Bo Olde et al.

Patent Trials and Appeals Board

Sep 29, 2020

13519559 - (D) (P.T.A.B. Sep. 29, 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.
13/519,559 09/12/2012 Bo Olde 3724361-00033 6294
29178 7590 09/29/2020
K&L Gates LLP - Gambro
P. O. BOX 1135
CHICAGO, IL 60690-1135
EXAMINER
BLOCH, MICHAEL RYAN
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
09/29/2020 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):
uspatentmail@klgates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BO OLDE and KRISTIAN SOLEM
Appeal 2020-000525
Application 13/519,559
Technology Center 3700
Before BRETT C. MARTIN, MICHELLE R. OSINSKI, and
ANNETTE R. REIMERS, Administrative Patent Judges.
MARTIN, 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, 21, 24, 25, and 38–46. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

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 GAMBRO LUNDIA
AB. Appeal Br. 2.
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CLAIMED SUBJECT MATTER
The claims are directed to an apparatus and method for prediction of
rapid symptomatic blood pressure decrease. Claim 1, reproduced below, is
illustrative of the claimed subject matter:
1. A monitoring device operating as part of a blood treatment
device including an extracorporeal blood flow circuit configured
to be coupled to a cardiovascular system of a subject and at least
one pressure sensor configured to generate measurement data
based on pressure within the extracorporeal blood flow circuit,
the monitoring device for predicting rapid symptomatic blood
pressure decrease during the subject's blood treatment, the
monitoring device comprising:
an input for receiving the measurement data from the at
least one pressure sensor in the extracorporeal blood flow circuit
coupled to the cardiovascular system of the subject, the
measurement data comprising a time sequence of pulse shape
parameters representing pressure variations in at least one blood
vessel of the subject;
and a data analysis part configured to repeatedly receive
the pulse shape parameters, calculate a pulse measure
representing an overall magnitude determined by averaging a
plurality of magnitudes from a plurality of the pulse shape
parameters within a time window, and cause an output signal to
be generated when the pulse measure fulfils a decision criterion,
the output signal indicating a predicted rapid symptomatic blood
pressure decrease in the subject,
wherein, when the pulse measure fulfils the decision
criterion, the output signal causes the blood treatment device to
(i) issue an alarm indicating that a treatment parameter of the
subject's blood treatment should be adjusted, or (ii) adjust the
treatment parameter of the subject's blood treatment.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Simard US 5,476,592 Dec. 19, 1995
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Bissler US 6,780,322 B1 Aug. 24, 2004
Balschat US 6,804,991 B2 Oct. 19, 2004

REJECTIONS
Claims Rejected 35 U.S.C. § Reference(s)/Basis
1, 21, 24, 25, 38–46 112 Written Description
1, 21, 24, 25, 38–46 112 Indefiniteness
1, 21, 24, 25, 38–46 101 Eligibility
1, 21, 24, 38–46 103 Bissler, Simard
25 103 Bissler, Simard,
Balschat

OPINION
Standard for Patent Eligibility
In issues involving subject matter eligibility, our inquiry focuses on
whether the claims satisfy the two-step test set forth by the Supreme Court in
Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014). The Supreme Court
instructs us to “first determine whether the claims at issue are directed to a
patent-ineligible concept,” id. at 216–18, and, in this case, the inquiry
centers on whether the claims are directed to an abstract idea. If the initial
threshold is met, we then move to the second step, in which we “consider the
elements of each claim both individually and ‘as an ordered combination’ to
determine whether the additional elements ‘transform the nature of the
claim’ into a patent-eligible application.” Id. at 217 (quoting Mayo
Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 79, 78 (2012)).
The Supreme Court describes the second step as a search for “an ‘inventive
concept’—i.e., an element or combination of elements that is ‘sufficient to
ensure that the patent in practice amounts to significantly more than a patent
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upon the [ineligible concept] itself.’” Id. (quoting Mayo, 566 U.S. at 72–
73).
The USPTO recently published revised guidance on the application of
§ 101. USPTO’s January 7, 2019 Memorandum, 2019 Revised Patent
Subject Matter Eligibility Guidance (“Memorandum”). Under that
guidance, we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract
ideas (i.e., mathematical concepts, certain methods of organizing
human interactions such as a fundamental economic practice, or
mental processes); and
(2) additional elements that integrate the judicial exception into a
practical application (see MPEP § 2106.05(a)–(c), (e)–(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that
exception into a practical application, do we then look to whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not
“well-understood, routine, conventional” in the field (see MPEP
§ 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities
previously known to the industry, specified at a high level of
generality, to the judicial exception.
See Memorandum.

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ANALYSIS
Claim Grouping
Although Appellant presents separate argument headings for claims 1,
39, and 42, the arguments for claims 39 and 42 merely refer to the
arguments presented for claim 1. App. Br. 22. We select claim 1 as
representative of the group, and the remaining claims stand or fall with claim
1. See 37 C.F.R. § 41.37(c)(1)(iv).
Examiner’s Findings and Conclusion
In the first step of the Alice inquiry, the Examiner rejects claims 1, 21,
24, 25, and 38–46 “because the claimed invention is directed to a judicial
exception, i.e. abstract idea without significantly more.” Final Act. 9. The
Examiner identifies the claimed device for monitoring blood pressure that
uses mathematical formulas based on input of medical data as the abstract
idea. Id. at 9–10. At Alice step 2, the Examiner additionally finds that the
claims do not add a meaningful limitation to the abstract idea so as to
amount to significantly more than the judicial exception. Final Act. 10.
Analysis According to the Guidelines
Step One: Does Claim 1 Fall within a Statutory Category of § 101?
We first examine whether the claim recites one of the enumerated
statutory classes of subject matter, i.e., process, machine, manufacture, or
composition of matter, eligible for patenting under 35 U.S.C. § 101. Claim
1 is directed to a device, which is one of the statutory classes (i.e., a
machine) under 35 U.S.C. § 101.
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Step 2A, Prong One: Does Claim 1 Recite a Judicial Exception?
We next look to whether the claim recites any judicial exceptions,
including certain groupings of abstract ideas, i.e., mathematical concepts,
certain methods of organizing human activity such as a fundamental
economic practice, or mental processes.
In this instance, claim 1, for example, recites a device for monitoring
blood pressure. Specifically, the claim recites:
an input for receiving the measurement data from the at
least one pressure sensor in the extracorporeal blood flow circuit
coupled to the cardiovascular system of the subject, the
measurement data comprising a time sequence of pulse shape
parameters representing pressure variations in at least one blood
vessel of the subject; and
a data analysis part configured to repeatedly receive the
pulse shape parameters, calculate a pulse measure representing
an overall magnitude determined by averaging a plurality of
magnitudes from a plurality of the pulse shape parameters within
a time window, and cause an output signal to be generated when
the pulse measure fulfils a decision criterion, the output signal
indicating a predicted rapid symptomatic blood pressure
decrease in the subject,
wherein, when the pulse measure fulfils the decision
criterion, the output signal causes the blood treatment device to
(i) issue an alarm indicating that a treatment parameter of the
subject's blood treatment should be adjusted, or (ii) adjust the
treatment parameter of the subject's blood treatment.
Although these components are claimed in structural form, they essentially
amount to computer components for applying a mathematical concept. We
therefore determine that claim 1 recites the abstract idea of a using a
mathematical formula based on input of medical data, which is a judicial
exception to patent-eligible subject matter.
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Step 2A, Prong Two: Does Claim 1 Recite Additional Elements that
Integrate the Judicial Exceptions into a Practical Application?
Following our Office guidance, having found that claim 1 recites a
judicial exception, we next determine whether the claim recites “additional
elements that integrate the exception into a practical application” (see MPEP
§§ 2106.05(a)–(c), (e)–(h)). See Memorandum, 84 Fed. Reg. at 54. As
noted above, each of the claimed components is merely a conventional tool
used to collect and process data using a mathematical formula. As used in
the claims, the data analysis part is merely a generic component of a
computer system that does not result in an improvement in the functioning
of a computer or other technology or technological field. The recitations of
the generic structures with which the recited steps are performed are merely
instructions to use a computer system as a tool to perform the abstract idea.
Thus, the claims do not apply, rely on, or use the mathematical formula in a
manner that imposes a meaningful limit on the use of that formula. Rather,
the claim is simply a drafting effort designed to monopolize the use of the
mathematical formula of claim 1.
The additional elements do not add meaningful limits to the mental
process steps recited in claim 1. Instead, the generic data analysis
components are no more than instructions to apply the judicial exception
(i.e., mathematical formula) using generic computer elements. See MPEP
§ 2106.05(f) (“Use of a computer or other machinery in its ordinary capacity
for . . . tasks (e.g., to receive, store, or transmit data) or simply adding a
general purpose computer or computer components after the fact to an
abstract idea . . . does not provide significantly more.”).
