Ex Parte Biel

Board of Patent Appeals and Interferences

Dec 19, 2011

09792578 (B.P.A.I. Dec. 19, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte MERRILL A. BIEL
____________

Appeal 2011-002819
Application 09/792,578
Technology Center 3700
____________

Before LINDA E. HORNER, JOHN C. KERINS, and
STEVEN D.A. McCARTHY, Administrative Patent Judges.

HORNER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Merrill A. Biel (Appellant) seeks our review under 35 U.S.C. § 134 of
the Examiner’s decision rejecting claims 1-5, 8, 10-14, 17-23, 25-35, 38-44,
46-51, 53, 55-60, 63-73, 77-79, 87-92, 94, 95, and 97-100, which are all of
the pending claims. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
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THE INVENTION
Appellant’s claimed invention relates to “a photodynamic therapy or
process utilizing a photosensitive material and a chemical agent, such as a
surfactant material, for in vitro and in vivo cellular and acellular organism
eradication.” Spec. 1. Claim 1, reproduced below, is representative of the
subject matter on appeal.
1. A method of photodynamic disruption of cellular
organisms comprising:
applying a surface acting agent in association with a
cellular organism, said surface acting agent disorienting a cell
membrane so that said cell membrane no longer functions as an
effective osmotic barrier, said surface acting agent being a
solution selected from the group consisting of SDS with a
concentration range of 0.001% to 1.0%, polymyxin B with a
concentration range of 3 µg/ml to 500 µg/ml, and cetrimide
with a concentration range of 0.005% to 1.0%;
passing a photosensitive material through the disoriented
cell membrane and into the cell interior; and
applying light to photosensitive material within the cell
interior to cause a cellular disruption of the cellular organism by
a photodynamic reaction of the photosensitive material within
the cell interior.
THE EVIDENCE
The following evidence is pertinent to the issues in this case:
Swartz US 4,181,128 Jan. 1, 1980
Lai US 4,882,234 Nov. 21, 1989
Wilk US 5,260,020 Nov. 9, 1993
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Williams1 US 5,576,013 Nov. 19, 1996
Wilson2 US 5,611,793 Mar. 18, 1997
Van den Berghe US 6,284,289 B1 Sep. 4, 2001
Yeshayahu Nitzan et al., Inactivation Of Gram-Negative Bacteria By
Photosensitized Porphyrins, 55 PHOTOCHEMISTRY AND
PHOTOBIOLOGY 89, 89-96 (1992) (“Nitzan”).
Michael M. Singer and Ronald S. Tjeerdema, Fate and Effects of the
Surfactant Sodium Dodecyl Sulfate, 133 REVIEWS OF
ENVIRONMENTAL CONTAMINATION AND TOXICOLOGY 95, 95-149
(1993) (“Singer”).
Robert L. Danner et al., “Purification, Toxicity, and Antiendotoxin
Activity of Polymyxin B Nonapeptide,” 33 ANTIMICROBIAL AGENTS
AND CHEMOTHERAPY 1428, 1428-1434, (Sept. 1989) (“Danner”).
Martti Vaara and Timo Vaara, “Polycations Sensitize Enteric
Bacteria to Antibiotics,” 24 ANTIMICROBIAL AGENTS AND
CHEMOTHERAPY 107, 107-113 (July 1983) (“Vaara”).
THE REJECTIONS
Appellant seeks review of the following rejections:
1. Rejection of claims 1-5, 8, 10, 13, 14, 17, 20-23, 25-31, 35, 38, 41-44,
46-50, 53, 55-60, 63-66, 68-73, 77-79, 87, 88, 90-92, 94, 95, 98, and
99 under 35 U.S.C. § 103(a) as unpatentable over Lai and Singer.

1 The Examiner refers to “Williams” in two grounds of rejection but does not
list this reference in the Evidence Relied Upon section of the Answer. A
review of the evidence of record in this application did not uncover any
reference to “Williams.” However, the Board located US 5,576,013 to
Williams, which contains the disclosure referenced by the Examiner.
2 The Examiner cites Wilson in the Evidence Relied Upon section of the
Answer but does not rely on Wilson in any of the grounds of rejection.
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2. Rejection of claims 1-5, 8, 10, 13, 14, 19, 21-23, 25-27, 49, 55-60, 64,
66-70, 87-923, 94, 95, and 97-99 under 35 U.S.C. § 102(b)/103(a) as
anticipated by and/or unpatentable over Nitzan.
3. Rejection of claims 1, 11, 12, 29, 32-34, 49, 51, 87, 98, and 100 under
35 U.S.C. § 103(a) as unpatentable over Wilk in combination with
Nitzan or Lai combined with Singer.
4. Rejection of claims 29 and 39 under 35 U.S.C. § 103(a) as
unpatentable over Swartz, Van den Berghe, and Williams.
5. Rejection of claims 29 and 40 under 35 U.S.C. § 103(a) as
unpatentable over Nitzan and Singer.
6. Rejection of claims 1 and 18 under 35 U.S.C. § 103(a) as unpatentable
over Swartz, Van den Berghe, Williams, and Singer.
CONTENTIONS AND ISSUES
The issues presented by this appeal are:
Would the combined teachings of Lai and Singer have led one of
ordinary skill in the art to apply, provide, or administer the claimed surface
acting agent where the agent disorients a membrane so that it no longer
functions as an effective osmotic barrier?
Does Nitzan’s polymyxin B nonapeptide contain polymyxin B or
would it have been obvious to one of ordinary skill to employ polymyxin B
in place of the polymyxin B nonapeptide in the method of Nitzan?

3 The Examiner’s statement of this ground of rejection included canceled
claim 93. Ans. 4.
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Would the proposed combination of Swartz, Van den Berghe, and
Williams result in the provision of the claimed surface acting agent that
disorients a membrane of an acellular organism so that the membrane no
longer functions as an osmotic barrier, such that photosensitive material
would pass through the disoriented membrane and into an interior and
application of light to the photosensitive material would cause a disruption
of the acellular organism as called for in claim 29?
Does Van den Berghe disclose use of cetrimide with a concentration
range of 0.005% to 1.0% as called for in claim 1?
STANDARD OF REVIEW
Appellant proposes that the Board review the Examiner’s rejections
for substantial evidence. Br. 26. Standards of proof must be distinguished
from standards of review. See SSIH Equip. S.A. v. U.S. Int’l Trade Comm’n,
718 F.2d 365, 371 n.9 (Fed. Cir. 1983). By proposing that the Board utilize
a substantial evidence standard of review, Appellant confuses two legal
canons designed to serve entirely distinct purposes. See id. at 379 (Nies, J.,
additional views). The Board’s decision is the final decision of the Agency
on patentability, and thus the Board reviews the fact finding of the Examiner
using a preponderance of the evidence (more likely than not) standard. In re
Caveney, 761 F.2d 671, 674 (Fed. Cir. 1985). On judicial review of agency
action, administrative findings of fact must be sustained when supported by
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substantial evidence on the record considered as a whole. In re Gartside,
203 F.3d 1305, 1315 (Fed. Cir. 2000).4
ANALYSIS
Rejection under 35 U.S.C. § 103(a) as unpatentable over Lai and Singer
Independent claims 1, 29, 49, 60, 71, and 87 call for the steps of
applying, providing, or administering an agent where the agent disorients a
membrane so that it no longer functions as an effective osmotic barrier and
wherein the agent is a solution selected from the group consisting of SDS
with a concentration range of 0.001% to 1.0%, polymyxin B with a
concentration range of 3 µg/ml to 500 µg/ml, and cetrimide with a
concentration range of 0.005% to 1.0%, passing a photosensitive material
through the disoriented membrane, and applying light to the photosensitive
material. The Examiner found that Lai teaches the claimed method
including using a solution wherein the agent is SDS at a concentration of
0.07 M (2.02wt%), and that it would have been obvious to use a lower
concentration of SDS than that disclosed in Lai in view of the teaching in
Singer that concentrations of SDS below those which cause complete lysis
increase membrane permeability. Ans. 3-4. In particular, the Examiner
explained that reducing the amount of SDS as taught by Singer, would
“reduce the toxicity of the mixture” and provide “a more economical
medication, since less material can be used.” Ans. 12. The Examiner also

