THE REGENTS OF THE UNIVERSITY OF MICHIGAN

Patent Trials and Appeals Board

Sep 29, 2021

2021002190 (P.T.A.B. Sep. 29, 2021)

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.
15/583,852 05/01/2017 Timothy L. HALL 10860-705.300 / UM-5222 1002
66854 7590 09/29/2021
SHAY GLENN LLP
2929 CAMPUS DRIVE
SUITE 225
SAN MATEO, CA 94403
EXAMINER
SAKAMOTO, COLIN T
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
09/29/2021 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):
info@shayglenn.com
shayglenn_pair@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TIMOTHY L. HALL, ADAM MAXWELL,
CHARLES A. CAIN, YOHAN KIM, and ZHEN XU
Appeal 2021-002190
Application 15/583,852
Technology Center 3700
Before STEFAN STAICOVICI, BENJAMIN D. M. WOOD, and
MICHAEL L. WOODS, Administrative Patent Judges.
WOOD, 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 1–13. Claims 14–20 have been
withdrawn. Appeal Br. 8–9 (Claims App.). We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 “Appellant” refers to the applicant as defined in 37 C.F.R. § 1.42(a).
Appellant identifies the real party in interest as The Regents of the
University of Michigan. Appeal Br. 2.
Appeal 2021-002190
Application 15/583,852

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CLAIMED SUBJECT MATTER
The claims are directed to ultrasound therapy systems. Claim 1,
reproduced below, is illustrative of the claimed subject matter:
1. An ultrasound therapy system, comprising:
an array housing including a plurality of openings;
a plurality of transducer module housings adapted to be
inserted into the plurality of openings of the array housing, each
of the plurality of transducer module housings comprising:
a transducer element; an acoustic lens; and
a matching layer disposed between the transducer element
and the acoustic lens; wherein the plurality of openings of the
array housing are arranged so as to align the transducer
elements to share a common focal point, wherein the transducer
elements are configured to apply therapeutic ultrasound energy
to tissue positioned at the common focal point.

REFERENCES
Name Reference Date
Talish US 2002/0145091 A1 Oct. 10, 2002
Dan US 2007/0161902 A1 July 12, 2007
Lee US 2012/0029393 A1 Feb. 2, 2012
Auboiroux WO 2011/154654 A2 Dec. 15, 2011

K. Kirk Shung, Diagnostic Ultrasound: Imaging and Blood Flow
Measurements (CRC Press 2006) (“Shung”).
David Bak, Rapid Prototyping or Rapid Production? 3D Printing
Processes Move Industry Towards the Latter, 23 Assembly
Automation 340 (MCP UP Ltd. 2003) (“Bak”).
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Application 15/583,852

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REJECTIONS
Claim(s) Rejected 35 U.S.C. § References
1, 3–6 103 Dan, Lee
2, 7–9 103 Dan, Lee, Shung
10, 11 103 Dan, Lee, Bak
11 103 Dan, Lee, Auboiroux
12, 13 103 Dan, Lee, Talish

