Ex Parte Zurbriggen et al

Patent Trial and Appeal Board

Mar 31, 2016

11823713 (P.T.A.B. Mar. 31, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111823,713 06/28/2007
78905 7590 04/04/2016
Saul Ewing LLP (Philadelphia)
Attn: Patent Docket Clerk
Centre Square West
1500 Market Street, 38th Floor
Philadelphia, PA 19102-2186
FIRST NAMED INVENTOR
Rinaldo Zurbriggen
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.
046549-5018US1 (00002) 1524
EXAMINER
POPA, ILEANA
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
04/04/2016 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):
patents@saul.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RINALDO ZURBRIGGEN, MARIO AMACKER, and SIL VIA
RASI 1
Appeal2013-008840
Application 11/823,713
Technology Center 1600
Before ERIC B. GRIMES, JACQUELINE T. HARLOW, and
RICHARD J. SMITH, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
biologically active composition. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We affirm.
1 According to Appellants, the real party in interest is Pevion Biotech Ltd.
(Br. 3.)
Appeal2013-008840
Application 11/823,713
STATEMENT OF THE CASE
Claims on Appeal
Claims 42, 45-59, 67-73 and 75-83 are on appeal. (Br. 102-108.)
Claims 42 and 45 are the independent claims, and claim 42 is illustrative:
42. A biologically active composition comprising at least one
immunopotentiating reconstituted influenza virosome (IRIV) and a cationic
cholesterol derivative:
wherein said cationic cholesterol derivative is present in the
membrane of the virosome;
further wherein said cationic cholesterol derivative has a positively
charged substituent in the 3-position of the cholesterol and is represented by
the following formula:
(I)
wherein R is selected from the group consisting of R'; R'- (C=O) -;
R'-0- (C=O) -; R'-NH- (C=O) -; R'-0- (C=O) -R"- (C=O) -;
R'-NH- (C=O) -R"- (C=O) -, wherein R' is C1-C6-alkyl being
substituted by at least one positively charged group, wherein said
positively charged group is an N-containing group of the formula
RiR2R3 N+- and the respective counter ion is x-; wherein Ri, R2
and R3 are independently selected from the group consisting of
hydrogen and C1-C6- alkyl; wherein x- is selected from the group
consisting of halogen, hydrogen sulphate, sulfonate, dihydrogen
phosphate, acetate, trihaloacetate and hydrogen carbonate;
and wherein R" is C1-C6-alkylene; and,
wherein the fusion activity of said virosome is preserved when said
composition is lyophilized and reconstituted.
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Examiner's Rejections
1. Claims 42, 45-52, 57-59, 67-73, and 75-82 stand rejected under 35
U.S.C. § 103(a) as obvious over Gluck '685,2 Kaneda, 3 and Panzer.4 (Ans.
6.)
2. Claims 42, 45--47, 50-55, 57-59, 67-73, and 75-82 stand rejected
under 35 U.S.C. § 103(a) as obvious over Gluck '685, Kaneda, Panzer, and
Anchordoquy.5 (Id. at 8-9.)
3. Claims 42, 45--47, 50-52, 56-59, 67-73, and 75-83 stand rejected
under 35 U.S.C. § 103(a) as obvious over Gluck '685, Kaneda, Panzer, and
Gluck.6 (Id. at 9.)
4. Claims 42, 45, 46, 48, 49, 57, 59, 67-73, and 75-79 stand rejected
under 35 U.S.C. § 103(a) as obvious over Kaneda, Markgraf,7 and
Bungener.8 (Id. at 10.)
2 Gluck et al., US 5,879,685, issued Mar. 9, 1999 ("Gluck '685").
1. TT 1 TT• 7 , • f' , 7 7 • , , 1 1 1 7 •
~ 1\ .. aneaa, vzrosomes: evotunon OJ rne tzposome as a rargerea arug aetzvery
system, ADVANCED DRUG DELIVERY REVIEWS 43, 197-205 (2000)
("Kaneda").
4 Panzer et al., US 2003/0099697 Al, published May 29, 2003 ("Panzer").
5 Anchordoquy et al., Maintenance of Transfection Rates and Physical
Characterization of Lipid/DNA Complexes after Freeze-Drying and
Rehydration, 348 ARCHIVES OF BIOCHEMISTRY AND BIOPHYSICS 1, 199-206
(1997) ("Anchordoquy").
