Ex Parte Southard et al

Patent Trial and Appeal Board

Oct 30, 2017

13656563 (P.T.A.B. Oct. 30, 2017)

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.
13/656,563 10/19/2012 Jeanette E. Southard 101672.0169P 5012
34284 7590
Rutan & Tucker, LLP
611 ANTON BLVD
SUITE 1400
COSTA MESA, CA 92626
EXAMINER
SUNWOO, NATE S
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
11/01/2017 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):
patents @ rutan. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JEANETTE E. SOUTHARD, JEREMY B. COX,
PAUL D. MORGAN, and SHAYNE MESSERLY
Appeal 2016-002878
Application 13/656,5631
Technology Center 3700
Before TAWEN CHANG, RYAN H. FLAX, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to systems and
methods for assisting in the placement of a catheter within the body of a
patient through the use of an ultrasound imaging system. The Examiner
entered final rejections for obviousness, improper claim format, and because
the claims are directed to nonstatutory subject matter.
We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE.
1 Appellants identify the Real Party in Interest as C.R. Bard, Inc. App. Br. 4.
Appeal 2016-002878
Application 13/656,563
STATEMENT OF THE CASE
Background
The Specification discloses:
Briefly summarized, embodiments of the present
invention are directed to systems and methods for assisting the
placement of a medical device, such as a catheter, within a
vessel or other suitable location within the body of a patient
through the use of an ultrasound imaging system. In particular,
the systems and methods described herein enable a clinician to
determine, prior to insertion of the medical device, how much
of the device will be disposed within the vessel, thus enabling
the clinician to choose a catheter with suitable length so as to
ensure a sufficient portion of the catheter is disposed within the
vessel.
Spec. 12.
The Claims
Claims 1—8, 10-19, and 22—33 are on appeal. Final Act. I.2 Claims
1, 12, 22, and 26 are illustrative and read as follows, with the relevant
language at issue highlighted in each claim:
1. An ultrasound imaging system for assisting with
placement of a medical device near a target location within a
blood vessel in a body of a patient, the system comprising:
a console;
a probe that remains external to the body and produces an
ultrasound image of the target location;
a processor;
a memory including instructions capable of causing the
processor, prior to insertion of the medical device into the body,
to process data to determine a depth of the target location in the
body, and to process data, including the depth of the target
2 Examiner’s Final Action, mailed December 5, 2014.
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location, to determine a length of the medical device that will
be disposed within the blood vessel when the medical device is
inserted into the body; and
a display for depicting the ultrasound image and the
length of the medical device that will be disposed within the
blood vessel.
12. A method for conveying information from an
ultrasound imaging system relating to insertion of a medical
device into a patient body, the method comprising:
depicting an ultrasonic image of at least one target
location within the patient body on a display, the ultrasonic
image obtained from a probe that remains external to the patient
body;
causing a processor of the ultrasound imaging system,
prior to insertion of the medical device into the patient body, to
process data to determine a depth of the at least one target
location in the patient body, and to process data, including the
depth of the at least one target location, to determine an
internal length of the medical device that will be disposed
within the patient body after the at least one target location
when the medical device is inserted into the patient body; and
displaying the depth of the at least one target location and
the internal length of the medical device on the display with the
ultrasonic image, the depth of the at least one target location
correlated with the ultrasonic image.
22. A non-transitory, computer-readable medium
including computer executable code that, when executed,
causes a processor to process data to perform the following in
relation to the insertion of a medical device into a patient body:
depict on a display of an ultrasound imaging system an
ultrasonic image of at least one target location within the patient
body, the ultrasonic image obtained from a probe that remains
external to the patient body;
determine, prior to insertion of the medical device into
the patient body, a depth of the at least one target location in the
patient body;
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determine an internal length of the medical device that
will be disposed within the patient body after the at least one
target location when the medical device is inserted into the
patient body; and
display the depth of the at least one target location and
the internal length of the medical device on the display with the
ultrasonic image, the depth of the at least one target location
correlated the ultrasonic image.
26. A method of using an ultrasonic imaging system in
inserting a catheter into a vessel of a patient, the method
comprising:
inputting into the ultrasound imaging system an overall
length of the catheter to be inserted into the vessel;
ultrasonically imaging for depiction on a display the
vessel with a probe of the ultrasound imaging device, the probe
remaining external to the patient;
observing information provided by the ultrasound
imaging system prior to catheter insertion, the information
including an insertion length of a distal portion of the catheter
that would be entirely disposed within the vessel after catheter
insertion; and
inserting the catheter into the vessel such that the
insertion length of the distal portion is entirely disposed within
the vessel.
