Ex Parte MOSKAL

Patent Trial and Appeal Board

Jan 17, 2019

14079213 (P.T.A.B. Jan. 17, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/079,213 11/13/2013 WITOLD MOSKAL
112722 7590 01/17/2019
Becker Patent Law, LLC
5424 W. Princeton Pines Ct.
Franklin, WI 53132
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
F-6680 9908
EXAMINER
MORGAN, ROBERT W
ART UNIT PAPER NUMBER
3626
MAIL DATE DELIVERY MODE
01/17/2019 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WITOLD MOSKAL
Appeal 2017-010441 1
Application 14/079 ,213 2
Technology Center 3600
Before NINA L. MEDLOCK, PHILIP J. HOFFMANN, and,
CYNTHIA L. MURPHY Administrative Patent Judges.
MEDLOCK, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's final
rejection of claims 1-13 and 15-21. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We AFFIRM-IN-PART.
1 Our decision references Appellant's Appeal Brief ("App. Br.," filed
February 16, 2017) and Reply Brief ("Reply Br.," filed July 31, 2017), and
the Examiner's Answer ("Ans.," mailed May 31, 2017) and Final Office
Action ("Final Act.," mailed September 21, 2016).
2 Appellant identifies Fenwal, Inc. as the real party in interest. App. Br. 1.
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CLAIMED INVENTION
Appellant's claimed invention "relates generally to the storage of
medical records with electronic signatures" (Spec. ,r 1 ).
Claims 1, 12, and 1 7 are the independent claims on appeal. Claim 1,
reproduced below, is illustrative of the claimed subject matter:
1. A server computer for storing an electronic medical
record with an electronic signature in a database, comprising:
a network interface circuit configured to provide
communications over a network; and
a processing circuit configured to:
receive an electronic medical record from a second
computing device, wherein the electronic medical record
comprises yield data from a procedure performed on a patient;
store the electronic medical record in the database in
compliance with at least one record storage criterion;
after storing the electronic medical record in the database
in compliance with the at least one record storage criterion,
receive an electronic signature for the electronic medical record,
wherein the electronic signature indicates approval of data in the
electronic medical record; and
store the electronic signature in association with the
electronic medical record in the database.
REJECTIONS 3
Claims 1-13, 15-17, 19, and 20 are rejected under 35 U.S.C. § 103 as
unpatentable over Romans (US 7,983,930 Bl, iss. July 19, 2011) and
Bisbee et al. (US 2012/0086971 Al, pub. Apr. 12, 2012) ("Bisbee").
Claim 18 is rejected under 35 U.S.C. § 103 as being unpatentable over
Romans, Bisbee, and Kaboff et al. (US 2010/0198608 Al, pub. Aug. 5,
2010) ("Kaboff').
3 The rejection of claims 1-13 and 15-21 under 35 U.S.C. § 101 has been
withdrawn (Ans. 2-3).
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Claim 21 is rejected under 35 U.S.C. § 103 as unpatentable over
Romans, Bisbee, and Case et al. (US 2013/0190674 Al, pub. July 25, 2013)
("Case").
ANALYSIS
In addressing Appellant's arguments, we treat the claims in the order
set forth in Appellant's Appeal Brief.
Dependent Claim 21
Claim 21 depends from independent claim 1, and recites that the
server computer of claim 1 further comprises:
the second computing device, wherein the second computing
device is an apheresis machine configured to perform an
apheresis procedure on a patient, 4 wherein the electronic medical
record comprises data regarding an apheresis procedure
performed on a patient, wherein the electronic medical record is
unsigned and received from an embedded computing device
within the second computing device,
wherein the electronic signature for the electronic medical record
is received from a third computing device over the network,
wherein the electronic signature comprises at least one
credential,
wherein the third computing device is a general-purpose
computing device, wherein the second computing device and
third computing device are distinct computing devices each
having their own housing.
Referring to claim 21, Appellant asserts that, in accordance with the claimed
invention, an electronic medical record comprising yield data from a patient
is stored in a database in compliance with a record storage criterion, and that
4 Appellant explains that "[a]n apheresis device removes a patient's (e.g.,
donor's) blood, separates out constituents of the blood, and may return
certain constituents of the blood to the patient" (App. Br. 3).
