Ex Parte McIntyre et alDownload PDFPatent Trial and Appeal BoardDec 15, 201411297785 (P.T.A.B. Dec. 15, 2014) 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. 11/297,785 12/08/2005 Jon T. McIntyre 10124/04801 3065 30636 7590 12/15/2014 FAY KAPLUN & MARCIN, LLP 150 BROADWAY, SUITE 702 NEW YORK, NY 10038 EXAMINER NGUYEN, HIEN NGOC ART UNIT PAPER NUMBER 3777 MAIL DATE DELIVERY MODE 12/15/2014 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 JON T. MCINTYRE, ISAAC OSTROVSKY, and TY FAIRNENY __________ Appeal 2012-005228 Application 11/297,785 Technology Center 3700 __________ Before ERIC B. GRIMES, LORA M. GREEN, and ULRIKE W. JENKS, 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 1–4, 6, 7, 9–18, and 20–31. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 The Real Party in Interest is Boston Scientific Scimed, Inc. (App. Br. 2). Appeal 2012-005228 Application 11/297,785 2 STATEMENT OF THE CASE The Specification discloses “a device for treating urinary incontinence, comprising an elongated body including a core portion having a diameter adapted to fit in the urethra” (Spec. 2 ¶ 0004). The Specification discloses that the device further comprises “a hollow, substantially cylindrical crystal disposed on the core portion for generating acoustic energy in combination with a power source coupled to the crystal” (id.). Claim 1 is representative of the claims on appeal and reads as follows: 1. An energy delivery device comprising: an elongated body sized and shaped for insertion into a body lumen via a naturally occurring body orifice; an acoustic energy element emitting energy around a circumference of a portion of the elongated body; an electrical connection between the acoustic energy element and a power source to drive the acoustic energy element; an acoustic coupler, which comprises a reservoir for containing a fluid, disposed in contact with and around a lateral surface of the acoustic energy element that is between a distal end and a proximal end of the acoustic energy element so that, when the device is received within a body lumen, the acoustic coupler is situated between the acoustic energy element and an inner wall of a body lumen; and an outer shell enclosing the acoustic energy element and the elongated body therein, wherein the acoustic coupler is radially disposed between the outer shell and the acoustic energy element, the reservoir formed via an inner surface of the outer shell and an outer surface of the acoustic energy element. Issue The Examiner has rejected claims 1–4, 6, 7, 9–18, and 20–31 under Appeal 2012-005228 Application 11/297,785 3 35 U.S.C. § 103(a) as obvious over the combination of Diederich,2 Fjield,3 and Schneider4 (Ans. 4–9). We focus our initial analysis on independent claim 1. The issue presented is: Has the Examiner established by a preponderance of the evidence that the combination of Diederich, Fjield, and Schneider would have made obvious an energy delivery device comprising an acoustic energy element, an acoustic coupler comprising a reservoir for containing a fluid, and an outer shell enclosing the acoustic energy element “wherein the acoustic coupler is radially disposed between the outer shell and the acoustic energy element, [and] the reservoir [is] formed via an inner surface of the outer shell and an outer surface of the acoustic energy element,” as required by claim 1? Findings of Fact FF1. The Specification discloses “a therapeutic device [that] delivers acoustic energy inside a body cavity or lumen to heat target tissue” (Spec. 4, ¶ 9). 2 Diederich et al., US 2003/0216721 A1, published Nov. 20, 2003. 3 Fjield et al., US 7,326,201 B2, issued Feb. 5, 2008. 4 Schneider et al., US 5,456,256, issued Oct. 10, 1995. App App Figu devi 108 gap b from via a (id.) prefe acou surro emit 16 ar devi 17A eal 2012-0 lication 11 FF2. Fig re 1 shows ce” (id. at FF3. Th is disposed etween th FF4. Th the acous n acoustic . FF5. Th rably incl stic energy und the ac FF6. Th ting energy e the acou ce)” (Ans. )). 