Court Opinion

ID: 2685766
Source: CourtListenerOpinion
Date Created: 2014-07-25 16:00:41.300039+00
Date Added: 2024-06-11T13:15:25.985660
License: Public Domain

NOTE: This disposition is nonprecedential.

  United States Court of Appeals
      for the Federal Circuit
                 ______________________

              IN RE RONALD S. KARPF
                ______________________

                       2014-1035
                 ______________________

    Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Serial No.
11/645,067.
                 ______________________

                 Decided: July 25, 2014
                 ______________________

    CHRISTIAN J. HURT, Nix, Patterson & Roach, LLP, of
Irving, Texas, argued for appellant. With him on the brief
was DEREK T. GILLILAND.

    MEREDITH H. SCHOENFELD, Associate Solicitor, United
States Patent and Trademark Office, of Alexandria,
Virginia, argued for appellee. With her on the brief were
NATHAN K. KELLEY, Solicitor, and KRISTI L. R. SAWERT,
Associate Solicitor.
                  ______________________

 Before O’MALLEY, REYNA, and HUGHES, Circuit Judges.
REYNA, Circuit Judge.
   Ronald S. Karpf appeals from a final decision by the
Patent Trial and Appeal Board (“Board”) of the United
2                                               IN RE: KARPF

States Patent and Trademark Office (“PTO”) rejecting all
pending claims in U.S. Patent Application No. 11/645,067
(“the ’067 application”) as anticipated by U.S. Patent No.
5,845,255 (“Mayaud”). 1 For the reasons below, we vacate
the Board’s decision and remand for further proceedings.
                       BACKGROUND
                 A. The ’067 application
    The ’067 application is directed to an electronic medi-
cal records (“EMR”) system that doctors may use to access
patients’ medical records and enter diagnoses and corre-
sponding treatment instructions after patient visits. It
also allows patients to access their records and receive the
treatment instructions from their doctors electronically.
To give patients access to and control over their own
medical information, patients are given two passwords:
(1) a patient password that each patient may use to log in
to the system to access individual medical information,
including diagnoses and treatment instructions; and (2) a
patient PIN that each patient can share with those doc-
tors to whom the patient wishes to grant access to his or
her information and records and from whom the patient
wishes to receive instructions. Medical personnel may
only access the information and records of those patients
for whom they have been provided a patient PIN. After a
doctor enters treatment instructions for a given patient
into the system, the system tracks the patient’s access to
the system to monitor compliance with the treatment
instructions and provide reminders when necessary.

    1   Ex parte Karpf, No. 2010-9172, 2013 WL 1225722
(P.T.A.B. Mar. 18, 2013) (“Board Decision”), aff’d on reh’g,
(P.T.A.B. Jul. 26, 2013) (“Reh’g Decision”).
IN RE: KARPF                                               3

   Two sets of claims are pending in the ’067 application:
method claims 9–18 and apparatus claims 23–25. 2 Inde-
pendent claim 9 recites:
    9. A method of using an electronic medical rec-
    ords (EMR) system, the method comprising:
    a) forming an EMR database comprising:
        a1) for at least one patient registered to use
        the EMR system, storing: patient identification
        data; patient password; and patient personal
        identification number (PIN);
        a2) for at least one medical practitioner regis-
        tered to use the EMR system, storing: medical
        personnel identification data; and medical per-
        sonnel password;
        a3) for at least one medical encounter between
        a patient and medical personnel, storing medi-
        cal encounter data relating to the at least one
        medical encounter, wherein the medical en-
        counter data includes information related to
        the at least one reason for the medical encoun-
        ter, and at least one diagnosis by medical per-
        sonnel corresponding to the medical encounter;
    b) allowing access to the EMR database through
    a patient program, in which an authorized patient
    has access only to information related to the au-
    thorized patient, wherein the authorized patient
    is assigned a patient PIN in the EMR database for
    controlling access to information in the EMR da-
    tabase related to the patient; and

    2  Original claims 1–8 and 19–22 were withdrawn in
response to a restriction/election requirement.
4                                               IN RE: KARPF

    c) allowing access to the EMR database through
    a medical personnel data entry program, in which
    authorized medical personnel may access records
    related to a given patient only upon entry of input
    data corresponding to the patient PIN assigned to
    the given patient.
Claims 10–18 depend from claim 9 and add limitations
generally directed to the storage or display of treatment
guidelines, patient compliance information, and other
patient information.
    Independent claim 23 recites:
    23. An article of manufacture comprising at least
    one machine-readable storage medium having
    stored therein indicia of a plurality of machine-
    executable control program steps, the control pro-
    gram comprising the steps of:
    a) storing patient data, including patient identi-
    fication data, and patient password;
    b) storing medical encounter data relating to at
    least one medical encounter between a medical
    personnel and a patient, wherein the medical en-
    counter data includes at least one reason for the
    medical encounter, and at least one diagnosis by
    medical personnel corresponding to the medical
    encounter; and
    c) storing medical condition data relating to at
    least one medical condition that may be deemed
    by medical personnel to relate to a patient as a re-
    sult of a medical encounter, wherein medical con-
    dition data includes general information about a
    given medical condition.
Claims 24–25 depend from claim 23 and add limitations
generally related to determining patient compliance and
issuing a notification to non-compliant patients.
IN RE: KARPF                                                  5

