Ex Parte Jolesz et al

Patent Trial and Appeal Board

Oct 25, 2017

13058945 (P.T.A.B. Oct. 25, 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.
13/058,945 05/03/2011 Ferenc Jolesz 129319.00077 5253
26710 7590
QUARLES & BRADY LLP
Attn: IP Docket
411 E. WISCONSIN AVENUE
SUITE 2350
MILWAUKEE, WI 53202-4426
EXAMINER
PARK, PATRICIA JOO YOUNG
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
10/27/2017 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):
pat-dept@quarles.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FERENC JOLESZ, KRISZTINA FISCHER, and
NATHAN MCDANNOLD
Appeal 2015-000980
Application 13/058,945
Technology Center 3700
Before EDWARD A. BROWN, LEE L. STEPINA, and
AMANDA F. WIEKER, Administrative Patent Judges.
BROWN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from the rejection of claims
1—20. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
CLAIMED SUBJECT MATTER
The claimed subject matter is directed to ultrasonic techniques for
modifying kidney filtration. Spec, 3, 19 20.
Appeal 2015-000980
Application 13/058,945
Claims 1, 5, and 14 are independent. Claim 1, reproduced below,
illustrates the claimed subject matter:
1. A method for modifying glomerular permeability in a
subject’s kidney with an ultrasound system, the steps
comprising:
a) administering an ultrasound contrast agent to the
subject; and
b) applying an acoustic energy, with the ultrasound
system, to temporarily modify glomerular filtration in the
kidney during a passage of the ultrasonic contrast agent through
the subject’s kidney.
REJECTIONS
I. Claims 1 and 3 stand rejected under 35U.S.C. § 101 as
unpatentable for being directed to non-statutory subject matter.
II. Claims 1 and 2 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Gelfand (US 2004/0163655 Al, pub. Aug. 26, 2004),
Prausnitz (US 2007/0073197 Al, pub. Mar. 29, 2007), and Miller et al.
{Bioeffects Considerations for Diagnostic Ultrasound Contrast Agents, 27 J.
Ultrasound Med. 611, 632 (2008)).
III. Claims 3 and 4 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Gelfand, Prausnitz, Miller, and Salmon et al. (Evidence
for restriction of fluid and solute movement across the glomerular capillary
wall by the subpodocyte space, 293 Am. J. Physiol. Renal Physiol. FI777,
F1786 (2007)).
IV. Claims 5—7, 9-14, and 16—20 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Vortman (US 2009/0088623 Al, pub. Apr. 2,
2009), Prausnitz, and Miller.
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V. Claims 8 and 15 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Vortman, Prausnitz, Miller, and Emery (US
2002/0082501 Al, pub. June 27, 2002).
DISCUSSION
Rejection I—35 U.S.C. §101
In rejecting claim 1 under 35 U.S.C. § 101, the Examiner applies the
two-step framework set forth in Mayo Collaborative Services v. Prometheus
Laboratories, Inc., 132 S. Ct. 1289, 1296—97 (2012) and reiterated in Alice
Corp. Pty. Ltd. v. CLS Bank International, 134 S. Ct. 2347, 2355 (2014). In
this framework, the first step considers whether the claims are “directed to”
a patent-ineligible concept, for example, a law of nature or natural
phenomenon, and the second step considers whether the claims, individually
and as an ordered combination, recite an inventive concept—an element or
combination of elements sufficient to ensure the claims amount to
“significantly more” than the abstract idea and transform the nature of the
claims into a patent-eligible concept. As for the first step of the analysis, the
Examiner finds the claims are directed to the law of nature and/or the natural
phenomenon of “temporarily modifying] glomerular filtration in the
kidney.” Final Act. 4; see also Ans. 14. As for the second step, the
Examiner finds the claims do not recite additional limitations amounting to
“significantly more” than the claimed law of nature or natural phenomenon,
because the additional limitations only involve well-understood, routine, and
conventional activity. Ans. 14. Specifically, the Examiner finds that
“applying acoustic energy with agent to a designated target” is conventional
in the field of ultrasound imaging/therapy. Id.
