Ex Parte Langer et al

Patent Trial and Appeal Board

Oct 9, 2018

13994242 (P.T.A.B. Oct. 9, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/994,242 08/13/2013
23575 7590 10/11/2018
CURATOLO SIDOTI CO., LPA
24500 CENTER RIDGE ROAD, SUITE 280
CLEVELAND, OH 44145
FIRST NAMED INVENTOR
Britta Langer
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.
LAK.Pll-072812 8592
EXAMINER
GULLEDGE, BRIAN M
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
10/11/2018 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):
docket@patentandtm.com
cortese@patentandtm.com
pair@patentandtm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BRITTA LANGER, BJORN SCHURAD, and HEIKE PRINZ 1
Appeal2017-009480
Application 13/994,242
Technology Center 1600
Before DEMETRA J. MILLS, ERIC B. GRIMES, and RY ANH. FLAX,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision under 35 U.S.C. § 134(a) involving claims directed
to a transdermal therapeutic system. Claims 1-3, 6, 8, 10-21, 27, 28, 31-35,
41, and 62 are on appeal as rejected under 35 U.S.C. § 103(a). We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as "Luye Pharma AG."
Appeal Br. 3. Herein we reference the Specification of June 14, 2013
("Spec."); the Non-Final Office Action of Apr. 11, 2016 ("Non-Final
Action"); the Appeal Brief of Mar. 7, 2017 ("Appeal Br."); the Examiner's
Answer of May 25, 2017 ("Answer"); and the Reply Brief of June 30, 2017
("Reply Br.").
Appeal2017-009480
Application 13/994,242
STATEMENT OF THE CASE
The Specification states that the invention relates to "a system for the
transdermal administration of an active substance, preferably rivastigmine."
Spec. 1 (first paragraph). The Specification further states:
It has been found that rivastigmine in transdermal patches is
sufficiently stable if the polymer matrix of the active substance
layer does not contain any free hydroxyl groups or carboxyl
groups. The present invention is based, inter alia, on the
selection of special polymers for the polymer matrix to thereby
prevent or minimize, respectively, the degradation of
rivastigmine.
Id. at 4 (first paragraph after Summary of the Invention heading). The
Specification indicates that the presence of "polyhydric alcohol," "Durotak®
387-2353," "glycerin, fatty acids," "[a]lcohols ... used as the permeation
enhancers," and "[ c ]ellulose polymers ... used as the gel-forming agents"
cause free hydroxyl groups and/ or carboxyl groups to be present in an
active-reservoir polymer matrix. Id. at 2-3.
Except for omitting undesirable components, as set forth above, the
Specification does not describe any specific means for eliminating the
presence of free hydroxyl groups and carboxyl groups in its drug reservoir
polymer matrix, other than selecting polymer materials as identified at pages
11-13.
Independent claim 1 is representative for purposes of this decision and
is reproduced below:
1. A transdermal therapeutic system for administering an
active substance through the skin comprising the layers arranged
in the following order with respect to each other:
a) a cover layer;
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Application 13/994,242
b) an active substance layer compnsmg a polymer matrix
containing a polymer or polymers and the active substance;
c) a membrane controlling the release of the active substance;
d) an adhesive layer comprising a contact adhesive; and
e) a pull-off layer;
wherein the active substance is rivastigmine or a physiologically
compatible salt, hydrate, solvate, or derivative thereof, wherein
the polymer matrix does not contain any free hydroxyl groups
and free carboxyl groups.
Appeal Br. 17 (Claims Appendix) (emphasis added to identify the limitation
argued by Appellants). Independent claim 17 is substantially similar to
claim 1, but further requires that the adhesive layer comprises "( 1) a
polyisobutylene or a mixture of several polyisobutylenes and (2) a
polybutene or a mixture of several polybutenes." Id. at 19. Independent
claim 32 is also substantially similar to claim 1, but further requires "that the
transdermal therapeutic system does not contain tocopherols." Id. at 21.
The following rejections are appealed:
Claims 1-3, 13-16, 32-35, 41, and 62 stand rejected under 35 U.S.C.
§ I03(a) over Ito2 and Gargiulo. 3 Answer 2. 4
Claims 6 and 8 stand rejected under 35 U.S.C. § I03(a) over Ito,
Gargiulo, and Wen. 5 Id. at 4.
