Ex Parte Knaus et al

Board of Patent Appeals and Interferences

Apr 30, 2009

09822261 (B.P.A.I. Apr. 30, 2009)

UNITED STATES PA ADEMARK OFFICE
____________
BEFORE T APPEALS
AND INTERFERENCES
____________
Ex parte WILLIAM A. KNAUS and RICHARD D. MARKS
____________
Technology Center 3600
____________
Dec 09
____________
. FETTING and JOSEPH
. FISCHETTI, Administrative Patent Judges.
ISCHETTI, Administrative Patent Judge.

DECISION ON APPEAL

TENT AND TR

HE BOARD OF PATENT

Appeal 2009-0552
Application 09/822,261

ided:1 May 1, 20

Before, MURRIEL E. CRAWFORD, ANTON W
A

F

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).

Appeal 2009-0552
Application 09/822,261

2
STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134 of the Examiner’s
final rejection of claims 1-29, 46-62, 64-71 and 73-75. We have jurisdiction
under 35 U.S.C. § 6(b). (2002).
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.
A broad-band, computer-based networked system
comprising:
a collection of patient-based electronic medical records of a plurality
of persons, at least one of which is encrypted or secured when collected,
accessed, inputted, viewed, integrated or transmitted, 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 medical information contained within said
medical records is verified as to accuracy and certified for accuracy;
the medical record of a person is transmitted in whole or in part only to that
person and others authorized by that person;
each medical record is supplemented with additional information; and
additional medical records for additional persons are added to the collection;
a secure access for allowing each person to access only their own medical
Appeal 2009-0552
Application 09/822,261

3
record; and at least another secure access for allowing said others authorized
to access only that person's medical record.

THE REJECTION
The Examiner relies upon the following as evidence of
unpatentability:
Shear 4,827,508 May 2, 1989
Shepard 6,026,363 Feb. 15, 2000
Malik US 2001/0037219 A1 Nov. 2001
Snowden US 2002/0026332 A1 Feb. 28, 2002
Baker, D.B. “PCASSO: A Model for Safe Use of the Internet in
Healthcare” Journal of AHIMA, March 2000, pp. 33-36
The following rejections are before us for review.
The Examiner rejected claims 1-11, 18-26, 29, 46-47 and 51-75 under
35 U.S.C. § 103(a) over Snowden in view of Shepard.
The Examiner rejected claim 12 under 35 U.S.C. § 103(a) as being
unpatentable over Snowden in view of Shepard and further in view of Baker.
The Examiner rejected claims 13-15, 27-28, and 48-50 under
35 U.S.C. § 103(a) as being unpatentable over Snowden in view of Shepard
and further in view of Malik.
Appeal 2009-0552
Application 09/822,261

4
The Examiner rejected claims 16-17 under 35 U.S.C. § 103(a) as
being unpatentable over Snowden in view of Shepard and further in view of
Shear.
ISSUE
Have Appellants shown that the Examiner erred in rejecting claims 1-
11, 18-26, 29, 46-47 and 51-75 on appeal as being unpatentable under
35 U.S.C. § 103(a) over Snowden in view of Shepard on the grounds that a
person with ordinary skill in the art would understand that Shepard discloses
"certification" and "non-repudiation" of the records created and stored
against a patient’s file?
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 Snowden and Malik references?
Have Appellants shown that the Examiner erred in rejecting claim 20
on appeal as being unpatentable under 35 U.S.C. § 103(a) over Snowden in
view of Shepard on the grounds that a person with ordinary skill in the art
would understand that Shepard discloses at least one medical record is better
than exists at a source site from which the medical record was obtained in
that the writer who vets the record, e.g., decodes key word and phrases does
create a record which is better than that verbalized by the healthcare worker
because it is no longer in encoded form and has benefited from a further
Appeal 2009-0552
Application 09/822,261

5
vetting process, such as, being run through word processing, e.g., cleared for
spelling errors, etc.
FINDINGS OF FACT
We find the following facts by a preponderance of the evidence:
1. The Examiner found that “… Snowden does not expressly disclose
one or more medical records of the collection possess a characteristic of
non-repudiation such that medical information contained within said medical
records is verified as to accuracy and certified for accuracy.” (Answer 4.)
2. The Examiner further found that “Shepard discloses one or more
medical records of the collection possess a characteristic of non-repudiation
such that medical information contained within said medical records is
verified as to accuracy and certified for accuracy (col. 13, line 54 - col. 14,
line 9 of Shepard).” (Answer 4).
3. The Examiner accordingly found “…it would have been obvious to
a person of ordinary skill in the art to combine the features of Shepard
within Snowden. The motivation for doing so would have been to provide
accurate and complete patient documentation to meet legal, insurance and
third party medical service provider requirements…. (Answer 5)
4. Shepard discloses:
When the transcriber has prepared the
patient final report, the transcriber or writer then
compares the final report to the encoded indicia
recorded on the preprinted form, which is depicted
by Box 44, to ensure that the final report is
accurate.
Appeal 2009-0552
Application 09/822,261