App. Br. 32—36 (Claims Appendix).
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The following rejections are before us to review:
Claims 1, 12, 22, and 26 are rejected under 35 U.S.C. § 101 as
directed to nonstatutory subject matter. Ans. 2.
Claims 8, 24, and 33 are rejected under 35 U.S.C. § 112, second
paragraph, as indefinite. Id. at 3.
Claims 1—3, 10, 12, 13, 19, 22, 26—28, and 31 are rejected under pre-
AIA 35 U.S.C. § 103(a) as obvious over Park.3 Id.
Claims 4—6, 14, 15, 29, 30, and 32 are rejected under pre-AIA
35 U.S.C. § 103(a) as obvious over and Rold.4 Id. at 6.
Claims 7, 8, and 18 are rejected under pre-AIA 35 U.S.C. § 103(a) as
obvious over Park, Rold, and Schmitt.5 Id. at 8.
Claim 11 is rejected under pre-AIA 35 U.S.C. § 103(a) as obvious
over Park and Beasley.6 Id. at 9.
Claims 16, 17, and 23—25 are rejected under pre-AIA 35 U.S.C.
§ 103(a) as obvious over Park, Rold, and Anderson.7 Id. at 10.
Claim 33 is rejected under pre-AIA 35 U.S.C. § 103(a) as obvious
over Park and Sheetz.8 Id. at 11.
I—PATENT-INELIGIBLE SUBJECT MATTER
In analyzing patent eligibility under 35 U.S.C. § 101, the Supreme
Court has set forth a “framework for distinguishing patents that claim
3 US 2007/0073155 Al, pub. Mar. 29, 2007 (“Park”).
4 US 2008/0051657 Al, pub. Feb. 28, 2008 (“Rold”).
5 US 2011/0071404 Al, pub. Mar. 24, 2011 (“Schmitt”).
6 US 2008/0033293 Al, pub. Feb. 7, 2008 (“Beasley”).
7 US 2007/0043341 Al, pub. Feb. 22, 2007 (“Anderson”)
8 US 2010/0211026 A2, pub. Aug. 19, 2010 (“Sheetz”).
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[patent-ineligible] laws of nature, natural phenomena, and abstract ideas
from those that claim patent-eligible applications of those concepts.” Alice
Corp. Pty. Ltd. v. CLS Bank Inti, 134 S. Ct. 2347, 2355 (2014). According
to that framework, first “we determine whether the claims at issue are
directed to one of those patent-ineligible concepts.” Id. “If so, we then ask,
‘[w]hat else is there in the claims before us?’” Id. (quoting Mayo
Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 78 (2012)). To
answer this second question,
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. [The Supreme Court has] described step two of this
analysis 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
upon the [ineligible concept] itself.
Id. (internal citations and quotation marks omitted).
The Examiner rejected claims 1, 12, 22, and 26 as directed to
nonstatutory subject matter. Ans. 2. According to the Examiner, the claims
are “directed to abstract ideas that do not amount to significantly more than
the ideas themselves or mathematical relationships [that] are directed to the
abstract idea of determining/anticipating proximity of an entity to a target by
using the mathematical concept of length.” Id. For step two of the analysis,
the Examiner concluded that the
additional limitations are no more than a field of use [i.e.,
linking the use of the abstract idea to a particular technological
environment such as medical in a general sense] or merely
involve extra solution activity [e.g., data gathering with a
generic/nominal probe, processing the abstract idea on a
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generic/nominal computer, and displaying information on a
generic/nominal display].
Id.
The Examiner did not separately address claims 1, 12, 22, and 26 as to
the § 101 rejection, but rejected the claims together based on the reasoning
described above. Our analysis focuses on claim 12 as representative.
