Ex Parte GoodwinDownload PDFPatent Trial and Appeal BoardSep 23, 201411012573 (P.T.A.B. Sep. 23, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARKOFFICE 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. 11/012,573 12/15/2004 Mark R. Goodwin CES 100 DIV CON 8447 23579 7590 09/23/2014 Pabst Patent Group LLP 1545 PEACHTREE STREET NE SUITE 320 ATLANTA, GA 30309 EXAMINER BOR, HELENE CATHERINE ART UNIT PAPER NUMBER 3768 MAIL DATE DELIVERY MODE 09/23/2014 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte MARK R. GOODWIN __________ Appeal 2012-003350 Application 11/012,573 Technology Center 3700 __________ Before DONALD E. ADAMS, LORA M. GREEN, and TINA E. HULSE, Administrative Patent Judges. PER CURIAM DECISION ON APPEAL This is a decision on appeal1 under 35 U.S.C. § 134 from the Examiner’s rejection of claims 24, 25, 27, 31–39, and 41–54. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 The Real Party in Interest is Cutting Edge Surgical, Inc. (App. Br. 2). Appeal 2012-003350 Application 11/012,573 2 STATEMENT OF THE CASE The Specification discloses an “IntraOsteal UltraSound (IOUS) based system [that] is used for the placement of implants . . . and for [the] detection and characterization of bone” (Spec. 5:2–4). The Specification discloses that “a titanium screw or pin . . . is implanted into a channel created by channeling a probe through the cortical bone into the cancellous bone” (id. at 6:14–15). The Specification discloses that the “system includes a device for sensing and alerting via an auditory or visual signal the absence of bone (cortical, cancerous, cartilaginous)” (id. at 5:8–10). Claim 24, the only independent claim, reads as follows: 24. A probe suitable for insertion into bone and real time interrogation comprising (a) a transducer and a receiver for ultrasound or audio signals for interrogation of a tissue, and (b) input and output connections for transmitting and receiving data from the probe to a central processing unit, to provide real time interrogation and feedback to an operator via an external electrical processing and monitoring means, allowing real time manipulation and navigation of the probe. The claims stand rejected as follows: I. Claims 32–37 under 35 U.S.C. § 112, second paragraph (Ans. 5, 12–13); II. Claims 24, 25, 27, 32–36, 38, 39, 41–46, and 49–54 under 35 U.S.C. § 102(a) as anticipated by Kleffner2 (Ans. 6–9); and 2 DE 199 21 279 C1, pub. Nov. 30, 2000. (All citations to Kleffner are to the certified English translation, PTO 11-3860.) Appeal 2012-003350 Application 11/012,573 3 III. Claims 31, 37, 47, and 48 under 35 U.S.C. § 103(a) over the combination of Kleffner and Wheeless3 (Ans. 10–11). I. The Examiner has rejected claims 32–37 under 35 U.S.C. § 112, second paragraph, as being indefinite “for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention” (Rejection I) (Ans. 5, 12–13). The Examiner sets forth a new ground of rejection with regard to claims 32–37, in which the Examiner cites language in claims 32 and 33 (Ans. 12). Claims 34–37 depend from claim 33. Appellant has not presented arguments to dispute this rejection, and thus we summarily dismiss the appeal as to claims 32–37. 37 C.F.R. § 41.39(b). II. Issue The Examiner has rejected claims 24, 25, 27, 32–36, 38, 39, 41–46, and 49–54 under 35 U.S.C. § 102(a) as anticipated by Kleffner (Rejection II) (Ans. 6–9). The Examiner has also rejected claims 31, 37, 47, and 48 under 35 U.S.C. § 103(a) as obvious over the combination of Kleffner and Wheeless (Rejection III) (Ans. 10–11). As we have dismissed the appeal as to claims 32–37, we do not address those claims further. 