Ex Parte DrewDownload PDFPatent Trial and Appeal BoardOct 21, 201312641372 (P.T.A.B. Oct. 21, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte TOUBY A. DREW __________ Appeal 2012-001337 Application 12/641,372 Technology Center 3700 __________ Before TONI R. SCHEINER, LORA M. GREEN, and ERICA A. FRANKLIN, Administrative Patent Judges. GREEN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 from the Examiner’s rejection of claims 15-28 and 30.2 We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. 1 The Real Party in Interest is Medtronic Inc. (App. Br. 3). 2 Claims 1-14 and 29 are also pending, but stand withdrawn from consideration (App. Br. 3) Appeal 2012-001337 Application 12/641,372 2 STATEMENT OF THE CASE The Specification discloses that “[d]rug infusion devices, such as implantable drug pumps, commonly include a reservoir for holding a supply of a therapeutic fluid, such as a drug, for delivery to a site in the patient” (Spec. 1, ¶ 0003). The Specification discloses “techniques for employing an expiration time of a therapeutic fluid [to be] delivered by a fluid delivery device to calculate a fill volume and/or determine a refill interval” (id. at 1, ¶0004). Claims 15-28 and 30 are on appeal. Claims 15 and 30, the only independent claims, read as follows: 15. A method comprising: determining a refill interval for a therapeutic fluid delivered by a fluid delivery device based on an expiration time for the therapeutic fluid; and generating a refill indication based on the refill interval. 30. A method comprising: identifying a therapeutic fluid configured to be delivered by an implantable fluid delivery device; determining an expiration time for the therapeutic fluid; and calculating an amount of the therapeutic fluid to store in the fluid delivery device based on the expiration time. The claims stand rejected as follows: • Claims 15, 17, 21, 23-28, and 303 under 35 U.S.C. § 102(e) in view of Villegas4 (Ans. 4); • Claim 30 under 35 U.S.C. § 102(b) in view of Ali5 (Ans. 8); 3 Although the statement of the rejection does not refer to claim 30, the Examiner addresses claim 30 at pages 7 and 8 of the Answer. 4 Villegas et al., US 2009/0043290 A1, issued Feb. 12, 2009. 5 Ali et al., US 2007/0271007 A9, issued Nov. 22, 2007. Appeal 2012-001337 Application 12/641,372 3 • Claims 15-18, 20-23, 27, and 28 under 35 U.S.C. § 103(a) in view of Ford6 (Ans. 9); • Claim 19 under 35 U.S.C. § 103(a) in view of Ford and Lowenstein7 (Ans. 11); and • Claim 19 under 35 U.S.C. § 103(a) in view of Villegas and Lowenstein (Ans. 11). I. The Examiner has rejected claims 15, 17, 21, 23-28, and 30 under 35 U.S.C. § 102(e) as anticipated by Villegas (Ans. 4). The Examiner finds that the limitation “expiration time for the therapeutic fluid” in claim 15 is broad enough to encompass “a) when the therapeutic fluid is emptied in the container, or b) [when] the shelf-life of the therapeutic is expired or … or c) … the [designated] time length for … treatment … or d) combinations thereof” (Ans. 4 (emphasis removed)). The Examiner finds that Villegas discloses a method of “determining a refill interval for … a fluid delivery device based on an expiration time” that corresponds to depletion of the fluid volume (id. at 5). The Examiner finds that Villegas discloses the generation of “a refill indication … based on the refill interval” (id.). Appellant contends that the Examiner interprets the claim term “an expiration time for the therapeutic” as being equivalent to “the time at which the fluid has been emptied from the container or alternatively the time length of treatment” (App. Br. 9). Appellant contends that when claim 15 is read in 6 Ford et al., US 7,471,994 B2, issued Dec. 30, 2008. 7 Lowenstein, US 7,775,056 B2, issued Aug. 17, 2010. Appeal 2012-001337 Application 12/641,372 4 view of the Specification, a reasonable claim interpretation would not construe that claim term “expiration time for the therapeutic fluid” “to be equivalent to a volume-based refill interval” (id. at 10). We agree with Appellant that the Examiner’s interpretation of the claim 15 term “a refill interval … based on an expiration time for the therapeutic fluid” to include a refill interval based on volume depletion is not consistent with the Specification. The Specification discloses “techniques for employing an expiration time of a therapeutic fluid delivered by a fluid delivery device to … determine a refill interval for refilling the device with the therapeutic fluid” (Spec. 1, ¶ 0004). The Specification discloses that the “expiration time of the therapeutic fluid may be based on or dictated by a stability time … [which] may be set … by the manufacturer of the therapeutic fluid, a clinician treating a patient to whom the fluid is to be delivered, the manufacturer of the [delivery] device … or combinations thereof” (id. at 1-2, ¶ 0004). The Specification discloses that “[t]herapeutic fluids delivered by implantable fluid delivery devices may be characterized by an expiration time, which generally refers to a limit on the amount of time the active agents in the fluid therapeutic retain their efficacy for treating a patient’s condition” (id. at 5, ¶ 0021). Thus, when read in view of the Specification, one of skill in the art would interpret the claim term “expiration time for the therapeutic fluid” to refer to the stability of the therapeutic fluid or, as recited in the Specification, “a limit on the amount of time the active agents in the fluid therapeutic retain their efficacy for treating a