Bearss, Mark

Patent Trials and Appeals Board

Feb 4, 2020

14049453 - (D) (P.T.A.B. Feb. 4, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/049,453 10/09/2013 Mark Bearss C00005809.USU1 9317
28390 7590 02/04/2020
MEDTRONIC VASCULAR, INC.
IP LEGAL DEPARTMENT
3576 UNOCAL PLACE
SANTA ROSA, CA 95403
EXAMINER
WIEST, PHILIP R
ART UNIT PAPER NUMBER
3781
NOTIFICATION DATE DELIVERY MODE
02/04/2020 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
rs.patents.five@medtronic.com
rs.vasciplegal@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARK BEARSS
Appeal 2019-003312
Application 14/049,453
Technology Center 3700
Before LINDA E. HORNER, JILL D. HILL, and LEE L. STEPINA,
Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–11, 13–16, and 18–23.2 We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Medtronic Vascular,
Inc. Appeal Br. 2.
2 Claims 12 and 17 have been cancelled. Appeal Br. 22 (Claims App.).
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CLAIMED SUBJECT MATTER
The claims are directed to methods for managing patient blood fluid
volume and hematocrit. Spec. ¶ 1.
Claim 1, reproduced below with emphasis added, is illustrative of the
claimed subject matter.
1. A computer-implemented method comprising:
receiving input regarding weight of a patient;
receiving input regarding hematocrit of blood of the
patient;
setting a low hematocrit limit for the patient;
calculating, based on the input regarding the weight of the
patient, the input regarding the hematocrit of the blood of the
patient, and the low hematocrit limit, a maximum volume of
hematocrit-free fluid that the patient can receive into a blood
compartment of the patient until the low hematocrit limit is
reached; and
displaying the maximum volume of hematocrit-free fluid
for a user to avoid.
Appeal Br. 20 (Claims App.).
REFERENCE
The prior art relied upon by the Examiner is:
Name Reference Date
Janssenswillen US 2013/0094996 A1 Apr. 18, 2013

REJECTIONS
I. Claims 1 and 16 are rejected under 35 U.S.C. § 112(a) as failing
to comply with the written description requirement.
II. Claims 1 and 16 are rejected under 35 U.S.C. § 112(b) as
indefinite.
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III. Claims 1–11, 13–16, and 18–23 are rejected under 35 U.S.C.
§ 103 as unpatentable over Janssenswillen.

OPINION
Rejection I–Written Description
Appellant argues for the patentability of the claims subject to the first
ground of rejection, i.e., claims 1 and 16, as a group. See Appeal Br. 9. We
select claim 1 as representative of the group, and claim 16 stands or falls
with claim 1.
The Examiner determines that the step of “displaying the maximum
volume of hematocrit-free fluid for a user to avoid” in claim 1 is not
supported by the original disclosure. See Final Act. 4–5. The Examiner
finds that instead of providing written description for this limitation, “the
[S]pecification repeatedly states that the system displays the amount of fluid
that can be added to avoid reaching, or to just reach but not fall below, the
threshold level.” Id. (citing Spec. ¶¶ 7, 21, 29, 34, 38, 47). In other words,
the Examiner finds that the Specification discloses displaying an amount of
fluid that would be acceptable to add rather than an amount that would not
be acceptable.
Appellant’s Summary of the Claimed Subject Matter in the Appeal
Brief indicates that paragraphs 7, 21, 31, 34, and 73 and Figure 2 satisfy the
written description requirement for the limitation at issue in claim 1. Appeal
Br. 4–5. In the Argument portion of the Appeal Brief, Appellant asserts that,
in particular, paragraphs 31, 34, and 73 of the Specification support this
limitation. Id. at 8–9.
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In response, the Examiner reiterates the rejection and explains, “[t]he
specification does not describe the step of displaying a maximum volume of
hematocrit-free fluid for a user to avoid, which is the language required by
the claims.” Ans. 12.
In reply, Appellant contends that, contrary to the proper standard for
satisfying the written description requirement, the Examiner is requiring
literal support in the Specification. See Reply Br. 3 (citing Eiselstein v.
Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995); Lockwood v. American Airlines,
Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Appellant contends that the
Specification provides “equivalent description” for the recitation at issue in
paragraphs 31, 34, and 73. Id. at 4.
We agree with the Examiner’s analysis. Paragraph 31 of the
Specification states, in part, “[t]he FVL[3] is the volume of hematocrit-free
fluid that may be added to the CPB circuit, which includes the PVB, the
pump prime volume, and the IV volume, to avoid reaching, or to just reach
but not fall below, the user-defined hematocrit low limit.” Thus, as the
Examiner determines (see Final Act. 4–5), the Specification describes an
amount of fluid that is permitted to be added to the system without crossing
the hematocrit low limit, i.e., an amount of fluid that may be added without
causing the hematocrit level to drop below a user-defined threshold.
Similarly, paragraph 34 of the Specification states, “[b]y displaying the
FVL, a healthcare provider such as a member of the surgical or post-surgical
team will know how much RBC-free fluid can be introduced into the
patient’s blood compartment to avoid reaching, or to just reach but not fall

3 FVL = “fluid volume limit.” Spec. ¶ 31.
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below, the user defined low hematocrit limit.” Paragraph 73 states, “[t]he
method includes determining the maximum amount of a fluid that can be
added to avoid reaching, or to just reach but not fall below, the low limit
hematocrit; e.g., as depicted in and described above with regard to FIG. 5.”4
Emphasis omitted. A person of ordinary skill in the art would understand
these portions of the Specification to indicate that the displayed fluid volume
limit (FVL) is permissive in nature, i.e., it is what can be added to the fluid
circuit, not something that is to be avoided, as recited in the final portion of
claim 1.
Contrary to Appellant’s argument, displaying a volume of fluid that is
allowed to be added is not the equivalent of displaying a volume of fluid that
should be avoided. This is true even if displaying the allowed volume would
allow a user to determine the volume to avoid. In this regard, we note that
claim 1 requires displaying a particular thing, namely, “the maximum
volume of hematocrit-free fluid for a user to avoid.” This language does not
equate to reciting the display of other information that would be sufficient
for a user to calculate the maximum volume of hematocrit-free fluid for a
user to avoid, as implied by Appellant’s assertions.5 Accordingly,
Appellant’s arguments regarding Rejection I are unavailing, and we sustain

4 The most pertinent portion of Figure 5 is step 135 in the depicted
flowchart, which includes the text “Display amount that can be added.”
5 For example, under certain circumstances, informing a person that the
result of a coin-flip is “heads” may be the equivalent of informing the person
that the result is not “tails.” Nonetheless, displaying the “heads” side of a
coin on a screen is not the same as displaying the “tails” side.
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the rejection of claims 1 and 16 as failing to comply with the written
description requirement.6
Rejection II–Indefiniteness
The Examiner determines that the “displaying” step discussed above
renders claim 1 indefinite because it implies avoiding providing the
hematocrit-free fluid, but “the method also requires that the [hematocrit-
free] fluid is added to the blood.” Final Act. 5.
Appellant asserts that claim 1 specifies that “the maximum volume of
hematocrit-free fluid is displayed for a user to avoid.” Appeal Br. 10.
Appellant contends that the Examiner’s interpretation omits the words
“maximum volume of” in the clause at issue, and that the “plain meaning” of
this clause is that “the user should avoid the maximum volume of hematocrit-
free fluid displayed.” Id. at 11.
Appellant’s argument is persuasive. As discussed above regarding
Rejection I, claim 1 requires displaying the maximum volume of hematocrit-
free fluid for a user to avoid. Contrary to the Examiner’s position, in claim
1, it is this volume of fluid displayed, not the fluid itself, that is “for a user to
avoid.” Accordingly, we do not sustain the rejection of claim 1 as indefinite.
The Examiner rejected claim 16 for reciting language similar to that
discussed above regarding claim 1. Final Act. 5. For the same reasons, we
do not sustain the rejection of claim 16 as indefinite.

