Hologic, Inc.

Patent Trials and Appeals Board

Mar 8, 2021

2020002449 (P.T.A.B. Mar. 8, 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.
15/595,440 05/15/2017 Kenneth DeFreitas 04576.0037USC2 2345
122617 7590 03/08/2021
Merchant & Gould Hologic
P.O.Box 2903
Minneapolis, MN 55402
EXAMINER
LUCK, SEAN M
ART UNIT PAPER NUMBER
2881
NOTIFICATION DATE DELIVERY MODE
03/08/2021 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 KENNETH DEFREITAS, IAN SHAW, and
TIMOTHY R. STANGO
Appeal 2020-002449
Application 15/595,440
Technology Center 2800
Before CATHERINE Q. TIMM, GEORGE C. BEST, and LILAN REN,
Administrative Patent Judges.
TIMM, 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 28–33 and 48–54. See Final Act. 1. We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant
identifies the real party in interest as Hologic, Inc. Appeal Br. 3.
Appeal 2020-002449
Application 15/595,440
2
CLAIMED SUBJECT MATTER
The claims are directed to a method of imaging a breast with x-rays.
See, e.g., claim 28. During mammography and breast tomosynthesis, a
patient’s breast is compressed, typically, between two rigid paddles. Spec.
¶ 3. Instead of using the rigid compression panel alone, Appellant’s method
uses a compression paddle fitted with an inflatable jacket, which according
to the Specification, enhances imaging and improves patient comfort. Spec.
¶ 1. In Appellant’s method, there is a step of selectively adjusting the degree
to which the inflatable jacket is inflated based on an event, such as the
compression paddle reaching a predetermined position or the compression
paddle exerting a specified pressure on the breast. Spec. ¶ 36; claims 28–31.
Claim 28, reproduced below with the limitations most at issue italicized, is
illustrative of the claimed subject matter:
28. A method of imaging a breast with x-rays
comprising:
supporting the breast on a breast platform and proximate
an inflatable element;
compressing the breast with a compression paddle;
detecting an event associated with the compression of the
breast;
based on the detection of the event, selectively adjusting
a degree of inflation of the inflatable element against the
breast;
imaging the compressed breast with x-ray; and
generating x-ray images of the breast.
Appeal Br. 15 (Claims Appendix) (emphasis added). Claim 29 limits the
event to the compression paddle reaching a predetermined position. Claim
30 limits the predetermined position to one measured relative to at least one
of the breast and the breast platform.
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REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Galkin ’211 US 7,512,211 B2 Mar. 31, 2009
Galkin US 2003/0099325 A1 May 29, 2003
REJECTIONS
Claim 28–33 and 48–51 are rejected under 35 U.S.C. § 102(b) as
being anticipated by Galkin. Final Act. 4.
Claims 52–54 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Galkin in view of Galkin ’211. Final Act. 6.
OPINION
Appellant’s arguments focus on the rejection of claims 28–30 as
anticipated by Galkin. Appeal Br. 8–13. Thus, we confine our discussion to
the rejection of those claims.
The issue is: Has Appellant identified a reversible error in the
Examiner’s finding that Galkin teaches, either expressly or inherently, all the
steps recited in claims 28–30?
Appellant has not identified such an error.
The Examiner finds that Galkin teaches the claimed method of
imaging in paragraph 20. Final Act. 4. Appellant contends that the Examiner
is relying on unsupported findings of inherency, particularly for the
detecting and adjusting steps of claims 28–30. Appeal Br. 8–13. Appellant
has not persuaded us that Galkin fails to support the Examiner’s inherency
findings.
Galkin uses a comfort device in a conventional mammography x-ray
unit such as that shown in Figures 1 and 2. Galkin ¶¶ 20, 31–32, 35. This
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conventional mammography unit includes a cassette holder 19 with an
imaging area 20 on which a patient’s breast is positioned. Galkin ¶¶ 5, 35.
As is standard practice, the patient’s breast is placed onto the imaging area
and compression paddle 3 is moved to flatten the breast as shown in Figure
2. Galkin ¶¶ 5, 35. The comfort device cushions the breast and increases
comfort during the flattening. Galkin ¶ 32. The comfort device may have at
least one inflatable chamber to contain air that can be forced or pumped into
the comfort device. Galkin ¶¶ 37.
In paragraph 20, Galkin discloses methods for shaping a patient’s
breast during a mammogram using the conventional mammography unit that
additionally has an inflatable comfort device on the cassette. Galkin ¶ 20. In
this method, a patient’s breast can be imaged twice without repositioning the
compression paddle. Id. To prepare for the first imaging, Galkin shapes the
breast by positioning the breast on the inflatable chamber and moves the
compression paddle 3 to compress the breast. See Galkin ¶ 20 (disclosing
steps of securing a cassette holder to a mammography unit, introducing a gas
into the inflatable chamber, positioning the breast on the inflatable chamber,
and compressing the breast into a first shape, and imaging); see also id. ¶ 46
