Ex Parte Goodrich et al

Patent Trial and Appeal Board

Oct 23, 2012

11428669 (P.T.A.B. Oct. 23, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte RAYMOND P. GOODRICH and CYNTHIA A. SCOTT
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Appeal 2011-011270
Application 11/428,669
Technology Center 1600
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Before LORA M. GREEN, MELANIE L. McCOLLUM, and STEPHEN
WALSH, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for reducing pathogens. The Examiner has rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 20, 22, 23, 25-27, 29, 31, and 32 are on appeal (App. Br. 9).1
The claims have not been argued separately and therefore stand or fall

1 Claims 28 and 30 are also pending but have been indicated to be allowable
if rewritten in independent form (Final Rejection 8).
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together. 37 C.F.R. § 41.37(c)(1)(vii). Claim 20 is representative and reads
as follows:
20. A method for reducing pathogens in a biological sample; said
method comprising the steps of:
providing a container for irradiating said biological sample; wherein
said container comprises poly(vinyl chloride) and at least one citrate
plasticizer wherein said citrate plasticizer is selected from the group
consisting of: triethyl citrate; acetyltriethyl citrate; n-butyryltri-n-hexyl
citrate; and acetyltri-n-butyl citrate; and wherein said container transmits
electromagnetic radiation having a selected distribution of wavelengths and
wherein the transmission of electromagnetic radiation having said selected
distribution of wavelengths by said container is substantially constant during
exposure to electromagnetic radiation;
measuring the percentages of transmission of said container as a
function of wavelength over said selected distribution of wavelengths;
generating electromagnetic radiation using a source of electro-
magnetic radiation;
monitoring the power of said electromagnetic radiation generated by
said light source;
calculating a radiant power delivered to said biological sample using
said measured percentages of transmission of said container;
determining an exposure time of said biological sample required to
provide a desired extent of pathogen reduction; and
exposing said container to electromagnetic radiation for said exposure
time, wherein electromagnetic radiation having said selected distribution of
wavelengths is transmitted by said container and is at least partially absorbed
by said biological sample, thereby reducing said pathogens in the biological
sample.

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Claims 20, 22, 23, 25-27, 29, 31, and 32 stand rejected under 35
U.S.C. § 103(a) as obvious over Goodrich,2 as evidenced by Cobe,3 in view
of Mahal4 and Medical Grade5 (Ans. 5).
The Examiner relies on Goodrich for teaching “a method for
inactivation of microorganisms in fluids containing blood or blood products
. . . by using electromagnetic radiation such as UV irradiation at about 300 to
700 nm . . . in the presence of endogenous photosensitizers such as 7, 8-
dimethyl-10-ribityl isoalloxazine” (id.). The Examiner finds that Goodrich
“also teach[es] the containers for the method of inactivation of micro-
organisms in fluids can be a bag such as collection bags (e.g. Spectra
apheresis systems of Cobe Laboratories, Inc.) for batch-wise treatment of the
fluid” (id.). The Examiner relies on Cobe as evidence that “the collection
bag disclosed by Goodrich, Jr. et al. is inherently made of citrate plasticized
PVC” (id. at 16).
The Examiner relies on Mahal for teaching “a medical container for
blood and blood component storage made of polyvinyl chloride (PVC) and a
citrate plasticizer” (id. at 6). The Examiner finds that “Mahal also teaches
that the preferred plasticizers include n-butyryl tri-n-hexyl citrate or acetyl
tri-n-butyl citrate” (id.). The Examiner concludes that it would have been
obvious to use “the PVC blood container comprising a citrate plasticizer for
the container used in the method of Goodrich . . . because the citrate ester