6 Gluck et al., Phase 1 Evaluation of Intranasal Virosomal Influenza Vaccine
with and without Escherichia coli Heat-Labile Toxin in Adult Volunteers,
73 JOURNAL OF VIROLOGY 9, 7780-86 (1999) ("Gluck").
7 Markgraf et al., Lipid Composition of Virosomes Modulates Their Fusion
Efficiency with Cryopreserved Bull Sperm Cells, 3 CLONING 1, 11-21 (2001)
("Markgraf').
8 Bungener et al., Delivery of Protein Antigens to the Immune System by
Fusion-active Virosomes: A Comparison with Liposomes and ISCOMs,
22 BIOSCIENCE REPORTS 2, 323-38 (2002) ("Bungener").
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5. Claims 42, 45--49, 57, 59, 67-73, and 75-79 stand rejected under 35
U.S.C. § 103(a) as obvious over Kaneda, Markgraf, Bungener, and Panzer.
(Id. at 11.)
6. Claims 42, 45, 46, 48-52, 57-59, 67-73, and 75-82 stand rejected
under 35 U.S.C. § 103(a) as obvious over Kaneda, Markgraf, Bungener, and
Gluck '685. (Id. at 12.)
7. Claims 42, 45, 46, 48, 49, 53-55, 57, 59, 67-73, and 75-79 stand
rejected under 35 U.S.C. § 103(a) as obvious over Kaneda, Markgraf,
Bungener, and Anchordoquy. (Id. at 13.)
8. Claims 42, 45, 46, 48, 49, 57, 59, 67-73, and 75-79 stand rejected
under 35 U.S.C. § 103(a) as obvious over Kaneda, Markgraf, Bungener, and
Gluck. (Id. at 14.)
9. Claims 42, 45-57, 67-73, and 75-82 stand provisionally rejected on
the ground of nonstatutory obviousness-type double patenting over claims 1
and 4-13 of copending Application No. 12/086,315.9 (Id. at 15.)
As to the double patenting rejection, Appellants present arguments for
the patentability of claims 42 and 45. (Br. 80-86.) Therefore, we limit our
discussion to claims 42 and 45, with claims 46-57, 67-73, and 75-82
standing or falling with those claims.
FINDINGS OF FACT
We adopt the Examiner's findings and analysis concerning the scope
and content of the prior art. The following findings are included for
emphasis and reference convenience.
9 Application No. 12/086,315 issued as US 8,496,962 on July 30, 2013
("Zurbriggen"). We address the double patenting rejection based on claims
1 and 4-13 of Zurbriggen.
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FF 1. The Examiner finds that Gluck '685 teaches "a biologically active
composition comprising IRIV s and an antigen, wherein the IRIV s comprise
phosphatidylcholine and phosphatidylethanolamine in a ratio of 4: 1 and the
antigen is attached on the IRIV surface." (Ans. 6.)
FF 2. The Examiner finds that Kaneda teaches adding DC-Chol10 to
virosomes, and further that Kaneda teaches a biologically active composition
comprising virosomes that comprise the Sendai virus fusogenic envelope
and DC-Chol. (Id. at 7, 10.)
FF 3. The Examiner finds that Panzer teaches that DC-Chol and TC-Chol 11
have similar properties and can be used interchangeably to prepare
liposomes. (Id. at 7.)
FF 4. The Examiner finds that Anchordoquy teaches that cryopreserving
liposome/DNA complexes requires sucrose or trehalose as a lyoprotectant.
(Id. at 9.)
FF 5. The Examiner finds that Gluck teaches an adjuvant in the form of
adding E.coli heat-labile toxin (HLT) to virosomes. (Id. at 10.)
FF 6. The Examiner finds that Markgraf and Bungener teach that IRIVs are
superior to the virosomes generated from Sendai viruses. (Id. at 10-11.)
ISSUES
Whether a preponderance of evidence of record supports the
Examiner's conclusion of (1) obviousness under 35 U.S.C. § 103(a), and
(2) obviousness-type double patenting.
10 DC-Chol refers to 3-beta{N-(N', N' -dimethylaminoethane)-
carbamoyl}cholesterol. (Kaneda, 199, left col.)
11 TC-Chol refers to 3-B-[N-(N', N', N'-trimethylaminoethane) carbamoyl
cholesterol. (Panzer, ,-i 31.)
