Ex Parte Giftakis et al

Patent Trials and Appeals Board

Mar 27, 2019

12236260 - (D) (P.T.A.B. Mar. 27, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/236,260 09/23/2008
71996 7590 03/29/2019
SHUMAKER & SIEFFERT, P.A
1625 RADIO DRIVE, SUITE 100
WOODBURY, MN 55125
FIRST NAMED INVENTOR
Jonathon E. Giftakis
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.
1023-803US01 /
P0033524.0
CONFIRMATION NO.
7565
EXAMINER
PORTER, RACHELL
ART UNIT PAPER NUMBER
3626
NOTIFICATION DATE DELIVERY MODE
03/29/2019 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):
pairdocketing@ssiplaw.com
rs.patents.five@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JONATHON E. GIFT AK.IS, PETER J. KOVACH,
WARREN W. BALL, JONATHAN C. WERDER, NINA M. GRAVES,
DAVID C. ULLESTAD, and SARAH B. ALME
Appeal2017-003514 1
Application 12/236,2602
Technology Center 3600
Before BIBHU R. MOHANTY, KENNETH G. SCHOPPER, and
MATTHEWS. MEYERS, Administrative Patent Judges.
MEYERS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's final
rejection of claims 1-22. We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Our decision references Appellants' Appeal Brief ("Appeal Br.," filed
April 4, 2016) and Reply Brief ("Reply Br.," filed January 2, 2017), and the
Examiner's Answer ("Ans.," mailed November 2, 2016) and Final Office
Action ("Final Act.," mailed October 28, 2015).
2 Appellants identify Medtronic, Inc. as the real party in interest. Appeal
Br. 3.
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CLAIMED INVENTION
Appellants' claimed invention relates to "evaluating one or more
therapy programs or groups of programs or adjusting therapy delivered by a
medical device based on an indication that a patient event occurred" (Spec.
Claims 1, 11, 20, and 22 are the independent claims on appeal.
Claim 1, reproduced below with bracketed notations added, is illustrative of
the claimed subject matter:
1. A method comprising:
[a] receiving, with a processor, input from a patient
indicating an occurrence of a patient event related to a condition
of the patient;
[b] generating, with the processor, an event marker based
on the input from the patient; and
[ c] adjusting, with the processor, therapy delivered by a
medical device to the patient, wherein the medical device
delivers therapy according to a therapy cycle comprising an on-
cycle during which therapy is delivered to the patient and an
off-cycle during which therapy is not delivered to the patient,
and
[ d] wherein adjusting therapy comprises:
[ d 1] determining, with the processor, whether the
medical device is in the off-cycle or the on-cycle of the
therapy cycle implemented by the medical device at a
time the event marker is generated;
[ d2] with the processor, initiating the on-cycle if
the medical device is in the off-cycle at the time the event
marker is generated, thereby shortening a duration of the
off-cycle of the therapy cycle implemented by the
medical device at the time the event marker is generated;
and
[d3] with the processor, restarting the on-cycle if
the medical device is in the on-cycle at the time the event
marker is generated, thereby elongating a duration of the
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on-cycle of the therapy cycle implemented by the
medical device at the time the event marker is generated.
REJECTIONS
Claims 1-22 are rejected under 35 U.S.C. § 101 as directed to non-
statutory subject matter.
Claims 1-22 are rejected under 35 U.S.C. § 103 as unpatentable over
Osorio (US 2004/0158119 Al, pub. Aug. 12, 2004) and Hickle (US
2004/0103897 Al, pub. June 3, 2004).
ANALYSIS
Patent-Ineligible Subject Matter
Independent claim 1 and dependent claims 2-10
Appellants argue independent claims 1-10 as a group (Appeal Br. 10-
12; Reply Br. 2-10). We select independent claim 1 as representative, and
the remaining claims stand or fall with independent claim 1. See 37 C.F.R.
§ 4I.37(c)(l)(iv).
An invention is patent-eligible if it claims a "new and useful process,
machine, manufacture, or composition of matter." 35 U.S.C. § 101.
However, the Supreme Court has long interpreted 35 U.S.C. § 101 to include
implicit exceptions: "[l]aws of nature, natural phenomena, and abstract
ideas" are not patentable. E.g., Alice Corp. v. CLS Bank Int 'l, 573 U.S. 208,
216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Supreme Court's two-step framework, described in Mayo
and Alice. Id. at 217-18 ( citing Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 75-77 (2012)). In accordance with that framework,
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we first determine what concept the claim is "directed to." See id. at 219
("On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk."); see also Bilski v. Kappas, 561 U.S. 593, 611 (2010) ("Claims 1 and 4
in petitioners' application explain the basic concept of hedging, or protecting
against risk.").
Concepts determined to be abstract ideas, and thus patent ineligible,
include certain methods of organizing human activity, such as fundamental
economic practices (Alice, 573 U.S. at 219-20; Bilski, 561 U.S. at 611 );
mathematical formulas (Parker v. Flook, 437 U.S. 584, 594--95 (1978)); and
mental processes ( Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). Concepts
determined to be patent eligible include physical and chemical processes,
such as "molding rubber products" (Diamond v. Diehr, 450 U.S. 175, 192
( 1981) ); "tanning, dyeing, making water-proof cloth, vulcanizing India
rubber, smelting ores" (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S.
252, 267---68 (1853))); and manufacturing flour (Gottschalk, 409 U.S. at 69
(citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited a mathematical formula, but the
Supreme Court held that "[a] claim drawn to subject matter otherwise
statutory does not become nonstatutory simply because it uses a
mathematical formula." Diehr, 450 U.S. at 176; see also id. at 191 ("We
view respondents' claims as nothing more than a process for molding rubber
products and not as an attempt to patent a mathematical formula."). Having
said that, the Supreme Court also indicated that a claim "seeking patent
protection for that formula in the abstract .... is not accorded the protection
of our patent laws, ... and this principle cannot be circumvented by
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attempting to limit the use of the formula to a particular technological
environment." Id. ( citing Benson and Flook); see, e.g., id. at 187 ("It is now
commonplace that an application of a law of nature or mathematical formula
to a known structure or process may well be deserving of patent
protection.").
If the claim is "directed to" an abstract idea, we tum to the second
step of the Alice and Mayo framework, where "we must examine 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 (quotation marks omitted). "A
claim that recites an abstract idea must include 'additional features' to
ensure 'that the [claim] is more than a drafting effort designed to
monopolize the [ abstract idea]."' Id. ( alterations in original) ( quoting Mayo,
566 U.S. at 77). "[M]erely requir[ing] generic computer implementation[]
fail[s] to transform that abstract idea into a patent-eligible invention." Id.
The PTO recently published revised guidance on the application of
§ 101. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed.
Reg. 50 (Jan. 7, 2019) ("2019 Guidance"). 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 activity such as a fundamental economic practice,
or mental processes); and
(2) additional elements that integrate the judicial exception into
a practical application, i.e., that "apply, rely on, or use the judicial
exception in a manner that imposes a meaningful limit on the judicial
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exception, such that the claim is more than a drafting effort designed
to monopolize the judicial exception." 2019 Guidance at 53; see also
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 Guidance.
Here, in rejecting the pending claims under 35 U.S.C. § 101, the
Examiner determined that the claims
are directed to a process of treating a patient by receiving
information regarding event marker has been triggered, and
adjusting treatment or therapy/treatment based upon whether
the received data indicates that the patient was not receiving
therapy (i.e. off-cycle) for therapy. As such, the claimed
invention is drawn to the abstract ideas of comparing new and
stored information and using rules to identify options and a
formula for updating alarm limits.
(Final Act. 2; Ans. 21 ). The Examiner also determined that the claims do
not include additional elements or a combination of elements sufficient to
transform the claim into a patent-eligible application of the abstract idea (see
Final Act. 2-3; see also Ans. 21-22).
We are not persuaded, as an initial matter, by Appellants' argument
that the Examiner erred in determining that independent claim 1 is directed
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to an abstract idea (Appeal Br. 10-11; see also Reply Br. 2-8). The Federal
Circuit has explained that "the 'directed to' inquiry applies a stage-one filter
to claims, considered in light of the [S]pecification, based on whether 'their
character as a whole is directed to excluded subject matter."' Enfzsh, LLC v.