6
The final report is then prepared by an
imaging device and may be in the form of a patient
report to be filed in a patient's history file or in the
form of a letter to be sent to a third party as
depicted by Box 46.
The final report or letter, as depicted by Box
46, is then reviewed and signed by the healthcare
professional who performed the examination of the
patient. If the medical history documentation
system is a manual system using a transcriber as
described above, the healthcare professional would
review all patient reports at the end of the day.
If the medical history documentation system
is a computerized system, e.g., a scanner is used to
scan the preprinted form and scan the
predetermined encoded indicia as an input to the
computer, the healthcare professional can be
provided a final report or letter for review and sign
upon completion of the physical examination of
the patient as depicted by Box 50. (Shepard, col.
13, l. 54 - col. 14, l. 9).
5. 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).
Appeal 2009-0552
Application 09/822,261

7
6. 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
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
Appeal 2009-0552
Application 09/822,261

8
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
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).
7. The Specification defines patient–based as “… the medical records
of an individual are controlled and managed by that individual.…”
(Specification 13:4-6.)
8. 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.
Appeal 2009-0552
Application 09/822,261

9
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.
(Specification 20:17-26)
9. Snowden discloses a patient centered record system in that it
allows “…patients to play a more active role in the management and
maintenance of their health. (Snowden, ¶[0102]).
10. The Specification describes that “… vetting is performed by the
patient, by the source from which the records were obtained, by the system
provider, or by a combination thereof.” (Specification 20:27-28.)
11. Snowden further discloses a patient centered record system in
that:
FIG. 1 shows a system in which medical
information for a consumer is gathered from a
variety of sources, a copy of which is stored in a
database that is controlled and owned by the
consumer. This database is automatically updated
on a regular basis. The database information can
then be transmitted by the consumer to doctors,
hospitals, other healthcare providers, or insurance
companies as desired by the consumer. (Snowden,
¶[0103])
Appeal 2009-0552
Application 09/822,261

10
12. The system in Shepard is primarily concerned with
documentation of medical history using a recording apparatus to record
information communicated by a healthcare person. (Shepard, col.1, ll. 20-
23.)
13. Shepard discloses that a “…writer, who accompanies the
healthcare professional, records in a predetermined format with a recording
device, for example the writer Records On a Preprinted Form 38 (or on a
computer input apparatus), the patient's medical information verbalized by
the healthcare professional during the physical examination of a patient.
(Shepard, col.13, ll. 5-10.)
14. Shepard further discloses that the writer, who accompanies the
healthcare professional then prepares a patient final report using a “…known
word processing system and hav[ing] templates of optional variable text
segments which the transcriber would select or program, essentially
decoding the key words and phrases to produce a final report.” (Shepard,
col.13, ll. 50-54.)
15. The Knaus Declaration Exhibit A discusses the involved system
and method in the future tense stating, e.g., “My approach would use….;
This would effectively eliminate….”; “they will also be able to devote
time….; “Individuals therefore would be the main customers for this
service.” (Knaus Declaration, p.4).
16. The Knaus Declaration Exhibit A states using the future tense, “I
can envision linking ….”; It could monitor and direct….”(Knaus
Appeal 2009-0552
Application 09/822,261

11
Declaration, p.6).
17. The Knaus Declaration Exhibit A admits the information outlined
is conceptual stating, “If we get through this conceptual phase….” (Knaus
Declaration, p. 7).
18. The Knaus Declaration seeks to antedate the effective dates of
each of Snowden, Malik, the Snowden Provisional and the Malik
Provisional applications relied on by the Examiner alleging inter alia:
Prior to December 6, 1999, 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. 09/908,524 (Snowden), U.S.
Provisional Application No. 60/169,065 (the
Snowden Provisional), U.S. Patent Application
No. 09/776,673 (Malik), and U.S. Provisional
Applieation No. 60/60/200,091 (the Malik
Provisional) (collectively the "Cited References").
Accordingly, Snowden, Malik, the Snowden
Provisional and the Malik Provisional cannot be
considered to be prior art to our claimed invention.
(Knaus Declaration, p. 1).
19. 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
Appeal 2009-0552
Application 09/822,261

