Ex Parte Fell

Patent Trial and Appeal Board

Feb 24, 2016

11908434 (P.T.A.B. Feb. 24, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111908,434 09/12/2007 Claude Fell
803 7590 02/26/2016
STURM & FIX LLP
206 SIXTH A VENUE
SUITE 1213
DES MOINES, IA 50309-4076
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.
2-0153-047 4003
EXAMINER
NGUYEN, HUONG Q
ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
02/26/2016 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):
shepherd@hsllp.com
potts@hsllp.com
campbell@hsllp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CLAUDE FELL
Appeal2013-007772
Application 11/908,434
Technology Center 3700
Before GEORGE R. HOSKINS, LEE L. STEPINA, and
FREDERICK C. LANEY, Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Claude Fell (Appellant) seeks our review under 35 U.S.C. § 134 of the
Examiner's decision rejecting claims 1-8, 11-18, and 20-25. We have
jurisdiction over the appeal under 35 U.S.C. § 6(b).
We AFFIRM.
THE CLAIMED SUBJECT MATTER
The claimed invention is directed to an integrated system for
collecting, processing and transplanting cell subsets, including adult stem
cells, for regenerative medicine. Spec. 1 (Title). Claim 1 is illustrative of
the claims on appeal and is reproduced below.
Appeal2013-007772
Application 11/908,434
1. A system for the extraction, collection, processing and
transplantation of cell subsets, including adult stem cells and
platelets, the system comprising a set of disposable sterile fluid-
transport elements, the set including:
- an extracting device for extracting bone marrow or other
sources of cell subsets from a patient. [sic]
- at least one chamber for the collection, processing and
reinfusion of the cell subsets extracted from the patient,
including a collection chamber pre-connected or connectable to
the extracting device for harvesting the cells extracted from the
patient by the extracting device; a processing chamber adapted
to cooperate with processing equipment to perform processing
and transfer operations on the harvested cells; and a reinfusion
chamber for storing processed cells to be delivered back to the
patient; wherein the processing chamber is a hollow generally
cylindrical centrifugal processing chamber that is rotatable
about the cylinder axis and has an inlet/outlet for the cells to be
processed and for the processed cells, the processing chamber
containing a movable piston which is fluid-tightly movably
mounted in the centrifugal processing chamber to define a
separation space of variable size for receiving the cells, the
piston being movable to intake a selected quantity cells to be
processed into the separation space via said inlet and to express
processed cells from the separation space via said outlet; and
wherein the collection, processing and reinfusion chambers are
separate and are pre-connected or interconnectable, or wherein
a multi-purpose processing chamber provides the combined
functions of a collection-processing chamber, a processing-
reinfusion chamber or a collection-processing-reinfusion
chamber; and
- a transplantation device pre-connected or connectable to the
reinfusion chamber for delivering processed cells back to the
patient,
wherein said set of disposable elements is contained in a pack,
the contained elements being pre-connected or including aseptic
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Application 11/908,434
connectors or being adapted for making interconnections
between them in an aseptic manner to provide a functionally
closed system for the extraction, collection, processing and
transplantation of cell subsets.
Appeal Br. 25-26.
REFERENCES RELIED ON BY THE EXAMINER
Ferguson
Lindsay
Fell
US 6,264,619 Bl
US 6,811,749 B2
EP 0 912 250 Bl
July 24, 2001
Nov. 2, 2004
Nov. 3, 1999
THE REJECTIONS ON APPEAL
(I) Claims 1, 3-8, 11-18, and 20-25 are rejected under 35 U.S.C. §
103(a) as unpatentable over Fell and Lindsay.
(II) Claim 2 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Fell, Lindsay, and Ferguson.
ANALYSIS
Rejection(!)
The Examiner finds that Fell discloses most of the features recited in
claim 1, but does not disclose the set of disposable elements is contained in a
pack. Final Act. 3--4. The Examiner relies on Lindsay to teach this feature,
and the Examiner determines that it would have been "obvious to also place
the elements of Fell into a similar disposable pack as taught by Lindsay to
reasonably and predictably provide a device that functions in the desired
manner but also provides the advantages of ease in connection and use of the
system as well as enhanced sterility." Final Act. 4.
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Appellant argues that Fell does not disclose the set recited in claim 1.
Appeal Br. 10-11. Specifically, Appellant asserts that "the differentiating
feature" between the arrangement recited in claim 1 and the system taught
by Fell "is that the set of disposable sterile elements forms a functionally
closed system for the extraction, collection, processing and transplantation
of cell subsets, that is contained in a pack and the contained elements are
pre-connected or adapted for making aseptic interconnections to provide the
functionally closed system." Appeal Br. 11. Appellant further asserts that
Fell does not solve the same problem as the arrangement recited in claim 1
because "Fell's disposable sets are supplied as individual elements that have
to be connected for use in 'clean room environments' for the purposes of
individually carrying out the operations of extraction/collection of cell
subsets, processing the cell subsets to separate the cell sub-sets into
components, and reinfusing/transplanting processed cell subsets." Appeal
Br. 11-12 (emphasis added). In this regard, Appellant contends that Fell
"does not disclose a functionally closed system as claimed." Reply Br. 3.
In response, the Examiner reiterates that Fell discloses all the
structural elements required by claim 1 except for their location in a pack.
Ans. 10. The Examiner finds "Fell discloses said elements 'being adapted
for making interconnections between them in an aseptic manner' (again, due
to alternative language, this is the only limitation required) to provide the
functionally closed system for the extraction, collection, processing, and
transplantation of cell subsets." Ans. 10-11. The Examiner further
determines that "the claims do not recite any particular structure or
limitation that necessitates how said system must be functionally closed. It
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Application 11/908,434
is noted that Fell discloses the system to be connected to the patient and
when connected as such, provides a functionally closed system." Ans. 11.
Appellant replies:
If Fell' s teaching were followed to use the described processing
chamber for cell separation and for transplantation of cell
subsets, the skilled person would have to complement Fell's
disclosure by providing an extraction device for that purpose
and a transplantation device for that purpose, these items not
being described as a set together for the given purpose.
Reply Br. 3 (emphasis added). Appellant further contends that a user would
have to gather the individual components taught by Fell and connect them
with aseptic connectors "and they could then be interconnected to become a
functionally closed system after connecting them all together and connecting
them to a patient." Reply Br. 3.
We are not apprised of Examiner error on this issue. In the discussion
of Figure 3 (which relates to blood separation), paragraph 33 of Fell states:
The disposable set used for this separation comprises a
centrifugal processing chamber 13 (like the processing chamber
of Figs. 1 and 2) connected to a set of tubing lines and bags. A
schematically-indicated phlebotomy needle 82 is connected to a
tubing line 93 which connects the processing chamber 13 to a
plasma bag 85, a buffy-coat bag 84 and a red cell bag 83.
Fell further explains that the disclosed system may be used with
haemapheresis, which processes blood and returns at least a portion of the
product to the donor. 1 See Fell i-f 54. Further with respect to haemapheresis,
1 Apheresis: A procedure in which blood is drawn from a donor and
separated into its components, some of which are retained, such as plasma or
platelets, and the remainder returned by transfusion to the donor. Also
called hemapheresis.
httns://www.ahdictionary.com/word/search.htm1?id=A5381400 (last visited
February 8, 2016).
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Application 11/908,434
Fell specifically states, "the instrumentation should incorporate the
necessary components and modules to manage the reinfusion procedure."
Fell i-f 54.
As for whether these components are "a functionally closed system"
as recited in claim 1, Appellant does not persuasively explain why the
system taught by Fell, which is disclosed as able to be connected to a
patient, does not, in the connected state, qualify as a functionally closed
system as recited in claim 1. Thus, we agree with the Examiner's statement,
"[i]t is noted that Fell discloses the system to be connected to the patient and
when connected as such, provides a functionally closed system." Ans. 11.
Nor does Appellant persuasively explain why the system, modified as
proposed by the Examiner to be contained in a pack, fails to qualify as the
set recited in claim 1. In this regard, Appellant does not direct our attention
to any definition of the word set that would exclude the arrangement
proposed by the Examiner. Further, contrary to Appellant's argument that
paragraphs 54 and 58 of Fell fail to "expressly disclose a set of components
for cell extraction, collection, processing[,] and transplantation" (Reply Br.
2), Fell explicitly discloses all the components required for cell extraction,
collection, and processing in Figures 1-3 and the discussion thereof. As for
transplantation, Appellant does not persuasively explain what element
required by claim 1 is not disclosed by the discussion of haemapheresis in
Fell.2 Thus, the Examiner's finding that Fell discloses all the elements
(except for containing the components in a pack) recited in claim 1,
2 Although not relied upon by the Examiner, Figure 11 and the discussion
thereof relate to autotransfusion and teach aspiration through line 120,
processing in chamber 13, and reinfusion via line 127. Fell i-f 55.