Microsoft Corp., 822 F.3d 1327, 1335 (Fed. Cir. 2016) (quoting Internet
Patents Corp. v. Active Network, Inc, 790 F.3d 1343, 1346 (Fed. Cir. 2015)).
It asks whether the focus of the claims is on a specific improvement in
relevant technology or on a process that itself qualifies as an "abstract idea"
for which computers are invoked merely as a tool. See id. at 1335-36.
Here, the Specification, including the claim language, make clear that the
claims focus on an abstract idea, and not on any improvement to computer
technology and/or functionality.
The Specification is titled "THERAPY ADJUSTMENT BASED ON
PATIENT EVENT INDICATION." The Specification discloses that the
present invention "is directed to evaluating one or more therapy programs or
groups of programs or adjusting therapy delivered by a medical device based
on an indication that a patient event occurred" (Spec. ,r 6). According to the
Specification and claims "the indication that a patient event occurred is
received via patient input" (id.). The Specification explains that "[ t ]he event
may be, for example, the occurrence of a symptom related to the patient's
condition, such as an aura related to a seizure or a headache related to
migraines" (id.). The Specification further describes that "the patient event
indication may be used to adjust therapy, such as restarting a therapy cycle
or modifying a duration of a therapy cycle" (id. ,r 7). And, taking
independent claim 1 as representative, the claimed subject matter is
generally directed to a set of steps for "receiving ... input from a patient,"
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"generating ... an event marker based on the input," and "adjusting .. .
therapy delivered by a medical device to the patient" by "determining .. .
whether the medical device is" in on-cycle or off-cycle "at a time the event
marker is generated," and turning it to the on-cycle if it is off when the event
marker is generated or restarting the on-cycle if the medical device is
already in the on-cycle at the time the event marker is generated.
Understood in light of the Specification, we agree with the Examiner
that independent claim 1 is directed broadly to "comparing new and stored
information and using rules to identify options and a formula for updating
alarm limits" (Final Act. 2; Ans. 21 ). And, when viewed through the lens of
the 2019 Revised Guidance, the Examiner's analysis depicts the claimed
subject matter as one of the ineligible "[ m ]ental processes" that include
"concepts performed in the human mind (including an observation,
evaluation, judgment, opinion)," and thus an abstract idea. See 2019
Revised Guidance, 52; See also Flook, 437 U.S. at 595 ("If a claim is
directed essentially to a method of calculating, using a mathematical
formula, even if the solution is for a specific purpose, the claimed method is
nonstatutory." (internal citations omitted)).
Turning to Prong Two of Step 2A, the 2019 Revised Guidance
provides five "exemplary considerations" that "are indicative that an
additional element ( or combination of elements)[] may have integrated the
exception into a practical application." Id. at 55 (emphasis added). The first
exemplary consideration is whether "[ a ]n additional element reflects an
improvement in the functioning of a computer, or an improvement to other
technology or technical field." Id. (citing MPEP § 2106.05(a)). Here,
Appellants argue that independent claim 1 "recites a specific way of
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adjust[ing] therapy delivered by a medical device" (Appeal Br. 10) and
"recites meaningful elements that provide a technical solution that improve
the operations of the technology itself' (Reply Br. 8-9 ( citing Spec. ,r 173);
see also id. at 6-8 (citing Spec. ,r,r 39, 163, 199)). More particularly,
Appellants argue that "the techniques of adjusting the therapy delivered to
the patient [are] based on the generated event marker, not necessarily a
processor in itself, that provide the improvement to the existing technology
of therapy delivery by a medical device" (Reply Br. 9-10).
However, we find no indication in the Specification, nor do
Appellants direct us to any indication, that the steps recited in independent
claim 1 invoke any assertedly inventive programming, require any
specialized computer hardware or other inventive computer components,
i.e., a particular machine, that the claimed invention is implemented using
other than generic computer components to perform generic computer
functions (see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1256
(Fed. Cir. 2014) ("[ A ]fter Alice, there can remain no doubt: recitation of
generic computer limitations does not make an otherwise ineligible claim
patent-eligible."), or similar to the claims found patent eligible in Vanda
Pharmaceuticals Inc. v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed.
