Ex Parte Savage et alDownload PDFPatent Trial and Appeal BoardJan 22, 201814046907 (P.T.A.B. Jan. 22, 2018) 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. 14/046,907 10/04/2013 Walter T. Savage 377871-991103 4790 26379 7590 DLA PIPER LLP (US ) 2000 UNIVERSITY AVENUE EAST PALO ALTO, CA 94303-2248 EXAMINER PATTON, AMANDA K ART UNIT PAPER NUMBER 3762 NOTIFICATION DATE DELIVERY MODE 01/24/2018 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): PatentDocketingU S -Palo Alto @ dlapiper. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte WALTER T. SAVAGE, SHELLEY J. SAVAGE, WALTER N. MACLAY, DOUGLAS C. MORRISON, THOMAS K. GERATY, MARK D. BRINKERHOFF, RONALD S. BOEDER, TONY M. TON, and JEFFREY S. GREGER (APPLICANT: CardioThrive, Inc.) Appeal 2017-0011651 Application 14/046,9072 Technology Center 3700 Before DONALD E. ADAMS, ELIZABETH A. LaVIER, and JOHN E. SCHNEIDER, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This Appeal under 35 U.S.C. § 134(a) involves claims 1, 8, 9, 16, 17, and 24 (Final Act.3 I).4 1 This Appeal is related to Appeal 2017-001185, Application US 14/046,892 (see Ans. 2). 2 Applicant, CardioThrive, Inc., is the real party in interest (App. Br. 1). 3 Office Action mailed August 14, 2015. 4 Pending “[cjlaims 2-7, 10-15, and 18-23 [stand] objected to as [] depending] upon a rejected base claim” (see Final Act. 6 (emphasis omitted)). Because the objection is a petitionable rather than appealable matter, we will not further address these claims. Appeal 2017-001165 Application 14/046,907 Examiner entered rejections under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. STATEMENT OF THE CASE Appellants’ disclosure “relates generally to methods and arrangements relating to cardiac medical devices” (Spec. 1: 8-9). Claims 1, 8, 9, and 17 are representative and reproduced below: 1. A portable defibrillator comprising: two paddles, each paddle including a hard protective housing and a defibrillator electrode within the hard protective housing; a connecting structure that electrically and physically connects the two paddles to each other, and an electrical system including at least a battery, a capacitor and a control circuit, the battery arranged to charge the capacitor, the capacitor arranged to apply a voltage at the defibrillator electrodes to facilitate delivering an electrical shock suitable for arresting a cardiac arrhythmia, the battery, the capacitor and the control circuit being disposed within the hard protective housing of each paddle. (App. Br. 36 (emphasis added).) 8. The portable defibrillator of claim 1, wherein each defibrillator electrode includes a plurality of electrically conductive protrusions. {Id. at 37.) 9. A portable defibrillator comprising: two paddles, each paddle including a hard protective housing and a defibrillator electrode, with at least one battery, at least one capacitor and control circuitry within the hard protective housing of each paddle', a connecting structure that electrically and physically connects the two paddles to each other, and 2 Appeal 2017-001165 Application 14/046,907 an electrical system with the batteries arranged to charge the capacitors, the capacitors arranged to apply a voltage at the defibrillator electrodes to facilitate delivering an electrical shock suitable for arresting a cardiac arrhythmia. {Id. (emphasis added).) 17. A portable defibrillator comprising: two paddles, each paddle including a hard protective housing, with a defibrillator electrode, at least one battery, at least one capacitor and control circuitry within the hard protective housing of each paddle, a connecting structure that electrically and physically connects the two paddles to each other, and an electrical system with the batteries arranged to charge the capacitors, the capacitors arranged to apply a voltage at the defibrillator electrodes to facilitate delivering an electrical shock suitable for arresting a cardiac arrhythmia. {Id. at 38 (emphasis added).) The claims stand rejected as follows: Claims 1, 9, and 17 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Kumar5 and Kroll.6 Claims 8, 16, and 24 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Kumar, Kroll, and Martinez.7 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? 5 Kumar, US 8,024,037 B2, issued Sept. 20, 2011. 6 Kroll et al., US 7,072,712 B2, issued July 4, 2006 7 Martinez, US 7,463,917 B2, issued Dec. 9, 2008. 3 Appeal 2017-001165 Application 14/046,907 FACTUAL FINDINGS (FF) FF 1. Kumar discloses that “[o]ne drawback of currently available wearable defibrillators ... is lack of patient compliance. Because of size, shape and weight of these wearable devices, patients are reluctant to wear them due to discomfort, their bulkiness under clothes or limitations in the devices themselves” (Kumar 2: 19-24; see generally Ans. 4). FF 2. Kumar “relates generally to external defibrillators. In particular, the invention relates to automatic external defibrillators that can be continuously and easily worn by a patient for an extended period of time” (Kumar 1: 22- 25; see generally Final Act. 3-4; Ans. 4). FF 3. Kumar’s “[djefibrillator [] has a design that distributes the weight of its components in order to make the device more comfortable to wear,” wherein the external defibrillator [has] a battery; a capacitor electrically communicable with the battery; at least two electrodes electrically communicable with the capacitor; a controller configured to charge the capacitor from the battery and to discharge the capacitor through the electrodes; and a support supporting the battery, capacitor, electrodes and controller in a deployment configuration, the defibrillator having a maximum thickness of 1 inch. (Kumar 3: 6-14, 4: 41^43; see generally Final Act. 3—4; Ans. 4-5). 4 Appeal 2017-001165 Application 14/046,907 FF 4. Kumar’s Figure 6 is reproduced below: t IK ) ( ____ v.«________________ * 40 \ A « > . 7 \ j 1 42 44 / FIG, 8 Kumar’s “FIG. 6 shows [an] external defibrillator according to . . . [an] embodiment of [Kumar’s] invention in place on a patient” (Kumar 4: 9-10 (emphasis removed); see generally Ans. 4-5). FF 5. Kumar’s Figure 6 is reproduced below: / 44, \ A / .a --A. 1/ i^/T“~—ih 46 ( '48 \ *4 jI FIG. 7 5 Appeal 2017-001165 Application 14/046,907 Kumar’s “FIG. 7 is a side view of the embodiment of [Kumar’s] FIG. 6 in place on a patient” (Kumar 4: 11-12 (emphasis omitted); see generally Ans. 4-5). FF 6. Kumar discloses: In FIGS. 6 and 7, the defibrillator 40 is supported by a strap support 42 that circumscribes the patient's torso and places 35 electrodes 44 and 46 on either side of the patient's torso. In this embodiment, the defibrillator’s battery, capacitor and control circuitry are within a housing 48 supporting electrode 44. Wires communicating electrode 46 with the remaining defibrillator components pass through or adjacent strap support 42. In some embodiments, each of the distributed components (with, the exception of the strap support 42) has a maximum weight per unit area of 0.1 lb/in2. (Kumar 5: 34^43 (emphasis omitted); see Final Act. 3—4; Ans. 4-5.) FF 7. Kumar’s Figure 10A is reproduced below: Kumar’s “FIG. 10A shows an external defibrillator [10] with an alternative capacitor [14] configuration” (Kumar 4: 17-18 (emphasis omitted); see Ans. 5). FF 8. Kumar discloses that “[t]he capacitor used in [Kumar’s] external defibrillators . . . may be long and wide with a narrow spacing to provide the required capacitance. Alternatively, the capacitor 14 may be formed as multiple capacitors connected in parallel; as shown in FIG. 10A, to provide 6 Appeal 2017-001165 Application 14/046,907 the required capacitance” (Kumar 6: 14-18 (emphasis omitted); see Ans. 4- 5). FF 9. Kumar’s Figure 10B is reproduced below: Kumar’s “FIG. 10B shows an external defibrillator with an alternative battery configuration” (Kumar 4: 19-20 (emphasis omitted); see Ans. 5). FF 10. Kumar discloses that the battery used in [Kumar’s] external defibrillators . . . can be made thin and with a relatively large surface area. For example, battery 12 may be formed as multiple batteries connected in series to provide the required current and voltage to charge the capacitor, as shown in FIG. 10B. (Kumar 6: 19-23 (emphasis omitted); Ans. 4-5.) FF 11. Examiner finds that “Kumar does not expressly disclose a device wherein