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"[t]he electronic medical record is not signed when it is stored" (App. Br. 3-
4; see also id. at 4 ("Only after the medical record with yield data is ...
stored in the database, an electronic signature for the medical record is
transmitted ... from a different computing device.")). Appellant, thus,
argues that the rejection of claim 21 cannot be sustained because Bisbee's
electronic record is already signed when it is stored (id. at 4--5).
Appellant's argument is not persuasive at least because the Examiner
relies on Romans, not Bisbee, as disclosing storage of an unsigned electronic
record (see Ans. 3). The Examiner explains that one of test units 15A---C, as
disclosed in Romans, is interpreted as the claimed "second computing
device" ("substituting one of the test units 15A---C with old and well known
apheresis machine as disclosed by Case") (id.). And the Examiner notes
that Romans discloses that intermediate server 25 receives data from the test
units, i.e., an unsigned electronic record, for holding and further processing,
e.g., a diagnostician's interpretation and signature (id. ( citing Romans,
col. 4, 11. 8---67; Figs. 15A and 15B)).
We also are not persuaded of Examiner error by Appellant's argument
that "[ e ]ven if Romans and Bisbee were combinable, the combination would
not result in the recitations in Claim 21 identified by the Office Action"
(App. Br. 5). Appellant notes that the Examiner takes the position in the
Final Office Action that Romans teaches storing the medical record in a
database, i.e., intermediate server 15 (id.). And Appellant argues that the
signed medical record in Romans is never sent to the intermediate server,
i.e., the electronic signature is not stored, in association with the electronic
medical record, in the database, as called for in claim 21 (id.). Instead,
according to Appellant, the signed medical record in Roman is sent from the
diagnostician to the test unit, e.g., test unit 15A (id. at 5-6 (citing Romans,
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col. 6, 11. 1-3; Fig. 1)). Appellant, thus, maintains that, even ifBisbee's
teaching (i.e., that a trusted repository system ("TRS") server allows secure
signing without relinquishing control of the document) were combined with
Romans, as proposed by the Examiner, "intermediate server 25 of Romans
would be the TRS server ( according to the Examiner) and it would never
receive any electronically signed document" (id. at 6). Appellant further
maintains that even if Romans were modified to have intermediate server 25
receive "the electronically signed analysis of Romans" (which Appellant
interprets as the diagnostician's analysis of the test data (e.g., at diagnosis
center 35A in Fig. 1 ), rather than the test data itself), this analysis was not
stored at intermediate server 25 before receiving the electronic signature for
the analysis (id.).
During prosecution, the USPTO gives claims their "broadest
reasonable interpretation consistent with the specification." In re Hyatt,
211 F.3d 1367, 1372 (Fed. Cir. 2000). TheExaminerproposeshereto
modify Romans to arrive at the claimed invention, as recited in claim 21, by
( 1) replacing the process of transmitting a patient record, including test data,
to a diagnostician computer (elements 35A---C in Figure 1 of Romans), as
disclosed in Romans, with the process of receiving an electronic signature
for an electronic record while retaining the record in the database and storing
the electronic signature in the database in association with the electronic
record, as disclosed in Bisbee (Ans. 5---6 (citing Bisbee ,r,r 26, 48-50)); and
(2) replacing the test unit in Romans, i.e., the claimed second computing
device, with an apheresis machine configured to perform an apheresis
procedure on a patient, as disclosed in Case (id. at 7 (citing Case ,r,r 23-27)).
Although Appellant suggests otherwise, the Examiner's rejection, as we
understand it, does not involve replacing Romans's intermediate server 25
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with Bisbee's TRS (see App. Br. 6; Reply Br. 4). Instead, the Examiner
proposes obtaining an electronic signature for the electronic medical record,
i.e., the signature from the diagnostician, while retaining the test data in
Roman's intermediate server 25.
Independent claim 1, and therefore, dependent claim 21, calls for
"receiv[ing] an electronic signature for the electronic medical record,
wherein the electronic signature indicates approval of data in the electronic
medical record." Although we note Appellant's argument that the
diagnostician can only sign off on his own analysis, and cannot sign off on
test data (App. Br. 6), in our view, receiving an electronic signature from a
diagnostician who interprets the electronic medical record, i.e., the test data,
and prepares a diagnosis based on the electronic medical record, as disclosed
in Romans, meets the claim language, i.e., the above-cited receiving step,
under a broad, but reasonable, interpretation.