Cir. 2018). Instead, we agree with the Examiner that Appellants'
Specification "fails to expand on how the additional elements provide an
unconventional use of the technology to achieve the desired result" (Ans. 22
( citing Spec. ,r,r 35, 70), i.e., adjust the therapy, delivered to the patient,
based on the event marker generated using manually-inputted patient data. 3
3The Specification describes:
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We also find no indication in the Specification that the claimed
invention effects a transformation or reduction of a particular article to a
different state or thing. Nor do we find anything of record, short of attorney
argument, that attributes any improvement in computer technology and/or
functionality to the claimed invention or that otherwise indicates that the
claimed invention "appl[ies ], rel[ies] on, or us[ es] the judicial exception in a
manner that imposes a meaningful limit on the judicial exception, such that
the claim is more than a drafting effort designed to monopolize the judicial
exception." See Guidance, 55.
Appellants further argue that the Examiner "improperly
characteriz[ es] the claims into an overly abstracted interpretation" (Reply
Br. 5). Appellants' argument is not persuasive at least because there is no
Patient programmer 24 may also include other input
mechanisms to allow patient 14 to enter information related to
an event. For example, any suitable input mechanism, such as a
keypad, touch screen, a push button, a soft-key, a voice
activated command, a means activated by other physical
interactions, a magnetically triggered switch, a contact defined
by a touch screen, or any other suitable user interface may be
used by patient 14 to enter information including, but not
limited to, the type or severity of the seizure, the duration of the
seizure, the efficacy of a therapy provided during, before or
after the seizure, the drug taken prior to or after the event, and
the like. Patient programmer 24 may then associate this entered
information with an event marker, such as an event indication
button press, and store the information in memory for
subsequent downloading and viewing using clinician
programmer 22, or for later viewing using patient programmer
24. In this way, patient programmer 24 may receive and record
information specifying the impact therapy system 10 may have
had on the patient event and/ or patient condition.
(Spec. ,r 64).
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requirement that the Examiner's formulation of the abstract idea copy the
claim language. The Examiner's characterization here, moreover, is fully
consistent with the Specification, as discussed above. That independent
claim 1 includes more words than the phrase the Examiner used to articulate
the abstract idea to which the claim is directed is an insufficient basis to
persuasively argue that the claim language has been mischaracterized or that
the Examiner has otherwise failed to consider all of the limitations of the
claim. See Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1240 (Fed. Cir.
2016).
An abstract idea can generally be described at different
levels of abstraction. As the Board has done, the claimed
abstract idea could be described as generating menus on a
computer, or generating a second menu from a first menu and
sending the second menu to another location. It could be
described in other ways, including, as indicated in the
specification, taking orders from restaurant customers on a
computer.
Appellants further argue that independent claim 1 is not directed to an
abstract idea because it "does not seek a monopoly over the alleged abstract
idea of 'comparing new and stored information and using rules to identify
options and a formula for updating alarm limit"' and does not seek "to
'wholly pre-empt' all manners in which information can be compared and
alarm limits can be updated" (Appeal Br. 10-11). That argument is not
persuasive of Examiner error at least because preemption is not the sole test
for patent-eligibility.
There is no dispute that the Supreme Court has described "the concern
that drives [the exclusion of abstract ideas from patent eligible subject
matter] as one of pre-emption." Alice Corp., 573 U.S. at 216. But,
characterizing preemption as a driving concern for patent eligibility is not
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the same as characterizing preemption as the sole test for patent eligibility.
"The Supreme Court has made clear that the principle of preemption is the
basis for the judicial exceptions to patentability" and "[ f]or this reason,
questions on preemption are inherent in and resolved by the§ 101 analysis."
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379
(Fed. Cir. 2015) (citing Alice Corp., 573 U.S. at 215). "[P]reemption may
signal patent ineligible subject matter, [but] the absence of complete
preemption does not demonstrate patent eligibility." Id.
Appellants further argue that the pending claims are not directed to an
abstract idea pursuant to the Federal Circuit decisions in Enfzsh and McRO,
Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299 (Fed. Cir. 2016) (see
Reply Br. 2-10). However, there is a fundamental difference between
computer functionality improvements, on the one hand, and uses of existing
computers as tools to perform a particular task, on the other. Indeed, the
Federal Circuit applied this distinction in Enfish in rejecting a§ 101
challenge at the step one stage of the Mayo/Alice analysis because the claims
at issue focused on a specific type of data structure, i.e., a self-referential
table for a computer database, designed to improve the way a computer
carries out its basic functions of storing and retrieving data, and not on
asserted advances in uses to which existing computer capabilities could be
put. Enfish, 822 F.3d at 1335-36.
We find no parallel here between independent claim 1 and the claims
in Enfzsh nor any comparable aspect in claim 1 that represents "an
improvement to computer functionality." In this regard, we note that the
Specification describes broadly that "patient programmer 24 may be a
handheld computing device" which allows patient 14 to interact with patient
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programmer 24, e.g., by using a by pressing a button, and a medical device
16 via wireless communication techniques known in the art (Spec. ,r,r 4, 64,
65). The Specification further discloses that "patient programmer 24 may
provide a signal to [ medical device] 16 that causes [ medical device] 16 to
initiate therapy delivery or modify at least one therapy parameter" (id. ,r 63).
Here, Appellants assert, without explaining, that "it is the techniques of
adjusting the therapy delivered to the patient based on the generated event
marker, not necessarily a processor in itself, that provide the improvement to
the existing technology of therapy delivery by a medical device" (Reply Br.
9-10). However, the alleged advantages that Appellants identify do not
appear to concern an improvement to computer capabilities or provide
details on the technological manner in which therapy is delivered by a
medical device, but instead relate to an alleged improvement for adjusting
therapy through a process in which a computer is used as a tool in its
ordinary capacity (see, e.g., Spec. ,r,r 61---65, 70, 73, 82-86).
We also find no parallel between independent claim 1 and the claim at
issue in McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299 (Fed.
Cir. 2016) (see Reply Br. 9-11). Appellants assert that like the claims in
McRO, independent claim 1 is patent-eligible because it includes limitations
that specify the how the claim "determines the adjustment of therapy to be
applied to the patient" (Reply Br. 6-7).
The Federal Circuit premised its determination that the claims in
McRO were patent-eligible, not merely on the specificity of the claimed
animation scheme, but rather on the fact that the claims, when considered as
a whole, were directed to a technological improvement over the existing,
manual 3-D animation techniques and used limited rules in a process
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specifically designed to achieve an improved technological result in
conventional industry practice. We are not persuaded that a comparable
situation is presented here (see, e.g., ,r 62, stating "patient 14 may use patient
programmer 24 to start, stop or adjust neurostimulation therapy."). As our
reviewing court has made clear, "relying on a computer to perform routine
tasks more quickly or more accurately is insufficient to render a claim patent
eligible." OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363 (Fed.
Cir. 2015).
Turning to step 2B of the Alice framework, Appellants argue that
"claim 1 amounts to significantly more than any asserted judicial exception,
at least because claim 1 recites claim elements that improve the functioning
of the technical field of therapy delivery" (Appeal Br. 11; see also Reply Br.
8-10). However, we agree with the Examiner that
the additional elements recited in the claims are not sufficient to
amount to significantly more than the judicial exception
because the additional elements (e.g. medical device, processor)
are recited and described using a high level of generality, such
that they include computer structure( s) which serve( s) to
perform generic computer functions that are well-understood,
routine, and conventional activities previously known to the
pertinent industry.
(Ans. 22). In this regard, we note that the steps for receiving patient
information, generating an event marker based on that information, and
adjusting therapy, i.e., turning on/off a medical device, delivered to the
patient based on the event marker, amount to nothing more than mere
instructions to implement the abstract idea on a computer-none of which
add an inventive concept because they merely require the application of
conventional, well-known analytical steps. See Ultramercial, Inc. v. Hulu,
LLC, 772 F.3d 709, 716 (Fed. Cir. 2014) ("[T]he claimed sequence of steps
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comprises only 'conventional steps, specified at a high level of generality,'
which is insufficient to supply an 'inventive concept."' (citing Alice, 134 S.
Ct. at 2357)). Thus, each limitation, at best, does no more than require a
generic computer to perform generic computer functions.
