Ex Parte Cantor

Board of Patent Appeals and Interferences

Nov 7, 2008

10405974 (B.P.A.I. Nov. 7, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte TOM L. CANTOR
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Appeal 2008-0590
Application 10/405,974
Technology Center 3700
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Decided: November 7, 2008
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Before TONI R. SCHEINER, ERIC GRIMES, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal from the final rejection of claims 31-40,
51-59, and 63-70. Jurisdiction is under 35 U.S.C. § 6(b). We affirm-in-part.

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Application 10/405,974

STATEMENT OF THE CASE
The claims are drawn to a device comprising an adsorption container
that comprises a binding means which is specific for affixing an infecting
bacterium, and methods of using the device. Claims 31-40, 51-59, and 63-
70 are pending and stand rejected as follows:
Claims 31, 33, 35, 38-40, 58, and 59 under 35 U.S.C. § 102(b) as
anticipated by Zimmermann et al. (U.S. Pat. No. 6,090,292, Jul. 18, 2000)
(Ans.1 3);
Claims 32, 34, and 51-55 under 35 U.S.C. § 103(a) as obvious over
Zimmermann (Ans. 4); and
Claims 36, 37, 56, 57, and 63-70 under 35 U.S.C § 103(a) as obvious
over Zimmermann and McCain et al. (U.S. Pat. No. 4,737,544, Apr. 12,
1988) (Ans. 6).
Claims 31 and 63 are representative and read as follows:
31. A device for treating a patient having a severe peripheral
bacterial infection, wherein the device comprises:
at least one adsorption container having an inlet means
and an outlet means, where the inlet means and outlet means
allow the patient’s blood, in a whole or separated form, to be
circulated through the adsorption container;
a first binding means associated with a solid support,
wherein the first binding means is specific for affixing an
infecting bacterium that is causing the severe peripheral
bacterial infection, and the solid support is disposed and
confined within the adsorption container;
thereby allowing for the removal of at least a portion of
the infecting bacterium when the patient’s blood is circulated
through the adsorption container.

1 “Ans.” refers to the Answer with a mail date of Jul. 16, 2007.
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63. A method for treating a patient having a severe peripheral
bacterial infection, the method comprising circulating the
patient’s blood, in whole or separated form, through an
adsorption container and returning the treated blood to the
patient,
wherein the adsorption container comprises an inlet
means and an outlet means to allow blood to circulate through
the adsorption container;
a solid support is disposed and confined within the
adsorption container;
and a first binding means that is specific for affixing an
infecting bacterium that is causing the severe peripheral
bacterial infection is associated with the solid support;
thereby removing at least a portion of the infecting
bacterium from the patient’s blood when the blood is circulated
through the adsorption container.

ANTICIPATION BY ZIMMERMANN
Claims 31, 33, 35, 38-40, 58, and 59 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Zimmermann.
Issue
The principal issue in this rejection is the proper interpretation of the
claimed “binding means” which is “specific for affixing an infecting
bacterium.” Appellant argues that “binding means” as recited in the claims
is a “means-plus-function” limitation that invokes § 112, sixth paragraph,
limiting it to the materials and structures disclosed in the Specification and
their equivalents (App. Br.2 5). The Examiner contends that “binding
means” does not invoke § 112, sixth paragraph, and interprets it more
broadly than the specific disclosure in the Specification (Ans. 8-9). Thus,
we first turn to the claim interpretation issue.

2 “App. Br” refers to the Appeal Brief dated Apr. 2, 2007.
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The claimed “binding means” must be “specific for affixing an
infecting bacterium.” That is, bacterial specificity is a characteristic of the
binding means. Turning to the Specification for clarification as we do when
interpreting claims (In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997)), we
find materials are disclosed in it which are specific for bacteria (antibodies)
and not specific for bacteria (i.e., “ConA” and “lectins”) (Spec. ¶¶ 11, 31,
32). The working examples describe the use of a “specific” antibody against
Bacillus anthracis which is prepared by immunizing against the bacteria and
then separating specific antibodies from antibodies that are not “against” the
targeted bacteria (id. at ¶¶ 31-35). The specific antibody is able to affix or
attach to the bacteria, enabling the bacteria to be removed from the patient’s
blood (id. at ¶¶ at 2, 9). In this context, we interpret the claimed “binding
means” which is “specific for affixing an infecting bacterium” to mean a
material that is specific for bacteria, such as antibodies, i.e., which is
“against” the bacteria (by binding and fixing it), but not against other
materials.
Because it is clear that a “binding means” which is “specific for
affixing an infecting bacterium” includes at least antibodies, and this
determination is sufficient to reach all the prior art rejections at issue in this
appeal, it is unnecessary for us to decide whether the claimed “binding
means” is also a “means-plus-function” limitation that requires interpretation
under § 112, sixth paragraph.
Findings of Fact
THE ZIMMERMANN PATENT
1. Zimmermann describes a device for purifying protein-containing
solutions such as blood and blood plasma (Zimmermann, Abstract).
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2. “This object is achieved by a device having a biocompatible support
material . . . covalently coated with albumin” (Zimmermann, at col. 2, ll. 30-
36).
3. The support material can be packed into a perfusable column with an
inlet and outlet (Zimmermann, at col. 2, ll. 43-48; Ans. 3).
4. Albumin is known to bind “metabolic toxins such as mercaptans, free
fatty acids, unconjugated bilirubin and endotoxins of gram-negative bacteria
as well as many exogenous toxins, specifically medications such as
nortriptyline, amitryptiline, diazepam, bromazepam, etc.” (Zimmermann, at
col. 1, ll. 12-19; see also at col. 4, ll. 45-46).
Analysis
Anticipation requires that every element and limitation of the claimed
invention must be found in a single prior art reference, arranged as in the
claim. Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383
(Fed. Cir. 2001). In this case, we do not agree with the Examiner that
Zimmermann describes a “binding means” which is “specific for affixing an
infecting bacterium” as recited in the claims. Albumin is characterized by
Zimmermann as binding to metabolic toxins, endotoxins, exogenous toxins,
and various medications (FF4). The Examiner has presented no evidence
that it would be “specific for affixing” bacteria, but not other materials, as
required by the claim language (see supra at p. 4). The Examiner states that
Zimmermann’s device can remove gram-negative bacterial endotoxins from
blood (Ans. 10), but does not explain how this property would form the
basis for reasonably believing3 that albumin could bind to a bacterium, let

3 The PTO does not have the ability “to manufacture products or to obtain
and compare prior art products.” In re Best, 562 F.2d 1252, 1255 (CCPA
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alone specifically affix it as required by the claims. Accordingly, we reverse
the rejection of claim 31, and dependent claims 33, 35, 38-40, 58, and 59, as
anticipated by Zimmermann.

OBVIOUSNESS OVER ZIMMERMANN
Claims 32, 34, and 51-55 stand rejected under 35 U.S.C. § 103(a) as
obvious over Zimmermann.
Claims 32, 34, and 51-55 depend on claim 31. As we have found that
Zimmermann does not describe a “binding means . . . specific for affixing an
infecting bacterium” as in claim 31, and the Examiner does not provide a
reason why it would have been obvious from Zimmermann’s disclosure
alone to have made such a binding means, we reverse the rejection of claims
32, 34, and 51-55 for the same reason that we concluded claim 31 is not
anticipated by Zimmermann.

OBVIOUSNESS OVER ZIMMERMANN AND MCCAIN
Claims 36, 37, 56, 57, and 63-70 stand rejected under 35 U.S.C
§ 103(a) as obvious over Zimmermann and McCain.
Findings of Fact
In making an obviousness determination, we must first ascertain the
scope and content of the prior art. Findings of Fact with respect to the
Zimmermann patent are listed above. Findings pertinent to the McCain
patent are as follows:
1977). Thus, once “the PTO shows sound basis for believing that the
products of the applicant and the prior art are the same, the applicant has the
burden of showing that they are not.” In re Spada, 911 F.2d 705, 708 (Fed.
Cir. 1990).
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THE MCCAIN PATENT
5. McCain describes “a biospecific polymer having immobilized reactive
biologicals” which “have a high specific activity for binding complements
which are pathological effectors” (McCain, at col. 3, ll. 28-31).
6. The biospecific polymer is utilized to treat diseases by removing
“specific pathological effectors” from the blood (McCain, at col. 10, ll. 16-
25).
7. Immunoglobulins (antibodies) are listed as an example of an immobilized
reactive biological which can be utilized in McCain’s biospecific polymer to
bind and remove pathological effectors (McCain, at col. 6, l. 3).
8. McCain’s working examples utilize antibodies and describe coupling
them to solid supports (McCain, at col. 15, l. 9 to col. 19, l. 34).
9. McCain teaches that various diseases states can be treated with its
biospecific polymer (FF6) and lists “infections” among six specific disease
categories (McCain, at col. 10, ll. 54-58).
10. McCain states that these disease states can be treated by removal of a
specific substance, i.e., pathological effectors (McCain, at col. 10, ll. 23-24,
48-49, and 59-63).
11. Bacteria, such as streptococci, are specifically identified as an infectious
agent associated with infection that can be treated with the biospecific
polymer (McCain, at col. 11, ll. 16-17) and thus logically would be
understood by skilled persons as an effector to be removed by McCain’s
biospecific polymer.
12. McCain describes using its method with whole blood. In this method,
the blood is removed from the patient, contacted with the biospecific
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polymer, and then the treated blood is returned to the patient (McCain, at
col. 13, l. 56 to col. 14, l. 1).
Difference between the prior art and the claimed invention
“A patent may not be obtained . . . if the differences between the
subject matter sought to be patented and the prior art are such that the
subject matter as a whole would have been obvious at the time the invention
was made to a person having ordinary skill in the art.” 35 U.S.C. § 103(a).
The following findings of fact are pertinent to this determination:
13. The Examiner finds that “Zimmermann discloses the apparatus and
method substantially as claimed,” but does not describe the claimed “binding
means as an immunoglobulin, monoclonal, or polyclonal antibody that
adsorbs a bacterium” as in the claims (Ans. 6-7).
14. However, the Examiner finds that McCain teaches “that bacterial
infections . . . may be treated with biospecific polymers that may be
comprised of immunoglobulins and antibodies (see column 6, lines 1-15)”
(Ans. 7; FF6, 7, 11).
Reason to combine the prior art
15. Persons of ordinary skill in the art would have been prompted to utilize
the specific binding means described by McCain in Zimmermann’s device
for removing bacteria in order to treat bacterial infection as taught by
McCain (see Ans. 7, 10, and 13).
Analysis
Claims 36, 37, 63, 65, and 68-70
The principal issues in this rejection are: 1) whether McCain suggests
using antibodies as a binding means to remove bacteria as in claims 36 and
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37; and 2) whether McCain suggests removing bacteria with a binding
means as in claim 63.
McCain clearly teaches that antibodies may be used as biospecific
polymers to remove pathological effectors (FF7) and lists bacteria as a
pathological effector – i.e., an infectious agent – associated with infection
that can be treated with its biospecific polymers (FF11). McCain does not
explicitly state that the antibodies can be used as a biospecific polymer to
remove bacteria, but such a disclosure is not necessary to establish prima
facie obviousness of claims 36, 37, and others. An invention may not be
patented if the differences between the claimed invention and the prior art
would have been obvious to persons of ordinary skill in the art. 35 U.S.C. §
103(a). Thus, the standard for obviousness under Section 103 is not whether
each element of the claimed invention is disclosed in the art as it is for
Section 102, but whether the differences between the prior art and the
claimed invention would have been obvious.
In this case, antibodies are one in a list of biologicals that can be used
in McCain’s method to remove pathological effectors (FF7). Antibodies are
also used in the working examples (FF8). Appellant contends that the
Examiner improperly utilized “hindsight” because antibodies appear in a
“laundry list” of biologicals and that there is “no indication that they are
separately preferred” (App. Br. 33). However, the fact that antibodies are
disclosed by McCain is evidence that they were contemplated for use by
McCain and expected to work. And, in fact, antibodies were utilized in the
working examples (FF8). It is well settled that, “in a section 103 inquiry,
‘the fact that a specific [embodiment] is taught to be preferred is not
controlling, since all disclosures of the prior art, including unpreferred
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embodiments, must be considered.”’ Merck & Co., Inc. v. Biocraft
Laboratories, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (quoting In re
Lamberti, 545 F.2d 747, 750 (CCPA 1976). Thus, “[a]ll the disclosures in a
reference must be evaluated, including nonpreferred embodiments.” In re
Mills, 470 F.2d 649, 651 (CCPA 1972) (citations omitted).
Appellant further contends that there is no guidance that would have
led persons of ordinary skill in the art to select antibodies from the list of
biologicals and then to select infection as a disease state (App. Br. 33). He
urges that this “combination appears to have been selected solely based on
the Applicant’s disclosure, using an improper hindsight analysis” (id.).
This argument does not convince us that the Examiner erred.
McCain has disclosed a number of different biologicals useful to remove
pathological effectors from blood (FF7). Antibodies are among those listed
and are specifically used in certain examples (FF8). McCain also lists six
specific disease states which can be treated with these biologicals (FF9).
Based on this disclosure, persons of ordinary skill in the art would have
recognized that each biological, including antibodies, could be used to treat
any one of the six specifically disclosed disease states, including infection, if
the biological bound to the pathological effector causing the disease.
McCain describes its method very generically and as applicable to a
variety of different diseases and disease states. Thus, it does not appear that
McCain’s invention would be understood as restricted to the specific and
preferred examples, but instead would more broadly be construed as a
general teaching of the utility of biologicals for treatment of diseases. This
conclusion is clearly reflected in the following statement by McCain:
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Today, plasmapheresis and cytophoresis [sic] are the
treatments for disease by removal of noxious substances or cells
from the blood. It is currently believed that any disease treated
by plasmapheresis and/or cytopheresis, where the desired result
is the removal of a specific substance, can be advantageously
treated with the product and process of the present invention.
(McCain, at col. 13, ll. 49-55.) Thus, persons of ordinary skill in the art
would clearly have recognized that antibodies, one of the specific biologicals
disclosed in McCain, could be used to treat infection, one of the six
identified disease states.
Appellant also argues that “the references do not disclose selective
removal of bacteria or any type of cells from blood” (App. Br. 35).
However, McCain explicitly teaches that its methods are for removing
pathological effectors (FF5, 10). When the disease to be treated is an
infection, it would be logical that the effector of the infection – i.e., the
bacterium – would be targeted for removal (FF11). McCain does not
expressly state that its biospecific polymer could be used to remove bacteria
from the blood, but in view of its teaching of removing pathological
effectors associated with disease, including diseases caused by infectious
agents, persons of ordinary skill in the art would have been prompted to
have removed bacteria from blood as in claim 63. “A person of ordinary
skill is . . . a person of ordinary creativity, not an automaton.” KSR Int’l Co.
v. Teleflex Inc., 127 S. Ct. 1727, 1742 (2007). The analysis under 35 U.S.C.
§ 103 therefore “need not seek out precise teachings directed to the specific
subject matter of the challenged claim, for a court can take account of the
inferences and creative steps that a person of ordinary skill in the art would
employ.” Id. at 1741.
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Appellant also states that Zimmermann “teaches away from using
other types of binding agents by suggesting that its only disclosed binding
agent, albumin covalently bound by peptide bonds to a solid support, is
especially suited to achieve its objectives (col. 2:36-8), while disparaging a
known ‘albumin-coated adsorber’ because it was not steam hemocompatible
or sterilizable (col. 2:13-17)” (App. Br. 37).
This argument is not persuasive. A solid support with antibodies is
expressly taught by McCain (FF8). Based on McCain’s teaching that the
pathological effector is removed from blood outside the body and then
returned to the patient (FF12), either McCain’s device would be understood
to have an inlet or outlet to meet all the limitations of claims 36 and 37, or it
would have been obvious to have utilized a container with an inlet and outlet
as taught by Zimmermann (FF3) in order to contact blood with the polymer
and then return it to the patient.
For the foregoing reasons, we affirm the rejections of claims 36, 37,
and 63. Claims 65 and 68-70 fall with claims 36, 37, and 63 because
separate reasons for their patentability were not provided. See 37 CFR §
41.37(c)(1)(vii).