each paddle contains a hard protective case and a part of the electrical system is included within the hard protective housing of each paddle” (Final Act. 4). FF 12. Kroll discloses “[a] pocket-sized disposable cardiac defibrillator relies on the use [of] a split unit packaging design to decrease the size” (Kroll, Abstract). FF 13. Kroll’s disclosed split unit design, comprises two halves, wherein “one half would hold the thermal batteries and capacitors while the other would hold the control circuitry and monitoring battery. This has the 7 Appeal 2017-001165 Application 14/046,907 advantage of keeping temperature sensitive components isolated from the hot thermal batteries” (Kroll 5: 23-27; see Final Act. 4). FF 14. Examiner finds that the combination of “Kumar and Kroll do not. . . disclose a battery, capacitor, and control circuitry in each paddle of the device” (Final Act. 4). FF 15. Martinez “relates to medical devices and, more particularly, to electrodes for medical devices” (Martinez 1: 6-7). FF 16. Martinez’s Figure 10 is reproduced below: .,-610 FIG. 10 Martinez’s “FIG. 10 is a side view of a percutaneous electrode array according to an embodiment of the invention” (Martinez 3: 15-16 (emphasis omitted); see Final Act. 5-6). FF 17. Martinez’s Figure 11 is reproduced below: 612 / -610 1 / s' ' s/ \ L '/ ' , '/ , /' , f o " ' c . ’ 7 c ; f; 7 '' ' s , / / 'i '/ ' dQQ§ 9 O O & O 0 6 O u''' 4 'l I A 7 , f"l S' > ' trn— " 616 -f v- ‘ / - 614 FIG. 11 8 Appeal 2017-001165 Application 14/046,907 Martinez’s “FIG. 11 is a plan view of a bottom side of the percutaneous electrode array of FIG. 10” (Martinez 3: 17-18 (emphasis omitted); see Final Act. 5-6). FF 18. Examiner finds that “Martinez teaches that it was known in the art of applying sustained delivery of energy to use an array of cylindrical microneedles for perforating the skin’s surface (e.g., electrode array 610 with needle-like extensions arranged to perforate and penetrate a layer of the skin” (Final Act. 5-6). ANALYSIS The rejection over Kumar and KrolT. Kumar discloses an external defibrillator designed to “be continuously and easily worn by a patient for an extended period of time,” such that “the weight of its components [are distributed] in order to make the device more comfortable to wear” (FF 2-3). In this regard, Examiner finds that: Kumar discloses the claimed portable defibrillator comprising: two paddles, each paddle including a defibrillator electrode covered in a protective housing (e.g. paddles 40 and 46 comprising electrodes 44 and 46 in protective housing 48); a connecting structure that electrically and physically connects the two paddles to each other (e.g. strap support 42 comprising wire for communication between the electrodes); and an electrical system including a battery and a capacitor, the battery arranged to charge the capacitor, the capacitor arranged to apply a voltage at the defibrillator electrodes to facilitate delivering an electrical shock suitable for arresting a cardiac arrhythmia wherein a part of the electrical system is disposed within the housing of each paddle (e.g. battery and capacitor found in housing 48 . . .). (Final Act. 3-4 (citing Kumar 5: 34^13); see FF 2-6.) Examiner recognizes, however, that “Kumar does not expressly disclose a device wherein each paddle contains a hard protective case” (FF 9 Appeal 2017-001165 Application 14/046,907 11). Examiner relies on Kroll to make up for this deficiency in Kumar, finding that “Kroll discloses that it was well known in the art to include hard protective casings on each electrode . . . wherein each protective housing holds some of the electronics (e.g. one half holds the batteries and one half holds control circuitry . . .)” (Final Act. 4 (citing Kroll 5: 19-27); FF 12-13). Further, Examiner finds that although Kumar discloses that the defibrillator’s “battery 12 may be formed as multiple batteries connected in series” and “capacitor 14 may be formed as multiple capacitors connected in parallel” the combination of “Kumar and Kroll do not. . . disclose a battery, capacitor, and control circuitry in each paddle of the device” (Final Act. 4; FF 7-11; cf. FF 14; see also FF 11 (“Kumar does not expressly disclose a device wherein ... a part of the electrical system is included within the hard protective housing of each paddle”)). To make up for this deficiency in Kumar, Examiner reasons: It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the electronics configuration as taught by Kumar and Kroll with the design as taught by Applicant, because Applicant has not disclosed that including a battery, capacitor, and control circuitry in each paddle provides an advantage, is used for a particular purpose, or solves a stated problem. (Final Act. 4-5.) In this regard, Examiner finds that Appellants’ Specification “does not give any indication that having a battery, a capacitor, and control circuitry in each paddle provides a specific advantage or is used for a particular purpose,” but instead discloses that “the battery and capacitors may be arranged in ‘any suitable manner’ . . . [providing] no reasoning why placing a battery and a capacitor in each of the pads provides any advantage to the disclosed invention” (Ans. 4; see also id. at 3-5 (citing 10 Appeal 2017-001165 Application 14/046,907 Specification 23: 10-30)). See e.g., In reKuhle, 526 F.2d 553, 555 (CCPA 1975) (“the particular placement of [an electrical] contact provides no novel or unexpected result”); see also id. (“Use of such a means of electrical connection in lieu of those used in the references solves no stated problem and would be an obvious matter of design choice within the skill of the art”). In the alternative, Examiner reasons that “it would have been obvious to try to place a battery, capacitor, and control circuitry in each paddle” (Final Act. 5). With regard to Examiner’s alternative rationale, Examiner asserts: At the time of [Appellants’] invention, there was a known problem of including all of the required electronics in a portable defibrillator in the smallest amount of space possible without causing detrimental interference between the parts. To do this, there is only a finite number of ways the parts can be placed together to solve that problem. [Thus,] [o]ne of ordinary skill could have used their knowledge to arrange the battery[, capacitor, and control circuitry] in the system in the way [required by Appellants’ claims] . . . with a reasonable expectation of success, since there are limited pieces in a defibrillator. (Id.; see FF 1.) We find no error in Examiner’s rationale that a person of ordinary skill in this art would have found it prima facie obvious to separate, or divide, the multiple batteries and capacitors, as well as the control circuitry of Kumar’s device into separate pads to accomplish Kumar’s objective of distributing “the weight of its components in order to make the device more comfortable to wear” (see FF 3; see generally Ans. 5). See In re Dulberg, 289 F.2d 522, 523 (CCPA 1961) (making separable that which is integrated is an obvious design choice when, as here, there is a reason to do so); see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) 11 Appeal 2017-001165 Application 14/046,907 (“The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”). Therefore, we find no error in Examiner’s prima facie case of obviousness. See KSR, 550 U.S. at 418 (It is proper to “take account of the inferences and creative steps that a person of ordinary skill in the art would employ”). Claim 1: For the reasons set forth above, we are not persuaded by Appellants’ contention that the combination of Kumar and Kroll fails to disclose a “defibrillation electrical system (including the battery, capacitor and controller) is . . . not disposed in the protective housing of each paddle[]” as required by Appellants’ claimed invention (App. Br. 13; see id. at 14; Reply Br. 9-11). Therefore, we are not persuaded by Appellants’ contention that Examiner’s conclusion of obviousness is based in “impermissible hindsight” (App. Br. 14; Reply Br. 11). Examiner makes clear that Kroll was relied upon to establish that, at the time of Appellants’ claimed invention, a person of ordinary skill in this art would have found it prima facie obvious to “include two hard [protective] housings for each electrode paddle” (Ans. 3). Examiner also makes clear that Kroll was not relied upon to suggest the substitution of Kumar’s batteries, with thermal batteries {id.). Appellants failed to provide persuasive argument or evidence to support a conclusion that Kroll’s batteries are thermal batteries, or otherwise includes batteries that would require the batteries to be separated from the circuitry of the defibrillator. 12 Appeal 2017-001165 Application 14/046,907 Therefore, we are not persuaded by Appellants’ contentions regarding “thermal batteries” (see Reply Br. 9-10). We agree with Examiner’s finding that Friedman8 “fails to outweigh [Examiner’s prima facie case of] . . . obviousness” (Final Act. 2; see Ans. 6- 9). Friedman declares that “[t]he housing of the various electrical components [of a defibrillator] in a single housing is more efficient since duplicate electrical components are not needed, and such duplicate components would also add to the complexity and costs of manufacturing each unit,” “the typical external defibrillator is easier and cheaper to manufacture and also to shield against electromagnetic signal interference,” and “having all of the various high energy electrical components in a single shielded portion of the housing reduces the electrical noise on the ECG signal traces and other low energy wires that are used to connect the various other electrical components” (Friedman ^[ 11). For these reasons, Friedman “had doubts about why CardioThrive[, the real party in interest in this Appeal,] was proposing to manufacture and sell an external defibrillator device in which the various electrical components were split between the two paddles,” because splitting “a capacitor, a battery and control circuits in each paddle . . . seemed to be an unnecessary and costly duplication,” and “about the technical feasibility and likely commercial success of a product with the various electrical components split between the two paddles and a capacitor, a battery and control circuits in each paddle” (id. ^[ 12). Nevertheless, Friedman states that CardioThrive persuaded him that their product “provides a far more intuitive human factors design compared 8 Declaration of Paul Friedman, MD, signed June 24, 2015. 13 Appeal 2017-001165 Application 14/046,907 to all previous devices on the market” and “allows the size of the unit to be significantly reduced, from the mostly laptop sized community-focused devices currently on the market... to a simple, lightweight and completely mobile/ambulatory device with the same footprint as a cell phone and that is less tha[n] two inches in total thickness” (id. 13). Friedman makes reference to a “typical external defibrillator,” but fails to identify whether such a “typical external defibrillator” is intended to include Kumar’s defibrillator (see Friedman 11; cf. FF 2-6). To the contrary, Friedman’s reference to a “typical external defibrillator” appears to refer to “laptop sized community-focused devices currently on the market” (see Friedman 11; cf. id. 13). In doing so, Friedman does not appear to recognize Kumar’s disclosure of an “automatic external defibrillator[] that can be continuously and easily worn by a patient for an extended period of time,” wherein the “design [] distributes the weight of its components in order to make the device more comfortable to wear,” and has “a maximum thickness of 1 inch” (FF 2-3). As discussed above, in producing a device within the scope of Kumar’s disclosure, wherein size, weight distribution, and comfort are important features, Kumar discloses duplicate electrical components connected in parallel (see FF 7-10). Where, as here, the prior art suggests duplicating parts, we are not persuaded by Friedman’s statement that “duplicate electrical components are not needed,” in a device such as that disclosed by Kumar (Friedman 11). See In re Harza, 274 F.2d 669, 671 (CCPA 1960) (“[i]t is well settled that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced”). 