Ex Parte Ruderman et al

Board of Patent Appeals and Interferences

Jan 30, 2009

09534946 (B.P.A.I. Jan. 30, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE 1
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3
BEFORE THE BOARD OF PATENT APPEALS 4
AND INTERFERENCES 5
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Ex parte FRANK R. RUDERMAN and DAVID T. SHEWMAKE 8
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Appeal 2008-1943 11
Application 09/534,946 12
Technology Center 3600 13
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Decided: January 30, 2009 16
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Before MURRIEL E. CRAWFORD, DAVID B. WALKER, and JOSEPH A. 19
FISCHETTI, Administrative Patent Judges. 20
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CRAWFORD, Administrative Patent Judge. 22
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DECISION ON APPEAL 25
26
STATEMENT OF THE CASE 27
Appellants appeal under 35 U.S.C. § 134 (2002) from a Final 28
Rejection of claims 22 to 28 and 38. We have jurisdiction under 35 U.S.C. 29
§ 6(b) (2002).30
Appeal 2008-1943
Application 09/534,946

2
Appellants invented a cardiovascular healthcare management system 1
that identifies patients who do not have hyperlipidemia based on total LDL 2
cholesterol and total HDL cholesterol, but are in need of treatment. The 3
cardiovascular healthcare management system includes a diagnostic engine 4
which analyzes patient test results for subclasses of LDL and HDL including 5
HDL 2b (Specification 1, 14 to 15). 6
Claim 38 under appeal reads as follows: 7
38. A cardiovascular healthcare 8
management system comprising: 9
(a) an infomediary site having databases for 10
cardiovascular healthcare management which 11
includes a database of test results of concentration 12
of subclasses of LDL particles and subclasses of 13
HDL particles from at least 900 cardiovascular 14
patients; 15
(b) a data entry interface for receiving 16
patient personal data and test results for 17
concentration of subclasses of LDL particles and 18
subclasses of HDL particles storing the data and 19
results in the infomediary site databases; 20
(c) a diagnostic engine for analyzing patient 21
test results for subclasses of LDL particles, 22
subclasses of HDL particles data and identifying 23
patients who do not have hyperlipidemia based on 24
total LDL cholesterol and total HDL cholesterol, 25
but are in need of treatment; and 26
(d) wherein the subclasses of LDL particles 27
and subclasses of HDL particles are levels 28
determined by segmented gradient gel 29
eletrophoresis and wherein the particle sub-classes 30
include HDL 2b. 31
32
Appeal 2008-1943
Application 09/534,946

3
The Examiner rejected claims 22, 24 to 28 and 38 under 35 U.S.C. § 1
103(a) as being unpatentable over Levin in view of Otvos, Krauss, and 2
Appellants’ Admitted Prior Art (“AAPA”). 3
The Examiner rejected claim 23 under 35 U.S.C. § 103(a) as being 4
unpatentable over Levin, Otvos, Krauss, AAPA and Surwit. 5
The prior art relied upon by the Examiner in rejecting the claims on 6
appeal is: 7
Levin US 5,724,580 Mar. 3, 1988 8
Krauss US 5,925,229 Jul. 20, 1999 9
Surwit US 6,024,699 Feb. 15, 2000 10
Otvos US 6,576,471 B2 Jun. 10, 2003 11
12
Appellants’ Admitted Prior Art (“AAPA”) on page 1 of the Specification. 13
14
Appellants contend that the cited prior art does not include a 15
diagnostic engine which analyzes test results for patients of levels of LDL 16
and HDL subclasses for identifying patients who do not have hyperlipidemia 17
based on total LDL cholesterol and total HDL cholesterol, but are in need of 18
treatment and wherein the particle subclasses include HDL 2b. 19
20
ISSUES 21
Have Appellants shown that the Examiner erred in holding that the 22
prior art discloses a diagnostic engine, which analyzes test results for 23
patients of levels of LDL and HDL subclasses for identifying patients who 24
do not have hyperlipidemia based on total LDL cholesterol and total HDL 25
cholesterol but are in need of treatment and wherein the particle subclasses 26
include HDL 2b. 27
Appeal 2008-1943
Application 09/534,946

4
FINDINGS OF FACT 1
FF1. Appellants disclose at page 1 of the Specification that: 2
The art describes cardiovascular risk factors 3
such as age, smoking, weight, family history, 4
blood pressure, lipid profiles including low density 5
lipoprotein (LDL) and high density lipoprotein 6
(HDL) and subclasses (fractions) of LDL and 7
HDL. Methods for measuring these factors and 8
relating them to patient treatment are also known. 9
10
FF2. Levin discloses a system for managing coronary disease having 11
databases for cardiovascular healthcare management which includes 12
database test results including LDL and HDL concentrations to calculate 13
total cholesterol (Figure 4, col. 8, ll. 21 to 47). 14
FF3. Otvos discloses that commercially prepared lipid panels only 15
include total cholesterol, total HDL and total LDL rather than LDL and HDL 16
subclass information. (Col. 1, ll. 43 to 48). Otvos discloses that NMR 17
analysis provides information about four subclasses of LDL and five 18
subclasses of HDL (col. 1, ll. 48 to 52). Otvos discloses that various 19
subclasses of lipoproteins may provide more reliable markers of the 20
metabolic conditions that predispose individuals to a greater or lesser risk of 21
heart disease (col. 1, ll. 59 to 62). Otvos discloses that using LDL subclass 22
information may reveal a patient that does not have lipid profile indicating 23
high risk when the total LDL is considered, but is still in need of treatment 24
(col. 16, ll. 53 to 57). In Figure 11, Otvos depicts that an examination of the 25
total HDL concentration of 32 mg/dl results in a positive risk factor when 26
the large HDL subclass which is 11 nmo/L is examined, it too results in a 27
Appeal 2008-1943
Application 09/534,946

5
positive risk factor. As such, Otvos does not disclose that an advantage can 1
be achieved by examining the large HDL subclass. 2
Krauss does not disclose a diagnostic engine for analyzing patient test 3
results for subclasses of LDL particles, subclasses of HDL particles, and 4
identifying patients who do not have hyperlipidemia based on total LDL 5
cholesterol and total HDL cholesterol, but are in need of treatment wherein 6
the particle subclasses include HDL 2b. 7
8
PRINCIPLES OF LAW 9
The test for obviousness is what the combined teachings of the 10
references would have suggested to one of ordinary skill in the art. See In re 11
Kahn, 441 F.3d 977, 987-88 (Fed. Cir. 2006); In re Young, 927 F.2d 588, 12
591 (Fed. Cir. 1991) and In re Keller, 642 F.2d 413, 425 (CCPA 1981). 13
Rejections on obviousness grounds cannot be sustained by mere 14
conclusory statements; instead, there must be some articulated reasoning 15
with some rational underpinning to support the legal conclusion of 16
obviousness. In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). A finding of 17
obviousness can be based on the effects of demands known to the design 18
community or present in the marketplace; or the background knowledge 19
possessed by a person having ordinary skill in the art, as support for his 20
conclusion that there existed at the time of the invention an apparent reason 21
to modify the sleeve nut and grommet of Borst in the manner claimed. See 22
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, ___, 127 S. Ct. 1727, 1740-41 23
(2007). 24
25
Appeal 2008-1943
Application 09/534,946

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ANALYSIS 1
Rejection of claims 22, 24 to 28 and 38 2
We will not sustain the Examiner’s Rejection. Although we agree 3
with the Examiner that Otvos discloses that more risk factors can be 4
determined when subclasses of LDL are examined, Otvos does not disclose 5
that examination of HDL subclasses leads to the same advantage. In fact, a 6
review of Figure 11 of Otvos indicates that the total HDL concentration lead 7
to one risk factor and the large HDL also lead to one risk factor and as such 8
does not disclose that an advantage is obtained by examining HDL 9
subclasses. And while the Appellants’ Specification discloses that 10
subclasses of LDL or HDL may be considered risk factors, the Specification 11
does not disclose which subclass concentrations are considered risk factors. 12
Further, none of the references discloses that the subclasses analyzed must 13
include HDL 2b or any reason to include HDL 2b. Therefore, there is no 14
reason to include subclass HDL 2b in Levin as modified by Otvos system. 15
In view of the foregoing, we will not sustain the Examiner’s rejection 16
of claim 38 and claims 22 and 24 to 28 dependent thereon. 17
We will also not sustain the Examiner’s rejection of claim 23 as being 18
unpatentable over Levin, Otvos, AAPA, Krauss and Surwit because claim 23 19
depends from claim 38, and Surwit does not cure the deficiencies noted 20
above for the Levin, Otvos, Krauss, AAPA combination. 21
22
CONCLUSION OF LAW 23
On the record before us, Appellants have shown that the Examiner 24
erred in rejecting the appealed claims. 25
Appeal 2008-1943
Application 09/534,946

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DECISION 1
The Examiner's rejection of claims is reversed. 2
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REVERSED 4
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hh 11
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MCDONNELL BOEHNEN HULBERT & BERGHOFF, LLP 13
300 S. WACKER DRIVE 14
32ND FLOOR 15
CHICAGO, IL 60606 16