3 Wheeless’ Textbook of Othropaedics, “Duke University School of Medicine,” Sept. 27, 2007, available at http://www.wheelessonline.com/ortho/screws. Appeal 2012-003350 Application 11/012,573 4 The issue with respect to this rejection is: Has the Examiner established by a preponderance of the evidence that Kleffner discloses a probe suitable for insertion into bone and real time interrogation comprising (a) a transducer and a receiver for ultrasound or audio signals and (b) input and output connections for transmitting and receiving data from the probe to a central processing unit? Findings of Fact FF1. The Examiner finds that Kleffner discloses a “probe comprising means for interrogation of a tissue comprising a transducer and a receiver for ultrasound or audio signals,” wherein the transducer sends the ultrasound signal and the receiver receives the ultrasound signal (Ans. 6 (citing Kleffner at Fig. 1)). FF2. The Examiner finds that Kleffner “teaches input and output connections for transmitting and receiving data from the probe to a central processing unit . . . to provide real time interrogation and feedback to an operator via an external electrical processing and monitoring means” (id., (citing Kleffner at Fig. 1)). FF3. The Examiner finds that the Kleffner system allows for “real time manipulation and navigation of the probe” (id. (citing Kleffner at Fig. 1)). FF4. The Examiner finds that Kleffner teaches that the probe further comprises “means for creating a lumen or channel into the bone at a desired site” (id. (citing Kleffner at Fig. 2)). FF5. The Examiner finds that Kleffner teaches that the means for creating a pilot hole in bone includes a “hollow drill bit comprising the App App trans Figs bone ultra can e Figu ultra 4 All botto eal 2012-0 lication 1 ducer and . 1 and 2)) FF6. Kl material” FF7. Kl sound con mit and re FF8. Fig re 1 shows sound mon reference m of each 03350 1/012,573 receiver in . effner disc (Kleffner effner disc verter . . . ceive ultr ure 1 of K a “schem itoring de to a page page of th the hollo loses “a ro , 2).4 loses that positioned asound wa leffner is atic view o vice havin number of e Kleffner 5 w drill bit tating sur the rotatin in . . . [the ves” (id. a shown bel f a drill to g an optic Kleffner r translatio ” (id. at 6– gical tool g surgical rotating t 3). ow: ol used on al display” efers to th n. 7 (citing K to create a tool comp surgical to a vertebr (id. at 8) e number leffner at recess in rises “an ol] which a with an . at the Appeal 2012-003350 Application 11/012,573 6 FF9. Figure 2 of Kleffner is shown below: Figure 2 shows an “enlarged cut-away view in area A in Figure 1 with a drill tool equipped with an ultrasound converter” (id.). FF10. Kleffner discloses that spiral drill 2 comprises “an interior channel 6 . . . which terminates in a receptacle area 7 that is located directly behind the cone-shaped cutting area 8 of the spiral drill 2” (id. at 9). FF11. Kleffner discloses that an “ultrasound converter 9 is positioned in this receptacle area 7 . . . [and] can radiate ultrasound radiation . . . perpendicular to the cutting surface 8 and . . . accept ultrasound radiation impacting on it from this direction” (id.). FF12. Kleffner discloses that the “ultrasound converter is connected with a line 10 . . . [to] a transmission and receiving device 11 that . . . is connected via line 12 with a display device 13” (id.). FF13. Kleffner discloses that that the “transmission and receiving device 11 . . . can produce and receive ultrasound radiation . . . [that] is sent in the form of an impulse through the ultrasound converter 9 into the surrounding bone 4” (id.). Appeal 2012-003350 Application 11/012,573 7 FF14. Kleffner discloses that the “reflected radiation then impacts again on the ultrasound converter 9 and is converted there into an electric signal that is sent to the transmission and receiver device 11” (id. at 10). FF15. Kleffner discloses that “the reflected ultrasound radiation produces signals that are a measure of the nature of the bone material in the direction of radiation” (id. at 3). FF16. Kleffner discloses that the “[t]he signals accepted by the transmission and receiver device 11 can be . . . displayed on the viewing device 13 . . . so that the operating physician receives an optical display of how the bone material around the spiral drill 2 is constituted” (id. at 11). As taught by Kleffner, that “makes it possible for the operating physician to . . . aim the spiral drill . . . [such] that during further penetration into the bone . . . it can always be as accurately centered in the bone material as possible and keep a sufficient separation from the boundary surfaces of the bone” (id.). FF17. Kleffner discloses that the “ultrasound converter rotates together with the spiral drill 2 and thus . . . can scan a cone-shaped shell which is formed by a cone positioned