Ex Parte McIntosh

Board of Patent Appeals and Interferences

Apr 30, 2012

12034186 (B.P.A.I. Apr. 30, 2012)

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.
12/034,186 02/20/2008 Charles L. McIntosh 8627/1966
(PA-6146-RFB)
7703
48003 7590 04/30/2012
BRINKS HOFER GILSON & LIONE/CHICAGO/COOK
PO BOX 10395
CHICAGO, IL 60610
EXAMINER
SCHMIDT, EMILY LOUISE
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
04/30/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
________________

Ex parte CHARLES L. McINTOSH
________________

Appeal 2011-006792
Application 12/034,186
Technology Center 3700
________________

Before STEVEN D.A. McCARTHY, GAY ANN SPAHN and
WILLIAM V. SAINDON, Administrative Patent Judges.

McCARTHY, Administrative Patent Judge.

DECISION ON APPEAL

The Appellant1 appeals under 35 U.S.C. § 134 from the Examiner’s 1
decision finally rejecting claims 1 and 3-20. Claim 2 is cancelled. We have 2
jurisdiction under 35 U.S.C. § 6(b). 3
We REVERSE.4

1 The Appellant identifies the real parties in interest as the Appellant
and Cook Incorporated.
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Application No. 12/034,186

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Claims 1, 19 and 20 are independent claims. Claim 1 is illustrative of 1
the claims on appeal: 2
1. A method of engrafting donor cells 3
into injured myocardium, comprising: 4
delivering via a coronary artery donor cells 5
to a delivery site adjacent to and distal from a 6
chronic total occlusion, wherein the donor cells are 7
capable of creating viable myocardial tissue, and 8
wherein distal from the chronic total occlusion is 9
downstream from the total chronic occlusion; 10
allowing the donor cells a time sufficient to 11
engraft, divide and establish themselves at the 12
delivery site thereby creating viable myocardial 13
tissue at the delivery site; and 14
following the delivering and the allowing 15
steps, ablating the chronic total occlusion to 16
establish blood supply to the donor cells. 17
Claim 19 recites a method of treating injured myocardium. Claim 20 recites 18
a method of engrafting donor cells into injured myocardium. Each of the 19
methods recited in independent claims 1, 19 and 20 includes the step of 20
“delivering via a coronary artery donor cells to a delivery site adjacent to 21
and distal from a chronic total occlusion” and the step of, “following the 22
delivering and the allowing steps, ablating the chronic total occlusion to 23
establish blood supply to the donor cells.” 24
The Examiner rejects under 35 U.S.C. § 103(a): 25
claims 1, 5, 6, 9, 11-13, 19 and 20 as being unpatentable 26
over Lewis (US 6,481,439 B1, issued Nov. 19, 2002) and 27
Akhtar (US 2005/0187607 A1, publ. Aug. 25, 2005); 28
claims 3 and 4 as being unpatentable over Lewis, Akhtar 29
and Alt (US 2004/0048375 A1, publ. Mar. 11, 2004); 30
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claims 7 and 8 as being unpatentable over Lewis, Akhtar 1
and Kletschka (US 2003/0009190, publ. Jan. 9, 2003); 2
claims 10 and 14 as being unpatentable over Lewis, 3
Akhtar and Mehta (US 5,476,453, issued Dec. 19, 1995); 4
claim 15 as being unpatentable over Lewis, Akhtar and 5
Fraser (US 2006/0083720 A1, publ. Apr. 20, 2006); 6
claim 16 as being unpatentable over Lewis, Akhtar and 7
Strauss (US 2007/0154555 A1, publ. Jul. 5, 2007); 8
claim 17 as being unpatentable over Lewis, Akhtar and 9
Smith (US 2006/0069346 A1, publ. Mar. 30, 2006); 10
claim 18 as being unpatentable over Lewis, Akhtar, 11
Smith and Sher (US 2006/0015126 A1, publ. Jan. 19, 2006); 12
claims 1, 3-6, 9, 11-14, 16, 19 and 20 as being 13
unpatentable over Strauss and Alt; 14
claims 7 and 8 as being unpatentable over Strauss, Alt 15
and Kletschka; 16
claims 10 and 14 as being unpatentable over Strauss, Alt 17
and Mehta; 18
claim 15 as being unpatentable over Strauss, Alt and 19
Fraser; 20
claim 17 as being unpatentable over Strauss, Alt and 21
Smith; and 22
claim 18 as being unpatentable over Strauss, Alt, Smith 23
and Sher. 24
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Lewis describes a method for re-establishing perfusion downstream 1
from a total occlusion of a blood vessel. The method uses catheterization to 2
penetrate the occlusion and introduce oxygenated fluid at a controlled 3
pressure or flow rate. (Lewis, col. 12, ll. 4-10 and 22-31; see also id., col. 4
13, l. 59 – col. 14, l. 2). Lewis also describes supplying drugs or therapeutic 5
agents through catheter ports downstream of the occlusion. (See, e.g., 6
Lewis, col. 15, ll. 8-10 and fig. 8). Lewis does not appear to describe 7
delivering cells to cardiac vessels. 8
Akhtar describes a medical device 10 including a stent structure 20 9
and a biologically active structure 60. The biologically active structure 60 10
includes first and second polymer layers 50, 52 separated by an impermeable 11
layer 40. Each of the first and second polymer layers 50, 52 elutes a 12
biologically active compound to promote recovery of an occluded vessel in 13
to which the medical device 10 is implanted. (Akhtar, paras. [0021] and 14
[0029]). 15
Akhtar also describes a method of treating tissue damage by 16
promoting engraftment and differentiation of hematopoietic stem cells or 17
endothelial progenitor cells at a site downstream of an occlusion. (Akhtar, 18
para. [0051]). The stem cells are either injected directly into the coronary 19
bed or autonomously recruited from a peripheral blood flow or a bone 20
marrow source. In accordance with the method, Akhtar’s medical device 10 21
delivers growth factors to target sites downstream of the device to promote 22
the viability, engraftment and eventual differentiation of the stem cells. 23
(Akhtar, para. [0054]). 24
With respect to the rejection of claims 1, 5, 6, 9, 11-13, 19 and 20 as 25
being unpatentable over Lewis and Akhtar, the Examiner concludes that the 26
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Application No. 12/034,186

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teachings of Akhtar “which teach effectively treating the damaged region 1
downstream from an occlusion with stem cells and other drugs to provide 2
sufficient reasoning to deliver such compounds using the device of [Lewis] 3
distally of the occlusion.” (Ans. 18). As the Appellants correctly point out, 4
however, neither Akhtar nor Lewis teaches delivery of stem cells to the 5
injury site downstream of the occlusion. (See App. Br. 14-15). 6
Furthermore, the Examiner’s reasoning does not adequately explain why 7
Akhtar’s teaching to deliver cells to the coronary bed by direct injection 8
would have provided one of ordinary skill in the art reason to deliver cells 9
by an arterial approach to a site downstream of an occlusion using a catheter 10
such as that described by Lewis. The Examiner has not articulated an 11
adequate reason why a method including the step of “delivering via a 12
coronary artery donor cells to a delivery site adjacent to and distal from a 13
chronic total occlusion” would have been obvious. We do not sustain the 14
rejection of claims 1, 5, 6, 9, 11-13, 19 and 20 as being unpatentable over 15
Lewis and Akhtar. 16
With respect to the rejection of claims 3 and 4 as being unpatentable 17
over Lewis, Akhtar and Alt, the Examiner cites Alt as teaching that 18
myocardial cells stop dividing ten days after birth. (Ans. 19; see Alt, para. 19
[0004]). This finding does not remedy the deficiencies in the teachings of 20
Lewis and Akhtar as applied to parent claim 1. We do not sustain the 21
rejection of claims 3 and 4 under § 103(a) as being unpatentable over Lewis, 22
Akhtar and Alt. 23
The Examiner cites Kletschka as teaching the treatment of occlusions 24
using either antegrade or retrograde approach. (Ans. 8). This teaching does 25
not remedy the deficiencies in the teachings of Lewis and Akhtar as applied 26
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Application No. 12/034,186

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to parent claim 1. We do not sustain the rejection of claims 7 and 8 under § 1
103(a) as being unpatentable over Lewis, Akhtar and Kletschka. 2
The Examiner cites Mehta as teaching the use of simultaneous right 3
and left angiograms to visualize the entire coronary system. (Ans. 8). This 4
teaching does not remedy the deficiencies in the teachings of Lewis and 5
Akhtar as applied to parent claim 1. We do not sustain the rejection of 6
claims 10 and 14 under § 103(a) as being unpatentable over Lewis, Akhtar 7
and Mehta. 8
The Examiner cites Fraser as teaching the delivery of on the order of 9
5.5 × 104 stem cells to an occlusion. (Ans. 9). This teaching does not 10
remedy the deficiencies in the teachings of Lewis and Akhtar as applied to 11
parent claim 1. We do not sustain the rejection of claim 15 under § 103(a) 12
as being unpatentable over Lewis, Akhtar and Fraser. 13
With respect to the rejection of claim 16 as being unpatentable over 14
Lewis, Akhtar and Strauss, the Examiner cites Strauss as teaching the 15
delivery of cells by way of a catheter placed within two centimeters of the 16
occlusion. (Ans. 10; see Strauss, para. [0019]). This finding does not 17
remedy the deficiencies in the teachings of Lewis and Akhtar as applied to 18
parent claim 1. We do not sustain the rejection of claim 16 under § 103(a) 19
as being unpatentable over Lewis, Akhtar and Strauss. 20
The Examiner cites Smith as teaching the delivery of a stent after the 21
removal of a chronic total inclusion in order to maintain the open vessel. 22
(Ans.10). This teaching does not remedy the deficiencies in the teachings of 23
Lewis and Akhtar as applied to parent claim 1. We do not sustain the 24
rejection of claim 17 under § 103(a) as being unpatentable over Lewis, 25
Akhtar and Smith. 26
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The Examiner cites Sher as teaching the use of drug coated stents to 1
reduce the risk of in-stent restenosis. (Ans.11). This teaching does not 2
remedy the deficiencies in the teachings of Lewis, Akhtar and Smith as 3
applied to claim 17. We do not sustain the rejection of claim 18 under 4
§ 103(a) as being unpatentable over Lewis, Akhtar and Smith. 5
Strauss describes a method for treating chronically occluded blood 6
vessels. The method includes delivering a therapeutically effective amount 7
of a pro-angiogenic substance to a location adjacent an occluding 8
atherosclerotic plaque for contact with the plaque; waiting a sufficient period 9
for microvessel formation in the plaque; and crossing the occlusive plaque 10
with an angioplasty guide wire. (Strauss, para. [0018]). The pro-11
angiogenic material may include stem cells. (Strauss, para. [0025]). 12
Alt describes a method for repairing or replacing myocardial tissue 13
using mesenchymal stem cells modified through co-culturing to mimic 14
natural myocardial cells. (Alt, para. [0052]). Alt teaches that: 15
In the absence of having encountered one or more 16
occluded coronary arteries that caused the 17
infarction and which cannot be re-opened, the 18
process of cell injection into the antegrade 19
circulation is performed by first introducing a 20
balloon catheter 11 into the cardiovascular system 21
at the patient’s groin 3 using an introducer 4, and 22
through a guiding catheter 5 over a guide wire 18 23
into the aorta 6 and the orifice 7 of a coronary 24
artery 8 of the heart 2 at or in the vicinity of the 25
designated site. The failed tissue is supplied with 26
blood through artery 8 and its distal branches 9 and 27
10. The cells are then injected through the inner 28
(central) lumen 12 of the balloon catheter . . . . The 29
exit point of the central lumen 12 is at the distal 30
end of catheter 11 which has been advanced into 31
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the coronary artery 8 in proximity to the site of the 1
desired repair. 2
(Alt, para. [0067] (italics added)). Alt further teaches that: 3
One is still faced with the problems of 4
allowing enough of the repair cells to migrate into 5
contact with the failing tissue and of achieving a 6
high number of transplanted cells [15] in the 7
tissue. This is the principal reason for using a 8
balloon catheter 11 or some other mechanism that 9
will allow the physician (operator) to selectively 10
block the antegrade blood flow and the retrograde 11
stem cell flow. . . . [The inflation of the balloon to 12
selectively block the antegrade blood flow] enables 13
the desired large number of adhesions of the cells 14
15 to the failing tissue to be achieved, because the 15
absence of blood flow at the critical site of this 16
tissue to be repaired has several advantageous 17
effects. 18
(Alt, para. [0070]). 19
With respect to the rejection of claims 1, 3-6, 9, 11-14, 16, 19 and 20 20
as being unpatentable over Strauss and Alt, the Examiner concludes that it 21
would have been obvious “to deliver the cells in [Strauss] to a site distal of 22
the occlusion because Alt teaches delivering stem cells to an area of no 23
blood flow is beneficial because it prevents the loss of cells.” (Ans. 11-12). 24
On the other hand, the Examiner finds that Strauss does not disclose 25
delivering cells to a site distal to an occlusion. (Ans. 11 (“Strauss et al. does 26
not specifically disclose which side of the occlusion the cells are being 27
delivered to.”)). The Appellant correctly points out that Alt discloses 28
delivering cells only after re-canalizing the vessel. (See App. Br. 31; see 29
also Alt, para. [0033]). Neither Strauss nor Alt teaches delivering donor 30
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cells via a coronary artery to a delivery site adjacent to and distal from a 1
chronic total occlusion before ablating the chronic total occlusion. 2
We do not sustain the rejection of claims 1, 3-6, 9, 11-14, 16, 19 and 3
20 under § 103(a) as being unpatentable over Strauss and Alt. Since the 4
secondary references cited by the Examiner do not remedy the deficiencies 5
in the combined teachings of Strauss and Alt as applied to parent claim 1, we 6
do not sustain the rejections under § 103(a) of claims 7 and 8 as being 7
unpatentable over Strauss, Alt and Kletschka; of claims 10 and 14 as being 8
unpatentable over Strauss, Alt and Mehta; of claim 15 as being unpatentable 9
over Strauss, Alt and Fraser; of claim 17 as being unpatentable over Strauss, 10
Alt and Smith; and of claim 18 as being unpatentable over Strauss, Alt, 11
Smith and Sher, either. 12
13
DECISION 14
We REVERSE the Examiner’s decision rejecting claims 1 and 3-20. 15
16
REVERSED 17
18
19
20
Klh 21