Ex Parte Odom et alDownload PDFPatent Trial and Appeal BoardAug 14, 201811487297 (P.T.A.B. Aug. 14, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 11/487,297 90039 7590 Covidien LP Attn: IP Legal 5920 Longbow Drive Mail Stop A36 07/14/2006 08/16/2018 Boulder, CO 80301-3299 FIRST NAMED INVENTOR Darren Odom 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. H-US-00473 (203-4967) 6470 EXAMINER GOOD, SAMANTHA M ART UNIT PAPER NUMBER 3739 NOTIFICATION DATE DELIVERY MODE 08/16/2018 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): mail@cdfslaw.com rs. patents. two@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DARREN ODOM, CRAIG WEINBERG, and AMY DENHAM Appeal2017-008045 1 Application 11/487,297 Technology Center 3700 Before ERIC B. GRIMES, FRANCISCO C. PRATS, and MICHAEL J. FITZPATRICK, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to an electrode assembly for performing surgery. The Examiner rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b)(l). We affirm. STATEMENT OF THE CASE The following rejections are before us for review: (1) Claims 1-3, 5, 8-10, 16, 17, and 19-23, under 35 U.S.C. § 103(a) for obviousness over Sakurai2 and Wrublewski3 (Final Act. 2---6); and 1 Appellants state that the real party in interest is Covidien AG. Appeal Br. 1. Appeal2017-008045 Application 11/487,297 (2) Claim 7, under 35 U.S.C. § I03(a) for obviousness over Sakurai, Wroblewski, and Goble4 (Ans. 14--16). Claim 1 is representative and reads as follows: 1. An electrode assembly comprising: two opposing jaw members at least one of which is movable relative to the other from an open position wherein the jaw members are disposed in spaced relation relative to one another to a closed position; each of the jaw members including at least one electrically-conductive tissue sealing surface extending along a length thereof, each of the tissue sealing surfaces adapted to connect to an electrosurgical energy source and configured to communicate electrosurgical energy between the tissue sealing surfaces of the two opposing jaw members; a first electrical connection adapted to permit electrical connection between the at least one electrically-conductive tissue sealing surface of each of the jaw members and the electrosurgical energy source; at least one heating element disposed within at least one of the jaw members and adapted to pre-heat the at least one electrically conductive tissue sealing surface of the at least one of the jaw members before the at least one electrically- conductive tissue sealing surface is activated with electrosurgical energy; a second electrical connection adapted to permit electrical connection between the at least one heating element and an alternate energy source; and at least one electrically conductive cutting element disposed upon a portion of the tissue sealing surf ace of at least one of the jaw members. 2 US 2003/0073987 Al (published Apr. 17, 2003). 3 US 6,174,309 Bl (issued Jan. 16, 2001). 4 US 2003/0139741 Al (published Jul. 24, 2003). 2 Appeal2017-008045 Application 11/487,297 Appeal Br. 11 ( emphasis added to show limitation at issue). OBVIOUSNESS- SAKURAI AND WRUBLEWSKI The Examiner's Prima Facie Case The Examiner found that Sakurai described a device having almost all of the features recited in representative claim 1, but conceded that Sakurai differs from claim 1 in that "Sakurai et al teaches cutting and sealing however fails to teach a cutting element" as recited in claim 1. Final Act. 3. As evidence that an ordinary artisan nonetheless would have considered claim 1 's device obvious, the Examiner cited Wroblewski as teaching an "analogous system comprising two opposing jaw members (101 and 102) each including a sealing surface (Col. 3, lines 18-23) comprising at least one electrically conductive cutting element (105) disposed upon a portion of the tissue sealing surface of at least one of the jaw members .... " Id. Based on the references' combined teachings, the Examiner reasoned that an ordinary artisan would have considered it obvious to modify Sakurai' s device to include Wroblewski' s electrically conductive cutting element "in order to simultaneously cut and seal tissue (Col. 1, lines 54-56)." Id. at 3--4. Analysis As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden ... of presenting a primafacie case ofunpatentability .... After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. 3 Appeal2017-008045 Application 11/487,297 In the present case, having carefully considered the arguments and evidence advanced by Appellants and the Examiner, Appellants do not persuade us that the preponderance of the evidence fails to support the Examiner's conclusion of obviousness as to claim 1. In particular, Appellants do not persuade us (see Appeal Br. 6-7; Reply Br. 3) that Sakurai teaches away from the Examiner's posited incorporation of Wrublewski's electrically conductive cutting element into Sakurai's device. Nor do Appellants persuade us (see Appeal Br. 7-8; Reply Br. 2-3) that the fundamental operating principle of Sakurai's device would be changed by incorporating Wrublewski's electrically conductive cutting element into Sakurai' s device, or that the Examiner's posited modification would render Sakurai's device unsuitable for its intended purpose. As the Examiner found, and Appellants do not dispute, Sakurai discloses an electrode assembly having the movable jaw members, tissue sealing surfaces connected to an energy source, and heating element also connected to an energy source, recited in Appellants' claim 1. See, e.g., Sakurai Figs. 1, 2, 5; see also id. ,r,r 71-72 (discussing embodiments shown in Figs. 1 and 2). Sakurai discloses that, when operating the device, the heating element (heating member 5) is initially used to coagulate tissue grasped by the jaw members: An operator manipulates the forceps body 1 by holding the