In short, the additional elements discussed above: (1) do not improve
the functioning of a computer or other technology; (2) are not applied with
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any particular machine; (3) do not effect a transformation of a particular
article to a different state; and (4) are not applied in any meaningful way
beyond generally linking the use of the judicial exception to a particular
technological environment. See MPEP §§ 2106.05(a)–(c), (e)–(h).
Consequently, the claimed invention does not integrate the abstract idea into
a “practical application.”
For these reasons, the additional elements of claim 1 do not integrate
the judicial exception into a practical application. Thus, claim 1 is directed
to an abstract idea, which is a judicial exception to patent eligible subject
matter under 35 U.S.C. § 101.
Step 2B: Does Claim 1 Recite an Inventive Concept?
We next consider whether claim 1 recites any elements, individually
or as an ordered combination, that transform the abstract idea into a patent-
eligible application, e.g., by providing an inventive concept. Alice, 573 U.S.
at 217–18. As noted above, the only additional elements are a data analysis
part and an input used for routine computer functionality to enact the data
analysis. These additional elements do not provide, either individually or as
a combination, improvements to another technology or technical field or the
functioning of the computer itself.
According to the Office guidance, under Step 2B, “examiners should
. . . evaluate the additional elements individually and in combination . . . to
determine whether they provide an inventive concept (i.e., whether the
additional elements amount to significantly more than the exception itself).”
See Memorandum, 84 Fed. Reg. at 56 (emphasis added). Thus, the second
step of the inquiry (Step 2B) looks at the additional elements in combination.
See, e.g., Examples accompanying Memorandum (Example 37 (claim 3
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analysis) and Example 40 (claim 2 analysis)). See also BSG Tech LLC v.
BuySeasons, Inc., 899 F.3d 1281, 1290 (Fed. Cir. 2018) (“It has been clear
since Alice that a claimed invention’s use of the ineligible concept to which
it is directed cannot supply the inventive concept that renders the invention
‘significantly more’ than that ineligible concept.”)
As noted above, the data analysis part and input are invoked as
conventional tools. Apart from being used to perform the abstract idea
itself, these generic computer system components only serve to perform
well-understood functions (e.g., storing, selecting, analyzing, and outputting
data). See FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 1096
(Fed. Cir. 2016) (“the use of generic computer elements like a
microprocessor or user interface do not alone transform an otherwise
abstract idea into patent-eligible subject matter”). In our view, claim 1 fails
to add a specific limitation beyond the judicial exception that is not ‘well-
understood, routine, conventional” in the field, but instead “simply appends
well-understood, routine, conventional activities previously known to the
industry, specified at a high level of generality, to the judicial exception.”
See Memorandum, 84 Fed. Reg. at 56. That is, we are not persuaded that
claim 1 is directed to a specific application designed to achieve an improved
technological result, as opposed to being directed to merely ordinary
functionality of the above-recited additional elements to apply an abstract
idea. For the reasons discussed above, we find no element or combination of
elements recited in claim 1 that contains any “inventive concept” or adds
anything “significantly more” to transform the abstract concept into a patent-
eligible application. See Alice, 573 U.S. at 221.
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Appellant’s Contentions
Appellant first briefly argues that the claims are eligible because “use
of the time sequence of pulse shape parameters representing pressure
variations provides a significant advantage in that Appellants’ system allows
for the use of ‘comparatively small processing resources and sensors [to be]
simple and cost-efficient.” App. Br. 19. Appellant does not expand on this
argument further. This argument does not explain how the use of the
mathematical formula and claimed data processing amounts to anything
more than the abstract idea of using conventional technology in known ways
to process medical data.
Appellant argues that “the claimed elements of a pressure sensor and
an input to obtain data from the sensor constitute additional elements that are
both non-computer elements, and which operate with the data analysis part
of the claim to analyze an extracorporeal or blood circuit.” App. Br. 20.
Appellant does not explain how the sensor and input are more than extra-
solution activity (i.e., data gathering so that the information can be analyzed
by mathematical formulas). See MPEP § 2106.05(g). Appellant next argues
that the claims integrate the abstract idea into a practical application of the
judicial exception via the use of an alarm or causing treatment parameter