coaxially to the rotation axis of spiral drill 2” (id. at 10). FF18. Appellant’s Specification discloses that “a titanium screw or pin . . . is implanted into a channel created [in the bone] by channeling a probe through the cortical bone into the cancellous bone within the bone to be immobilized” (Spec. 6:14–16). FF19. Appellant’s Specification discloses that instruments that “can be used to create the images and pilot holes for the surgeon . . . [include] Appeal 2012-003350 Application 11/012,573 8 drill bits currently in use, [which are] modified to include a transducer” (id. at 9:3–6). FF20. According to Appellant’s Specification, such instruments “may be made by modifying existing ultrasound probes to include a hard pointed end” (id. at 9:8–9). Analysis Appellant argues that Kleffner does not disclose or suggest a probe as required by claim 24, but that “Kleffner discloses a drill, not a probe” (App. Br. 9). Appellant argues that Kleffner “discloses a mechanically rotating surgical power tool for cutting bone material . . . [but] does not disclose or suggest any device other than a mechanically rotating surgical tool, such as a drill, milling cutter, reamer, trephine, etc.” (id. at 8). Appellant’s argument is not persuasive. The Specification discloses that a channel is created in a bone by channeling a probe through the cortical bone into the cancellous bone (FF 18). The Specification discloses that instruments that can be used to create the pilot holes for the surgeon include drill bits that have been modified to include a transducer (FF 19). Thus, one of skill in the art would have understood that the probe of claim 24 that comprises a transducer could be a drill bit that comprises a transducer, which Kleffner discloses (FF 11). Claim 24 is directed to a probe comprising “(a) a transducer and a receiver for ultrasound or audio signals” and “(b) input and output connections for transmitting and receiving data from the probe to a central processing unit, to provide real time interrogation and feedback to an operator . . . [to allow for] real time manipulation and navigation of the Appeal 2012-003350 Application 11/012,573 9 probe .” Appellant concedes that Kleffner teaches part (a) of claim 24, stating that “Kleffner discloses a drill which contains an ultrasonic transducer,” wherein the “transducer sends out a signal . . . which is reflected and received by the transducer” (App. Br. 10). Appellant, therefore, only argues that Kleffner does not teach part (b) of claim 24. Specifically, Appellant argues that Kleffner’s device does not contain “a means of transmitting and receiving signals both from the tissue being interrogated AND with a central processer that returns signals to the probe which then acts in response thereto - i.e., real time interrogation” (App. Br. 10). Appellant argues that Kleffner’s drill contains a transducer that “sends out a signal, such as ultrasonic radiation, which is reflected and received by the transducer” (id.). Appellant argues that the reflected “signal is converted to an electronic signal which is fed to the transmitter and receiver” (id.). Appellant argues that the “transmitter and receiver are not located within the surgical drill, but rather, distal in a separate drilling machine or power supply component” (id.). Appellant argues, therefore, “there can be no interaction between the distant separate drilling machine or power supply [of Kleffner] and the drill, only transmission of signal” (id.). Appellant’s arguments are not persuasive because Kleffner’s transducer/receiver is connected by line 10 to a transmission and receiving device 11 (FF 12–13). Kleffner discloses that the reflected radiation impacts ultrasound converter 9 and is converted into an electric signal that is sent to the transmission and receiver device 11 (FF 14). Kleffner also discloses that the ultrasound signals received by the transmission and receiver device 11 are displayed on viewing device 13 so that the physician receives an optical Appeal 2012-003350 Application 11/012,573 10 display of the bone material constitution that surrounds around the drill, and can thus accurately aim the drill for further penetration into the bone (FF 16). Thus, contrary to Appellant’s argument, Kleffner discloses a probe the comprises “input and output connections for transmitting and receiving data from the probe to a central processing unit, to provide real time interrogation and feedback to an operator,” as required by part (b) of claim 24. Thus, we affirm the rejection of claim 24 as being anticipated by Kleffner. Claims 25, 27, 38, and 39 have not been argued separately and therefore fall with claim 24. 