OPINION
Claims 1 and 3–6—§ 103—Dan and Lee
Appellant argues claims 1 and 3–6 as a group. Appeal Br. 2–4. We
select claim 1 as representative of the group, and decide the appeal of this
rejection on the basis of claim 1 alone. 37 C.F.R. § 41.37(c)(1)(iv).
The Examiner finds that Dan teaches an array housing and a plurality
of transducer modules adapted to be inserted into the plurality of openings of
the array housing, each of the plurality of transducer modules comprising a
transducer element, the transducer elements configured to apply therapeutic
ultrasound energy to tissue positioned at a common focal point, and the
plurality of openings in the array housing arranged to permit alignment of
the transducer elements to share a common focal point. Final Act. 8–9
(citing Dan ¶¶ 105, 108, Fig. 3B). The Examiner acknowledges, however,
that Dan does not teach that the transducer modules are transducer module
housings that each further comprises an acoustic lens and a matching layer
disposed between the transducer element and the acoustic lens. Id. at 9. The
Examiner therefore relies on Lee to teach this limitation.
The Examiner finds that Lee teaches a transducer module housing
comprising a transducer element, an acoustic lens, and a matching layer
disposed between the transducer element and the acoustic lens. Final Act. 9
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(citing Lee ¶ 54, Fig. 11). The Examiner further finds that “[t]he technique
of Lee is applicable to each of the transducer modules of Dan because Dan is
concerned with focusing the ultrasound to a focal point, and the ordinarily
skilled artisan would have predictably recognized that the acoustic lens of
Lee could be used to provide additional focusing to each of the plurality of
transducer modules in Dan.” Id. at 10. The Examiner thus submits that one
of ordinary skill in the art would have recognized that employing a
transducer module housing “would allow each transducer module in Dan to
accommodate such lens and matching layer by structurally supporting the
lens and matching [layer] (in combination with the transducer element) of
each transducer module in Dan to provide additional focusing.” Id. The
Examiner concludes that one of ordinary skill in the art would have modified
Dan in accordance with Lee because the modification
would have merely involved applying a known technique (i.e.,
a transducer module housing comprising a transducer element;
an acoustic lens; and a matching layer disposed between the
transducer element and the acoustic lens, as taught by Lee) to a
known device (method, or product) ready for improvement (i.e.,
applying the technique of Lee to each of the plurality of
transducer modules in Dan) to yield predictable results (e.g.,
provide additional focusing to each of the plurality of
transducer modules in Dan). The ordinarily skilled artisan
would have been motivated to make this modification in order
to improve the ability to provide localized treatment;
acoustically couple each of the transducer elements to its
corresponding acoustic lens; and to structurally support the
matching layer and the lens (in combination [with] the
transducer element) of each transducer module.
Id. at 10–11 (emphasis omitted).
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We have considered Appellant’s arguments in opposition to the
Examiner’s rejection of claim 1 and are not persuaded of Examiner error.
Therefore, we sustain the rejection for essentially those reasons expressed in
the Final Action and Answer, and add the following primarily for emphasis.
Appellant first argues that Dan does not teach transducer modules that
“comprise separate housings within which the transducer element, the
matching layer, and the acoustic lens are all disposed.” Appeal Br. 2.
Appellant similarly argues that “Lee also does not teach transducer module
housings inserted into a separate array housing, as required by the claims.”
Id. at 3. These arguments are unpersuasive, however, as they merely
identify the shortcomings of each reference individually rather than address
the combination of Dan and Lee on which the rejection is based. Final Act.
8–11; Ans. 3–7; see In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir.
1986) (“Non-obviousness cannot be established by attacking references
individually where the rejection is based upon the teachings of a
combination of references.”).
Appellant next argues that “it is unclear how the Lee device would
even be inserted into a separate transducer array, as the Lee device has no
features configured for attaching or connecting it to another device, much
less the Dan housing shell.” Appeal Br. 3. The Examiner responds that “the
features upon which appellant relies (i.e., ‘features configured for attaching
or connecting it to another device’) are not recited in the rejected claim(s).”
Ans. 7 (emphasis omitted).
This argument is also not persuasive. “It is well-established that a
determination of obviousness based on teachings from multiple references
does not require an actual, physical substitution of elements,” In re
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Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012), or in this case, a detailed
description of how Lee’s transducer modules would be attached or
connected to Dan’s housing. One of ordinary skill can be expected to use
ordinary skill, creativity, and common sense to make the necessary
adjustments and further modifications to result in a properly functioning
device. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (“[T]he
[obviousness] analysis need not seek out precise teachings directed to the
specific subject matter of the challenged claim, for a court can take account
of the inferences and creative steps that a person of ordinary skill in the art
would employ”). Appellant does not argue, much less support with evidence
or persuasive analysis, that the proposed modification of Dan in accordance
with Lee would have been beyond ordinary skill at the time of the invention.
Appellant next argues that “[t]here is simply no reason, suggestion, or
rational basis to combine multiple of the Lee imaging and therapy devices
into the transducer housing taught by Dan.” Appeal Br. 3. Appellant asserts
that “[t]he Examiner’s arguments amount to the suggestion that it may be
possible to modify the Lee devices so that a plurality of the Lee imaging and
therapy devices could be inserted into a single housing shell as taught by
Dan,” but this analysis “falls well short of making a prima facie case of
obviousness” because “the obviousness of a claim cannot be established by
mere possibilities, but instead requires that the Examiner articulate a reason
why one of ordinary skill in the art would find it obvious to combine these
reference teachings.” Id. at 3–4 (citing Polaris Industries, Inc. v. Arctic Cat,
Inc., 882 F.3d 1056 (Fed. Cir. 2018) (emphasis omitted)).
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The Examiner responds that the rejection is not based on “combining
the multiple of the Lee imaging and therapy devices into the transducer
housing taught by Dan,” but rather
on modifying each of the transducer modules in Dan (which are
already taught in Dan as being adapted to be inserted into the
plurality of openings of the array housing) to further comprise
an acoustic lens and a matching layer disposed between the
transducer element and the acoustic lens in view of the
teachings of Lee, and further modifying each of the transducer
modules to be a transducer module housing in view of the
teachings of Lee.

Ans. 8–9. The Examiner further responds that the rejection is not based
merely on what is possible, “but rather based on what the ordinarily skilled
artisan would have been motivated to do.” Id. at 9. In this regard, the
Examiner reiterates that one of ordinary skill in the art would have
recognized that Lee’s acoustic lens provides focusing of the therapeutic
ultrasound energy, and such focusing improves the ability to provide
localized treatment. Id. (citing Lee ¶ 25; Dan ¶ 108). The Examiner also
explains that Lee’s matching layer between the transducer element and the
acoustic lens to provide acoustic coupling between the transducer element
and the acoustic lens, the absence of which “would degrade the efficiency of
applying the therapeutic ultrasound energy from the transducer element to
the tissue.” Id. (citing Lee ¶ 57).
“[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988
(Fed. Cir. 2006)). Here, the Examiner articulates a reason why one of
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ordinary skill in the art would have combined the teachings of Dan and Lee,
and supports the reasoning with a rational underpinning: essentially, that
(1) one of ordinary skill in the art would have combined Lee’s acoustic lens
with Dan’s transducer elements—which are disposed in the plurality of
openings in Dan’s array housing such that they are aimed at a common focal
point to which the acoustic energy is applied—to improve focusing of the
acoustic energy; (2) one of ordinary skill in the art would have known that
the matching layer prevents poor acoustic coupling between the transducer
element and the acoustic lens; and (3) one of ordinary skill in the art would
have used a housing as taught by Lee to accommodate and structurally
support these components. Ans. 9–10. Appellant does not directly address
this reasoning or dispute the findings of fact on which it relies. Therefore,
we are not persuaded of Examiner error.
We also disagree with Appellant’s final argument that the Examiner’s
reasoning relies on hindsight. Appellant does not identify any knowledge
relied upon by the Examiner that was gleaned only from Appellant’s
disclosure and that was not otherwise within the level of ordinary skill in the
art at the time of the invention as noted by the Examiner with respect to the
teachings of Dan and Lee. See In re McLaughlin, 443 F.2d 1392, 1395
(CCPA 1971) (“Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it takes into
account only knowledge which was within the level of ordinary skill at the
time the claimed invention was made and does not include knowledge
gleaned only from applicant's disclosure, such a reconstruction is proper.”).
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Because we are not persuaded that the Examiner erred in rejecting
claim 1, we sustain the Examiner’s rejection of claims 1 and 3–6 as
unpatentable over Dan and Lee.
Remaining Rejections
Appellant does not separately argue the patentability of the remaining
claims on appeal, but relies on the arguments made in connection with claim
1, which we found unpersuasive. Appeal Br. 4–5. Therefore, we sustain the
Examiner’s rejection of claims 2 and 7–9 as unpatentable over Dan, Lee, and
Shung; claims 10 and 11 as unpatentable over Dan, Lee, and Bak; claim 11
as unpatentable over Dan, Lee, and Auboiroux; and claims 12 and 13 as
unpatentable over Dan, Lee, and Talish.
DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 3–6 103 Dan, Lee 1, 3–6
2, 7–9 103 Dan, Lee, Shung 2, 7–9
10, 11 103 Dan, Lee, Bak 10, 11
11 103 Dan, Lee,
Auboiroux
11
12, 13 103 Dan, Lee, Talish 12, 13
Overall
Outcome
1–13

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).
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AFFIRMED