05228 /297,785 ure 1 of th “a cutaw 2 ¶ 5). e Specific around th e core 102 e Specific tic energy coupler 1 e Specific udes a rese more eff oustic ene e Examine around a stic energ 4 (citing D e Specific ay view of ation discl e acoustic and the o ation discl element 1 06 surroun ation discl rvoir of fl iciently tha rgy eleme r finds tha circumfer y elements iederich a 4 ation is sh an embod oses that “ energy el uter shell oses that “ 04 to the s ding the a oses that t uid having n the air w nt 104 wit t Diederic ence of th and it is h t 16 ¶¶ 24 own below iment of a a substant ement 104 108” (id. a the transfe urroundin coustic en he “acoust propertie hich wou hin the co h disclose e elongate ouse[d] in 5–246 and : n energy d ially rigid , forming t 5–6 ¶13) r of acous g tissue is ergy elem ic coupler s enabling ld otherwi re 102” (id s “a transd d body (. . the elong Figs. 3A, elivery outer shel an annular . tic energy enhanced ent 104” 106 it to carry se .). ucer . element ated body 3B, and l Appeal 2012-005228 Application 11/297,785 5 FF7. The Examiner finds that Diederich also discloses “water cooling flow into the device between [the] acoustic energy element and an inner wall of a body lumen to cool the device and serve as acoustic coupler” (id. at 4–5, citing Diederich ¶ 373). FF8. The Examiner finds that Diederich’s “acoustic coupler is not a reservoir for containing water wherein the acoustic coupler is radially disposed between the outer shell and the acoustic energy element and the reservoir formed via an inner surface of the outer shell and an outer surface of the acoustic energy element” (id. at 5). FF9. Diederich discloses “a system and method for delivering therapeutic levels of ultrasound energy invasively within the body in order to treat disorders associated with the spine and other joints” (Diederich 1, ¶ 5). FF10. Figure 17A of Diederich is shown below: Figure 17A shows “an ultrasound treatment device assembly with transducers inside of an outer cooling jacket that is interfaced with a fluid circulation pump to actively cool the transducers” (id. at 10 ¶ 147). FF11. Diederich discloses that “[o]uter jacket 15 is adapted to circulate fluids around transducers 16 and therefore is interfaced with a circulation pump 70 in an overall system” (id. at 20 ¶ 278). FF12. Diederich discloses that Fluids provided in an outer jacket surrounding transducers 16 . . . may also be used beneficially for ultrasound coupling to intended tissues to be treated. This may be in addition to or instead of being used for cooling. In particular, such coupling Appeal 2012-005228 Application 11/297,785 6 fluids may be provided in a jacket 15 that is conformable, such that irregular surfaces to be treated receive uniform energy coupling from the assembly. (Id. at 20 ¶ 279.) FF13. The Examiner finds that Schneider “discloses an acoustic coupler which comprise[s] a reservoir that is disposed in contact with and around a lateral surface of the acoustic energy element” (Ans. 5 (citing Schneider, col. 5, ll. 40–62 and Fig. 2). FF14. The Examiner finds that Schneider’s [A]coustic coupler is radially disposed between the outer shell and the acoustic energy element and the reservoir [is] formed via an inner surface of the outer shell and an outer surface of the acoustic energy element (. . . element 34 is the transducer and the acoustic energy element; element 64 is the outer shell; element 50 is the liquid; [and the] reservoir is form[ed] by the outer surface of the acoustic energy element and the inner surface of the outer shell). (Id. (citing Schneider, Fig. 2).) FF15. Schneider discloses “ultrasonic method and apparatus for imaging human and animal tissue” (Schneider, col. 1, ll. 34–35). FF16. Figure 2 of Schneider is shown below: Appeal 2012-005228 Application 11/297,785 7 Figure 2 shows “a fragmentary cross-sectional view, partly diagrammatic, of the probe means” (id. at col. 2, ll. 28–29). FF17. Schneider discloses that “transducer 34 is mounted to a probe arm 48 . . . [which] is attached to the shaft of . . . motor 38” (id. at col. 5, ll. 41–43). FF18. Schneider discloses that the “transducer is positioned directly under the platen 30 in which the finger to be imaged is placed” (id. at col. 5, ll. 45–47). FF19. Schneider discloses that, “[i]n order to minimize attenuation of the ultrasonic energy as it propagates to the finger, the entire transducer is positioned in a liquid-filled region, i.e. in a water filled cavity 50. This requires establishing a water tight seal in two places on the probe” (id. at col. 5, ll. 47–51). FF20. Schneider discloses that the “first seal is an oscillating seal generally