Ex Parte Poux et al

Board of Patent Appeals and Interferences

Feb 26, 2010

10401683 (B.P.A.I. Feb. 26, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte CHRISTOPHER J. POUX, GARY D. FLETCHER,
STERLING E. McBRIDE, JOHN M. MARGICIN,
PETER J. ZANZUCCHI, JOHN G. ACETI, SYROUS PARSAY
and DEREK D. MAHONEY
____________________

Appeal 2009-004683
Application 10/401,683
Technology Center 3700
____________________

Decided: February 26, 2010
____________________

Before STEVEN D.A. McCARTHY, STEFAN STAICOVICI and
FRED A. SILVERBERG, Administrative Patent Judges.

McCARTHY, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE 1
The Appellants appeal under 35 U.S.C. § 134 from the Examiner’s 2
decision finally rejecting claims 72, 73, 76, 79, 80 and 82-85 under 353
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§ 103(a) as being unpatentable over Sesekura (US 5,891,053, issued Apr. 6, 1
1999) and Douglas (US 6,332,871 B1, issued Dec. 25, 2001); and finally 2
rejecting claim 87 under § 103(a) as being unpatentable over Sesekura, 3
Douglas and Lum (US 6,391,005 B1, issued May 21, 2002). We have 4
jurisdiction under 35 U.S.C. § 6(b). 5
We AFFIRM. 6
Claim 72 is the sole independent claim on appeal: 7
72. A method of extracting a sample of 8
body fluid, the method comprising: 9
(i) attaching a device comprising at least 10
one microneedle to the body; 11
(ii) stimulating the skin in an area in 12
which the microneedle is to be inserted by 13
applying a vacuum to draw up the skin at the 14
area; 15
(iii) inserting at least one microneedle into 16
the skin at the area thereby creating a wound 17
having an opening; 18
(iv) allowing body fluid to pool in the 19
wound; 20
(v) removing the vacuum thereby 21
releasing the skin at the area; 22
(vi) withdrawing a sample of body fluid 23
from the sampling site through the at least one 24
microneedle while obstructing the would opening 25
with the microneedle. 26
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ISSUES 1
The Appellants argue the rejections of claims 72, 73, 76, 79, 80, 82 2
and 85 as a group for purposes of the rejection of the claims under § 103(a). 3
(See App. Br. 6-11). As such, we select claim 72 as representative of the 4
group, and claims 73, 76, 79, 80, 82 and 85 stand or fall with claim 72. See 5
37 C.F.R. § 41.37(c)(1)(vii). The Appellants provide no argument 6
explaining why dependent claim 87 might be patentable over Sesekura, 7
Douglas and Lum if parent claim 72 is not patentable over Sesekura and 8
Douglas. Therefore, the rejection of claim 87 raises no issues separate from 9
the rejection of claim 72 under § 103(a). 10
The Appellants contend that the Examiner has not clearly articulated 11
reasoning adequate to support the conclusion that the subject matter of 12
representative claim 72 would have been obvious (App. Br. 9-11; Reply Br. 13
6-11); that the Examiner made erroneous findings of fact concerning the 14
disclosure of Sesekura (App. Br. 8-9); and that the modification proposed by 15
the Examiner, as support for the conclusion that the subject matter of claim 16
72 would have been obvious, would have altered impermissibly the principle 17
by which Sesekura’s method operated (App. Br. 7-8; Reply Br. 1-5).1 18
Although the Appellants argue the rejections of claims 83 and 84 separately 19