(further describing the method in the context of Figure 8A). To prepare for
the second imaging, Galkin either releases gas from, or adds gas to, the
comfort device to reform the breast into a second shape. Id. This portion of
the method is further explained in conjunction with Figures 8B and 8C.
Galkin ¶¶ 46–50. Here, Galkin states that Figure 8B shows the cassette
holder of Figure 8A after gas release and explains that the second image is
taken “without having to release the compression paddle 3, reposition the
breast, and then compress the breast again.” Galkin ¶ 49. Galkin describes a
Appeal 2020-002449
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technician-operated controller 60 associated with the manifolds used to add
and remove the gas. Galkin ¶ 47.
As we pointed out above, claim 28 requires a step of detecting “an
event associated with the compression of the breast.” The “event associated
with the compression of the breast” may be, for instance, the positioning of
the compression paddle into a predetermined position. Claim 29 is limited to
this event. Galkin discloses such an event. Galkin teaches moving
compression paddle 3 to a position at which it flattens the breast so an image
can be taken. Although Galkin doesn’t expressly say so, this movement of
the paddle is performed in the conventional manner as is evidenced by the
fact that Galkin is using the conventional mammography apparatus with a
movable paddle. Thus, the technician is lowering the compression paddle 3
until it flattens the breast to the extent required for the first imaging step as
was conventional. Thus, the technician is detecting “an event associated with
the compression of the breast,” i.e., the technician is detecting when the
paddle reaches the required position for the first imaging step. This is the
predetermined position for the first imaging step, and it is measured relative
to the breast and its extent of flattening. The detection by the technician
meets the requirements of the detecting step of claims 28 through 30.
Claim 28 further requires that, based on the detection of the event,
which here is the detection made by the technician that the breast is in the
correct flattened position for the first image, the degree of inflation of the
inflatable element against the breast be selectively adjusted. Galkin discloses
such selective adjustment. In Galkin’s method the selective adjustment
occurs when Galkin removes gas from the inflatable comfort device to
reshape the breast for the second image. Galkin does this deflating without
repositioning the paddle. Galkin ¶ 49. Thus, based on the detection of the
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event, i.e., the compression paddle reaching the predetermined position
relative to the flattening of the breast for the first image, the degree of
inflation of the comfort device is selectively adjusted as required by claim
28.
As pointed out by Appellant, Galkin describes adjusting the degree of
inflation, but provides “no explanation of initiating such an adjustment.”
Appeal Br. 10. Although true, the ordinary artisan would understand that the
technician initiates the adjustment based on the technician’s detection of the
breast as being in the flattened position for imaging. This follows from the
teaching of using the conventional mammography process. This is enough to
establish anticipation under the current facts. “Anticipation is an inquiry
viewed from the perspective of one skilled in the art.” Wasica Fin. GmbH v.
Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1284 (Fed. Cir. 2017). “[T]he
dispositive question regarding anticipation is whether one skilled in the art
would reasonably understand or infer from the prior art reference's teaching
that every claim element was disclosed in that single reference.” Dayco
Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir.
2003) (internal alterations and quotation marks omitted). The disclosure may
be inherent rather than explicit. In re Omeprazole Patent Litig., 483 F.3d
1364, 1373 (Fed. Cir. 2007). One of ordinary skill in the art reading Galkin’s
disclosure would have reasonably understood Galkin to teach a breast
imaging method with a step of detecting when the breast is sufficiently
flattened by the paddle to allow the first imaging step and then imaging (an
event associated with the compression of the breast) and, based on the
detection of the flattening and first imaging, and without repositioning the
paddle, adjusting the degree of inflation before imaging the compressed
breast (Galkin’s second imaging step).
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Reading between the lines of Appellant’s arguments, it appears
Appellant believes the claims require a device perform the detecting and
adjusting steps (see, e.g., Appeal Br. 10), but claims 28–30 are not so
limited. It is enough that a technician performs the recited steps.
CONCLUSION
The Examiner’s decision to reject claims 28–33 and 48–54 is
AFFIRMED.
DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
28–33, 48–
51
102(b) Galkin 28–33, 48–
51

52–54 103(a) Galkin, Galkin ’211 52–54
Overall
Outcome
28–33, 48–
54

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).
AFFIRMED