HOLOGIC INC.

Patent Trials and Appeals Board

Apr 2, 2021

2021001364 (P.T.A.B. Apr. 2, 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.
15/728,106 10/09/2017 Timothy R. STANGO 04576.0004USC1 5606
122617 7590 04/02/2021
Merchant & Gould Hologic
P.O.Box 2903
Minneapolis, MN 55402
EXAMINER
LUCK, SEAN M
ART UNIT PAPER NUMBER
2881
NOTIFICATION DATE DELIVERY MODE
04/02/2021 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):
USPTO122617@MerchantGould.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TIMOTHY R. STANGO, KENNETH F. DEFREITAS, IAN
SHAW, JAY STEIN, LYNNE JAMESON-MEEHAN, and LOREN
NIKLASON
Appeal 2021-001364
Application 15/728,106
Technology Center 2800
Before BRADLEY W. BAUMEISTER, MICHAEL J. ENGLE, and
PHILLIP A. BENNETT, Administrative Patent Judges.
BENNETT, 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 1–3, 5–10, 12, 15, 16, 18, and 34–38,
which are all of the pending claims. We have jurisdiction under
35 U.S.C. § 6(b).
We reverse.

1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42(a).
Appellant identifies the real party in interest as Hologic, Inc. Appeal Br. 3.
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Application 15/728,106

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CLAIMED SUBJECT MATTER
The claims are directed to an x-ray breast imaging system having a
substantially rigid compression paddle having concave surface extending
between the side walls of the compression paddle, which corresponds to the
shape of a patient’s breast. See Spec. ¶ 56; Figs. 15A–15C. Claim 1,
reproduced below, is illustrative of the claimed subject matter:
1. An x-ray breast imaging system comprising:
an x-ray source;
an x-ray detector;
a breast support platform disposed between the x-ray
source and the x-ray detector; and
a compression paddle disposed between the x-ray source
and the breast support platform, the compression paddle
comprising:
a substantially rigid front wall configured to be adjacent
and face a chest wall of a patient during imaging;
a substantially rigid bottom wall extending from the front
wall and configured to extend away from the patient’s chest wall
and to be adjacent and in contact with a length of a top of a
compressed breast, wherein the bottom wall comprises a central
portion and two outer edge portions, wherein the two outer edge
portions define a reference plane, wherein the central portion is
disposed at an angle to the breast support platform, and wherein
the compression paddle is movable; and
a first axis substantially orthogonal to the front wall,
wherein the central portion of the bottom wall is pitched along
the first axis from a high point proximate the front wall and raised
relative to the reference plane.
Appeal Br. 24 (Claims Appendix).
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REFERENCES2
The Examiner relies on the following references as prior art:
Name Reference Date
Evans US 3,971,950 July 27, 1976
Adamkowski US 5,706,327 Jan. 6, 1998
Mertelmeier US 7,742,558 B2 June 22, 2010
Hoernig US 2008/0043904 A1 Feb. 21, 2008
REJECTIONS
Claims 1–3, 7, 10, 12, 15, 16, 34–36, and 38 stand rejected under
35 U.S.C. § 102(b) as being anticipated by Hoernig. Non-Final Act. 3–15.
Claims 1, 5, 6, 10, and 18 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Evans.3 Non-Final Act. 15–18.
Claims 8 and 9 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Hoernig and Mertelmeier. Non-Final Act. 19–20.
Claim 37 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Hoernig and Adamkowski. Non-Final Act. 20.
ISSUES
First Issue: Has the Examiner erred in finding Hoernig discloses a
“substantially rigid front wall” and a “substantially rigid bottom wall,” as
recited in claim 1?

