Ex Parte Salminen

Patent Trial and Appeal BoardDec 18, 2018

13496043 (P.T.A.B. Dec. 18, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. 13/496,043 93255 7590 Intrinsic Law Corp. 221 Moody Street Waltham, MA 02453 FILING DATE FIRST NAMED INVENTOR 03/14/2012 Heikki Salminen 12/18/2018 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 ATTORNEY DOCKET NO. CONFIRMATION NO. PMIP.USPAT.0600 4837 EXAMINER ROY, BAISAKHI ART UNIT PAPER NUMBER 3793 MAIL DATE DELIVERY MODE 12/18/2018 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 HEIKKI SALMINEN Appeal2017-010218 Application 13/496,043 Technology Center 3700 Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and RACHEL H. TOWNSEND, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal 1,2 under 35 U.S.C. Â§ 134 involving claims to a high intensity focused ultrasound positioning mechanism for positioning a high intensity focused ultrasound transducer. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. Â§ 6(b). We reverse. 1 Appellant identifies the Real Party in Interest as KONINKLIJKE PHILIPS N.V. (App. Br. 2). 2 We have considered and herein refer to the Specification of Mar. 14, 2012 ("Spec."); Final Office Action of Oct. 7, 2015 ("Final Act."); Appeal Brief of Nov. 22, 2016 ("App. Br."); Examiner's Answer of June 2, 2017 ("Ans."); and Reply Brief of July 28, 2017 ("Reply Br."). Appeal2017-010218 Application 13/496,043 Statement of the Case Background "[H]igh intensity focused ultrasound can be used for heating a region within the subject, it can be used for rupturing tiny capsules of a drug and activating the drug, it can be used for ablating tissue, and at higher powers cavitation can be used to destroy regions within the subject" (Spec. 1 :8-11 ). "High intensity focused ultrasound is focused onto a region of the subject using a transducer." (id. at 1: 11-12). "[T]ypically the transducer is physically moved. For treatment of the breast, typically three degrees of freedom are used for mechanically moving the high intensity focused ultrasound transducer. In other modes of treatment therapy, such as for treating fibroids, five degrees of freedom are used" (id. at 1: 16-19). The Claims Claims 1 and 6-14 are on appeal. 3 Claim 1 is representative and reads as follows: 1. A high intensity focused ultrasound positioning mechanism for positioning a high intensity focused ultrasound transducer, the mechanism comprising: a positioning plate adapted for receiving the high intensity focused ultrasound transducer; a mechanism support adapted for mounting the positioning mechanism; a plurality of rods, wherein each rod has a first end and a second end, wherein the first end of each rod forms a separate ball joint with the positioning plate, wherein the plurality of 3 Claims 2 and 3 were objected to as being dependent upon a rejected base claim (see Final Act. 3). 2 Appeal2017-010218 Application 13/496,043 rods are configured to move the positioning plate in at least three degrees of freedom; and a plurality of linear drives, wherein the plurality of linear drives are mounted to the mechanism support, wherein each of the linear drives comprises a drive block, wherein the second end of each of the plurality of rods forms a separate ball joint with one of the drive blocks, wherein the positioning plate is movable along three orthogonal axes. The Rejections A. The Examiner rejected claims 1 and 11-14 under 35 U.S.C. Â§ I03(a) as obvious over Quistgaard, 4 Wagshul, 5 and Shmulewitz6 (Final Act. 3-7). B. The Examiner rejected claim 6 under 35 U.S.C. Â§ I03(a) as obvious over Quistgaard, Wagshul, Shmulewitz, and Sanghvi 7 (Final Act. 7). C. The Examiner rejected claim 7 under 35 U.S.C. Â§ I03(a) as obvious over Quistgaard, Wagshul, Shmulewitz, Sanghvi, and Kim8 (Final Act. 7). D. The Examiner rejected claims 8 and 9 under 35 U.S.C. Â§ I03(a) as obvious over Quistgaard, Wagshul, Shmulewitz, and Hamman9 (Final Act. 7-8). E. The Examiner rejected claim 10 under 35 U.S.C. Â§ I03(a) as obvious over Quistgaard, Wagshul, Shmulewitz, and Claverie 10 (Final Act. 8). 4 Quistgaard et al., US 2005/0154431 Al, published July 14, 2005. 5 Wagshul, US 6,208,142 Bl, issued Mar. 27, 2001. 6 Shmulewitz et al., US 6,027,457, issued Feb. 22, 2000. 7 Sanghvi et al., US 2012/0035473 Al, published Feb. 9, 2012. 8 Kim, US 2013/0165974 Al, published June 27, 2013. 9 Hamman, US 2005/0250070 Al, published Nov. 10, 2005. 1Â° Claverie et al., US 2009/0062869 Al, published Mar. 5, 2009. 3 Appeal2017-010218 Application 13/496,043 A. 35 USCÂ§ 103(a) over Quistgaard, Wagshul, and Shmulewitz The Examiner finds Quistgaard teaches "a high intensity focused ultrasound positioning mechanism" that employs a "mechanical arm 200 for positioning" the transducer, which mechanism also comprises "a positioning plate 534a that is magnetically coupled to a plate 534b attached to the energy applicator for receiving the high intensity focused ultrasound transducer," "a plurality of rods 520, 528," and "a plurality of motor linear drives 508, 51 O" (Final Act. 3--4). The Examiner finds Quistgaard's device "has further controls such that it is capable of movement by six degrees of freedom" (id. at 4). The Examiner also finds that the mechanical arm that is guided to position the transducer or therapy head "has sufficient mobility and extension to allow the six DOF [ degrees of freedom] to be conveyed to the therapy head without interfering with other objects present during a medical procedure ... The reference therefore explicitly teaches that the therapy head may have at least 3 DOF" (id. at 5). The Examiner acknowledges that Quistgaard does "not explicitly teach of the positioning system being movable along three orthogonal axes" nor does Quistgaard teach an "MR imaging system" (Final Act. 5). The Examiner also acknowledges that Quistgaard does not teach a threaded drive rod (Final Act. 6). The Examiner finds Wagshul teaches "a combined MR and HIFU imaging/therapy system" and a "positioning system [that] is movable along three orthogonal axes where the positioning system 23 includes mechanism for movement in multiple degrees of freedom including translation in all vertical and horizontal directions and rotation about three orthogonal axes" (Final Act. 5-6). The Examiner finds Shmulewitz teaches "drive systems 90 4 Appeal2017-010218 Application 13/496,043 and 94 that may employ a threaded drive block" (id. at 6). The Examiner finds that it would have been obvious to "use the teaching by Wagshul to modify Quistgaard et al. to effectively obtain MR images of the patient to provide more specific therapy ... and provide more accurate and precise alignment of the positioning system relative to the patient" (Final Act. 6). The Examiner also finds that it would have been obvious to "use the teaching by Shmulewitz et al. to modify the previously cited references for effective positioning of the gantry so that that the gantry can be moved in the proximal and distal directions in precise increments" (id. at 6-7). The issue with respect to this rejection is: Does a preponderance of the evidence of record support the Examiner's conclusion that the prior art suggests a "plurality of rods" that "are configured to move the positioning plate in at least three degrees of freedom" as required by claim 1? Findings of Fact (FF) 1. Quistgaard teaches "a system for the application of energy to a body region. The system has three principle subsystems: a scan head, a suspension device and a treatment controller" (Quistgaard ,r 54). 5 Appeal2017-010218 Application 13/496,043 2. Figure 1 of Quistgaard is reproduced below: P10--.._ ..... r;;;;. ,:_--202 c;--1r~~ / - ---( ' ;--,~~1212 -120 2:-2-1. L Â· -- : ,;c \\ --222 ., 1/' ..... :: .. I\ l l . ~ 'Â· 250 , \ I ----Â· \. \ ii 400 '\1 // \1 \-,--1 oo I \\ \ ; ~\ I I I 1'0/~, J . '-102 FIG. 1 Figure 1 illustrates a system with "a scan head 500 that includes an energy applicator 600 [ not shown]. . . The system 10 also has a means for suspending the scan head in space, such as a mechanical arm 200 . ... joints 240, 210 provide added degrees of freedom to the therapy head 500" ( Quistgaard ,r,r 5 5, 5 7). 3. Quistgaard teaches that "[i]deally the robotic arm has six DOF through the therapy head, and has sufficient mobility and extension to allow the six DOF to be conveyed to the therapy head without physically interfering with other objects present during a medical procedure, such as the patient or the user" (Quistgaard ,r 103). 4. Quistgaard teaches that the "robotic arm may be constructed with any number ofDOF while the therapy head is manually adjusted for the remainder requirement DO F" ( Quistgaard ,r 131). 6 Appeal2017-010218 Application 13/496,043 5. Figures 2 and 4A of Quistgaard are reproduced below: ti~1 7-12 .,/ tl ) :Â· l : : " / 111 ,4,""l i 1i ~- /._,->Â·'" , '1 !i I - - ~::,.. -~-5()0 ..7 "-l UJ ,Â·ca - -" #' ~;.-::-~Â· ~'"'*~:IV \._ .1? .f$=~f;i~~~~~~~~- ~~~~-~~~, Â·,\ g ii ! 51!6 ~ i \, ~ i I '.-.-_:::~~~~~]L~~~~~-.:.~ Ii I ~ ti i; ! 510 c:, t !l ! ~ ~ ii' i! Â·1: i t1 ~~ Â·!! ! ! l t: t~ ~ ii ~Â·') Ii ~Â·'c> ' I 'l tl ii "'' ---1-i Â·Â·""' '. Ji ~ ' 13()() FIG. 2 F!G.4A Figures 2 and 4A illustrate a therapy head 500 that "contains motor drives 508, 510 for moving the energy applicator 600 within the enclosure. The motor drives are connected directly, or through a gear assembly (not shown), to a pair of traveler rods 520, 528. The traveler rods in tum move a pair of slotted actuators 520', 528"' (Quistgaard ,r 66). 6. Figure 4B of Quistgaard is reproduced below: FIG.4B 7 Appeal2017-010218 Application 13/496,043 Figure 4B illustrates another embodiment where "motor drive units 508, 510 can be used to control a plate 534a that is magnetically coupled to a plate 534b attached to the energy applicator. The plate is moved by the motors and the energy applicator moves in response. The energy applicator is not physically connected to any sort of traveler rod or moving device except by the magnetic connection" (Quistgaard ,r 67). 7. Figure 1 ofWagshul is reproduced below: Figure 1 illustrates, in part, that "[p ]ositioning system 23 includes conventional devices such as hydraulic or pneumatic actuators, screw jacks and rotary movement devices for moving chassis in multiple degrees of freedom including translation in all vertical and horizontal directions and rotation about three orthogonal axes" (Wagshul 5:56-61). 8. Shmulewitz teaches "drive systems 90 and 94 may employ, for example, a motorized track, a threaded block carried on a threaded drive rod" (Shmulewitz 5: 17-19). Principles of Law A prima facie case for obviousness "requires a suggestion of all limitations in a claim," CFMT, Inc. v. Yieldup Int'! Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) and "a reason that would have prompted a person of 8 Appeal2017-010218 Application 13/496,043 ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Analysis Appellant contends "Quistgaard fails to teach 'wherein the plurality of rods are configured to move the positioning plate in at least three degrees of freedom,' as recited in claim 1. The traveler rods of Quistgaard are configured such that the scan head 500 has only two degrees of freedom" (App. Br. 7). Appellant contends (id.). since Quistgaard provides further controls, other than the rods, that make the device capable of up to six degrees of freedom, there would be no incentive to modify the rods. In other words, since the result of additional degrees of freedom was already accomplished by alternative methods, other than rods, a person of ordinary skill in the art would not further modify the rods for the purpose of achieving the already accomplished result. The Examiner responds that Quistgaard teaches a robotic arm that is guided by the control mean or computer input device to position the therapy or scan head has six DOF through the therapy head and has sufficient mobility and extension to allow the six DOF to be conveyed to the therapy head without interfering with other objects present during a medical procedure [0103, 0113]. The reference therefore explicitly teaches that the therapy head may have at least 3 DOF. (Ans. 8). We begin our analysis with claim interpretation. Claim 1 recites that "the plurality of rods are configured to move the positioning plate in at least three degrees of freedom." We interpret this claim limitation to require that 9 Appeal2017-010218 Application 13/496,043 the rods themselves must move the positioning plate to result in movement along the x, y, or z dimensions or in the form of pitch, yaw, or roll (see, e.g., Quistgaard ,r 178 ( describing examples of degrees of freedom)). Quistgaard teaches the device as a whole may have six degrees of freedom. However, Quistgaard clearly explains that it is a robotic arm, mechanical arm 200 in figure 1, which provides these degrees of freedom, and not the rods within the scan head (FF 2--4). More importantly, we note that the only teaching in Quistgaard that the Examiner relies on does not clearly teach that rods are configured to move the positioning plate at all (FF 6). Similarly, Wagshul's positioning system 23 is located external to the scan head, and does not expressly teach using rods for movement of the positioning plate (FF 6). That is, while movement of the entire scan head by an external device, such as a robotic arm, might result in movement of the positioning plate along one of the six degrees of freedom, that movement would not be performed using rods that "are configured to move the positioning plate" as required by claim 1. Therefore, in order to satisfy this claim limitation, the rods themselves must perform the movement of the positioning plate in at least three degrees of freedom, not some external component or robotic arm or even a "manually adjusted" therapy head (FF 4 ). We are not persuaded by the Examiner's contention that even if the reference does not explicitly teach of the rods have 3DOF, the rods rotate and therefore have more than 2 degrees of freedom and furthermore, if the scan or therapy head or positioning system has three to six DOF, then the individual positioning component such as the rods or the positioning plate would also be capable of such motion. (Ans. 8-9). As discussed above the claim requires that the rods themselves 10 Appeal2017-010218 Application 13/496,043 must perform the movement of the positioning plate in at least three degrees of freedom, not some external component or robotic arm or even a "manually adjusted" therapy head (FF 4). That is, while movement of the entire scan head by an external device, such as a robotic arm in Quistgaard, might result in movement of the positioning plate along one of the six degrees of freedom, what is described in Quistgaard is not a plurality of rods that "are configured to move the positioning plate" as required by claim 1. Movement of the entire scan head with a robotic arm in more than three degrees of freedom does not satisfy a claim limitation requiring that the rods themselves function to move a positioning plate in at least three degrees of freedom. Even if the Examiner is correct that Quistgaard teaches the use of rods within the scan head and that these rods result in movement of the positioning plate (FF 5), a position that is in some doubt (FF 6), the Examiner has expressly acknowledged that the prior art does not teach movement of the rods with at least three degrees of freedom. We also do not see any indication in Quistgaard that the rods result in movement in at least three degrees of freedom as required by claim 1. To the extent that the Examiner is relying on inherency, "[i]nherency ... may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient." MEHL/Biophile Int 'l. Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999). The Examiner has provided no evidence to support the position that the rods themselves are necessarily capable of causing the positioning plate to move with at least three degrees of freedom. We also agree with Appellant's reasoning that because the robotic arm 11 Appeal2017-010218 Application 13/496,043 as a whole can move in six degrees of freedom, "there would be no incentive to modify the rods" to do so (see App. Br. 7). That is, we agree that without a specific reason to modify the rods to increase their ability to move the positioning plate with at least three degrees of freedom, the ordinary artisan would not have had reason to do so because the robotic arm would have allowed movement with six degrees of freedom of the entire scan head in which the rods and positioning plate are located. We, therefore, agree with Appellant that the Examiner has not established that the rods within the scan head of Quistgaard have "at least three degrees of freedom" as required by a broadest reasonable interpretation of claim 1. Conclusion of Law A preponderance of the evidence of record does not support the Examiner's conclusion that the prior art suggests a "plurality of rods" that "are configured to move the positioning plate in at least three degrees of freedom" as required by claim 1. B.-E. 35 USCÂ§ 103(a) Having reversed the obviousness rejection of claim 1 for failing to teach or suggest a device where a "plurality of rods are configured to move the positioning plate in at least three degrees of freedom" for the reasons given above, we also find that the further combinations with additional references do not render the rejected claims obvious for the same reasons. 12 Appeal2017-010218 Application 13/496,043 SUMMARY In summary, we reverse the obviousness rejections. REVERSED 13