Court Opinion

ID: 4362987
Source: CourtListenerOpinion
Date Created: 2019-01-30 16:00:43.251019+00
Date Added: 2024-06-11T14:48:43.818599
License: Public Domain

NOTE: This disposition is nonprecedential.

  United States Court of Appeals
      for the Federal Circuit
                ______________________

             IN RE: RONALD S. KARPF,
                       Appellant
                ______________________

                      2018-2090
                ______________________

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

               Decided: January 30, 2019
                ______________________

   RONALD S. KARPF, Corvallis, OR, pro se.

   THOMAS W. KRAUSE, Office of the Solicitor, United
States Patent and Trademark Office, Alexandria, VA, for
appellee Andrei Iancu. Also represented by MONICA
BARNES LATEEF, JOSEPH MATAL, MEREDITH HOPE
SCHOENFELD.
                ______________________

  Before LOURIE, O’MALLEY, and REYNA, Circuit Judges.
LOURIE, Circuit Judge.
    Ronald S. Karpf (“Karpf”) appeals from a decision of
the Patent Trial and Appeal Board (“the Board”) affirming
the rejection in the U.S. Patent and Trademark Office
(“the PTO”) of pending claims 23 and 25 of U.S. Patent
2                                              IN RE: KARPF

Application 11/645,067 (“the ’067 application”) as obvious
over U.S. Patent 5,845,255 (“Mayaud”) in view of U.S.
Patent 6,270,456 (“Iliff”). Because the Board’s decision
was supported by substantial evidence, we affirm.
                     I.   BACKGROUND
                 A. The ’067 application
    The ’067 application discloses an electronic medical
records (“EMR”) system accessible to a patient, so that the
patient may review his or her records, including the
treatment instructions that have been provided to the
patient by the medical practitioner. In addition, the
disclosed EMR system may determine the patient’s com-
pliance with a treatment regimen and send compliance
reminders to non-compliant patients as needed.
    In order to give patients control over the identity of
individuals who may access their records in the EMR
system, the ’067 application discloses giving them two
passwords: (1) a patient password that each patient uses
to log in to the system; and (2) a patient PIN that the
patient can share with healthcare providers to provide
them with access to the patient’s records.
   At issue in this appeal are claims 23 and 25.      Inde-
pendent claim 23 recites:
    23. An article of manufacture comprising at least
    one non-transitory machine-readable storage me-
    dium having stored therein indicia of a plurality
    of machine executable control program steps, the
    control program comprising the steps of:
    a) storing patient data, including patient identifi-
    cation 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
IN RE: KARPF                                               3

   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.
   d) storing treatment information for at least one
   medical encounter of a given patient
   e) determining compliance by the given patient
   with the treatment information stored in said
   storing step (d) for a given medical encounter; and
   f) issuing a notification based on a determination
   of non-compliance in said determining step (e).
SAppx4. Claim 25 depends from claim 23 and is further
limited to:
   25. The article of manufacture as recited in claim
   23, wherein:
   said storing step (b) includes storing data regard-
   ing: a medical encounter in the form of a doctor’s
   office visit, medical personnel in the form of a doc-
   tor who examined the patient during the office
   visit, and a patient complaint as a reason for the
   office visit;
   the treatment information in said storing step (d)
   includes medication regimen issued by the doctor
   who examined the given patient during a given of-
   fice visit; and
   said issuing step (f) includes issuing a notification
   in the form of a reminder message sent to the giv-
4                                               IN RE: KARPF

    en patient to comply with the medication regimen
    issued by the doctor.
SAppx17–18.
                        B. Prior Art
     Mayaud, the primary reference relied upon to reject
the instant application, discloses an electronic prescrip-
tion management system, where prescribers can access
patient information through desktop computers or mobile
devices. Mayaud col. 7 ll. 57–67. The system stores
patient data, id. col. 1 ll. 46–51, and identification infor-
mation, id. col. 17 ll. 44–53. It also teaches securing the
patient’s information by use of a password or an access
code, which may be provided directly by the patient. Id.
col. 10 ll. 12–27. The stored information may comprise
medical encounter data, id. col. 13 l. 31–col. 15 l. 6, in-
cluding diagnosis, id. col. 14 ll. 38–55, and the reason for
the medical encounter, id. col. 13 l. 45. The data stored
may be medical condition data or treatment information,
including prescriptions. Id. col. 5 ll. 9–12. Mayaud
further discloses electronically readable dosing indicator
devices that detect when medications have not been taken
and issue audible or visual notifications to patients ac-
cordingly. Id. col. 30 ll. 10–56.
     Iliff discloses a computerized medical diagnostic sys-
tem that allows patients to perform an examination on
themselves and then consult the system to refine their
diagnosis. Iliff col. 1 l. 63–col. 2 l. 10. Patients gain
access to this system by entering a PIN or password. Id.
col. 21 ll. 24–31. The examiner further relied on Iliff as
disclosing a patient password.
                  C. Procedural History
   Karpf, along with his late co-inventor, Dr. Arthur B.
White, filed the instant application on December 26,
2006. During prosecution, the examiner rejected then-
pending claims, including previous versions of the instant
IN RE: KARPF                                              5