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Application 11/908,434
including an extraction device and transplantation device, is supported by a
preponderance of the evidence.
Appellant also asserts that Lindsay is non-analogous art, a person of
skill in the art seeking to improve Fell would not look to the disclosure of
Lindsay, and Lindsay is directed to a different purpose from Appellant's
claimed arrangement. See Appeal Br. 12-21; Reply Br. 3---6.
Our reviewing court has set forth a two-prong test for determining
whether a prior art reference is analogous: (1) whether the reference is from
the same field of endeavor as the claimed invention, and (2) if the reference
is not within the same field of endeavor, whether the reference is reasonably
pertinent to the particular problem with which the inventor is involved. In re
Klein, 647 F.3d 1343 (Fed. Cir. 2011). In this regard, Appellant's
Specification states, "[ t ]he invention provides a simple system for
automatically processing/concentrating cell subsets in a closed system that
can provide an on-line cell processing system at the patient's bedside, as set
out in Claim 1." Spec. 3. Lindsay is directed to "[a] self-contained pack
assembly includ[ing] all of the disposable components of an extracorporeal
support circuit for cardiac bypass surgery. The pack assembly comprises a
blood reservoir, a blood oxygenator, and a carrier for vertically mounting the
blood reservoir and blood oxygenator." Lindsay, Abstract. Lindsay further
states, "[t]he invention provides an assembly pack that contains the major
disposable components of an extracorporeal support circuit, conveniently
packaged in ready-to-use condition." Lindsay, col. 2, 11. 47-53. Although
directed to a different type of treatment from Appellant's system, Lindsay is
directed to providing a closed system that provides blood processing at a
patient's bedside. See Lindsay, col. 4, 11. 7-17. Thus, we are not persuaded
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that Lindsay does not satisfy at least the second prong of the two-prong test
set forth in Klein.
Appellant further argues that a person of skill in the art would not
consult Lindsay inasmuch as "Lindsay does not describe or suggest
extrapolating his cardiac by-pass system to any other blood circulation
system and in particular not a system for the extraction, collection,
processing and transplantation of cell subsets." Appeal Br. 14.
This argument does not address the rationale set forth by the
Examiner, i.e., that the proposed modification to the system in Fell would
"reasonably and predictably provide a device that functions in the desired
manner but also provides the advantages of ease in connection and use of the
system as well as enhanced sterility." Final Act. 4. Accordingly, we are not
persuaded that the Examiner's reasoning for the proposed combination of
Fell and Lindsay is inadequate.
Appellant further argues that "[t]he concept of having three chambers
or a multipurpose chamber is absent from Lindsay." Appeal Br. 16. In this
regard, we note that the Examiner relies on processing chamber 13 of Fell
for the recited chamber. Final Act. 3.
In relation to the interpretation of claim 1, Appellant states, "it is
noted in the Final Office Action that the alternative language of the claims
only require a multi-purpose chamber to perform all three functions of
collection, processing, and reinfusing. In fact, the claims require
alternatively separate collection, processing and reinfusion chambers or a
combined multipurpose chamber performing the three functions." Appeal
Br. 19.
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Application 11/908,434
Claim 1 recites, in part:
wherein the collection, processing and reinfusion chambers are
separate and are pre-connected or interconnectable, or wherein
a multi-purpose processing chamber provides the combined
functions of a collection-processing chamber, a processing-
reinfusion chamber or a collection-processing-reinfusion
chamber.
Appeal Br. 25 (emphasis added). Thus, claim 1 requires the collection,
processing, and reinfusion chambers to be separate, or these functions may
be provided by a multi-purpose chamber. Thus, we are not apprised of
Examiner error in addressing this feature by finding one of the above-noted
alternatives (a multi-purpose chamber) to be taught by Fell. See Final Act. 3
(referring to processing chamber 13).
Appellant discusses other components disclosed by Lindsay and
further discusses the purpose of the arrangement taught by Lindsay, pointing
out differences between what Lindsay teaches and the arrangement recited in
claim 1. See Appeal Br. 19-21. Appellant :farther contends that the
Examiner's rejection of claim 1 is based on hindsight. Reply Brief 5---6. We
find this discussion unpersuasive inasmuch as it does not address the
Examiner's rejection based on Fell and Lindsay. As noted above, Examiner
finds that Fell discloses all the structural elements required by claim 1
except for their location in a pack. See Final Act. 4, Ans. 10. As further
noted above, we are not persuaded that the Examiner's reasoning in making
the proposed combination of Fell and Lindsay is inadequate.
Appellant makes arguments for the patentability of claim 1 7 similar to
those made for the patentability of claim 1. Appeal Br. 15-16. We find
these arguments unpersuasive for the reasons discussed above with respect
to the rejection of claim 1.
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Application 11/908,434
On page 2 of the Reply Brie±: Appellant presents arguments for the
patentability of claims 4, 5, and 11 that were not presented in the Appeal
Brief. We note that the presentation of the Grounds of Rejection for claims
4, 5, and 11 in the Examiner's Answer (see Ans. 6-7) appears to be
substantively identical to rejection of record (see Final Act. 5---6), from
which the instant appeal is taken, such that these new arguments in the
Reply Brief are not responsive to an argument raised or a position taken in
the Examiner's Answer. The rules applicable to present appeal provide:
Any argument raised in the reply brief which was not raised in
the appeal brief, or is not responsive to an argument raised in
the examiner's answer, including any designated new ground of
rejection, will not be considered by the Board for purposes of
the present appeal, unless good cause is shown.
37 C.F.R. § 41.41(b)(2) (2014). Appellant does not present a showing of
good cause for why these new arguments were not presented in the Appeal
Brief. Accordingly, these arguments are waived for the purposes of this
Appeal.
Aside from the above-noted untimely arguments for the patentability
of claims 4, 5, and 11, Appellant does not make separate arguments for
claims 3-8, 11-18, and 20-25. See Appeal Br. 10 (stating "Claims 1-8, 11-
18 and 20-25 are grouped in the Appeal. The Appellant suggests that Claim
1 is the most appropriate claim that may be singled out for a determination
of patentability in that the patentability of all claims stems from claim 1. ").
Accordingly, claims 3-8, 11-18, and 20-25 fall with claim 1.
Re} ection (II)
Claim 2 recites,
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The system of claim 1, wherein the set of disposable
elements is packaged in a blister pack on a tray or tray-like
support, the blister pack having one compartment for receiving
the entire interconnected set or a plurality of compartments
each receiving a part of the set that includes an aseptic
connector for connection to another part of the set.
Appeal Br. 26.
The Examiner relies on Ferguson to teach a blister pack as recited and
reasons that it would have been obvious "to have the disposable elements of
Fell as modified by Lindsay above be packaged in a blister pack on a tray as
taught by Ferguson as a well-known and effective disposable type of
packing for analogous medical elements." Final Act. 8.
Appellant contends, "Ferguson is strictly limited to a kit
for taking a blood sample as clearly repeated throughout Ferguson's
disclosure." Appeal Br. 22. Appellant asserts, "Ferguson does not relate to
a kit for extracting, collecting, processing and reinfusing transplanting cell
subsets." Appeal Br. 22. Appellant contends that Lindsay does not suggest
use of a blister pack with the assembly disclosed therein, and "Lindsay's
described and illustrated embodiment of a pack assembly looks eminently
unsuitable for being contained in a blister pack." Appeal Br. 23. Appellant
also states, "[t]he further theoretical combination of Ferguson with Lindsay
does not lead in an obvious way to the system of claim 2 because these
documents contain no suggestion that would lead to a blister pack for a
functionally closed system for the extraction, collection, processing and
transplantation of cell subsets." Appeal Br. 23.
We are not persuaded by this argument inasmuch as it does not
address the Examiner's rationale for modifying the proposed combination of
Fell and Lindsay. It is not necessary for Lindsay to suggest the
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Application 11/908,434
modification. Rather, the Examiner's analysis "need not seek out precise
teachings directed to the specific subject matter of the challenged claim, for
a court [or examiner] can take account of the inferences and creative steps
that a person of ordinary skill in the art would employ." KSR International
Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). As for whether the pack in
Lindsay is unsuitable for containment in a blister pack, Appellant provides
no persuasive evidence or argument that this is so, much less that the
Examiner's proposed combination of Fell and Lindsay would suffer from
this problem. Accordingly, we sustain the Examiner's rejection of claim 2
as unpatentable over Fell, Lindsay, and Ferguson.
DECISION
We affirm the Examiner's rejection of claims 1-8, 11-18, and 20-25.
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)(l )(iv).
AFFIRMED
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