Appellants argue the claims are not directed to an abstract idea and
that simply because “one particular mathematical concept might be used in
discrete aspects of the claims (i.e., ‘using the mathematical concept of
length’),” this fact “does not render the claims non-statutory.” App. Br. 12—
13. Appellants contend, inter alia, the Examiner erred in focusing on a
particular limitation in isolation — a mathematical formula — without
considering the claimed application of “depicting an ultrasonic image and
displaying the depth of the at least one target location” {id. at 14—15) and
that use of the formula does not preempt others from “the entire universe of
that operation.” Reply Br. 6. Appellants contend claim 12, along with the
other claims, “add[s] significantly more structure that improve[s] the
technology,” including the physical components recited in claim 1, the
“console, probe and display.” Id. at 7. Appellants contend that, like
Example 24 set forth in the USPTO’s July 2015 Guidance on Subject Matter
Eligibility, the claim9 “is not directed to an exception, even though it recites
a mathematical operation to be performed . . . [and] the remainder of the
claim cites specific structure (manifolds, valves, sensors, etc.) that clearly
amounts to significantly more than any recited exception.” Id. at 4—6.
9 Appellants reference claim 1 in this argument, but advance the same
argument with respect to all claims. See, e.g., Reply Br. 4—8.
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Under step one of the Alice!Mayo framework, we ask whether claim
12 is directed to a patent ineligible concept, such as an abstract idea.
Because all inventions, at some level, embody or apply laws of nature,
abstract ideas, etc., we must “ensure at step one that we articulate what the
claims are directed to with enough specificity to ensure the step one inquiry
is meaningful.” Thales Visionix Inc. v. U.S., 850 F.3d 1343, 1347 (Fed. Cir.
2017); see also Alice, 134 S. Ct. at 2354 (“[W]e tread carefully in construing
this exclusionary principle lest it swallow all of patent law.”). Moreover,
even at step one, it is appropriate to consider whether the claims are directed
to a technological improvement. Enfish, LLC. v. Microsoft Corp., 822 F.3d
1327, 1335 (Fed. Cir. 2016) (holding it is “relevant to ask whether the
claims are directed to an improvement to computer functionality versus
being directed to an abstract idea, even at the first step of the Alice
analysis”).
We are unpersuaded the Examiner has properly characterized
Appellants’ invention under step one. As mentioned above, the Examiner
finds that claim 12 is directed to the abstract idea of “of
determining/anticipating proximity of an entity to a target by using the
mathematical concept of length.” Ans. 2. Inasmuch as the Examiner is
referring to the mathematical functions recited in the claim, those functions
might be characterized as abstract. Yet focusing on the math alone
overgeneralizes the claim, which requires more.
Appellants’ invention requires the orchestrated interaction of various
elements (including a medical device inserted into a patient, a processor that
calculates the internal length of the medical device that will be disposed
within the patient body after the target location is reached, a probe that
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generates an ultrasonic image of the inserted device, and a device on which
the image will be displayed) to “enable[e] the clinician to choose a catheter
with suitable length so as to ensure a sufficient portion of the catheter is
disposed within the vessel.” See, e.g., claim 12 and Spec. 12. To be sure,
mathematical relationships are necessary — indeed critical — to carry out
the claimed method. But, heeding the Supreme Court’s and Federal
Circuit’s cautions, we are not persuaded the mere presence of a
mathematical equation means the claims are directed to an abstract idea. See
Alice, 134 S. Ct. at 2354; Thales, 850 F.3d at 1349 (“That a mathematical
equation is required to complete the claimed method and system does not
doom the claims to abstraction.”).
Under step one of the Alice!Mayo framework, we instead find claim
12 is directed to using an ultrasound imaging system to determine an internal
length of a medical device that will be inserted within a patient’s body after
the target location is reached. See, e.g., Spec. 137. Characterized in this
way, claim 12 is sufficiently concrete and non-abstract.
Although moving to step two of the Alice!Mayo framework is not
necessary, we nevertheless do so for the sake of completeness.10 As
described below, even if claim 12 was directed to an abstract idea based on
the Examiner’s characterization, the combination of claim elements provide
a sufficient “inventive concept” to satisfy the requirements of § 101.
Claim 12 requires an arrangement of components that are necessary to
determine the depth to which a medical device should be inserted.
10 Thales, 850 F.3d at 1349 (“Because we find the claims are not directed to
an abstract idea, we need not proceed to step two.”).