And, considered as an ordered combination, the computer components
of Appellants' independent claim 1 add nothing that is not already present
when the limitations are considered separately. Viewed as a whole,
Appellants' claims simply recite the concept of adjusting therapy delivered
by a medical device based on patient input, i.e., "comparing new and stored
information and using rules to identify options and a formula for updating
alarm limits" (Final Act. 2; Ans. 21 ). The claims do not, for example,
purport to improve the functioning of the computer itself. Nor do they effect
an improvement in any other technology or technical field. Instead, the
claims at issue amount to nothing significantly more than an instruction to
apply the abstract idea, which under our precedents, is not enough to
transform an abstract idea into a patent-eligible invention. See Alice, 134
S. Ct. at 2360.
Appellants' other arguments, including those directed to now-
superseded USPTO guidance, have been considered but are not persuasive
of error. (See 2019 Guidance at 51 ("Eligibility-related guidance issued
prior to the Ninth Edition, R---08.2017 of the MPEP (published Jan. 2018)
should not be relied upon.").)
We are not persuaded, on the present record, that the Examiner erred
in rejecting independent claim 1 under 35 U.S.C. § 101. Therefore, we
sustain the Examiner's rejection of claims 2-10, which fall with independent
claim 1.
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Independent claims 11, 20, and 22, and dependent claims 12-19 and 21
Appellants also separately argue independent claims 11, 20, and 22,
and their respective dependent claims (see Appeal Br. 12-15; Reply Br. 10).
However, independent claims 11, 20, and 22 include language substantially
similar to the language of independent claim 1, and stand rejected based on
the same rationale applied with respect to claim 1 (see Final Act. 2-3).
Aside from reproducing language from independent claims 11, 20, and 22,
and asserting that independent claims 11, 20, and 22 are patent eligible for
the same reasons as independent claim 1, Appellants offer no separate
arguments for the patent-eligibility of these claims.
Therefore, we sustain the Examiner's rejection under 35 U.S.C. § 101
of independent claims 11, 20, and 22, and claims 5-13 and 17-23, which
depend therefrom, for the same reasons set forth above with respect to
independent claim 1.
Obviousness
We are persuaded by Appellants' argument that the Examiner erred in
rejecting independent claim 1 under 35 U.S.C. § 103(a), because Hickle,
upon which the Examiner relies, does not disclose or suggest "restarting [an]
on-cycle if [a] medical device is in the on-cycle at the time [an] event
marker is generated, thereby elongating a duration of the on-cycle of the
therapy cycle implemented by the medical device at the time the event
marker is generated," as recited by limitation [ d3] of independent claim 1,
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and similarly recited by independent claims 11, 20, and 22 (see Appeal Br.
15-18, 20-21, 22-23; see also Reply Br. 11-17).
The Examiner maintains that the rejection is proper, and cites Hickle,
at paragraphs 10 and 29 (Final Act. 6-7). The Examiner also cites to Hickle,
at paragraphs, 24, 29, and 34--35, in the Examiner's Answer (Ans. 23-24).
However, we agree with Appellants that there is nothing in the cited portions
that discloses or suggests the argued limitation.
In making this determination, we note that Osorio is directed to "a
method and a medical device system for screening different configurations
for therapeutic treatment" (Osorio ,r 2). Osorio discloses that its "medical
device detects a neurological event, such as a seizure, and may report a
neurological event focus location, a neurological event spread, an intensity,
and a duration to the user" (id. ,r 7). Osorio describes "[t]he user may use
the information to provide a configuration of a therapeutic delivery unit and
associated therapy parameters" and "[t]he user may modify the configuration
and therapy parameters in order to achieve acceptance" (id.). Osorio's
system "support[ s] a therapeutic delivery unit that delivers a controlled
infusion of a drug or delivers an electrical stimulus through a set of
electrodes that is situated at selected locations of the brain" (id.).
Hickle is directed to "bolus drug delivery in conjunction with
integrated patient monitoring and drug delivery systems" (Hickle ,r 2). More
particularly, Hickle discloses
a drug delivery system that incorporates the benefits of an
integrated patient monitoring system and that quickly brings a
patient to the desired level of sedation or anesthesia while
reducing the risk of overmedication or under-medication, while
giving the clinician the capability to safely and efficiently
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Application 12/236,260
deliver a precise and calculated bolus drug dosage at any point
during the procedure.