2 US 2007 /0259028 Al (published Nov. 8, 2007) ("Ito").
3 US 2007/0128263 Al (published June 7, 2007) ("Gargiulo").
4 "The Examiner notes that the rejection over the combination of Ito and
Gargiulo et al. alone (rejection # 1) for instant claim 17, as well as dependent
claims 21, 27, and 28, has been withdrawn." Answer 13.
5 US 2009/0291127 Al (published Nov. 26, 2009) ("Wen").
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Application 13/994,242
Claims 10-12, 18-20, and 31 stand rejected under 35 U.S.C. § I03(a)
over Ito, Gargiulo, Wen, and Stroebeck. 6 Id. at 5.
Claims 1-3, 6, 8, 13-17, 21, 27, 28, 32-35, 41, and 62 stand rejected
under 35 U.S.C. § I03(a) over Wen. Id. at 6.
Claims 10-12, 18-20, and 31 stand rejected under 35 U.S.C. § I03(a)
over Wen and Stroebeck. Id. at 8.
DISCUSSION
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting aprimafacie case ofunpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Arguments made by Appellants in the Appeal Brief and properly presented
in the Reply Brief have been considered in this Decision; arguments not so-
presented in the Briefs are waived. See 37 C.F.R. § 4I.37(c)(l)(iv) (2015);
see also Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010)
(informative) ("Any bases for asserting error, whether factual or legal, that
are not raised in the principal brief are waived.").
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results"
and "when a patent claims a structure already known in the prior art that is
altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result." KSR
Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007) (citing United States v.
Adams, 383 U.S. 39, 50-51 (1966)). "In determining whether the subject
6 US 2009/0171258 Al (published July 2, 2009) ("Stroebeck").
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Application 13/994,242
matter of a patent claim is obvious, neither the particular motivation nor the
avowed purpose of the patentee controls. What matters is the objective
reach of the claim. If the claim extends to what is obvious, it is invalid
under§ 103." Id. at 419.
It is obvious to those skilled in the art to substitute one known
equivalent for another. See In re Omeprazole Patent Litigation, 483 F.3d
1364, 1374 (Fed. Cir. 2007) ("[T]his court finds no ... error in [the]
conclusion that it would have been obvious to one skilled in the art to
substitute one ARC [alkaline reactive compound] for another."). "[A]
reference is not limited to the disclosure of specific working examples." In
re Mills, 470 F.2d 649, 651 (CCPA 1972)).
I. THE REJECTION OF CLAIMS 1-3, 13-16, 32-35, 41, AND 62 OVER ITO
AND GARGIULO
The Examiner determined that Ito disclosed each claim limitation, but
included polyhydric alcohol in the drug reservoir polymer matrix as a
permeation enhancer. See Answer 2-3 (generally citing Ito abstract ,r,r 15,
35, 48, 53, 69, 71, 76, 102, 103, example 1, claims 1, 12, 13); see also Ito
,r,r 36, 42, 61, Figure 1. In view of the fact that Appellants' Specification
identified polyhydric alcohol as a potential source for free hydroxyl groups,
the Examiner determined that it would have been obvious to substitute
therefor any of the permeation enhancers disclosed in Gargiulo, which
disclosed a transdermal drug delivery device similar to Ito's; such
permeation enhancers included urea, for example, which is not identified by
Appellants' Specification as a potential source for free hydroxyl or free
carboxyl groups. Id. at 3 (generally citing Gargiulo abstract, ,r 49, Figure 2);
see also Spec. 2; Gargiulo ,r,r 1, 2, 25-29, 35, 39. We discern no error in the
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Application 13/994,242
Examiner's determinations and adopt the Examiner's rationale and findings
of fact.
Appellants argue "there is no disclosure or suggestion in Ito or
Gargiulo to form a transdermal therapeutic system with a polymer matrix
that does not contain any free hydroxyl groups and free carboxyl groups."
Appeal Br. 9. In support of this argument, Appellants identify that Ito
discloses its drug reservoir polymer matrix includes polyhydric alcohol. Id.