Therefore, we sustain the Examiner's rejection of dependent claim 21
under 35 U.S.C. § 103.
Independent Claim 1 and Dependent Claims 2-7
Appellant argues that the Examiner erred in rejecting claims 1-7 by
reference to Appellant's arguments with respect to claim 21, which we
found unpersuasive. Therefore, we sustain the Examiner's rejection of
claims 1-7 under 35 U.S.C. § 103.
Dependent Claim 8
Claim 8 depends from independent claim 1, which recites that "the
electronic medical record comprises yield data from a procedure performed
on a patient." Claim 8 further requires that "the electronic medical record
comprises data regarding an apheresis procedure performed on a patient."
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We are not persuaded that the Examiner erred in rejecting claim 8 under
35 U.S.C. § 103 at least because the feature that Appellant maintains is not
disclosed or suggested by the cited references, i.e., that the electronic
medical record comprises data regarding "an apheresis procedure"
performed on a patient, does not alter or in any way affect the manner in
which the claimed method is performed. As such, it constitutes
nonfunctional descriptive material that may not be relied on to distinguish
over the prior art for purposes of patentability.
The Federal Circuit has long held that where a limitation claims
printed matter that is not functionally or structurally related to its physical
substrate, the printed matter may not be relied on to distinguish over the
prior art for purposes ofpatentability. In re Gulack, 703 F.2d 1381, 1385
(Fed. Cir. 1983) (when descriptive material is not functionally related to the
substrate, the descriptive material will not distinguish the invention from the
prior art in terms of patentability). In applying the printed matter doctrine,
the first step is to determine whether the limitation is, in fact, directed to
printed matter, i.e., whether the limitation claims the content of information.
See In re Distefano, 808 F.3d 845, 848 (Fed. Cir. 2015). If so, "one must
then determine if the matter is functionally or structurally related to the
associated physical substrate, and only if the answer is 'no' is the printed
matter owed no patentable weight." Id. at 851. See also King Pharms Inc.
v. Eon Labs, Inc., 616 F.3d 1267, 1278-79 (Fed. Cir. 2010) (applying the
"printed matter" reasoning to method claims).
Here, claim 8 claims the informational content of the electronic
medical record, and as such, is directed to printed matter. The relevant
inquiry then is whether the recitation that the electronic medical record
comprises "data regarding an apheresis procedure performed on a patient"
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has a "new and unobvious functional relationship" with the method. Id.
at 1279. In other words, we look to whether the medical-procedure-specific
content of "the data from a procedure performed on a patient" changes the
way the steps of independent claim 1 are performed.
There is no objective evidence of record that the fact that the
electronic medical record comprises data regarding an apheresis procedure
performed on a patient, as opposed to another medical procedure performed
on the patient, affects the function of the claimed method in any way.
Regardless of the medical-procedure-specific nature of the data in the
electronic medical record, the steps of the claimed method (e.g., the
receiving and storing steps) are still performed the same way, and the
underlying method is the same. As such, the argued limitation, i.e., that the
electronic medical record comprises data regarding "an apheresis procedure"
performed on a patient, constitutes non-functional descriptive material that
may not be relied on for patentability. See In re Ngai, 367 F.3d 1336, 1339
(Fed. Cir. 2004).
Therefore, we sustain the Examiner's rejection of dependent claim 8
under 35 U.S.C. § 103.
Dependent Claim 9
Claim 9 depends from independent claim 1, and recites that "the
electronic medical record is received from an embedded processor of a
medical device, wherein the medical device is configured to perform a
medical procedure on a patient." Appellant's argument with respect to
claim 9 is substantially similar to Appellant's argument with respect to
claim 21, and is similarly unpersuasive. Therefore, we sustain the
Examiner's rejection of dependent claim 9 under 35 U.S.C. § 103.
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Dependent Claim 10
Claim 10 depends from independent claim 1, and recites that "the
processing circuit is configured to receive medical records from at least two
different care areas within an environment." We agree with the Examiner
that Romans meets the claim language (Final Act. 12 ( citing Romans, col. 3,
11. 35-67)). To the extent that Appellant argues that Romans does not
disclose that medical records are received from care areas such as "an
intensive care unit, a primary care unit, a clinic, etc.," as described in
paragraph 18 of Appellant's Specification (App. Br. 9), we note that
limitations appearing in the specification are not read into the claim.
See E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369 (Fed. Cir.
2003).
We sustain the Examiner's rejection of dependent claim 10 under
35 U.S.C. § 103.
Dependent Claim 11
Claim 11 depends from independent claim 1, and recites that
"processing circuit is configured to, after storing the electronic medical
record in the database in compliance with the at least one record storage
criterion, transmit a notification that causes a remote computing device to
request credentials for the electronic signature." The Examiner cites
Romans at column 4, lines 45---67 and column 5, lines 50-67, as disclosing
the claim limitation (Final Act. 12). There, Romans discloses that the
intermediate computer transmits the electronic record containing the test
data to a diagnosis center for interpretation/analysis by a diagnostician.
Romans further discloses, as the Examiner notes with respect to claim 21,
that the diagnosticians are provided with computers that are equipped with
signature recorders that are capable of biometric recognition.
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In our view, Romans meets the claim language under a broad, but
reasonable, interpretation. Therefore, we sustain the Examiner's rejection of
dependent claim 11 under 35 U.S.C. § 103.
Independent Claim 12 and Dependent Claims 13, 15, and 16
Appellant's arguments with respect to claims 12, 13, 15, and 16 are
substantially similar to Appellant's arguments with respect to claim 21,
which we found unpersuasive. Therefore, we sustain the Examiner's
rejection of claims 12, 13, 15, and 16 under 35 U.S.C. § 103.
Independent Claim 17 and Dependent Claims 18 and 20
Independent claim 1 7 is directed to a server computer for storing an
electronic medical record with an electronic signature in a database and
recites that the server computer comprises a processing circuit configured to,
inter alia, "generate a user interface screen configured to receive an
electronic signature for the medical record" and "transmit the user interface
screen to the medical device over the network." The Examiner
acknowledges that Romans does not specifically disclose this limitation, and
the Examiner cites Bisbee to cure the deficiency of Romans (Final Act. 18).
The Examiner reasons that "Bisbee teaches it is old and well known [to]
transmit the user interface screen to the medical device over the network;
receive an electronic signature entered using the user interface screen" (id.
( citing Bisbee ,r,r 3 8--45) ). And the Examiner concludes that it would have
been obvious to a person of ordinary skill in the art at the time of
Appellant's invention to modify Romans to include transmitting the user
interface screen to the medical device over the network and receiving an
electronic signature entered using the user interface screen because "it will
allow securely signing stored electronic original information objects without
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the trusted repository system (TRS) ever relinquishing control of the
authoritative copy of the electronic original information object or document"
and further because "merely combining well known elements in the prior art
with predictable results does not render an invention patentably distinct over
such combination" (id. at 18-19).
Appellant maintains that neither Romans nor Bisbee, alone or in
combination, discloses or suggests modifying a medical device to receive a
user interface screen from a server computer for receiving an electronic
signature (App. Br. 11 ). Appellant, thus, observes if the
sphygmomanometer, i.e., a medical device, of Romans were modified to
receive an electronic signature user interface, the interface would be at the
practitioner's location 15A (see Romans, Fig. 1), not at the diagnostician's
location 35A, i.e., where the analysis is signed (id.).
Appellant's argument is persuasive. Accordingly, we do not sustain
the Examiner's rejection under 35 U.S.C. § 103 of independent claim 17.
For the same reason, we also do not sustain the rejection of claims 18
and 20, which depend therefrom. Cf In re Fritch, 972 F.2d 1260, 1266
(Fed. Cir. 1992) ("dependent claims are nonobvious if the independent
claims from which they depend are nonobvious").
Dependent Claim 19
Claim 19 depends from independent claim 17, and recites that "the
processing circuit is configured to transmit the user interface screen to an
apheresis machine." We do not sustain the Examiner's rejection under
35 U.S.C. § 103 of independent claim 17; therefore, we also do not sustain
the rejection of dependent claim 19. Cf In re Fritch, 972 F.2d at 1266.
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DECISION
The Examiner's rejections of claims 1-13, 15, 16, and 21 under
35 U.S.C. § 103 are affirmed.
The Examiner's rejections of claims 17-20 under 35 U.S.C. § 103 are
reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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