designated 52 and is used to seal the oscillating motor shaft” (id. at col. 5, ll. 51–53). FF21. Schneider discloses that the [S]econd seal is a large bellows 54 responsible for forming the overall water cavity 44. One end of bellows 54 is fastened in a liquid tight manner . . . to a motor bracket 58, and the other end of bellows 54 is fastened in a liquid-tight manner . . . to the portion of the probe housing 64 surrounding platen 30. (Id. at col. 5, ll. 51–59). FF22. The Examiner concludes that it would have been obvious to one of ordinary skill in the art [T]o modify Diederich’s device . . . to have an acoustic coupler that is a reservoir . . . situated between [the] acoustic energy element and the tissue[,] as taught by . . . Schneider[,] because Appeal 2012-005228 Application 11/297,785 8 . . . an acoustic coupler that is a reservoir for containing water eliminate[s] the inconvenien[ce] of having to pump water in and out of the device to . . . provide coupling for [the] acoustic wave. (Ans. 5–6 (citing Schneider, Fig. 2).) FF23. The Examiner finds that Diederich “does not disclose using his medical device for insertion into a body lumen via a naturally occurring body orifice” (Ans. 5). FF24. The Examiner finds that Fjield “discloses a tube shape[d] medical device for insertion into a body lumen via a naturally occurring body orifice” (id. (citing Fjield, col. 28, ll. 13–26 and Figs. 9 and 10)). FF25. Fjield discloses an apparatus that “directs the applied ultrasonic energy in a generally conical pattern, [which] can be employed to treat benign prostatic hyperplasia” (Fjield, col. 28, ll. 13–18). FF26. Fjield discloses that the “apparatus may be inserted into the urethra and ultrasonic energy may be directed into a ring-like focal region outside of the urethra, within the surrounding prostatic tissue so as to ablate the prostate and relieve the swelling” (id. at col. 28, ll. 19–22). FF27. The Examiner concludes that it “would have been obvious to one of ordinary skill in the art . . . to modify Diederich’s device for insertion into a body lumen via a naturally occurring body orifice . . . because the device is used to deliver energy to tissue inside the body” (Ans. 5). Analysis Appellants argue that it would not have been obvious to one of ordinary skill in the art to combine Diederich and Fjield with the Schneider device because “Diederich and Fjield teach devices for treating tissue using Appeal 2012-005228 Application 11/297,785 9 acoustic energy while Schneider . . . teaches a device for ultrasonic imaging” (App. Br. 5–6). Appellants argue that Schneider discloses that “a finger is placed on a surface 32 of the probe 12 and scanned via a transducer 34 to produce an image . . . [such that] the device of Schneider is not suited for insertion into a body to treat body tissues using ultrasound therapy” (id. at 6). The Examiner responds that “Schneider was NOT cited for teaching a probe that is to be inserted into a body—Fj[i]eld was cited for that particular teaching by disclosing a tube shaped medical device for insertion into a body lumen” (Ans. 10). The Examiner further responds that “Schneider was cited for teaching the well-known configuration of the claimed reservoir with the conventional acoustic elements used in ultrasound devices such as those of Diederich and Fjield” (id.). We agree with the Examiner’s reasoning. Diederich and Fjield both disclose treatment devices that deliver acoustic energy, and Fjield discloses a treatment device for insertion into a body cavity (FFs 9, 25, and 26). Diederich discloses a treatment device in which the acoustic element is surrounded by water for the purpose of acoustic coupling (FF 12), but does not explicitly disclose that the water is contained within a reservoir. Schneider discloses a device for acoustic imaging wherein water contained in a reservoir is used for acoustic coupling (FF 19). We thus agree with the Examiner that it would have been obvious to one of skill in the art to use a water reservoir for acoustic coupling in a treatment device because Diederich expressly discloses that water surrounding an acoustic element may be used for acoustic coupling in a treatment device. Appeal 2012-005228 Application 11/297,785 10 Appellants argue that the combination of the cited references would not have made obvious a “reservoir