Appellants also point to Ito's disclosed Examples 1-3, where glycerin is
included in the preparation of the drug reservoir layer; glycerin being a
component containing hydroxyl groups according to Appellants. Id. at 10
( citing Ito ,r 115). Appellants argue Ito requires polyhydric alcohol and that
the skilled artisan would have no reason to replace it with a non-carboxyl
and non-hydroxyl compound disclosed by Gargiulo. Id. at 10-11. Further,
Appellants argue Gargiulo discloses a polymer matrix including "Durotak®
387-2353 which contains carboxyl groups." Id. at 11 (citing Gargiulo ,r 95).
Appellants' arguments are not persuasive. Ito includes polyhydric
alcohol because of its advantages as a penetration enhancer. Ito ,r,r 48-54.
Other than this functional quality of polyhydric alcohol, Ito discloses no
special characteristic of the component as necessary to its transdermal drug
delivery device. As determined by the Examiner, Gargiulo discloses a
transdermal drug delivery device similar to that of Ito, and discloses a list of
skin penetration enhancers, including urea and others that would not include
hydroxyl groups or carboxyl groups. We agree with the Examiner's
determination that it would have been obvious to substitute one of
Gargiulo's penetration enhancers, e.g., urea, in place of Ito's polyhydric
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alcohol because they would perform the same function. See In re
Omeprazole Patent Litigation, 483 F.3d at 1374. Furthermore, although
some of Ito's working examples indicate that glycerin was used in preparing
a drug reservoir layer, Ito's disclosure is not limited to its working examples.
See In re Mills, 470 F.2d at 651. Ito does not indicate glycerin is necessarily
included in its devices. Finally, although Gargiulo may disclose using a
polymer that Appellants identify as containing carboxyl groups, this
component need not be incorporated into the combination with Ito, at least
because Ito already discloses other non-carboxyl-group-containing polymers
to serve as a drug reservoir. See, e.g., Ito ,r,r 33--4 7 ( disclosing
methacrylates, e.g., Eudagit ElOO); see also Spec. 11 (disclosing various
methacrylates as suitable reservoir materials). Therefore, the combined Ito
and Gargiulo would have rendered the claimed structures obvious.
Regarding claims 3, 28, and 32-34, Appellants argue these claims
require the TTS ( transdermal therapeutic system) not include tocopherols
and/or antioxidants and contend Gargiulo discloses that including an
antioxidant, such as a-tocopherol, is preferred. Appeal Br. 12 ( citing
Gargiulo ,r 48).
This argument is not persuasive. While a preferred embodiment of
Gargiulo may include an antioxidant or tocopherol, this is not a requirement.
Further, Ito does not require such components. "Non-obviousness cannot be
established by attacking references individually where the rejection is based
upon the teachings of a combination of references. . . . [The reference] must
be read, not in isolation, but for what it fairly teaches in combination with
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the prior art as a whole." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir.
1986).
IL THE REJECTION OF CLAIMS 6 AND 8 OVER ITO, GARGIULO, AND WEN
The Examiner determined that adding Wen to the Ito-Gargiulo
combination provided a teaching of an adhesive layer blend of
polyisobutylenes, specifically a high molecular weight polyisobutylene ( e.g.,
Oppanol L80) and a low molecular weight polyisobutylene ( e.g., Oppanol
B 10), also potentially including polybutene, as claimed. See Answer 4; Wen
Appellants argue "[t]he alleged disclosure in Wen does not cure the
above-stated deficiencies of Ito and Gargiulo [regarding the rejection of
claim 1 ], as there is no teaching, suggestion or motivation in Wen to use
polymers that are free of hydroxyl and carboxyl groups in the active
substance layer of a TTS. Indeed, Wen is notably silent on this claim
element." Appeal Br. 12.
Because, as discussed above, we discern to error in the Examiner's
combination of Ito and Gargiulo and agree that the combination of these
references with Wen renders claims 6 and 8 obvious, we are unpersuaded by
this argument as well.
III. THE REJECTION OF CLAIMS 10-12, 18-20,AND31 OVERITO,
GARGIULO, WEN, AND STROEBECK
The Examiner added Stroebeck to the Ito-Gargiulo-Wen combination
(in view of the claim elements where, e.g., "the adhesive layer comprises at
least two polyisobutylenes") and determined that Stroebeck taught that
"[t]ackifiers are ... useful in the adhesive layer (paragraph [27]), and
tackifiers can be polybutenes (paragraph [33]). Useful polybutenes taught
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by Stroebeck et al. include the one sold under the trade name Indopol H-
18000 (paragraph [68])." See Answer 5; Stroebeck ,r,r 27, 33, 68.
Appellants argue "[t]he alleged disclosure in Stroebeck fails to cure
the above-stated deficiencies of Ito, Gargiulo and Wen [regarding the
rejections of claims 1 and 6], as there is no teaching, suggestion or
motivation in Stroebeck to use polymers that are free of hydroxyl and
carboxyl groups in the reservoir layer of a TTS." Appeal Br. 12-13.
Because, as discussed above, we discern to error in the Examiner's
combination of Ito and Gargiulo ( or also including Wen) and agree that the
combination with Stroebeckrenders claims 10-12, 18-20, and31 obvious,
we are unpersuaded by this argument as well.
IV. THE REJECTION OF CLAIMS 1-3, 6, 8, 13-17, 21, 27, 28, 32-35, 41, AND
62 OVER WEN
The Examiner determined that Wen, individually, renders all the
appealed claims obvious. Answer 6 (citing Wen abstract, ,r,r 29, 30, 41, 42,
53, 55, 56, Examples, Figure 2). We discern no error in the Examiner's
determinations and adopt the Examiner's rationale and findings of fact.
Appellants argue "Wen does not disclose or suggest that rivastigmine
may be stabilized against degradation in a TTS by the use of specific matrix
polymers lacking hydroxyl and carboxyl groups" and "[ t ]here is no
disclosure, suggestion or motivation in Wen to use a specific polymer matrix
lacking carboxyl and hydroxyl groups in combination with rivastigmine to
form a TTS." Appeal Br. 13. As support, Appellants argue "all of the
formulations actually prepared by Wen included Durotak® 87-2516 which
contains hydroxyl groups. (See the Tables for Examples 1-4 disclosed at
paragraphs [0079] to [0082]." Id. Further, Appellants argue "there is no
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motivation for one of ordinary skill in the art to specifically exclude the
hydroxyl-containing Duro-tak 87-2516 that was used in all of the Wen
Examples and the hydroxyl-containing percutaneous absorption enhancers
disclosed in paragraph [0045] such as aliphatic alcohols and alcohol
amines." Id. at 14.
These arguments are not persuasive. Stabilizing rivastigmine is not a
claim limitation. Wen clearly discloses a transdermal drug delivery device
having layers as claimed. See Wen Figure 2 and related disclosure, e.g.,
,r,r 29--30. As for the claimed drug reservoir polymer matrix without free
hydroxyl and carboxyl groups, Wen discloses polymeric materials, e.g.,
ethylene vinyl acetate (EV A) (i-f 41 ), that would not have such groups
according to the listing of undesirable components in Appellants'
Specification, as discussed above. While Wen states that its active agent
formulation "may contain a percutaneous absorption enhancer" (i-f 43) and
lists several that Appellants' Specification identifies as potentially
introducing free hydroxyl or carboxyl groups to the active layer, it is clear
that this is merely an optional component, which could be included or not.
As for Wen's examples including Durotak® 87-2516, as discussed above, a
reference is not limited to the disclosure of its working examples; Wen also
discloses EV A and Eudagit® E 100 as potential active layer polymers, which
are not evidenced as including free hydroxyl or carboxyl groups. (i1i141--42).
Appellants present no separate arguments over the Wen reference
regarding the other appealed claims. See, e.g., Appeal Br. 15. Therefore, all
claims fall with representative claim 1.
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V. THEREJECTIONOFCLAIMS 10-12, 18-20,AND31 OVER WEN AND
STROEBECK
The Examiner combines Stroebeck with Wen in a similar fashion as
discussed above regarding the Ito-Gargiulo-Wen combination. Again, we
discern no error in the Examiner's determinations.
Appellants argue
[t]he alleged disclosure in Stroebeck fails to cure the above-
stated deficiencies of Wen [regarding the rejection of claim 1].
That is, there is no teaching, suggestion or motivation in either
Wen or Stroebeck to use polymers that are free of hydroxyl and
carboxyl groups in the reservoir layer of a TTS.
Appeal Br. 15. Because we discern no error in the Examiner's
determinations concerning the teachings of Wen, as discussed above, this
argument is not persuasive.
SUMMARY
The obviousness rejections under 35 U.S.C. § 103(a) are each
affirmed.
TIME PERIOD FOR RESPONSE
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
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