2 Goodrich, Jr. et al., US 6,277,337 B1, Aug. 21, 2001.
3 COBE Spectra Apheresis System Operator’s Manual 1-1 to 1-63 (1997).
4 Mahal, EP 0,138,147 A2, Apr. 24, 1985.
5 Medical “Grade Citroflex®” Plasticizers 1-20 (1993).
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plasticized PVC container of Mahal is suitable for the storage of blood and
blood components” (id.).
The Examiner finds that, “[a]lthough Mahal does not teach triethyl
citrate or acetyltriethyl citrate for the citrate plasticizer used in the PVC
container, it is well known in the art that these species are citrate plasticizers
called Citroflex®,” as disclosed in Medical Grade (id.). The Examiner
concludes that it would have been obvious “to use the[se] well known
citrate-ester plasticizers for the medical container of Mahal” (id.).
“With regard to the steps of measuring the percentages of
transmission of the container as a function of wavelength over said selected
distribution of wavelengths, monitoring the power of radiation, calculating a
radiant power and determining exposure time,” the Examiner finds “that
these steps are directed to optimization steps of result-effective parameters
associated with the photosensitization therapy of Goodrich” and that
Goodrich teaches that “analyzing effects of inactivation based on various
parameters (treatment conditions) such as energy level of exposure,
photoradiation intensity, duration and photosensitizer concentration will
optimize microbial inactivation and minimize damage to desired proteins
and/or cellular components in the fluid” (id. at 6-7). In particular, the
Examiner finds that “Example 4 disclosed by Goodrich, Jr. et al. is directed
to measuring the percentages of transmission through a plastic cuvette” (id.
at 7). The Examiner concludes that it would have been obvious “to carry out
the optimization steps for the desired outcome by using the method of
Goodrich” (id.).
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With regard to the “limitation directed to the container transmits
electromagnetic radiation having a selected distribution of wavelengths, and
that the transmission of electromagnetic radiation is substantially constant
during exposure to electromagnetic radiation,” the Examiner concludes that,
“since Goodrich, Jr. in view of Mahal teach the same container of citricized
PVC bag as claimed, the citricized PVC bag of Goodrich in view of Mahal
would have the same properties as the claimed container” (id. at 10).
FINDINGS OF FACT
1. Goodrich discloses a method “for inactivation of
microorganisms in fluids,” such as blood or blood products, including
“adding an effective, non-toxic amount of an endogenous photosensitizer to
a fluid and exposing the fluid to photoradiation sufficient to activate the
endogenous photosensitizer whereby microorganisms are inactivated”
(Goodrich, Abstract).
2. Goodrich also discloses:
The fluid containing the photosensitizer is exposed to
photoradiation of the appropriate wavelength to activate the
photosensitizer. . . . The wavelength used will depend on the
photosensitizer selected, as is known to the art or readily
determinable without undue experimentation following the
teachings hereof. Preferably the light source is a fluorescent or
luminescent source providing light of about 300 nm to about
700 nm, and more preferably about 340 nm to about 650 nm of
radiation.
(Id. at col. 8, ll. 50-63.)
3. In addition, Goodrich discloses that the “fluid containing the
photosensitizer may be flowed into a photopermeable container for
irradiation” (id. at col. 9, ll. 17-18).
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4. Goodrich also discloses: “A cuvette has been used to
exemplify one embodiment of the invention involving a flow-through
system. Collection bags, such as those used with the Trima™ Spectra™ and
apheresis systems of Cobe Laboratories, Inc., have been used to exemplify
another embodiment involving batch-wise treatment of the fluid.” (Id. at
col. 9, ll. 23-28.)
5. In addition, Goodrich discloses that the “term ‘photopermeable’
means the material of the container is adequately transparent to
photoradiation of the proper wavelength for activating the photosensitizer”
(id. at col. 9, ll. 29-31).
6. Goodrich also discloses that the “photopermeable container is
preferably a blood bag made of transparent or semitransparent plastic” (id. at
col. 9, ll. 55-56).
7. In addition, Goodrich discloses: “In an[] embodiment the fluid
is placed in a photopermeable container such as a blood bag . . . and agitated
while exposing to photoradiation. . . . Collection bags used in the Spectra™
system or Trima™ apheresis system of Cobe Laboratories, Inc. are
especially suitable.” (Id. at col. 12, ll. 12-18.)
8. Goodrich also discloses: “Appropriate temperatures for the
reaction of the photosensitizer with its substrate are determined, as well as
the ranges of temperature, photoradiation intensity and duration, and
photosensitizer concentration which will optimize microbial inactivation and
minimize damage to desired proteins and/or cellular components in the
fluid.” (Id. at col. 14, ll. 59-64.)
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9. In Example 4, Goodrich discloses: “The existing Spectra
Cuvette is composed of polycarbonate. The light transmission properties of
this cuvette were measured at 373 and 447 nm by placing the cuvette in the
light path of a UV spectrophotometer. . . . For the region above 350 nm, the
