Ex Parte Vogel et al

Patent Trial and Appeal Board

Sep 28, 2018

12122590 (P.T.A.B. Sep. 28, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/122,590 05/16/2008
69821 7590 10/02/2018
MERIT MEDICAL SYSTEMS, INC.
C/0 STOEL RIVES, LLP
ONE UTAH CENTER
201 SOUTH MAIN STREET -- SUITE 1100
SALT LAKE CITY, UT 84111
FIRST NAMED INVENTOR
Jean-Marie Vogel
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.
37621/60603 9157
EXAMINER
KISHORE, GOLLAMUDI S
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
10/02/2018 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):
msbethards@STOEL. COM
patlaw@stoel.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JEAN-MARIE VOGEL and EGISTO BOSCHETTI 1
Appeal2016-006789
Application 12/122,590
Technology Center 1600
Before TONI R. SCHEINER, FRANCISCO C. PRATS, and
SUSAN L.C. MITCHELL, Administrative Patent Judges.
SCHEINER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the Non-Final
Rejection of claims directed to a method of treating prostatic hyperplasia.
The claims have been rejected as obvious. We have jurisdiction under 35
U.S.C. § 6(b ).
We reverse.
1 Appellants identify the Real Party in Interest as BioSphere Medical, Inc.
Appeal Br. 4.
Appeal 2016-006789
Application 12/122,590
BACKGROUND
Therapeutic embolization involves partial or total occlusion of arteries
or veins in order "to correct a dysfunction ... or to stop the blood flow."
Spec. ,r 78. In particular, embolization methods and compositions "are
provided for inhibiting angiogenesis in patients with non-tumorigenic,
angiogenesis-dependent diseases" (id. ,r 41 ), or "non-tumorigenic, non-
angiogenesis-dependent diseases" (id. ,r 42).
The Specification describes, in relevant part, "compositions
comprising bioactive therapeutic factors in association with microspheres as
carriers (which have been coated with or otherwise contain such factors), as
well as methods for using such compositions for active embolization
therapy." Id. ,r 2. Therapeutic embolization may also be "a 'passive'
operation in the sense that no active molecules are carried and/or delivered
where the embolic material is deposited." Id. ,r 78.
STATEMENT OF THE CASE
Claims 1, 2, 8-10, 18, 19, 23, 25-34, and 40-43 are on appeal; claims
3-7, 11-17, 20-22, 24, and 35-39 have been canceled. Independent claims
1, 29, and 40 are representative and read as follows:
1. A method of reducing the blood supply to a
prostate of a patient to treat a hyperplasia, comprising
administering to the prostate of the patient biocompatible,
hydrophilic and substantially spherical microspheres
compnsmg
(i) an acrylamide, acrylate, or acrylic polymer or
copolymer, and
(2) a drug,
wherein the drug is associated with the polymer by an
ionic interaction, and wherein the diameter of the microspheres
ranges from 10 µm to 2000 µm.
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29. A method of treating a benign hyperplasia in the
prostate of a patient by embolization, said method comprising
administering to the prostate of the patient,
biocompatible, hydrophilic and substantially spherical
microspheres comprising an acrylamide polymer,
wherein the diameter of the microspheres ranges from
10 µm to 2000 µm.
40. A method of treating a benign hyperplasia in the
prostate of a patient by embolization, said method comprising
administering to the prostate of the patient, biocompatible and
substantially spherical polymer microspheres, wherein the
diameter of the micro spheres ranges from 10 µm to 2000 µm.
In rejecting the claims, the Examiner relies on the following evidence:
Okada et al.
Boschetti et al.
("Boschetti '215")
Boschetti et al.
("Boschetti '100")
us 5,202,352
us 6,635,215
us 5,648,100
Amsden et al. US 6,224,794 Bl
Garibaldi et al. US 6,364,823 Bl
Hunter et al. US 2003/0203976 Al
Amberg et al. US 2013/0261431 Al
Hori JP 60 56676 A
(English language translation ("Hori-II"))
Apr. 13, 1993
June 3, 1997
July 15, 1997
May 1, 2001
Apr. 2, 2002
Oct. 30, 2003
Oct. 3, 2013
Mar. 1, 1994
Shuji Kitamura et al., Polymer with a High Water Absorption Property-
Sumika Gel, SUMITOMO CHEMICAL 1-9 (1980) ("Kitamura").
Yao Jiaqi et al., A New Embolic Material: Super Absorbent Polymer (SAP)
Microsphere and Its Embolic Effects, 56 NIPPON ACTA RADIOLOGICA 19-24
(1996) ("Jiaqi").
Shinichi Hori et al., Study on the Effect of Arterial Embolism with Super-
Absorbent polymer, 11 JAPANESE J. INTERVENTIONAL RADIOLOGY 375-381
(1996) ( citations are to English language translation, pages 1-11) ("Hori-I").
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Application 12/122,590
Appellants rely on the following additional evidence:
Francisco Cesar Carnevale et al., Prostatic Artery Embolization as a
Primary Treatment for Benign Prostatic Hyperplasia: Preliminary Results
in Two Patients, 33 CARDIOVASC INTERVENT RADIOL 355-361 (2010)
("Carnevale")
Declaration of Dr. Melodie Domurad, submitted under 37 C.F.R. § 1.132,
dated November 30, 2012 ("Domurad Declaration" or "Domurad Deel.")
Declaration of Dr. Shivank Bhatia, submitted under 3 7 C.F .R. § 1.132, dated
March 30, 2015 ("Bhatia Declaration" or "Bhatia Deel.")
The claims stand rejected under 35 U.S.C. § 103(a) as follows:
Claim(s) Reference( s)
I 1, 2, 8-10, 18, 19, Hunter
23,25,40,41,43
II 29,30,40,41,43 Boschetti ' 100
III 29-32 Hunter and Boschetti '215
IV 1, 8-10, 18, 19, 23, Hunter and Kitamura, Jiaqi, or Hori-I
25,40-43
V 25-28,31-34 Hunter alone, or further in view of
Kitamura, Jiaqi, or Hori-I, and further in
view of Garibaldi
VI 25-28,31-34 Boschetti '100, Hunter, and Garibaldi
VII 1, 2, 8-10, 18, 19, Okada and Kitamura, optionally in view of
23,25-34,40-43 Hunter and/ or Boschetti ' 100
VIII 1, 2, 8-10, 18, 19, Okada and Jiaqi or Hori-I
23,25-28,34,40-43
IX 1, 2, 8-10, 18, 19, Hori-II and Okada
40-43
X 10 Okada and Kitamura; or Okada and Jiaqi or
Hori-I; or Boschetti '100 alone, or in
combination with Hunter, and further in
view of Amsden
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THE PRIOR ART
Hunter
Hunter discloses "methods for treating cancer and other angiogenic-
dependent diseases, and more specifically, to compositions comprising anti-
angiogenic factors and polymeric carriers, stents which have been coated
with such compositions, as well as methods for utilizing these stents and
compositions." Hunter ,r 2. In other words, Hunter discloses microspheres
coated with anti-angiogenic agents, and also discloses stents coated with
anti-angiogenic agents.
Hunter teaches that "there are a number of clinical situations
(e.g., bleeding, tumor development) where it is desirable to reduce or abolish
the blood supply to an organ or region" (id. ,r 167), and also teaches that
"benign and malignant tumors may be embolized utilizing [these]
compositions" (id. ,r 176). Hunter teaches that "this may be accomplished
by injecting anti-angiogenic compositions ... into a desired blood vessel,"
thereby "occluding the blood vessel." Id. ,r 167. Hunter explains that "the
reduced or abolished blood flow to the selected area results in infarction
( cell death due to an inadequate supply of oxygen and nutrients) or reduced
blood loss from a damaged vessel." Id. "In addition to this effect, the
presence of an anti-angiogenic factor(s) prevents the formation of new blood
vessels to supply the tumor or vascular mass, enhancing the devitalizing
effect of cutting off the blood supply." Id. ,r 173.
Hunter does not discuss embolization of benign prostatic hyperplasia,
or indicate that BPH is included in the conditions treatable by embolization.
