Ex Parte GinggenDownload PDFPatent Trial and Appeal BoardJul 24, 201712619900 (P.T.A.B. Jul. 24, 2017) 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. 12/619,900 11/17/2009 Alec Ginggen 22719-107 (COD5011USCNT1) 9520 21125 7590 07/26/2017 NUTTER MCCLENNEN & FISH LLP SEAPORT WEST 155 SEAPORT BOULEVARD BOSTON, MA 02210-2604 EXAMINER GILBERT, ANDREW M ART UNIT PAPER NUMBER 3763 NOTIFICATION DATE DELIVERY MODE 07/26/2017 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): docket @ nutter.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ALEC GINGGEN Appeal 2015-005261 Application 12/619,900 Technology Center 3700 Before EDWARD A. BROWN, LYNNE H. BROWNE, and BRANDON J. WARNER, Administrative Patent Judges. BROWNE, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Alec Ginggen (Appellant) appeals under 35 U.S.C. § 134 from the rejection under 35 U.S.C. § 103(a) of claims 1—11, 16—27, and 31—35 as unpatentable over Adams (US 2004/0073196 Al, pub. Apr. 15, 2004) and Flaherty (US 6,669,669 B2, iss. Dec. 30, 2003). We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2015-005261 Application 12/619,900 CLAIMED SUBJECT MATTER The claims are directed to an implantable pump with integrated refill detection. Spec. 1. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. An implantable device with an integral refill port with refill instrument placement detection, comprising: a refill port integral with the implantable device having: a pierceable septum disposed on the refill port for admitting a refill instrument, the pierceable septum having a first outer surface at least a portion of which is exposed outside the refill port and a second inner surface at least a portion of which is exposed inside the refill port; and a detector disposed inside the refill port with respect to the second inner surface of the pierceable septum for determining the placement of a refill instrument within the refill port; and control electronics located within the implantable device in electronic communication with the detector, the detector sending an electronic communication to the control electronics based upon the placement of a refill instrument within the refill port; wherein the electronic communication triggers activation of a diagnostic program to be run by the control electronics. DISCUSSION Appellant argues independent claims 18, 28, and 31 with claim 1. See Appeal Br. 8. Appellant does not provide separate argument for any of the dependent claims, except for claim 34. Id. at 12. Thus, Appellant argues claims 1—11, 16—27, 31—33, and 35 together. We select claim 1 as the illustrative claim, and claims 2—11, 16—27, 31—33, and 35 stand or fall with claim 1. See 37 C.F.R. § 41.37(c)(l)(iv). 2 Appeal 2015-005261 Application 12/619,900 Claims 1—11, 16—27, 31—33, and 35 The Examiner finds that Adams discloses all of the limitations of claim 1 except “for expressly disclosing wherein the electronic communication triggers activation of a diagnostic program to be run by the control electronics, the diagnostic program being a fluid pressure or level.” Final Act. 4. In particular, the Examiner finds that Adams discloses “an integral refill port with refill instrument placement detection (Fig 3; Summary; |11).” Id. The Examiner further finds that “Flaherty teaches that it is known to have a refill port (Fig 30a-b) and infusion device (100), wherein the electronic communication triggers activation of a diagnostic program to be run by the control electronics.” Id. at 5 (citations omitted). Based on these findings, the Examiner determines that it would have been obvious to modify the device and method as taught by Adams et al with the diagnostic program and sensors checking the fluid level or pressure of the port reservoir as taught by Flaherty for the purpose of monitoring the fluid level of the port reservoir to properly activate after refilling or disable the infusion device if too much or too little liquid is in the reservoir. Id. (citing Flaherty 7:14—23). Appellant contends that “[njeither of the references, alone or combined, discloses[,] teaches[,] or suggests the feature of triggering a diagnostic procedure based upon a communication by the detector that the refill instrument has been appropriately placed.” Appeal Br. 10 (emphasis omitted). In support of this contention, Appellant argues that “Adams has no diagnostic capability at all,” and that “Flaherty merely provides sensors for the purpose of monitoring the flow of drugs into the patient, and to test whether there are any blockages in that flow path.” Id. 3 Appeal 2015-005261 Application 12/619,900 Responding to this argument, the Examiner explains that the combined teachings of Adams and Flaherty suggest the limitation at issue. See Ans. 3—6. Specifically, the Examiner explains that in Adams indicator signal (106) [] is indicative of a needle refilling instrument (20) being properly placed within the refill port (see Final Rejection dated 11/8/2013, 1 12). The electric indicator signal (106) can also provide feedback to an[] alarm and to an infusion pump to, for example, start or stop drug administration (Adams et al, Tflf 22—23). Thus, Adams et al discloses generation of an electronic signal that triggers the activation and performance of several functions (i.e. alarm and control of a pump) upon the placement of the needle within the refill port. Id. at 3. The Examiner further explains that: Flaherty discloses a refill port (Fig 30a-b) and reservoir (30) of a drug delivery pump (100) having a processor (50) with programming and circuitry to activate the device as necessary (see Br. 7—8). The reservoir volume transducer or reservoir pressure transducer transmits electronic communications to the processor (50) that controls the activation of the dispenser (40) and indicates conditions of the reservoir volume (i.e. too little/much fluid) or pressure (i.e. too low/high). Thus, the processor (i.e. control electronics) runs a diagnostic program that tests the fluid pressure or fluid level within the reservoir based on the feedback from the reservoir volume transducer or reservoir pressure transducer. Id. at 4. Based on these observations, the Examiner concludes that in a modified device and method of Adams et al in view of Flaherty the modification would result in the device of Adams et al having a diagnostic program that tests the fluid pressure or fluid level within the refill port based on the feedback from a reservoir volume transducer or reservoir pressure transducer. The electronic communication signal (106) in Adams et al detecting that the needle has been correctly placed would trigger activation ... of the diagnostic program and reservoir volume/ pressure transducers as taught by Flaherty to transmit the fluid level/pressure of the refill port (i.e. empty or leaking or too 4 Appeal 2015-005261 Application 12/619,900 much/too little liquid is in and/or being dispensed) after correct placement of the needle and during the use of the device. Id. at 5. Responding to the Examiner’s explanation with regard to Adams, Appellant argues that “Adams does not provide a refill port” because “[i]n Adams there is nothing to refill.” Reply Br. 3. Although Appellant admits that “Adams provides a detector that creates an alarm to let the health care professional know when the need is properly placed in the vascular access port,” Appellant contends that Adams’s teaching is limited to that “a person of ordinary skill should be careful to run the external refill pump only when the needle is in the refill port.” Id. at 3^4 (citing Adams | 6). However, claim 1 does not recite a reservoir or any other specific structure that is to be refilled. See Appeal Br. i (Claims App.). Moreover, Appellant does not explain why Adams’s teachings are not applicable to a port on a reservoir or other refillable component. Rather, as discussed supra, Appellant admits that Adams teaches a detector for detecting proper placement of a needle in a port. Thus, Appellant’s argument is unconvincing. In addition, Appellant argues that “Flaherty appears to provide in its figure 2 ... an infusion pump that cannot be refilled (the refillable embodiments, which come much later, have refill ports).” Appeal Br. 10; see also Reply Br. 5. Responding to this argument, the Examiner identifies Flaherty’s Figures 30a and 30b as illustrating a refillable reservoir 30 with a refill port. See Ans. 4. Responding to the Examiner’s explanation with regard to Flaherty, Appellant contends that “Flaherty provides a single use fill port as part of its low cost device. It is not at all clear that Flaherty can provide for refilling at 5 Appeal 2015-005261 Application 12/619,900 all.” Reply Br. 5. Although Flaherty does describe a single use embodiment (see, e.g., Flaherty 19:17—19), this is not the embodiment relied upon in the rejection. Rather, as discussed supra, the rejection relies upon an embodiment with a refillable reservoir. See id. at 7:41—46. Thus, Appellant’s contention does not apprise us of error. Appellant further argues that “the notion that the pump can be disabled if the fluid level is low betrays the notion that in order for Flaherty’s sensor to work for its intended purpose, it works all the time — it is not, and would not be, triggered by a (non-existent) re-fill.” Reply Br. 5. However, as discussed above, the rejection does not propose any modification of Flaherty’s sensor. Rather, the rejection proposes modifying Adams’s detector to test fluid pressure or fluid level. See Ans. 5. Moreover, as discussed supra, Flaherty contemplates re-fill and use of its sensor(s) to trigger activation. See, e.g., Flaherty 7:31—39. Thus, Appellant does not apprise us of error. Next, Appellant argues that in Flaherty “there is no suggestion that these sensors would be triggered by placement of a needle in a refill port.” Appeal Br. 11; see also Reply Br. 4. Although Appellant is correct about Flaherty alone, this is not indicative of error, as the rejection relies upon the combined teachings of Adams and Flaherty to meet the claim limitation at issue, as discussed supra. Specifically, the rejection relies on Adams to teach instrument placement detection. See Final Act. 4. Moreover, Appellant’s argument attacks the reference separately. Such attacks cannot established nonobviousness when the rejection is predicated upon a combination of prior art disclosures. See In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). 