Ex Parte van RIJN et al

Patent Trial and Appeal Board

Jul 26, 2018

14163344 (P.T.A.B. Jul. 26, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/163,344 01/24/2014 Cornelis Johannes Maria van RIJN
137713 7590 07/30/2018
Potomac Law Group, PLLC
8229 Boone Boulevard
Suite 430
Vienna, VA 22182
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.
1456-001 OUS02 4933
EXAMINER
MENON, KRISHNAN S
ART UNIT PAPER NUMBER
1777
NOTIFICATION DATE DELIVERY MODE
07/30/2018 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@potomaclaw.com
eofficeaction@appcoll.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CORNELIS JOHANNES MARIA VAN RIJN,
JACOB BAGGERMAN, and
ILANREICH
Appeal2017-010272
Application 14/163,344 1
Technology Center 1700
Before KAREN M. HASTINGS, JAMES C. HOUSEL, and
JEFFREY R. SNAY, Administrative Patent Judges.
HASTINGS, Administrative Patent Judge.
DECISION ON APPEAL
Appellant seeks our review under 35 U.S.C. § 134(a) of the
Examiner's decision rejecting claims 46-71 and 73-81.
We have jurisdiction over the appeal under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellant is the Applicant, Viatar, LLC., which, according to the Brief, is
the real party in interest (Br. 1 ).
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Independent claim 46 below is illustrative of the subject matter on
appeal ( emphases added):
46. A method of separating circulating tumor cells from
blood cells in a bodily fluid using a filter membrane that has a
first side, a second side opposite the first side, and a plurality of
pores between the first side to the second side, the blood cells
including leukocytes, the method comprising:
contacting the bodily fluid with the first side of the filter
membrane; and
applying a pressure differential across the filter
membrane such that at least a majority of leukocytes in the
bodily fluid pass through the pores to produce a filtrate at the
second side of the filter and such that at least 7 5% of the
circulating tumor cells are retained at the first side of the filter
membrane,
wherein the leukocytes that pass through the filter
membrane retain their vitality,
each of the pores of the filter membrane has a minimum
dimension, in a plane parallel to the first side, of between 3µm
and 8µm,
the pores of the filter membrane have a length in a
direction from the first side to the second side that is between
about 1 % and about 3 0% of the minimum dimension of each
pore.
The Examiner maintains the following rejections2 :
(a) claim 46 under 35 U.S.C. § 112, first paragraph, as failing to
comply with the written description requirement;
(b) claims 46-71 and 73-81 under 35 U.S.C. § 112, second
paragraph, as being indefinite; and
2 We refer to the Specification, filed Jan. 24, 2014 ("Spec."); the Final
Office Action, notice emailed Oct. 26, 2016 ("Final Act."), Appeal Brief,
filed Mar. 27, 2017 ("Br."); and the Examiner's Answer, notice emailed
May 8, 2017 ("Ans.").
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(c) claims 46-71 and 73-81 under 35 U.S.C. § I03(a) as being
unpatentable over Goldkom et al. (US 2011/0053152 Al, published Mar. 3,
2011) ("Goldkom") in view of Tai et al. (US 6,622,872 Bl, issued Sept. 23,
2003) ("Tai"), Wenthold et al. (US 5,683,584, issued Nov. 4, 1997)
("Wenthold"), Lentz (US 6,231,536 Bl, issued May 15, 2001) ("Lentz"),
and Chen et al. (US 2005/0244843 Al, published Nov. 3, 2005) ("Chen"). 3
ANALYSIS
Written Description Rejection
Claim 46 is rejected under 35 U.S.C. § 112, first paragraph, as failing
to comply with the written description requirement.