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DISCUSSION
Obviousness Under 35 U.S.C. § 103(a)
Principles of Law
The Examiner bears the initial burden of establishing a prima facie
case of obviousness. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Analysis
The Examiner sets forth eight separate obviousness rejections. For
each rejection, we find that the Examiner has satisfied the burden of showing
"some articulated reasoning with some rational underpinning to support the
legal conclusion of obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S.
398, 418 (2007). Moreover, the Examiner has established a prima facie case
of obviousness and, as discussed below, Appellants have not overcome that
prima facie case.
Appellants advance several arguments in response to specific
rejections, and those arguments are addressed below. However, where
Appellants fail to specifically address the basis for a rejection, rely on
arguments previously advanced, or do not separately argue rejected claims,
we will affirm those rejections without additional analysis. See 37 C.F.R. §
41.37(c)(l)(iv); Hyatt v. Dudas, 551F.3d1307, 1314 (Fed. Cir. 2008).
Rejection No. 1
The Examiner concluded that the claims were obvious based on the
combined teachings of Gluck '685, Kaneda, andPanzer. 12 (Ans. 6-8.)
Furthermore, the Examiner found that "kits" were in use in the art prior to
the claimed invention. (Id. at 8.)
12 Appellants refer to Gluck '685 as "Gluck II" and Panzer as "Panzer II."
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The Examiner also found that the recitations in claims 42, 45, 73, and
75 relating to preserving IRIV fusion activity or "for enhancing the
reconstitutability of said virosome after lyophilisation" were merely
descriptions of the properties that naturally flow from combining the
teachings of the prior art. (Id.) For emphasis, we agree that such language
merely states a property of a composition as claimed (e.g., including a
cationic cholesterol derivative), and thus adds nothing to the patentability or
substance of the claims. See Texas Instruments Inc. v. U.S. Int 'l Trade
Comm 'n, 988 F.2d 1165, 1172 (Fed. Cir. 1993).
Claim 42
1. Appellants argue that a composition based on a combination of
Gluck '685 and Kaneda "would have at least two glycerol-phospholipids and
cholesterol ... as strictly required components" whereas "claim 42 does not
require at least two glycerol-phospholipids and cholesterol." (Br. 16.)
However, use of the open-ended term "comprising" in claim 42 permits
phospholipids (and cholesterol) to be added without falling outside the scope
of the claims. See Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed.
Cir. 1997).
2. Appellants argue that Kaneda teaches away from the claimed
invention. (Br. 16-17.) In particular, Appellants point to a section in
Kaneda for the proposition that "a virosome comprising a positively charged
cholesterol derivative is much less efficient in in vivo delivery than a
corresponding non-modified virosome." (Id. at 17.) Appellants also argue
that Kaneda teaches that "positively charged constructs are generally toxic
while the corresponding negatively charged constructs are not." (Id.)
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We are not persuaded by Appellants' arguments. "[l]n general, a
reference will teach away if it suggests that the line of development flowing
from the reference's disclosure is unlikely to be productive of the result
sought by the applicant." In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
That is not the case here. The section of Kaneda relied upon by Appellants
is followed by the sentence "[h ]owever, we recently found that HVJ-cationic
liposomes were more effective for in vivo gene transfer in some cases"
followed by examples. 13 (Kaneda, 202, left col.) Kaneda also states that
"HVJ-cationic liposomes were 100 times more effective in luciferase gene
expression than the anionic liposomes." (Id. at 201, left col.) Moreover,
Kaneda states that " [ n] ew virosome vectors will possess the properties
of ... lessened toxicity derived from liposomes." (Id. at 202, right col.)
Accordingly, Kaneda does not teach away from the claimed invention.
3. Appellants argue that Panzer does not cure the deficiencies of
Gluck '685 and Kaneda, and that Panzer teaches away from the claimed
invention. (Br. 18.) However, Panzer was cited for the teaching that DC-
Chol and TC-Chol have similar properties and can be used interchangeably.
(FF 3; Ans. 7.) Moreover, notwithstanding the limitations of certain
liposomes referenced in paragraph 7 of Panzer, Panzer does not "teach
away" because the nature of its teaching is not such that a person of ordinary
skill would be led "in a direction divergent from the path that was taken by
the applicant." See Gurley, 27 F.3d at 553.
13 HVJ refers to hemagglutinating virus of Japan or the Sendai virus.
(Kaneda, 199, right col.) HVJ-liposomes are virosomes. (Id. at 202, right
col.)
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4. Appellants argue "unexpected results" and "long-felt need."
These arguments are unpersuasive for the reasons set forth below under the
headings "Unexpected Results" and "Long-Felt Need."
Claim 45
Appellants make the same arguments as set forth above in connection
with claim 42, and they are unpersuasive for the reasons set forth above.
Dependent Claims
Appellants' responses to the rejection of the dependent claims rely on
the same arguments as set forth above, and the claims are not separately
argued.
The rejection of claims 42, 45-52, 57-59, 67-73, and 75-82 is
affirmed.
Rejection No. 2
The Examiner concluded that the claims were obvious based on the
combined teachings of Gluck '685, Kaneda, Panzer, andAnchordoquy.
(Ans. 8-9.) In particular, the Examiner further applied the teaching of
Anchordoquy of a lyoprotectant to claims 53-55. (Id.) Appellants argue
claims 42 and 45 by referring to their previous arguments regarding Gluck
'685, Kaneda, and Panzer, and by arguing that Anchordoquy is "unrelated to
the problem addressed by the present invention" and that one skilled in the
art would have "no reasonable expectation of success regarding the
application of the teachings in Anchordoquy." (Br. 27-30.) However,
because Appellants rely on arguments previously advanced, never
specifically address the basis for the rejection of claims 53-55, and do not
separately argue the other dependent claims, the rejection of claims 42, 45-
47, 50-55, 57-59, 67-73, and 75-82 is affirmed.
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Rejection No. 3
The Examiner concluded that the claims were obvious based on the
combined teachings of Gluck '685, Kaneda, Panzer, and Gluck. 14 (Ans. 9-
10.) In particular, the Examiner further applied Gluck's teaching of an
adjuvant to claims 56 and 83. (Id.) Appellants argue claims 42 and 45 by
referring to their previous arguments regarding Gluck '685, Kaneda, and
Panzer, and by arguing that Gluck does not "cure the deficiencies" of those
references and is "unrelated to the problem" addressed by the present
application. (Br. 35-37.) However, because Appellants rely on arguments
previously advanced, never specifically address the basis for the rejection of
claims 56 and 83, and do not separately argue the other dependent claims,
the rejection of claims 42, 45--47, 50-52, 56-59, 67-73, and 75-83 is
affirmed.
Rejection No. 4
The Examiner concluded that the claims were obvious based on the
combined teachings ofKaneda, Markgraf, and Bungener. (Ans. 10-11.)
The Examiner also found that the recitations in claims 42, 45, 73, and 75
relating to preserving IRIV fusion activity or "for enhancing the
reconstitutability of said virosome after lyophilisation" were "inherent to the
composition taught by the cited art because all that is required to achieve
such is to include a cationic cholesterol derivative in the virosomes." (Id. at
11.) Furthermore, the Examiner found that "kits" were in use prior to the
claimed invention. (Id.)
14 Appellants refer to Gluck as "Gluck I." (Br. 9.)
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Claim 42
Appellants make the same arguments regarding Kaneda as set forth
above. (Br. 42--47.) Furthermore, Appellants argue that neither Markgraf
nor Bungener cure the deficiencies of Kaneda. (Id.) Appellants also repeat
their arguments regarding unexpected results and long-felt need. (Id. at 47.)
We are unpersuaded for the reasons set forth above, or below with respect to
unexpected results and long-felt need, and affirm the rejection of claim 42.
Claim 45
Appellants make the same arguments as set forth above in connection
with claim 42, and they are unpersuasive for the reasons set forth above.
Dependent Claims
Appellants' responses to the rejection of these claims rely on the same
arguments as set forth above, and the rejections are not separately argued.
The rejection of claims 42, 45, 46, 48, 49, 57, 59, 67-73, and 75-79 is
affirmed.
Rejection No. 5
The Examiner concluded that the claims were obvious based on the
combined teachings of Kaneda, Markgraf, Bungener, and Panzer. (Ans. 11-
12.) Panzer was cited for the teaching that DC-Chol and TC-Chol have
similar properties and can be used interchangeably, and further applied to
claims 47 and 77. (Id. at 12.) Appellants argue claims 42 and 45 by
referring to the same arguments regarding Kaneda, Markgraf, Bungener, and
Panzer as set forth above. (Br. 53-56.)
Appellants further argue that Panzer "identifies DC-Chol and TC-
Chol as strongly cationic lipids in the context of a list of fifteen ( 15) other
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cationic lipids, but fails to point to DC-Chol or TC-Chol among the other
cationic lipids." (Br. 54.) We are not persuaded. That Panzer specifically
teaches DC-Chol and TC-Chol among a list of several other cationic lipids
does not render any particular cationic lipid less obvious. See Merck & Co.,
Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) ("That the
[prior art] patent discloses a multitude of effective combinations does not
render any particular formulation less obvious"). Because Appellants rely
on arguments previously advanced, and do not separately argue the other
dependent claims, the rejection of claims 42, 45--49, 57, 59, 67-73, and 75-
79 is affirmed.
Rejection No. 6
The Examiner concluded that the claims were obvious based on the
combined teachings ofKaneda, Markgraf, Bungener, and Gluck '685. (Ans.
12-13.) In particular, Gluck '685 was further cited with respect to claims
50-52, 58, and 80-82. (Id.) Appellants argue claims 42 and 45 by referring
to the same arguments regarding Kaneda, Markgraf, and Bungener as set
forth above, and arguing that Gluck '685 does not cure the deficiencies of
Kaneda, Markgraf, and Bungener. (Br. 59-62.) However, because
Appellants rely on arguments previously advanced, never specifically
address the basis for the rejection of claims 50-52, 58, and 80-82, and do
not separately argue the other dependent claims, the rejection of claims 42,
45, 46, 48-52, 57-59, 67-73, and 75-82 is affirmed.
Rejection No. 7
The Examiner concluded that the claims were obvious based on the
combined teachings of Kaneda, Markgraf, Bungener, and Anchordoquy.
(Ans. 13-14.) In particular, Anchordoquy was further cited with respect to
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claims 53-55. (Id.) Appellants argue claims 42 and 45 by referring to the
same arguments regarding Kaneda, Markgraf, and Bungener as set forth
above, and restate their previous arguments regarding Anchordoquy. (Br.
67-70.) Appellants also argue that "the teachings in Markgraf and
Anchordoquy are contradictory," but that argument does not address
Anchordoquy's teaching of a lyoprotectant as applied to claims 53-55. (Id.
at 68-70.) However, because Appellants rely on arguments previously
advanced, never specifically address the basis for the rejection of claims 5 3-
55, and do not separately argue the other dependent claims, the rejection of
claims 42, 45, 46, 48, 49, 53-55, 57, 59, 67-73, and 75-79 is affirmed.
Rejection No. 8
The Examiner concluded that the claims were obvious based on the
combined teachings of Kaneda, Markgraf, Bungener, and Gluck. (Ans. 14.)
In particular, Gluck was further cited with respect to claims 56 and 83. (Id.)
Appellants argue claims 42 and 45 by referring to their previous arguments
regarding Kaneda, Markgraf, and Bungener, and by arguing that Gluck does
not "cure the deficiencies" of those references and is "unrelated to the
problem addressed by the present invention." (Br. 74-77.) However,
because Appellants rely on arguments previously advanced, never
specifically address the basis for the rejections of claims 56 and 83, and do
not separately argue the other dependent claims, the rejection of claims 42,
45, 46, 48, 49, 57, 59, 67-73, and 75-79 is affirmed.
Hindsight
Appellants make several references to "impermissible hindsight" in
response to various obviousness rejections. We are unpersuaded by this
argument. We find that, rather than using hindsight, the Examiner points to
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specific disclosures in the prior art that describe the limitations of
Appellants' claimed composition, and that the Examiner's obviousness
conclusions are based on sufficiently articulated reasoning that overcomes
any concerns about hindsight bias. See KSR, 550 U.S. at 418. Moreover,
Appellants fail to sufficiently explain why combining the relevant teaching
for which a reference is cited constitutes impermissible hindsight.
Unexpected Results
Appellants argue that they have "unexpectedly found that the
virosomes of the invention have the superior characteristic of preserving
their fusion activity after lyophilization and reconstitution." (Br. 19, 22.) In
support of that argument, Appellants submit a Declaration 15 and argue
"unexpected results" along with an explanation of the Amacker Declaration.