Hunter does, however, teach that "[ e ]xtrinsic narrowing of the urethra as it
passes through the prostate, due to hypertrophy of the prostate," i.e., BPH,
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Application 12/122,590
may be treated by "inserting a urethral stent into a urethra, the stent having a
generally tubular structure ... coated with an anti-angiogenic composition,
such that the urethral obstruction is eliminated." Id. ,r 196.
Boschetti 'JOO and Boschetti '215
Boschetti '100 discloses "calibrated and adhesive particles, especially
suited to embolization" of "tumors, vascular malformations, hemorrhagic
processes, etc." Boschetti '100, 1: 8-9, 15-16. The embolic particles
comprise nonresorbable and nonbiodegradable microspheres composed of a
hydrophilic acrylic copolymer, with diameters ranging between about 10 to
about 2,000 µm, and coated with a cell adhesion promoter. Id. at 1 :49-63.
The disclosure ofBoschetti '215, in relevant part, is the same as that
of Boschetti '100.
Okada
Okada "relates to a therapeutic agent for the treatment of cancer
which forms emboli in the vascular system surrounding the cancer lesion or
tumor. The agent comprises an intravascular embolizing substance and an
angiogenesis-inhibiting substance. Okada, 1 :8-12. The embolizing
substance may comprise microspheres made from copolymers of acrylic acid
and vinyl alcohol. Id. at 7:62---68, 9: 1.
Okada teaches that "the intravascular embolizing agent ... is effective
for the chemotherapy by intraarterial injection ... to tumors including
hepatic tumor, renal tumor, pyelo tumor, pancreatic tumor, urinary bladder
tumor, prostatic tumor, breast cancer, stomach cancer, large intestinal tumor,
colonic tumor, etc." Id. at 11 :62---68.
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Kitamura
Kitamura discloses "a polymer (Sumika Gel®) with a high water
absorption property mainly composed of a vinyl alcohol-acrylate
copolymer." Kitamura 7. Kitamura teaches that "Sumika Gel in a fine
powder state exhibits considerable thickening [ viscosity improving] effect
when it absorbs water" (id. at 19), and suggests the gel would be useful as a
water retention agent for agriculture, an absorbent for sanitary materials, a
perfume carrier, a drying agent, and a thickening agent (id. at 20-22).
Kitamura does not disclose microspheres made from the gel, nor does
the reference discuss using the gel as an embolizing agent.
Hori-I, Hori-II, and Jiaqi
These three references discuss multiple advantages of the SAP-
microsphere, an arterial embolic material comprising particles of a super
absorbing sodium acrylic acid-vinyl alcohol copolymer.
For example, according to Hori-I:
After embolization and even after 16 weeks, the SAP-
Microsphere retains the spherical shape in the artery. Its
destruction [decomposition] was not observed ... [I]f the SAP-
Microsphere is used as the embolization material, ... there is
no problem in classifying it as a long-term-use embolus
material.
Hori-I, 11.
Garibaldi
Garibaldi discloses an embolic agent "for treating vascular defects
such as aneurysms." Garibaldi, Abstract. The embolic agent comprises a
mixture of a biocompatible polymer material ( e.g., polymethylmethacrylate ),
a biocompatible solvent, an adhesive, and magnetic particles ( e.g., iron or
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iron oxide) for controlling the delivery of the embolic agent. Id. at 3:56-67,
12: 17-26. The embolic agent may also include radiopaque particles, which
may be the magnetic particles, to facilitate imaging the embolic material. Id.
at 4:16-20.
Amsden
Amsden discloses microspheres suitable for embolization to treat
vascular diseases, and teaches that the microspheres may also be used to
deliver a bioactive agent, e.g., an antibiotic, to a subject in need of treatment.
Amsden, 13:58-14: 11.
DISCUSSION
The dispositive issue raised by each of Rejections I-Xis whether the
Examiner has established by a preponderance of the evidence that it would
have been obvious for one of ordinary skill in the art to use embolization to
treat hyperplasia of the prostate (i.e., benign prostatic hyperplasia, or BPH).
Rejection I
Claims 1, 2, 8-10, 18, 19, 23, 25, 40, 41, and 43 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Hunter (Ans. 2).
The Examiner finds that Hunter "teaches that both benign and
cancerous tumors can be treated using arterial embolization," and discloses
"anti-angiogenic compositions (microspheres)" for that purpose. Ans. 2
(citing Hunter,r,r 151, 155,156,159, 166-178, Abstract, Example 8). The
Examiner acknowledges that "Hunter does not specifically teach through
examples the use of polymethyl methacrylate microspheres," but concludes
that "it would have been obvious to one of ordinary skill in the art to use this
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polymer for the preparation of microspheres from the guidance provided by
Hunter in Example 8, manufacture of microspheres." Id.
Appellants contend that the claims are directed to embolization of "a
benign hyperplasia in the prostate of a patient, also known as benign
prostatic hyperplasia (BPH)" (Appeal Br. 8), but Hunter makes no mention
of BPH, "which is not a tumor, benign or malignant" (id. at 14 ( citing Bhatia
Deel. ,r 6)). Appellants contend that "the Examiner's assertions are based on
an impermissibly broad interpretation of Hunter" (id. at 13), and Hunter does
not "disclose or even suggest that the principles of embolization could be
used in the treatment of benign prostate hyperplasia" (id. at 13-14).
Appellants, relying on Dr. Bhatia's Declaration,2 additionally contend
that "benign prostatic hyperplasia has a pathogenesis that differs from that of
a tumor" (id. at 15 ( citing Bhatia Deel. ,r,r 6-11) ), and "traditional methods
of treating benign prostate hyperplasia also differ significantly from methods
of treating tumors, and thus one would not look to use methods of treating
tumors (benign or malignant) for use in treating benign prostate hyperplasia"
(id. at 16 ( citing Bhatia Deel. ,r,r 12-24) ). In particular, Appellants attest
that "none of the traditional treatment therapies for benign prostate
hyperplasia discussed by Dr. Bhatia alter the dynamics of blood flow to the
prostate gland." Id. (citing Bhatia Deel. ,r 25).
Briefly, according to Dr. Bhatia, "[t]he pathogenesis of BPH is very
different from that of tumors" (Bhatia Deel. ,r 7) and involves "the
2 Dr. Bhatia asserts that his experience includes "working with patients with
benign prostatic hyperplasia (BPH), and ... patients with various types of
cancers, both benign and malignant" and also "working with various
embolic agents." Bhatia Deel. ,r 2.
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proliferation of normal cells ... [which] appear identical to normal cells but
are increased in number leading to organ enlargement" (id. ,r 10). Dr. Bhatia
explains that BPH is at least partially dependent on androgens, e.g.,
dihydrotestosterone (DHT), the biologically active form of testosterone (id.
,r,r 8, 10), and that the cells in BPH "remain subject to normal regulatory
control mechanisms, while neoplastic growths involve genetically abnormal
cells proliferating in a non-physiological manner that is unresponsive to
normal stimuli" (id. ,r 11 ).
More importantly, Dr. Bhatia asserts that "one of ordinary skill in the
art would not have been led to employ methods of embolization in the
treatment of BPH" because "BPH is not a hypervascular tumor and therefore
does not selectively take up the embolic materials" (id. ,r 33); "angiogenesis
has never been implicated in the pathophysiology of BPH" (id. ,r 25); and
"none of the traditional treatment therapies for BPH described above alter
the dynamics of blood flow to the prostate gland" (id.). For example,
Dr. Bhatia contends that "[t]raditional treatment strategies for BPH can be
broadly divided into two categories" (id. ,r 16): lifestyle/medical
management, and surgical treatment (id.). For example, BPH may be treated
with medications promoting relaxation of the prostatic smooth muscle and
bladder neck (e.g., al-adrenergic receptor antagonists) (id.), or medications
preventing the conversion of testosterone to DHT (e.g., 5a-reductase
inhibitors) (id. ,r 17). In addition, surgical options for BPH include
transurethral resection of the prostate, laser therapy, transurethral microwave
thermotherapy, and transurethral needle ablation. Id. ,r 19.
The Examiner does not address Dr. Bhatia' s Declaration in any
meaningful way, but responds that Amberg, a post-filing date reference,
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provides evidence "that some in the art would consider BPH as a benign
tumor as opposed to [a] malignant tumor (cancer)." Ans. 11 ( citing Amberg
,r,r 2, 34, 52, wherein the phrase "BPH tumor" appears). 3 The Examiner also
contends that "the name itself indicates BPH is a benign tissue of
hyperplastic prostate gland." Id. at 8. Further in response, the Examiner
contends that "Hunter teaches in paragraph 0167 that there are a number of
clinical situations (e.g. bleeding, tumor development) where it is desirable to
reduce or abolish the blood supply to an organ or region." Id. at 12.
According to the Examiner, "[ t ]his statement certainly implies that one could
use the process of embolization in blood vessels in prostatic hyperplasia
situations also ... since blood vessels are present whether the tumor is
malignant or benign or whether the tissue has hyperplasia." Id.
Whether or not benign prostatic hyperplasia is properly classified as a
benign tumor, we agree with Appellants that the Examiner's assertions are
based on an unreasonably broad interpretation of Hunter, and the Examiner
has not established a commonality between the pathogenesis and/or
conventional treatment of benign prostatic hyperplasia and any of the
conditions discussed in Hunter, such that one of ordinary skill in the art
would have a reason look to embolization for treatment of benign prostatic
hyperplasia. That being the case, the Examiner's assertion that "Hunter
teaches ... that there are a number of clinical situations ( e.g. bleeding,
3 We note that Carnevale, a reference cited by Appellants as "[ e ]vidence
that the claimed methods of treating BPH are effective" (Domurad Deel.
,r 9), also refers to BPH as a tumor. For example, Carnevale indicates that
"[ s ]ymptomatic benign prostatic hyperplasia (BPH) typically occurs in the
sixth and seventh decades, and more than 40% of men older than this present
with clinical manifestations of this tumor." Carnevale 355.
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tumor development) where it is desirable to reduce or abolish the blood
supply to an organ or region" (Ans. 12) is beside the point.
We determine that the Examiner has not shown by a preponderance of
the evidence that one of ordinary skill in the art would have had a reason to
treat benign prostatic hyperplasia using embolization. Accordingly, the
rejection of claims 1, 2, 8-10, 18, 19, 23, 25, 40, 41, and 43 as unpatentable
over Hunter is reversed.
Rejections II & III
Claims 29, 30, 40, 41, and 43 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Boschetti '100 (Ans. 2-3); and claims 29-32 stand
rejected under 35 U.S.C. § 103(a) as unpatentable over Hunter and Boschetti
'215 (Ans. 3).
Rejection II, in its entirety, is as follows:
Boschetti teaches various acrylate polymers acrylamide
copolymer microspheres for embolization concerning blood
vessels of various processes including vascular malformations,
tumors, hemorrhagic processes etc. ( col. 1, line 5 through col.
2, line 59, Examples and claims). Although Boschetti does not
specifically teach embolization of blood vessels in benign
prostatic hyperplasia tissue, in the absence of showing
unexpected results it is deemed obvious to one of ordinary skill
in the art to use Boschetti's microspheres in the treatment of
BPH since the principle[] of embolization is the same.
Ans. 3.
Rejection III, in its entirety, is as follows:
The teachings of Hunter have been discussed above.
What is lacking in Hunter is use of micro spheres of acrylamide
polymer.
Boschetti ['215] similar to Boschetti ['100] teaches
various acrylate polymers acrylamide copolymer microspheres
for embolization concerning blood vessels of various processes
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including vascular malformations, tumors, hemorrhagic
processes etc. ( col. 1, line 5 through col. 2, line 59, Examples
and claims).
The use of micro spheres of acrylamide copolymer in
Hunter would have been obvious to one of ordinary skill in the
art with a reasonable expectation of success since Boschetti
['215] teaches hydrophilic acrylates and acrylamide
microspheres could be used for embolization.
Ans. 3.
With respect to Rejection II, Appellants contend that "Boschetti
[' 100], like Hunter, does not disclose methods of 'treating a benign
hyperplasia in the prostate of a patient by embolization"' (Appeal Br. 19),
and "nowhere does Boschetti ['100] disclose or even suggest that the
principles of embolization could be used in the treatment of benign prostate
hyperplasia" (id.). Appellants contend that the Examiner's rejection is
flawed "for reasons analogous to those set forth above with respect to the
first rejection." Id. at 20.