The test for sufficiency of a written description is whether the
disclosure "'clearly allow[s] persons of ordinary skill in the art to recognize
that [the inventor] invented what is claimed"' (Ariad Pharms., Inc. v. Eli
Lilly & Co., 598 F.3d 1336, 1351 (Fed.Cir.2010) (en bane) (quoting Vas-
Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562-63 (Fed.Cir.1991))). The
disclosure must "reasonably convey[ ] to those skilled in the art that the
inventor had possession of the claimed subject matter as of the filing date"
(id. at 1351 ). Possession means "possession as shown in the disclosure" and
"requires an objective inquiry into the four comers of the specification from
the perspective of a person of ordinary skill in the art" (id.).
3 The Examiner further cites Zheng et al. (Zheng et al., Membrane
micro filter device for selective capture, electrolysis and genomic analysis of
human circulating tumor cells, 1162 J. of Chromatography 154--161 (2007)
("Zheng")) as an alternative reference to Goldkom in case the latter is pre-
dated as a reference under 35 U.S.C. § I02(e). Final Act. 4, 5. In view of
the discussion below, we do not reach Zheng in our analysis.
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The Examiner finds the limitation "the pores of the filter membrane
have a length in a direction from the first side to the second side that is
between about 1 % and about 30% of the minimum dimension of each pore"
of claim 46 is not supported by Appellant's disclosure, as originally filed,
noting that pore length can be different from membrane thickness. Final
Act. 2.
Appellant asserts the disclosure, particularly page 27, lines 23-25, and
pages 30-32 of the Specification and Figure 1, supports the limitation cited
by the Examiner (Br. 6). Specifically, Appellant argues that the embodiment
described at pages 30-32 of the Specification involves etching in a direction
perpendicular to a surface of a filter, which results in pores perpendicular to
the surface and having a length matching the thickness of the membrane
(id.). Appellant further argues the rejection is based on assertions lacking
factual support, such as the Examiner's statement that pore length can be
different from membrane thickness (id. at 6-7).
To address this rejection, we first interpret claim 46 and determine
whether claim 46 requires pore length to equal membrane thickness. Claim
46 recites using a membrane having, among other things, "a plurality of
pores between the first side to the second side." One could construe this
language as meaning ( 1) the pores extend between the first side and the
second side (i.e., the length of the pores is the same as the membrane
thickness) or construe this language as meaning (2) the pores are between
the first side and the second side (i.e., pore length is not necessarily the same
as membrane thickness; pore length may be smaller). The remaining
limitations of claim 46 do not relate pore length to membrane thickness. For
instance, the limitation at issue relates pore length to a minimum pore
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dimension in a plane parallel to the first side of the membrane.
In a response dated October 13, 2016, Appellant amended claim 46 to
use the language "a plurality of pores between the first side to the second
side" instead of the previous language "a plurality of pores extending from
the first side to the second side." Thus, the prosecution history demonstrates
Appellant considered language in which pores extend from the first side to
the second side, but changed this language to the pores being "between the
first side to the second side."4
The plain meaning of the language "a plurality of pores between the
first side to the second side" favors an interpretation in which pores may be
located between the first and second sides (i.e., the second interpretation in
which pore length does not necessarily equal membrane thickness).
Interpreting the language to require pores to extend between the first and
second side involves adding the word "extending," which was removed by
Appellant's amendment.
Appellant asserts claim 46 should be interpreted as requiring pore
length to match membrane thickness, citing the embodiment described at
pages 30-32 of the Specification (id. at 6). However, interpreting claim 46
in such a way would not be under the broadest reasonable interpretation of
the claims in light of the Specification but would import features from the
Specification into the claims. Although claims are to be interpreted in light
of the specification, limitations from the specification are not to be read into
the claims. See In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993).
Moreover, a review of claim 54, which depends from claim 46, further
4 It appears that the "to" is a typographical error and should be a different
word, such as "and."
5
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supports an interpretation in which pore length does not equal membrane
thickness. Claim 54 recites that membrane thickness is "between 5% and
25% of the minimum dimension of each pore." This relationship differs
from the relationship between pore length and pore minimum dimension
recited in claim 46. Thus, claim 54 encompasses methods using membranes
having a thickness different from pore length.
