Hologic, Inc.Download PDFPatent Trials and Appeals BoardMar 8, 20212020002449 (P.T.A.B. Mar. 8, 2021) Copy Citation 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. Appeal 2020-002449 Application 15/595,440 3 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 Appeal 2020-002449 Application 15/595,440 4 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 Application 15/595,440 5 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 Appeal 2020-002449 Application 15/595,440 6 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). Appeal 2020-002449 Application 15/595,440 7 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 Copy with citationCopy as parenthetical citation