Ex Parte Blakley et alDownload PDFPatent Trial and Appeal BoardApr 21, 201411107273 (P.T.A.B. Apr. 21, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte DANIEL ROBERT BLAKLEY, CHARLES BRUCE, STEVEN JOHN SIMSKE, TONG ZHANG, PAUL FRIEDMAN, and VIREND SOMERS ____________ Appeal 2011-011674 Application 11/107,273 Technology Center 3600 ____________ Before HUBERT C. LORIN, ANTON W. FETTING, and JOSEPH A. FISCHETTI, Administrative Patent Judges. LORIN, Administrative Patent Judge. DECISION ON APPEAL Appeal 2011-011674 Application 11/107,273 2 STATEMENT OF THE CASE Daniel Robert Blakley, et al. (Appellants) seek our review under 35 U.S.C. § 134 of the final rejection of claims 1-17 and 20-23. We have jurisdiction under 35 U.S.C. § 6(b) (2002). SUMMARY OF DECISION We AFFIRM.1 THE INVENTION Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. A method for dynamic control of medications provided to a patient at a remote location, comprising steps of: selecting a customized set of medications for a patient, the customized set of medications at least partially reflecting a medical diagnosis of the patient; providing the customized set of medications to the patient, the customized set of medications being inaccessible to the patient without authorization from a medical care provider; authorizing the patient to receive a first medication regimen from the customized set of medications; monitoring remotely at least one health parameter of the patient; and 1 Our decision will make reference to the Appellants’ Appeal Brief (“App. Br.,” filed Mar. 25, 2011) and Reply Brief (“Reply Br.,” filed May 26, 2011), and the Examiner’s Answer (“Answer,” mailed Apr. 18, 2011). Appeal 2011-011674 Application 11/107,273 3 authorizing the first medication regimen to be modified to a second medication regimen based at least partially on the at least one health parameter. THE REJECTIONS The Examiner relies upon the following as evidence of unpatentability: Shusterman Bogash US 6,471,087 B1 US 2005/0240305 A1 Oct. 29, 2002 Oct. 27, 2005 The following rejections are before us for review: 1. Claims 1 and 15 are rejected under 35 U.S.C. §101 as being directed to non-statutory subject matter. 2. Claims 1-17 and 20-23 are rejected under 35 U.S.C. §103(a) as being unpatentable over Bogash and Shusterman. ISSUES Did the Examiner err in rejecting claims 1 and 15 under 35 U.S.C. §101 as being directed to non-statutory subject matter? Did the Examiner err in rejecting claims 1-17 and 20-23 under 35 U.S.C. §103(a) as being unpatentable over Bogash and Shusterman? FINDINGS OF FACT We rely on the Examiner’s factual findings stated in the Answer. Additional findings of fact may appear in the Analysis below. Appeal 2011-011674 Application 11/107,273 4 ANALYSIS The rejection of claims 1 and 15 under 35 U.S.C. §101 as being directed to non-statutory subject matter. Claim 1 Various factors must be considered and weighed when analyzing claims as a whole before reaching a conclusion on patent subject matter eligibility under 35 U.S.C. § 101. The factors relevant in this case are the lack of recitation in the claims to a transformation, the lack of recitation of a particular apparatus to which the process is tied, and that the claim recites mere statements of general concept. Inquiries from the machine-or-transformation test as initially articulated in In re Bilski, 545 F.3d 943, 954 (Fed. Cir. 2008) (en banc), remain relevant. In that regard, only the transformation prong of that test is at issue here because the claimed method recites no apparatus, explicitly or implicitly. The “Appellants submit that at least two articles in the present claim are transformed; the medication is transformed within the patient's body and the medication is changed based upon health parameter.” App. Br. 12. The Appellants’ argument that the article is changed to a different state or thing via the claimed process is not commensurate in scope with what is claimed and thus unpersuasive as to error in the rejection. The Appellants argue that the process causes medication to be transformed within a patient's body. However, the process as claimed does not include an administration step. The claim calls for a “patient to receive” the medication but this is not limited so as to require administration of the Appeal 2011-011674 Application 11/107,273 5 medication. The Appellants argue that the process causes medication to be changed based upon a health parameter. The claim actually uses the phrase “the first medication regimen to be modified to a second medication regimen” (claim 1). According to the Specification, this refers to modifying “a particular schedule of medication, including type, dosage, amount, timing, etc., being taken by a patient” (5:3-9). Accordingly, the claim covers for example changing a medication’s timing. The claimed modification is not limited so as to cause the first medication to be modified a different state or thing. As reasonably broadly construed, the subject matter of representative claim 1 is made up of mere statements of the general concept of (a) providing to a patient a selected set of customized medications that are inaccessible without authorization; (b) providing authorization to receive a first regimen from the selected set of customized medications; (c) remotely monitoring a health