In view of the above considerations, we construe claim 46 as reciting
the use of a membrane in which, among other things, a plurality of pores
may be between the first side and the second side.
We now tum our analysis to the merits of the rejection. Page 27, lines
23-25, of Appellant's Specification states "an unexpected advantage has
been observed when the thickness of the membrane is between about 1 %
and about 30%, and preferably, between about 5% and about 25% of the
width of the openings in the membrane." This disclosure provides support
for a relationship between membrane thickness and membrane width.
Because pore length does not necessarily equal membrane thickness within
the scope of claim 46, as construed herein, this passage does not sufficiently
support the scope of the limitation at issue. Further, the embodiment
described at pages 30-32 of the Specification also does not provide support,
either explicitly or implicitly, for the limitation.
For these reasons and those set forth in the Examiner's Answer, we
sustain the Examiner's rejection of claim 46 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
Indefiniteness Rejection
Claims 46-71 and 73-81 are rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite. The Examiner sets forth a rejection for
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independent claims 46, 59, and 68 and their dependent claims as well as
separate rejections for dependent claims 53 and 54 (Final Act. 3). We
separately address these rejections below.
Claims 46, 59, 68, and their dependents
The Examiner concludes the recitations of claims 46, 59, and 68
regarding a pore minimum dimension being between 3 µm and 8 µm are
indefinite (id.).
Appellant asserts claims 59 and 68 do not recite the relationship
between pore minimum dimension and pore length that is recited in claim 46
(Br. 7-9). With regard to claim 46, Appellant contends one of ordinary skill
in the art would understand what is claimed and the Examiner has not set
forth a prima facie case of indefiniteness because claim 46 can be interpreted
as varying the thickness of a membrane or reciting a range of thickness for a
membrane having a constant thickness (id. at 9-10). Appellant argues,
however, such claim breadth does not equate to indefiniteness (id. at 10).
Appellant's arguments are unpersuasive. As explained by the
Examiner at pages 5---6 of the Examiner's Answer, it is unclear what the
minimum dimension refers to. For instance, claims 46, 59, and 68 do not
specify a geometry or shape for the pores. Therefore, the pores of claims 46,
59, and 68 encompass pores having almost any shape, such as a shape
including parallel or substantially parallel sidewalls from one end of a pore
to the other, as exemplified by pores 4 in Appellant's Figure 1. The
minimum dimension of such a pore geometry might not change or
substantially change along its length (i.e., from the first side of a membrane
to the second side of the membrane). Such a minimum dimension may be
easily understood.
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However, claims 46, 59, and 68 also encompass pores of other shapes,
such as pores having a spherical cross-section, oval cross-section, or
irregularly shaped cross-section with respect to the length of a pore. The
cross sectional width (i.e., a minimum dimension) of such shapes relative to
a first side of a membrane would vary along the length of the pore from the
first side of the membrane to the second side, as explained by the Examiner
at page 6 of the Examiner's Answer.
Appellant does not cite a definition for the "minimum dimension" and
we do not discern one in Appellant's Specification. Therefore, it is unclear
what dimension of a pore the "minimum dimension" refers to ( e.g., what
cross-sectional width is selected along the length of a pore that changes in
width along its length). Further, it is unclear whether the range of 3-8 µm
recited in claims 46, 59, and 68 is a range that a selected minimum
dimension must fall within ( e.g., for each pore) or is a range that a minimum
dimension of a pore may vary within along its length, as explained by the
Examiner at page 5 of the Examiner's Answer. As a result, the scopes of
claims 46, 59, and 68 are unclear. In view of the indefiniteness for the
meaning and scope of the "minimum dimension" recited in claims 46, 59,
and 68, we do not reach other issues raised in the Final Office Action and
Examiner's Answer. The recitations of dependent claims 47-58, 60-67, 69-
71, and 73-81 do not cure the deficiencies of claims 46, 59, and 68.
For purposes of appeal, we interpret a pore' s minimum dimension in a
plane parallel to a first side of a membrane to be the smallest width of a hole
formed by the pore at the first side of a membrane, as measured in a plane
parallel to the first side.
For these reasons and those set forth in the Examiner's Answer, we
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sustain the Examiner's rejection of claims 46-71 and 73-81 under 35 U.S.C.
§ 112, second paragraph, as being indefinite.
Claim 53
Claim 53 depends from claim 46 and recites "wherein the minimum
dimensions of the pores differ by no more than 0.5 µm from each other."
The Examiner concludes it is indefinite how the range of minimum
dimensions recited by claim 46 is further reduced by claim 53 because it is
unclear whether the limitation of claim 53 is the variation in minimum
dimension permitted along the length of a pore or the variation in minimum
dimension permitted from pore to pore (Final Act. 3; Ans. 7).
Appellant argues the Examiner has not identified an issue that would
preclude one of ordinary skill in the art from understanding what is claimed
and that claim 53 constrains the range of pore sizes so they do not vary by, at
most, 0.5 µm from each other (Br. 10-11).
Appellant's arguments are persuasive. Although claim 53 still suffers
from the indefiniteness due to the meaning and scope of what a pore
"minimum dimension" is, there is no separate issue of indefiniteness for
claim 53. As argued by Appellant, claim 53 requires the minimum
dimension of the pores to vary no more than 0.5 µm from one another.
As a result, we do not sustain the separate rejection for claim 53 under
35 U.S.C. § 112, second paragraph, as being indefinite.
Claim 54
Claim 54 depends from 46 and recites "wherein the filter membrane
has a thickness in a direction from the first side to the second side that is
between 5% and 25% of the minimum dimension of each pore."
The Examiner concludes claim 54 is indefinite because it is unclear if
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membrane thickness varies at each pore location (Final Act. 3). Appellant
asserts the rejection has not identified an issue that would preclude one of
ordinary skill in the art from understanding what is claimed and argues the
claim is not indefinite whether it is directed to a membrane of constant
thickness or varying thickness because breadth should be equated with
indefiniteness (Br. 11 ).
Appellant's arguments are unpersuasive. As described above with
regard to claims 46, 59, and 68, the language "minimum dimension" is
indefinite. Claim 54 does not cure this deficiency, and de facto extends the
indefiniteness to membrane thickness by relating the latter to the minimum
dimension. As a result, it is unclear what the scope of membrane thickness
would be in claim 54.
For these reasons and those set forth in the Examiner's Answer, we
sustain the Examiner's additional rejection of claim 54 under 35 U.S.C.
§ 112, second paragraph, as being indefinite.
Obviousness Rejection
Claims 46-71 and 73-81 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Goldkom in view of Tai, Wenthold, Lentz, and
Chen. Appellant argues the following groups of claims: 46; 59; 62 and 75;
68; and 81 (Br. 12-21). Appellant does not argue dependent claims 47-58,
60, 61, 63----67, 69-71, 73, 74, and 76-80 separately from independent claims
46, 59, and 68 (id.).
Claims 46-61, 63-71, 73, 74, and 76-80
Although claims 46, 59, and 68 are argued separately, we address
them together here for purposes of efficiency, as well as their dependent
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claims that have not been argued separately.
Appellant's principal argument on appeal is that the applied
references do not disclose the relationship between pore length and a pore' s
minimum dimension recited in claim 46 (Br. 14). Specifically, Appellant
contends Goldkom does not disclose that "the pores of the filter membrane
have a length in a direction from the first side to the second side that is
between about 1 % and about 30% of the minimum dimension of each
pore," as recited in claim 46, and the Examiner provides no citation to
Goldkom to demonstrate discloses or meets this limitation (id. at 14--15).
Appellant's arguments are unpersuasive. The Examiner finds
Goldkom discloses filtering blood to capture circulating tumor cells (CTCs)
via a membrane having pores with a minimum size of about 6 microns,
which can be circular in shape (Final Act. 4). The Examiner further finds
the filter can have a thickness of 1 micron or more (id.). In view of this, the
Examiner finds that although Goldkom does not explicitly disclose the
relationship between pore length and pore minimum dimension recited in
claim 46, Goldkom discloses pore lengths and pore widths that would meet
the claimed relationship (id.; Ans. 9).
Goldkom discloses systems and methods for cancer detection in
which a parylene filtration device is used to capture CTCs from blood
(Goldkom ,r,r 5---6). The filtration device can includes holes of various
shapes, such a circles, that can have a cross sectional length of 1, 2, 3, 4, 5,
or 8 microns (as well as other sizes) and the filter can be from 0.5 to 20
microns thick (id. ,r,r 35-37, 41). Thus, Goldkom discloses a filter
membrane including pores having a minimum dimension between 3-8 µm
(e.g., 3, 4, 5, or 8 microns) and a pore length that is between about 1 % and
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30% of the minimum dimension.
In view of the above, Goldkom discloses specific sizes and size
ranges for pore length and the minimum dimension of a pore that meet the
relationship recited in claim 46. Specifically, filter thickness would
necessarily limit the length of a pore, which cannot be longer than the
thickness of the filter material it is formed within. Thus, for example, if a
filter is 1 micron thick, pores would be no more than 1 micron long. If the
pore has a cross sectional width (i.e., minimum dimension) of 5 microns, the
pore' s length is at most 20% of its cross sectional width, which meets the
relationship recited in claim 46. This example also meets the limitations of
claims 59 and 68, which specify that membrane thickness is less than the
minimum dimension of each pore.
Appellant further argues the Examiner does not address whether
Goldkom discloses leukocytes passing through its filter membrane and
retaining their vitality, as recited in claim 46, and that Goldkom is silent
with regard to the lysing of cells or the problem claim 46 addresses (Br. 17).
In response, the Examiner concludes there is no clear definition of
"lysed" in the Specification but it appears this term is being used in place of
"hemolysis" (Ans. 11 ). Appellant does not challenge this interpretation.
The Examiner finds Goldkom discloses the membrane used in the method of
claim 46 so one would have expected Goldkom to operate in the same
manner and not cause hemolysis (id.). The Examiner further finds Goldkom
discloses that the use of a low pressure drop across its filter minimizes the
forces exerted on cells and results in high cell viability (id.).
We agree that Goldkom's filtration device possesses the structure
recited in claim 46. Further, Goldkom discloses its device results in high
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cell viability (greater than 90% ), preserves the morphology of captured cells,
and minimizes the forces exerted on cells when a low and constant pressure
drop is used across the filter (Goldkom ,r,r 56-57). As a result, the
Examiner's findings and Goldkom's disclosure demonstrate that the
membrane used in claim 46 is identical or substantially identical to
Goldkom's filtration device (see In re Best, 562 F.2d 1252, 1255 (CCP A
1977) (where the claimed and prior art products are identical or substantially
identical, the USPTO can require an applicant to prove that the prior art
products do not necessarily or inherently possess the characteristics of the
claimed product)).
Based on the foregoing, the Examiner has set forth a prima facie case
of obviousness and the burden properly shifted to Appellant to show that
leukocytes passing through Goldkom's filtration device would not retain
their vitality, as recited in claim 46 (Best, 562 F.2d at 1254--55 (discussing
In re Swinehart, 439 F.2d 210 (CCPA 1971) and In re Ludtke, 441 F.2d 660
(CCPA 1971))). Appellant, however, has not presented persuasive evidence
or sufficient technical reasoning that Goldkom's filtration device would not
function in this manner.