adjustment based on the analysis. App. Br. 20–21. We generally agree with
Appellant that the treatment parameter adjustment would amount to the
integration of the abstract idea into a practical application, but disagree that
the mere use of an alarm does so. An alarm is essentially just a notification
that a certain result of the data has occurred. It still amounts to nothing more
than mere data processing. The Examiner is correct, regarding the alarm,
that “such activity has been consistently viewed as extra-solution to the
exception by the Courts and not an implementation into a practical
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application.” Ans. 5.
As for the adjustment of treatment parameters, this limitation is
claimed in the alternative such that it is not required by the claims. As such,
the claims may be read to encompass nothing more than input of data, data
processing, and a notification of a certain result achieved by the data
processing. As the Examiner states “inclusion of the ‘OR’ for the treatment
prevents such result from being required, and thus does not implement the
exception in a practical application of treatment.” Ans. 4. We agree with
the Examiner that “[i]t seems that for claims 39/42, if the treatment were
required as opposed to an alternative, then the claims would be a practical
application.” Ans. 6. This assessment applies equally to claim 1, which also
includes the potential practical application in the alternative.
Lastly, Appellant asserts “that the underlying measurement data from
the at least one pressure sensor of the present claims has been enhanced.”
App. Br. 22. We disagree. The claims merely use conventional components
to process data as discussed above, and then utilize the result of that data to
sound an alarm or adjust treatment. Because the claims do not require the
treatment adjustment and the alarm by itself does not integrate the abstract
idea into a practical application, we are not persuaded that the Examiner
erred in finding the claimed subject matter ineligible. See also Ass'n for
Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591 (2013)
(“Groundbreaking, innovative, or even brilliant discovery does not by itself
satisfy the § 101 inquiry.”); Parker v. Flook, 437 U.S. 584, 594–96 (1978)
(determining claims to “a new and presumably better method for calculating
alarm limit values,” which were of undisputed usefulness, were nevertheless
directed to patent-ineligible subject matter).
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Written Description
The Examiner asks, “What positively claimed structure[s] of the blood
treatment device are capable of issuing an alarm and adjusting treatment?”
Ans. 7. The Examiner further states that “the claimed functions are
unlimited functional claims that extend to all means or methods of resolving
the problem of issuing an alarm and adjusting treatment parameter not
[commensurate with] the original disclosure.” Ans. 8. As Appellant
correctly argues, Claim 1 is directed toward a monitoring device as part of a
blood treatment device and “that the positively claimed structure for issuing
the alarm is the blood treatment device or dialysis machine.” Appeal Br. 23.
Indeed, as Appellant points out, the Specification explains that “[t]he
monitoring device 120 and/or the alarm device 27 may alternatively be
incorporated as part of the dialysis machine 110.” Appeal Br. 24
(quoting Spec. 13, ll. 16–26). We agree that “one of skill finds direct
support in clear terms for the language in claim 1 calling for the blood
treatment device to issue an alarm.” Id. The same argument applies equally
to claims 39 and 42.
The Examiner likewise rejects claim 38 regarding the specifically
claimed options for adjusting the treatment parameter. As with claim 1,
Appellant points out that the claims recite the analysis portion of a
generalized dialysis machine. Appeal Br. 25. The Specification states that
the dialysis device may perform a series of “actions to counter-act the
occurrence of a hypotension event and/or reducing negative consequences to
the subject where [a] hypotension event is unavoidable.” Spec. 12, l. 27–13,
l. 12. We do not agree that the claims require some specific structure
claimed to perform each of these various functions as long as one of skill in
the art understands the capabilities of a typical dialysis machine and that the
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claimed tasks are within those capabilities. In the same manner as an
applicant does not need to claim a steering wheel and all the components of
a drive train when claiming an analysis component of a car that may affect
how the car’s steering operates, we see no need for Appellant to claim each
and every structure in a generic dialysis machine to have written description
support for generic functions understood by those of skill in the art to be
within the normal capabilities of a dialysis machine. Accordingly, we do not
sustain the Examiner’s rejections.
Indefiniteness
Regarding claim 1, the Examiner asserts that the claim is indefinite
essentially for the same reasons discussed above regarding what structure