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Appellants contend that the claim is directed to express method steps
of administering an ultrasonic contrast agent and applying acoustic energy
via an ultrasound system. Br. 5. Appellants further contend applying
acoustic energy using an ultrasound system during passage of contrast agent
through a subject’s kidney, to temporarily modify glomerular filtration,
cannot be construed as conventional or routine practice. Id. at 6.
Appellants’ contentions are persuasive. First, method steps effecting
a transformation or reduction of a particular article to a different state or
thing may be enough to provide significantly more. See Diamond v. Diehr,
450 U.S. 175, 184 (1981). Here, the claim requires “applying an acoustic
energy, with the ultrasound system, to temporarily modify glomerular
filtration in the kidney during a passage of the ultrasonic contrast agent
through the subject’s kidney” (emphasis added). Thus, the claim is directed
to specific steps using a contrast agent and acoustic energy via ultrasound to
effect a physical transformation in the glomerulus of a kidney to a more
permeable state, thereby temporarily modifying glomerular filtration.
Second, courts have held that additional limitations that are well-
understood, routine, conventional activities and specified at a high level of
generality may fail to provide significantly more (see, e.g., Mayo, 132 S. Ct.
at 1303). In this case, however, the Examiner does not establish, with
evidence, that the additional limitations are well-understood, routine, and/or
conventional. Even assuming, arguendo, that applying acoustic energy
during passage of a contrast agent in a designated target was well-
understood, routine, conventional activity, as asserted by the Examiner, the
claim specifically requires applying acoustic energy during passage of the
contrast agent through the subject’s kidney. The Examiner does not
sufficiently show that it was well-understood, routine, or conventional that
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such designated targets include the kidney. Additionally, the Examiner does
not establish sufficiently that the additional limitations are specified at a high
level of generality.
For these reasons, we do not sustain the Examiner’s determination
that claim 1, and claim 3 depending therefrom, is directed to non-statutory
subject matter.
Rejection II—35 U.S.C. § 103: Gelfand, Prausnitz, and Miller
Claim 1
Regarding claim 1, the Examiner finds Gelfand discloses altering
glomerular permeability in the kidney, but does not disclose altering
glomerular permeability via application of acoustic energy with an
ultrasound system. Final Act. 6. The Examiner relies on Prausnitz to cure
this deficiency, finding Prausnitz discloses altering glomerular permeability
by applying acoustic energy with an ultrasound system. Id. The Examiner
concludes it would have been obvious to combine Gelfand with Prausnitz,
because altering the permeability of the glomerulus via acoustic energy from
an ultrasound system is “well known in the art and suitable for use in the
method of altering permeability.” Id.
First, Appellants argue that the proposed combination fails to disclose
all the elements of the claim. Br. 7. Specifically, Appellants point out that
Gelfand discloses reducing glomerular filtration rate, not altering
glomerular permeability. Id. Second, Appellants argue that the Examiner
provided insufficient motivation to combine Gelfand with Prausnitz. On
both counts, Appellants have apprised us of Examiner error.
As correctly pointed out by Appellants, Gelfand does not disclose
modifying glomerular permeability in the kidney. Rather, Gelfand discloses
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modifying glomerular filtration rate. Gelfand discloses that the filtration
rate is altered via changes in blood and/or urine pressure (rather than via
changes in permeability). Id. (citing Gelfand 126). As noted by Appellants,
Gelfand is silent as to permeability. Id. at 8. Therefore, we are persuaded of
error regarding the finding that Gelfand discloses altering permeability.
Furthermore, Gelfand seeks to reduce glomerular filtration rate (id. at
7), whereas Prausnitz seeks to increase glomerular filtration rate (by
increasing glomerular permeability using ultrasound) (id. at 10). See
Gelfand 126; Prausnitz 125. Stated differently, although both Gelfand and
Prausnitz “alter” glomerular filtration rate, the references do so in opposite
ways. As Gelfand seeks to reduce filtration, modifying Gelfand with the
ultrasound system of Prausnitz would appear to increase filtration
undesirably. Accordingly, the Examiner’s reasoning that altering
permeability with ultrasound is well-known in the art and suitable for use in
Gelfand’s method is flawed also. Specifically, the Examiner does not
provide sufficient evidence or technical reasoning to show why one of
ordinary skill in the art would have used Prausnitz’s ultrasound in Gelfand’s
method of reducing glomerular filtration rate. Therefore, we are persuaded
that the Examiner does not provide an adequate reason with a rational
underpinning to combine Gelfand and Prausnitz.