In addition, Appellant asserts the claimed relationship between pore
dimension and pore length provides unexpected advantages, citing pages
27-29 of the Specification (Br. 16). The Examiner responds by finding the
asserted unexpected result of no hemolysis is present only in Appellant's
example 1, which is limited to 5 micron circular pores ( Ans. 10-11 ). In
view of this, the Examiner finds there is no nexus between the asserted
unexpected results and the claims (id. at 11). Moreover, the Examiner's
finding demonstrates the asserted unexpected results are not commensurate
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in scope with the claims, which are not limited to pores having a minimum
dimension of 5 microns or to pores having a circular shape. A showing of
unexpected results generally must be commensurate in scope with a claimed
range (In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005)). Based on the
foregoing, the Appellant's evidence of unexpected results is entitled to little
weight. A preponderance of the evidence supports the Examiner's
obviousness determination of claim 46 over Goldkom.
Appellant makes further arguments with regard to Tai (Br. 15-16).
However, as stated by the Examiner at page 10 of the Examiner's Answer,
Tai was cited as an alternative reference to Goldkom in case the latter was
antedated as a prior art reference. Because Appellant's arguments with
regard to Goldkom do not identify a reversible error, the arguments
regarding Tai are moot. Wenthold, Lentz, and Chen are cited for the
limitations of dependent claims (Final Act. 6).
With regard to claim 59, Appellant contends the limitation of
"monitoring a first pressure at the first side and a second pressure at the
second side" has not been directly addressed and Goldkom discloses the use
of a constant pressure, not a pressure differential or monitoring pressure
downstream (i.e., at a second side) of a filter (Br. 12-14).
Appellant's arguments are unpersuasive. Although Goldkom does not
explicitly disclose monitoring pressure at a second side of its filtration
device (Ans. 8), Goldkom discloses an increase of a pressure drop across a
filter in paragraph 56. This implies the monitoring of pressure at a first side
(i.e., upstream side) and a second side (i.e., downstream side) in order to
determine the pressure drop value and whether it has increased. Therefore,
Goldkom's disclosure supports the rejection of claim 59.
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With regard to claim 68, Appellant argues the Examiner does not
present evidence that the cited references disclose a method in which fewer
than 1 % of blood cells in a filtrate are lysed, as recited in claim 68 (Br. 20-
21 ).
In response, the Examiner finds Goldkom's filtration device is the
same or similar to that claimed and Goldkom teaches the use of low pressure
with the filtration device minimizes forces exerted on cells (Ans. 13). Thus,
for the same reasons discussed above in the rejection of claim 46, the
Examiner has set forth a prima facie case of obviousness that Goldkom's
filtration device is the same as or substantially similar to that used in the
method of claim 68 and would function in the same way (i.e., permit fewer
than 1 % of filtered blood cells to be lysed), which properly shifts the burden
to Appellant. However, Appellant has not presented persuasive evidence or
sufficient technical reasoning that Goldkom's filtration device would not
function as recited in claim 68.
Appellant further asserts the unexpected advantages discussed above
with regard to the rejection of claim 46 (Br. 20). As discussed above with
regard to claim 46, the asserted evidence of unexpected results is entitled to
little weight. A preponderance of the evidence supports the Examiner's
obviousness determination of claim 68 over Goldkom.
Claims 62 and 75
Claim 62 depends from claim 46 and recites, among other things,
"wherein the filter membrane has a bio-compatible coating that comprises
one or more zwitterionic polymeric materials." Claim 7 5 depends from
claim 68 and includes a similar limitation.
The Examiner rejects claims 62 and 75 by finding Wenthold discloses
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a biocompatible coating to make a membrane wettable and that the coating
can be zwitterionic (Final Act. 6; Ans. 12). The Examiner concludes it
would have been obvious to use the coating of Wenthold in Goldkom's
device because the materials of Goldkom's device and Wenthold's device
are considered obvious equivalents (Final Act. 6).
Appellant contends the Examiner has not provided any support that
the material of Wenthold would have been considered an obvious equivalent
to the material of Goldkom's device (Br. 18).