2 All citations herein to the references are by reference to the first named
inventor/author only.
3 The heading of the rejection erroneously states the rejection is based on
Mertermeier. However, both Appellant and the Examiner make clear that
they recognize this as a typographical error, and address the substantive
rejection which was made based on Evans. We will do the same.
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Second Issue: Has the Examiner erred in finding Evans discloses a
“bottom wall comprises a central portion and two outer edge portions,
wherein the two outer edge portions define a reference plane . . . wherein the
central portion of the bottom wall is . . . raised relative to the reference
plane,” as recited in claim 1?
ANALYSIS
Legal Standard
Anticipation is a test of strict identity. Trintec Indus., Inc. v. Top-
U.S.A. Corp., 295 F.3d 1292, 1296 (Fed. Cir. 2002). That is, to meet the
strict identity test for anticipation, all elements must be disclosed, in a single
reference, in exactly the same way as they are arranged or combined in the
claim. Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325, 1332
(Fed. Cir. 2010).
First Issue
The Examiner rejects claim 1 as anticipated by Hoernig. Non-Final
Act. 4–5. Relevant to this issue, the Examiner finds Hoernig discloses a
compression paddle that includes “a substantially rigid front wall configured
to be adjacent and face a chest wall of a patient during imaging” (citing
Hoernig Figs. 2, 4; ¶ 56). The Examiner further finds Hoernig discloses “a
substantially rigid bottom wall extending from the front wall and configured
to extend away from the patient’s chest wall” (citing Hoernig Fig. 4; ¶ 56).
Appellant argues the Examiner’s findings are in error because claim 1
requires substantially rigid walls, and “Hoernig’s device 10 is partially rigid
and partially elastically-deformable.” Appeal Br. 13. Appellant asserts that
the Examiner’s determination that Hoernig’s plate having both rigid and
flexible portions anticipates the claimed substantially rigid walls is
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erroneous because “[t]he term ‘substantially rigid,’ as used in the claims,
unambiguously modifies the entirety of the following recited claim element,
including any subsequent features of that claimed element.” Appeal Br. 15.
We agree with Appellant.
Hoernig describes a compression plate 12 that includes compression
plate elements 13 which are elastically-deformable and “can be adapted to
an arbitrary usage purpose of the compression itself or to the subject to be
compressed.” Hoernig ¶ 56. As shown in Hoernig’s Figure 4, the central
portion of the wall adjacent the chest wall of the patient is flexible, and is
designed to conform to the patient’s anatomy as it compresses against their
body. Thus, the substantial portion of Hoernig’s wall is not rigid, and
instead is substantially flexible.
The Examiner rejects Appellant’s position because the claim does not
explicitly recite that the entire bottom wall is substantially rigid. Non-Final
Act. 2 (“Applicant supports this position by arguing features not recited in
the claims, specifically that the ‘entire’ bottom wall is substantially rigid.”).
We agree with Appellant, however, that “substantially” modifies the
adjective “rigid,” which in turn modifies “bottom wall” in the claim. That
is, the “bottom wall” is rigid, and its degree of rigidity is substantial. The
Examiner’s interpretation is unreasonably broad because it interprets
“substantially rigid” to mean “partially rigid” in that only a portion of the
wall needs to be rigid. However, such an interpretation is inconsistent with
the description in Appellant’s Specification, which states that “[u]se of rigid
materials allows the paddle to sufficiently compress the breast without
deforming.” Spec. ¶ 58 (emphasis added).
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The bottom wall depicted in Hoernig’s Figure 4 does not allow the
paddle to compress the breast without deforming, rather it deforms by
design. As such, under the strict identity standard imposed by the law of
anticipation, Hoernig fails to disclose each and every element recited in
claim 1, and we therefore do not sustain the rejection. For the same reasons,
we also do not sustain the rejection of independent claim 10, which recites
limitations commensurate in scope to those discussed above.
Second Issue
The Examiner also rejects claim 1 as anticipated by Evans. Non-Final
Act. 15–17. Relevant to this issue, the Examiner finds Evans discloses
“wherein the bottom wall comprises a central portion . . . and two outer edge
portions, . . . wherein the two outer edge portions define a reference plane,
. . . wherein the central portion of the bottom wall is . . . raised relative to the
reference plane.” Non-Final Act. 16 (citing Evans Figs. 1, 4).
The Examiner finds that Appellant argues Evans does not disclose
“wherein the central portion of the bottom wall is . . . raised relative to the
reference plane,” as recited in claim 1. Specifically, Appellant argues that
“the lower surface 40 of Evans’ compression paddle has a constant cross-
section in the left-right direction (see FIG. 4). The claimed bottom wall does
not have this constant cross-sectional profile in the left-right direction.”
Appeal Br. 19. We agree with Appellant.
The Examiner cites Evans’ lower surface 40 of the compression
paddle 14 depicted in Figures 1 and 4 as disclosing the claimed
configuration. Evans’ lower surface is a flat surface that extends from one
outer edge to the other. To the extent that a plane is defined by the outer
edges of Evans’ lower surface 40, that central portion of the surface is on the
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same plane because Evans’ lower surface lacks the concave shape manifest
in Appellant’s claimed structure that creates the difference between the
reference plane and the central portion. That is, in Evans, the midpoint (i.e.,
the “central portion of the bottom wall”) between any two points on the
outer edges is on the same plane as the outer edges themselves, whereas in
the claimed configuration, the midpoint between any two points on the outer
edges is “raised relative to the reference plane.” As such, we agree with
Appellant that Evans’ compression plate is not exactly the same as what is
claimed, and we do not sustain the rejection of claim 1 as anticipated by
Evans. Independent claim 10 recites a limitation similar in scope. See
Appeal Br. 25–26 (“a central portion non-coplanar with the two outer edge
portions”). We do not sustain the rejection of claim 10 for the same reasons.
Remaining Claims
The remaining claims each depend from claim 1 or claim 10, and as
such, they stand together with their base claim.
CONCLUSION
We reverse the Examiner’s decision to reject the claims. Because the
Board is an appellate body, we do not address the separate question whether
the disclosed shapes of Hoernig’s invention, in combination with Hoernig’s
teaching that rigid, inflexible compression plates were known in the prior art
(Hoernig ¶¶ 5, 6), render any of the claims unpatentable under 35 U.S.C. §
103. We review the appealed rejections for error based upon the issues
identified by Appellants, and in light of the arguments and evidence
produced thereon. See Ex Parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010)
(precedential).

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DECISION SUMMARY
In summary:
Claims
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
1–3, 7, 10,
12, 15, 16,
34–36, 38
102 Hoernig 1–3, 7, 10,
12, 15, 16,
34–36, 38
1, 5, 6, 10,
18
102 Evans 1, 5, 6, 10,
18
8, 9 103 Hoernig, Mertelmeier 8, 9
37 103 Hoernig, Adamkowski 37
Overall
Outcome
1–3, 5–10,
12, 15, 16,
18, 34–38

REVERSED