parameter; and, (d) based on the health parameter authorizing modifying the first regiment to a second regimen. The vague instructions listed in the claims do no more than authorize a change in a medication regimen based on a remotely monitored health parameter. The claim covers any use of the concept of authorizing a change in medication regimen based on a remotely monitored health parameter - known and unknown. The instructions could be performed by any means, existing or future-devised. In the words of Gottschalk v. Benson, 409 U.S. 63 (CCPA 1972), the claimed process would wholly pre-empt the [(a) providing to a patient a selected set of customized medications that are inaccessible without Appeal 2011-011674 Application 11/107,273 6 authorization; (b) providing authorization to receive a first regimen from the selected set of customized medications; (c) remotely monitoring a health parameter; and, (d) based on the health parameter authorizing modifying the first regiment to a second regimen] and in practical effect would be a patent on the [concept] itself. Id. at 72. For the foregoing reasons, we are unpersuaded as to error in the rejection of claim 1 as being patent-ineligible subject matter under 35 U.S.C. § 101. Claim 15 In addition to the arguments made in challenging the rejection of claim 1, which arguments are unpersuasive for the same reasons (i.e., claim 15 does not include the argued-over administration and/or medication- changing steps), the Appellants argue “that claim 15 recites that the medication is dispensed from a medical cabinet.” App. Br. 13 (emphasis original). For this reason, the Appellants find that “claim 15 is also tied to a particular machine” and therefore also satisfies the machine prong of the machine-or-transformation test. We are unpersuaded. “The Supreme Court has defined the term “machine” as “a concrete thing, consisting of parts, or of certain devices and combination of devices.” Burr v. Duryee, 68 U.S. (1 Wall.) 531, 570 (1863). This “includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result.” Corning v. Burden, 56 U.S. 252, 267 (1854).” In re Nuijten, 500 F.3d 1346, 1355 (Fed. Appeal 2011-011674 Application 11/107,273 7 Cir. 2007). There is insufficient evidence on the record in support of characterizing a “medical cabinet” per se as an apparatus as that term has been legally defined. A “medical cabinet” is reasonably broadly construed as covering a box-like enclosure, which may not be an “apparatus.” The Appellants argue that “the present method claims requires storage of the medication into a particular machine; i.e., the medical cabinet, which also controls the accessibility of the medication.” Reply Br. 7 (emphasis added). And we do note that there is mention in the Specification of an “intelligent medical cabinet” (see 5:27) of the type the Appellants are arguing for. But claim 15 makes no mention of the medical cabinet “control[ling] the accessibility of the medication” as the Appellants argue. To add that sort of control, or any “intelligent” aspect for that matter, as a feature of the “medical cabinet” as broadly claimed would impermissibly read a limitation into the claim. Given its scope, we are unpersuaded that the recitation of “medical cabinet” in claim 15 ties the method to a particular machine sufficient to satisfy the machine prong of the machine-or- transformation test. For the foregoing reasons, we are unpersuaded as to error in the rejection of claim 15 as being patent-ineligible subject matter under 35 U.S.C. § 101. The rejection of claims 1-17 and 20-23 under 35 U.S.C. §103(a) as being unpatentable over Bogash and Shusterman. The Appellants argued claims 1-17 and 20-23 as a group (App. Br. 17-20). We select claim 1 as the representative claim for this group, and Appeal 2011-011674 Application 11/107,273 8 the remaining claims 2-17 and 20-23 stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii) (2007). The Examiner takes the position that Bogash discloses all the claim limitation but for “a method for dynamic control of medications provided to a patient at a remote location, comprising steps of: monitoring remotely at least one health parameter of the patient; and authorizing the first medication regimen to be modified to a second medication regimen based at least partially on the at least one health parameter” (Ans. 6) for which Shusterman is relied upon. Ans. 6-7. According to the Examiner, One of ordinary skill in the art would have recognized that applying the known technique of Shusterman would have yielded predictable results and resulted in an improved system. It would have been recognized that applying the technique of Shusterman to the teachings of Bogash would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate such data processing features into similar systems. Ans. 6. The Appellants disagree, arguing that [c]ol. 6, lines 9-31 of Shusterman discloses a patient monitoring unit that can monitor vital signs of a patient and “when the vital signs of the patient fall outside certain thresholds, possible indicating that the patient is in discomfort, in danger, or in need of attention, patient monitoring unit 214 generates a nurse-call signal on line 214a.” Notably, the passage does not disclose authorizing the first medication regime to be modified to a second medication regime based at least partially on the at least one health parameter. Additionally, col. 12, lines 21-26, 61-64 discloses a medical dispensing unit including a keypad that can be used by health care workers where such workers can access data stored on the micro controller 800 as necessary or can customize the operation and/or configuration of the microcontroller Appeal 2011-011674 Application 11/107,273 9 800. The passage does not disclose authorizing the first medication regime to be modified to a second medication regime based at least partially on the at least one health parameter. Appellants submit that modifying the microcontroller does not equate to a modification of a medication regime based at least partially on the at least one health parameter. .... To be clear, Appellants are not arguing that the microcontroller cannot be modified. Rather, Appellants note that Shusterman does not teach or disclose using the microcontroller to authorize a first medication regime to be modified to a second medication regime based on a health parameter. App. Br. 17-18 (emphasis added). The question before is one of obviousness, not anticipation. In that regard, it is proper to take into account not only what it specifically teaches but also the inferences which one skilled in the art would reasonably be expected to draw therefrom in evaluating Shusterman. In re Preda, 401 F.2d 825, 826 (CCPA 1968). Various passages (e.g., col. 6, lines 5-51; col. 7, lines 17-31; col. 12, lines 21-67; col. 18, lines 43-67; and, Figs. 9, 16-17, and 19) in Shusterman would lead one of ordinary skill in the art to authorize a first medication regime to be modified to a second medication regime based on a remotely monitored health parameter. Shusterman discloses a patient monitoring unit that monitors a patient’s vital signs, such as blood pressure (see e.g., col. 6, lines 24-25). The monitoring unit sends signals corresponding to the vital signs to a remote system, such as a PC (element 202). See e.g., col. 6, line 16. “Medication dispensing unit 212 communicates with serial interface box 208 to receive commands from PC 202, and to transfer signals representing the status of medication doses to PC 202.” Col. 7, lines 23-26. Medication Appeal 2011-011674 Application 11/107,273 10 dispensing unit 212 is shown in Fig. 8. It comprises various components connected to each other via a controller 800. A communication port 826 is coupled to microcontroller 800. An exemplary communication port 826 is a serial port that allows data to be uploaded or downloaded from microcontroller 800 as necessary. Communication port 826 might be used, for example, to upload new software into microcontroller 800, to download data from micro controller 800 reflecting taken or missed doses over a given time interval, or to upload a new medication dispensing schedule into microcontroller 800. Communication port 826 also allows support personnel to otherwise interact with microcontroller 800, such as with a portable laptop PC, and to connect medication dispensing unit 212 with PC 202. Col. 14, lines 54-65. For example, if the patient misses a dose, medication dispensing unit 212 can be configured to broadcast an e-mail message to the pharmacist, medical support personnel, or to a physician. Also, medication dispensing unit 212 could be programmed via Internet communication, if appropriate security precautions are taken. Col. 15, lines 1-6. Thus, Shusterman discloses a medication dispensing unit receiving, for example, a dosage amount of medication based on remotely monitored health parameters. The details about the medical dispensing unit 212 that Shusterman describes would lead one of ordinary skill in the art to provide instructions for new dosages to medication dispensing unit 212 via a new schedule programmed into controller 800. See col. 14, line 60: “to upload a new medication dispensing schedule into microcontroller 800”. One skilled in the art would reasonably be expected to draw from these disclosures in Shusterman the inference that the Shusterman process can be used to modify Appeal 2011-011674 Application 11/107,273 11 a first old medication regime to a second new medication regime based on a remotely-monitored health parameter. That a patient would take the medication according to a schedule necessarily means the patient would have been authorized to do so. Likewise, in the context of the process described in Shusterman, it is implicit in uploading a new medication dispensing schedule that the modified medication regime was authorized. For the foregoing reasons, we are not persuaded as to error in the the Examiner’s finding that, given Shusterman, one of ordinary skill in the art would have reached the claimed process comprising authorizing a first medication regime to be modified to a second medication regime based at least partially on at least one health parameter as claimed. CONCLUSIONS The rejection of claims 1 and 15 under 35 U.S.C. §101 as being directed to non-statutory subject matter is sustained The rejection of claims 1-17 and 20-23 under 35 U.S.C. §103(a) as being unpatentable over Bogash and Shusterman is sustained. DECISION The decision of the Examiner to reject claims 1-17 and 20-23 is affirmed. AFFIRMED Appeal 2011-011674 Application 11/107,273 12 Tkl Copy with citationCopy as parenthetical citation