activates the alarm. Because we consider the alarm function to be supported
by the overall dialysis device we do not agree that any specific structure is
necessary. For the same reasons as discussed above, we do not sustain this
rejection.
As to claims 39 and 42, the Examiner finds that it is unclear whether
the pressure sensor is just measuring pressure within the extracorporeal
circuit or is actually in the circuit. Ans. 10. We agree with Appellant “that
it could be either.” Appeal Br. 27. This claim language does not conflict
with any other recited limitation and merely amounts to broad language that
could cover more than one way for the sensing to occur. This does not make
the claim indefinite; it merely provides broad coverage to Appellant. See
SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1341 (Fed. Cir.
2005) (breadth is not indefiniteness). Accordingly, we do not sustain this
rejection.
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Lastly, the Examiner rejects claim 38 essentially for the same reasons
related to the written description rejection. We do not sustain this rejection
for the same reasons as stated above.
§ 112, Sixth Paragraph
Although the Examiner has given no reason as to why the rejection
requires an interpretation of the claims under 35 U.S.C. § 112, sixth
paragraph, the Examiner nonetheless determines that certain claim language,
namely “an input” and “a data analysis part,” should be interpreted as means
plus function claim language and thus limited to the disclosure found in the
Specification. The Examiner asserts that the language used amounts to
nonce terms modified by functional language. Ans. 13.
First, we note that the data analysis part is essentially a generic
computing device used to perform the data analysis found in the claims.
According to the Examiner’s reasoning, all claims that include a generic
computer for performing data analysis would have to be considered means
plus function language. Additionally, Appellant is correct that a rebuttable
presumption exists against interpreting claims as means plus function when
the term “means” is not found in the claims. Appeal Br. 31. We agree that
the Examiner has provided no evidence as to why this presumption is or
should be rebutted. Appeal Br. 32. We also agree that the term “input”
amounts to a structural part and should not be interpreted as the Examiner
has done. Although there is no rejection associated with this interpretation,
we do not support the Examiner’s use of means plus function interpretation
in applying the claim terms at issue.
Double Patenting
As Appellant points out, the proper standard for double patenting is
that “[w]hen two claims in an application are duplicates, or else are so close
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in content that they both cover the same thing, despite a slight difference in
wording, it is proper after allowing one claim to object to other claims under
37 CFR 1.75 as being a substantial duplicate of the allowed claim.” App.
Br. 16–17. Appellant is correct that claim 39 claims a “monitoring device,”
which is not found in claim 42. Appeal Br. 33. This alone is sufficient such
that Double Patenting would not apply. Accordingly, we do not sustain the
Examiner’s rejection.
Obviousness
The Examiner’s combination relies on Simard to teach at least
averaging a plurality of magnitudes from a plurality of the pulse shape
parameters within a time window, which the Examiner admits is missing
from Bissler. First, we note that Simard is a pumping device used to inject a
sterile and anti-pyrogenic fluid and has nothing to do with monitoring blood
pressure as claimed. As Appellant states, “Simard concerns filter integrity,
not patient symptomatic blood pressure decrease” and is concerned with
checking a filter during use of the device. Appeal Br. 34. Simard is
concerned with measuring pressure drops within the injection system that
may indicate a clogged filter. This has nothing to do with measuring blood
pressure of a patient.
Appellant is also correct that Bissler “does not disclose or identify any
components in its system having variations in pressure” and that “[t]here
would have been NO motivation for the skilled artisan to make the argued
combination.” Reply Br. 14. We do not see how introducing pressure
monitoring of an injection device related to filter integrity would cure a
deficiency of a device that has nothing to do with varying pressure in the
first place. Accordingly, we do not sustain the Examiner’s rejections, all of
which rely on this improper combination.
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CONCLUSION
The Examiner’s rejection is AFFIRMED.
More specifically,
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 21, 24,
25, 38–46
112 Written
Description
1, 21, 24,
25, 38–46
1, 21, 24,
25, 38–46
112 Indefiniteness 1, 21, 24,
25, 38–46
1, 21, 24,
25, 38–46
101 Eligibility 1, 21, 24,
25, 38–46

1, 21, 24,
38–46
103 Bissler, Simard 1, 21, 24,
38–46
25 103 Bissler, Simard,
Balschat
25
Overall
Outcome
1, 21, 24,
25, 38–46

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED