (stating
Appellants did not provide any data, evidence or reasoning to support their
position that the patch disclosed by Richlin does not exhibit a comparable
drug release profile to that of the instant invention as claimed). The
Examiner further found that Appellants did not provide any evidence to
support their claim that the drug permeation profiles of the claimed patch
5
Appeal 2014-009387
Application 13/516,094
were unexpected or surprising. Id. at 10. The Examiner found that that the
alleged “surprising nature” of the drug permeation profiles is based only on
Appellants’ opinion of the data and that Appellants did not provide an
appropriate basis for determining the observed results were in any way
surprising. The Examiner concluded the “consisting essentially of’
language of claim 1 did not exclude the additional ingredients found in the
Richlin patch. Id. at 9.
Appellants present similar arguments for both sets of rejections, so we
will discuss the rejections together. See App. Br. 9—12. For each rejection,
Appellants argue the claims as a group. Id. We select claim 1 as
representative of each group and the remaining claims stand or fall with
claim 1. See 37 C.F.R. § 41.37(c)(l)(iv).
Appellants argue the Examiner erred in rejecting claim 1 because the
claim requires an adhesive layer “consisting essentially of’ only two
ingredients (an analgesic and an anesthetic) while Richlin’s preparation has
five ingredients (the analgesic and anesthetic as well as a vasoconstrictor, a
permeation enhancer, and another analgesic). App. Br. 7—12. Appellants
contend that because Richlin “teaches a particular role for” each of its
ingredients, modifying Richlin by omitting the vasoconstrictor and the
permeation enhancer, as well as limiting the anesthetic and analgesic to
those recited in Appellants’ claims, would render Richlin unfit for its
intended purpose. Id. at 10-12.
These arguments are not persuasive as Appellants have not shown that
any of the additional ingredients of Richlin would have a material effect on
the basic and novel characteristics of Appellants’ claimed invention. It is
well settled that the phrase “consisting essentially of’ limits the scope of a
6
Appeal 2014-009387
Application 13/516,094
claim to the specified ingredients and to unlisted ingredients that do not
“materially affect the basic and novel properties of the invention.” PPG
Indus, v. Guardian Indus. Corp., 156 F.3d 1351, 1354 (Fed. Cir. 1998); In re
Hertz1 537 F.2d 549, 551—52 (CCPA 1976). The Examiner found, and
Appellants do not dispute, that Richlin’s patch and Appellants’ patch possess
similar properties as both are directed to “a transdermal adhesive patch for
delivering therapeutic agents through the skin . . . .” See, e.g., Ans. 6—7.
Thus, it is Appellants’ burden to show how Richlin’s additional components
would materially change the basic and novel characteristics of applicant’s
invention. See In re De Lajarte, 337 F.2d 870, 874 (CCPA 1964); see also
Ex parte Hoffman, 12 USPQ2d 1061, 1063-64 (BPAI 1989) (“[I]t is an
applicant’s burden to establish that a step practiced in a prior art method is
excluded from his claims by ‘consisting essentially of language.”). Based
on the record before us, Appellants have not met this burden.
To determine what the basic and novel characteristics of Appellants’
invention are, we look to Appellants’ Specification and claims. See PPG
Indus., 156 F.3d at 1355 (looking to specification and claims for a “clear
indication” of what the basic and novel characteristics of the invention are
and noting, absent such clear indication, “consisting essentially of’ will be
construed as equivalent to “comprising”).
Appellants’ Specification states the invention relates to an adhesive
patch containing an analgesic as well as an anesthetic that acts as both an
anesthetic and an absorption promoter for the analgesic. Spec. 11. The
Specification states that by having both the analgesic and anesthetic in the
base, the patch provided “excellent releasing of the basic anti-inflammatory
analgesic” “without losing the transdermal absorption of the local
7
Appeal 2014-009387
Application 13/516,094
anesthetic.” Id. at 17; see also Spec. 19 (“The basic aspect of the present
invention ... is a transdermally absorbable adhesive patch, which contains
both a basic anti-inflammatory analgesic and a local anesthetic as an
absorption promoter for the basic anti-inflammatory analgesic.”).