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According to the claimed steps, the various components process data to
determine a depth of at least one target location in the patient’s body, display
the depth of the location, and depict the inserted medical device during the
procedure to permit the medical practitioner to accurately reach the target
device based on the planned trajectory. As noted above, this requires at least
a console, probe, processor and display. The Examiner asserts this is simply
a field of use or merely involves extra-solution activity. Ans. 2. But the
Examiner does not support this assertion with adequate evidence. Among
other things, the Examiner does not show that using a processor and probe in
combination with the calculations performed, is merely conventional or
routine. Reply Br. 7. Neither does the Examiner show that such
calculations were known and useful, much less routine or conventional, for
calculating the internal length of the medical device that will be disposed
within the patient’s body after the at least one target location is reached. In
these respects, the unique configuration of steps and features of claim 12 is
comparable to the patent-eligible claims in Thales that recited a unique
configuration of inertial sensors that used a mathematical equation to
calculate an object’s location on a platform. Thales, 850 F.3d at 1345; see
also Diamond v. Diehr, 450 U.S. 175, 188 (1981) (holding that a claim
drawn to an improved rubber-curing process that used a mathematical
equation was patent eligible under § 101).
We also contrast the claims here with the patent-ineligible claims in
Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016),
which were directed to monitoring a power grid. In Electric Power, the
Federal Circuit found the claimed process did not differentiate from an
“ordinary mental process,” and did “not even require a new source or type of
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information, or new techniques for analyzing it.” 830 F.3d at 1355. The
court further found the claims did not “require an arguably inventive set of
components or methods, such as measurement devices or techniques, that
would generate new data” or “invoke any assertedly inventive
programming.” Id. Appellants’ claim 12 does not have the same
shortcomings. For example, claim 12 recites calculation of a new type of
information (e.g., “process data to determine a depth of the at least one
target location in the patient body, and to process data, including the depth
of the at least one target location, to determine an internal length of the
medical device that will be disposed within the patient body after the at least
one target location when the medical device is inserted into the patient
body”).
In sum, we are persuaded claim 12 requires a unique set of steps and
arrangement of features to produce new data, and to use that data for a
practical and improved effect — calculation of the internal length of the
medical device that will be disposed within the patient’s body after the at
least one target location is reached. Claim 12 thus includes a sufficient
inventive concept and recites patent-eligible subject matter under § 101.
For the reasons explained above, we reverse the Examiner’s rejection
of claim 12 (and the related rejection of claims 1, 22, and 26) under
35U.S.C. § 101.
II-INDEFINITENESS
The Examiner has rejected claims 8, 24, and 33 as indefinite for lack
of an antecedent basis. Ans. 2—3. In rejecting claim 8, the Examiner finds
claim 8 “recites the limitation ‘the catheter’” without sufficient antecedent
basis. Id.
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However, we agree with Appellants that, “[i]n the context of claim 8
‘the catheter’ does not confuse because it merely adds specificity to claim
1 ’s requirement that a medical device be disposed within the blood vessel”
and that the catheter refers to the medical device being inserted. App. Br.
17; Reply Br. 9. We further agree that the multiple disclosures regarding use
of a catheter in the Specification clarify the meaning of “the catheter” in
claim 8. App. Br. 16.
In view of the foregoing, we reverse the Examiner’s rejection under
35 U.S.C. § 112, second paragraph, of claim 8. See Orthokinetics, Inc. v.
Safety Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986) (The test
for definiteness under 35 U.S.C. § 112, second paragraph, is whether “those
skilled in the art would understand what is claimed when the claim is read in
light of the specification.”).
In rejecting claims 24 and 33 under 35 U.S.C. § 112, second
paragraph, the Examiner finds these claims recite “the proximity
information” without sufficient antecedent basis. Ans. 3.
However, we agree with Appellants that that use of the term in the
claims and the explicit definitions of the phrase provided in the Specification
would permit the skilled artisan to understand what is meant by these terms
in the claims. App. Br. 17—18; Reply Br. 10.
In view of the foregoing, we reverse the Examiner’s rejection under
35 U.S.C. § 112, second paragraph, of claims 24 and 33. See Orthokinetics,
806 F.2d at 1576.
Ill-OBVIOUSNESS
The Examiner has rejected each independent claim as obvious over
Park, and each dependent claim as obvious over Park alone or in
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combination with additional references: Rold, Schmitt, Beasley, Anderson,
and Sheetz. Ans. 3—11. The Examiner finds that these references, in the
stated combinations, suggest to the ordinarily skilled artisan each limitation
of the pending claims. Id.