patient’s condition.” (Id.). Appeal 2012-001337 Application 12/641,372 5 Since we conclude that the claim 15 limitation of “a refill interval … based on an expiration time for the therapeutic fluid” should not be interpreted as including a refill interval based on depletion of the fluid volume, and that claim interpretation was the basis for the rejection, we reverse the anticipation rejection of independent claim 15. The Examiner has also rejected claim 30 as anticipated by Villegas. Claim 30 is directed to a method comprising the steps of, among others, “determining an expiration time for the therapeutic fluid.” For the same reasons set forth above, we find that the Examiner has not adequately shown how Villegas anticipates claim 30. Thus, we reverse the anticipation rejection of independent claims 15 and 30 and dependent claims 17, 21, 23-28. II. The Examiner has rejected claim 30 under 35 U.S.C. § 102(b) as anticipated by Ali (Ans. 8). The Examiner finds that Ali discloses a method comprising the step of “identifying a therapeutic fluid . . . configured/capable of to be delivered/delivering by an implantable fluid delivery device” (Ans. 8). The Examiner finds that Ali discloses a method comprising the step of “determining an expiration time for the therapeutic fluid” as required by claim 30, because the physician determines the “expiration time/time length for the treatment of patient, for example: in 1 day or in 24hrs period” (id.). The Examiner finds that Ali discloses a method comprising the step of “calculating an amount of the therapeutic fluid to store in the fluid delivery Appeal 2012-001337 Application 12/641,372 6 device . . . based on the predetermined period of time,” i.e. time length for the treatment of patient (id.). Appellant argues that “Ali fails to disclose or suggest the concept of an expiration time, let alone disclosing determining an expiration time for the therapeutic fluid and calculating an amount of the therapeutic fluid to store in the fluid delivery device based on the expiration time” (App. Br. 19- 20). The Examiner responds that the “the term ‘expiration time’ is equivalent to the period of time of treatment (i.e. time length for the treatment)” (Ans. 19). The Examiner further responds that Ali discloses that the physician determines “the time length for treatment of the patient … depending on the type of disease… [and] expiration time is interpreted as the time length of … treatment” (id.). The Examiner further responds that therefore, Ali discloses “calculating the amount of drug provided … based on [a] predetermined … time length of the treatment” (id.) We agree with Appellant that the Examiner has not adequately shown how Ali discloses the method of claim 30 with the method steps of “determining an expiration time for the therapeutic fluid; and calculating an amount of the therapeutic fluid to store in the fluid delivery device based on the expiration time.” (Id.) The Examiner has interpreted the claim term “expiration time for the therapeutic fluid” to be equivalent to the time length for treatment of the patient (id.). As discussed, above, however, we disagree with that portion of the Examiner’s claim interpretation. We thus reverse the rejection of claim 30 as being anticipated by Ali. Appeal 2012-001337 Application 12/641,372 7 III. The Examiner has rejected claims 15-18, 20-23, and 27-28 under 35 U.S.C. § 103(a) as obvious in view of Ford (Ans. 9). The Examiner finds that Ford discloses “a method which includes determining that a label includes an expiration date . . . for a given drug and then alerting the user of the expired date” (id. at 10). The Examiner finds that “Ford does not explicitly disclose a refill interval time but such [refill interval time] would have been obvious to any person having ordinary skill in the art … because it is common sense … [not] to use an expired drug for injecting into an individual’s body” (id.). The Examiner finds that Ford further discloses that the pump “includes means for preventing the controller from running the drive mechanism if the current date is later than the expiration date” such that the device is stopped until the drug is replaced (id.). The Examiner also finds that “Ford teaches the equivalence of generating a date of expiration alert to using a refill alarm indication” (id.). Specifically, Ford teaches that a label containing a specified drug may include an expiration date for the drug, and that the infusion pump includes an internal clock indicating a current date, as well as means for comparing the expiration date to the current date as indicated by the internal clock (Ford, col. 5, l. 66- col. 6, l. 4). Ford also discloses that the pump includes “means for issuing a warning if the current date is later than the expiration date … [and] means for preventing the controller from running the drive mechanism if the current date is later than the expiration date” (id. at col. 6, ll. 4-9). Appeal 2012-001337 Application 12/641,372 8 Appellant contends that claim 15 “requires determining a refill interval . . . based on the expiration time of the therapeutic fluid, which is neither disclosed nor suggested by Ford” (App. Br. 21). Appellant argues that the “asserted means for preventing the controller from running if the current date is after the expiration date could simply compare the current date to the expiration date. There is no requirement that a refill interval be determined, or that it be the same as the expiration date” (id.). Those arguments are not persuasive. As