Claims 56 and 57
Claims 56 and 57 depend on claim 51 which recites, inter alia, that
the device of claim 31 further comprises a second binding means which is
“specific for affixing at least one toxin produced by an infecting bacterium
that is causing the severe peripheral bacterial infection.” Claims 56 and 57
further specify that the binding means for affixing the toxin is an
immunoadsorbent and antibody, respectively.
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Zimmermann expressly teaches that albumin can be utilized to
remove bacterial toxins (FF4). McCain also teaches that its methods can be
used for toxins (McCain, at col. 11, ll. 5-7). Furthermore, McCain teaches
that its therapeutic treatment method can involve “two or more biospecific
polymers each having the same or different reactive biologicals or groups of
biologicals” (McCain, at col. 29, l. 14 to col. 30, l. 3). McCain also uses
antibodies in its method (FF7-8) which are immunoabsorbents. Thus,
persons of ordinary skill in the art would have been prompted to utilize one
antibody to remove bacteria and another antibody to remove a toxin
associated with the bacteria in order to fully treat the bacterial infection for
the reasons provided by McCain (see FF6).
Appellant argues that there is no specific teaching in the cited prior art
that would have led to a second binding means for removing toxins (App.
Br. 36-37). We do not agree. McCain specifically mentions toxins
(McCain, at col. 11, ll. 5-7), albeit not bacterial. Zimmermann teaches
removing bacterial endotoxins (FF4). Thus, there is express reason to have
utilized a binding means specific for toxins as recited in the claims. We
affirm the rejection of claims 56 and 57 as obvious over the combination of
Zimmermann and McCain.