12
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., 127 S.Ct. 1727,
1734 (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, 127 S.Ct. at 1734 (“While the sequence of these
questions might be reordered in any particular case, the [Graham] factors
continue to define the inquiry that controls.”).
ANALYSIS
We affirm the rejection of claims 1-29, 46-62, 64-71 and 73-75.
Appellants’ arguments against each of independent claims 1, 20, 46
and 65 are based on perceived deficiencies of Shepard. Inasmuch as
Appellants raise the same issues with respect to each of these claims, we
discuss them together, addressing each of Appellants’ arguments in turn.
Initially, we note that the Appellants argue the claims 1, 46, and 65
together as a group. Correspondingly, we select representative claim 1 to
decide the appeal of these claims, remaining claims standing or falling with
claim 1.
Group I: Claims 1-11, 18-26, 29, 46-47 and 51-75.
Preliminarily, we address the scope of the claims. Each of the
independent claims requires non-repudiation and certification. Appellants
Appeal 2009-0552
Application 09/822,261

13
state that these claim elements are understood by those of ordinary skill in
the art and thus “Appellant (sic) is not incorporating a definition from the
specification, but merely demonstrating that the specification is consistent
with the context and the plain meaning of this term in the claims.” (Appeal
Br. 8, 9). Having been alerted to the presence of such a definition, we thus
use the definition provided by the Specification for these terms in our
analysis. Accordingly we interpret non-repudiation as meaning 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 (FF5) and certification
to mean that the record is correct in all material respects or that the record is
internally consistent (FF 6c).
Appellants maintain that “Shepard is not combinable with Snowden
and would not lead one skilled in the art toward Appellants’ invention.
Appellants’ claimed invention is directed to patient-based records. Shepard
is directed to the conventional hospital-based or physician-office system, or,
in other words, to an institutional source-centered record system, which
leads one skilled in the art in exactly the wrong direction.” (Appeal Br. 10)
We disagree with Appellants. First, we find that Snowden discloses a
patient centered record system because in Snowden, patients play an active
role in the management and maintenance of their health (FF 9) and further
that medical information for a consumer is controlled and owned by the
consumer (FF 11). This is congruent with Appellants’ definition of patient-
based (FF 7). Thus, we conclude that a system such as taught by Snowden
Appeal 2009-0552
Application 09/822,261

14
which explicitly discloses allowing a patient to play a more active role in the
management of their health and allowing them to control and own their
medical information is patient-based or centered.
Second, we find nothing in the disclosure of Shepard which would
prohibit the medical records of a patient once entered and verified from
being controlled and owned by that patient as taught by Snowden because
Shepard is primarily concerned with the documentation of medical history
communicated by a healthcare person into fixed form (FF 12). Since the
Examiner has provided some articulated reasoning with some rational
underpinning for why a person with ordinary skill in the art would modify
Snowden to use the characteristic of non-repudiation of Shepard (FF 3),
Appellants’ argument is not persuasive as to error in the rejection.
Appellants next argue:
The Shepard medical record management system
is directed to physician- or a hospital- based
records system…. Thus, Shepard's records would
be verified as correct only by the health care
professional who conducted the examination. This
is not a patient-based record system as described in
the instant application, but a conventional hospital-
based record system for creating original medical
records. (Appeal Br. 10).
That argument is not well taken because the Appellant is attacking the
Shepard reference individually when the rejection is based on a combination
of references to both Shepard and Snowden and Snowden is being used to
teach the patient-based feature as discussed above. See In re Keller, 642
Appeal 2009-0552
Application 09/822,261

15
F.2d 413, 426 (CCPA 1981); In re Young, 403 F.2d 754, 757-58 (CCPA
1968).
Appellants next argue that
[a]ll the instances noted in Shepard refer to
verification of the patient's record by the physician
or health care worker who is tasked by the source
with creating the record in the first place. Shepard
describes delegating the task of actually writing
the medical record to another person employed by
the source office or hospital, and yet who is not
administering the care. The recorder is, for
example, to be present in the room when the
patient is being examined by the physician….
(Appeal Br. 10).
We disagree with Appellants because the Specification describes that
vetting can be performed by any of the patient, the source from which the
records were obtained, the system provider, or by a combination thereof
(FF 10). Thus, the transcriber in Shepard who works for the provider meets
the claim requirement.
Appellants further argue error in the Examiner’s finding of accuracy
in the asserted prior art because “… her analytical approach is devoid of
logic, arbitrary and capricious, and a violation of MPEP § 706.” (Appeal Br.
12). We disagree with Appellants.
The pertinent claim language recites: one or more medical records of
the collection possess a characteristic of non-repudiation such that medical
information contained within said medical records is verified as to accuracy
and certified for accuracy. The Examiner found that “Shepard discloses one
Appeal 2009-0552
Application 09/822,261

16
or more medical records of the collection possess a characteristic of non-
repudiation such that medical information contained within said medical
records is verified as to accuracy and certified for accuracy (col. 13, line 54 -
col. 14, line 9 of Shepard).” (FF 2). The cited to portion of Shepard
discloses that “when the transcriber has prepared the patient final report, the
transcriber or writer then compares the final report to the encoded indicia
recorded on the preprinted form, which is depicted by Box 44, to ensure that
the final report is accurate (emphasis added).” (FF 4). Thus, we agree with
the Examiner, Shepard discloses verifying for accuracy.
Further, according to Appellants, certification may simply state that
the record is correct in all material respects or that the record is internally
consistent (FF 6c). We find that Shepard discloses that the final report or
letter is reviewed and then signed by the healthcare professional who
performed the examination of the patient (FF 4). As such, we conclude that
Shepard discloses certification in that the act of reviewing the content of the
report and subsequent signing certifies by the signature to its internal
consistency.
In addition, Shepard discloses that if the medical history
documentation system is a computerized system, a scanner is used to scan
the preprinted form and scan the predetermined encoded indicia as an input
to the computer (FF 4). The healthcare professional is then provided a final
report or letter for review and sign upon completion of the physical
examination (FF 4). The Specification defines a non-repudiation document
Appeal 2009-0552
Application 09/822,261

17
as one where 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). Since a scanner will copy the document having accuracy and
correctness of at least as good as the original, it thus meets the claim
requirement. In light of the breadth of the claim, the Appellants’ argument
is not persuasive as to error in the rejection.
Regarding the dependent claims which Appellants include as part of
Group I, we also affirm the rejections of these dependent claims since
Appellants have not challenged such with any reasonable specificity (see In
re Nielson, 816 F.2d 1567, 1572, (Fed. Cir. 1987)).
Declaration Evidence:
Group II Claims 1-29, 46-62, 64-71 and 73-75;
Group III Claims 13-15, 27-28 and 48-50.

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 Snowden
and Malik references. Rather, we find that the evidence presented in Exhibit
A appended to the Declarations at best shows conception in that it only
discusses the system in the future tense as actions to be completed by the
concept (FF 16,17). In fact, the Exhibit A even references itself as a
conceptual phase (FF 18).
Moreover, the Knaus and Marks Declarations Exhibit A fail to assert
any facts of due diligence from the alleged time of conception date and thus
cannot support conception of the invention prior to the effective date of the
Appeal 2009-0552
Application 09/822,261

18
reference coupled with due diligence from prior to said date to a subsequent
reduction to practice or to the filing of the application.
Accordingly, we reject Appellants’ assertion that the Knaus and
Marks Declarations are effective to antedate the effective dates of the
Snowden and Malik references and the rejections which rely on these
references.
Group IV Claim (claim 20)
Appellants argue claim 20 separately, maintaining that “...information
contained within Shepard's source medical records cannot be better than
exists at the source from which the record was obtained. This is at least
because the hospital, physician or health care worker is the source of the
record.” (Appeal Br. 11) Claim 20 recites: medical records representing a
plurality of persons, wherein the medical information of at least one medical
record of the plurality has been vetted, such that the medical information of
said at least one medical record is better than exists at a source site from
which the medical record was obtained and thereby is not subject to
repudiation.
We disagree with Appellants’ position here because we read the
source site in Shepard as being the healthcare professional. As such, we find
that the writer who vets the record, e.g., decodes key word and phrases (FF
13,14) does create a record which is better than that verbalized by the
healthcare worker because it is no longer in encoded form and has benefited
from a further vetting process, such as, being run through word processing,
Appeal 2009-0552
Application 09/822,261

19
e.g., cleared for spelling errors, etc. See KSR Int’l. Co. v. Teleflex Inc., 127
S.Ct. 1727, 1741 (2007) (In making the obviousness determination one “can
take account of the inferences and creative steps that a person of ordinary
skill in the art would employ”).

CONCLUSIONS OF LAW
We conclude the Appellants have not shown that the Examiner erred
in rejecting claims 1-11, 18-26, 29, 46-47 and 51-75 under 35 U.S.C. §
103(a) over Snowden in view of Shepard.
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
Snowden in view of Shepard and further in view of Baker.
We conclude the Appellants have not shown that the Examiner erred
in rejecting claims 13-15, 27-28, and 48-50 under 35 U.S.C. § 103(a) as
being unpatentable over Snowden in view of Shepard and further in view of
Malik.
We conclude the Appellants have not shown that the Examiner erred
in rejecting claims 16-17 under 35 U.S.C. § 103(a) as being unpatentable
over Snowden in view of Shepard and further in view of Shear.
Appeal 2009-0552
Application 09/822,261

20

DECISION
The decision of the Examiner to reject claims 1-11, 18-26, 29, 46-47
and 51-75 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) (2006).
AFFIRMED

JRG

JAMES REMENICK
NOVAK DRUCE & QUIGG, LLP
1300 I STREET NW
SUITE 1000 WEST TOWER
WASHINGTON, DC 20005