discussed above, even if a drug is not expired when loaded onto the device, the importance of not using an expired drug would have motivated one of skill in the art to include a further safety means for identifying a time point when a currently loaded drug become expired. Thus, identifying a future date of expiration would have been a predictable variation of the Ford method. Appellant’s argument that the means for preventing the controller from running after the expiration date could be to continually compare the current date to the expiration date, if anything, supports the Examiner’s position, because such a comparison would establish a refill interval. Appellant also argues the rejection of claim 20 (App. Br. 22). Claim 20 depends from claim 15 and further requires the step of determining “a modified expiration time based on a shelf-life of the therapeutic fluid and determining the refill interval … based on the modified expiration time for the therapeutic fluid.” The Examiner finds that “the expiration time comprises a stability time or shelf-life (label of manufacturer includes an expiration date) for therapeutic fluid” (Ans. 10). Appeal 2012-001337 Application 12/641,372 9 Appellant argues that “the limitations of claim 20 require both a shelf life and an expiration time, both of which concepts, while related, are distinct from one another” (App. Br. 22). Appellant argues that the Examiner does not provide support that Ford actually discloses determining a modified expiration time based on the shelf life of the therapeutic fluid (id.). Appellant’s arguments are not persuasive. The Specification does not define the term “modified expiration time” or “shelf-life,” but provides that In some examples, processor 26 determines expiration time from the time the therapeutic fluid is loaded into IMD 12 based on . . . the actual time the fluid is on the shelf as input by, e.g., a clinician . . . . Processor 26 then calculates the remaining time the therapeutic fluid will be stable by subtracting the shelf- life from the total prescribed stability time stored in, e.g., memory 28. (Spec. 30, ¶ 0089.) Thus, the term “a modified expiration time based on a shelf-life” appears to mean an expiration time or period from which spent time has been subtracted, e.g., if a solution has an expiration time of two weeks but has been on the shelf for one week, then the expiration time will be one week. We agree with the Examiner that it would have been obvious for one of ordinary skill in the art to account for the shelf-life, or the expired portion of the stability period or expiration time, when establishing the refill interval, since to not do so would risk the administration of an ineffective drug. Appellant also argues the rejection of claim 21 (Ans. 23). Claim 21 depends from claim 15 and further requires that “the expiration time comprises a period of time prescribed by a clinician.” The Examiner finds Appeal 2012-001337 Application 12/641,372 10 that “Ford discloses … a Manual or Auto schedule set up by the user (clinician), [such that] the user specifies a volume to be delivered” (Ans. 10). The Examiner further finds that “the expiration time is interpreted as the time length for the treatment of the patient … [which] is inherently determined by [a] physician for treatment” of a particular disease and a particular patient. Appellant argues that the “cited portions of Ford, including the manual schedule and the auto schedule … do not disclose or suggest an expiration time that includes a period of time prescribed by a clinician” (App. Br. 23). We agree with Appellant that the Examiner has not adequately shown how cited references would have obvious the method of claim 21 such that the expiration time “comprises a period of time prescribed by a clinician.” As discussed above, we have determined that the Examiner’s claim interpretation of the claim term “an expiration time for the therapeutic fluid” as being the same as treatment time was in error, and that same reasoning applies here. Thus, we reverse the rejection of claim 21 as being obvious over Ford. Appellant also argues the rejection of claim 22. Claim 22 depends from claim 15 and further requires that “the expiration time comprises a period of time prescribed by a manufacturer of the fluid delivery device based on empirical data for the therapeutic fluid.” The Examiner finds that Ford’s “expiration time comprises a stability time or shelf-life (label of manufacturer includes an expiration date) for [the] therapeutic fluid” (Ans. 10). Appeal 2012-001337 Application 12/641,372 11 Appellant argues that the “discussion of a drug expiration date by Ford, without further explanation, does not satisfy the requirement of … claim 22” (App. Br. 24). This argument is not persuasive. Although Ford does not explicitly disclose that the expiration time for the drug is the expiration time set by the manufacturer, this limitation would have been obvious to one of skill in the art since expiration times for drugs are often established by manufacturers. Thus, we affirm the rejection of claims 15, 20, and 22 as being obvious in view of Ford. Claims 16-18, 23, 27, and 28 have not been argued separately and therefore fall with claim 15. 37 C.F.R. § 41.37(c)(1)(iv). We reverse, however, the rejection of claim 21 as being obvious in view of Ford. IV. Issue The Examiner has rejected claim 19 under 35 U.S.C. § 103(a) as obvious in view of Ford and Lowenstein, or in the alternative, as obvious in view of Villegas and Lowenstein (Ans. 11). Claim 19 depends from claim 15 and further requires that the method comprises the step of determining a modified expiration time based on one or more environmental conditions under which the therapeutic fluid is stored and determining the refill interval for the therapeutic fluid delivered by the fluid delivery device based on the modified expiration time for the therapeutic fluid. The Examiner relies on Ford as discussed above. The Examiner finds Ford does not disclose “a modified expiration time based on one or more environmental conditions under which the therapeutic fluid is stored” (Ans. Appeal 2012-001337 Application 12/641,372 12 11). The Examiner finds that Lowenstein discloses a system that indicates “an environmental problem condition with a particular pharmaceutical (e.g., that it is counterfeit, expired, suspect, spoiled …), [and] then [delivers] a message or warning … via an attached … display screen, speaker or printer” (id.). The Examiner finds that Lowenstein’s system monitors “different conditions such as: product name, expiration date, time out of refrigeration … [and] the temperature in the vicinity of the pharmaceutical product” (id.). The Examiner concludes that, in view of Lowenstein, it would have been obvious to the ordinary artisan to modify the Ford method of alerting the user to expired pharmaceuticals to further take into account that the pharmaceutical has been subjected to an “abnormal condition (e.g., that it is … suspect, spoiled …) [to avoid] … the possible loss of efficacy or potency of a medication” (id. at 12). Appellant contends that the cited references would not have made obvious the method of claim 19 with the step of determining a refill interval based on a modified expiration time because “Lowenstein is directed to tracking information regarding a particular drug so [that] it would not be dispensed to a patient … [but not for the purpose of] modify[ing] how long the drug is used once it has been provided to the patient” (App. Br. 26). This argument is not persuasive. As discussed, Ford would have made obvious the modification of a pump infusion system to include a means for establishing a refill interval based on the drug’s expiration date as a way of ensuring that the expired drug is not delivered to patient. The Examiner relies on Lowenstein only to show that one of skill in the art would have known to determine a modified safety date for a drug based on Appeal 2012-001337 Application 12/641,372 13 environmental exposure factors that might compromise the integrity of the drug. Thus, we affirm the rejection of claim 19 as being obvious in view Ford and Lowenstein. Because we agree with the Examiner that claim 19 is obvious in view of Ford and Lowenstein, we vacate the cumulative rejection of claim 19 in view Villegas and Lowenstein. NEW GROUNDS OF REJECTION We enter a new ground of rejection for independent claim 30 under 35 U.S.C. § 103(a) as being obvious in view of Ford and Lowenstein. Claim 30 is as follows: 30. A method comprising: identifying a therapeutic fluid configured to be delivered by an implantable fluid delivery device; determining an expiration time for the therapeutic fluid; and calculating an amount of the therapeutic fluid to store in the fluid delivery device based on the expiration time. As discussed above, Ford discloses programmable infusion pumps that include a label reader for reading drug container labels such that the label includes an expiration date for the drug (Ford, col. 5, l. 66-col. 6, l. 1). The Ford infusion pump also includes a means for comparing the expiration date to an internal clock in order to determine if the drug has expired and a means for issuing a warning if the drug is expired, thereby ensuring that expired drug is not delivered to a patient (id. at col. 6, ll. 1-8). Lowenstein discloses an intelligent refrigerator system that tracks drugs and their expiration times, and environmental exposure events for the Appeal 2012-001337 Application 12/641,372 14 drugs, for the purpose of ensuring that expired or compromised drugs are not delivered to a patient (Lowenstein, Abstract). In view of these disclosures, it would have been obvious for one of skill in the art to calculate an amount of the therapeutic fluid to store in the fluid delivery device based on the expiration time as a further means of ensuring that expired or compromised drug is not delivered to a patient. That is, even if a drug is not expired when loaded onto the device, the importance of not using expired and potentially ineffective drug would have motivated one of skill in the art to include a further safety means of ensuring the expired drug is not administered. SUMMARY We affirm the rejection of claims 15-20, 22, 23, 27, and 28 under 35 U.S.C. § 103(a). We reverse, however, the rejection of claim 21 under 35 U.S.C. § 103(a), the rejection of claims 15, 17, 21, 23-28, and 30 under 35 U.S.C. § 102(e), and the rejection of claim 30 under 35 U.S.C. § 102(b). We enter a new ground of rejection of claim 30 under 35 U.S.C. § 103(a). TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 (August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” Appeal 2012-001337 Application 12/641,372 15 37 C.F.R. § 41.50(b) also provides that the Appellant, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the proceeding will be remanded to the examiner … (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record … AFFIRMED-IN-PART; 37 C.F.R. § 41.50(b) lp Copy with citationCopy as parenthetical citation