Appellants state the examples provided in the Specification “demonstrate the
enhanced permeation of the acetaminophen and valdecoxib contained in the
adhesive layer, without an inhibition of lidocaine and oxybyprocaine [sic]
permeation.” App. Br. 8 (citing Spec Tfl[ 57—61; Figs. 1—6). The
Specification also states that the objects of the invention are to provide an
“external adhesive patch having excellent drug releasing [properties] without
damaging the physical properties of the preparation.” Id. at | 8.
Therefore, based on the claims and the Specification, the alleged basic
and novel characteristics of the claimed transdermal patch are (1) a drug
permeation profile demonstrating enhanced permeation of the anti­
inflammatory analgesic (i.e., acetaminophen or valdecoxib) by including a
local anesthetic (i.e., lidocaine or oxybuprocaine), without inhibiting
permeation of the local anesthetic, as well as (2) a patch that has excellent
drug releasing properties without damaging the physical properties of the
preparation.
Appellants do not provide sufficient evidence to meet their burden to
show Richlin’s additional ingredients have a material effect on the basic and
novel characteristics of Appellants’ invention. See In re Geisler, 116 F.3d
1465, 1470 (Fed. Cir. 1997) (stating attorney arguments and conclusory
8
Appeal 2014-009387
Application 13/516,094
statements that are unsupported by factual evidence are entitled to little
probative value).
Rather, Appellants merely allege that because the three additional
ingredients of Richlin’s patch are each identified to have a particular
activity, they, therefore, must alter the basic and novel characteristics of the
patch. Specifically, Appellants contend:
Including additional active ingredients such as the
vasoconstrictors, the permeation enhancers, the other anesthetics
and the short-acting and the long-acting analgesics, each having
a particular activity in the patches of Richlin et al. would alter
the basic and novel characteristics of the active ingredient
adhesive layer of Appellants’ claimed patches, which active
ingredient adhesive layer consists essentially of the anti­
inflammatory analgesic acetaminophen or valdecoxib, and the
local anesthetic is lidocaine or oxybuprocaine as adsorption
promoters for the acetaminophen or valdecoxib.
App. Br. 8.
However, Appellants fail to provide sufficient evidence to show what
affect, if any, the additional ingredients of Richlin would have upon the
basic and novel characteristics of the invention.
For example, Appellants present no evidence or argument as to how
adding the additional analgesic of Richlin has any impact upon the patch of
the claimed invention. Appellants merely point to Richlin’s teaching that
the analgesic retards “inflammatory and algesic response.” App. Br. 10.
This is not sufficient evidence that adding an additional analgesic has a
material effect on the pertinent characteristics of the claimed invention, such
9
Appeal 2014-009387
Application 13/516,094
as any effect upon the alleged surprising drug permeation profile of the
claimed invention.
Similarly, Appellants allege that “including the vasoconstrictor and
the penetration enhancer disclosed by Richlin et al. in Appellants’ patches
would materially alter the permeation of the active ingredients in
Appellants’ adhesive layer through skin and, as such, alter a basic and novel
characteristics of the adhesive layer.” App. Br. 9—10 (citing Richlin || 10,
18).
However, contrary to Appellants’ allegations, Richlin does not state
that the vasoconstrictor has any effect upon permeation of any ingredients of
the adhesive patch. Instead, Richlin discusses the effect of the
vasoconstrictor on various patch ingredients after they have permeated from
the patch and penetrated through the skin. Specifically, Richlin explains that
the vasoconstrictor “retard[s] vascular dispersion of the therapeutic agents.”
Richlin 143 (emphasis added). Richlin does not state or imply that a
vasoconstrictor would have impact upon the particular drug permeation
profiles of the therapeutic agents through the skin. Indeed, Richlin does not
test the permeation profiles of the therapeutic agents through the skin —
which are the properties measured in the Specification. See Spec. Tflf 57—67,
Figs. 1—6 (describing rat skin test permeability tests as allegedly showing the
preparation results in enhanced permeation of the anti-inflammatory
analgesic (i.e., acetaminophen or valdecoxib) by including a local anesthetic
(i.e., lidocaine or oxybuprocaine), without losing the permeation of the local
anesthetic).
With respect to the permeation enhancer, the Examiner found, and we
agree, that even if Richlin’s permeation enhancer may have some effect on
10
Appeal 2014-009387
Application 13/516,094
permeation, Appellants did not provide sufficient evidence or argument that
the permeation enhancer would have a material effect on the drug
permeation profile of the claimed transdermal patch. Specifically, the
Examiner found that Richlin’s patch, like Appellants’ patch, provides good
transmission of therapeutic agents through the skin and that Appellants did
not provide any data or evidence as to how the drug permeation profile of
Richlin differs from that of the patch as claimed. Ans. 6—8; Final Act. 9.
Appellants do not provide persuasive evidence or argument to rebut
the Examiner’s findings. Rather, Appellants merely repeat their argument
that because Richlin teaches “that each ingredient has an essential role” it is
“illogical for the Examiner to conclude that adding Richlin et al.’s
penetration enhancer and vasoconstrictor to a therapeutic preparation would
not materially alter the preparation’s characteristics and efficacy.” Reply Br.
7; see also id. at 5 (citing Richlin || 37, 41 as disclosing “the essential role
that each ingredient plays in the therapeutic preparation”). Again, these
arguments are not persuasive as they do not address how Richlin’s
ingredients would materially affect the basic and novel characteristics of
Appellants’ claimed invention, such by addressing what kind of impact the
additional ingredients would have on the release profile of the anti­
inflammatory analgesic, (e.g., acetaminophen or valdecoxib) as compared to
the local anesthetic (e.g., lidocaine or oxybuprocaine) or upon the physical
integrity of the preparation. See Kim v. ConAgra Foods, Inc., 465 F.3d
1312, 1319—20 (Fed. Cir. 2006) (holding patentee’s conclusory testimony,
unsupported by any examinations or tests of actual accused products, was
insufficient to show additional ingredients would not have materially
affected the pertinent characteristics of the invention); Hoffman, 12 USPQ2d
11
Appeal 2014-009387
Application 13/516,094
at 1063—64 (BPAI 1989) (“[I]t is an applicant’s burden to establish that a
step practiced in a prior art method is excluded from his claims by
‘consisting essentially of language.”).
Finally, we note that it is reasonable to place the burden on Appellants
to show that Richlin’s additional components would materially change the
claimed invention because the Patent Office does not have the resources to
test whether the additional ingredients would materially change Appellants’
defined basic and novel properties. See, e.g., In re Best, 562 F.2d 1252,
1255 (CCPA 1977); see also In re Brown, 459 F.2d 531, 535 (CCPA 1972)
(“As a practical matter, the Patent Office is not equipped to manufacture
products by the myriad of processes put before it and then obtain prior art
products and make physical comparisons therewith.”).
Appellants have not met their burden of showing that “consisting
essentially of’ language excludes the vasoconstrictor, permeation enhancer,
or additional analgesic of Richlin. Therefore, we are not persuaded the
Examiner erred in finding each of the appealed claims would have been
obvious over, inter alia, Richlin, which teaches a patch comprising
valdecoxib and lidocaine.
Appellants also argue that none of the other prior art references cited
by the Examiner (Griswold, Swann, or Bookbinder) teach modifying Richlin
to omit the vasoconstrictor and the permeation enhancer and limit the
anesthetic and analgesic to those recited in Appellants’ claims. App. Br. 11—
12. However, the Examiner does not rely upon these references for any such
teaching. Rather, the Examiner cited Griswold for teaching acetaminophen
is interchangeable with other anti-inflammatory drugs for analgesia (Final
Act. 7), cited Swann for teaching that acetaminophen is a “quick-onset” anti-
12
Appeal 2014-009387
Application 13/516,094
inflammatory drug (id.), and cited Bookbinder for teaching lidocaine and
oxybuprocaine are interchangeable alternatives for use in transdermal
patches (id. at 8). Appellants do not dispute these findings or otherwise
argue that the Examiner erred in combining these references. As such, this
argument is not persuasive.
On appeal, the Board “reviews the obviousness rejection for error
based upon the issues identified by appellant, and in light of the arguments
and evidence produced thereon.” Ex parte Frye, 94 USPQ2d 1072, 1075-76
(Bd. Pat. App. & Interf. 2010) (Precedential). Based upon the arguments
and evidence presented by Appellants, we are not persuaded the Examiner
erred. We therefore sustain the Examiner’s obviousness rejections of claims
1, 3, 4, 13, and 14 under 35 U.S.C. § 103(a).
DECISION
The Examiner’s rejection of 1, 3, and 4 under 35 U.S.C. § 102(b) is
reversed.
The Examiner’s rejections of claims 1, 3, 4, 13, and 14 under
35 U.S.C. § 103(a) are 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)(l)(iv).
AFFIRMED
13