(Br. 94-99.) The Amacker Declaration states that "[t]he invention relates to
the unexpected discovery that the preservation of fusogenic activity ...
depends on the nature of the lipid included in the composition." (Deel. ,-i 8.)
The Amacker Declaration also includes data that purportedly "supports
superior properties of cationic cholesterol derivatives of Formula (I) or (II)
over neutral cholesterol or neutral/anionic cholesterol derivatives." (Id. ,-i 9.)
Unexpected results must be shown to be unexpected compared with
the closest prior art, and the mere recognition of latent properties in the prior
art does not render nonobvious an otherwise known invention. In re Baxter
Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (citing cases). The
closest prior art in this case is Kaneda, disclosing a virosome that also
15 Declaration of Mario Amacker, Ph.D. Pursuant to 37 C.F.R. § 1.132,
dated Feb. 28, 2012 ("Amacker Declaration" or "Deel.").
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comprises DC-Chol, yet Appellants do not provide a comparison of the
claimed invention to Kaneda's virosome. Moreover, Appellants'
"discovery" regarding the preservation of fusogenic activity is merely the
recognition of latent properties in the prior art. According, we are not
persuaded by Appellants' arguments regarding unexpected results.
Long-Felt Need
Long-felt need is "analyzed as of the date of an articulated identified
problem and evidence of efforts to solve that problem." Texas Instruments,
988 F.2d at 1178. In this case, Appellants have provided no objective
evidence that preservation of fusion activity was an art-recognized problem,
or that there were any efforts to solve that problem. Accordingly,
Appellants' long-felt need argument is unpersuasive.
Conclusions of Law
A preponderance of evidence of record supports the Examiner's
conclusions of obviousness with respect to Rejection Nos. 1-8 above.
Furthermore, Appellants have not provided evidence of unexpected results or
long-felt need that, when weighed with the evidence favoring obviousness,
shows that any of claims 42, 45-59, 67-73 and 75-83 would have been
nonobvious.
Obviousness-Type Double Patenting
Principles of Law
Obviousness-type double patenting prohibits the issuance of claims in
a second patent that are "not patentably distinct from the claims of the first
patent." In re Langi, 759 F.2d 887, 892 (Fed. Cir. 1985) (citations omitted).
"A later patent claim is not patentably distinct from an earlier patent claim if
the later claim is obvious over, or anticipated by, the earlier claim." Eli Lilly
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& Co. v. Barr Labs., Inc., 251F.3d955, 968 (Fed. Cir. 2001) (citations
omitted).
Analysis
The Examiner found that claims 42 and 45 were not patentably
distinct from claims 1and4-13 of Application No. 12/086,315 (now
Zurbriggen) because both claim sets are drawn to a composition comprising
IRIV, wherein the IRIV comprises DC-Chol or TC-Chol in their membrane.
(Ans. 15.) Appellants argue in response that "Zurbriggen 116 is directed to a
novel trans-adjuvant system, which is completely unrelated to the problem
addressed by the present application: identification of virosomes that
preserve their fusion activity even after lyophilization and reconstitution."
(Br. 80-81.) Appellants also make the same arguments as above regarding
"unexpected results" and "long-felt need." (Id. at 81-82.)
The Examiner has established a prima facie case of obviousness-type
double patenting and Appellants' arguments do not overcome that prima
facie case. Claim 10 of Zurbriggen includes, for example, a pharmaceutical
composition comprising an IRIV containing cationic lipids comprising
cholesterol derivatives DC-Chol or TC-Chol, the same basic elements of
claims 42 and 45. (Zurbriggen, col. 23-24, claim 10.) Appellants'
arguments regarding unexpected results and long-felt need are also
unpersuasive for the reasons set forth above.
16 Appellants refer to Application No. 12/086,315 as "Zurbriggen I." (Br.
10.)
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Conclusion ofLaw
A preponderance of evidence of record supports the Examiner's
conclusion that claims 42 and 45 are unpatentable on the ground of
nonstatutory obviousness-type double patenting over claims 1 and 4-13 of
Zurbriggen. Furthermore, Appellants have not provided evidence of
unexpected results or long-felt need that, when weighed with the evidence
favoring obviousness, shows that claims 42 or 45 would have been
nonobvious.
Claims 46-57, 67-73, and 75-82 were not argued separately and fall
with claims 42 and 45.
SUMMARY
We affirm all rejections on appeal.
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. § l.136(a).
AFFIRMED
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