Bharat, Shyam et al.Download PDFPatent Trials and Appeals BoardJan 10, 202014415825 - (D) (P.T.A.B. Jan. 10, 2020) 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. 14/415,825 01/20/2015 Shyam Bharat 2012P00427WOUS 7266 24737 7590 01/10/2020 PHILIPS INTELLECTUAL PROPERTY & STANDARDS 465 Columbus Avenue Suite 340 Valhalla, NY 10595 EXAMINER MATTSON, SEAN D ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 01/10/2020 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): katelyn.mulroy@philips.com marianne.fox@philips.com patti.demichele@Philips.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte SHYAM BHARAT, CYNTHIA MING-FU KUNG, and JOCHEN KRUECKER ____________ Appeal 2019-004055 Application 14/415,825 Technology Center 3700 ____________ Before JENNIFER D. BAHR, WILLIAM A. CAPP, and RICHARD H. MARSCHALL, Administrative Patent Judges. CAPP, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 seeks our review under 35 U.S.C. § 134(a) of the final rejection of claim 12 under 35 U.S.C. § 112(b) as indefinite and also of claims 1–13, 21, and 25 as unpatentable under 35 U.S.C. § 103(a) over Chan (WO 2011/098926 Al, pub. Aug. 18, 2011) and Verard (WO 2011/080606 Al, pub. July 7, 2011). 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(a). Appellant identifies Koninklijke Philips N.V., as the Applicant and real party in interest. Appeal Br. 3. Appeal 2019-004055 Application 14/415,825 2 THE INVENTION Appellant’s invention relates to positioning a medical instrument. Spec. 1–2. Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. A system, comprising: a shape sensing enabled device having a body which includes one or more imaging devices, the shape sensing enabled device including at least one optical fiber; a shape sensing module configured to receive optical signals from the at least one optical fiber within a structure and interpret the optical signals to determine a shape of the shape sensing enabled device; a device positioning module configured to determine position information of the one or more imaging devices based upon one or more spatial relationships between the at least one optical fiber and the one or more imaging devices; and a mapping module configured to register frames of reference of the at least one optical fiber, the shape sensing enabled device, and a mapping system of a target device to provide an adjusted position of the target device based on the position information. OPINION Indefiniteness of Claim 12 Claim 12, with paragraph indentation added, recites as follows: 12. At least one imaging array having a flexible body, said at least one imaging array including the system as recited in claim 1. Claims App. The Examiner states that it is unclear how the imaging array is meant to refer to the imaging devices of claim 1 or if it is in addition to the limitations of claim 1. Final Action 5. Appeal 2019-004055 Application 14/415,825 3 Appellant argues that the claim language is “simple and clear” and includes all of the elements of claim 1. Appeal Br. 6. In response, the Examiner states that it is unclear how an entire system made up of a shape sensing device and multiple software modules could have one flexible body. Ans. 4. In reply, Appellant accuses the Examiner of having a limited conception of the meaning of the term “array.” Reply Br. 5. Appellant argues that, contrary to the Examiner’s interpretation, the claim does not require having a single flexible body. Id. at 6. The PTO can properly reject a claim as indefinite if the claim is ambiguous, vague, incoherent, opaque, or otherwise unclear. See In re Packard, 751 F.3d 1307, 1311 (Fed. Cir. 2014). A claim is properly rejected as indefinite under 35 U.S.C. § 112 second paragraph if, after applying the broadest reasonable interpretation in light of the specification, the metes and bounds of a claim are not clear because the claim “contains words or phrases whose meaning is unclear.” Id. 1310, 1314 (approving, for pre-issuance claims, the standard from MPEP § 2173.05(e)); see also Ex parte McAward, Appeal 2015-006416, 2017 WL 3669566, at *5 (PTAB Aug. 25, 2017) (precedential) (adopting the approach for assessing indefiniteness approved by the Federal Circuit in Packard). Section 112 places the burden of precise claim drafting on Appellant. See In re Morris, 127 F.3d 1048, 1056-57 (Fed. Cir. 1997). The patent drafter is in the best position to resolve ambiguity in the claims, and it is highly desirable that patent examiners demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation. Appeal 2019-004055 Application 14/415,825 4 Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255 (Fed. Cir. 2008) (cited with approval in Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 910 (2014)). We agree with the Examiner that the meaning of claim 12 is unclear. The mere fact that Appellant can offer one possible construction for the claim does not render it definite. The claim, as drafted, is uncertain as to what type and how many other components, besides imaging devices, may be included in an imaging array. It is also unclear and confusing as to which components have a body that is flexible. We sustain the Examiner’s indefiniteness rejection of claim 12. Unpatentability of Claims 1–13, 21, and 25 over Chan and Verard Appellant argues independent claims 1, 13, and 21 together and does not separately argue any of the claims that depend therefrom. See Appeal Br. 8–11. We select claim 1 as representative. 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds that Chan discloses the invention substantially as claimed except for registering frames of reference, for which the Examiner relies on Verard. Final Action 6–8. The Examiner concludes that it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify Chan by the teachings of Verard to achieve the claimed invention. Id. at 8. According to the Examiner, a person of ordinary skill in the art would have done this to allow for real time tracking of radiation sources. Id. Appellant argues that Chan fails to disclose the claim limitation directed to determining position based on a spatial relationship between an Appeal 2019-004055 Application 14/415,825 5 optical fiber and an imaging device. Appeal Br. 9, Reply Br. 6. According to Appellant, Chan makes no mention of such a relationship. Id. In response, the Examiner directs our attention to page 10, lines 10–21 of the Chan reference. Ans. 6. The Examiner further states that a person of ordinary skill in the art would recognize that the position of the transducer is calculated based on the bend of optical fibers and that a spatial relationship must have been used to obtain a spatial geometry of the transducers relative to the optical fibers. Id. Chan is directed to a transducer device that is configured to receive signals from a console and generate images based upon reflected waves. Chan, p. 2, ll. 5–7. Chan uses an optical fiber with a shape and position that corresponds to a shape and position of a cable. Id. p. 2, ll. 9–10. Chan discloses sensors that are configured to measure deflection and bending in the optical fiber to determine position of the transducer. Id. p. 2, ll. 11–14. Chan further teachers that: System 100 includes a medical imaging device 101 with guidance feedback through shape sensing. The device 101 includes one or more transducer elements 102 . . . The transducer elements 102 may be connected to a cart/console 104 via a cable 108. The cable 108 may include an endoscope housing or other medical device, a catheter or other flexible member. Cable 108 includes at least one optical shape sensing fiber 110 embedded therein for real-time high accuracy spatial localization of the transducer elements 102 and associated cabling (108). Id. p. 9, ll. 8–19 (emphasis added); see also id. p. 10, ll. 10–18. In view of the foregoing, the Examiner’s finding regarding determining position information based on spatial relationships between an Appeal 2019-004055 Application 14/415,825 6 optical fiber and an imaging device is supported by a preponderance of the evidence. Appellant next argues that Verard fails to disclose registering frames of reference of an optical fiber and first (shape sensing) and second (target) devices as claimed. Appeal Br. 10. Appellant argues that the Examiner’s finding that registration is based on the location of the imaging transducer is not supported by the text of Verard. Id. at 11. In response, the Examiner directs our attention to the following passage in Verard: [A] template 56 for use in the placement of an applicator with respect to the target region 40 is coupled with respect to the ultrasound probe, via suitable coupling means, wherein a registration between the template (and subsequently the applicator) can be readily determined with reference to the ultrasound probe. In other words, appropriate registration between the imaging system of the ultrasound probe 48 and that of tracking a position of the applicator relative to the target region 40 and a treatment plan, as will be discussed herein below, can be obtained. Ans. 7 (quoting Verard ¶ 35, emphasis added). In reply, Appellant argues that the Examiner’s position is based on a “novel” construction of claim language. Reply Br. 6. The Examiner’s further arguments regarding the teachings of the Verard reference depend on an inaccurate interpretation of the claim language . . . Verard determines the position using fibers in the catheters and does not need to know the position of the ultrasound itself – hence Verard does not use position information for the imaging devices. Id. at 7–8. Appellant takes the position that the claim recites a list of things that are registered, but does not recite that they are necessarily registered “to each other.” Id. at 7. Instead, according to Appellant, the list of things are Appeal 2019-004055 Application 14/415,825 7 registered “based on position information” as opposed to “one another.” Id. Appellant then argues that position information enables the registration of each of the recited components to provide the adjusted position of the target device. Id. Verard is directed to high dose rate brachytherapy in which an applicator in the form of a catheter/applicator is positioned in a patient. Verard, ¶ 4. A high dose rate source is moved through the catheter and dwells at a preplanned position for a period of time. Id. Verard’s ultrasound probe 48 moves in relation to target region 40 by means of stepper motor 54. Id. ¶ 35. Template 56 is used to place a catheter/applicator with respect to target region 40 in a manner that is coupled with respect to probe 48 such that a registration between the template/applicator can be determined with reference to the probe. Id. Verard achieves “appropriate registration” between the imaging system of probe 48 and the position of the applicator. Id. Verard discusses optical shape sensing with optical fibers “only briefly” as such is recognized as being “known in the art.” Id. ¶ 21. Verard further discloses that: The embodiments of the present disclosure advantageously use Fiber Bragg Grating optical fiber(s) as an adjunct to existing afterloader devices, the FBG optical fiber(s) adapted to measure the location and shape of each catheter, and collect information about the entire set of catheters in 3D to ensure no significant motion occurred from one catheter to another . . . Fiber Bragg Grating technology advantageously provides for real-time localization (<1 mm) and strain information of the flexible catheters utilized during HDR brachytherapy delivery fractions. The FBG optical fibers advantageously provide a simple, fast and accurate way to verify and monitor the entire shape of implanted catheters prior to and during radiation delivery of brachytherapy treatment. Appeal 2019-004055 Application 14/415,825 8 Id. ¶¶ 26–27. In summary, Verard discloses positional registration between an ultrasound probe and a catheter/applicator. Verard’s ultrasound probe corresponds to Appellant’s claimed imaging device and Verard’s catheter/applicator corresponds to Appellant’s claimed target device. Verard uses optical fibers to measure the shape and location of each catheter. Appellant’s argument that claim 1 registers items “based on position” instead of to “one another” is unpersuasive. Appellant’s claim is best understood as positioning an imaging device, a target device, and a shape sensing optical fiber within a common frame of reference. Once all such devices are registered within such common frame of reference, they are also understood to be registered in relation to each other. Having considered Appellant’s arguments regarding frames of reference in view of the combined teachings of Chan and Verard, we determine that the Examiner’s findings of fact are supported by a preponderance of the evidence. In view of the foregoing, we sustain the Examiner’s unpatentability rejection of claims 1–13, 21, and 25. CONCLUSION Claims Rejected § References / Basis Aff’d Rev’d 12 112 Indefiniteness 12 1–13, 21, 25 103 Chan, Verard 1–13, 21, 25 Overall Outcome 1–13, 21, 25 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation