Ex Parte Gage

Patent Trial and Appeal Board

Mar 16, 2017

11654553 (P.T.A.B. Mar. 16, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
HLPF-1002US 7381
EXAMINER
HIRIYANNA, KELAGINAMANE T
ART UNIT PAPER NUMBER
1633
MAIL DATE DELIVERY MODE
11/654,553 01/18/2007 Fred Gage
22186 7590 03/16/2017
MENDELSOHN DUNLEAVY, P.C.
1500 JOHN F. KENNEDY BLVD., SUITE 312
PHILADELPHIA, PA 19102
03/16/2017 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FRED GAGE1
Appeal 2015-000915
Application 11/654,553
Technology Center 1600
Before JOHN G. NEW, JOHN E. SCHNEIDER, and TIMOTHY G.
MAJORS, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
for extracting stem cells, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.2
1 Appellant identifies the Real Party in Interest as Hemacell Perfusion. Inc.
(Appeal Br. 2.)
2 A hearing in this appeal was held on March 9, 2017. A transcript of the
hearing will be added to the file when it becomes available.
Appeal 2015-000915
Application 11/654,553
STATEMENT OF THE CASE
The Specification describes a method for extracting non-embryonic
stem cells from a source by perfusing the source with a pulsatile flow of a
perfusion solution. Spec 113.
Claims 1—5 and 21 are on appeal. Claim 1 is the sole independent
claim and reads as follows:
1. A method for extracting stem cells from a non-embryonic
stem cell source, comprising:
providing an isolated non-embryonic stem cell source
comprising stem cells;
perfusing the non-embryonic stem cell source with a
rhythmic, intermittent flow of a perfusion solution through the
stem cell source in a manner whereby said flow is pulsed to
simulate an in vivo pulse rate to produce a perfusate comprising
stem cells and a perfused nonembryonic stem cell source; and
isolating the stem cells from the perfusate to produce
isolated stem cells.
The claims stand rejected as follows:
Claims 1—5 and 21 have been rejected under 35U.S.C. § 112, second
paragraph as indefinite3.
3 The Examiner raises this rejection for the first time in the Examiner’s
Answer. Ans. 7. We find nothing in the record that indicates that the
Examiner secured the Director’s approval to make this new rejection as
required by 37 C.F.R. § 41.39(a)(2). Appellant, however, has elected to
respond to the new rejection and we will address the rejection in this
opinion.
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Application 11/654,553
Claims 1—5 and 21 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Hariri4 in view of Bomstein5, Leeser6, Peng7 and Nevo.8
THE INDEFINITENESS REJECTION
Issue
The issue with respect to this rejection is whether the evidence of record
supports the Examiner’s determination that the claims are indefinite.
According to the Examiner, the term pulsed to simulate an in vivo
pulse rate renders the claims indefinite as the claims do not set forth which
pulse rate is to be used. Ans. 7
Appellant contends that one skilled in the art would understand how
to determine what pulse rate to simulate as the pulse rates can be readily
obtained. Reply Br. 2.
Appellant has the better position. The Examiner has not shown that
one skilled in the art would be unable to determine which value to use for
the pulse rate. As Appellant points out the question is more one of the
breath of the claims as opposed to indefmiteness.
We conclude that the evidence of record does not support the
Examiner’s rejection for indefmiteness.
4 Hariri, US 7,468,276 B2, issued Dec. 23, 2008 (“Hariri”).
5 Bomstein et al., A Modified Blood Collection Method Achieves Sufficient
Cell Levels for Transplantation in Most Adult Patients, 23 Stem Cells 324
(2005) (“Bomstein”).
6 Leeser et al., Pulsatile Pump Perfusion of Pancreata Before Human Islet
Cell Isolation, 36 Transplantation Proc. 1050 (2004) (“Leeser”).
7 Peng et al., In vitro system to study realistic pulsatile flow and stretch
signaling in cultured vascular cells, 279 Am. J. Physiol. Cell Physiol. Cl91
(2000) (“Peng”).
8 Nevo et al., US 6,632,651 Bl, issued Oct. 14, 2003 (“Nevo”).
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Application 11/654,553
THE OBVIOUSNESS REJECTION
Issue
The issue with respect to this rejection is whether the preponderance
of the evidence supports the Examiner’s conclusion that the pending claims
would have been obvious over Hariri combined with Bomstein, Leeser,
Peng and Nevo.
The Examiner finds that Hariri teaches a method for extracting stem
cells from umbilical cords by perfusing the cord and collecting the perfusate.
Ans. 5. The Examiner finds that Bomstein teaches a method for collecting
stem cells from a placenta be perfusing the placenta and gathering the stem
cells from the perfusate. Ans. 6. The Examiner finds that Leeser teaches the
use of a pulsatile perfusion pump to extend the preservation of human islet
cells as well as improve yield of the islet cells. Id. The Examiner finds that
Peng teaches the use of a pulsatile perfusion system to maintain endothelial
cells and that Nevo teaches applying rhythmic pulses of perfusate at rates of
from 5 to 300 pulses per minute. Id. The Examiner concludes that
it would have been obvious for one of ordinary skill in the art to
substitute a continuous flow perfusion pump used by Hariri
with a pulsatile pump of Leeser or Nevo and extract cells from
a non-embryonic stem cell source. One of ordinary skill in the
art would have been motivated to make and use pulsatile pump
as it would extend the viability and the yield of cells would try
out different pumping rates including that simulates in vivo
rates on stem cell extraction from blood vessels of tissue
following Peng reference that teaches that computerized servo
motor adopted pump systems for generating in vivo rhythm
which is generally 60-80 are readily available. One of ordinary
skill in the art would have reasonable expectation of success
making and using a pulsatile pump for isolating cells from a
stem cell source because the art teaches it is routine to isolate
cells from a stem cell source by repeated perfusions using a
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Application 11/654,553
machine pump and the art further teaches an equivalent or
better performing pulsatile pumps in the preservation and
isolation of mammalian cells. Thus, the claimed invention was
prima facie obvious.
Ans. 6—7.
Appellant contends that Hariri does not teach the claimed invention
and in fact teaches away from using a rhythmic flow as called for in the
instant claims. Appeal Br. 4—6. Appellant contends that Bomstein does not
teach a rhythmic flow. Appeal Br. 7. With respect to Peng and Leeser,
Appellant argues that while both teach a pulsed flow of perfusate, neither
reference teaches the use of a pulsed flow to recover stem cells. Appeal Br.
8—9. Appellant contends that the Examiner has not explained why one
skilled in the art would combine the references or would have a reasonable
expectation for success in combining the references. Appeal Br. 10—14.
Finally, Appellant argues that there is sufficient evidence of unexpected
results to overcome a prima facie case of obviousness. Appeal Br. 15—16.
Findings of Fact
We adopt as our own the Examiner’s findings and analysis. The
following findings are included for emphasis and reference convenience.
FF1. Hariri discloses “a method for extracting and recovering
embryonic-like stem cells, including, but not limited to pluripotent or
multipotent stem cells, from an exsanguinated human placenta.” Hariri
Abstract.
FF2. Hariri teaches that
[t]he placenta may be perfused continually, with equal volumes
of perfusate introduced and effluent perfusate removed or
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Application 11/654,553
collected. Alternatively, the placenta may be perfused
periodically, e.g., at every 2 hours or at 4, 8, 12, and 24 hours,
with a volume of perfusate, e.g., 100 ml of perfusate (sterile
normal saline supplemented with or without 1000 u/1 heparin
and/or EDTA and/or CPDA (creatine phosphate dextrose)). In
the case of periodic perfusion, preferably equal volumes of
perfusate are introduced and removed from the culture
environment of the placenta, so that a stable volume of
perfusate bathes the placenta at all times.
Hariri col. 13,11. 6—17.
FF3. Hariri teaches that a placenta can be maintained by perfusing
the placenta. Hariri col. 5,11. 53—59.
FF4. Bomstein teaches isolation of cord blood collection from
placenta by umbilical venipuncture and placental perfusion. Bomstein
Abstract.
FF5. Bomstein teaches the desirability to enhance the recovery of
stem cells from a placenta so as to provide more stems cells for
transplantation. Bomstein 324—325.
FF6. Feeser teaches pulsatile perfusion of whole pancreases which
improves yield, viability and function of human islets. Feeser Abstract and
Figure 1.
FF7. Peng discloses the use of pulsed perfusion to maintain cells.
Peng Figure 1.
FF8. Nevo discloses a pulsed perfusion system where the perfusate
is pulsed at a rate of from 5—300 pulses per minute with 60 —100 pulses per
minute preferred. Nevo col. 5,11. 27—29.
FF9. The Specification teaches that “[t]he present method can
employ any conventional pulsatile perfusion machine. The constmction and
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Application 11/654,553
operation of such pulsatile perfusion machines is well known to those of
ordinary skill in the art.” Spec. 33.
FF10. The Specification teaches that “[s]uitable perfusion solutions
are well known to those of ordinary skill and many are commercially
available.” Spec. 141.
Principles of Law
“[W]hen a patent claims a structure already known in the prior art that
is altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result.” KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007), citing United States v.
Adams, 383 U.S. 39, 50-51 (1966).
Expressed preference for certain embodiments within a disclosed
genus does not teach away from the rest of the embodiments within the
genus. In re Susi, 440 F.2d 442, 446 n.3 (CCPA 1971).
“The prior art’s mere disclosure of more than one alternative does not
constitute a teaching away from . . . alternatives because such disclosure
does not criticize, discredit, or otherwise discourage the solution claimed.”
In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
In determining whether the subject matter of a patent claim is
obvious, neither the particular motivation nor the avowed
purpose of the patentee controls........ [A]ny need or problem
known in the field of endeavor at the time of invention and
addressed by the patent can provide a reason for combining the
elements in the manner claimed.
KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 419-20 (2007).
“Mere improvement in properties does not always suffice to show
unexpected results. In our view, however, when an applicant demonstrates
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Application 11/654,553
substantially improved results . . . and states that the results were
unexpected, this should suffice to establish unexpected results in the absence
of evidence to the contrary.” In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995)
(emphasis in original).
“The evidence presented to rebut a prima facie case of obviousness
must be commensurate in scope with the claims to which it pertains.” In re
Dill, 604 F.2d 1356, 1361 (CCPA 1979).
Analysis
Claim 1 is representative of the rejected claims and is directed to the
use of a rhythmic, intermittent flow of a perfusion solution through the stem
cell source to recover non-embryonic stem cells.
The evidence of records supports the Examiner’s conclusion that the
subject matter of claim 1 would have been obvious to one skilled in the art at
the time the invention was made. Hariri and Bomstein both teach the
extraction of stem cells from placentas and the desirability to increase yields
of those cells. FF1—5. Hariri also teaches that perfusion helps maintain the
placenta for further use. Leeser teaches that pulsatile perfusion of a
pancreases improves longevity of the organ and enhances the yield of islet
cells. FF6. Peng also teaches that pulsatile perfusion extends the viability of
cells. FF7. We agree with the Examiner that
it would have been obvious for one of ordinary skill in the art to
substitute a continuous flow perfusion pump used by Hariri
with a pulsatile pump of Leeser and extract cells from a non-
embryonic stem cell source. One of ordinary skill in the art
would have been motivated to make and use pulsatile pump as
it would extend the viability and the yield of cells would try out
different pumping rates including that simulates in vivo rates on
stem cell extraction from blood vessels of tissue following Peng
reference that teaches that computerized servo motor adopted
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Application 11/654,553
pump systems for generating in vivo rhythm which is generally
60-80 are readily available.
Final Act. 3^4.
Appellant contends that Hariri teaches away from using a pulsed flow
of perfusate in that it teaches that a stable volume of perfusate is preferred.
Appeal Br. 4. We are not persuaded. That a particular embodiment is
preferred is not the same as a teaching not to use alternative embodiments.
In re Susi, 440 F.2d at 446 n.3. The cited passages of Hariri do not
“criticize, discredit, or otherwise discourage the solution claimed.” In re
Fulton, 391 F.3d at 1201.
Appellant contends that there is no motivation to combine the
references. Appeal Br. 10-14. Again we are unpersuaded. Hariri teaches
that perfusion of a placenta extracts stem cells from the placenta and
maintains the placenta. FF1—3. Bomstein teaches the desirability to
increase the yield of stem cell extraction using a placenta. FF5. Leeser and
Peng teach that pulsatile perfusion increases the viability of the perfused
organ and cells. FF6and7. Leeser also teaches that pulsatile perfusion
improves the yield of islet cells. FF6. We agree with the Examiner that one
skilled in the art would have been motivated to combine the references to
improve the viability of the placenta and improve the yield of stem cells.
Final Act. 3^4.
Appellant contends that the evidence submitted in the Hardy
Declaration9 shows that the results achieved by the claimed method are
unexpected when compared with the prior art and that this shows the claims
9 Declaration of James Hardy Pursuant to 37 C.F.R. § 1.132, filed Aug. 25,
2011 (“Decl.”).
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Application 11/654,553
are nonobvious. Appeal Br. 15—16. We have reviewed the declaration and
find it unpersuasive. While Mr. Hardy opines that there is a significant
improvement obtained using pulsatile perfusion versus perfusion by a
peristaltic, roller-pump system, Decl. 110, nowhere does he state that the
results are unexpected. To be persuasive the evidence of unexpected result
must show that the results are both significant and unexpected. In re Soni,
54 F.3d at 751. The only evidence that Appellant offers that the results are
unexpected consist of attorney argument, which is unpersuasive.
“Attorney’s argument in a brief cannot take the place of evidence.” In re
Pearson, 494 F.2d 1399, 1405 (CCPA 1974).
In addition, the evidence of unexpected results is not commensurate
with the scope of the claims. While the Hardy Declaration states that a
pulsatile perfusion system was used, Decl. 1 6, the declaration is silent as to
whether the perfusate was pulsed to simulate an in vivo pulse rate, much less
provide data persuasively demonstrating that the results would be
representative across the broad range of cell types and pulse rates
encompassed by claim 1.10 The Declaration does not clearly indicate what
pulse rate was used.
Conclusion of Law
We conclude that a preponderance of the evidence in the record
supports the Examiner’s finding that claim 1 would have been obvious over
Hariri combined with Bomstein, Leeser, Peng and Nevo under 35 U.S.C.
§ 103(a).
10 For example, claim 1 does not limit the non-embryonic stem cell source or
in vivo pulse rate to any particular species, nor indicate that the stem cell
source or pulse rate be from the same species.
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Application 11/654,553
Claims 2—5 and 21 have not been argued separately and therefore fall
with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
DECISION
We reverse the rejection under 35U.S.C. § 112, second paragraph.
We affirm the rejection of claims 1—5 and 21 under 35 U.S.C.
§ 103(a).
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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