Ex Parte ZHANG et al

Patent Trial and Appeal Board

Dec 27, 2018

13397959 (P.T.A.B. Dec. 27, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/397,959 02/16/2012
25889 7590 12/28/2018
COLLARD & ROE, P.C.
1077 NORTHERN BOULEVARD
ROSLYN, NY 11576
FIRST NAMED INVENTOR
Wei ZHANG
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.
ZHANG ET AL - 2 PCT
DIV
CONFIRMATION NO.
9200
EXAMINER
FITZSIMMONS, ALLISON G
ART UNIT PAPER NUMBER
1778
MAIL DATE DELIVERY MODE
12/28/2018 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 WEI ZHANG and ELKE SCHUL TE
Appeal2017-000283
Application 13/397,959
Technology Center 1700
Before LINDA M. GAUDETTE, CHRISTOPHER C. KENNEDY, and
JENNIFER R. GUPTA, Administrative Patent Judges.
GUPTA, Administrative Patent Judge.
DECISION ON APPEAL 1
Appellants2 appeal under 35 U.S.C. § 134(a) from the Examiner's
final decision rejecting claims 1-10. We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM and enter a new ground of rejection.
1 In this Decision, we refer to the Specification filed February 16, 2012
("Spec."), the Final Office Action dated October 26, 2015 ("Final Act."), the
Appeal Brief filed May 20, 2016 ("Appeal Br."), the Examiner's Answer
dated August 9, 2016 ("Ans."), and the Reply Brief filed October 4, 2016
("Reply Br.").
2 Appellants identify the real party in interest as Fresenius Medical Care
Deutschland GmbH. Appeal Br. 1.
Appeal2017-000283
Application 13/397,959
The subject matter of the claims on appeal relates to a dialyzer with a
measuring unit assigned thereto, where the measuring unit transmits data to
the dialyzer wirelessly. Spec. 1, ,r 2.
Claim 1, reproduced below from the Claims Appendix of the Appeal
Brief, is illustrative of the claims on appeal.
1. A method for signalling a possible connection of a
measuring unit to a wrong patient, whereby the measuring unit
is assigned to a dialyzer, whereby data transmission from the
measuring unit to the dialyzer ensues wirelessly, wherein the
method comprises steps of:
commencement of a dialysis procedure performed via the
dialyzer on a patient,
determining during the dialysis procedure a first value of
at least one measurable variable measured by the measuring
unit at a point in time t or in a time window ti,
transmitting to the dialyzer via a wireless link between
the measuring unit and the dialyzer the determined first value of
the at least one measurable variable,
determining a second value of the at least one measurable
variable measured at the same point in time tor in the same
time window ti from the patient and by a measuring device that
is connected physically to the dialyzer, and
evaluating the first value in comparison to the second
value so that a difference between the first value and the second
value is determined,
wherein if the difference is greater than a predetermined
threshold value a warning is given indicating that the possible
connection of the measuring unit to the wrong patient has
occurred.
Appeal Br. 37 (Claims App.).
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REJECTIONS
The Examiner maintains the following rejections on appeal:
Rejection 1: Claims 1-10 under 35 U.S.C. § 112, first paragraph, as
failing to comply with the enablement requirement (Final Act. 2; Ans. 3);
Rejection 2: Claims 1-10 under 35 U.S.C. § 112, second paragraph, as
indefinite (Final Act. 7-8; Ans. 8);
Rejection 3: Claims 1-10 under 35 U.S.C. § 101 as directed to
judicially-excepted subject matter (i.e., an abstract idea) (Final Act. 11;
Ans. 11); and
Rejection 4: Claims 1-10 under 35 U.S.C. § I03(a) as unpatenable
over Spickermann (US 6,736,789 Bl, issued May 18, 2004) in view of
Vosburgh et al. (US 2005/0096557 Al, published May 5, 2005)
("Vosburgh) (Final Act. 16; Ans. 16).
DISCUSSION
Appellants argue the claims as a group with regard to each rejection
above. See Appeal Br. 7-36. We select claim 1 as the representative claim
for this group, and remaining claims 2-10 stand or fall with claim 1. 37
C.F.R. § 4I.37(c)(l)(iv).
Rejection 1
When rejecting a claim for lack of enablement, "the [United States
Patent and Trademark Office] bears an initial burden of setting forth a
reasonable explanation as to why it believes that the scope of protection
provided by that claim is not adequately enabled by the description of the
invention provided in the specification of the application." In re Wright, 999
F.2d 1557, 1561-62 (Fed. Cir. 1993) (citing In re Marzocchi, 439 F.2d 220,
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223-24 (CCP A 1971 )). "[T]o be enabling, the specification of a patent must
teach those skilled in the art how to make and use the full scope of the
claimed invention without 'undue experimentation."' Id. at 15 61. The
"undue experimentation" analysis involves the consideration of such factors
as: (1) the quantity of experimentation; (2) the amount of direction or
guidance presented; (3) the presence or absence of working examples; (4)
the nature of the invention; ( 5) the state of the prior art; ( 6) the relative skill
of those in the art; (7) the predictability or unpredictability of the art; and (8)
the breadth of the claims (the "Wands factors"). In re Wands, 858 F.2d 731,
737 (Fed. Cir. 1988).
After considering the Wands factors, we find that on this record, the
preponderance of evidence supports Appellants' position that the claims are
enabled. We highlight Wands factors (5}-(8) in our discussion below.
Appellants and the Examiner agree that the relative skill of those in
the art is high. Compare Appeal Br. 10, with Final Act. 3. And, as
Appellants point out, and the Examiner acknowledges, the prior art teaches a
method of measuring two values and then comparing the measured values to
a predetermined threshold value to indicate if an alarm should be sounded so
that corrective action can be taken. Compare Appeal Br. 9-10, with Final
Act. 3.
In addition, as Appellants point out, the Examiner's conclusion that
the nature of the art is "unpredictable" (Final Act. 4) is unfounded given that
using a dialyzer to perform a dialysis procedure on a patient is well known
in the art. Appeal Br. 11; Spec. 1, ,r 3. Thus, any experimentation needed to
practice the scope of the claimed invention would seemingly be routine in
the art. Likewise, we agree with Appellants that the Examiner's finding that
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"[t]here is no indication when the measurements are being taken, how they
are being taken, how they are compared to make such a determination (i.e.
calculated)" (Final Act. 4) is also unfounded. Appeal Br. 13. As Appellants
explain, claim 1 and Appellants' Specification set forth that the
measurements are taken at the same point in time or within the same time
window (Spec. 3--4), and one of ordinary skill in the art would know how to
obtain such measurements (e.g., pulse rate). Appeal Br. 13. Further, claim 1
and Appellants' Specification set forth that the two measured values are
compared to determine if the measurements are in agreement (i.e., whether
there is a difference between the two measured values) (Spec. 3--4).
Therefore, the Specification provides a scope of enablement commensurate
with the scope of claim 1.
Because the evidence of record regarding the Wands factors supports
Appellants' position that the claims are enabled, we do not sustain the
rejection of claims 1-10 under§ 112, first paragraph, for lack of enablement.
Rejection 2
The Examiner finds that claims 1-10 are indefinite under 35 U.S.C.
§ 112, second paragraph, because the claim language "wrong patient" and
"threshold value" are unclear. Final Act. 8-9.
The legal standard for definiteness in prosecution is whether a claim
reasonably apprises those of skill in the art of its scope. In re Warmerdam,
33 F.3d 1354, 1361 (Fed. Cir. 1994).
With regard to claim 1 's "wrong patient" language, the Examiner
finds that "[i]t is unclear what a 'wrong patient' is and what makes the
patient 'wrong."' Final Act. 8. The Examiner finds that "the disclosure
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never defines what comprises 'wrong patient' or how the 'possible
connection' is determined and how the signal is made." Id.
Appellants argue, and we are persuaded that, "[t]hose of ordinary skill
in the art are familiar with the terminology of 'patient' and are familiar with
the terminology 'wrong."' Appeal Br. 21. Thus, one of ordinary skill in the
art would read claim 1 's language, in view of Appellants' Specification, and
understand that "the 'possible connection' of the measuring unit to the
wrong patient refers to the possibility that the measuring unit[, which
transmits data to the dialyzer wirelessly,] is connected to a patient who is not
the intended patient that is matched with or assigned[, i.e., connected
physically,] to a particular dialyzer." Id.; Spec. 2, ,r 3 (full), 3, ,r 1 (full).
Accordingly, the terminology "wrong patient" in claim 1 is clear and
definite.
With regard to claim 1 's "threshold value" language, the Examiner
finds that "[i]t is unclear what the 'threshold value' is that would be
necessary to indicate that the 'measuring unit is [possibly] connected to a
wrong patient."' Final Act. 9.
Appellants argue that "[a] person of ordinary skill in the art knows to
predetermine the threshold value to be above the measuring accuracy of the
measuring unit." Appeal Br. 23.
Appellants' argument is not persuasive of reversible error because we
are not convinced that one of ordinary skill in the art would readily
understand that "a predetermined threshold value," is a value above the
measuring accuracy of the measuring unit rather than some other value. Nor
do Appellants direct us to any evidence in their Specification that defines or
explains how to determine the scope of "a predetermined threshold value" as
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recited in the claims. Accordingly, the terminology "predetermined
threshold value" is not clear and definite. We therefore sustain the rejection
of claims 1-10 as indefinite under 35 U.S.C. § 112, second paragraph.
Although we sustain the rejection of claims 1-10 as indefinite, we
need not speculate about the meaning of the indefinite language in order to
consider the merits of the rejection under 35 U.S.C. § 103(a).
Rejection 3
According to the Examiner, in determining "101 eligibility a process
claim must pass the machine-or-transformation test in order to be
determined as patent eligible subject matter under 35 U.S.C. § 101." Final
Act. 11. Based on that test, the Examiner concludes that "the claim[ s fail]
the machine-or-transformation test and the claims are not 101 compliant."
Id. at 15.
The Supreme Court has held that the machine-or-transformation test is
a useful and important clue or investigative tool, it "is not the sole test for
deciding whether an invention is a patent-eligible 'process'" under§ 101.
Bilski v. Kappas, 561 U.S. 593, 604 (2010). Thus, although we agree with
the Examiner that ultimately the claims are directed to judicially-excepted
subject matter (i.e., an abstract idea), the Examiner has presented an
insufficient rationale to establish a prima facie case of patent ineligible
subject matter by basing the rejection of claims 1-10 only on application of
the machine-or-transformation test.
To determine whether a claim is directed to patent ineligible subject
matter, we apply the analytical framework set out in Mayo Collaborative
Services. v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), and further
explained in Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014).
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This framework was applicable at the time of the Final Office Action dated
October 26, 2015, and the Appeal Brief filed May 20, 2016, but was not
employed by either the Examiner or Appellants. Compare Final Act. 11-15,
and Ans. 11-15, 26-30, with Appeal Br. 26-30. We apply the Mayo/Alice
analytical framework below. Our analysis focuses solely on independent
claim 1.
According to the Mayo/Alice framework, the first step requires
determining whether the claims at issue are directed to a patent-ineligible
concept, such as an abstract idea. See Alice, 573 U.S. at 217 (citing
Mayo, 566 U.S. at 76-77).
Claim 1 is directed to a method "for signaling a possible connection of
a measuring unit to a wrong patient." The steps to accomplish the claimed
method involve commencement of a dialysis procedure followed by:
(1) "determining during the dialysis procedure a first value of at least one
measurable variable measured by the measuring unit," (2) "transmitting to
the dialyzer via a wireless link between the measuring unit and the dialyzer
the determined first value of the at least one measureable variable,"
(3) "determining a second value of the at least one measureable variable ...
by a measuring device that is connected physically to the dialyzer,"
( 4) "evaluating the first value in comparison to the second value so that a
difference ... is determined," and ( 5) "if the difference is greater than a
predetermined threshold value a warning is given indicating that the possible
connection of the measuring unit to the wrong patient has occurred."
Similar to the claims found patent ineligible in Electric Power Group,
LLC v. Alstom S.A., 830 F.3d 1350, 1353-54 (Fed. Cir. 2016), the recited
steps in claim 1 do not appear to do anything more than collect and analyze
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data, followed by displaying the results of the collection and analysis to the
user by giving a warning. Although claim 1 recites a "dialyzer," the claim
focuses on the "determining," transmitting," and "evaluating" steps. The
steps themselves are not rooted in computer technology as evidenced by the
fact that all that is needed to perform them is a generic "dialyzer." See
Appeal Br. 28 ( admitting that the plain language of claim 1 implies that a
computer or device that is part of the dialyzer performs the evaluation and
comparison step and would also give the warning or cause another device to
give the warning is greater than the threshold value).
The second step of the Mayo/Alice framework requires examining
"the elements of the claim to determine whether it contains an 'inventive
concept' sufficient to 'transform' the claimed abstract idea into a patent-
eligible application." Alice, 573 U.S. at 221 ( quoting Mayo, 566 U.S.
at 72, 79).
Appellants admit that "those of ordinary skill in the art understand the
language of ... claim 1 to imply that a computer or device that is part of the
dialyzer performs the evaluation and comparison step and would also give
the warning or cause another device to give the warning is greater than the
threshold value." Appeal Br. 28; Alice, 573 U.S. at 221 ("[C]laims, which
merely require generic computer implementation, fail to transform [an]
abstract idea into a patent-eligible invention."). Moreover, as discussed
above, the claims merely require a generic "dialyzer" to perform claim 1 's
method, which as evidenced by Appellants' Specification is well-
understood, routine, and conventional. Spec. 1, ,r 3 (Dialyzers as used in
Appellants' invention, "in which the blood pressure is measured
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automatically by the dialyser during the dialysis treatment, are already
known.").
In view of the foregoing, we sustain the Examiner's conclusion that
claim 1 is directed to patent-ineligible subject matter for being judicially-
excepted from 35 U.S.C. § 101. Because we have relied on facts and
reasoning not raised by the Examiner, we designate our affirmance as
including a new ground of rejection. In re Leithem, 661 F.3d 1316, 1319
(Fed. Cir. 2011) ("Mere reliance on the same statutory basis ... alone, is
insufficient to avoid making a new ground of rejection when the Board relies
on new facts and rationales not previously raised to the applicant by the
examiner.").
We enter the new ground only for independent claim 1 and leave the
evaluation of the patent ineligibility of dependent claims 2-10 to the
Examiner.
Rejection 4
The Examiner finds that Spickermann teaches a method for
continuous, noninvasive monitoring of an extracorporeal blood treatment
that comprises all the steps of claim 1 's method including comparing the
relative change in blood pressure to a predetermined limit value (Final Act.
16 (citing Spickermann, 5:15-17, 40-53, 55-60, 6:4--8, 22-28, 7:8-22,
Abstract)), but does not teach that "if the difference is greater than a
predetermined threshold value a warning is given indicating that the possible
connection of the measuring unit to the wrong patient has occurred" (id. at
17), and transmitting data wirelessly (id. at 18).
According to Appellants, Spickermann watches for a critical situation
(i.e., when the blood pressure or relative change in blood pressure drops
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below a predetermined limit (Abstract)) by (1) calculating a patient's blood
pressure by utilizing multiple measurements of one or more of the multiple
sensors, namely electrocardiograph 45, and photoplethysmograph 29 or
pressure sensor 46 (5: 15---60), and (2) comparing the calculated blood
pressure with a predefined threshold (6:9-27). Appeal Br. 34.
Electrocardiograph 45 and photoplethysmograph 29 or pressure sensor 46
measure different variables----electrocardiograph 45 measures the pulse wave
transit time and photoplethysmograph 29 or pressure sensor 46 measures the
pulse waves (Spickermann 5:54---60, 6:12-14, 28-29). The measurement of
the other sensor, namely sphygmomanometer 43, in Spickermann is used to
continuously measure blood pressure when the blood pressure or relative
change in blood pressure drops below a predetermined limit. Appeal Br. 34;
Spickermann 7:7-22. Thus, Appellants argue that Spickermann teaches a
method for determining a patient's blood pressure by using data from
multiple devices measuring different variables at different points in time.
Appeal Br. 34.
Appellants' arguments are persuasive of reversible error. On this
record, the Examiner has not established with sufficient evidence that
Spickermann teaches or suggests measuring the same variable ( e.g., pulse
rate) using two different measuring devices at the same point in time t or in
the same time window ti from the patient. The Examiner does not rely on
Vosburgh to cure the deficiencies of Spickermann discussed above. Final
Act. 18. Thus, the Examiner has not met the initial burden of setting forth a
prima facie case of obviousness for claims 1-10 under 35 U.S.C. § 103(a)
over Spickermann and Vosburgh. Accordingly, we do not sustain the
rejection of claims 1-10 under 35 U.S.C. § 103(a).
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DECISION
The rejection of claims 1-10 under 35 U.S.C. § 112, first paragraph,
and the rejection of claims 1-10 under 35 U.S.C. § 103(a) as unpatenable
over Spickermann in view of Vosburgh are reversed.
The rejection of claims 1-10 under 35 U.S.C. § 112, second paragraph
is affirmed.
The rejection of claims 1-10 under 35 U.S.C. § 101 is affirmed, and
designated as a new ground of rejection under 37 C.F.R. § 4I.50(b).
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 4I.50(b). 37 C.F.R. § 4I.50(b) provides "[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review." 37 C.F.R. § 4I.50(b) also provides that Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
( 1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new Evidence relating to the claims so rejected,
or both, and have the matter reconsidered by the examiner, in which
event the prosecution will be remanded to the examiner. The new
ground of rejection is binding upon the examiner unless an
amendment or new Evidence not previously of Record is made which,
in the opinion of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be reheard
under§ 41.52 by the Board upon the same Record. The request for
rehearing must address any new ground of rejection and state with
particularity the points believed to have been misapprehended or
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overlooked in entering the new ground of rejection and also state all
other grounds upon which rehearing is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure§ 1214.01.
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; 37 C.F.R. § 4I.50(b)
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