37 C.F.R. § 41.37(c)(1)(vii). Appellant also argues the rejection of claim 41 (App. Br. 15). Claim 41 is directed to a method for diagnosing bone disease, bone thickness, absence of bone, cartilage interface, failed spinal fusions, detection of bone to avascular necrosis interface, fractures, neoplasms, osteoid osteoma, and vascular lesions comprising inserting the probe of claim 24 into a bone or tissue and detecting defined differences in acoustical impedence signal. Appellant argues that “Kleffner only discloses an ability to determine ‘the condition of bone and the thickness of bone’ in the area adjacent to the drill . . . [but] does not disclose or suggest a method of diagnosing or detecting the specific conditions recited in claim 41” (App. Br. 15). The Examiner responds that claim 41’s recitation of a “method of diagnosing or detecting the specific conditions . . . has not been given patentable weight because the recitation occurs in the preamble” (Ans. 20). The Examiner responds that a “preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend Appeal 2012-003350 Application 11/012,573 11 on the preamble for completeness” (id.). The Examiner reasons that, because the claim body “fully and intrinsically sets forth all of the limitations . . . and the preamble merely states . . . the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations,” the preamble is not a limitation (id.). We agree with the Examiner that Kleffner discloses the invention of claim 41. “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Further, “[a]n intended use or purpose usually will not limit the scope of the claim because such statements usually do no more than define a context in which the invention operates.” Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Claim 41 recites: A method for diagnosing bone disease, bone thickness, absence of bone, cartilage interface, failed spinal fusions, detecting of bone avascular necrosis interface, fractures, neoplasms, osteoid osteoma, and vascular lesions comprising inserting the probe of claim 24 into a bone or tissue and detecting defined differences in acoustical impedance signal. As found by the Examiner, Kleffner teaches the method step of inserting a probe that meets the limitations of claim 24 into bone or tissue and detecting defined differences in the acoustic impedance signal (Ans. 7). Kleffner teaches also that such a method may be used to determine bone thickness and structural changes of the bone material (Ans. 7 (citing Kleffner, 4, first paragraph of translation)). Thus, Kleffner teaches all of the steps required by claim 41, that is, Kleffner teaches inserting the probe into bone or tissue and detecting defined differences in acoustical impedance signal. The Appeal 2012-003350 Application 11/012,573 12 recitation of the conditions in the preamble of claim 41 do not add additional steps to the method steps recited, and thus are a benefit of the process of Kleffner not specifically recognized by Kleffner, or, as argued by the Examiner, an intended use of the process of Kleffner. Moreover, Kleffner specifically notes that the disclosed method can be used to determine bone thickness, which is one of the items recited in the preamble of claim 41. Thus, we affirm the rejection of claim 41 as being anticipated by Kleffner. Appellant also argues the rejection of claims 42–44 (App. Br. 15-16), which depend from claim 41 and further recite the following: in claim 42, “the video signal is used to measure or provide analysis of one or more factors or variables in bone selected from the group consisting of Bone mineral density (BMD), disease, lesion or neoplasm, vascular defects, or areas of avascular necrosis;” in claim 43, “the method is used to determine areas of bony non-union, fracture, or regions between bone;” and in claim 44, “the method is used to determine water content or cartilage composition.” Appellant argues that Kleffner does not disclose the particular method uses recited in claims 42, 43, and 44 (App. Br. 16). The Examiner responds that the “appellant did not positively recite the steps of determining areas of bony unions or determine water content” and that “[p]atentability does not rely on what the method is used for” (Ans. 21). The Examiner also notes that Kleffner teaches that it is possible to determine inhomogeneities in the bone, as well as boundary areas, and thus may be used as a measure for bone condition (id. (citing Kleffner, 10)). Appeal 2012-003350 Application 11/012,573 13 We agree with the Examiner that Kleffner discloses the methods of claims 42–44. As discussed above with regard to claim 41, claims 42-44 do not add any additional method steps, and thus would be a benefit not recognized by Kleffner of the disclosed process of Kleffner. Thus, we affirm the rejection of claims 42–44 as being anticipated by Kleffner. Appellant also argues the rejection of claim 45 (App. Br. 16–17). Claim 45 is directed to a method for guiding and placing an implant within a region of tissues or bone characterized by defined differences in video signal or acoustical impedence comprising introducing into the region the probe of claim 24 and monitoring differences in video signal or acoustical impedence as the probe including the transducer and receiver are moved through the region. Appellant argues that “Kleffner discloses a mechanically rotating surgical power tool for cutting bone material” (App. Br. 17). Appellant argues that “[w]hile Kleffner suggests that the drill may be useful for preparing ‘drill holes for receiving bone screws,’ Kleffner does not disclose or suggest any method of guiding and placing an implant within these drill holes” (id., (emphasis deleted)). The Examiner responds that the recitation of a method “for guiding and placing an implant within a region of tissues or bone characterized by defined differences in video signal or acoustical impedence” has not been given patentable weight (Ans. 20). The Examiner reasons that the cited language occurs in the preamble and is not considered a limitation because the body of the claim “fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states . . . the purpose or intended use of the invention” (id.). Appeal 2012-003350 Application 11/012,573 14 We agree with the Examiner that Kleffner discloses the method of claim 45. As discussed above with regard to claim 41, the broadest reasonable interpretation of claims 45 is that the preamble claim language that is directed to a particular use of the claimed method steps is merely a statement of intended use that defines a context in which the invention operates. Thus, Appellant’s arguments are not persuasive, and we affirm the rejection of claim 45 as being anticipated by Kleffner. Claims 46 and 49–54 have not been argued separately and therefore fall with claim 45. 37 C.F.R. § 41.37(c)(1)(vii). The Examiner has also rejected claims 31, 47 and 48 under 35 U.S.C. § 103(a) as obvious over the combination of Kleffner and Wheeless (Rejection III) (Ans. 10–11). Appellant argues that, “for at least the reasons set forth with respect to claims 24 and 45, claims 31, 37, 47, and 48 are non- obvious in view of Kleffner” (App. Br. 17). That argument is not persuasive because, as discussed above, we have found that Appellant’s arguments with regard to claims 24 and 45 were not persuasive. Conclusion of Law A preponderance of the evidence supports the Examiner’s finding that Kleffner discloses a probe suitable for insertion into bone and real time interrogation comprising (a) a transducer and a receiver for ultrasound or audio signals and (b) input and output connections for transmitting and receiving data from the probe to a central processing unit. Appeal 2012-003350 Application 11/012,573 15 SUMMARY We summarily dismiss the appeal as to claims 32–37. We also affirm the rejection of claims 24, 25, 27, 38, 39, 41–46, and 49–54 under 35 U.S.C. § 102(a) and the rejection of claims 31, 47, and 48 under 35 U.S.C. § 103(a). TIME PERIOD FOR 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). AFFIRMED cam Copy with citationCopy as parenthetical citation