Specifically with regard to the issues on appeal, the Examiner finds
that “Park teaches a way to determine the length of insertion depth, 8, of the
medical device.” Id. at 4. The Examiner cites the following teaching of
Park for this finding:
The insertion distance 8 for needle 50 may be obtained from the
insertion angle 02 and other known distances which may be
stored with the X, Y Position Parameters discussed earlier. For
example, the insertion depth may be determined from 02, the
distance from surface 37 and target 64, the horizontal distance
between the needle shaft centerline (at the needle clip) and the
scanning plane B and the vertical distance between the needle
shaft centerline (at the needle clip) and the bottom surface of
probe 30.
Park 166. The Examiner finds that “the length of the medical device that
will be disposed within the blood vessel when the medical device is inserted
into the body is the difference between the overall length of the medical
device and the insertion depth.” Ans. 4. The Examiner concludes it would
have been obvious for the skilled artisan
to include instructions to the memory for determining the length
of the medical device that will be disposed within the blood
vessel when the medical device is inserted into the body and to
configure the display to depict the length, in order to ensure that
the distal end of the medical device does not puncture through
the other side of the vessel.
Id.
Appellants argue that Park does not teach two limitations critical to
every rejected claim. According to Appellants, “Park does not teach causing
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a processor to determine the length of the medical device inside the patient’s
body. Second, Park does not teach displaying the length of the medical
devices within the patient’s body.” App. Br. 19—23.
Appellants argue first that because the “inserted length” of a medical
device will naturally be different from the “overall length” of the device, that
the skilled artisan must account for this difference in measuring, e.g. “a
length of the medical device that will be disposed within the blood vessel.”
App. Br. 19. Appellants argue claim 1 requires that the processor
“determine a length of the medical device that will be disposed within the
blood vessel,” but Park does not teach any method to identify that length of
the device within the blood vessel. Id. at 20. Appellants argue that because
Park does not teach identifying the portion of the device “disposed within
the blood vessel,” that Park additionally does not teach “displaying the
length of the medical device disposed within the blood vessel.” Id. at 21.
We agree with Appellants that the Examiner has not shown that Park
identifies the portion of the device disposed within the blood vessel and
displays that portion, as required by claim 1. The relevant section of Park is
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cited above. Figure 3 A of Park, cited by Appellants, shows a needle length
being measured by an ultrasound probe, and is reproduced below:
Fig. 3A
Figure 3 A is a “side view of the ultrasound probe of FIG. 2A and needle
mounted thereto corresponding to the monitor image of FIG. 3, with the
probe placed on the patient and after the needle has been placed at a target
within the patient and the probe is enclosed in a sterile shell.” Park 138.
Park discloses using an ultrasound needle guidance system to assist in
placement of a needle in a target of interest within a patient’s body. Park H
16, 65, 66. However, as noted by the Appellants, Park’s focus is on
identifying a target location (e.g., target depth), to which point within the
patient’s body the medical device can be inserted to reach. App. Br. 19-21.
Park does not disclose differentiating between any portions of the device as
it is inserted, including identifying which portion of the device may reside
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within a blood vessel, determining the length of an inserted portion, or
displaying that measured portion.
We are not persuaded by the Examiner’s explanation that modifying
Park to ‘“[depict] the length of the medical device that will be disposed
within the blood vessel’ as claimed would have been obvious to one of
ordinary skill in the art [and] would have required only a routine and
conventional skill in the art to bring about a predictable result.” Ans. 16.
The Examiner has not identified a teaching or other disclosure in Park of a
mechanism for measuring the specific section of the device that is disposed
within the blood vessel, and has not provided a basis for concluding that the
proposed modification would have been routine or conventional based upon
other knowledge in the art.
A prima facie case for obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003), and “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007). Absent this showing, we are constrained to reverse the rejection
of claim 1. We likewise reverse the rejection for independent claims 12, 22,
and 26, as each claim includes a similar requirement, to “determine an
internal length of the medical device that will be disposed within the patient
body” (claims 12, 22) and “observing information . . . including an insertion
length of a distal portion of the catheter that would be entirely disposed
within the vessel. . . and inserting the catheter into the vessel such that the
insertion length of the distal portion is entirely disposed within the vessel”
(claim 26). Furthermore, as each of the Examiner’s obviousness rejections
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is based upon the Examiner’s finding that Park renders obvious this
limitation of the independent claims, we reverse all of the rejections for the
same reason.
SUMMARY
We reverse all of the rejections on appeal.
REVERSED
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