Ex Parte Biel

Board of Patent Appeals and Interferences

Nov 30, 2011

10026198 (B.P.A.I. Nov. 30, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte MERRILL A. BIEL
____________

Appeal 2010-000634
Application 10/026,198
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

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STATEMENT OF THE CASE
Merrill A. Biel (Appellant) seeks our review under 35 U.S.C. § 134 of
the Examiner’s decision rejecting claims 1-7, 9-16, 18-20, 22-34, and 40-52,
which are all of the pending claims. We have jurisdiction under 35 U.S.C.
§ 6(b).
We REVERSE.1
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 containing benzalkonium
chloride at a concentration of between 0.001% to 1.0% to a cell
membrane of a cellular organism, said surface acting agent
disorienting a cell membrane so that said cell membrane no
longer functions as an effective osmotic barrier;
passing a photosensitive material through the disoriented
membrane and into the cell interior; and
applying light to the cellular organism to cause a cellular
disruption of the cellular organism.

1 An oral hearing was held on November 17, 2011.

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THE EVIDENCE
The Examiner relies upon the following evidence:
Wilk ‘675 US 5,240,675 Aug. 31, 1993
Wilk ‘020 US 5,260,020 Nov. 9, 1993
Vogel US 5,262,401 Nov. 16, 1993
Yeshayahu Nitzan et al., Inactivation Of Gram-Negative Bacteria By
Photosensitized Porphyrins, 55 PHOTOCHEMISTRY AND
PHOTOBIOLOGY 89, 89-96 (1992) (“Nitzan”).
THE REJECTIONS
Appellant seeks review of the following rejections:
1. Rejection of claims 1-3, 5-7, 9, 11, 15, 16, 19, 20, 22-25, and 30-32
under 35 U.S.C. § 102(b) as being anticipated by Vogel.
2. Rejection of claims 1-7, 9, 11, 15, 16, 18-20, 22-25, 30-34, and 40-52
under 35 U.S.C. § 103(a) as being unpatentable over Wilk ‘020,
Wilk ‘675, and Vogel.
3. Rejection of claims 1, 5, 10-15, 20, and 26-29 under 35 U.S.C.
§ 103(a) as being unpatentable over Vogel and Nitzan.
CONTENTIONS AND ISSUES
Appellant argues that Vogel does not anticipate the claimed method
because it does not disclose “the mechanism of passing photosensitive
material into the cell interior, i.e., by applying benzalkonium chloride to
compromise a cell membrane so as to permit the photosensitive material to
diffuse into the cell interior” and does not disclose applying the
benzalkonium chloride at a concentration of between 0.001% to 1.0% to a
cell membrane, at a cell site, or to an area of cell activity. Br. 17-18.
Appellant argues that the Examiner engaged in impermissible hindsight
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reconstruction in rejecting the claimed method as being obvious in view of
Wilk ‘020, Wilk ‘675, and Vogel. Br. 20. Appellant argues that the claimed
method is not obvious in view of Vogel and Nitzan because it would not
have been obvious to employ benzalkonium chloride in the method of
Nitzan because Vogel does not teach that benzalkonium chloride can be
added to improve the viscosity of a gel. Br. 23.
The issues presented by this appeal are:
Does Vogel disclose applying benzalkonium chloride at a
concentration of between 0.001% to 1.0% to a cell membrane, at a cell site,
or to an area of cell activity such that the cell membrane would be
compromised so as to permit the photosensitive material to diffuse into the
cell interior?
Has the Examiner articulated adequate reasoning based on rational
underpinnings to support the proposed combination of Wilk ‘020, Wilk
‘675, and Vogel?
Did the Examiner err in concluding that it would have been obvious to
employ benzalkonium chloride in the method of Nitzan based on the
teaching in Vogel that surfactants may be added to a topical formulation to
improve gel properties?
STANDARD OF REVIEW
Appellant proposes that the Board review the Examiner’s rejection for
substantial evidence. 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 review the
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Examiner’s decision using a substantial evidence standard of review,
Appellant has confused two legal canons designed to serve distinct purposes.
See SSIH, 718 F.2d at 379 (Nies, J., additional views). The Board’s decision
is the final agency decision on patentability, and thus the Board reviews the
fact finding using a preponderance of the evidence (more likely than not)
standard of proof. In re Caveney, 761 F.2d 671, 674 (Fed. Cir. 1985) (Other
than for fraud or violation of the duty of disclosure, preponderance of the
evidence is the standard that must be met by the PTO in making rejections).
On judicial review of agency action, administrative findings of fact must be
sustained when supported by substantial evidence on the record considered
as a whole. In re Gartside, 203 F.3d 1305, 1315 (Fed. Cir. 2000).2
ANALYSIS
Rejection under 35 U.S.C. § 102(b) as anticipated by Vogel
This ground of rejection covers independent claims 1, 15, and 31 and
several of their dependent claims. Independent method claim 1 is directed to
a method of photodynamic disruption of cellular organisms including the
step of applying a surface acting agent containing benzalkonium chloride at
a concentration of between 0.001% to 1.0% to a cell membrane of a cellular
organism. Independent claim 15 is similarly directed to a method of
photodynamic disruption of organisms including topically applying the same
concentration of benzalkonium chloride to a cell site with an organism.

2 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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Independent claim 31 is directed to a method of photodynamic disruption of
cells including applying the same concentration of benzalkonium chloride
and a photosensitive material to an area of identified cell activity.
Appellant argues that Vogel’s use of benzalkonium chloride as a
bactericidal agent to prevent bacterial or fungal growth in a multiple dose
container for intravenous administration of a compound would not result in a
benzalkonium chloride concentration at a cell site within a range of 0.001%
to 1%, as called for in the claims, because the formulation would be
“instantly and effectively diluted” within the patient’s blood. Br. 16-17.
The Examiner responds that Vogel’s “administration route is
parenteral, not intravenous” and that “parenteral encompasses ‘By some
other means than through the gastrointestinal tract; referring particularly to
the introduction of substances into an organism by intravenous,
subcutaneous, intramuscular, or intramedullary injection.’” Ans. 5, 7 (citing
STEDMAN’S MEDICAL DICTIONARY, 26th Edition).
Vogel discloses compounds having utility as photodynamic therapy
dyes for use in cancer therapy, dermatological diseases, and blood
purification for elimination of viruses and bacteria. Col. 3, ll. 34-37. Vogel
discloses therapeutic formulations containing the compounds as solutions for
parenteral injection and topical dermatological preparations. Col. 11, ll. 40-
42. For the parenteral solutions, Vogel discloses “[t]he photoactivatable
porphycene dyes generally are used with additional solvents and adjuvants
to prepare solutions suitable for intravenous injection.” Col. 11, ll. 45-47.
In this regard, Vogel further discloses that “[w]hen the solution will be
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dispensed from multiple dose containers, antimicrobial agents in
bacteriostatic or fungistatic concentrations must be added.” Col. 12, ll. 41-
43. Vogel teaches that an example of one such agent is benzalkonium
chloride at 0.01% concentration. Col. 12, ll. 46-47. Based on this
disclosure, we find that Vogel discloses that the parenteral formulation is for
intravenous injection. As such, we disagree with the Examiner’s reading of
Vogel as disclosing parenteral formulations other than solutions for
intravenous injection.
The Examiner also responds that Vogel “undeniably teach[es] topical
formulations for the photosensitizer compounds taught therein (see for
example column 13, lines 36-42).” Ans. 6. For the topical formulations,
Vogel discloses that the porphycene compounds may be formulated “in the
form of a lotion, cream, ointment, or gel containing a sufficient amount of
the porphycene compound to be effective for [photodynamic therapy].”
Col. 13, ll. 38-42. With regard to the gel form, Vogel discloses that “[o]ne
skilled in the art can readily obtain the desired gel viscosity by adjusting the
concentration of gelling agent” and that “[a]dditives, such as cosolvents
and/or surfactants, frequently improve the gel properties and may be added
as desired.” Col. 14, ll. 45-49. Vogel provides that “[s]uitable
cosolvents/surfactants include propylene glycol and glycerine.” Col. 14,
ll. 49-50. Vogel does not disclose using benzalkonium chloride as an
additive to improve the gel properties of the topical gel formulation.
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As such, Vogel does not anticipate the methods of independent claims
1, 15, and 31, or their dependent claims 2, 3, 5-7, 9, 11, 16, 19, 20, 22-25,
30, and 32.
Rejection under 35 U.S.C. § 103(a) as unpatentable over Wilk ‘020, Wilk
‘675, and Vogel
The Examiner proposes to employ the photoactivatable solution of
Vogel in the method of Wilk ‘675, which teaches the use of irradiation and a
sterilizing solution, to sterilize long-dwelling catheters of Wilk ‘020 upon
which biofilms form. Ans. 4. The Examiner has not articulated an adequate
explanation as to why one of ordinary skill in the art would have been led to
combine the teachings of these references in the manner proposed.
Wilk ‘020 discloses a method for sterilizing a long-dwelling catheter
while the catheter is inserted intravenously. Col. 3, ll. 66-67. The method of
Wilk ‘020 uses optical fibers embedded in the catheter that are adapted to
transmit ultraviolet or infrared radiation at a wavelength sufficient to
incapacitate microorganisms on the catheter. Col. 1, ll. 6-8 and ll. 54-59,
col. 2, ll. 56-58, and col. 4, ll. 32-47. As such, the method of Wilk ‘020 is
already effective to sterilize the catheter, and the Examiner has not provided
an adequate explanation as to why one of ordinary skill in the art would have
sought to modify the method of Wilk ‘020 to add a photoactivatable
solution, such as the solution of Vogel, to this method.
Wilk ‘675 discloses a method for cleaning the biopsy channel of a
flexible endoscope using a flexible elongate cleaning member insertable into
the endoscope biopsy channel and at least one optical fiber embedded in the
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elongate cleaning member, where the optical fiber transmits electromagnetic
radiation of a wavelength effective in inhibiting growth of certain
microorganisms. Col. 4, ll. 15-31; fig. 1. Wilk ‘675 also discloses that the
elongate cleaning member includes a bore connected to a sterilant reservoir
and through which liquid sterilant is passed during use of the cleaning
member. Col. 4, ll. 56-66; fig. 1. We see no reason why the disclosure in
Wilk ‘675 to use a sterilant in combination with radiation to clean an
endoscope biopsy channel in vitro would have prompted one of ordinary
skill to add a sterilant to the method of Wilk ‘020, which is used for
sterilizing a catheter in vivo.
For these reasons, we will not sustain the rejection of claims 1-7, 9,
11, 15, 16, 18-20, 22-25, 30-34, and 40-52 under 35 U.S.C. § 103(a) as
being unpatentable over Wilk ‘020, Wilk ‘675, and Vogel.
Rejection under 35 U.S.C. § 103(a) as unpatentable over Vogel and Nitzan
The Examiner’s conclusion of obvious is based in part on the finding
that Vogel teaches that surfactants may be added to improve gel properties.
Ans. 5. Appellant argues that Vogel does not teach the use of benzalkonium
chloride to improve the viscosity of a gel. Br. 23. The Examiner responds
that while Vogel does not contain the teaching ipsis verbis, Vogel teaches
“the use of surfactants to improve gel properties” and since benzalkonium
chloride is a surfactant, the teaching is “fairly contained therein.” Ans. 14-
15. For the reasons provided supra in our analysis of Vogel in the
anticipation rejection, we disagree with the Examiner’s reading of Vogel.
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As such, we do not sustain the rejection of claims 1, 5, 10-15, 20, and 26-29
under 35 U.S.C. § 103(a) as unpatentable over Vogel and Nitzan.
CONCLUSIONS
Vogel does not disclose applying benzalkonium chloride at a
concentration of between 0.001% to 1.0% to a cell membrane, at a cell site,
or to an area of cell activity such that the cell membrane would be
compromised so as to permit the photosensitive material to diffuse into the
cell interior.
The Examiner has not articulated adequate reasoning based on
rational underpinnings to support the proposed combination of Wilk ‘020,
Wilk ‘675, and Vogel.
The Examiner erred in concluding that it would have been obvious to
employ benzalkonium chloride in the method of Nitzan based on the
teaching in Vogel that surfactants may be added to a topical formulation to
improve gel properties.
DECISION
The decision of the Examiner to reject claims 1-7, 9-16, 18-20, 22-34,
and 40-52 is REVERSED.

REVERSED

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