Claim 2
The rejection of claim 2, which depends from claim 1, suffers from
the same deficiencies as the rejection of claim 1. Therefore, we likewise do
not sustain the rejection of claim 2 over Gelfand, Prausnitz, and Miller.
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Rejection III—35 U.S.C. §103: Gelfand, Prausnitz, Miller, and Salmon
For the reasons discussed above (rejection II), the rejection of
dependent claims 3 and 4 suffers from the same deficiencies as the rejection
of claim 1. The Examiner’s reliance on Salmon does not cure these
deficiencies. See Final Act. 7—9. Therefore, we likewise do not sustain the
rejection of claims 3 and 4 over Gelfand, Prausnitz, Miller, and Salmon.
Rejection IV—35 U.S.C. § 103: Vortman, Prausnitz, and Miller
Claims 5—7 and 9-13
Appellants argue for patentability of claims 5—7 and 9—13 together.
See Br. 14—17. We select claim 5 as the representative claim, and claims 6,
7, and 9-13 stand or fall with claim 5. See 37 C.F.R. § 41.37(c)(l)(iv).
Regarding claim 5, the Examiner finds Vortman discloses an image-
guided ultrasound system including a processor configured to direct an
ultrasonic transducer to apply acoustic energy to identified locations through
the kidney. Final Act. 9; Ans. 21; see also Vortman || 28—29 (discussing
therapeutically destroying tissue mass such as tumors with acoustic energy).
The Examiner acknowledges that Vortman does not explicitly disclose an
ultrasonic contrast agent or temporarily-modified glomerular permeability or
filtration with the applied acoustic energy. Final Act. 9-10.
The Examiner relies on Miller to disclose the well-known use of an
ultrasonic contrast agent with ultrasound, resulting in a better use of acoustic
energy application. Final Act. 10.
To cure the other deficiency of Vortman, the Examiner relies on
Prausnitz to disclose that acoustic energy can be used therapeutically, for
example, to temporarily modify the permeability of biological membranes or
to destroy tissue mass. Id. at 10; see also Prausnitz || 13, 25 (acoustic
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energy can be used for “destruction of tissue such as cancers . . . [and]
kidney . . . stones” and “increases the permeability of the biological barrier
. . . reversibly”). The Examiner concludes it would have been obvious to
incorporate the teachings of Prausnitz into Vortman’s method, as it was
known to adjust acoustic energy/ultrasonic parameters to achieve
temporarily modified membrane permeability, and doing so is “well known
in the art and suitable for use in . . . therapy.” Final Act. 10; Ans. 20—21. In
the alternative, the Examiner concludes it would have been obvious to
incorporate Vortman’s image-guiding into Prausnitz’s method to provide
target visualization and localization. Ans. 21.
Appellants argue that (1) Vortman fails to disclose the target region
being a “kidney,” (2) Prausnitz fails to disclose “how” one could use
ultrasound to modify permeability specifically in the kidney, (3) the
Examiner failed to establish a motivation, and (4) the Vortman-Prausnitz-
Miller combination is contrary to the purpose of the references, because
Vortman uses acoustic energy to destroy tissue rather than temporarily
modify tissue permeability. See Br. 15—17.
Appellants’ contentions are not persuasive. Regarding Appellants’
argument that Vortman does not disclose the kidney region in particular (Br.
15), as pointed out by the Examiner, Vortman discloses monitoring any
target tissue in the body. Ans. 20. Additionally, Vortman discloses
accounting for kidney movement during imaging of a target tissue mass,
which suggests the target can be within the kidney. Vortman 144.
Regarding Appellants’ argument that Prausnitz, which generally
discloses modifying permeability of nonspecific biological membranes, fails
to disclose how one could use ultrasound to modify permeability (and
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therefore filtration) specifically in the kidney (Br. 15—16), we are not
persuaded.
The obviousness analysis “can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). We are apprised of no
error in the Examiner’s position that the ordinarily-skilled artisan would
have taken routine steps to “adjust ultrasonic parameters” to temporarily
modify the permeability and filtration property of the kidney, based on the
combined teachings of Vortman, Prausnitz, and Miller. Ans. 20-21; see also
KSR, 550 U.S. at 421 (“A person of ordinary skill is also a person of
ordinary creativity, not an automaton”); Ball Aerosol & Specialty Container,
Inc. v. Limited Brands, Inc., 555 F.3d 984, 993 (Fed. Cir. 2009) (the PTO
must take account of “the inferences and creative steps,” as well as routine
steps, an ordinary artisan would employ).
Appellants’ argument that the Examiner failed to provide a motivation
or sufficient reasoning (Br. 16—17) is also not persuasive. Based on the
findings that Vortman discloses destroying tissue mass (Vortman 129), and
Prausnitz teaches both destroying tissue mass and temporarily altering
permeability (Prausnitz || 25, 13, 10), we are not apprised of error with
respect to the Examiner’s reasoning, which we understand is that destroying
tissue mass and altering permeability are art recognized approaches suitable
for the intended use of therapeutically treating tissue. See Final Act. 10.
Further, the Examiner provides alternative reasoning in support of the
combination of Vortman, Prausnitz, and Miller (Ans. 21), to which
Appellants did not respond.
Regarding Appellants’ argument that the Vortman and Prausnitz
procedures are incompatible (Br. 17), we are not persuaded. Vortman
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discloses the use of ultrasound in a kidney to destroy tissue. Vortman 129.
Similarly, Prausnitz discloses the use of ultrasound in a kidney to destroy
tissue and an alternative use of ultrasound to temporarily modify biological
membrane permeability. Prausnitz || 25, 13. Accordingly, both are related
to the use of ultrasound to therapeutically treat tissue, and Appellants have
not persuaded us that the teachings of the references are incompatible, or
that the proposed combination is contrary to the express purposes of the
references.
Furthermore, because Appellants have not addressed persuasively the
Examiner’s alternative combination (i.e., modifying Prausnitz with image-
guiding in the kidney as disclosed by Vortman), we also do not see any
incompatibility regarding this alternative proposed combination of
references and reasoning set forth by the Examiner. See Ans. 21.
For these reasons, we sustain the Examiner’s decision rejecting claim
5. Claims 6—7 and 9-13 fall with claim 1.
Claims 14 and 16—20
Regarding claims 14 and 16—20, Appellants make similar arguments
as for those for claim 5. See Br. 18—20. As discussed above, those
arguments are not persuasive. Therefore, we are not apprised of Examiner
error, and we sustain the rejection of claims 14 and 16—20.
Rejection V—35 U.S.C. § 103: Vortman, Prausnitz, Miller, and Emery
Claims 8 and 15 depend from claims 5 and 14, respectively.
Appellants do not substantially address this rejection. See Appeal Br.
21. Consequently, Appellants have waived any argument of error, and we
summarily sustain this rejection. See 37 C.F.R. § 41.31(c); see also Hyatt v.
Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (“When the appellant fails to
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contest a ground of rejection, ... the Board may treat any argument with
respect to that ground of rejection as waived.”).
DECISION
We reverse the rejection of claims 1 and 3 as directed to non-statutory
subject matter.
We reverse the rejection of claims 1 and 2 as unpatentable over
Gelfand, Prausnitz, and Miller.
We reverse the rejection of claims 3 and 4 as unpatentable over
Gelfand, Prausnitz, Miller, and Salmon.
We affirm the rejection of claims 5—7, 9-14 and 16—20 as
unpatentable over Vortman, Prausnitz, and Miller.
We affirm the rejection of claims 8 and 15 as unpatentable over
Vortman, Prausnitz, Miller, and Emery.
No time period for taking any subsequent action in connection with
this appeal maybe extended according to 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED-IN-PART
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