Ex Parte Knaus et al

Board of Patent Appeals and Interferences

Jun 26, 2009

09816152 (B.P.A.I. Jun. 26, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte WILLIAM A. KNAUS
and
RICHARD D. MARKS
____________

Appeal 2007-004016
Application 09/816,152
Technology Center 3600
____________

Decided:1 June 29, 2009
____________

Before MURRIEL E. CRAWFORD, ANTON W. FETTING, and JOSEPH
A. FISCHETTI, Administrative Patent Judges.

FISCHETTI, Administrative Patent Judge.

DECISION ON APPEAL

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).
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STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134 of the Examiner’s
final rejection of claims 1-59. We have jurisdiction under 35 U.S.C. § 6(b)
(2002). An Oral Hearing was held on April 22, 2009.

SUMMARY OF DECISION
We AFFIRM.

THE INVENTION
Appellants claim a system and method for individualized control and
management of medical records. In particular, the invention relates to
methods in which the creation, control, and management of medical records
are secure and certified as accurate, having the attribute of non-repudiation.
(Specification 1:8-10.)
Claim 1, reproduced below, is representative of the subject matter on
appeal.
1. A broad-band, computer-based networked
system comprising:
a collection of patient-based electronic
medical records containing medical information of
a plurality of persons, wherein:
the medical records are obtained and
electronically compiled from a plurality of
sources;
one or more medical records of the
collection possess a characteristic of non-
repudiation such that the medical information
contained within said medical records is verified as
accurate and correct;
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the medical record of a person is
transmissible in whole or in part only to that
person and others authorized by that person;
each medical record can be
supplemented with additional information; and
additional medical records for
additional persons may be added to the collection;
a secure access for allowing each
person to access only their own medical record;
and
at least another secure access for allowing
said others authorized to access only that person's
medical record.

THE REJECTIONS
The Examiner relies upon the following as evidence of
unpatentability:
Shear US 4,827,508 May 2, 1989
Ertel US 5,307,262 Apr. 26, 1994
Joao US 6,283,761 B1 Sep. 4, 2001
Malik US 2001/0037219 A1 Nov. 1, 2001
Segal US 2001/0041991 A1 Nov. 15, 2001

Dixie B. Baker, PCASSO: A Model for Safe Use of the Internet in
Healthcare, J. of AHIMA, 33-36 (2000) (hereinafter “Baker”).
The following rejections are before us for review.
The Examiner rejected claims 1-11, 17, 30, 34-47, 51-55, and 57-59
under 35 U.S.C. § 102(e) as being anticipated by Segal.
The Examiner rejected claim 12 under 35 U.S.C. § 103(a) as being
unpatentable over Segal in view of Baker.
The Examiner rejected claims 13-15, 20-22, 25-29, 32-33, and 48-50
under 35 U.S.C. § 103(a) as being unpatentable over Segal in view of Malik.
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The Examiner rejected claim 16 under 35 U.S.C. § 103(a) as being
unpatentable over Segal in view of Shear.
The Examiner rejected claims 18-19 and 31 under 35 U.S.C. § 103(a)
as being unpatentable over Segal in view of Ertel.
The Examiner rejected claims 23-24 under 35 U.S.C. § 103(a) as
being unpatentable over Segal in view of Malik as applied to claim 20
above, and further in view of Ertel.
The Examiner rejected claim 56 under 35 U.S.C. § 103(a) as being
unpatentable over Segal in view of Joao.
The Examiner rejected claim 40 under 35 U.S.C. § 112, second
paragraph, as being indefinite for failing to particularly point out and
distinctly claim the subject matter which applicant regards as the invention.
The Examiner rejected claim 40 under 35 U.S.C. § 101 as directed to
non-statutory subject matter.

ISSUES
Have Appellants shown that the Examiner erred in rejecting claims 1-
59 on appeal as being unpatentable under 35 U.S.C. § 102(b) and 35 U.S.C.
§ 103(a) using Segal on the grounds that a person with ordinary skill in the
art would understand that Segal’s disclosure that computerized records are
inherently more accurate than paper-based records in conjunction with an
image server performs quality assurance checks on the images to verify
diagnostic quality before releasing same constitutes a characteristic of non-
repudiation such that the medical information contained within the medical
records is verified as accurate and correct?
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Have Appellants shown that the Examiner erred in rejecting claims
10,11, 21, 22, 41-43 and 45 on appeal as being unpatentable under 35 U.S.C.
§ 102(b) and 35 U.S.C. § 103(a) using Segal on the grounds that a person
with ordinary skill in the art would understand that Segal’s disclosure that
“computerized records are more organized, accurate, and accessible in
comparison to paper-based records…” and “…before forwarding the images,
image server performs quality assurance checks on the images to verify
diagnostic quality” constitutes certification?
Have Appellants shown the Knaus and Marks Declarations to be
sufficient in character and weight as to establish reduction to practice prior
to the effective dates of the Segal and Malik references?
FINDINGS OF FACT
We find the following facts by a preponderance of the evidence:
1. The Specification describes the limitation “non-repudiation” in
terms of:
[m]edical records that are verified as accurate
attain the aspect of non-repudiation (i.e.[,] that the
accuracy and correctness of the information is as
good or better than exists at the source sites from
which the records were obtained), and may for all
purposes be relied upon. As such, non-repudiated
records may therefore be primary for future
treatment or diagnoses.
(Specification 17:14-18.)
2. The Specification describes “certification” as having three modes as
set forth below as follows:
[a.] Certification levels may refer to standards of
verification such as, for example, "initial" being
self-certification wherein the member certifies that
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the record is correct, "basic" whereby the system
provider certifies that the record is complete for all
information gathered, "enhanced" whereby the
system provider certifies that the information is
complete and correct, or comprehensive" whereby
the system provider certifies that the information
provides a complete, accurate and verifiable
medical record. Subdivisions of each level such as,
for example, grades may also be utilized (e.g.[,]
Basic-l, -2, -3, etc.).
(Specification 15:22-29.)
[b.] Alternatively, the certification level may also
provide an indication of the level of completeness
of the record. For example, an initial level of
certification may be limited to annual medical
examinations. Data associated with such an
examination is input into the system and each input
would include an indication of source which may
be verified by the system provider according to
provider-defined criteria. A basic certification
level may include information necessary for
a initial certification level, plus additional
information relating to hospital out-patient
procedures performed along with source and
source verification. An enhanced level of
certification may include basic information plus
further in-patient information. A comprehensive
level may include enhanced information plus
correlation information such as, for example, a
review for completeness, vetting, a review for
accuracy, and noting and/or linking of any
discrepancies (e.g.[,] drug allergies, disparate
diagnoses, anomalies, and otherwise unexplained
treatments and observations).
(Specification 15:29-16:12.)
[c.] Certification may simply state that the record
is correct in all material respects or that the record
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is internally consistent. Errors identified in
medical records may be corrected (with
appropriate annotation) or simply noted.
Suggestions in the form of supplemental
computerized evaluations or other helpful
comments may be included with comprehensive
certification as to possible diagnoses, possible
treatment or health options, and the like. Thus, a
part of each level of certification may be a
verification that the information is exactly as it
appears in the paper or other tangible or even
electronic file of the original source, or possibly
better.
(Specification 16:12-19.)
3. The Specification defines patient–based as “… the medical records
of an individual are controlled and managed by that individual.…”
(Specification 13:4-6.)
4. The Specification describes vetting in the context of
[f]urther information can be obtained from other
sources (medical professionals and
paraprofessionals, nurses, physicians), and all of
the information subject to review and appraisal by
clinically trained experts or record-experienced
experts. Medical records that have been so
reviewed are considered to have been vetted.
Vetted medical records contain corrections and
annotation information such as, for example, a
review for accuracy and completeness noting
and/or linking any errors or discrepancies (e.g.[,]
drug allergies, disparate diagnoses, anomalies, and
otherwise unexplained treatments and
observations). Vetting may be a part of a
certification standard (e.g.[,] comprehensive) or
may simply be a statement that the record has been
vetted and is correct in all material respects, is
internally consistent and/or has been corrected.
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(Specification 20:17-26.)
5. The Examiner found that Segal discloses “one or more medical
records of the collection possess a characteristic of non-repudiation such that
the medical information contained within said medical records is verified as
accurate and correct (para. 6, para. 8, and para. 131 of Segal).” (Answer 6.)
6. The Examiner found that “Segal does not disclose wherein said
collection complies with a federal or state standard of privacy and security,
wherein the federal standard is the Health Insurance Portability and
Accountability Act of 1996…” but that “Malik discloses wherein said
collection complies with a federal or state standard of privacy and security,
wherein the federal standard is the Health Insurance Portability and
Accountability Act of 1996…” (Answer 14).
7. Segal discloses
Electronic medical records (EMRs) digitally store
the information found in traditional paper-based
records. Other terms synonymous with EMR are
computerized medical records (CMRs) and
computer-based patient records (CPRs). As used
herein, the term "patient medical record" (PMR)
covers these electronic records (EMR, CMR, and
CPR) as well as paper-based records. Inherently,
these computerized records are more organized,
accurate, and accessible in comparison to paper-
based records. In addition, the computerized
records have the potential to accommodate a
greater variety of record media, such as medical
imaging and videography.
(Segal, ¶[0008].)
8. Segal discloses:
Image workstation 604 then forwards the digitized
images and report, if generated, through an image
center NAD 710 and an operations center NAD
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702 to image server 126. Image server 126 then
sends the images and report, if generated, for long
term storage to expanded memory image archive
105 through NAD 702. Preferably, before
forwarding the images, image server 126 performs
quality assurance checks on the images to verify
diagnostic quality.
(Segal, ¶[0131].)
9. The Knaus and Marks Declarations Exhibit A discusses the
involved system and method in the future tense stating, e.g.: “PatientDirect
will take advantage . . . ” (p. 1¶B); “We will also expect to be involved in
efforts to create an Extensible Markup Language. . . ” (p. 4,¶C); “This
illustrates the type and function of decision support tools possible for
implementation in PatientDirect.” (p.5, l. 2-3); “PatientDirect will collect
and compile data from various locations of an individual’s existing medical
records . . . . ” (p. 10, ¶B); “PatientDirect will strengthen. . . ,” (p. 11¶A);
“Web Links- will also be established with other support services that are
applicable to the individual patient.” (p. 13, ll. 3-4); “There will be two
types of transaction fees . . . . ” (p. 20,¶B). (Knaus Declaration, Exh. A.)
10. The Knaus and Marks Declarations seek to antedate the effective
dates of each of Segal, Malik, the Segal Provisional, and the Malik
Provisional applications relied on by the Examiner alleging inter alia:
Prior to February 9, 2000, we conceived and
reduced to practice the systems and methods
according to the claims of the instant patent
application, at least to the extent that such systems
and methods are disclosed in U.S. Patent
Application No. 09/838,878 (Segal), U.S.
Provisional Application No. 60/181,215 (the Segal
Provisional), U.S. Patent Application No.
09/776,673 (Malik), and U.S. Provisional
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Application No. 60/60/200,091 (the Malik
Provisional) (collectively the "Cited References"),
as disclosed in the attached documents. Sections
of the attached documents are highlighted to
emphasize aspects of the instant invention that
were alleged to be disclosed in these Cited
References. Accordingly, Segal, Malik, the Segal
Provisional and the Malik Provisional cannot be
considered to be prior art to our claimed invention.
(Knaus and Marks Declarations, pp. 1-2.)
11. The Knaus Declaration does not assert any facts which show
diligence.