light transmission properties are adequate for this application.” (Id. at
col. 20, ll. 39-60.)
10. Cobe is a manual “intended for the person who will be
operating the COBE Spectra™ Apheresis System” (Cobe 1-1).
11. Cobe discloses collect bags “made from citricized PVC” (id. at
1-18).
12. Mahal discloses: “Citrate-ester plasticized polyvinyl chloride
containers for the storage of blood and blood components. Preferred
plasticizers include tri-esters of citric acid (or acylated citric acid) and 4-10
carbon alcohols such as acetyl tri-butyl citrate, n-butryl tri-n-hexyl citrate
and acetyl tri-n-octyl or decyl citrate.” (Mahal, Abstract.)
ANALYSIS
In view of the forgoing findings of fact, we conclude that the
Examiner has set forth a prima facie case that claim 20 would have been
obvious. In particular, we agree with the Examiner that it would have been
obvious to use “the PVC blood container comprising a citrate plasticizer for
the container used in the method of Goodrich” (Ans. 6). “The combination
of familiar elements according to known methods is likely to be obvious
when it does no more than yield predictable results.” KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 416 (2007).
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Appellants argue, however, that, from the teachings in Goodrich, “one
skilled in the art would think that the illumination container must be made of
polycarbonate, not citrate-plasticized PVC” (App. Br. 12). We are not
persuaded. While Goodrich exemplifies a polycarbonate cuvette (Finding of
Fact (FF) 9), Goodrich generally discloses a photopermeable container
(FF 3), and, in fact, discloses the use of blood collection bags, such as those
used with Cobe Spectra™ apheresis systems (FF 4 & 7), which use
citricized PVC collection bags (FF 10-11).
Appellants also argue: “Neither Mahal nor Goodrich . . . give[s] an
indication that citrate-plasticized PVC containers would have the desired
optical characteristics for irradiation of blood and blood components.
Hence, there was no reasonable expectation of success in using the claimed
method.” (App. Br. 16.) We are not persuaded.
As discussed above, Goodrich generally discloses the use of a
photopermeable container, which “means the material of the container is
adequately transparent to photoradiation of the proper wavelength for
activating the photosensitizer” (FF 3 & 5). To activate the photosensitizer,
Goodrich discloses the use of a light source providing “light of about
300 nm to about 700 nm” (FF 2). In particular, Goodrich discloses that the
“photopermeable container is preferably a blood bag made of transparent or
semitransparent plastic” (FF 6).
Mahal, as well as Cobe, discloses blood bags made from citrate-
plasticized PVC (FF 10-12). We conclude that one of ordinary skill in the
art would understand that citrate-plasticized PVC is photopermeable (see
Spec. 27 (“The citrate plasticized poly(vinyl chloride) bag also significantly
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transmits (i.e. has percentage transmission greater than about 30%) light
having wavelengths ranging from 285 nanometers to 365 nanometers.”)).
As a result, we agree with the Examiner that there would have been a
reasonable expectation for success.
In addition, Appellants argue:
There is . . . no teaching in Goodrich of the steps of:
“measuring the percentages of transmission of said
container as a function of wavelength over said selected
distribution of wavelengths”
“monitoring the power of said electromagnetic radiation
generated by said light source”
“calculating a radiant power delivered to said biological
sample using said measured percentages of transmission of said
container” and
“determining an exposure time of said biological sample
required to provide a desired extent of pathogen reduction.”
(App. Br. 11.) We are not persuaded.
Goodrich discloses measuring the amount of transmission of the
container as a function of wavelength (FF 9). “While this measurement is
based on the plastic (polycarbonate) cuvette,” we agree with the Examiner
that it would have been obvious “to use the same assay system to determine
light transmission [through citrate-plasticized PVC] in terms of percentage”
(Ans. 7). In addition, we agree with the Examiner that, in order to optimize
Goodrich’s method, it would have been obvious to monitor the power of the
electromagnetic radiation generated by the light source, calculate a radiant
power delivered to the biological sample using the measured percentages of
transmission of the container, and determine an exposure time of the
biological sample required to provide a desired extent of pathogen reduction
(id. at 6-7; see FF 8).
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Appellants also argue that the claimed method “represents a
significant and unexpected improvement over methods of irradiating blood
contained in other types of containers” (App. Br. 15). However, Appellants
have not presented sufficient evidence that the claimed method provides an
unexpectedly superior result, as compared to the closest prior art, to
overcome the prima facie case of obviousness.
CONCLUSION
The evidence supports the Examiner’s conclusion that representative
claim 20 would have been obvious. We therefore affirm the obviousness
rejection.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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