HOLOGIC INC.Download PDFPatent Trials and Appeals BoardApr 2, 20212021001364 (P.T.A.B. Apr. 2, 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. 15/728,106 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. Appeal 2021-001364 Application 15/728,106 2 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). Appeal 2021-001364 Application 15/728,106 3 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. Appeal 2021-001364 Application 15/728,106 4 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 Appeal 2021-001364 Application 15/728,106 5 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). Appeal 2021-001364 Application 15/728,106 6 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 Appeal 2021-001364 Application 15/728,106 7 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). Appeal 2021-001364 Application 15/728,106 8 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 Copy with citationCopy as parenthetical citation