Similarly, with respect to Rejection III, Appellants contend that the
Examiner's rejection is flawed "for reasons analogous to those set forth
above with respect to the first rejection." Id.
The Examiner's response is "the same response ... as discussed
above for Hunter's teachings." Ans. 14, 15.
As discussed above, Boschetti '100 discloses particles suitable for
embolization of "tumors, vascular malformations, hemorrhagic processes,
etc." Boschetti '100, 1:15-16. Boschetti '215's disclosure is the same.
Boschetti '215, 1: 14--15. Thus, the Boschetti references disclose no more
than Hunter with respect to conditions treatable by embolization.
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With respect to Rejections II and III, we determine that the Examiner
has not shown by a preponderance of the evidence that one of ordinary skill
in the art would have had a reason to treat benign prostatic hyperplasia using
embolization, for the same reasons discussed above in connection with
Rejection I.
Accordingly, rejections II and III are reversed.
Rejections IV-VI
Claims 1, 8-10, 18, 19, 23, 25, and 40-43 stand rejected as
unpatentable over Hunter and Kitamura, Jiaqi, or Hori-I (Ans. 4); claims
25-28 and 31-34 stand rejected as unpatentable over Hunter alone, or
further in view of Kitamura, Jiaqi, or Hori-I, and further in view of Garibaldi
(Ans. 4--5); and claims 25-28 and 31-34 stand rejected as unpatentable over
Boschetti '100, Hunter, and Garibaldi (Ans. 5---6).
In these three rejections, the Examiner relies on the teachings of
Hunter and/ or Boschetti '100 as evidence that one of ordinary skill in the art
would have had a reason to use embolization to treat BPH.
Again, we agree with Appellants that Rejections IV-VI are flawed
"for reasons analogous to those set forth above with respect to the [previous]
rejections" (Appeal Br. 21 ), and the teachings of Kitamura, Jiaqi, Hori-I, and
Garibaldi do not remedy the underlying deficiencies.
Accordingly, Rejections IV, V, and VI are reversed.
Re} ections VII-X
Claims 1, 2, 8-10, 18, 19, 23, 25-28, 34, and 40-43 stand rejected as
unpatentable over Okada and Kitamura, optionally in view of Hunter and/or
Boschetti '100 (Ans. 6-8); claims 1, 2, 8-10, 18, 19, 23, 25-28, 34, and 40-
43 stand rejected as unpatentable over Okada and Jiaqi or Hori-I (Ans. 8-9);
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claims 1, 2, 8-10, 18, 19, and 40-43 stand rejected as unpatentable over
Hori-II and Okada (Ans. 9-10); and claim 10 stands rejected as unpatentable
over Okada and Kitamura; or Okada and Jiaqi or Hori-I; or Boschetti '100
alone, or in combination with Hunter, and further in view of Amsden (Ans.
10-11).
In these four rejections, the Examiner relies on the teachings of
Hunter and/ or Boschetti '100 and/ or Okada as evidence that one of ordinary
skill in the art would have had a reason to use embolization to treat BPH.
The Examiner's contentions with respect to Hunter and Boschetti '100
are discussed above. With respect to Okada, the Examiner contends, in
relevant part, that Okada discloses "microsphere compositions for
embolizing vascular structures in tumors including prostate tumors" (Ans.
6), but acknowledges that "Okada does not specifically teach the nature of
the prostate tumors" (id.). That being the case, we find that Okada discloses
no more than Hunter or Boschetti '100 with respect to conditions treatable
by embolization.
Again, we agree with Appellants that Rejections VII-X are flawed
"for reasons analogous to those set forth above with respect to the [previous]
rejections" (Appeal Br. 22, 23), and the teachings of Kitamura, Jiaqi, Hori-I,
and Amsden do not remedy the underlying deficiencies.
Accordingly, Rejections VII, VIII, IX, and X are reversed.
SUMMARY
Rejections I-X of claims 1, 2, 8-10, 18, 19, 23, 25-34, and40-43
under 35 U.S.C. § 103(a) are reversed.
REVERSED
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