Appellant's arguments are unpersuasive. As discussed above,
Goldkom discloses systems and methods for cancer detection in which a
parylene filtration device is used to capture CTCs from blood (Goldkom ,r,r
5-6). Wenthold discloses hollow fiber membranes useful for separation
processes, such as hemofiltration (Wenthold 1: 15-24, 35--43). Wenthold
discloses the wettability of the fibers can be increased by a surfactant, which
can be zwitterionic (id. 19:55---67, 20:1-25). Thus, Goldkom and Wenthold
disclose materials for devices that are useful for the same purpose (i.e.,
blood filtration). "It is prima facie obvious to combine two compositions
each of which is taught by the prior art to be useful for the same purpose, in
order to fonn a third composition which is to be used for the very same
purpose" (In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (citations
omitted) (see also In re Fout, 675 F.2d 297,301 (CCPA 1982) ("Express
suggestion to substitute one equivalent for another need not be present to
render such substitution obvious")). Moreover, Wenthold would have
provided a reason to modify Goldkom's filtration device by disclosing a
surfactant that can increase the wettability of a material useful for blood
filtration.
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As a result, Appellant's arguments do not identify a reversible error in
the rejection of claims 62 and 75.
Claim 81
Claim 81 depends from claim 80, which depends from claim 79,
which depends from claim 46. Claim 81 recites a method to fuse retained
circulating tumor cells with dendritic cells (see claim 79) by applying an
alternating electric field including 250-300 V/cm at 1 MHz and
subsequently applying 1500 V/cm for 30-50 microseconds.
The Examiner rejects claims 79--81 by finding Chen discloses CTC's
can be fused with dendritic cells to form anti-cancer vaccines and finding the
Inventors disclose that such fusion is done by known methods, citing page 6
of the Specification (Final Act. 6).
Appellant argues the Examiner has not demonstrated that the steps
recited in claim 81 5 were known in the art because page 6 of the
Specification "only admits that 'an adequate RF pulse train' is known" (Br.
19--20).
The Specification states:
In some embodiments, a method for fusion to produce hybrid
cells from the captured CTCs is provided. For example, a
membrane with CTCs (e.g., approximately 100,000 or greater) is
placed on the bottom of a cell fusion chamber with the membrane
surface (having the CTCs) facing up. Preferably, an equal
number of dendritic cells are fed into the chamber. The dendritic
cells slowly deposit (by at least one of gravity and filtration via
the openings in the membrane) on top of the CTCs. Next, an
adequate RF pulse train (as known in the art) is applied to fuse
the dendritic cells with the CTCs, which results in the formation
of hybrid cells. For example, a membrane with the cells is
5 Appellant cites claims 79--81 at page 19 of the Appeal Brief but the
substance of the arguments focus upon the steps recited in claim 81.
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subject to an alternating field, e.g., about 250-300 V/cm at 1
MHz (for example) to stabilize the cell suspension. Next, a
fusion pulse of 15 sufficient amplitude ( for example, about 1500
V/cm) and duration (for example, about 30-50 µs), is applied
(Spec. 6:6-16 (emphasis added)). Thus, the Specification states that RF
pulse trains are known in the art for fusing dendritic cells with CTCs.
However, the Specification further discloses an example by stating "[ f]or
example," and describes the steps recited in claim 81. The Specification
does not describe the exemplary steps as an improvement upon the RF pulse
trains known in the art or something other than what is known in the art.
Instead, the Specification appears to describe the steps as an example of "an
adequate RF pulse train" that is "known in the art." As a result, we agree
with the Examiner that the Specification admits the steps of claim 81 as
being known in the prior art and Appellant's arguments do not identify a
reversible error in the rejection of claim 81.
For the reasons discussed above and those set forth in the Examiner's
Answer, we sustain the Examiner's§ 103(a) rejection of claims 46-71 and
73-81 over Goldkom, Tai, Wenthold, Lentz, and Chen.
DECISION
The Examiner's rejection of claims 46-71 and 73-81 is affirmed.
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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