            B. The Mayaud Prior Art Reference
    Mayaud is prior art to the ’067 application under 35
U.S.C. § 102(e). Mayaud discloses an electronic prescrip-
tion management system that doctors can use to prescribe
medications to patients, manage prescriptions, and com-
municate with pharmacies and patients. Mayaud, Ab-
stract. The system can be used to access patients’
prescription history and track the efficacy of particular
medications to treat the conditions for which they were
prescribed. See, e.g., id. col. 14 ll. 10–31; col. 21 ll. 42–63.
    To ensure that personal information is protected, Ma-
yaud uses “patient record access codes” that can be gener-
ated by or provided to patients prior to a doctor’s
appointment. Id. col. 10 ll. 20–23. Patients can then
decide whether to share their codes with doctors or other
third parties on a need-to-know basis, thereby controlling
access to their personal information and records. Id. col.
10 ll. 24–26. Mayaud also explains that users may access
the system from multiple stations by using user-specific
passwords, which may provide varying degrees of access
depending on the users’ authorization levels. Id. col. 10 ll.
12-19, ll. 37–43. Some of the stations may run “patient-
directed data access control software” that includes “pa-
tient interface components.” Id. col. 46 ll. 41–45. These
stations are separate from the stations used by prescrib-
ers and may be located, for example, in administrative or
reception areas of health care facilities. Id.
               C. Proceedings Before the PTO
    During prosecution, the PTO Examiner rejected
claims 9–18 and 23–25 as anticipated by Mayaud. With
respect to limitation b) in claim 9 (the “patient access
limitation”), the Examiner pointed to a discussion in
Mayaud regarding electronic identifiers (e.g., signature
recognition) for remote electronic authorization of pre-
scription fulfillment at the pharmacy. See Non-Final
6                                              IN RE: KARPF

Office Action at 7–8 (Feb. 4, 2009). The Examiner reject-
ed claim 23 “for the same reason” as claim 9. Id. at 12.
    In response, Mr. Karpf argued that Mayaud did not
disclose: (1) a system to which a patient, and not simply a
patient’s doctor, has access; (2) a patient password for a
patient to gain access to the system and the patient’s own
records, as opposed to a patient PIN for others to use; and
(3) the specific information about individual medical
encounters and other patient-related information recited
in the claims. See Applicant’s Response at 15–16 (Apr. 30,
2009). Mr. Karpf also argued that the portion of Mayaud
cited by the Examiner as anticipating the patient access
limitation merely referred to security measures used to
verify the signature of a doctor who has prescribed medi-
cine and, indeed, a pharmacy would not need to verify a
patient’s signature to determine whether a prescription
has been authorized. Id. Mr. Karpf additionally noted
that the Examiner provided no details as to how the
limitations of claim 23 were specifically met by Mayaud.
While acknowledging that some aspects of claim 9 may be
broadly found in claim 23, Mr. Karpf pointed to specific
limitations in claims 23–25 that he argued were not
present in Mayaud. Id. at 16.
     The Examiner maintained the anticipation rejection
of claims 9–18 and 23–25 based on Mayaud. With respect
to the patient access limitation, the Examiner pointed to
Mayaud’s disclosure of signature recognition. See Final
Office Action at 10 (Jul. 16, 2009). The Examiner also
continued to reject claim 23 “for the same reason” as
claim 9. Id. at 15.
    Mr. Karpf appealed the anticipation rejection to the
Board, essentially repeating the same arguments made
before the Examiner. See Applicant’s Appeal Br. at 9–14
(Dec. 10, 2009). Mr. Karpf emphasized his argument that
Mayaud fails to disclose both patient access to an EMR
system and the use of a “patient password” for patients
IN RE: KARPF                                               7

themselves to gain access. Id. at 9–10. With respect to
claims 23–25 in particular, Mr. Karpf argued that patient
access to the system is implicitly required by the limita-
tion directed to a “patient password.” Id. at 12.
     The Board affirmed the Examiner’s anticipation rejec-
tion of claims 9–18 and 23–25. Regarding the patient
access limitation, the Board did not rely on Mayaud’s
discussion of signature recognition, but found that the
following paragraph in Mayaud discloses granting pa-
tients access to the system:
    Patient record access codes can, in selected in-
    stances, be patient provided, or granted by in-
    telligent security control cards, having been
    furnished to the patient by a system administra-
    tor, or agent, prior to the physician encounter.
    Physician or other user access to a patient’s rec-
    ord, or to sensitive details thereof, can thereby be
    restricted to a need-to-know basis. Access by
    third parties to physician related data can be sim-
    ilarly protected.
Board Decision at 6 (quoting Mayaud col. 10 ll. 20–27).
The Board also found that Mayaud discloses password
protection, including patient passwords, and storing
patient history files and medical records, including diag-
noses and the type of medical encounter data recited in
the claims. See id. at 7. The Board noted that, to the
extent that Mayaud did not disclose the specific type of
medical encounter data and other patient-related infor-
mation recited in the claims, those limitations constituted
non-functional descriptive material not entitled to any
weight in the patentability analysis. Id. at 7 n.5.
    Mr. Karpf requested rehearing on the grounds that
the Board misapprehended the distinction between giving
a patient control over who may access data (as in Ma-
yaud) and giving a patient access to the data (as required
in the claims). Applicant’s Request for Rehearing at 2
8                                               IN RE: KARPF

