Ex Parte PURUSHOTHAMAN et al

Patent Trials and Appeals Board

Jul 8, 2019

14648571 - (D) (P.T.A.B. Jul. 8, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/648,571 05/29/2015
1009 7590 07/10/2019
KING & SCHICKLI, PLLC
800 CORPORATE DRIVE, SUITE 200
LEXINGTON, KY 40503
FIRST NAMED INVENTOR
Suresh PURUSHOTHAMAN
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.
642C-019 A 7684
EXAMINER
PRAKASH, GAUTAM
ART UNIT PAPER NUMBER
1799
NOTIFICATION DATE DELIVERY MODE
07/10/2019 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):
uspto@iplawl.net
laura@iplawl.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SURESH PURUSHOTHAMAN,
JOSE ANTIONIO CASTILLO GONZALEZ,
JEAN-CHRISTOPHE DRUGMAND, VISHW AS PETRE,
DEREK PENDLEBURY, and FABIEN MONCAUBEIG
Appeal 2018-008396
Application 14/648,571
Technology Center 1700
Before JEFFREY B. ROBERTSON, JAMES C. HOUSEL, and
GEORGIANNA W. BRADEN, Administrative Patent Judges.
ROBERTSON, Administrative Patent Judge.
DECISION ON APPEAL 1
STATEMENT OF THE CASE
Appellants2 appeal under 35 U.S.C. § 134(a) from the Examiner's
Final Rejection of claims 1-10, 27, and 80-88. (Appeal Br. 2.) We have
jurisdiction pursuant to 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 This Decision includes citations to the following documents:
Specification filed May 29, 2015 ("Spec."); Final Office Action mailed
December 21, 2017 ("Final Act."); Appeal Brief filed May 21, 2018
("Appeal Br."); Examiner's Answer mailed June 25, 2018 ("Ans."); and
Reply Brief filed August 27, 2018 ("Reply Br.").
2 Appellants identify Pall Life Sciences Belgium as the real party in interest.
(Appeal Br. 2.)
Appeal 2018-008396
Application 14/648,571
THE INVENTION
Appellants state that the invention relates to a system and method for
detachment of cells in a fixed bed reactor. (Spec. 1, 11. 2-4.)
Claim 1 is representative and reproduced below from the Claims
Appendix to the Appeal Brief:
1. An apparatus for processing cells, comprising:
a fixed bed reactor for the cells, the fixed bed reactor including
a portion movable from a first position corresponding to a
packed condition of a fixed bed to a second position
corresponding to a depacked condition of the fixed bed,
a vibrator for vibrating the fixed bed;
whereby movement of the portion expands the fixed bed to
facilitate harvesting of the cells when the fixed bed is vibrated
by the vibrator;
wherein the fixed bed reactor is sealed from an ambient
environment during use in order to maintain a sterile interior
condition for growing cells.
(Appeal Br. 10, Claims Appendix.)
Claims 80 and 82 are also independent and similarly recite an
apparatus for processing cells including fixed bed reactor and vibrator.
(Appeal Br. 11-12, Claims Appendix.)
REJECTIONS
1. The Examiner rejected claims 1, 2, 4-7, 9, 27, and 80-83 under 35
U.S.C. § 103 as obvious over Boulay et al. (JP 7-506250, published
July 13, 1995, citations to English equivalent US 5,707,868, issued
January 13, 1998, hereinafter "Boulay") and Hvichia (US
2007/0072290 Al; published March 29, 2007). (Final Act. 3-4.)
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2. The Examiner rejected claims 3, 87, and 88 under 35 U.S.C. § 103 as
obvious over Boulay, Hvichia, and Wang et al. (US 7,856,704 B2,
issued December 28, 2010, hereinafter "Wang"). (Final Act. 4-5.)
3. The Examiner rejected claim 8 under 35 U.S.C. § 103 as obvious over
Boulay, Hvichia, and Cohee et al. (US 2004/0159616 Al; published
August 19, 2004, hereinafter "Cohee"). (Final Act. 5-6.)
4. The Examiner rejected claim 10 under 35 U.S.C. § 103 as obvious
over Boulay, Hvichia, and Gay (US 2011/0281343 Al; published
November 17, 2011. (Final Act. 6.)
5. The Examiner rejected claims 84-86 under 35 U.S.C. § 103 as
obvious over Boulay, Hvichia, and Schweigert (US 8,501,430 B2,
issued August 6, 2013). (Final Act. 6-7.)
Appellants present arguments for claims 1, 3, 10, 27, 80-86 on appeal.
(See Appeal Br. 3, 6-8.) We select claims 1, 3, 10, 27, 80, and 84 as
representative for disposition of this appeal. 37 C.F.R. § 41.37(c)(l)(iv).
Rejection 1
ISSUE
As to representative independent claims 1 and 80, the Examiner found
that Bouley discloses a reactor for processing cells comprising a portion
movable from a first position to a second position, which increased the
volume of the cultivation portion of the reactor. (Final Act. 3.) The
Examiner found that Boulay discloses isolating clamps, which means the
reactor is sealed from the ambient environment during use. (Id.) The
Examiner found Boulay discloses that cells are deposited on a screen at the
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bottom of the reactor after culturing, but does not teach a vibrator for
vibrating the fixed bed. (Id. at 4.) The Examiner found Hvichia discloses
that cells can be harvested by vibrating the apparatus. (Id.) The Examiner
determined that it would have been obvious to have modified the apparatus
of Boulay to include a means for vibration as taught by Hvichia because it
would increase the yield of the cells by helping dislodge them from the
screen, and a vibrator is a well-known means by which an apparatus can be
vibrated. (Id.) Regarding representative claim 27, the Examiner found
Boulay discloses a stirrer for circulating fluid within the fixed bed, and
although Boulay does not disclose that the stirrer is in the fixed bed reactor,
it would have been obvious to rearrange Boulay so that the stirrer is in the
fixed bed reactor as a rearrangement of parts. (Id.)
Appellants argue that the Examiner's reasoning for providing
vibration does not have adequate rational underpinning because in Boulay,
no cells are grown on the screen, which is used for separating the fluid from
the fluidized particles. (Appeal Br. 4-5.) Appellants argue also that the
isolating clamps in Boulay are valves, and the Examiner's rationale is based
on speculation that the use of valves means that the reactor in Boulay is
sealed from the ambient environment, because Boulay discloses an opening
to make it possible to introduce or withdraw liquid or introduce particles into
the enclosure. (Id. at 5-6.) Regarding claim 80, Appellants argue that the
Examiner did not explain why a skilled artisan would seek to vibrate the
Boulay arrangement in a depacked condition. (Id. at 6.) Regarding claim
27, Appellants contend the Examiner has not provided sufficient explanation
to support the position that incorporating a stirrer into Boulay' s reactor
would have been obvious. (Id.)
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Accordingly, the dispositive issues with respect to this rejection are:
Have Appellants identified a reversible error in the Examiner's
position that apparatus for processing cells recited in the claims would have
been obvious over Boulay and Hvichia?
Have Appellants identified a reversible error in the Examiner's
position that it would have been obvious to rearrange Boulay to include a
stirrer in the fixed bed reactor as recited in claim 27?
DISCUSSION
Issue 1
At the outset, we are not persuaded by Appellants' argument that
Boulay does not disclose that cells are grown on the screens such that the
Examiner's reasoning is unsupported by sufficient rational underpinnings.
Boulay discloses an apparatus for separating a cellular biological material
from a culture medium, the apparatus comprising a screen on which the
cellular biological material is deposited during separation. (Boulay, col. 1,
1. 59 - col. 2, 1. 40, col. 8, 11. 34-42.) Hvichia discloses that "in situations
where adhesion between cells and a step upon which they rest occurs, it can
be advantageous to apply energy to the apparatus to dislodge the cells or
otherwise facilitate their removal." (Hvichia ,i 27.) Hvichia discloses that
such energy may be in the form of "vibrating the apparatus." (Id.) As the
Examiner makes clear, the application of the vibrating apparatus in Hvichia
is to dislodge any cell that may end up on the screen, or any cells that may
be attached to the wall of the reactor in order to ensure the cells are in the
fluid bed mixture of Boulay. (Ans. 5.) Thus, we are of the view that the
Examiner's reasoning is sufficiently supported by the record.
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We also are not persuaded by Appellants' argument that the
Examiner's position that the valves in Boulay allow for the reactor to be
sealed from the ambient environment during use is based on speculation. As
the Examiner points out, if the valves are closed, the reactor is isolated from
the ambient environment. (Ans. 6; see Boulay col. 6, 11. 31, 52-64
discussing how the isolating clamps may open and close to control liquid
flow.) In addition, with respect to Appellants' position that the opening 13
provides evidence that the system is not closed to the ambient environment,
Boulay clearly discloses that the opening can be closed and opened,
"especially for the introduction of cells into the enclosure." (Boulay, col. 6,
11. 23-24; see col. 7, 1. 66 -col. 8, 1. 5; Ans. 6.) Thus, Appellants' position
that the Examiner is engaging in speculation is not well-founded.
We also are not persuaded by Appellants' argument that there is
insufficient explanation for vibrating Boulay in a depacked condition as
recited in claim 80. We agree with the Examiner that by disclosing
adjusting the volume to decrease density, Boulay discloses a depacked
condition. (Ans. 7.) That is, claim 80 is directed to an apparatus for
processing cells, and as such, the "depacked condition" corresponds to an
arrangement where the volume of the reactor has been increased (see
Spec. 7, 11. 11-18), such that the application of the vibration apparatus to the
culture chamber in Boulay where the volume of the culture chamber has
been increased meets the claims. (Boulay, col. 2, 11. 12-17.)
Issue 2 - Claim 2 7
We agree with Appellant the Examiner has not presented sufficient
reasoning to support the position that it would have been obvious to have
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included a stirrer in the reactor of Boulay. Specifically, although Boulay
discloses a stirrer in the receptacle forming a reservoir for the fluid medium
(Fig. 1, reservoir 10, homogenizer 16b; col. 6, 11. 19-20, 30), such a
modification would appear to require more than a mere rearrangement of
parts as the Examiner suggests. In this regard, although the Examiner cited
to a portion of Boulay disclosing that circulation of the liquid medium
prevents particles from gathering together (Ans. 7, citing Boulay col. 3,
11. 61-64 ), we agree with Appellants that this general disclosure is
insufficient to support the position that it would have been obvious to have
incorporated a stirrer into the reactor disclosed in Boulay. (Reply Br. 5.)
As a result, we reverse the Examiner's rejection of claim 27 and
claims 81 and 83 dependent therefrom.
In summary, we affirm the Examiner's rejection of claims 1, 2, 4-7, 9,
80, and 82 as obvious over Boulay and Hvichia. However, we reverse the
Examiner's rejection of claims 27, 81, and 83 as obvious over Boulay and
Hvichia.
In addition, because claim 8, the subject of Rejection 3, depends from
claim 1, and Appellants do not present separate arguments for claim 8, we
affirm the Examiner's decision to reject claim 8 for similar reasons as
discussed above for claim 1.
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Rejection 2
ISSUE
Regarding claim 3, which depends from claims 1 and 2, and recites
"an expandable retainer[3J for retaining the partition in the first position in a
non-expanded condition of the retainer and the second condition in an
expanded condition of the retainer," the Examiner found that Boulay in view
of Hvichia do not disclose this limitation. (Final Act. 5.) However, the
Examiner found that as evidenced by Wang, an expandable retainer for
retaining a partition in the manner recited in claim 2 is well-known. (Id.) In
view of Wang, the Examiner determined that it would have been obvious to
modify Boulay in view of Hvichia to include an expandable retainer as a
well-understood means by which to move and retain a partition. (Id.)
Appellants contend the Examiner does not provide sufficient
reasoning with rational underpinning to combine the disparate teachings of
the prior art to arrive at the claimed invention. (Appeal Br. 7.)
The issue with respect to this rejection is:
Did the Examiner provide sufficient reasoning with rational
underpinnings to support the position that it would have been obvious to
include an expandable retainer as disclosed in Wang in the apparatus of
Boulay in view of Hvichia to render claim 3 obvious?
DISCUSSION
We agree with Appellants, the Examiner did not provide sufficient
support for the rejection. Although the Examiner does not particularly point
3 The Specification discloses that an example of an "expandable retainer" is
a spring. (Spec. 2, 11. 17-20.)
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to what portion of Figure 1 of Wang corresponds to the expandable retainer,
we understand the Examiner to be referring to the coil compression spring
24. (Wang, Fig. l; col. 2, 11. 1-15.) We observe that the coil compression
spring 24 is in the expanded state when the plunger 16 in Figure 1 is in its
rest position, and in the compressed state when the plunger is lowered.
(Wang, col. 2, 11. 12-15, 36-37, Figs. 1, 2.) Thus, it appears the
arrangement of the compression spring 24 is opposite to what is required in
claim 3, where the partition in the first position is in a non-expanded
condition of the retainer and the partition is in a second condition is in an
expanded condition of the retainer. (See Figs. 3, 4.) Therefore, we agree
with Appellant, that in view of the disparate teachings of the prior art, the
Examiner has not provided sufficient support for the rejection.
As a result, we reverse the Examiner's rejection of claim 3, and claims
87, and 88 dependent therefrom.
Rejection 4
ISSUE
Regarding claim 10, which depends from claim 1, and recites
"wherein the reactor comprises a roller bottle," the Examiner found that
Boulay in view of Hvichia does not disclose that the reactor includes a roller
bottle. (Final Act. 6.) The Examiner found that as evidenced by Gay, the
use of roller bottles containing fixed beds as processing reactors is well
known. (Id.) The Examiner determined that it would have been obvious to
modify the disclosure of Boulay in view of Hvichia as a roller bottle,
because roller bottles provide good oxygenation and gentle rolling action
suitable for most anchorage-dependent cells. (Id. citing Gay ,-J 6.)
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Appellants contend that the Examiner has not provided a sufficient
basis for concluding that a skilled artisan would use a roller bottle in the
arrangement of Boulay, and that the Examiner ignored the arrangement in
Boulay in combining the prior art. (Appeal Br. 8; Reply Br. 6.)
Accordingly, the dispositive issue with respect to this rejection is:
Did the Examiner provide sufficient reasoning with rational underpinnings
to support the position that it would have been obvious to modify the reactor
of Boulay and Hvichia as a roller bottle in view of Gay to render claim 10
obvious?
DISCUSSION
We agree with Appellants the Examiner has not set forth sufficient
reasoning to support the position that it would have been obvious to have
formed the reactor of Boulay as a roller bottle. That is, although the
Examiner identified benefits of a roller bottle as disclosed in Gay (,-J 6), we
agree with Appellants that in view of the apparatus in Boulay ( as modified
by Hvichia), the Examiner has not provided sufficient explanation to support
the combination of prior art in the rejection. It is unclear why one of
ordinary skill in the art would have turned to Gay, in view of Gay's
disclosure of conventional horizontal roller bottles as culture chambers (Gay
,-J 6, Fig. 1) and roller bottles packed with parallel arrays of rods ( Gay ,-J 32,
Fig. 2), to modify Boulay's cylindrical column arrangement as situated in
the device disclosed therein (Boulay Fig. 1, col. 6, 11. 1-64) in order to take
advantage of the good oxygenation and gentle rolling action provided by
roller bottles as identified by the Examiner. We do not see how Boulay' s
silence as to dimensions of the reactor disclosed therein provides suitable
support for the rejection as posited by the Examiner. (Ans. 8.)
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Accordingly, we reverse the Examiner's rejection of claim 10.
Rejection 5
ISSUE
Regarding claim 84, which depends from claim 1 and recites that "the
vibrator comprises a vibrating table for supporting the fixed bed reactor," the
Examiner found that Boulay in view of Hvichia does not disclose a vibrating
table. (Final Act. 6.) The Examiner found that Schweigert discloses that
vibration tables are well-known pieces of extraction equipment, and that it
would have been obvious to modify the disclosure of Boulay in view of
Hvichia to use a vibrating table as taught by Schweigert because it is merely
the simple substitution of one known method of vibration by another to
obtain predictable results. (Id. at 6-7.) Claims 85 and 86 contain similar
limitations as claim 84.
Appellants contend that the Examiner provides no reason for the
combination, that there is no simple substitution involved, and no reasonable
expectation of success in the combination of prior art set forth by the
Examiner. (Appeal Br. 8.)
Accordingly, the dispositive issue with respect to this rejection is:
Did the Examiner provide sufficient reasoning with rational underpinnings
to support the position that it would have been obvious to use the vibration
table of Schweigert in order to vibrate the reactor of Boulay and Hvichia to
render claim 84 obvious?
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DISCUSSION
We are not persuaded by Appellants' argument. That is, as discussed
above, Hvichia discloses that vibration is a technique used to dislodge the
cells or otherwise facilitate their removal. (Hvichia ,-J 27.) Schweigert
provides evidence that vibrating tables are commonly employed to provide
vibration during extraction procedures. (Schweigert, col. 5, 11. 41-46.)
Accordingly, the Examiner has provided sufficient reasoning with rational
underpinnings to support the position that it would have been obvious to
have employed a vibration table as a mechanism to supply the vibration
rendered obvious by the combination of Boulay and Hvichia as discussed
above. Appellants' allegations that there is no "simple substitution" or
"reasonable expectation of success" due to the allegedly "remarkably
different" arrangements of Boulay and Hvichia are insufficient to
demonstrate error in the Examiner's position. (Appeal Br. 8; Reply 7-8.)
Given the express function of the vibrating table to provide vibration in
extraction applications, we are not persuaded that simply because
Schweigert is directed to extracting blood and solvent in combination, it is
"purely speculative" that the vibrating table would work if applied to the
arrangement in Boulay. (Reply Br. 8.)
Accordingly, we affirm the Examiner's rejection of claims 84-86.
DECISION
We affirm the Examiner's decision rejecting claims 1, 2, 4-9, 80, 82,
and 84-86.
We reverse the Examiner's decision rejecting claims 3, 10, 27, 81, 83,
87, and 88.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l .136(a)(l )(iv).
AFFIRMED-IN-PART
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