Claims 64, 66, and 67
Appellant separately addresses claims 64, 66, and 67.
Claims 64 is directed to the method of independent claim 63 in which
“the blood is circulated through the adsorption container until the bacterial
load has been reduced to a level such that the use of an antibiotic does not
put the patient at a significant risk of induced bacteremia or septicemia.”
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Claim 66 is drawn to the method of claim 63 “in which the blood is
monitored for the reduction in the level of bacteria.”
Each of Zimmermann and McCain teach removing pathological
effectors from the blood. It would be logical to remove as much of the
effector as possible from the blood, since it would have been recognized that
leaving bacteria would allow for recolonization of the host and recurrence of
the disease. Such reduction in bacterial load would inherently result in
reduced risk of bacteremia or septicemia as recited in claim 64.
Appellant argues the “Examiner has not shown that the prior art
recognized bacterial load as a result-effective variable for a treatment related
to removing bacteria from blood” (App. Br. 41). This argument is not
persuasive. For the reasons discussed above, persons of skill in the art
would have recognized the benefit of removing the pathological effector
from the blood. An explicit teaching from the prior art is not necessary to
establish prima facie obviousness. In this case, there is a sound scientific
reason which would have prompted the ordinary skilled worker to achieve
the claimed invention. Appellant has not provided any evidence to the
contrary. Thus, we affirm the rejection of claim 64.
Since bacteria are the pathogenic agent, it would be the logical agent
to monitor as in claim 66. We also affirm the rejection of claim 66.
Claim 67 is directed to the method of claim 63 in which “any
antibiotic treatment of the patient is curtailed until the infecting bacterial
load has been lowered to an acceptable risk level.” We agree with Appellant
that Examiner has not provided any reason that would have prompted
persons of ordinary skill in the art to curtail antibiotic treatment (App. Br.
42). Consequently, we reverse the rejection of claim 67.
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CONCLUSION
In summary, we reverse the anticipation and obviousness rejections of
claims 31-35, 38-40, 51-55, 58, and 59 over Zimmermann. We affirm the
obviousness rejection of claims 36, 37, 56, 57, 63-66, and 68-70 over
Zimmermann and McCain, but reverse the rejection of claim 67 over the
same references.
TIME PERIOD
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-IN-PART

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