6 Neither Appellant nor the Examiner addresses whether the rejection of
independent claims 1 and 16 for failing to comply with the written
description requirement implicates dependent claims 2–11, 13–15, and 18–
23. See Final Act. 4–5; Appeal Br. 7–9.
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Rejection III–Janssenswillen
The Examiner finds that Janssenswillen discloses many of the
elements recited in claim 1, but does not disclose the “displaying” step.
Final Act. 7. In comparing claim 1 to the prior art, the Examiner interprets
this step as requiring that “the system displays the amount of fluid that can
be added to avoid reaching, or to just reach but not fall below, the threshold
level.” Final Act. 5. To address the deficiency in Janssenswillen, the
Examiner finds Janssenswillen discloses a hemodilution target (a low
hematocrit limit for a patient) and a GUI that allows the display of other
pertinent data. Id. at 7–8 (citing Janssenswillen ¶¶ 11–22, 93). The
Examiner then discusses paragraphs 45, 46, and 93 of Janssenswillen and
finds that “[e]ven if Janssenswillen does not explicitly and specifically
require that the hematocrit limit/hemodilution target is displayed on the GUI,
Janssenswillen clearly suggests that the volume of hematocrit-free fluid that
can be received by the patient is an important variable in the procedure.” Id.
at 8. Based on these findings, the Examiner concludes it would have been
obvious “to modify Janssenswillen’s computer-implemented treatment
method to display the volume of hematocrit-free fluid that can be received
by the patient, because doing so would allow the perfusionist to make
informed decisions regarding the amount of hemodilution that can be
tolerated by the patient.” Id. (emphasis added)
Appellant argues Janssenswillen does not disclose a volume of
hematocrit-free fluid that can be received by the patient. Appeal Br. 14.
This argument does not apprise us of Examiner error because the
rejection of claim 1 does not rely on Janssenswillen to explicitly teach this
feature. Final Act. 7–8. Rather, the Examiner determines it would have
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been obvious to modify the method disclosed by Janssenswillen to include
this step. See id. at 8.
Appellant also contends that the Examiner’s reasoning is not
supported by rational underpinnings because Janssenswillen fails to disclose
“allowing a perfusionist to make informed decisions regarding the amount of
hemodilution that can be tolerated by the patient.” Appeal Br. 17–18.
Therefore, according to Appellant, the Examiner’s reason for modifying the
method disclosed by Janssenswillen is based on impermissible hindsight. Id.
at 18.
We disagree with Appellant’s argument on this point because the
Examiner’s reason for modifying the method taught by Janssenswillen does
not rely on Janssenswillen explicitly teaching that a perfusionist makes
decisions regarding the amount of hemodilution that can be tolerated by the
patient. Rather, allowing this action to occur is the benefit that the Examiner
determines would be the result of the proposed modification. See Final Act.
8. The Examiner’s reasoning for the proposed modification is based on
finding that Janssenswillen discloses real-time monitoring of certain
variables to assist the perfusionist and that the volume of hematocrit-free
fluid that can be received by a patient is an important variable in
Janssenswillen’s procedure. See id. We address these findings below.
Janssenswillen discloses that its hematocrit evolution graph generator
monitors the evolution of a patient’s hemodilution throughout the procedure.
See Janssenswillen ¶¶ 45, 108. Paragraph 46 of Janssenswillen indicates
that this graph enables the perfusionist to make “better[-]founded decisions
based on accurate up-to-date information.” Janssenswillen discloses a
priming module able to determine priming constitution, volume, and flow to
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achieve a hemodilution target. See id. ¶ 14; see also id. ¶ 65 (describing that
the invention provides “a real monitor assisting the perfusionist during the
procedure and enabling him to make better founded decisions throughout the
whole procedure”). Accordingly, the Examiner’s findings that
“Janssenswillen teaches that real and theoretically calculated hematocrit
levels are monitored throughout the treatment to enable the perfusionist to
make better decisions based on accurate up-to-date information,” and that
Janssenswillen suggests that the volume of hematocrit-free fluid that can be
received by the patient is an important variable, are supported by a
preponderance of the evidence. These findings provide adequate
underpinnings for the proposed modification to the method of
Janssenswillen.
Appellant also argues that the Examiner does not address the
“displaying” step in claim 1, and, therefore, has not established a prima facie
case of obviousness. Appeal Br. 13–16. In this regard, Appellant quotes the
Examiner’s statement of the result of the proposed modification and
contrasts it to the language in the displaying step, pointing out that what is
displayed is the maximum volume of hematocrit-free fluid for a user to
avoid (rather than what is permitted for a patient to receive). Id. at 13–14.
Appellant’s argument is persuasive. The Examiner’s claim
interpretation does not comport with the plain language in the last line of
claim 1. Specifically, the Examiner’s interpretation of claim 1, set forth on
page 5 of the Final Office Action, does not account for the requirement that
what is displayed in the last step of claim 1 is something that is “for the user
to avoid.” Accordingly, we agree with Appellant that the Examiner has not
set forth a prima facie case of obviousness. Consequently, we do not sustain
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the rejection of claim 1, and claims 2–11, 13–15 depending, therefrom as
unpatentable over Janssenswillen. The Examiner applies the same
unreasonably broad claim interpretation in the rejection of independent
claim 16 as unpatentable over Janssenswillen. See Final Act. 5, 10, 11.
Therefore, for the same reasons, we do not sustain the rejection of claim 16,
and associated dependent claims 18–23, as unpatentable over
Janssenswillen.

CONCLUSION
Rejection I is affirmed, and Rejections II and III are reversed.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 16 112(a) Written
Description
1, 16
1, 16 112(b) Indefiniteness 1, 16
1–11, 13–16,
18–23
103 Janssenswillen 1–11, 13–
16, 18–23
Overall
Outcome
1, 16 2–11, 13–
15, 18–23

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART