B-K Medical Aps

Patent Trials and Appeals Board

Jan 12, 2022

2021003918 (P.T.A.B. Jan. 12, 2022)

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. 15/307,420 10/28/2016 Niels-Christian SASADY ANA1231WOUS_BKM107607 8572 23266 7590 01/12/2022 Dept. GEN DAUGHERTY & DEL ZOPPO CO., L.P.A. P.O. Box 431 Mentor, OH 44061 EXAMINER SHENG, CHAO ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 01/12/2022 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): adelzoppo@dd-iplaw.com info@dd-iplaw.com pdaugherty@dd-iplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte NIELS-CHRISTIAN SASADY, PER EHRENREICH NYGAARD, and BO HANSEN ____________ Appeal 2021-003918 Application 15/307,420 Technology Center 3700 ____________ Before STEFAN STAICOVICI, EDWARD A. BROWN, and MICHAEL L. HOELTER, Administrative Patent Judges. BROWN, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 seeks review under 35 U.S.C. § 134(a) of the Examiner’s decision rejecting claims 1-4, 8, 11-13, 15, 16, and 21-26.2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies BK Medical Holding Company, Inc., as the real party in interest. Appeal Br. 2. 2 Claims 5-7, 9, 10, 14, and 17-20 are cancelled. Appeal Br. (Claims App.). Appeal 2021-003918 Application 15/307,420 2 CLAIMS Claims 1-4, 8, 11-13, 16, 21, and 23-26 are directed to an ultrasound probe, and claims 15 and 22 are directed to a method. Claims 1, 15, and 24 are independent. Appeal Br. 11-14 (Claims App.). Claim 1, reproduced below, is illustrative. 1. An ultrasound probe, comprising: an elongate shaft having a long axis, a first end, a second opposing end that spatially opposes the first end, a first side and a second opposing side that spatially opposes the first side; a probe head disposed at the first end and including: a transducer array disposed along the long axis, including a transducing surface that is parallel to the long axis and transverse to the first and second ends, and configured to emit from the first side in a first direction away from the probe; a slot that extends entirely through the elongate shaft from the first side to the second opposing side, that is angled relative to the transducer array, and that is configured as an instrument guide; and a light source that is angled relative to the transducer array and that is configured to emit light from the second side in a second direction away from the probe, away from the first end, towards the second end, and opposite the first direction, wherein the light source includes only one light emitting element and surrounds an outer perimeter of the slot. Appeal Br. 11 (Claims Appendix). REJECTIONS ON APPEAL 1. Claim 23 is rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. Final Act. 6. Appeal 2021-003918 Application 15/307,420 3 2. Claim 23 is rejected under 35 U.S.C. § 112(b) as being indefinite.3 Final Act. 7. 3. Claims 1-4, 8, 13, 16, 21, and 23 are rejected under 35 U.S.C. § 103 as being unpatentable over Tanaka (US 6,149,598, issued Nov. 21, 2000), Nygaard (US 2009/0171218 A1, published July 2, 2009), Schmitt (US 2013/0012811 A1, published Jan. 10, 2013), and Vayser (US 2007/0270653 A1, published Nov. 22, 2007). Final Act. 9. 4. Claims 15 and 22 are rejected under 35 U.S.C. § 103 as being unpatentable over Schmitt, Tanaka, Nygaard, and Vayser. Final Act. 17. 5. Claim 11 is rejected under 35 U.S.C. § 103 as being unpatentable over Tanaka, Nygaard, Schmitt, Vayser, and Hurst (US 2004/0143252 A1, published July 22, 2004). Final Act. 22. 6. Claim 12 is rejected under 35 U.S.C. § 103 as being unpatentable over Tanaka, Nygaard, Schmitt, Vayser, and Tsui (US 2008/0242975 A1, published Oct. 2, 2008). Final Act. 23. 7. Claims 24 and 25 are rejected under 35 U.S.C. § 103 as being unpatentable over Tanaka, Nygaard, and Schmitt. Final Act. 24. 8. Claim 26 is rejected under 35 U.S.C. § 103 as being unpatentable over Tanaka, Nygaard, Schmitt, and Vayser. Final Act. 29. ANALYSIS Rejection 1 The Examiner rejects claim 23 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. Final Act. 6. Claim 23 3 The rejection of claims 24-26 under this ground has been withdrawn. Adv. Act. 2 (dated Jan. 11, 2021); Final Act. 7. Appeal 2021-003918 Application 15/307,420 4 depends from claim 1 and recites that “an entirety of the slot and an entirety of the light source are part of the probe head.” Appeal Br. 13 (Claims App.) (emphasis added). The Examiner finds: There is NO disclosure regarding the ‘entirety’ of the light source. Applicant fails to provide detail [sic] definition of the ‘entirety’ of the light source. It is unknown what components are included in the ‘entirety’ of the light source. As known in the art, a light source may include plurality of components such as emitting element, optics, waveguide, power source, driving electronics or more. In addition, Figure 11 is a cross-section view of the probe head, which does not provide enough geometric information that the ‘entirety’ of light source is part of the probe. Final Act. 6-7. The Examiner notes that the Specification describes that “‘[t]he light source 140 can include one or more light emitting elements such as one or more of a laser, a light emitting diode (LED), an optic fiber, or the like.’” Ans. 29 (boldface omitted); see Spec. 6, ll. 28-29. According to the Examiner, “[b]y using the term ‘include’, the light source is disclosed inclusively which does not exclude additional, unrecited elements.” Id. The Examiner submits, for example, “[i]f the light source includes a single LED, there is no disclosure about the position of power source, optical lens, or electronic driving module.” Id. at 30. Appellant contends that the Specification defines the light source as light source 140, and “the light source 140 is only shown in the head 118, and the head 118 does not change from figure to figure.” Reply Br. 2-3 (citing Figs. 1, 4-13, 17). Appellant further contends: The examples of the different types of light sources do not change where the light source is located in the probe, in the Appeal 2021-003918 Application 15/307,420 5 head 118. A source of power of the light source 140 and driving electronics of the light source are not themselves light sources and are not limited to any particular location in the application. Id. at 2. The test for sufficiency under the written description requirement “is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). This test “requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” Id. To have “possession,” “the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.” Id. Figures 4, 5, and 7-12 illustrate a light source 140 located in head 118 and not elsewhere in the ultrasonic probe. The Specification discloses that light source 140 can “include” different types of light emitting elements. Appeal Br. 4 (citing Spec. 6, ll. 28-29). We interpret the term “include” as used in this context to mean “be.” As for the power source for light source 140, the Specification discloses: Power for the light source 140 can be from an internal battery (re-chargeable or disposable), capacitor, etc. located in the shaft 112, the handle 110 and/or otherwise in connection with the ultrasound probe 104, and/or from an external power supply, for example, from the console 106 and/or otherwise. See Spec. 7, ll. 3-6. Appeal 2021-003918 Application 15/307,420 6 We understand Appellant’s position is that the term “light source” means “light emitting element,” but does not encompass a “power source” or “driving electronics” for the light emitting element. Reply Br. 2. Appellant acknowledges that the power source and driving electronics are “not limited to any particular location in the application,” i.e., the power source and driving electronics are not required to be “part of the probe head,” as claimed. Reply Br. 2. Appellant’s position is supported by the Specification. Each of Figures 4, 5, and 7-12 shows that an “entirety” of element 140 (i.e., the “whole” of element 140), which the Specification describes as a “light source,” is “part of” head 118. We disagree with the Examiner that “there is no disclosure about the position of power source, optical lens, or electronic driving module.” Ans. 30 (emphasis added). The Specification discloses that the power source provides power “for the light source 140.” See Spec. 7, ll. 3-6. Consistent with this disclosure, we construe the phrase “an entirety of the light source [is] part of the probe head” as not requiring the power source to also be “part of the probe head.” We further note that the Specification discloses that “[a] window 412 provides a path for the light source 140 to exit the shaft 112. The window 412 can include a lens, a prism, a filter, and/or other optical element.” See Spec. 6, ll. 22-23 (emphasis added). This description indicates that window 412 is a different element from light source 140. The Examiner does not establish that either an “optical lens” or an “electronic driving module” must be considered part of the claimed light source. For the foregoing reasons, Appellant’s disclosure reasonably conveys to those skilled in the art that the inventors had possession of the claimed Appeal 2021-003918 Application 15/307,420 7 subject matter. Thus, we do not sustain the rejection of claim 23 as failing to comply with the written description requirement of 35 U.S.C. § 112(a). Rejection 2 The Examiner rejects claim 23 under 35 U.S.C. § 112(b) as being indefinite. Final Act. 7. Particularly, the Examiner determines that “since there is no written description support (see 112a rejection), it is unclear how several components can be considered as ‘entirety’ of the light source without knowing the definition of ‘entirety.’” Id. at 7-8. “A claim [in an application] is indefinite when it contains words or phrases whose meaning is unclear.” In re Packard, 751 F.3d 1307, 1314 (Fed. Cir. 2014); see Ex parte McAward, No. 2015-006416, slip op. at 11 (PTAB Aug. 25, 2017) (precedential) (same). The test for definiteness under 35 U.S.C. § 112, is whether “those skilled in the art would understand what is claimed when the claim is read in light of the specification.” Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986) (citations omitted). We disagree with the Examiner that claim 23 is indefinite. We agree with Appellant that there is adequate written description support for the phrase “an entirety of the light source are part of the probe head,” as recited in claim 23. We also agree with Appellant that one of ordinary skill in the art would understand the meaning of this phrase in light of the Specification. Appeal Br. 5. Consistent with the Specification, we construe the term “light source” to mean “light emitting element,” and not including other “components,” and furthermore, construe the phrase “an entirety of the light source” to mean the “whole” light emitting element, which is “part of the probe head.” We agree with Appellant that the meaning of the phrase “an Appeal 2021-003918 Application 15/307,420 8 entirety of the light source are part of the probe head” is sufficiently clear, and thus, do not sustain the rejection of claim 23 as being indefinite under 35 U.S.C. § 112(b). Rejection 3 The Examiner rejects claims 1-4, 8, 13, 16, 21, and 23 under 35 U.S.C. § 103 as being unpatentable over Tanaka, Nygaard, Schmitt, and Vayser. Final Act. 9. In contesting the rejection, Appellant argues the claims as a group. Appeal Br. 5-8. We decide the appeal of the rejection on the basis of claim 1, and claims 2-4, 8, 13, 16, 21, and 23 stand or fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(iv) (“When multiple claims subject to the same ground of rejection are argued as a group or subgroup by appellant, the Board may select a single claim from the group or subgroup and may decide the appeal as to the ground of rejection with respect to the group or subgroup on the basis of the selected claim alone. . . . Under each heading identifying the ground of rejection being contested, any claim(s) argued separately or as a subgroup shall be placed under a separate subheading that identifies the claim(s) by number.”). The Examiner finds that Tanaka discloses an ultrasound probe comprising a transducer array (ultrasound transducer 18) configured to emit from a first side in a first direction away from the probe, a slot (instrument passage 28), and a light source (illumination light emitting portions 14) angled relative to the transducer array. Final Act. 9-10 (citing Tanaka, Figs. 1-3). The Examiner acknowledges that Tanaka does not disclose “a slot that extends entirely through the elongate shaft from the first side to the second opposing side,” and “a light source that is configured to emit light from the second side in a second direction away from the probe, away from the first Appeal 2021-003918 Application 15/307,420 9 end, towards the second end, and opposite the first direction . . . and surrounds an outer perimeter of the slot,” as claimed. Id. at 10. The Examiner submits that “[t]he difference from the ‘light source’ in [the] claimed invention is that Tanaka’s light source is configured to emit light from the same side of the ultrasound transducer, while the claimed invention require[s] that the light is emitted from the opposite side of the ultrasound transducer.” Ans. 33-34. The Examiner relies on Nygaard as teaching a slot (transverse needle guide 203) that extends entirely through an elongate shaft from a first side to a second opposing side. Id. at 11 (citing Nygaard, ¶ 48, Fig. 2). The Examiner concludes that it would have been obvious to one of ordinary skill in the art to modify the instrument passage taught by Tanaka with Nygaard’s transverse needle guide to “‘enhance the use of the ultrasound probe to be used for taking biopsy samples along two different biopsy paths while providing safe monitoring of both the paths.’” Id. (citing Nygaard ¶ 46). The Examiner further relies on Schmitt as teaching a transducer (optical transducer 14) that emits an acoustic beam (“ab”), and a light source (optical transducer 14 including optical lens assembly 16 attached to single mode fiber 18) configured to emit light (optical beam “ob”) from a second side in a second direction away from the probe, away from the first end, towards the second end, and 180° opposite to the first direction. Final Act. 11-12 (citing Schmitt ¶¶ 36, 38, 39, Fig. 1A); Ans. 34. The Examiner concludes that it would have been obvious to a skilled artisan to modify Tanaka’s light emitting portion with the optical subsystem taught by Schmitt “to make it emit light in a different direction.” Id. at 12; Ans. 34. The Examiner reasons, “[b]y arranging the two beams opposite to each other, it Appeal 2021-003918 Application 15/307,420 10 ensures easier real-time or post-processing alignment of the two images for an overlay display.” Final Act. 12 (citing Schmitt ¶ 39). The Examiner submits: In addition, the light emitting portion in Tanaka is used for endoscopic imaging (one type of optical imaging) and there is also ultrasound imaging transducers taught in Tanaka. Both Tanaka and Schmitt teach taking two images including [an] optical image and ultrasound image, and Schmitt clearly teaches such arrangement of light beam direction “ensures easier real-time or post-processing alignment of the two images for an overlay display.