claims, as anticipated by Mayaud. Karpf argued before
the Board that Mayaud does not disclose a system to
which a patient has access or a patient password which
allows a patient to gain access to the system, but only a
patient-held password or access code that a patient can
disclose to a medical professional to use. Nonetheless, the
Board affirmed the rejection, Ex parte Ronald S. Karpf &
Arthur B. White, No. 2010-9172, 2013 WL 1225722
(P.T.A.B. Mar. 18, 2013), and Karpf appealed to this
court.
    We vacated the Board’s decision and remanded for
further proceedings. In re Karpf, 576 F. App’x 968 (Fed.
Cir. 2014). With respect to claims 23 and 25, we noted
that neither the examiner nor the Board ever offered a
ground of rejection specific to these claims. Id. at 972–
73. We held that, while the claims do not expressly
require that a patient be able to access his or her own
records, the Board erred by failing to clearly address
Karpf’s argument that the patient password limitation
inherently requires patient access. Id.
     The Board in turn remanded to the examiner to reo-
pen prosecution. The examiner rejected claims 23 and 25
as obvious over Mayaud in view of Iliff. In the examiner’s
view, Mayaud discloses all the limitations of claims 23
and 25 except a patient password, which is disclosed in
Iliff. The examiner concluded that, since Mayaud and Iliff
concern the same field of endeavor, treatment manage-
ment programs, an ordinary artisan would have had
reason to integrate the patient password of Iliff into
Mayaud’s system, and therefore rejected claims 23 and 25
as obvious.
    Karpf appealed the rejection of claims 23 and 25 to
the Board. He argued that Mayaud’s dosing indicator
device does not disclose the claimed feature of a control
program that determines patient compliance with a
treatment regimen and sends reminders to the patient
6                                               IN RE: KARPF

because the claims require that the control program
perform this function, not a standalone device. Karpf
further contended that the rejection was in error because
the examiner failed to explain the motivation to combine
Mayaud with Iliff and because Mayaud does not disclose
patient access to its EMR system.
    The Board affirmed. Ex parte Ronald S. Karpf & Ar-
thur B. White, No. 2016-5324, 2018 WL 1773794 (P.T.A.B.
Mar. 30, 2018) (“Board Decision”). It found that the alerts
issued by Mayaud’s dosing indicator device met the com-
pliance and reminder limitations. Id. at *6. The Board
further concluded that an ordinary artisan would have
had reason to combine Mayaud with Iliff because both are
from the same field of endeavor and because Mayaud
discloses limited patient access to the EMR system in the
form of a patient interface at medical facilities. Id. at *6–
7; Mayaud col. 46 ll. 41–49.
    Karpf timely appealed to this court. We have jurisdic-
tion pursuant to 28 U.S.C. § 1295(a)(4)(A).
                      II. DISCUSSION
     We review the Board’s legal determinations de novo,
In re Elsner, 381 F.3d 1125, 1127 (Fed. Cir. 2004), but we
review the Board’s factual findings underlying those
determinations for substantial evidence, In re Gartside,
203 F.3d 1305, 1316 (Fed. Cir. 2000). A finding is sup-
ported by substantial evidence if a reasonable mind might
accept the evidence as adequate to support the find-
ing. Consol. Edison Co. v. NLRB, 305 U.S. 197, 229
(1938). The ultimate judgment of obviousness is a legal
conclusion, KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
427 (2007), but it is premised on underlying findings of
fact, Bristol-Myers Squibb Co. v. Teva Pharm. USA, Inc.,
752 F.3d 967, 972 (Fed. Cir. 2014). The Supreme Court
has held that “a patent composed of several elements is
not proved obvious merely by demonstrating that each of
its elements was, independently, known in the prior art,”
IN RE: KARPF                                              7