handle portions 21 and 22 and peels living-body tissue to be coagulated/resected. Then, the living-body tissue is grasped and held by using the jaws 31 and 32. After that, the operator steps on the pedal 11 in the thermal surgical knife side of the foot switch 10 to supply current from the generator 9 to the heating 4 Appeal2017-008045 Application 11/487,297 member 5 for the thermal surgical knife. Then, heat is generated in the heating member 5, and the operator manipulates so as to coagulate living-body tissue grasped by the jaws 31 and 32. Id. ,I 90. Sakurai discloses that, by continuously applying heat to the tissue for a sufficient time, a separation, i.e., a cut or resection, is generated in the tissue grasped by the jaw members: In general, when heat is continuously given to the living- body tissue, the temperature increases gradually to coagulate the living-body tissue properly. The temperature at that time is about 80° C. The temperature of the living-body tissue is increased to about 150° C. by continuing to give heat thereto. Thus, a separating action is caused in the living-body tissue, and the forceps body 1 can resect the living-body tissue. Id. f 91 ( emphasis added). Sakurai discloses that, when excessive tissue or blood is present such that heating member 5 cannot generate enough heat to coagulate or resect the target tissue, the electrode portions 71 and 72 in the jaws 31 and 32 are energized to supplement the heat provided by heating member, allowing the grasped tissue to be coagulated: [B]ipolar electric surgical knife current can be flown [ sic, flowed] for a short period of time between the electrode portions 71 and 72 provided at the sides of the jaws 31 and 32. Then, the electrode portions 71 and 72 increase[] the temperature of living-body tissue grasped by the jaws 31 and 32 quickly up to about 60° C. After that, the forceps body 1 and the generator 9 can coagulate the living-body tissue by using heat generated by the heating member 5 for the thermal surgical knife. Id. ,I 93. Sakurai explains that the combination of the heating member 5 and electrodes 71 and 72 in the jaws allows the distal portion of the device to be 5 Appeal2017-008045 Application 11/487,297 heated rapidly to perform tissue coagulation and resection under all surgical conditions, without excessively increasing the size of the device: [E]lectrode portions 71 and 72, which can supply high frequency current to treat living-body tissue, are provided with the jaws 31 and 32, respectively. Thus, the size of the distal end treating portion 3 including the jaws 31 and 32 is not increased. The features of the thermal surgical knife can be used effectively, and, at the same time, the temperature of the distal end treating portion 3 can be increased quickly up to close to the target temperature even under a condition where the temperature of the distal end treating part 3 is hard to increase. Therefore, the forceps body 1 according to the first embodiment has the distal end treating portion 3 including the pair of jaws 31 and 32, which is not so large. Thus, coagulation and resection of living-body tissue can be performed by using the distal end treating portion 3 in any operation cases. Id. ,I 94. As to the electrically conductive cutting element recited in Appellants' claim 1, as the Examiner found, and Appellants do not dispute, Wroblewski discloses a forceps-like device similar to Sakurai' s device that grasps, cuts, and seals tissue, but which also includes a cutting member encompassed by Appellants' claim: An electrosurgical instrument has a handle and a body which position and close a jaw about a tissue site for simultaneously cutting and sealing relatively large tissue structures. The jaw includes an electrosurgical cutting member, which may be a blade or wire, against which tissue is biased along a cut line, and a clamping assembly that clamps a region adjacent to or surrounding the cut line. The clamping assembly includes sealing electrodes for heating the region and welding tissue along the side of the cut as the cutter parts the tissue. Wroblewski, abstract; see also id. at Fig. 1 ( showing blade 105 disposed between and within grasping jaws 101a and 102a). 6 Appeal2017-008045 Application 11/487,297 As the Examiner found (Final Act. 3--4; Ans. 2-3), Wroblewski discloses that the configuration of its device is desirable in that it "may be used to simultaneously cut and seal multiple vessels of the mesentery," and also in that it "coagulates quickly while producing little heat in the body of the instrument so that it may be used for prolonged periods in operation on major tissue structures such as the colon, small bowel, lungs, stomach or uterus, as well as smaller structures." Wroblewski 1:56-63. Given Wroblewski' s teaching that its electro surgical cutting member was a useful element for surgical devices, like Sakurai' s, that grasp, cut, and seal tissue, and further given Wroblewski' s teachings regarding the advantages of a device including such a cutting member, we agree with the Examiner that an ordinary artisan had good reason for, and a reasonable expectation of success in, modifying Sakurai' s device to include Wrublewski's cutting member. Because the Examiner's conclusion of obviousness is, thus, based on the teachings in the prior art, Appellants do not persuade us that the Examiner's rejection of claim 1 relies on improper hindsight. To the contrary, as the Supreme Court has explained, "when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). In the present case, Appellants identify no specific unpredictable result stemming from the combination of known elements recited in claim 1. As to Appellants' teaching away argument, our reviewing court has explained that a reference "does not teach away ... if it merely expresses a 7 Appeal2017-008045 Application 11/487,297 general preference for an alternative invention but does not criticize, discredit, or otherwise discourage investigation into the invention claimed." DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009) (internal quotations omitted). In the present case, we acknowledge Sakurai' s disclosure that, in its tissue resecting process, "when heat is continuously given to the living-body tissue, the temperature increases gradually to coagulate the living-body tissue properly." Sakurai ,r 91. We acknowledge also Wroblewski' s disclosure that one advantage of its device is that it "coagulates quickly while producing little heat in the body of the instrument so that it may be used for prolonged periods in operation on major tissue structures such as the colon, small bowel, lungs, stomach or uterus, as well as smaller structures." Wroblewski 1:59-63. We are not persuaded, however, that Sakurai' s disclosure of a gradual increase in tissue temperature when using its tissue-resecting device sufficiently criticizes, discredits, or discourages investigation into alternative techniques for resecting tissue, such that Sakurai teaches away from deploying Wroblewski' s electrosurgical cutting member in Sakurai' s device. To the contrary, rather than criticizing resecting devices, like Wrublewski's, that function quickly, Sakurai discloses that the rapid function of its own device is advantageous: The features of the thermal surgical knife can be used effectively, and, at the same time, the temperature of the distal end treating portion 3 can be increased quickly up to close to the target temperature even under a condition where the temperature of the distal end treating part 3 is hard to increase. Sakurai ,r 94 ( emphasis added). 8 Appeal2017-008045 Application 11/487,297 Moreover, because Sakurai discloses that the rapid function of its own device is advantageous, Appellants do not persuade us that the fundamental operating principle of Sakurai' s device would be changed by incorporating Wroblewski' s electrically conductive cutting element into Sakurai' s device, or that the Examiner's posited modification would render Sakurai' s device unsuitable for its intended purpose. In sum, for the reasons discussed, Appellants do not persuade us that the preponderance of the evidence fails to support the Examiner's conclusion of obviousness as to claim 1. We, therefore, affirm the Examiner's rejection of claim 1 over Sakurai and Wroblewski. Because they were not argued separately, claims 2, 3, 5, 8-10, 16, 17, and 19-23, fall with claim 1. See 37 C.F.R. § 4I.37(c)(l)(iv). OBVIOUSNESS- SAKURAI, WRUBLEWSKI, AND GOBLE The Examiner's Prima Facie Case Claim 7 recites "[t]he electrode assembly according to claim 1, wherein the at least one heating element is disposed within the electrically conductive cutting element." Appeal Br. 12. In rejecting claim 7 over Sakurai, Wroblewski, and Goble, the Examiner relied on the teachings in Sakurai and Wroblewski, discussed above, and cited Goble as evidence that it was known in the art to include a heating element within an electrically conductive cutting element on surgical scissors-type devices. Final Act. 6 (citing Goble ,r 125). Based on the references' combined teachings the Examiner reasoned that it would have been obvious to "modify the heating element, as taught by Sakurai et al[.], to be disposed within the electrically conductive cutting element, as taught by Goble, in order to allow for both cutting and coagulating tissue while 9 Appeal2017-008045 Application 11/487,297 reducing tissue build up and extending the operating life of the device (paragraph 0125)." Id. Analysis Appellants do not persuade us that the preponderance of the evidence fails to support the Examiner's conclusion of obviousness as to claim 7. Appellants argue: [I]n the cited portion of Goble, Goble disclosed cutting blades including a PTC material coating applied to the blades to prevent the adherence of tissue on the blades. (See Goble, ,r [0125]). Accordingly, Goble has not been shown to have disclosed or made obvious, "the at least one heating element is disposed within the electrically conductive cutting element," as recited in claim 7. (Emphasis added). Appeal Br. 9; see also Reply Br. 5 ("[T]o the extent that the Examiner contends that the PTC material coating of Goble is a heating element, Appellant respectfully submits that the PTC material is a coating disposed on the blades."). We acknowledge Goble' s disclosure that its device includes a PTC coating material that "provides improved temperature control preventing the adherence of tissue to the blades" which is a "common problem" with surgical scissors-type devices. Goble ,r 125. Appellants fail to explain, however, how the presence of the PTC coating demonstrates that the Examiner mischaracterized Goble as disclosing that it was known in art to include a heating element within a cutting element of devices such as those described in Sakurai, Wroblewski, and Goble. To the contrary, Goble suggests that it was well known in the art to include heating elements for coagulating tissue within cutting elements of such devices. See id. (describing "bipolar scissors devices [that] can be used 10 Appeal2017-008045 Application 11/487,297 to both cut and coagulate tissue" as "entirely conventional apart from the PTC material coating applied to the blades"). In sum, for the reasons discussed, Appellants do not persuade us that the preponderance of the evidence fails to support the Examiner's conclusion of obviousness as to claim 7. We, therefore, affirm the Examiner's rejection of claim 7 over Sakurai, Wroblewski, and Goble. SUMMARY For the reason discussed, we affirm both of the Examiner's obviousness rejections. TIME PERIOD No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.I36(a). AFFIRMED 11 Copy with citationCopy as parenthetical citation