PRINCIPLES OF LAW
“Section 103 forbids issuance of a patent when ‘the differences
between the subject matter sought to be patented and the prior art are such
that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains.’” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 406
(2007). The question of obviousness is resolved on the basis of underlying
factual determinations including (1) the scope and content of the prior art,
(2) any differences between the claimed subject matter and the prior art, (3)
the level of skill in the art, and (4) where in evidence, so-called secondary
considerations. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). See
also KSR, 550 U.S. at 407 (“While the sequence of these questions might be
reordered in any particular case, the [Graham] factors continue to define the
inquiry that controls.”)
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
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art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d
628, 631 (Fed. Cir. 1987), cert. denied, 484 U.S. 827 (1987).

ANALYSIS
Appellants’ arguments against each of the rejections on the merits are
based on perceived deficiencies of Segal. Inasmuch, as Appellants raise the
same issues with respect to each of the rejections, we discuss them together,
addressing each of Appellants’ arguments in turn.
Preliminarily, we address the scope of the claims. Each of claims 1,
8, 9, 25, 26, and 54 requires non-repudiation, and each of claims 10, 11, 21,
22, 41-43, and 45 require certification. We rely on the Specification for the
meaning of these terms in our analysis. According to the Specification, non-
repudiation means that the accuracy and correctness of the information is as
good or better than exists at the source sites from which the records were
obtained (FF 5). Certify/certification means that the record is correct in all
material respects or that the record is internally consistent (FF 6c).
Appellants argue that Segal fails to disclose nonrepudiation because
“[i]n a preferred embodiment (e.g., claims 23, 24, 31), nonrepudiation is
attained from an accurate medical record that is then subjected to a separate
additional step of verification or vetting (also see specification, page 17,
lines 11-21).” (Appeal Br. 11.) We disagree with Appellants. The involved
claim language recites: “one or more medical records of the collection
possess a characteristic of non-repudiation such that the medical
information contained within said medical records is verified as accurate
and correct.” (Emphasis added.) Nowhere in this language is there a
requirement of a two step process such as argued by Appellants whereby a
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determined accurate medical record is subsequently subjected to a separate
additional step of verification or vetting. All the claim language requires is
that a record possess a characteristic of non-repudiation which is medical
information contained within said medical records is verified as accurate
and correct. This is not the same as the two step process which Appellants
assert.
Appellants also assert that the language “each medical record is
certified as accurate” (emphasis added) contained in each of claims 10, 11,
21, 22, 41-43 and 45 is not found in or made obvious by Segal. (Appeal
Br. 11.) The Examiner however found the Segal at ¶¶ [0008] and [0131]
discloses “one or more medical records of the collection possess a
characteristic of non-repudiation such that the medical information
contained within said medical records is verified as accurate and correct (FF
5). In these sections, Segal discloses “[i]nherently, these computerized
records are more organized, accurate, and accessible in comparison to paper-
based records…” and “…before forwarding the images, image server 126
performs quality assurance checks on the images to verify diagnostic
quality….” (FF 7, 8.) We thus disagree with Appellants and agree with the
Examiner’s finding that Segal discloses record certification. As found
supra, certification means that the record is correct in all material respects or
that the record is internally consistent. (FF 2.) A computerized record
which has undergone a quality assurance not only has the inherent accuracy
of its nature, but Segal further discloses that the record is affirmatively
checked for quality, e.g., accuracy. In light of the breadth of the claim, the
Appellants’ argument is not persuasive as to error in the rejection.
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Declaration Evidence:
Claims 1-59
We are not persuaded by Appellants’ showing of facts in the Knaus
and Marks Declarations to be sufficient in character and weight as to
establish reduction to practice prior to the effective dates of the Segal and
Malik references. Rather, we find that the evidence presented in Exhibit A
appended to the Declarations does not establish conception in that it
discusses the concept only broadly and in the future tense (FF 9). Moreover,
the Knaus and Marks Declarations Exhibit A fail to assert any facts of due
diligence from the alleged time of conception date (FF 11), and thus cannot
support conception of the invention prior to the effective date of the
reference coupled with due diligence from prior to said date to a subsequent
reduction to practice or to the filing of the application even if conception
was established.
Accordingly, we reject Appellants’ assertion (FF 10) that the Knaus
and Marks Declarations are effective to antedate the effective dates of the
Segal and Malik references and the rejections which rely on these
references.
Claim 37
Claim 37 requires that the medical information contained within the
medical records be more accurate and correct as compared to those sources
from which the medical records were obtained. Appellants assert that this
feature is not found “in any of the cited references relating to claim 37….”
(Appeal Br. 7.) We disagree with Appellants because we read the source in
Segal as the paper based record which when scanned or electronically
copied, is expressly disclosed by Segal as being more accurate than the
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paper based records. (FF 7.) In light of the breadth of the claim, the
Appellants’ argument is not persuasive as to error in the rejection.
Malik
Appellants argue that “Malik fails to disclose or suggest at least the
elements of ‘certification of medical records’ (claims 21 and 22) or
‘nonrepudiation of medical records’ (claims 25 and 26) as these elements are
claimed by Appellant.” (Appeal Br. 17.) That argument is not well taken
because the Appellants are attacking the reference individually when the
rejection is based on a combination of references to both Segal and Malik,
and Malik is only used to supplant the HIPPA requirement deficiency
(Answer, 14). See In re Keller, 642 F.2d 413, 426 (CCPA 1981); In re
Young, 403 F.2d 754, 757-58 (CCPA 1968).
Claim 40
The Examiner rejected claim 40 under 35 U.S.C. § 112, second
paragraph, as being indefinite for failing to particularly point out and
distinctly claim the subject matter which applicant regards as the invention.
Appellants do not respond to this rejection in their Brief, and thus the
rejection is deemed conceded.
The Examiner rejected claim 40 under 35 U.S.C. § 101 as directed to
non-statutory subject matter. Appellants do not respond to this rejection in
their Brief, and thus the rejection is deemed conceded.

CONCLUSIONS OF LAW
We conclude the Appellants have not shown that the Examiner erred
in rejecting claims 1-11, 17, 30, 34-47, 51-55, and 57-59 under 35 U.S.C. §
102(e) as being anticipated by Segal.
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We conclude the Appellants have not shown that the Examiner erred
in rejecting claim 12 under 35 U.S.C. § 103(a) as being unpatentable over
Segal in view of Baker.
We conclude the Appellants have not shown that the Examiner erred
in rejecting claims 13-15, 20-22, 25-29, 32-33, and 48-50 under 35 U.S.C. §
103(a) as being unpatentable over Segal in view of Malik.
We conclude the Appellants have not shown that the Examiner erred
in rejecting claim 16 under 35 U.S.C. § 103(a) as being unpatentable over
Segal in view of Shear.
We conclude the Appellants have not shown that the Examiner erred
in rejecting claims 18-19 and 31 under 35 U.S.C. § 103(a) as being
unpatentable over Segal in view of Ertel.
We conclude the Appellants have not shown that the Examiner erred
in rejecting claims 23-24 under 35 U.S.C. § 103(a) as being unpatentable
over Segal in view of Malik and further in view of Ertel.
We conclude the Appellants have not shown that the Examiner erred
in rejecting claim 56 under 35 U.S.C. § 103(a) as being unpatentable over
Segal in view of Joao.
We conclude the Appellants have not shown that the Examiner erred
in rejecting claim 40 under 35 U.S.C. § 112, second paragraph.
We conclude the Appellants have not shown that the Examiner erred
in rejecting claim 40 under 35 U.S.C. § 101 as directed to non-statutory
subject matter.
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DECISION
The decision of the Examiner to reject claims 1-59 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2007).
AFFIRMED

hh

James Remenick
Novak, Druce & Quigg, LLP
East Tower, Suite 400
1300 Eye Street, N.W.
Washington, DC 20005