but “[t]he combination of familiar elements according to
known methods is likely to be obvious when it does no
more than yield predictable results.” KSR, 550 U.S. at
416–18.
    On appeal, Karpf argues that Mayaud’s system does
not teach a patient’s access to his own records stored in
the system. Second, Karpf contends that Mayaud’s sys-
tem does not teach sending non-compliance notifications
directly to patients. Instead, Karpf asserts that Mayaud’s
system only notifies physicians of patient noncompliance,
and the physicians in turn must notify the patients them-
selves; he further distinguishes Mayaud’s dosing indicator
devices as not meeting the limitation of a “control pro-
gram.” Karpf also argues that there is no motivation to
add Iliff’s patient password feature to Mayaud because
Mayaud’s system only concerns prescriptions, and to give
patients access to the system through the patient pass-
word would lead to patients prescribing themselves
medication or viewing other patients’ confidential infor-
mation. Finally, Karpf argues that there was a long-felt,
unmet need for better patient compliance with prescribed
treatment regimens which weighs against finding obvi-
ousness of the claimed methods.
    The PTO responds that the claims at issue, unlike
previous claims, do not require patient access to the
system. The PTO further argues that Mayaud’s system
discloses the limitation of sending a patient a notice of
non-compliance, including as a message, through the
audio or visual alerts sent by the dosing indicator device.
Finally, the PTO argues that the Board properly found
that a person of skill would have had reason to modify
Mayaud’s system by adding a patient password as dis-
closed in Iliff to support a patient’s access to his own
records. The PTO does not respond to Karpf’s argument
on the long-felt, unmet need for better patient compliance
with treatment regimens.
8                                              IN RE: KARPF

     We agree with the PTO that the rejected claims would
have been obvious at the time the invention was
made. 1 While Karpf points to our previous opinion for the
proposition that Mayaud does not teach patient access or
use of a patient password, claims 23 and 25 at issue here
do not require that a patient have direct access to his or
her own medical records. In addition, Mayaud does
disclose a patient-held access code or password, id. col. 10
ll. 11–27, as the claims do require, and the Board further
found that an ordinary artisan would have had reason to
modify Mayaud’s system to allow patients to use the
password, as disclosed in Iliff. Board Decision, 2018 WL
1773794, at *6–7.
    We also conclude that substantial evidence supports
the Board’s finding that Mayaud discloses a system that
sends reminder messages to non-compliant pa-
tients. Karpf asserts that Mayaud does not disclose a
“control program determin[ing] compliance and issu[ing]
reminder messages.” But the Board found that Mayaud’s
EMR system can print out a patient’s medication regi-
men, Board Decision, 2018 WL 1773794, at *6–7, which
can be inserted into an electronic pill container that
issues “audio or visual” alerts when the patient has not
complied with the medication regimen. Mayaud col. 28 ll.
50–62, col. 30 ll. 11–16. We note that the claimed pro-
gram requires “at least one non-transitory machine read-
able storage medium” (emphasis added), so we find
Karpf’s argument that the claims exclude an electronic
pill container from performing the reminder function

    1   The ’067 application was filed in 2006, so pre-AIA
§ 103 applies. See Leahy–Smith America Invents Act,
Pub. L. No. 112–29, sec. 3(c), 125 Stat. 284 at 293 (2011)
(explaining that the pre-AIA version of the Patent Act
generally applies to patents with effective filing dates
before March 16, 2013).
IN RE: KARPF                                                   9

unpersuasive. Cf. In re Yamamoto, 740 F.2d 1569, 1571
(Fed. Cir. 1984) (“The PTO broadly interprets claims
during examination of a patent application since the
applicant may amend his claims to obtain protection
commensurate with his actual contribution to the art.”)
(citation omitted).
    Karpf argues that an ordinary artisan would not have
combined Mayaud with Iliff because Mayaud’s system
manages prescriptions, and allowing patients to have
access to that system could result in patients self-
prescribing or viewing other patients’ information. How-
ever, we agree with the PTO that, because Mayaud dis-
closes tailoring access to different professionals (including
non-prescribers), id. col. 10 ll. 11–19, col. 18 ll. 53–57, this
concern is misplaced. We hold that substantial evidence
supports the Board’s conclusion that an ordinary artisan
would have combined Iliff’s patient password functionali-
ty with Mayaud.
    Finally, we conclude that Karpf’s claim of a long-felt,
unmet need for improved patient compliance technology
does not render claims 23 and 25 nonobvious. Karpf
provides extensive documentation showing that patient
non-compliance is a prevalent and costly issue. However,
he does not provide evidence, other than attorney argu-
ment, that the claimed invention meets that need. See In
re Huai-Hung Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011)
(“For objective evidence of secondary considerations to be
accorded substantial weight, its proponent must establish
a nexus between the evidence and the merits of the
claimed invention.”) (citation omitted). Thus, we conclude
that the nexus between the claimed invention and the
purported long-felt, unmet need is too attenuated to
provide a persuasive rationale for nonobviousness.
                      III. CONCLUSION
    We have considered Karpf’s other arguments but do
not find them persuasive. We conclude that substantial
10                                         IN RE: KARPF

evidence supports the Board’s conclusion that claims 23
and 25 properly stand rejected as obvious. We therefore
affirm.
                     AFFIRMED