6 Appeal 2015-005261 Application 12/619,900 Finally, noting that “[t]he Answer posits that Applicant’s reliance on the term ‘triggers’ is inappropriate because there is no claim limitation requiring the diagnostic program to stop,” Appellant contends that “[t]his position misunderstands the definition of the term ‘triggers.’” Reply Br. 5. However, it is unclear what statement in section ii of the Answer, Appellant is contesting. The Examiner correctly points out that claim 1 does not require that “the diagnostic program must run and end during a time period, i.e. during a refill of the refill port.” Ans. 6. Appellant does not explain how the claim differentiates between programs that are triggered and then continue to run and those that are triggered and then stopped. Thus, Appellant does not apprise us of error. In the Reply Brief, Appellant for the first time argues that Adams fails to disclose an implantable device. See Reply Br. 2. In accordance with 37 C.F.R. § 41.41(b)(2), lacking a showing of good cause, we do not consider this untimely argument raised for the first time in the Reply Brief, which is not responsive to an argument raised in the Answer. For these reasons, we sustain the Examiner’s decision rejecting claim 1, and claims 2—11, 16—27, 31—33, and 35, which fall therewith. Claim 34 The Examiner finds that “Flaherty discloses triggering a notification signal via the fluid pressure/level transducer sensors” and that Adams “discloses triggering an alarm in the event of removal of the needle from the refill port.” Final Act. 6 (citations omitted). Based on these findings, the Examiner reasons that it would have been obvious “to modify the notification signal of Flaherty with the alarm as taught by [Adams] for the 7 Appeal 2015-005261 Application 12/619,900 purpose of indicating to the user that there is an improper fluid level in the port reservoir.” Id. Appellant argues that “Adams has no testing. Flaherty only checks to see if the reservoir is empty. There is no diagnostic feature that tests for a high drug amount and triggers an alarm.” Appeal Br. 12. Responding to this argument, the Examiner directs our attention to the section of Flaherty which states that the device can include sensors or transducers ... to indicate other parameters determining flow, pump flowpath prime condition, blockage in flowpath, contact sensors, rotary motion or other motion indicators, as well as conditions such as the reservoir 30 being empty or leaking, or the dispensing of too much or too little fluid from the reservoir, etc. Flaherty 7:31—39. The Examiner notes that the reservoir volume transducer can also measure other non limiting conditions which a person having ordinary skill in the art at the time the invention was made would recognize includes transmitting information to the processor for both a low level amount and a high level amount within the reservoir (i.e. empty or too little fluid or too much fluid). Ans. 9. Based on these noted facts, the Examiner explains that “[i]t is clear from this disclosure that a reservoir volume transducer in Flaherty is fully capable of measuring both a high volume level and a low volume level within the reservoir.” Ans. 9.1 The Examiner further explains that one skilled in the art “would recognize that such a reservoir volume transducer and processor as contemplated by Flaherty includes transmitting a signal to the processor when the fluid level within the reservoir reaches a high level amount and triggering a response from the processor, i.e. stopping or 1 We understand a high volume level in the reservoir to correspond to the claimed high drug amount. 8 Appeal 2015-005261 Application 12/619,900 activating the dispenser.” Id. Given these explanations, the Examiner reasons that it would have been obvious “to modify the notification signal of Flaherty with the alarm as taught by Adams et al for the purpose of indicating to the user that there is an improper fluid level in the port reservoir.” Id. Appellant does not respond to the Examiner’s logical explanations and reasoning. See generally Reply Br. The Examiner’s explanations are supported by reasoning with rationale underpinning. Thus, Appellant does not apprise us of error. Accordingly, we sustain the Examiner’s decision rejecting claim 34. DECISION The Examiner’s rejection of claims 1—11, 16—27, and 31—35 is AFFIRMED. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 9 Copy with citationCopy as parenthetical citation