(May 13, 2013). The Board denied rehearing, reasoning
that patient control necessarily requires that the patient
have access to the system in order to create controls or
restrictions for doctors to access patient’s records. Reh’g
Decision at 3–4. The Board also pointed, for the first
time, to Figure 16 in Mayaud, which the Board argued
showed devices having “patient-directed data access
control software” to allow patients to access the system by
way of the “patient record access codes.” Id. at 4 (citing
Mayaud col. 45 ll. 18–25; col. 46 ll. 32–49; col. 47 ll. 45–
46). Finally, the Board rejected Mr. Karpf’s argument
that no due consideration was given to additional limita-
tions in the dependent claims, reaffirming its view that
much of Mr. Karpf’s arguments were predicated on non-
functional descriptive material. Id. at 5.
    Mr. Karpf timely appealed to this court. We have ju-
risdiction pursuant to 28 U.S.C. § 1295(a)(4)(A).
                       DISCUSSION
    We vacate the Board’s decision that Mayaud antici-
pates claims 9–18 and 23–25. The Board’s factual finding
that Mayaud discloses an EMR system that patients can
use to access their own information is unsupported by
substantial evidence. 3
    Claims 9–18 require an EMR system “in which an au-
thorized patient has access only to information related to
the authorized patient[.]” According to the specification,
patient access to the EMR system is to be distinguished
from access by medical personnel. While medical person-
nel may use the system to update patient information or
enter treatment instructions, patient access is required

    3   See In re Gleave, 560 F.3d 1331, 1335–36 (Fed.
Cir. 2009) (the Board’s determination regarding anticipa-
tion is a question of fact that we review for substantial
evidence).
IN RE: KARPF                                              9

for the patient to be able to review treatment instructions
and receive reminders to comply with the instructions.
     Although Mayaud discloses giving patients the ability
to control who may access their information, it stops short
of granting patients actual access to that information
through the prescription system. The closest disclosure in
this regard is the single reference to a “patient interface”
of the “patient-directed data access control software” that
runs in stations located in administrative or reception
areas of health care facilities. See Mayaud col. 46 ll. 35–
45. That discussion, however, is silent regarding who
uses the patient interface or whether patients can use it
to view their individual information. Indeed, the one use
of the “patient interface” that is described in Mayaud is
allowing the reading of data access rights off a patient’s
data access control card, which does not require direct
interaction between a patient and the system. See id.
col. 46 ll. 46–49.
    Likewise, Mayaud’s disclosure of “patient record ac-
cess codes” is insufficient to support the Board’s finding
regarding patient access to patient information. All
Mayaud teaches is that patients may use the codes to
restrict doctors’ access to patient information by sharing
the codes with doctors on a need-to-know basis. See
Mayaud col. 10 ll. 20–27. There is no suggestion that
patients may use the codes to access their own infor-
mation through the system. Indeed, other portions of
Mayaud explain that user access to system workstations
is password-protected, and there is no mention of patients
receiving passwords. See id. col. 10 ll. 32–43.
     In sum, the Board’s finding that Mayaud anticipates
the patient access limitation of claims 9–18 lacks substan-
tial evidence. We therefore need not address Mr. Karpf’s
argument that the Board raised a new ground of rejection
in its rehearing decision by pointing to Figure 16 in
Mayaud for the first time.
10                                             IN RE: KARPF

     With respect to claims 23–25, the Examiner’s rejec-
tion did not clearly specify any particular grounds for
rejecting claim 23 beyond the “same reason” for rejecting
claim 9. The Board also did not identify any grounds of
rejection specific to claim 23. While the patient access
limitation of claim 9 is not expressly recited in claim 23,
Mr. Karpf argued before the Board that the “patient
password” limitation of claim 23 implicitly requires pa-
tient access. The Board, however, did not address Mr.
Karpf’s argument and treated the grounds of rejection for
claim 9 as if they applied equally to claim 23. Because
the record is not clear regarding the grounds on which the
Board relied to reject claim 23, we vacate the rejection of
claims 23–25 and remand for the Board to consider in the
first instance whether Mayaud’s failure to disclose patient
access is relevant to the anticipation of those claims. 4
                       CONCLUSION
    The Board’s finding that Mayaud discloses an EMR
system that patients can use to access their own infor-
mation is unsupported by substantial evidence.
             VACATED AND REMANDED

     4  See Getcher v. Davidson, 116 F.3d 1454, 1459
(Fed. Cir. 1997) (remanding to the Board for lack of a
claim construction analysis as well as conclusory anticipa-
tion findings).