14 Appeal 2017-001165 Application 14/046,907 Friedman fails to identify an evidentiary basis to support the assertion that “duplicate components would [] add to the complexity” of Kumar’s device, or that Kumar’s disclosure fails to account for any such additional complexity (see Friedman 11). Therefore, we are not persuaded by Friedman’s contentions regarding complexity resulting from duplicate components. Similarly, Friedman fails to identify an evidentiary basis to support the assertion that “duplicate components would add to the costs of manufacturing each unit” relative to a “typical external defibrillator” (see Friedman ^ 11). In this regard, Friedman fails to explain whether any such additional costs would have been reasonable to those of ordinary skill in this art when manufacturing a device with the features disclosed by Kumar. Friedman fails to identify an evidentiary basis to support the conclusion that Kumar failed to properly shield its device, or that those of ordinary skill in this art seeking to attain a device having the features disclosed by Kumar, would not find such shielding obvious, and any additional costs (relative to the manufacturing costs associated with a typical, i.e. laptop sized, external defibrillator) reasonable to achieve the objectives set forth in Kumar (see Friedman 1 1; cf FF 1-10). Friedman fails to explain how CardioThrive’s device differs from Kumar, such that CardioThrive’s device “provides a far more intuitive human factors design compared to [Kumar]” and “allows the size of the unit to be significantly reduced,” relative to Kumar’s device (see Friedman ^ 13; cf. FF 1-10). For the foregoing reasons, we are not persuaded by Appellants’ contentions regarding Friedman (App. Br. 16-20; Reply Br. 11-16). 15 Appeal 2017-001165 Application 14/046,907 Claim 9: We agree with Examiner’s finding that “Appellants’ argument regarding [Appellants’ claim 9] are substantially the same as the arguments made regarding the identical limitation in [Appellants’] claim 1” (Ans. 9 (citing App. Br. 20-27)). Therefore, for the reasons set forth above, we are not persuaded by Appellants’ contentions regarding Appellants’ claim 9 (see App. Br. 20-27; Reply Br. 16-23). Claim 17: We agree with Examiner’s finding that “Appellants’ argument regarding [Appellants’ claim 17] are substantially the same as the arguments made regarding similar claim limitation[s] in [Appellants’] claim 1” (Ans. 9 (citing App. Br. 27-34)). Therefore, for the reasons set forth above, we are not persuaded by Appellants’ contentions regarding Appellants’ claim 9 (see App. Br. 27-34; Reply Br. 23-30). The rejection over the combination of Kumar, Kroll, and Martinez: Based on the combination of Kumar, Kroll, and Martinez, Examiner concludes that, at the time Appellants’ invention was made, it would have been prima facie obvious “to include the microneedle array of Martinez in the defibrillator of Kumar and Kroll [because] such a modification would provide the system with the predictable results of more reliable location of the electrode array and lowered impedance resulting in more effective transfer of defibrillation energy” (Final Act. 6). We find no error in Examiner’s prima facie case of obviousness. 16 Appeal 2017-001165 Application 14/046,907 Having found no deficiency in Examiner’s combination of Kumar and Kroll, for the reasons set forth above, we find no error in Examiner’s reliance on Martinez to suggest the inclusion of a microneedle array in Kumar’s device to provide for a more effective transfer of defibrillation energy (see id.; see also id. at 5-6). Thus, we are not persuaded by Appellants’ contentions that Martinez fails to make up for Appellants’ alleged deficiencies in Kumar (see App. Br. 34-35; Reply Br. 31). CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness. The rejection of claims 1, 9, and 17 under 35 U.S.C. § 103(a) as unpatentable over Kumar and Kroll is affirmed. The rejection of claim 8 Claims 8, 16, and 24 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Kumar, Kroll, and Martinez is affirmed. The rejection of claim 8 under 35 U.S.C. § 103(a) as unpatentable over the combination of Kumar, Kroll, and Martinez is affirmed. Claims 16 and 24 are not separately argued and fall with claim 8. 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 17 Copy with citationCopy as parenthetical citation