4 Substantial evidence is defined as “such relevant evidence as a reasonable
mind might accept as adequate to support a conclusion.” In re Jolley, 308
F.3d 1317, 1329 (Fed. Cir. 2002) (citation omitted).
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found that Lai teaches the claimed method including using a solution
wherein the agent is cetyltrimethyl ammonium bromide (CTAB)5 at a
concentration of 0.01M (0.364wt%). Ans. 3.
Appellant argues that Lai’s disclosure of solutions containing SDS
and CTAB are within the context of conducting in vitro tests of the relative
photodynamic activity of preparations and materials, Lai does not disclose
injecting a material containing SDS or CTAB, and there is no teaching or
suggestion to use a solution containing SDS or CTAB in an in vivo
application. Br. 29-30.
Lai relates to a composition of matter containing an oligomeric
porphin-based material which is used for tumor imaging and as a
photodynamic therapy agent. Col. 5, ll. 60-65 and col. 6, ll. 9-13. Lai
describes in vitro photodynamic activity tests in which the biological
properties of the poly(-hematoporphyrin ester) or “PHE” product of part A
of Example 1 and two similar products prepared in accord with the general
teachings of Examples 1 through 5 were determined. Col. 15, ll. 59-65. Lai
describes that the in vitro tests were “carried out” in five aqueous solutions,
including tetrahydrofuran:sodium dodecal sulfate (30:70 THF:SDS, 0.07 M
SDS) and cetyltrimethyl ammonium bromide (CTAB, 0.01M) in phosphate
buffer. Col. 15, l. 67 – col. 16, l. 6. Lai describes that the photodynamic
activity of the product is determined from the “quantum yields of oxygen
uptake (moles of oxygen consumed/Einsteins of photons (630 nm)
absorbed)” “as measured by a recording oxygen electrode system.” Col. 16,

5 Cetyltrimethyl ammonium bromide (CTAB) is another name for cetrimide.
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ll. 6-10. Lai further describes in vivo tests of the PHE products without any
reference to a solution containing SDS or CTAB. Col. 16, ll. 14-23.
While Lai describes the use of a photosensitive material in
combination with a surface acting agent, it teaches this combination only for
in vitro testing of its photosensitive material. Since Lai discloses merely
conducting in vitro testing of the biological activity of its photosensitive
material in an aqueous SDS or CTAB solution, and since Lai does not
disclose using SDS or CTAB in its injectable pharmaceutical formulation of
its PHE product, the Examiner’s reason to combine (to “reduce the toxicity
of the mixture” and provide “a more economical medication”) appears not to
be based on a rational underpinning. For these reasons, we do not sustain
the rejection of claims 1-5, 8, 10, 13, 14, 17, 20-23, 25-31, 35, 38, 41-44, 46-
50, 53, 55-60, 63-66, 68-73, 77-79, 87, 88, 90-92, 94, 95, 98, and 99 under
35 U.S.C. § 103(a) as unpatentable over Lai and Singer.

Rejection under 35 U.S.C. § 102(b)/103(a) as anticipated by and/or
unpatentable over Nitzan
The Examiner found that Nitzan teaches the claimed method and that
“[s]ince the PMNP (polymyxin nonapeptide) of Nitzan . . . is produced from
polymyxin B Sulfate (see page 90, column 1, third paragraph), the product is
clearly polymyxin B nonapeptide (PMBN) and thus falls under the broadest
reasonable interpretation of ‘polymyxin B’ as used in the claims.” Ans. 4.
With regard to anticipation, Appellant argues that Nitzan’s purified
polymyxin nonapeptide preparation is a derivative of polymyxin B, and that
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there is no indication of polymyxin B present in the preparation. Br. 37.
With regard to obviousness, Appellant argues that Nitzan fails to teach or
suggest the claim limitation of specific concentration ranges of the three
specific surface acting agents and that PMNP “is not an ionophoric
surfactant which allows a photosensitive material to pass into the interior of
the cell,” i.e., past the inner cytoplasmic membrane which defines the
perimeter of the cell interior. Br. 37-38.
Nitzan describes that “[p]olymyxin nonapeptide was prepared as
described previously (Vaara and Vaara, 1983a) with minor modifications.
The purity of PMNP batches was examined on cellulose-coated aluminum
foil TLC plates.” Nitzan 90, 1st col., 3rd para. Vaara describes that PMBN
was prepared by an enzymatic hydrolysis of polymyxin B. Vaara 108, 1st
col., 4th para. Vaara describes that the PMBN preparation obtained using its
method “contained less than 0.25% polymyxin.” Vaara 108, 2nd col., 2nd
para.
We agree with Appellant in that we find no explicit or inherent
disclosure of polymyxin B in Nitzan’s polymyxin B nonapeptide
preparation. First, we find that PMBN is not the claimed polymyxin B. The
prior art Vaara article appears to distinguish in the art between PMBN and
polymyxin. Second, we disagree with the Examiner’s position that because
PMBN is a derivative of polymyxin B, some remnant polymyxin B would
inherently be present to meet the claimed surface acting agent. The
Examiner states that “[t]he mere fact that the purity of [Nitzan’s polymyxin
B nonapeptide] was examined does not serve to prove that either the
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polymyxin B nonapeptide was absolutely 100% pure, or that the impurities
did not include polymyxin B sulfate.” Ans. 22. The corollary, however, is
also true in that it is possible that Nitzan’s preparation was absolutely 100%
pure or that the impurities did not include polymyxin B sulfate. “Inherency
. . . may not be established by probabilities or possibilities. The mere fact
that a certain thing may result from a given set of circumstances is not
sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citations
and quotation marks omitted).
The Examiner proposes, in the alternative, that “it would have been
obvious to the artisan of ordinary skill to employ polymyxin B in place of
the polymyxin B nonapeptide in the method of Nitzan . . . since polymyxin
B is a known surfactant, thus producing a method such as claimed.” Ans. 5.
Appellant argues that one of ordinary skill would not have been led to
substitute polymyxin B for PMNP as proposed because “[p]olymyxin B is a
relatively toxic antibiotic” and “PMNP is less toxic than polymyxin B and is
devoid of antibiotic activity” and that “[t]he toxicity of polymyxin B limits
its potential as a therapeutic agent.” Br. 37 (citing Danner).
Danner shows that one of ordinary skill in the art at the time of
Appellant’s invention would have known that both polymyxin B
nonapeptide and polymyxin B have the capacity to disorganize the outer
membrane of gram-negative bacteria. Danner, Abst. Further, Danner shows
that one of ordinary skill in the art at the time of Appellant’s invention
would have known that polymyxin B is a “relatively toxic antibiotic” and
that polymyxin B is 63 times more effective on a weight basis than
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polymyxin B nonapeptide in inhibiting lipopolysaccharide-induced
neutrophil priming in a concentration-dependent manner. Id. Because both
PMBN and polymyxin B have the same effect on the outer membrane of
gram-negative bacteria, and because of the known toxicity of polymyxin B,
which limits its utility as a therapeutic agent, we are not persuaded that one
of ordinary skill in the art would have been led to substitute polymyxin B for
PMBN in the method of Nitzan to result in the claimed invention. For these
reasons, we do not sustain the rejection of claims 1-5, 8, 10, 13, 14, 19, 21-
23, 25-27, 49, 55-60, 64, 66-70, 87-92, 94, 95, and 97-99 under 35 U.S.C.
§ 102(b)/103(a) as anticipated by or unpatentable over Nitzan.

Rejection under 35 U.S.C. § 103(a) as unpatentable over Wilk in
combination with Nitzan or Lai combined with Singer
The Examiner’s proposes to combine the sterilizing solutions of
Nitzan or Lai with Singer in the optical fiber sterilizing method of Wilk to
sterilize long-dwelling catheters. Ans. 5. Wilk discloses a method for
sterilizing a long-dwelling catheter while the catheter is inserted
intravenously. Col. 3, ll. 66-67. Wilk uses optical fibers embedded in the
catheter that are adapted to transmit ultraviolet or infrared radiation at a
wavelength sufficient to incapacitate microorganisms. Col. 1, ll. 6-8, 54-59,
col. 2, ll. 56-58, and col. 4, ll. 32-47. Wilk discloses that “[t]he techniques
may also be used with other, known methods, such as ultrasonic
sterilization.” Col. 6, ll. 53-55. The Examiner found that this suggestion in
Wilk to use “other known methods” of sterilization would have prompted
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one of ordinary skill to use the sterilizing solutions of Nitzan or Lai
combined with Singer, “since these destroy undesirable organisms.” Ans. 5.
Even if one were to use the sterilizing solution of Nitzan or Lai
combined with Singer in the method of Wilk, one would not arrive at the
claimed invention because Wilk fails to cure the above-noted deficiencies in
Nitzan and Lai combined with Singer. For these reasons, we do not sustain
the rejection of claims 1, 11, 12, 29, 32-34, 49, 51, 87, 98, and 100 under
35 U.S.C. § 103(a) as unpatentable over Wilk in combination with Nitzan or
Lai combined with and Singer.

Rejection under 35 U.S.C. § 103(a) as unpatentable over Swartz, Van den
Berghe, and Williams
Appellant argues claims 29 and 39 as a group. Br. 47-48. We select
claim 29 as representative, and claim 39 stands or falls therewith. See
37 C.F.R. § 41.37(c)(1)(vii).
The Examiner determined that it would have been obvious to one of
ordinary skill in the art “to employ the surfactant and concentration of Van
Den Berghe in the method of Swartz et al, since this would increase the viral
inactivation as taught by Van Den Berghe and would provide improved gel
properties, as taught by Williams et al, producing a method such as
claimed.” Ans. 5-6. Appellant argues that even assuming that the
Examiner’s proposed combination is proper, “the combination of references
would fail to disclose or teach the invention as presently claimed, i.e.,
improved photodynamic cellular disruption by the mechanism of introducing
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a photosensitive material into a cell interior via diffusion through a
surfactant compromised cell membrane.” Br. 47.
Swartz teaches a method for “destruction of Herpes viruses, tumor
cell lines, and toxins.” Col. 1, ll. 8-9. Swartz’s method entails applying to a
region “a solution containing methylene blue (MB) which is a component
capable of assuming an excited electronic state when subjected to light and
an electric field concurrently.” Col. 5, ll. 56-59. Swartz teaches that the
electric field and the light act cooperatively to activate the MB that serves to
inactivate the Herpes virus in the region. Col. 5, l. 65 – col. 6, l. 13.
Van den Berghe discloses a pharmaceutical composition for the
treatment of Herpes simplex virus (HSV) consisting of a quaternary
ammonium compound such as cetrimide as a first component, and/or an
antiviral agent as a second component, and/or a plant extract as a third
component, where the three components are mutually compatible. Abst. and
col. 1, ll. 56-61. Van den Berghe further discloses that a preferred
composition contains “0.5 – 1.8%, preferably 1% cetrimide.” Col. 5, ll. 14-
17. Van den Berghe discloses that cetrimide is a known disinfectant for its
virucidal action against HSV. Col. 2, ll. 34-36.
Appellant does not appear to contest the Examiner’s proposed
combination of the concentration of cetrimide disclosed in Van den Berge in
the method of Swartz. Appellant argues only that such a combination would
not result in the method of claim 29. We understand that the Examiner’s
position is that application of cetrimide at the concentration disclosed in Van
den Berghe, along with application of the methylene blue disclosed in
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Swartz, to a region where HSV is present, as disclosed in Swartz, would
inherently operate to disorient a membrane of the virus so that the membrane
no longer functions as an effective osmotic barrier, and would thereby
inherently allow the methylene blue to pass through the disoriented
membrane into an interior, such that when one practices the remaining step
of the method of Swartz, i.e., applying light to the methylene blue region,
the application of light will cause a disruption of the virus through the
photodynamic reaction of the methylene blue within the HSV organism. In
other words, Swartz, as modified to add cetrimide to the topical formulation,
discloses all the steps of the claimed invention. To the extent that Swartz, as
modified, does not disclose the mechanism as claimed, because the
mechanism occurs naturally as a result of the application of the combined
surface acting agent and photosensitive material, the naturally-occurring
mechanism does not distinguish the steps of the claimed method from steps
of the prior art method.6 See In re King, 801 F.2d 1324, 1326-27 (Fed. Cir.
1986) (affirming the Board’s finding of inherent anticipation of method
claims directed to enhancing color effects produced by ambient light by a
prior art article of manufacture that inherently performed the method when
placed in the environment in which the article will be used).

6 We note that the Specification states “[i]n one example, the photosensitive
material and the surfactant are provided in a combined solution and topically
applied to the cell site” and that “[i]n alternative embodiments, the
photosensitive material may be applied or delivered or dispensed to a tissue
site before, during, or after the application or delivery of the surfactant
through known delivery/administration approaches.” Spec. 11-12. As such,
there is no necessary or required temporal order of steps claimed.
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“It is well settled that a prior art reference may anticipate when the
claim limitations not expressly found in that reference are nonetheless
inherent in it. Under the principles of inherency, if the prior art necessarily
functions in accordance with, or includes, the claimed limitations, it
anticipates.” In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir.
2002) (citations and quotation marks omitted). The Federal Circuit rejected
“the contention that inherent anticipation requires recognition in the prior
art.” Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1377 (Fed.
Cir. 2003).
Once a prima facie case of unpatentability has been established, the
burden shifts to Appellant to prove that the prior art does not necessarily or
inherently possess the characteristics of the claimed invention. In re Best,
562 F.2d 1252, 1255 (CCPA 1977) (“Where, as here, the claimed and prior
art products are identical or substantially identical, or are produced by
identical or substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product.”). Appellant argues only
that the combination would not result in the claimed method and does not
further explain this argument. This is not sufficient to rebut the Examiner’s
determination of obviousness based on inherency of the claimed mechanism.
For these reasons, we sustain the rejection of claims 29 and 39 under
35 U.S.C. § 103(a) as unpatentable over Swartz, Van den Berghe, and
Williams.

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Rejection under 35 U.S.C. § 103(a) as unpatentable over Nitzan and Singer
The Examiner states that “[t]he teachings of Nitzan et al and the
motivations for modification thereof are essentially those set forth above”
and that it would have been obvious to use the method of Nitzan to disrupt
acellular organisms in light of the teachings of Singer. Ans. 6. Singer does
not cure the noted deficiencies in Nitzan. As such, for the reasons provided
supra in our analysis of Nitzan, we do not sustain the rejection of claims 29
and 40 under 35 U.S.C. § 103(a) as unpatentable over Nitzan and Singer.

Rejection under 35 U.S.C. § 103(a) as unpatentable over Swartz, Van den
Berghe, Williams, and Singer
Appellant argues claims 1 and 18 as a group. Br. 49-50. We select
claim 1 as representative, and claim 18 stands or falls with claim 1. See
37 C.F.R. § 41.37(c)(1)(vii).
The Examiner states that “[t]he teachings and motivations for
combination of Swartz et al, Williams et al, and Van Den Berghe are
essentially those already set forth above with regard to claim 39 [sic, 29]”
and that it would have been obvious to use the combined method of Swartz,
Van den Berghe, and Williams to disrupt cellular organisms in light of the
teachings of Singer. Ans. 6. Appellant argues that “[t]he combination of
Swartz et al, Van Den Berghe, Williams et al, and Singer et al. fail to teach
or suggest the claim limitation of specific concentration ranges of 3 specific
surface acting agents.” Br. 49. The Examiner responded that
“concentrations of certamide (CBAT) even within the narrowly claimed
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ranges are expressly disclosed in Van den Berghe” and “Van den Berghe
teaches that these concentrations are useful for viral inactivation.” Ans. 32.
Claim 1 calls for the surface acting agent to be “a solution selected
from the group consisting of SDS with a concentration range of 0.001% to
1.0%, polymyxin B with a concentration range of 3 µg/ml to 500 µg/ml, and
cetrimide with a concentration range of 0.005% to 1.0%.” Claim 1 calls for
the presence of only one of the three listed solutions. We agree with the
Examiner that “Van Den Berghe teaches the use of a cetrimide in the
claimed concentration range to prevent viral infection.” Ans. 5 (citing col.
5, ll. 20-46, including Table 1 (describing an example preparation having
1% cetrimide) and col. 7, ll. 1-40, including Tables 2 and 3 (describing that
cetrimide has virucidal activity up to a concentration of 100µg/ml)). See
also Van den Berghe, col. 5, ll. 14-17 (disclosing that a preferred
composition contains “0.5-1.8%, preferably 1% cetrimide). As such, the
Appellant’s argument does not persuade us of error in the Examiner’s
rejection of claims 1 and 18 under 35 U.S.C. § 103(a) as unpatentable over
Swartz, Van den Berghe, Williams, and Singer.
CONCLUSIONS
The combined teachings of Lai and Singer would not have led one of
ordinary skill in the art to apply, provide, or administer the claimed surface
acting agent where the agent disorients a membrane so that it no longer
functions as an effective osmotic barrier.
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Nitzan’s polymyxin B nonapeptide does not contain polymyxin B and
it would not have been obvious to one of ordinary skill to employ polymyxin
B in place of the polymyxin B nonapeptide in the method of Nitzan.
The proposed combination of Swartz, Van den Berghe, and Williams
would have resulted in the provision of the claimed surface acting agent to
result in disorienting a membrane of an acellular organism so that the
membrane no longer functions as an osmotic barrier, such that
photosensitive material would pass through the disoriented membrane and
into an interior, and such that application of light to the photosensitive
material would cause a disruption of the acellular organism as called for in
claim 29.
Van den Berghe discloses use of cetrimide with a concentration range
of 0.005% to 1.0% as called for in claim 1.
DECISION
The decision of the Examiner to reject claims 1, 18, 29, and 39 is
AFFIRMED. The decision of the Examiner to reject claims 2-5, 8, 10-14,
17, 19-23, 25-28, 30-35, 38, 40-44, 46-51, 53, 55-60, 63-73, 77-79, 87-92,
94, 95, and 97-100 is REVERSED.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED-IN-PART
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