(Id. ,r 10). Hickle also describes an embodiment where a user "wish[es] to
confirm a bolus drug delivery outside of the pre-programmed safe drug
level" (id. f 29). However, Hickle describes that its system utilizes
thresholds, "at which point user 13 may no longer deliver a bolus drug
infusion," based on various factors, e.g., age, sex, height weight (id.). In one
example, Hickle describes that "sedation and analgesia system 22 may be
pre-programmed not to exceed a target site concentration drug level of 20
ug/cc, where user 13 is attempting to deliver a bolus drug infusion while
patient 18 is currently at the 20 ug/cc level" (id.). Hickle also describes that
its drug delivery display provides visual data regarding "historical timeline
40, current bar 42, and anticipated timeline 41," as well as "drug level axis
34, drug label 31, and drug unit 32" (id. ,r,r 34--35).
We have reviewed the cited portions of Hickle, as well as the cited
portions of Osorio, and agree with Appellants that none of the cited portions
of Hickle in light of Osorio discloses or suggests the argued limitation. In
the Final Office Action, the Examiner finds that the "thresholds" in Hickle
"may be adjusted to elongate or shorten patient treatment and other
parameters as needed" (Final Act. 7 (citing Hickle ,r 29)). However, the
"thresholds" in Hickle are simply levels upon which "user 13 will not be
allowed to administer the bolus drug infusion and exceed the threshold"
(Hickle ,r 29). Thus, we agree with Appellants that "Hickle does not
disclose that the 'thresholds ... may be adjusted to elongate or shorten
patient treatment and other parameters as needed" (Appeal Br. 16).
Responding to Appellants' argument in the Answer, the Examiner
takes the position that
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Application 12/236,260
Hickle describes a system and process wherein a first and a
second bolus of medication delivered to the patient based upon
the user's response. As understood by the examiner, the ability
to manipulate/ tum on the system to deliver a second and/or
multiple cycles of medication means that the system may be
turned on again (i.e. restarted) based upon user input. As such,
Hickle addresses the claimed limitation of "restarting [an] on-
cycle if [a] medical device is in the on-cycle at the time [an]
event marker is generated .... "
(Ans. 23 (citing Hickle ,r 24)). The Examiner further reasons that Hickle
"discloses that the drug delivery system and method to cycle patient
treatment on and off (par. 34--35), and teaches the use of thresholds which
may be adjusted to elongate or shorten patient treatment and other
parameters as needed" ( Ans. 23 ( citing Hickle ,r,r 29, 34--3 5) ). We cannot
agree.
Instead, we agree with Appellants that
Hickle does not disclose or suggest that a drug was already
being delivered at the time the user makes the initial drug
delivery request, such that there is no support for the
Examiner's assertion that Hickle's initial drug deliver request
restarts an on-cycle, much less elongates a duration of an on-
cycle of a particular therapy cycle implemented by the medical
device at the time the request ( the "event marker" generation,
according to the Examiner) was received.
(Reply Br. 13). Moreover, as discussed above, we do not see, and the
Examiner does not adequately explain, how a patient who is at one of the
"thresholds" described by Hinkle, e.g., a drug level of 20 ug/cc, would be
able to "restart[] the on-cycle if the medical device is in the on-cycle at the
time the event marker is generated, thereby elongating a duration of the on-
cycle of the therapy cycle implemented by the medical device at the time the
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Application 12/236,260
event marker is generated," as called for by limitation [ d3] of independent
claim 1, and similarly recited by independent claims 11, 20, and 22.
In view of the foregoing, we do not sustain the Examiner's rejection
of independent claims 1, 11, 20, and 22 under 35 U.S.C. § 103(a). For the
same reasons, we also do not sustain the Examiner's rejection of claims 2-
10, 12-19, and 21, which depend therefrom.
DECISION
The Examiner's rejection of claims 1-22 under 35 U.S.C. § 101 is
affirmed.
The Examiner's rejection of claims 1-22 under 35 U.S.C. § 103(a) is
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
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