1 The Appellants cite Medline Plus Medical Encyclopedia, Monitor
Blood Glucose, www.nlm.nih.gov/medlineplus/ency/presentations
/100220_1.htm (last visited Mar. 9, 2008)(“Medline”) and Shain (US
6,027,459, issued February 22, 2000) in support of their arguments. (See
App. Br. 4). We do not consider Medline since the Appellants have not
indicated where in the record this document was entered and since it has not
been relied as evidence of unapatentability against the claims on appeal. See
37 C.F.R. § 41.37(c)(2). The Examiner relied on Shain in the course of
prosecution. See, e.g., Office Action mailed Feb. 13, 2007 at 23.
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from the rejection of claim 72, their arguments directed against the rejection 1
of claims 83 and 84 rest on their assertion that the same modification 2
proposed by the Examiner as support for the conclusion that the subject 3
matter of claim 72 would have been obvious would have altered 4
impermissibly the principle by which Sesekura’s method operated. (App. 5
Br. 12-14; Reply Br. 11-12). 6
Two issues are raised in this appeal: 7
Do the evidence and articulated reasoning, on which the 8
conclusion that the subject matter of claim 72 would have been 9
obvious rests, adequately support that conclusion? 10
In particular, would modifying the teachings of Sesekura, 11
as proposed in the rejections of claim 72, 83 and 84, have 12
altered impermissibly the principle by which Sesekura’s 13
method operates? 14
15
FINDINGS OF FACT 16
The record supports the following findings of fact (“FF”) by a 17
preponderance of the evidence. 18
1. Sesekura describes a blood-collecting device. (Sesekura, col. 1, 19
l. 4). Sesekura’s blood-collecting device includes a needle 2. (Sesekura, 20
col. 3, ll. 14-15). 21
2. Sesekura’s blood-collecting device also includes a body 1 with 22
an upper air chamber 11; a lower air chamber 12 pneumatically partitioned 23
from the upper air chamber 11 by a diaphragm 4; and a decompression 24
chamber 3 connected to the lower air chamber 12. (Sesekura, col. 3, ll. 12-25
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14, 15-17 and 21-23). Figures 1 and 2 of Sesekura depict the decompression 1
chamber 3 encompassing the needle 2. 2
3. Sesekura also describes a method for collecting blood. 3
According to the method, the body 1 is attached, that is, contacted, to the site 4
from which the blood is to be collected. The upper and lower air chambers 5
11, 12 are depressurized, thereby creating a back pressure or vacuum to the 6
skin at the collection site within the decompression chamber 3. The back 7
pressure or vacuum stimulates the skin at the collection site by inducing the 8
skin to swell. The upper air chamber 11 is subsequently pressurized so as to 9
drive the needle 2 against the bias of a spring 13 into the skin. (Sesekura, 10
col. 3, l. 56 – col. 4, l. 4). 11
4. Ultimately, the decompression chamber 3 necessarily must be 12
depressurized either to remove the body 1 from the skin or by exposure to 13
the atmosphere after the body 1 is removed. 14
5. Sesekura discloses decompressing the upper air chamber 12 to 15
withdraw the needle 2 from the skin and then suctioning blood through the 16
incision to form a droplet on the surface of the skin. (See Sesekura, col. 4, ll. 17
6-16 and fig. 3(c)). During the period when the upper air chamber 12 18
decompresses, blood will be allowed to pool in the incision. 19
6. Sesekura does not describe what happens to the droplet after the 20
droplet is formed on the skin. Neither does Sesekura limit how the droplet 21
may be used. In particular, Sesekura does not appear to criticize or 22
disparage methods which collect blood through a needle obstructing the 23
wound formed by the needle. 24
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7. Douglas describes a minimally invasive sampling device. The 1
device includes a disposable 3 attached to a syringe 13 and a plunger 14. 2
(Douglas, col. 10, ll. 11-12 and 23-24). 3
8. Douglas’ disposable 3 includes a sampling needle 16. 4
(Douglas, col. 10, ll. 17-20). Figure 4 of Douglas depicts the sampling 5
needle 16 as being hollow. 6
9. Douglas also describes a method for collecting blood. 7
According to the method, drive springs 11 drive the sampling needle 16 to 8
pierce the skin to form a wound of controlled depth. Next, a suction spring 9
retracts the plunger 14 to create a back pressure or vacuum in the syringe 13. 10
This back pressure or vacuum actively draws a blood sample through the 11
sampling needle 16. (Douglas, col. 10, ll. 58-67). 12
10. Douglas describes stimulating the skin by allowing the 13
sampling needle 16 to remain in the wound for a period of time while 14
moving the needle to keep the wound open for blood to pool. (Douglas, col. 15
3, ll. 58-62) 16
11. Douglas alternatively discloses withdrawing the needle and 17
stimulating the wound to cause blood to flow through the wound and onto 18
the surface of the skin. (Douglas, col. 3, ll. 50-54). 19
12. Shain (US 6,027,459, issued February 22, 2000)2 discloses a 20
method for obtaining a sample of blood for carrying out a diagnostic test. 21
(Shain, col. 6, ll. 65-67). In describing a preferred embodiment of the 22
method (see Shain, col. 3, ll. 49-52), Shain teaches that, if a cutting or 23
puncturing device is used to form an opening in the skin for obtaining the 24
blood sample, the cutting or puncturing device “must be retracted from the 25

2 See Footnote 1.
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opening prior to the step of extracting the sample of blood from the opening. 1
This retraction will allow the unrestricted flow of blood through the 2
opening.” (Shain, col. 3, l. 64 – col. 4, l. 1). 3
13. Shain does not appear to criticize or disparage methods which 4
collect blood through a needle obstructing the wound formed by the needle. 5
14. The disclosures of Sesekura, Douglas and Shain do not support 6
a finding that designers in the field would have been discouraged from 7
collecting blood for any and all purposes through a needle obstructing the 8
wound formed by the needle because a larger volume of blood or body fluid 9
might be more readily expressed from an open, unobstructed wound. 10
11
PRINCIPLES OF LAW 12
An improvement must be more than a “predictable use of prior art 13
elements according to their established functions” in order to be patentable. 14
KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 417 (2007). In particular, the 15
substitution of one known element for another is likely to be obvious unless 16
the implementation of the substitution is beyond the level of ordinary skill in 17
the art or the results of the substitution would not have been predictable. Id. 18
19
ANALYSIS 20
The Examiner has articulated the reasoning underlying the conclusion 21
that the subject matter of representative claim 72 would have been obvious. 22
The Examiner finds that Sesekura and Douglas each disclose methods for 23
collecting a sample of a body fluid such as blood. (Ans. 12 and 13). The 24
finding is supported by the disclosures of Sesekura and Douglas. That is, 25
both Sesekura and Douglas disclose stimulating the skin, although not 26
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necessarily by applying a vacuum to draw up the skin (compare FF 3 with 1
FF 10); inserting a needle into the skin at the sampling site so as to create a 2
wound (compare FF 3 with FF 9); and allowing blood to pool in the wound 3
before collection of the sample (compare FF 5 with FF 10). 4
The Examiner finds that Sesekura’s method includes every step 5
recited in claim 72 except the step of withdrawing a sample of body fluid 6
from the sampling site through the at least one microneedle while 7
obstructing the wound opening with the microneedle. (Ans. 3). The finding 8
is supported by the disclosure of Sesekura. (See FF 2-4). The Appellants 9
object to the Examiner’s finding, as they contend that Sesekura fails to 10
disclose attaching a device comprising at least one hollow microneedle to the 11
body of the user. (See App. Br. 9). Claim 72 does not expressly recite the 12
use of a hollow needle in any step. Instead, to the extent that the method of 13
claim 72 is limited inherently to the use of a hollow microneedle, that 14
limitation is inherent only in the step of withdrawing a sample of body fluid 15
from the sampling site through the at least one microneedle while 16
obstructing the wound opening with the microneedle. Doulgas discloses the 17
use of a hollow needle in a blood collection method. (FF 8). 18
The Examiner finds that Sesekura discloses collecting the sample 19
from the surface of the skin (Ans. 9) while Douglas teaches collecting the 20
sample either off the surface of the skin or through a needle obstructing a 21
wound in the skin (Ans. 13). These findings are supported by the disclosure 22
of Sesekura and Douglas. (See FF 5, 9 and 11). The findings regarding the 23
disclosure of Douglas imply that collecting the sample off the surface of the 24
skin and collecting the sample through a needle obstructing a wound in the 25
skin were known alternatives. Douglas indicates that the choice between the 26
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two alternatives was dependent on known factors such as the use to which 1
the sample was to be put. 2
The Examiner concludes that it would have been obvious to modify 3
Sesekura’s method by substituting the known step of collecting body fluid 4
through a needle obstructing the wound in the skin for Sesekura’s step of 5
collecting the fluid from the surface of the skin. (Ans. 13). Although 6
Sesekura describes forming a droplet of blood on the surface of the skin (FF 7
5), Sesekura does not limit how the droplet might be used. Neither does 8
Sesekura appear to criticize or disparage methods such as Douglas’ which 9
collected blood through a needle obstructing the wound formed by the 10
needle. (FF 6). The choice between the two alternative methods of 11
collecting blood would have been driven by the use to be made of the 12
sample. 13
The Examiner’s characterization of the apparent reason for combining 14
the teachings of Sesekura and Douglas in the fashion claimed as “design 15
choice” (Ans. 5) implies recognition that the substitution would provide a 16
blood-collecting device capable of collecting blood samples in a form better 17
suited for certain purposes such as presentation of the samples to remote 18
testing devices. Even were one to question the Examiner’s characterization 19
of the apparent reason for combining the elements disclosed by Sesekura and 20
Douglas in the fashion claimed in claim 72 as “design choice,” the Examiner 21
on pages 13 and 14 of the Answer has clarified that the Examiner’s 22
reasoning proposes a simple substitution consistent with the types of 23
reasoning endorsed by the Supreme Court in KSR Int’l. 24
The Appellants provide no reason why the substitution proposed by 25
the Examiner would have been beyond the level of ordinary skill in the art. 26
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The fact that the structure disclosed by Sesekura would have to be modified 1
in view of the teachings of Douglas does not imply that the modification 2
would have been beyond the level of ordinary skill. Neither do the 3
Appellants provide a persuasive reason why the results of the substitution 4
proposed by the Examiner would not have been predictable. The Appellants 5
argue that the obstruction of the wound by a hollow needle during the 6
withdrawal of the body fluid sample results in advantages, namely, 7
preventing the sealing of the wound around the needle while enabling access 8
to the body for sampling purposes. (Reply Br. 10). The Specification, on 9
the other hand, attributes these advantages to a step of partially withdrawing 10
the needle from the wound. (See Spec. 27, ll. 14-20). This step of partially 11
withdrawing the needle from the wound is not recited in any claim on 12
appeal. As such, the argument is not commensurate with the scope of 13
representative claim 72. 14
The Appellant contends that the combined teachings of Sesekura and 15
Douglas do not support the conclusion that the subject matter of claims 72, 16
83 and 84 would have been obvious because the substitution proposed by the 17
Examiner would have altered impermissibly the principle of operation of 18
Sesekura’s device. (App. Br. 7-8 and 12-14; Reply Br. 1-5 and 11-12). 19
The Appellants’ reliance on Ratti is misplaced. In Ratti, the claimed 20
subject matter was a seal for insertion in a cylindrical bore in a housing 21
about a relatively movable, centrally located shaft. The claimed seal had an 22
annular bore-engaging mounting portion of resiliently deformable material 23
and spring fingers for biasing the mounting portion into contact with the 24
bore so as to facilitate removal and replacement of the seal without 25
damaging the surface of the bore. Ratti, 270 F.2d at 811-12. The primary 26
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reference also disclosed a seal designed to fit between a bore and a shaft 1
centrally located within the bore. Unlike the claimed seal, however, the seal 2
of the primary reference included a reinforcing member to reinforce the seal 3
against deformation that might degrade the press fit between the bore and 4
the shaft. Id. 5
Our reviewing court held in Ratti that the manner in which the seal of 6
the primary reference operated was so different from the manner in which 7
the claimed seal operated that the primary reference pointed or taught away 8
from the claimed seal. Id. at 813. Our reviewing court further held that the 9
teachings of the secondary reference were so remote that the secondary 10
reference failed to remedy the substantial deficiencies in the teachings of the 11
primary reference. Id. 12
Sesekura discloses a method which forms a droplet of blood on the 13
surface of the skin. (FF 5). In contrast to the primary reference at issue in 14
Ratti, Sesekura does not explain why it is desirable to form a droplet of 15
blood on the surface of the skin as opposed to collecting the blood through a 16
needle obstructing the wound formed by the needle. (FF 6). Sesekura’s 17
method does not appear to address a problem which requires the formation 18
of a droplet of blood on the skin as opposed to collection of the blood 19
through a needle obstructing the wound formed by the needle. 20
In contrast to the secondary reference at issue in Ratti, Douglas shows 21
that collecting blood from a droplet on the surface of the skin and collecting 22
the sample through a needle obstructing a wound in the skin were known 23
alternatives. Although Sesekura’s method clearly differs from the method of 24
claim 72, the methods disclosed by Sesekura and Douglas are sufficiently 25
similar that one of ordinary skill in the art would have had reason to choose 26
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among the alternatives disclosed in Douglas by substituting the known step 1
of collecting body fluid through a needle obstructing the wound in the skin 2
for Sesekura’s step of collecting the fluid from the surface of the skin. 3
Therefore, the differences in principle of operation between Sesekura’s 4
method and the method of claim 72 were not so fundamental as to 5
discourage one of ordinary skill in the art from combining the teachings of 6
Sesekura and Douglas in the fashion claimed. 7
8
CONCLUSIONS 9
The conclusion that the subject matter of claims 72 would have been 10
obvious is adequately supported by the evidence and articulated reasoning 11
on which the conclusion rests. 12
Modifying the teachings of Sesekura as proposed in the rejection of 13
claim 72 would not have altered impermissibly the principle by which 14
Sesekura’s method operates. 15
The rejections of representative claim 72, along with the rejections of 16
claims 73, 76, 79, 80, 82 and 85, under § 103(a) as being unpatentable over 17
Sesekura and Douglas are sustained. Since modifying the teachings of 18
Sesekura as proposed in the rejection of claim 72 would not have altered 19
impermissibly the principle by which Sesekura’s method operates, the 20
rejections of claims 83 and 84 under § 103(a) as being unpatentable over 21
Sesekura and Douglas are sustained. Since the Appellants provide no 22
argument explaining why dependent claim 87 might be patentable over 23
Sesekura, Douglas and Lum if parent claim 72 is not patentable over 24
Sesekura and Douglas, the rejection of claim 87 under § 103(a) as being 25
unpatentable over Sesekura, Douglas and Lum is sustained. 26
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DECISION 1
We AFFIRM the Examiner’s decision rejecting claims 72, 73, 76, 79, 2
80, 82-85 and 87. 3
No time period for taking any subsequent action in connection with 4
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. 5
§ 1.136(a)(1)(iv) (2007). 6
7
AFFIRMED 8
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Klh 10
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