formed via an inner surface of the outer shell and an outer surface of the acoustic energy element,” as required by claim 1 (App. Br. 7 (emphasis removed)). Appellants argue that “Schneider discloses a transducer entirely immersed in a fluid filled cavity such that the transducer does not form any portion of the cavity” (id. at 6). Appellants argue that Schneider’s transducer 34 “is positioned in a liquid-filled cavity 50 formed via large bellows” (id.). Appellants argue that the “cavity 50 would remain completely intact even if the transducer 34 were removed therefrom . . . [and] would maintain its size and shape even when the transducer 34 oscillates” (id. at 7). The Examiner responds that “element 34 is the transducer and the acoustic energy element . . . element 64 is the outer shell; [and] element 50 is the liquid” (Ans. 10 (citing Schneider’s Fig. 2, which is shown above in FF 16)). The Examiner further responds that “the reservoir is form[ed] by the outer surface of the acoustic energy element [34] and the inner surface of the outer shell [64]” (id.). We agree with the Examiner’s reasoning. We further note that the Supreme Court has emphasized that the obviousness “analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007). “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. Appeal 2012-005228 Application 11/297,785 11 Moreover: The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 425 (CCPA 1981). Here, the obviousness rejection is based on the combination of the references. We agree with the Examiner that the application of the reservoir concept to the acoustic energy treatment devices would have been rendered obvious by the combination of Diederich and Fjield. Because Diederich discloses that water, which is used as an acoustic coupling element, is disposed between the acoustic element and an outer shell (FF 12), it would have been obvious to use the inner surface of the outer shell and the outer surface of the acoustic element to form the reservoir. Thus, we affirm the rejection of independent claim 1 as being obvious over the combination of Diederich, Fjield, and Schneider. Dependent claims 2–4, 6, 7, 9–16, 28, and 30 have not been argued separately from claim 1 and therefore fall with that claim. 37 C.F.R. § 41.37(c)(1)(vii). Appellants also argue the rejection of independent claim 17. Claim 17 is directed to a device for treating urinary incontinence that comprises, among other things, a crystal for generating acoustic energy, an outer shell, and an acoustic coupler comprising a reservoir for containing a fluid, wherein the acoustic coupler is “disposed around a lateral surface of the Appeal 2012-005228 Application 11/297,785 12 crystal . . . [and] the reservoir [is] formed via an inner surface of the outer shell and an outer surface of the crystal.”5 Appellants argue that, “[f]or at least the same reasons as discussed above in regard to claim 1,” claim 17 is not rendered obvious by the combination of Diederich, Fjield, and Schneider (App. Br. 8). Appellants’ arguments are not persuasive for the reasons discussed. Thus, we affirm the rejection of independent claim 17 as being obvious over the combination of Diederich, Fjield, and Schneider. Dependent claims 18, 20–27, 29, and 31 have not been argued separately from claim 17 and therefore fall with that claim. 37 C.F.R. § 41.37(c)(1)(vii). Conclusion of Law The preponderance of the evidence supports the Examiner’s conclusion that the combination of Diederich, Fjield, and Schneider would have made obvious an energy delivery device comprising an acoustic energy element, an acoustic coupler comprising a reservoir for containing a fluid, and an outer shell enclosing the acoustic energy element “wherein the acoustic coupler is radially disposed between the outer shell and the acoustic energy element, [and] the reservoir [is] formed via an inner surface of the outer shell and an outer surface of the acoustic energy element,” as required by claim 1. SUMMARY We affirm the rejection of claims 1–4, 6, 7, 9–18, and 20–31 under 35 U.S.C. § 103(a). 5 The full text of independent claim 17 can be found in the Claims Appendix to the Appeal Brief (App. Br. 12–13). Appeal 2012-005228 Application 11/297,785 13 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 cdc Copy with citationCopy as parenthetical citation