Ex Parte Schachter et al

Patent Trial and Appeal Board

Jan 25, 2018

13141094 (P.T.A.B. Jan. 25, 2018)

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.
13/141,094 06/21/2011 Deborah M. Schachter TIP0202USPCT 2534
27777 7590 01/29/2018
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
BECKHARDT, LYNDSEY MARIE
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
01/29/2018 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):
j nju spatent @ corn s .j nj. com
lhowd@its.jnj.com
pair_jnj @ firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DEBORAH M. SCHACHTER, QIANG ZHANG,
LIE YEN ELVIRE COLETTE BAERT, and HAN CUIL.1
Appeal 2017-004147
Application 13/141,094
Technology Center 1600
Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS,
and JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to an
implantable device for delivery of medication which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as Janssen Sciences Ireland
UC, an affiliate of Johnson & Johnson. Appeal Br. 1.
Appeal 2017-004147
Application 13/141,094
STATEMENT OF THE CASE
One of the classes of drugs used to treat HIV are non-nucleoside
reverse transcriptase inhibitors (“NNRTTs”). Spec. 1. For NNRTTs to be
effective, patients must adhere to the treatment protocol to prevent the
development of drug resistant strains. Spec. 1—2. Among the factors
affecting adherence to the treatment protocol are the large number of pills
that need to be ingested (“pill burden”) and the need for taking the drug at
extremely regular intervals. Spec. 2. TMC278, also known as rilpivirine, is
an NNRTI which is currently being evaluated. Id. The present invention is
an implant containing TMC278 which provides for a sustained release of
TMC278 for a prolonged period of time, thereby eliminating the pill burden
and the need for frequent dosing. Spec. 2—3.
Claims 1—6 and 8—22 are on appeal. Claim 1 is illustrative and reads
as follows:
1. A implantable, one-piece device comprising a
biocompatible, biodegradable polymer mixed with TMC278
and with one or more release-enhancing agents selected from
the group consisting of poloxamers, polysorbates, and a
combination of dimethyl sulfoxide (DMSO) and poly(vinyl
pyrrolidone) (PVP), wherein the device contains from 40% to
about 70% by weight of TMC278, wherein the device is to be
administered intermittently at a time interval of at least two
weeks and wherein said implantable, one piece device is
removable.
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The claims stand rejected as follows:
Claim 22 has been rejected under 35 U.S.C. § 112, second paragraph
as being indefinite.
Claims 1—6, 8—14, and 16—22 have been rejected under 35 U.S.C.
§ 103(a) as unpatentable over Baert I,2 in view of Baert II3 Rabin4, and
Schwendeman.5
Claims 1—6, 8, 10, 11, 13, 14, and 16—22 have been rejected under 35
U.S.C. § 103(a) as unpatentable over Gibson6 in view of Baert I and Rabin.
Claim 9 has been rejected under 35 U.S.C. § 103(a) as unpatentable
over Gibson in view of Baert I, Rabin and Schwendeman.
Claim 12 has been rejected under 35 U.S.C. § 103(a) as unpatentable
over Gibson in view of Baert I, Rabin and Nicol.7
Claim 15 has been rejected under 35 U.S.C. § 103(a) as unpatentable
over Gibson in view of Baert I, Rabin and Miller.8
INDEFINITENESS
Appellants have offered no arguments with respect to this rejection.
Therefore we summarily affirm this rejection.
2 Baert et al., WO 2006/106103 A2, published Oct. 12, 2006 (“Baert I”).
3 Baert et al., WO 2007/147882 A2, published Dec. 27, 2007 (“Baert II”).
4 C. Rabin et al., In vitro and in vivo demonstration of risperidone implants
in mice, 98 Schizophr. Res. 66 2008 (“Rabin”). Citations are to the NIH
Public Access manuscript.
5 Schwendeman et al., US 2002/0009493 Al, published Jan. 24, 2002
(“Schwendeman”).
6 Gibson et al., US 2006/0003008 Al, published Jan, 5, 2006 (“Gibson”).
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THE REJECTIONS UNDER 35 U.S.C. § 103(a)
Baert I Combined with Baert II, Rabin and Schwendeman
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that claims 1—6, 8—14, and
16—22 would have been obvious over Baert I combined with Baert II, Rabin
and Schwendeman.
The Examiner finds that Baert I discloses a composition comprising a
biocompatible, biodegradable polymer with TMC278. Final Act. 4. The
composition forms a gel under the skin after injection. Id. The Examiner
finds that Baert I teaches administering the formulation intermittently at an
interval of at least one week. Id.
The Examiner finds that Baert II discloses a composition containing
TMC278 which also includes a surface modifier which can be a poloxamer.
Final Act. 6. The Examiner also finds that Baert II teaches that TMC278 is
present in amounts ranging from 3 to 50%. Id.
The Examiner finds that Rabin teaches the use of implantable drug
delivery systems to ensure compliance with treatment protocols. Final Act.
7. The Examiner finds that Rabin teaches that one advantage of the devices
used in Rabin is that they can be removed. Id.
With respect to Schwendeman, the Examiner finds that Schwendeman
teaches implantable drug delivery systems in the shape of cylinders and
having dimensions which overlap with the claimed ranges.
7 Nicol et al., US 2003/0206910 Al, published Nov. 6, 2003 (“Nicol”).
8 Miller, US 7,526,234 B2, issued Apr. 28, 2009 (“Miller”).
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The Examiner concludes that
It would have been prima facie obvious to one of
ordinary skill in the art at the time the invention was made to
use a cylindrical polymer implant taught by the '496 publication
to administer the formulation taught by the combination of the
T03 publication and the '882 publication as Rabin teaches drug
depots are irreversible, where PLGA sterile implants are
reversible (page 2, second through third paragraph). One of
ordinary skill in the art at the time the invention was made
would have a reasonable expectation of success as the '103
publication teaches the compositions comprise PLGA (page 10,
lines 25-35) and the '496 publication and Rabin teach implants
formed of PLGA (Rabin: abstract; '493: claim 22). [T]he '103
publication teaches the desire for controlled release of the
active agent over a prolonged period (page 10, lines 1-25) and
the '493 publication teaches delivery systems for releasing and
active agent over a prolonged period of time wherein the pH
can be controlled by a basic additive and the desired release rate
can be obtained by the use of a pore forming molecule
(abstract) and have low initial burst release [0007]. One of
ordinary skill in the art at the time the invention was made
would have a reasonable expectation of success in using the
active agent of the '103 publication in the delivery device of the
'493 publication because the '103 publication teaches
encapsulation of the active agent with PLGA (page 10, lines 27-
35) and the '493 publication teaches the device includes the use
of PLGA as the delivery system [0007]. It would have been
obvious to the skilled individual that the cylindrical delivery
system of the '493 publication can be used in place of the
microspheres of the '103 publication because the '493
publication teaches the interchangeability of microspheres and
cylinders for the delivery of active agents [0004],
Pinal Act. 9—10.
Appellants contend that Baert I discloses a drug depot which is neither
a one piece construction nor is removable. Appeal Br. 6. Appellants
contend that one skilled in the art would not have been motivated to use the
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device of Rabin in that there is nothing to suggest that the system in Rabin
would work with TMC278 and that the Specification teaches that the Rabin
system is unsuitable. Appeal Br. 6—7.
Appellants contend that the combined references do not teach or
suggest implantable cylinders with the dimensions recited in the claims.
Appeal Br. 7—8. Appellants argue that one skilled in the art would not have
followed the teachings of Schwendeman in developing the claimed device as
Schwendeman is directed to devices for delivering water soluble drug
compositions and TMC is lipophilic. Appeal Br. 8.
Appellants also contend that the references do not teach or suggest use
of the claimed release enhancing agents. Appeal Br. 8—10.
Finally, Appellants argue that the references would not lead one
skilled in the art to develop a device with the claimed amounts of TMC278
in that Baert I teaches amounts in percentages of weight per volume whereas
the Baert II teaches amounts in term of weight percent. Appeal Br. 10.
Findings of Fact
We adopt as the Examiner’s findings. The following findings are
included for emphasis and reference convenience.
FF1. Baert I teaches the use of a parenteral formulation of TMC278
for the long term prevention of HIV comprising intermittent administration
of the formulation. Baert I 1.
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FF2. Baert I teaches that
the active ingredient TMC278 may be encapsulated into small
polymeric microspheres, which degrade slowly and release the
active ingredient at a controlled 30 rate. One form of
microspheres are those wherein the active ingredient is
encapsulated in a biodegradable polymer such as
polylactide/polyglycolide polymers or copolymers. Another
polymer based technology is the ReGel™ technology from
MacroMed which uses triblock copolymers of poly(lactide-co-
glycolide) and polyethylene glycol. These are thermosensitive
and biodegradable polymers that become a gel upon heating
and return to their original state upon cooling. These
polymers/hydrogels systems are applied as solutions at
administration temperature and become insoluble gels at the
injection site. An insoluble gel depot is formed immediately
upon injection and remains at the site for a period of several
weeks. Drug release is controlled through a combination of
diffusion from and degradation of the polymer.
Baert I 10—11.
FF3. Baert I teaches that the composition may also include
ingredients which promote solubility such as solubilizers and surfactants
including polyethoxylated sorbitan ethers such as Tween 20. Baert I 9.
FF4. Tween 20 is a polysorbate and acts as a release-enhancing agent.
Spec. 7.
FF5. Baert II discloses
pharmaceutical compositions for administration via
intramuscular or subcutaneous injection, comprising micro- or
nanoparticles of the NNRTI compound TMC278, suspended in
an aqueous pharmaceutically acceptable carrier, and the use of
such pharmaceutical compositions in the treatment and
prophylaxis of HIV infection.
Baert II1.
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FF6. Baert II teaches that the composition may comprise TMC278 in
combination with a surface modifier. Baert II 16.
FF7. Baert II teaches the use of poloxamers as surface modifiers
which act as a wetting agent. Baert II 17.
FF8. Baert II teaches that the surface modifier acts as a wetting agent
and as a stabilizer. Baert II 16.
FF9. Rabin teaches that one problem with depot injections is that they
“are irreversible and thus lack flexibility in administration and clinical
management. . . . Depot treatment can also result in prolonged pain at the
injection site, which increases the likelihood that patients will discontinue
treatment.” Rabin 2.
FF10. Rabin teaches that “implants provide a complementary
approach for improved adherence while bypassing the major limitation of
depot formulations — their irreversibility.” Id.
FF11. The implants of Rabin are made with Poly Lactic Co Glycolic
Acid (PLGA) polymers which durable and biodegradable. Id.
FF12. Rabin teaches a drug loading of from 10 to 60 wt. %. Rabin 3.
FF13. The implants of Rabin can be in the shape of rods. Id.
FF14. Schwendeman teaches that
[t]wo injectable polymer configurations are currently used to
deliver peptides and proteins: spherical particles on the
micrometer scale (4 -100 f im), which are commonly referred to
as “microspheres,” and single cylindrical implants on the
millimeter scale (-0.8-1.5 mm in diameter), which we term
“millicylinders.” Both configurations are prepared from the
biocompatible copolymer class, poly(lactide-co-glycolide)
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(PLGA) commonly used in resorbable sutures, and each
configuration has distinct advantages and disadvantages.
Schwendeman 14.
FF15. Schwendeman discloses a microcylinder with a length of 1 cm.
Schwendeman 130.
Principles of Law
[T]he examiner bears the initial burden, on review of the
prior art or on any other ground, of presenting a prima facie
case of unpatentability. If that burden is met, the burden of
coming forward with evidence or argument shifts to the
applicant.
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
The test for obviousness is what the combined teachings of the
references as a whole would have suggested to those of ordinary skill in the
art. In re Keller, 642 F.2d 413, 425 (CCPA 1981).
Analysis
We agree with the Examiner’s conclusion that the subject matter of
the rejected claims would have been obvious to one of skill in the art at the
time the invention was made. Rabin discloses the advantages of using a
drug delivery implant over a drug depot. FF9 & 10. The implants of Rabin
are made of a biocompatible, biodegradable polymer. FF10. BaertI
discloses the intermittent delivery of TMC278 using a drug depot. FF1 & 2.
The composition of Baert I can also include polysorbate to improve the
solubility of TMC278. FF3 & 4. Baert II discloses a composition of
TMC278 with a surface modifier which acts as a wetting agent. FF6—8.
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It would have been obvious to one skilled in the art to use the implant
of Rabin to deliver TMC278 to ensure treatment protocol compliance. The
motivation to use an implant stems from the fact that the implant in Rabin
can be removed as taught by Rabin. Both Baert I and Baert II teach the use
of polysorbates and poloxamers to improve the solubility of TMC278. Thus
it would have been obvious to one skilled in the art to include these
compound in the formulation.
Appellants argue that Baert I does not disclose a one piece design
which is removable that contains the claimed amount of TMC. Appeal Br.
6. Appellants also contend that Baert I does not disclose the use of the
claimed release enhancing agents. We are unpersuaded.
. It is the combined teachings of the references which renders claim 1
obvious. Both Rabin and Schwendeman teach the use of rods which are one
piece devices. FF13—15. Baert I specifically teaches the use of a
polysorbate with TMC278 as a wetting agent. FF3
As to other limitations Appellants contend are missing from Baert I,
as shown above, those limitation are taught by the remaining references.
“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 the prior art as a whole.” In re Merck &
Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Appellants contend that the implant disclosed in Rabin is unsuitable
for release of TMC. Appeal Br. 6—7. Appellants point to example 2 in the
Specification where an implant without a release—enhancing agent exhibited
a delay in releasing the desired amount of TMC 278. Id. Again, Appellants
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have failed to address the teachings of the combined references. As
discussed above, both Baert I and Baert II teach the use of poloxamers and
polysorbates with TMC278.
Appellants argue that one skilled in the art would not be motivated to
substitute the solubility enhancers of Baert I with the surface modifiers of
Baert II, nor would one skilled in the art select the specific compounds
recited in the claims. Appeal Br, 8—9. Again, we are unpersuaded. Baert II
teaches that the surface modifiers act as wetting agents which improve
solubility. FF7 & 8. Baert I specifically identifies Teen 20 as a polysorbate
that can be used as a solubility enhancer. FF3 & 4. Baert II teaches
“[particular surface modifiers are selected from poloxamers.” Baert II17.
Baert specifically claims poloxamers as a surface modifier. Baert II 27,
claim 3. Both Baert I and Baert II provide sufficient guidance to one killed
in the art to select either a poloxamer or a polysorbate to enhance the
bioavailability of TMC278.
Appellants contend that one skilled in the art would not have used
TMC in the ranges claimed in claims 1,17, and 18 in that Baert II used
weight per volume for TMC278 and Baert I uses weight per weight. Appeal
Br. 10. We are unpersuaded. As the Examiner points out, the Specification
does not specify what is meant by “% by weight” and can properly read on a
percent based on weight per volume. As such the teachings of Baert II
overlap with the claimed ranges.
With respect to claims 4, 5, and 6, Appellants contend that one skilled
in the art would not have looked to the teachings of Schwendeman in that
Schwendeman is directed to water soluble drugs whereas TMC278 is
lipophilic. Appeal Br. 8. This argument is unpersuasive. As the Examiner
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points out, Schwendeman uses the same polymer system as the claimed
invention PLGA and as used in Baert I. Ans. 24—25. Thus one skilled in the
art would find the teachings of Schwendeman applicable to TMC278.
CONCLUSION
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claims 1, 4, 5, 6, 17, and 18 would have been
obvious over Baert I combined with Baert II, Rabin and Schwendeman.
Claims 2, 3, 8—14, 16, and 19-22 have not be argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
Gibson Combined with Baert I and Rabin
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that claims 1—6, 8, 10, 11,
13, 14, and 16—22 would have been obvious over Gibson combined with
Baert I and Rabin.
The Examiner finds that Gibson teaches an implantable drug delivery
system comprising a biocompatible, biodegradable polymer mixed with a
drug and one or more release-enhancing agents such as poloxamers. Final
Act. 10—11. The Examiner finds that the device of Gibson can be shaped as
a rod or cylinder and contains up to 40 wt% of the active agent. Id. The
Examiner also finds that the device in Gibson would be removable. Id. at
11. The Examiner finds that Gibson teaches that the active agent is release
over a period of up to 70 days. Id.
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The Examiner finds that Baert I teaches the use of TMC 278 as the
active agent and the desirability to release TMC278 intermittently over a two
week period. Final Act. 13.
The Examiner finds that Rabin teaches using implantable drug
delivery system as opposed to a drug depot can help ensure adherence to the
treatment protocol. Final Act. 14. The Examiner finds that Rabin teaches
drug loadings of from 40 to 90%. Id.
The Examiner concludes that
Based on the teachings of the '008 publication and the
T03 publication, it would have been obvious to include the
active agent TMC278 as taught by the T03 publication in the
drug delivery device as taught by the '008 publication because
the '103 publication teaches administration of TMC278 for the
long term prevention of HIV infection (page 1, lines 5-10) and
the '008 publication teaches controlled release of an active
agent through the implantable device with uniform drug release
[0001]. One of ordinary skill in the art at the time the invention
was made would have had a reasonable expectation of success
in using the drug of the '103 publication in the device of the
'008 publication as the '008 publication teaches essentially any
active agent can be incorporated with the polymer system to
form a device [0054], One of ordinary skill in the art at the time
the invention was made would have a reasonable expectation of
success in using the active agent of the '103 publication in the
device of the '008 publication as the '008 publication teaches
the device formed of PLGA and PEG [0104] and the '103
publication teaches TMC278 being administered in
combination with PLGA and PEG (column 10, lines 30-35).
One of ordinary skill in the art at the time the invention was
made would be motivated to use TMC278 in a cylinder or rod
solid implant as taught by the '008 publication because Rabin
teaches Rabin teaches drug depots are irreversible, where
PLGA sterile implants are reversible (page 2, second through
third paragraph), thus providing motivation to get from the
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injectable depot taught by the '103 publication (abstract, page
10, lines 16-26) to the solid depot of the '008 publication.
Final Act. 15—16.
Appellants contend that the Examiner has not shown why one skilled
in the art would have selected poloxamers from the different release­
enhancing agents recited in Gibson. Appeal Br. 11. Appellants also argue
that one skilled in the art would not have substituted TMC 278 for the active
agents in Gibson in that the agents in Gibson are peptides and are water
soluble whereas TMC 278 is not a peptide and is not water soluble. Appeal
Br. 12.
Findings of Fact
FF16. Gibson discloses
Polymeric devices for controlled release of an active
agent of interest are provided. The devices comprise a
biodegradable polymer system selected from the group
consisting of copolymers and polymeric blends comprising a
hydrophobic component and a hydrophilic component
combined with an active agent. The polymer system does not
form a hydrogel when the device is contacted with an aqueous
system. In addition, the device releases the agent without a lag
period or with a minimal lag period. In this manner, the
polymeric devices of the invention provide for zero order or
linear controlled release of active agents.
Gibson | 8.
FF17. Gibson teaches that the active agent is present in an amount of
up to 40 wt%. Gibson 19.
FF18. Gibson teaches that the device can be shaped as a rod or
cylinder. Gibson 115.
FF19. Gibson teaches that use of water soluble polymers such as
polyethylene glycol and poloxamers. Gibson 143.
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FF20. Gibson teaches that
Essentially any active agent can be incorporated with the
polymer system to form a device according to the present
invention using conventional processes including those
methods described herein. Accordingly, as used herein an
“active agent” can include any compound or composition of
matter which, when administered to an organism (human or
animal subject) induces a desired pharmacologic and/or
physiologic effect by local and/or systemic action. The term
therefore encompasses those compounds or chemicals
traditionally regarded as drugs, biopharmaceuticals (including
molecules such as peptides, proteins, nucleic acids), and
vaccines. The term further encompasses those compounds or
chemicals traditionally regarded as diagnostic agents.
Gibson | 54
FF21. Gibson teaches that the active agents which can be
incorporated into the delivery device include antiviral agents. Gibson | 56.
Principles of Law.
Picking one of a finite number of known solutions to a known
problem is obvious. KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 421
(2007)(“When there is a design need or market pressure to solve a problem
and there are a finite number of identified, predictable solutions, a person of
ordinary skill has good reason to pursue the known options within his or her
technical grasp. If this leads to the anticipated success, it is likely the
product not of innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might show that it
was obvious under § 103”)
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Analysis
As noted above, claim 1 is representative of the rejected claims.
We agree with the Examiner’s conclusion that the subject matter of
claim 1 would have been obvious over Gibson combined with Baert I and
Rabin. Gibson teaches an implantable drug delivery system comprising a
biocompatible polymer and an active agent. FF16. The device also contains
a water soluble polymer which may be a poloxamer. FF17. The active
agent used in Gibson may be an antiviral agent. FF20. The amount of
active agent in Gibson can be up to 40 wt%. FF16. Baert I teaches the use a
drug depot containing TMC278 as an antiviral agent for treatment of HIV.
FF1. Rabin teaches the desirability of using an implantable drug delivery
device over a drug depot to improve adherence to a treatment protocol. FF9
& 10. Rabin teaches the use of a rod shaped drug delivery device containing
10 to 60 wt% of an active agent. FF12 & 13. The combination of references
teach all of the elements of claims 1. Rabin provides the motivation to use
the device of Gibson with the agent of Baert I in that Rabin teaches that use
of an implanted drug delivery device increases adherence to the treatment
protocol. See FF. 9 & 10.
Appellants contend that the Examiner has not provided any reasoning
for why one skilled in the art would select poloxamer from the list of
polymers recited in Gibson. Appeal Br. 11. We are unpersuaded. As the
Examiner points out, Gibson teaches the use of 19 different polymers which
can be used and the water soluble polymer includes poloxamers. Ans. 28;
Gibson 143. We agree with the Examiner that this represents a finite group
of identified options making the selection of a poloxamer obvious.
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Appellants also argue that one skilled in the art would not have used
TMC278 in the device of Gibson in that Gibson uses water soluble peptides
as the active agent and TMS is neither a peptide nor water soluble. Appeal
Br. 11. Again we are unpersuaded. Gibson expressly teaches that any active
agent can be used in the disclosed device and lists compounds other than
proteins, e.g. nucleic acids. FF20. Gibson specifically teaches that antiviral
agents can be used. FF21.
Conclusion
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claim 1 would have been obvious over Gibson
combined with Baert I and Rabin.
Claims 2—6, 8, 10, 11, 13, 14, and 16—22 have not be argued separate
and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
Claims 9, 12, and 15
Claims 9, 12, and 15 have been rejected as obvious over Gibson
combined with Baert I and Rabin, further combined with Schwendeman,
Nicol, or Miller.
Appellants argue that the additional references do not make up for the
deficiencies of Gibson combined with Baert I and Rabin. Appeal Br. 12—13.
As disused above, we do not find any deficiency in the teachings of
the references. Therefore, we affirm these rejections.
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SUMMARY
We affirm the rejections under 35 U.S.C. § 103(a).
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).
AFFIRMED
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