[”] Ans. 34 (citing Schmitt ¶ 39). Lastly, the Examiner relies on Vayser as teaching a light source that includes only one light emitting element, as claimed. Final Act. 12. Appellant disagrees that it would have been obvious to a person of ordinary skill in the art to modify Tanaka “to ensure easier real-time or post- processing alignment of the two images for an overlay display.” Appeal Br. 7. Appellant contends that Schmitt discloses an optical coherent tomography (OCT) sensor and an ultrasound sensor, each configured to emit and sense, wherein the sensed signals are processed to produce cross- sectional images. Id. (citing Schmitt ¶¶ 4, 7). Appellant also contends that Schmitt describes a beam alignment approach to facilitate aligning the OCT and ultrasound images. Id. (citing Schmitt ¶ 39). In contrast, Appellant contends, Tanaka discloses a light source which illuminates the region where the ultrasound data will be acquired, and does not disclose a sensor to sense light, let alone to create an image, and does not disclose or suggest overlaying ultrasound and OCT images. Id. (citing Tanaka, col. 5, ll. 28-67, Figs. 1-3, 5, 6). Thus, Appellant contends, it would not have been obvious to one of ordinary skill in the art to modify Tanaka and Nygaard with Appeal 2021-003918 Application 15/307,420 11 Schmitt, as proposed by the Examiner, “at least because Tanaka and Nygaard do not align images from two different imaging sources located on opposite sides of the probe for an overlay display.” Id. Appellant’s contentions are unpersuasive. We agree that Tanaka discloses a light source which illuminates the region where the ultrasound data will be acquired. Appeal Br. 7; see Tanaka, col. 5, ll. 63-67. However, we understand that the Examiner’s rejection modifies Tanaka by adding the optical subsystem taught by Schmitt. This also appears to be Appellant’s understanding. See Appeal Br. 7 (“Tanaka illuminates from the ultrasound side and Nygaard does not disclose or suggest a light source. Thus, it would not have been obvious to modify Tanaka and Nygaard with Schmitt to add a light source to illuminate the opposing side. . . .” (Emphasis added)). As such, Appellant’s contentions do not address persuasively the Examiner’s rejection. That is, the Examiner proposes to combine the teachings of Tanaka, Nygaard, and Schmitt to result in an ultrasound probe comprising a transducer array and also “a light source that is angled relative to the transducer array and that is configured to emit light from the second side in a second direction away from the probe, away from the first end, towards the second end, and opposite the first direction,” as recited in claim 1. Schmitt teaches that optical transducer 12 can produce an image, which can be aligned with an image produced by ultrasonic transducer 14. See Schmitt ¶¶ 38-39. Appellant does not persuade us that the Examiner’s proposed combination would be unable to align images from two different imaging sources located on opposite sides of the probe for an overlay display. Appeal 2021-003918 Application 15/307,420 12 For the above reasons, we sustain the rejection of claim 1, and claims 2-4, 8, 13, 16, 21, and 23 which fall with claim 1, as being unpatentable over Tanaka, Nygaard, Schmitt, and Vayser. Rejections 4-8 Appellant contends that independent claims 15 and 24 both “recite[] aspects similar to those recited in connection with claim 1, at least with respect to the light source emitting light in the opposite direction of the transducer emission,” and contends that the argument presented for claim 1 also applies to claims 15 and 24. Appeal Br. 8, 9. Appellant also contends that claims 11, 12, 22, 25, and 26 are patentable based on their dependency from claim 1, 15, or 24. Id. at 8-9. As Appellant does not apprise us of error in the rejection of claim 1 over Tanaka, Nygaard, Schmitt, and Vayser, we sustain the following rejections under 35 U.S.C. § 103 for the same reasons as those for claim 1: claims 15 and 22 over Schmitt, Tanaka, Nygaard, and Vayser; claim 11 over Tanaka, Nygaard, Schmitt, Vayser, and Hurst; claim 12 over Tanaka, Nygaard, Schmitt, Vayser, and Tsui; claims 24 and 25 over Tanaka, Nygaard, and Schmitt; and claim 26 over Tanaka, Nygaard, Schmitt, and Vayser. CONCLUSION We reverse the rejections under 35 U.S.C. §§ 112(a) and 112(b), and affirm the rejections under 35 U.S.C. § 103. Appeal 2021-003918 Application 15/307,420 13 DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 23 112(a) Written Description 23 23 112(b) Indefiniteness 23 1-4, 8, 13, 16, 21, 23 103 Tanaka, Nygaard, Schmitt, Vayser 1-4, 8, 13, 16, 21, 23 15, 22 103 Schmitt, Tanaka, Nygaard, Vayser 15, 22 11 103 Tanaka, Nygaard, Schmitt, Vayser, Hurst 11 12 103 Tanaka, Nygaard, Schmitt, Vayser, Tsui 12 24, 25 103 Tanaka, Nygaard, Schmitt 24, 25 26 103 Tanaka, Nygaard, Schmitt, Vayser 26 Overall Outcome 1-4, 8, 11-13, 15, 16, 21-26 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